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Medical examiners and coroners do have the right to receive patient health information in order to determine the cause of the death. Such as a accidental homicidal, suicidal or sudden & suspicious deaths. They may also request an autopsy of the patient who died depending on the circumstances on how the patient passed away. There aren't any HIPPA regulations being violated because they fall under public interest and benefit exceptions such as public health activities, disclosure for law enforcement purposes, or about decedents.

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Going forward, my plan would be to make sure we make contact with all users of devices we are implanting if we receive a medical alert. I would hire doctors to do house calls for the elderly so we can monitor any potential risks that we are being warned about.

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As of right now, we do not know who is at fault for the patient's death. We would need to wait for the results from the medical examiner/coroner to determine that information.

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The device manufacturer can have liability but there would need to be a more in depth investigation to the cause of death and to the device.

What if there was evidence to prove the hospital had attempted to reach the patient at the senior living and the facility never let the patient leave or schedule an appointment.

What if there was evidence to prove the hospital gave the patient too much sedative that it killed him.

There were only medical alerts to say the patient should see their primary care physician for a follow up, not for a serious matter.

With the bruising, the cause of death could have been from the senior living facility.

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Under federal rules, hospitals have 10 days to report serious device-related injuries to the device's manufacturer and to notify both the manufacturer and the FDA about any deaths that may have resulted.

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The FDA and manufacturer are responsible for notifying the hospital that a medical device in use may cause harm to patients.

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The additional report that Wesley Glen and the hospital need to do are:

Reporting the patient died within 24 hours of arriving to the hospital

How long has the implant been in the patient

How much sedative was given to the patient

How long had the patient been getting agitated and physically abusive

The reason for the bruising

Anything out of the ordinary with the patient

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Medical examiners and coroners have the right to received patient information needed to investigate a case, in fact, it's a critical part of their investigation.

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The hospital is required to report this patient's death to the medical examiner/coroner because of the circumstances of his death. When examined at the hospital, he was found to have bruising on this back side and he had a defibrillator implanted that was being flagged as having medical alerts.

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As a "device user facility", it is the hospital's responsibility to contact the FDA and manufacturer to report a suspected medical-device related death within ten days of becoming aware of the death.

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On this Page:

Mandatory Medical Device Reporting:

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation specified that reports be filed on the FDA's Medwatch Form 3500A or an electronic equivalent. The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. This rule will be effective as of Aug.14, 2015.

Information on the requirements for each mandatory reporting group follows:

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions are available for completing the required 3500A form. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. For more information please see the guidance for manufacturers on medical device reporting.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Summary of Mandatory Reporting Requirements for Manufacturers and Importers

Manufacturers
30 day reports of deaths, serious injuries and malfunctions

Form FDA 3500A *

FDA

Within 30 calendar days of becoming aware of an event

Importers
Reports of deaths and serious injuries

Form FDA 3500A *

FDA and the manufacturer

Within 30 calendar days of becoming aware of an event

* Or electronic equivalent

Device User Facility Reporting Requirements

A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

Form 3419 Annual User Facility Report

Please note that 803.30 (which addresses User Facility Reporting Requirements) does NOT state that device user facilities are required to report device malfunctions where the malfunction would likely cause or contribute to death or serious injury if the malfunction were to recur.

Although a user facility is not required to report a device malfunction, they can voluntarily inform the FDA of such product problems through MedWatch, the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA.

The FDA's "Medical Device Reporting for User Facilities" guidance document provides additional information.

Summary of Mandatory Reporting Requirements for User Facilities

Complaint Files and Medical Device Reporting

Complaint files are linked to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event. A complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Manufacturers and importers are required to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints. Importers are also subject to complaint files because "initial distributors of foreign entities" fall under the definition of a manufacturer in 21 CFR 820.3.

Complaint files that are found to be reportable MDR events should be maintained in a separate portion of the complaint file or otherwise clearly identified.

Electronic Medical Device Reporting (eMDR)

More information on how to submit MDRs electronically is available on the eMDR website.

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Food and Drug Administration
Center for Devices and Radiological Health
MDR Reporting Team
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002

Other Resources

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Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

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My mitigation plan would include mandatory mandated reporter and knowing the signs of abuse training for all providers and staff involved with the patient's care. I would also require providers to update knowledge through CEs for being more aware that difficult behavior is a possible sign of a physical ailment especially of the patient is unable to explain what they are feeling. Another part of my plan would be to have providers reconsider sedation when a patient has had an unknown cause for unconsciousness. The last part of my plan would be to make sure that my facility contacts the FDA whenever a manufacturer sends an alert of a possible flaw in a medical device.

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It is unclear who or what is at fault for the patient's death. In my opinion, it was a confluence of likely elder abuse, being restrained for hours due to difficult behavior, being sedated after the patient was found unconscious and in poor health, and the device malfunctioning. A autopsy would be needed to confirm the actual cause of death.

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The manufacturer may have some liability if the flaw in the device can be definitively attributed to the patient's death. In addition, it must be determined if the manufacturer breached its duty of care owed to those that use the product.

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Many people rely on medical devices for a better quality of life. Companies that design and manufacture medical devices sometimes make mistakes during the designing or manufacturing process. When defects occur, patients who receive medical devices can be seriously injured or killed. Determining the responsible parties in a defective medical device claim can be difficult, making it important for you to seek help from an experienced product liability attorney at Raynes & Lawn. Our attorneys can evaluate your case and discuss its legal merits with you. We might be able to help you recover compensation for the losses you have suffered.

What are medical devices?

The Food and Drug Administration regulates medical devices and defines them as including instruments, machines, apparatuses, and other devices that contain components that are intended to treat, prevent, diagnose, or cure diseases or influence the structure or function of the body. These types of devices must be checked and maintained regularly to ensure they are working properly. Devices that are implanted in the body must be regularly monitored. However, a defective device can still injure a patient even if it is properly maintained and monitored.

Types of medical devices

There is a broad variety of different types of medical devices in use by people across the U.S. Devices that can place patients at a high risk of injury or death when they contain defects include the following:

Defective medical devices and common types of injuries

Defective medical devices can cause many different injuries, depending on how the device is used and its type. Some of the common types of injuries caused by defective medical devices include the following:

Liability in a defective medical device case

The Food and Drug Administration regulates medical devices to protect the public. While the FDA requires clinical trials and has a lengthy approval process, defective medical devices still are introduced and make their way through the FDA's process. Many devices are recalled by various manufacturers each year. When a medical device is defective, the following parties might be potentially liable in a claim:

Determining liability in a defective medical device case

Liability must be determined before you can hold defendants responsible in a product liability claim. To prove this type of claim, you must first identify the defect. Defects can include design flaws, manufacturing defects, and marketing defects. They can happen because of mistakes during the designing or manufacturing process. They can also happen when a device deteriorates over time and causes injuries.

Once the defect has been identified, you will then need to determine all of the parties that are responsible for the flaw. You will need to show that the party had a duty of care it owed to you, it breached the duty, and the breach caused your injuries and resulting losses. The attorneys at Raynes & Lawn understand how to investigate defective medical devices to identify the defects and determine liability. We also understand the types of evidence that might be needed to prove our clients' claims.

Damages in a defective medical device claim

The types of compensatory damages you might recover in a claim involving a defective medical device include the following:

We can investigate your case and properly value it.

Call Raynes & Lawn

If you have been injured or have lost your loved one because of a defective medical device, you may be entitled to pursue compensation. Call the experienced product liability attorneys at Raynes & Lawn to learn more about your case at 1-800-535-1797.

For the general public: This Blog/Website is made available by the law firm publisher, Raynes & Lawn for educational purposes. It provides general information and a general understanding of the law but does not provide specific legal advice. By using this site, commenting on posts, or sending inquiries through the site or contact email, you confirm that there is no attorney-client relationship between you and the Blog/Website publisher. The Blog/Website should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.

For attorneys: This Blog/Website is informational in nature and is not a substitute for legal research or a consultation on specific matters pertaining to your clients. Due to the dynamic nature of legal doctrines, what might be accurate one day may be inaccurate the next. As such, the contents of this blog must not be relied upon as a basis for arguments to a court or for your advice to clients without, again, further research or a consultation with our professionals.

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Who Is Liable for Medical Device Injuries?

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If you have been injured or have lost your loved one because of a defective medical device, you may be entitled to pursue compensation. Call the experienced product liability attorneys at Raynes & Lawn to learn more about your case at 1-800-535-1797.

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As mandated reporters, the admitting physician should have reported the possible elder abuse (restraints and bruises) happening at Wesley Glen. Someone on the staff of Wesley Glen should have also reported the restraints and bruises as they are also mandated reporters. If they feared for their job, they could have anonymously called the Adult Protective Services Hotline.

In addition, the hospital must report the suspected death of a patient with medical device that has an alert to the FDA. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

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As soon as the medical device manufacturer becomes aware of the potential risks or injuries and deaths contributed to their device, they should notify the hospital of recalls as well as report it to the FDA.

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This is the first in a series of stories on medical device safety. Future stories will explore a seminal Supreme Court decision and other product safety topics.

Medical device recalls require speed to ensure patient safety.

But the system used to pull defective products with potential risk of serious injury or death is clunky and uncoordinated, and results at times in recalled devices being used by or implanted in patients.

Reliance on paper communications and mail services to deliver recall notifications, limited use of device-specific identifiers and a lack of data reporting standardization results in a system that can take weeks for hospitals to learn about a manufacturer's recall and months for patients to discover they're using or have been implanted with a defective product.

The system also lacks uniformity, with crucial steps varying by the company issuing a recall, the hospital addressing a recall or the specific product at issue.

Nancy LeMaster, a consultant specializing in the healthcare supply chain, said while consumers can check on recalls for products like peanut butter directly on their smartphones as they shop, medical device recalls are burdened by decades-old communication methods.

"People would be astounded to know that it can take the FDA 90 days to even categorize a recall, that all of that information is done on paper, that it is transcribed by the FDA, by the providers, by the distributors, by third-party recall services, [and] the level of error involved," LeMaster said. "It truly is like we are operating in about the 1950s."

The FDA can receive over one thousand recalls every year, labeled as either a Class I, II, or III event. Class I is the most serious, suggesting "a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Adding potential confusion, recall classifications are ordered opposite of device classifications: Class I devices pose the least risk to patients, followed by Class II and Class III devices.

The FDA has held two public meetings in the last 11 months to hear from patients and experts and find ways to improve the system. The meetings follow several high-profile safety incidents with devices, such as Allergan's recall of breast implant products that caused cancer in hundreds of women, hundreds of deaths and thousands of injuries related to the use of surgical staplers, which led to the uncovering of the FDA's shadow medical device reporting database, and most recently Philips' recall of millions of sleep apnea and ventilator machines.

Reasons for recalls vary greatly, ranging from life-threatening malfunctions of pacemakers to simple labeling changes for non-implantable products. And the action does not always mean products must be pulled; sometimes a recall means a product needs to be checked or fixed.

The FDA can technically require a device maker to recall a product - but it rarely does, leaving the initiative to the manufacturer, which most often does so voluntarily.

An agency officialspeaking on background said that FDA-forced recalls are extremely rare and could likely be counted on one hand, adding that voluntary recalls are easier and faster than mandating products be pulled. Some critics, including patient groups, call that approach flawed and too deferential to industry, leaving patients unnecessarily at risk.

FDA recall classification definitions

Class I

A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

41

Class II

A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

994

Class III

A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

43

SOURCE: U.S. Food and Drug Administration

"Unless you're hands-on dealing with recalls - even at a hospital - a lot of people don't realize just how broken the process is," said Guillermo Ramas, CEO and founder of NotiSphere, a company that works with providers and suppliers to help process recalls.

Wasted time

Medical device recalls typically begin with safety or manufacturing issues identified by the device maker, physicians or patients. Such issues can be flagged to companies, providers or the FDA itself through the agency's Manufacturer and User Facility Device Experience (MAUDE) database.

MAUDE, however, has several complications, such as incomplete or inaccurate reports, duplicated reports or reports mislabeled as "injury" when it should be marked as "death." The FDA even acknowledges some of the problems with the database.

Reports of patient safety risks, device malfunctions or manufacturing problems are measured against risk thresholds, which companies create before a product is released. Manufacturers use these as road maps to determine whether issues identified will require an investigation and eventual recall of the product, according to an industry spokesperson.

The risk thresholds vary by device. For example, safety risks might be more serious for permanent implanted devices compared to a non-implantable device, or patient deaths linked to a product might require an immediate recall rather than the company conducting a longer investigation if patient impact is not as serious.

Michael Heyl, a partner with the law firm Hogan Lovells, said manufacturers will investigate once they receive reports of safety issues, looking at factors such as the severity of impact on patients, how many affected devices are in the field or the rate of occurrence of a malfunction.

These early steps can lack standardization and vary by manufacturer or even by product within a manufacturer, which some experts say complicates the system. However, Heyl contends the process is similar across the industry with some variation by company.

"The general process should be consistent," Heyl said. "The numbers and where thresholds are, that's where you'll see some variability."

As reports of malfunctioning devices or patient injuries or deaths come in, manufactures are required to report them to the FDA through MAUDE, along with importers and device user facilities.

If the adverse event reports add up or are serious enough to require immediate action, such where there are patient deaths, medical device manufacturers will send letters to healthcare providers that a recall has been initiated. And for a process that requires speed, wasted time is a consistent critique.

Manufacturers communicate recalls in a predominantly paper-based system, sending out notifications to providers and distributors through the mail or FedEx.

Joan Meléndez, CEO of Xcelrate UDI, which works with providers to identify and track recalls, said notifications often go to the wrong people in hospitals, sometimes taking weeks or months to get those actually responsible for pulling products from inventories.

In practice, devices have been implanted or used on patients after a recall has been triggered because of the time it takes for notifications to make it from the manufacturer to the appropriate people inside a healthcare facility, Meléndez and Ramas said.

"By the time it trickles down to the actual operating room, it could be months, so recalled items are being used that whole entire time ... there's a lot of failure," Meléndez said.

Manufacturers have 10 days to deliver the first report to the FDA once a recall has been issued, and then the agency reviews information collected by the company and classifies the recall. If the FDA labels the recall as Class I or determines that a device poses a big enough threat to patients, the agency will issue a public recall notice or safety alert. However, these notifications can come several weeks after a manufacturer has sent the original recall letter to providers.

This delay in notification to classification to publication has led to patients saying they can be the last to know about a recall even though they are the most at risk; sometimes patients find out via news reports or social media.

"The majority of people believe they will be promptly notified by their healthcare provider if the device in their body needs to be removed. This is not always the case," Rich Kucera, CEO of Symmetric Health Solutions, a software company for healthcare supply chain data, said during an Oct. 6 FDA committee meeting.

An example of this fragmented timetable can be seen in Philips' recent recall of millions of sleep apnea machines and ventilators. The company recalled the machines due to foam used to dampen noise breaking down and possibly being inhaled or ingested by users.

The defect, which affected devices manufactured between April 2007 and April 2021, was first made public by the company this April as part of an earnings release. The company did not initiate a recall until June, and patients, some of which are suing the company, have said they were never contacted by physicians or Philips.

Timeline of Philips sleep apnea, ventilator device recall

Philips notifies the public when reporting Q1 earnings that there are "possible risks to users " in certain sleep and respiratory care machines. The company takes a €250 million provision to cover costs.

Philips initiates a recall of 3 to 4 million machines, warning users they can be exposed to "possible toxic and carcinogenic effects" when the sound abatement foam breaks down and is inhaled or ingested.

FDA releases a safety communication for the Philips recall.

FDA officially labels the recall as a Class I event and publishes a public notification.

Erin Keith, associate director of compliance & quality with the Office of Product Evaluation & Quality in the FDA's Center for Devices and Radiological Health, said during the recent committee meeting the responsibility to contact patients falls to device makers' customers, meaning hospitals, providers, retailers and distributors.

However, providers as a point of contact is not always the most effective as patients may go to a primary care physician if there are health issues rather than the hospital or center where their operation took place.

Hospitals and providers also may not contact patients, instead waiting for them to come in with symptoms, according to Meléndez.

"There's no clear cut accountability for who's actually responsible for notifying a patient that they may have a recalled implant [or] that they may have been touched by a recalled device," LeMaster said.

If that contact is not made, patients can get lost in a series of databases, recall notices, press releases and safety alerts trying to figure out if they are or are not at risk.

"The FDA actually needs to step up and become that trusted source. Because I gotta be honest here, nobody trusts the FDA anymore," Rachel Brummert, communications lead for the healthcare group American Society of Pharmacovigilance, said at the October FDA meeting on the topic.

Brummert called on the FDA to take the lead role in notifying patients.

Connecting devices to patients

A key step is tracking down affected patients.

When Medtronic pulled its HeartWare ventricular assist device from the market in June, approximately 4,000 people had the defective product still implanted. Patients and doctors were notified by Medtronic in the announcement that the benefits of the device might outweigh the risk of removing the device even though the system had raked up numerous Class I recalls. Medtronic did coordinate with rival Abbott Laboratories, which makes a similar device, to ensure that patients have an option if the HeartWare implant needs to be taken out.

Philips had between 3 to 4 million machines to track down and set up an online registry for patients to register their machines for possible repair or replacement. Similar to Medtronic, the company said certain users should consult with their physicians before stopping use.

While manufactures can sometimes identify the majority of devices in a recall quickly, either by having them sent back or being notified from providers that they've been destroyed, identifying and tracking down 100% of the devices can take months and require routine communication with providers or distributors.

Identifying every device can also be challenging for manufacturers because providers can be unresponsive to notices, according to Heyl.

"It gets hard ... You've got a large volume product and there are some people who refuse to send [a product] back, refuse to not use it or just refuse to reply," Heyl said. "The expectation for industry is that you will just show your due diligence as to what you did to get the word out to those customers."

The multiple communications can cause even more confusion, making it look like a separate recall was initiated.

Similar issues that hamper recall communications can make locating the correct products and patients difficult.

One hurdle is the lack of specific device identification. Recalls are typically reported in lot numbers, which can be defined differently by manufacturer. According to an industry spokesperson, a lot number may refer to an 8-hour manufacturing window, and how many individual devices manufactured during this window can vary by the product.

The lot numbers included in recall notifications can be in the tens of thousands, making it hard for workers in charge of pulling inventory to navigate, according to Meléndez.

Use of unique device identifiers to quickly identify the specific device recalled could help. UDIs are numeric or alphanumeric codes that generally contain two parts, the device identifier (DI) and the production identifier (PI).

The FDA issued a final rule in 2013 requiring UDIs to be part of product labeling, with a phased-in implementation. Currently, Class II and III medical devices and all implantable devices are required to be labeled with a UDI.

However, the code is not required to be used in recalls.

Terrie Reed, director of partnerships for Symmetric Health Solutions, said UDIs make it easier to connect specific devices to patients that products are used on or implanted into.

A device's UDI can be scanned when taken out of inventory for use and logged in a patient's electronic health record. When a product is then recalled, that UDI can be traced quickly from the recall to the patient.

"When that device, especially an implant, gets recalled - if you have that same device identifier information, that same UDI, then it's really easy to match for a hospital," said Reed, who was with the FDA for nearly 15 years, working on projects like the unique device identification system. "If the FDA is not using UDI, or structured data in their recalls, it makes that whole process more difficult."

But UDIs are only used in a fraction of recalls, according to a report from the Learning UDI Community, a partof the supply chain armof the American Hospital Association. The report contends that manufacturers and hospitals are not using UDIs because the FDA does not require them to be part of recalls.

Another more modern improvement to the recall process is the standardization of data format and reporting, according to Reed. What data is being reported, such as UDIs, or the format data is presented in, such as consistent date entry, varies by manufacturers. Information can also be sent in a PDF or email, which requires transcription rather than downloading structured data.

The lack of data standardization slows the system down and compromises patient safety, Reed said.

What's next?

While the FDA is exploring requests from the two public meetings, an agency official was unable to say if there will be an overhaul of the process.

From the industry point of view, Heyl argued that the process needs variation and enforcement like more mandated deadlines or fines would not work because companies need time to investigate and identify the causes of safety issues.

Any change would need the coordination of the key players - device manufacturers, regulators, providers and distributors - which may be hard to accomplish. An industry spokesperson said they were hesitant to back a more standard reporting system because past changes to the process had numerous issues and costs typically fell on manufacturers.

An overhaul may not be needed right away as smaller changes can still have a big impact on patient safety, according to Reed.

"I recognize this is not a simple problem to solve," Reed said. "But that doesn't mean we can't try to fix at least little pieces of it."

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Anatomy of a medical device recall: How defective products can slip through an outdated system

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"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.

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According to California Health and Safety Code 102850, the coroner must be notified when a cause of death is unknown. The cause of death for the 75 year old patient is unknown as it could have had something to do with with the multiple bruises noted by the physician or it may have been due to the his cardiac defibrillator not working properly as noted by the alert received by the hospital.

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A covered entity can release patient information in a few instances. The PI may be used by medical examiners and coroners in order to determine cause of death or identify a Jane or John Doe as well as other duties that are authorized by law.

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As Contained in the HHS HIPAA Privacy Rules

HHS Regulations as Amended August 2002
Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Uses and Disclosures About Decedents - § 164.512(g)

Standard: uses and disclosures about decedents.

1. Coroners and medical examiners. A covered entity may disclose protected health information to a coroner or medical examiner for the purpose of identifying a deceased person, determining a cause of death, or other duties as authorized by law. A covered entity that also performs the duties of a coroner or medical examiner may use protected health information for the purposes described in this paragraph.

2. Funeral directors. A covered entity may disclose protected health information to funeral directors, consistent with applicable law, as necessary to carry out their duties with respect to the decedent. If necessary for funeral directors to carry out their duties, the covered entity may disclose the protected health information prior to, and in reasonable anticipation of, the individual's death

HHS Description
Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Uses and Disclosures About Decedents

In the NPRM we proposed to allow covered entities to disclose protected health information without individual authorization to coroners and medical examiners, consistent with applicable law, for identification of a deceased person or to determine cause of death.

In § 164.512(g) of the final rule, we permit covered entities to disclose protected health information to coroners, medical examiners, and funeral directors as part of a new paragraph on disclosures related to death. The final rule retains the NPRM approach regarding disclosure of protected health information to coroners and medical examiners, and it allows the information disclosed to coroners and medical examiners to include identifying information about other persons that may be included in the individual's medical record. Redaction of such names is not required prior to disclosing the individual's record to coroners or medical examiners. Since covered entities may also perform duties of a coroner or medical examiner, where a covered entity is itself a coroner or medical examiner, the final rule permits the covered entity to use protected health information in all cases in which it is permitted to disclose such information for its duties as a coroner or medical examiner.

Section 164.512(g) allows covered entities to disclose protected health information to funeral directors, consistent with applicable law, as necessary to carry out their duties with respect to a decedent. For example, the rule allows hospitals to disclose to funeral directors the fact that an individual has donated an organ or tissue, because this information has implications for funeral home staff duties associated with embalming. When necessary for funeral directors to carry out their duties, covered entities may disclose protected health information prior to and in reasonable anticipation of the individual's death.

Whereas the NPRM did not address the issue of disclosure of psychotherapy notes without individual authorization to coroners and medical examiners, the final rule allows such disclosures. The NPRM did not include in proposed § 164.510(e) language stating that where a covered entity was itself a coroner or medical examiner, it could use protected health information for the purposes of engaging in a coroner's or a medical examiner's activities. The final rule includes such language to address situations such as where a public hospital performs medical examiner functions. In such cases, the hospital's on-staff coroners can use protected health information while conducting post-mortem investigations, and other hospital staff can analyze any information associated with these investigations, for example, as part of the process of determining the cause of the individual's death.

HHS Response to Comments Received
Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Uses and Disclosures About Decedents
Coroners and Medical Examiners
Comment: We received several comments, for example, from state and county health departments, a private foundation, and a provider organization, in support of the NPRM provision allowing disclosure without authorization to coroners and medical examiners.

Response: The final rule retains the NPRM's basic approach to disclosure of coroners and medical examiners. It allows covered entities to disclose protected health information without authorization to coroners and medical examiners, for identification of a deceased person, determining cause of death, or other duties authorized by law.

Comment: In the preamble to the NPRM, we said we had considered but rejected the option of requiring covered entities to redact from individuals' medical records any information identifying other persons before disclosing the record to a coroner or medical examiner. We solicited comment on whether health care providers routinely identify other persons specifically in an individual's medical record and if so, whether in the final rule we should require health care providers to redact information about the other person before providing it to a coroner or medical examiner.

A few commenters said that medical records typically do not include information about persons other than the patient. One commenter said that patient medical records occasionally reference others such as relatives or employers. These commenters recommended requiring redaction of such information in any report sent to a coroner or medical examiner. On the other hand, other commenters said that redaction should not be required. These commenters generally based their recommendation on the burden and delay associated with redaction. In addition to citing the complexity and time involved in redaction of medical records provided to coroners, one commenter said that health plans and covered health care providers were not trained to determine the identifiable information necessary for coroners and medical examiners to do thorough investigations. Another commenter said that redaction should not be required because coroners and medical examiners needed some additional family information to determine what would be done with the deceased after their post-mortem investigation is completed.

Response: We recognize the burden associated with redacting medical records to remove the names of persons other than the patient. In addition, as stated in the preamble to the NPRM, we recognize that there is a limited time period after death within which an autopsy must be conducted. We believe that the delay associated with this burden could make it impossible to conduct a post-mortem investigation within the required time frame. In addition, we agree that health plans and covered health care providers may lack the training necessary to determine the identifiable information necessary for coroners and medical examiners to do thorough investigations. Thus, in the final rule, we do not require health plans or covered providers to redact information about persons other than the patient who may be identified in a patient's medical record before disclosing the record to a coroner or medical examiner.

Comment: One commenter said that medical records sent to coroners and medical examiners were considered their work product and thus were not released from their offices to anyone else. The commenter recommended that HHS establish regulations on how to dispose of medical records and that we create a "no re-release" statement to ensure that individual privacy is maintained without compromising coroners' or medical examiners' access to protected health information. The organization said that such a policy should apply regardless of whether the investigation was civil or criminal.

Response: HIPAA does not provide HHS with statutory authority to regulate coroners' or medical examiners' re-use or re-disclosure of protected health information unless the coroner or medical examiner is also a covered entity. However, we consistently have supported comprehensive privacy legislation to regulate disclosure and use of individually identifiable health information by all entities that have access to it.

Comment: One commenter recommended modifying the proposed rule to allow disclosure without authorization to funeral directors. To accomplish this change, the commenter suggested either: (1) adding another subsection to proposed § 164.510 of the NPRM, to allow disclosure without authorization to funeral directors as needed to make arrangements for funeral services and for disposition of a deceased person's remains; or (2) revising proposed § 164.510(e) to allow disclosure of protected health information to both coroners and funeral directors. According to this commenter, funeral directors often need certain protected health information for the embalming process, because a person's medical condition may affect the way in which embalming is performed. For example, the commenter noted, funeral directors increasingly receive bodies after organ and tissue donation, which has implications for funeral home staff duties associated with embalming.

Response: We agree with the commenter. In the final rule, we permit covered entities to disclose protected health information to funeral directors, consistent with applicable law, as necessary to carry out their duties with respect to a decedent. When necessary for funeral directors to carry out their duties, covered entities may disclose protected health information prior to and in reasonable anticipation of the individual's death.

Comment: One commenter recommended clarifying in the final rule that it does not restrict law enforcement agencies' release of medical information that many state records laws require to be reported, for example, as part of autopsy reports. The commenter recommended stating that law enforcement officials may independently gather medical information, that such information would not be covered by these rules, and that it would continue to be covered under applicable state and federal access laws.

Response: HIPAA does not give HHS statutory authority to regulate law enforcement officials' use or disclosure of protected health information. As stated elsewhere, we continue to support enactment of comprehensive privacy legislation to cover disclosure and use of all individually identifiable health information.

Comment: One commenter recommended prohibiting health plans and covered health care providers from disclosing psychotherapy notes to coroners or medical examiners.

Response: We disagree with the commenter who asserted that psychotherapy notes should only be used by or disclosed to coroners and medical examiners with authorization. Psychotherapy notes are sometimes needed by coroners and medical examiners to determine cause of death, such as in cases where suicide is suspected as the cause of death. We understand that several states require the disclosure of protected health information, including psychotherapy notes, to medical examiners and coroners. However, in the absence of a state law requiring such disclosure, we do not intend to prohibit coroners or medical examiners from obtaining the protected health information necessary to determine an individual's cause of death.

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HIPAA Privacy Regulations: Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Decedents - § 164.512(g)

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Text, HHS commentary and analysis of the uses and disclosures about decedents in the HIPAA privacy regulations.

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Once the patient's cause of death is determined, then appropriate steps should be taken to first have a better response to follow up on medical alerts especially for implanted cardiac devices. Also, it must determined why the patient was put in to physical restraints without a physician's order.

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The cause of the patient's death is yet to be determined, pending a possible investigation by the medical examiner/coroner's office.

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If it is determined that the patient's illnesses and or death was directly caused or hastened by the malfunction of the implanted cardiac defibrillator, then yes, the device manufacturer would face some liability.

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The hospital is responsible for reporting this matter to the FDA within 10 days.

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While the FDA oversees the regulations regarding various medical devices, the primary responsible party for notifying the hospital is either the patient's primary care physician or the electrophysiologist.

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1. Whether or not there was a physician's order for the use of physical restraints.

2. Information regarding the recent medical device alert for the patient's cardiac defibrillator.

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Yes, especially if there is a possibility of a serious crime that might have been committed.

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Since the patient was a resident of a senior living facility, and there seems to be several red flags of possible abuse and neglect, this must be reported to the proper authorities so that an investigation can be opened.

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Based on cause of death I would review previous medical hx to see if there was something that was overlooked. You would need to go over if the proper use of restraints were used and if hte length of use had any influence on the patient's death.

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You can't make that determination with the information provided. There is no cause of death determined.

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Yes if they knew of possible malfunction of said device they must report to FDA for recall.

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Must report deaths and injuries through mandatory reporting system: Safety Information and Adverse Event Reporting
Program or MedWatch online. The FDA also encourages voluntary reporting of adverse events related to products or
technologies or EHR system to MedWatch.

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The FDA is responsible for notifying the hospital about a medical device potentially being harmful to a patient.

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They would need to report reason for restraining the patient at Wesley Glen and for how long. If they noticed any sort of bruising prior to the patient arriving at the ER. The hospital would need to report information about the cardiac defibrillator to see if the death was at any fault of the device.

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Yes, in this week's reading we learned that the "MEs and coroners have right to receive medical information needed to investigate the case without authorization and may have subpoena powers to collect such information".

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The patient had "multiple bruises on back, buttocks and thighs". These findings could be linked to suspicious death. The patient also passed 15 hours after which could be ruled as sudden death. State laws determine that for these reasons the hospital is required to report the death to the medical examiner/coroner.

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The mitigation plan for both West Glen and the hospital would be:

1. Ensuring competency training is conducted regarding care of patients throughout the lifespan, mobilizing patients, restraint use and monitoring, de-escalation techniques, alternatives to restraint use, and chemical restraints (sedation) vs. physical restraints (wrist/ankle, bedrails, etc.), reporting deaths, caring for the deceased, reporting medical devices to include malfunction and next steps.

2. Current policies, procedures and protocols regarding restraint use and monitoring (chemical and physical), reporting deaths, reporting medical devices, notifying patients of medical device equipment maintenance and malfunction.

3. Ensuring current licenses, certifications, and accreditation for both facilities and staff members responsible for patient care.

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I can not determine who is at fault for the patient's death, if there is any fault at all. Based on the information presented, a thorough investigation should be conducted, to include an autopsy.

I understand that some may jump to conclusions regarding this case as a senior patient being abused in a senior living facility. No where in the synopsis of the case did it state that. What I gathered is a 75-year old patient with a cardiac history, as stated in the implanted cardiac defibrillator, who has a history of becoming agitated and physically abusive to himself and others.

I would deduce that the patient may experience sundowners (as seen in the geriatric population) or drug-drug/drug-food interactions that may cause his agitation. Also, since he has a cardiac history, he may likely be on medication that "thins" the blood, which makes the patient at a higher risk of falling and sensitivity to bruising.

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There are a lot of factors to consider in this case regarding liability of the cardiac defibrillator. Based on the facts presented, the responsible choice would be an autopsy and an investigation into the entire case.

Per the FDA, manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

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If the death was attributed to the implanted cardiac defibrillator, the hospital, also known as the user facility must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

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The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown (Center for Devices and Radiological Health, 2023).

Center for Devices and Radiological Health. (2023, July 27). Medical Device Reporting (MDR): How to report medical device problems. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#:~:text=Mandatory%20Medical%20Device%20Reporting%20Requirements,-The%20Medical%20Device&text=Manufacturers%3A%20Manufacturers%20are%20required%20to,a%20death%20or%20serious%20injury.

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Additional required reporting from West Glen include:

1. Physician, nurse, and care team on duty during transfer.

2. Active and current licenses, certification, accreditation for senior living care facility, as well as use of restraints.

3. Audits of restraint use (competency of staff members, frequency log (hourly, daily) of restraint use and monitoring, orders for restraints, justification of use, other measures used before restraint use, etc.

4. Activities of daily living (ADL) documentation/logs, to include any use of mobility devices such as a walker, gait belt, etc.

5. List of medications.

6. List of staff members caring for patient in a certain timeframe (ie. last 30 days).

7. Medical records regarding cardiac defibrillator and any follow-up correspondence regarding medical device alert.

List of required items from the hospital:

1. Similar items as stated above; however, since the patient expired shortly after hospital admission, items such as ADL may not be appropriate in this case.

2. H&P

3. Medications ordered and reconciled.

4. Orders for restraint and sedation use.

5. Audits for restraint use to include competency of staff members, documentation of monitoring restraints (time of order and placement of restraints will be reviewed, as well as any existing policy regarding hospital restraint use).

6. Physician, nurse, and other staff members' documentation of the care, treatments, procedures provided to the patient.

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The hospital is certainly required to report the patient's death to the medical examiner/coroner, as the time elapsed while the patient was in the hospital was less than 24 hours. In the state of California, any death deemed “violent, sudden, or unusual” is to be investigated by the coroner, which may include an autopsy. The death in this case falls into the “sudden” and “unusual” categories (barring any criminal activity occurring at the hospital). Factors that would indicate reporting include: the rapid sequence from agitation to expiration, the use of restraints, the unusual bruising, and the unknown status of the patient’s implant. Also unusual is whether the combination of these and possible other factors may have contributed to the patient’s death. Although the patient was advanced in years and was residing at a nursing home, his age cannot be a factor to exclude him from an investigation into his death.

Assuming that there are no other details surrounding the patient’s disposition, it is quite unclear what the cause of death was. Thus, it was correct (and lawful) that the death was reported to the coroner. An independent pathologist/medical examiner conducting an autopsy would be better qualified as a resource to determine cause of death. Toxicology, organ examination (especially the heart, brain, and lungs), and the nature of the bruising could provide clues. This is especially pertinent in this case as there are several potential targets for litigation if legal action is sought by the patient’s family (or the State if criminal activity is involved). The hospital/staff members, the nursing home/its physician(s)/nursing team/care staff, as well as the device manufacturer, could be found liable.

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Coroner/Medical Examiner Laws

Is medical death investigation system centralized, county-based, or district-based?
County-based. Cal. Gov't Code § 24010.

If centralized, in which department or agency is the system housed?
Not applicable.

Does the state system have a coroner, medical examiner, or coroners and medical examiners?
Coroners and medical examiners. Notwithstanding any other provision of law, the board of supervisors may by ordinance abolish the office of coroner and provide instead for the office of medical examiner, to be appointed by the said board and to exercise the powers and perform the duties of the coroner. Cal. Gov't Code § 24010 [Title 3, Government of Counties].

Notwithstanding the provisions of Section 24300, in counties of the 11th class, the board of supervisors by ordinance may consolidate the duties of certain of the county offices, in one or both of these combinations:

(a) County clerk, assessor, and recorder.

(b) Sheriff, coroner, and public administrator.

Cal. Gov't Code § 24304.1.

"In practice" notes
None.

Is there a state medical examiner?
No.

If so, what is the state medical examiner's role?
Not applicable.

In what department or agency is the state medical examiner's office located?
Not applicable.

Are there deputies?
Every county or district officer, except a supervisor or judicial officer, may appoint as many deputies as are necessary for the prompt and faithful discharge of the duties of his office. Cal. Gov't Code § 24101.

If so, what are the deputies' roles?
If the coroner is absent or unable to attend, the duties of his office may be discharged by any of his deputies with like authority and subject to the same obligations and penalties as the coroner. Cal. Gov't Code § 27530.

What are the qualifications for deputies?
Unspecified.

Is the coroner or medical examiner position elected?
Coroners: appointed or elected
Medical examiners: appointed

[T]he board of supervisors may by ordinance abolish the office of coroner and provide instead for the office of medical examiner, to be appointed by the said board and to exercise the powers and perform the duties of the coroner. Cal. Gov't Code § 24010.

(a) Except as provided in subdivision (b), the county officers to be elected by the people are the treasurer, county clerk, auditor, sheriff, tax collector, district attorney, recorder, assessor, public administrator, and coroner.

(b) Except for those officers named in subdivision (b) of Section 1 of Article XI of the California Constitution, any county office that is required to be elective may become an appointive office pursuant to this subdivision. In order to change an office from elective to appointive, a proposal shall be presented to the voters of the county and approved by a majority of the votes cast on the proposition . . .

Cal. Gov't Code § 24009.

If so, how many years is the term of office?
Unspecified.

What are the qualifications specified by law? The medical examiner shall be a licensed physician and surgeon duly qualified as a specialist in pathology. Cal. Gov't Code § 24010.

What types of deaths are required to be investigated?
It shall be the duty of the coroner to inquire into and determine the circumstances, manner, and cause of all violent, sudden, or unusual deaths; unattended deaths; deaths where the deceased has not been attended by either a physician or a registered nurse, who is a member of a hospice care interdisciplinary team . . . in the 20 days before death; deaths related to or following known or suspected self-induced or criminal abortion; known or suspected homicide, suicide, or accidental poisoning; deaths known or suspected as resulting in whole or in part from or related to accident or injury either old or recent; deaths due to drowning, fire, hanging, gunshot, stabbing, cutting, exposure, starvation, acute alcoholism, drug addiction, strangulation, aspiration, or where the suspected cause of death is sudden infant death syndrome; death in whole or in part occasioned by criminal means; deaths associated with a known or alleged rape or crime against nature; deaths in prison or while under sentence; deaths known or suspected as due to contagious disease and constituting a public hazard; deaths from occupational diseases or occupational hazards; deaths of patients in state mental hospitals serving the mentally disabled and operated by the State Department of State Hospitals; deaths of patients in state hospitals serving the developmentally disabled and operated by the State Department of Developmental Services; deaths under such circumstances as to afford a reasonable ground to suspect that the death was caused by the criminal act of another; and any deaths reported by physicians or other persons having knowledge of death for inquiry by coroner. . . The coroner shall have discretion to determine the extent of inquiry to be made into any death occurring under natural circumstances and falling within the provisions of this section . . . For the purpose of inquiry, the coroner shall have the right to exhume the body of a deceased person when necessary to discharge the responsibilities set forth in this section. Cal. Gov't Code § 27491.

What types of deaths are required to be autopsied?
[T]he coroner shall, within 24 hours, or as soon thereafter as feasible, perform an autopsy in any case where an infant has died suddenly and unexpectedly. However, if the attending physician desires to certify that the cause of death is sudden infant death syndrome, an autopsy may be performed at the discretion of the coroner. If the coroner performs an autopsy pursuant to this section, he or she shall also certify the cause of death . . . Cal. Gov't Code § 27491.41.

For purposes of inquiry the coroner shall, within 24 hours or as soon as feasible thereafter, where the suspected cause of death is sudden infant death syndrome and, in all other cases, the coroner may, in his or her discretion, take possession of the body, which shall include the authority to exhume the body, order it removed to a convenient place, and make or cause to be made a postmortem examination or autopsy thereon, and make or cause to be made an analysis of the stomach, stomach contents, blood, organs, fluids, or tissues of the body . . . The coroner shall have the right to retain only those tissues of the body removed at the time of the autopsy as may, in his or her opinion, be necessary or advisable to the inquiry into the case, or for the verification of his or her findings . . . Nothing in this section shall be deemed to prohibit the discretion of the coroner to conduct autopsies upon any victim of sudden, unexpected, or unexplained death or any death known or suspected of resulting from an accident, suicide, or apparent criminal means, or other death, as described in Section 27491. Cal. Gov't Code § 27491.4.

Does the state require that pathologists perform the autopsies?
No.

Disclaimer: Information available on this website that was not developed by the Centers for Disease Control and Prevention (CDC) does not necessarily represent any CDC policy, position, or endorsement of that information or of its sources. The information contained on this website is not legal advice; if you have questions about a specific law or its application you should consult your legal counsel.

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Coroner/Medical Examiner Laws Is medical death investigation system centralized, county-based, or district-based? County-based. Cal. Gov't Code § 24010. If centralized, in which department or agency is the system housed? Not applicable. Does the state system have a coroner, medical examiner, or coroners and medical examiners? Coroners and medical examiners.

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From my own personal experience as an RN, working in several ICUs in 2 different states, typically there is a form or a list of requirements to provide the ME/coroner when contacting them (usually via telephone). Information such as the patient's demographics, diagnosis, vitals, physician on record (who is usually the one that determines time of death and completes/signs the death certificate). The ME/coroner may require more information, in which they have privileges to have, when conducting an investigation.

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From my experience as a RN who has worked in several ICUs in 2 different states, if a patient is admitted into the hospital and expires within 24 hours of admission, it is required to report this death to the medical examiner (ME)/ coroner, to rule out any suspicion surrounding the death. This case in particular raises red flags such as possible abuse or neglect as the patient was a resident at a senior living facility with the hospital/ED physician noting "multiple bruises on the patient's back, buttocks, and thighs," a history of restraint use both in the senior living facility and during admission in the hospital, sedation use in the hospital, and a cardiac defibrillator implant with an active alert for implanted medical device follow-up.

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The FDA requires the facilities user of the medical device and the manfacturers to report death that have occur or have related to serious injurys due the medical devices, its report through Safety Information and adverse Event reporting or MedWatch to a online system. (FDA 2018b.) (FDA 2018c.)

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It needs to be reported to the FDA because they are responsible to review any medical devices , to ensure the safety, of the medical device is working effectively and properly and safe for public (human)use. The FDA oversees the safe of the medical devices. ( FDA 2018a).

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Yes, the medical examiner or coroner have th right to the patient medical records without an authorization to investigate the cause of death.

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§ 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required.

A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity's information and the individual's agreement may be given orally.

(a) Standard: Uses and disclosures required by law.

(b) Standard: Uses and disclosures for public health activities -

(ii) A public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect;

(iii) A person subject to the jurisdiction of the Food and Drug Administration (FDA) with respect to an FDA-regulated product or activity for which that person has responsibility, for the purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity. Such purposes include:

(A) To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations;

(B) To track FDA-regulated products;

(C) To enable product recalls, repairs, or replacement, or lookback (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of lookback); or

(D) To conduct post marketing surveillance;

To conduct an evaluation relating to medical surveillance of the workplace; or

(B) The protected health information that is disclosed consists of findings concerning a work-related illness or injury or a workplace-related medical surveillance;

(vi) A school, about an individual who is a student or prospective student of the school, if:

(A) The protected health information that is disclosed is limited to proof of immunization;

A parent, guardian, or other person acting in loco parentis of the individual, if the individual is an unemancipated minor; or

(c) Standard: Disclosures about victims of abuse, neglect or domestic violence -

(iii) To the extent the disclosure is expressly authorized by statute or regulation and:

(2) Informing the individual. A covered entity that makes a disclosure permitted by paragraph (c)(1) of this section must promptly inform the individual that such a report has been or will be made, except if:

(ii) The covered entity would be informing a personal representative, and the covered entity reasonably believes the personal representative is responsible for the abuse, neglect, or other injury, and that informing such person would not be in the best interests of the individual as determined by the covered entity, in the exercise of professional judgment.

(d) Standard: Uses and disclosures for health oversight activities -

(i) The health care system;

(ii) Government benefit programs for which health information is relevant to beneficiary eligibility;

(iii) Entities subject to government regulatory programs for which health information is necessary for determining compliance with program standards; or

(iv) Entities subject to civil rights laws for which health information is necessary for determining compliance.

(i) The receipt of health care;

(ii) A claim for public benefits related to health; or

(iii) Qualification for, or receipt of, public benefits or services when a patient's health is integral to the claim for public benefits or services.

(e) Standard: Disclosures for judicial and administrative proceedings -

(ii) In response to a subpoena, discovery request, or other lawful process, that is not accompanied by an order of a court or administrative tribunal, if:

(C) The time for the individual to raise objections to the court or administrative tribunal has elapsed, and:

No objections were filed; or

(A) The parties to the dispute giving rise to the request for information have agreed to a qualified protective order and have presented it to the court or administrative tribunal with jurisdiction over the dispute; or

(B) The party seeking the protected health information has requested a qualified protective order from such court or administrative tribunal.

(A) Prohibits the parties from using or disclosing the protected health information for any purpose other than the litigation or proceeding for which such information was requested; and

(i) As required by law including laws that require the reporting of certain types of wounds or other physical injuries, except for laws subject to paragraph (b)(1)(ii) or (c)(1)(i) of this section; or

(ii) In compliance with and as limited by the relevant requirements of:

(A) A court order or court-ordered warrant, or a subpoena or summons issued by a judicial officer;

(B) A grand jury subpoena; or

(C) An administrative request, including an administrative subpoena or summons, a civil or an authorized investigative demand, or similar process authorized under law, provided that:

The information sought is relevant and material to a legitimate law enforcement inquiry;

The request is specific and limited in scope to the extent reasonably practicable in light of the purpose for which the information is sought; and

De-identified information could not reasonably be used.

(i) The covered entity may disclose only the following information:

(A) Name and address;

(B) Date and place of birth;

(C) Social security number;

(D) ABO blood type and rh factor;

(E) Type of injury;

(F) Date and time of treatment;

(G) Date and time of death, if applicable; and

(H) A description of distinguishing physical characteristics, including height, weight, gender, race, hair and eye color, presence or absence of facial hair (beard or moustache), scars, and tattoos.

(ii) Except as permitted by paragraph (f)(2)(i) of this section, the covered entity may not disclose for the purposes of identification or location under paragraph (f)(2) of this section any protected health information related to the individual's DNA or DNA analysis, dental records, or typing, samples or analysis of body fluids or tissue.

(3) Permitted disclosure: Victims of a crime. Except for disclosures required by law as permitted by paragraph (f)(1) of this section, a covered entity may disclose protected health information in response to a law enforcement official's request for such information about an individual who is or is suspected to be a victim of a crime, other than disclosures that are subject to paragraph (b) or (c) of this section, if:

(6) Permitted disclosure: Reporting crime in emergencies.

(i) A covered health care provider providing emergency health care in response to a medical emergency, other than such emergency on the premises of the covered health care provider, may disclose protected health information to a law enforcement official if such disclosure appears necessary to alert law enforcement to:

(A) The commission and nature of a crime;

(B) The location of such crime or of the victim(s) of such crime; and

(C) The identity, description, and location of the perpetrator of such crime.

(g) Standard: Uses and disclosures about decedents -

(i) Standard: Uses and disclosures for research purposes -

(A) An Institutional Review Board (IRB), established in accordance with 7 CFR lc.107, 10 CFR 745.107, 14 CFR 1230.107, 15 CFR 27.107, 16 CFR 1028.107, 21 CFR 56.107, 22 CFR 225.107, 24 CFR 60.107, 28 CFR 46.107, 32 CFR 219.107, 34 CFR 97.107, 38 CFR 16.107, 40 CFR 26.107, 45 CFR 46.107, 45 CFR 690.107, or 49 CFR 11.107; or

Does not have any member participating in a review of any project in which the member has a conflict of interest.

(A) Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research;

(B) Documentation, at the request of the covered entity, of the death of such individuals; and

Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;

(B) The research could not practicably be conducted without the waiver or alteration; and

(iv) Review and approval procedures. A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures, as follows:

(A) An IRB must follow the requirements of the Common Rule, including the normal review procedures ( 7 CFR 1c.108(b), 10 CFR 745.108(b), 14 CFR 1230.108(b), 15 CFR 27.108(b), 16 CFR 1028.108(b), 21 CFR 56.108(b), 22 CFR 225.108(b), 24 CFR 60.108(b), 28 CFR 46.108(b), 32 CFR 219.108(b), 34 CFR 97.108(b), 38 CFR 16.108(b), 40 CFR 26.108(b), 45 CFR 46.108(b), 45 CFR 690.108(b), or 49 CFR 11.108(b)) or the expedited review procedures ( 7 CFR 1c.110, 10 CFR 745.110, 14 CFR 1230.110, 15 CFR 27.110, 16 CFR 1028.110, 21 CFR 56.110, 22 CFR 225.110, 24 CFR 60.110, 28 CFR 46.110, 32 CFR 219.110, 34 CFR 97.110, 38 CFR 16.110, 40 CFR 26.110, 45 CFR 46.110, 45 CFR 690.110, or 49 CFR 11.110);

(B) A privacy board must review the proposed research at convened meetings at which a majority of the privacy board members are present, including at least one member who satisfies the criterion stated in paragraph (i)(1)(i)(B)(2) of this section, and the alteration or waiver of authorization must be approved by the majority of the privacy board members present at the meeting, unless the privacy board elects to use an expedited review procedure in accordance with paragraph (i)(2)(iv)(C) of this section;

(C) A privacy board may use an expedited review procedure if the research involves no more than minimal risk to the privacy of the individuals who are the subject of the protected health information for which use or disclosure is being sought. If the privacy board elects to use an expedited review procedure, the review and approval of the alteration or waiver of authorization may be carried out by the chair of the privacy board, or by one or more members of the privacy board as designated by the chair; and

(j) Standard: Uses and disclosures to avert a serious threat to health or safety -

(A) Is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and

(ii) Is necessary for law enforcement authorities to identify or apprehend an individual:

(2) Use or disclosure not permitted. A use or disclosure pursuant to paragraph (j)(1)(ii)(A) of this section may not be made if the information described in paragraph (j)(1)(ii)(A) of this section is learned by the covered entity:

(4) Presumption of good faith belief. A covered entity that uses or discloses protected health information pursuant to paragraph (j)(1) of this section is presumed to have acted in good faith with regard to a belief described in paragraph (j)(1)(i) or (ii) of this section, if the belief is based upon the covered entity's actual knowledge or in reliance on a credible representation by a person with apparent knowledge or authority.

(k) Standard: Uses and disclosures for specialized government functions -

(1) Military and veterans activities -

(i) Armed Forces personnel. A covered entity may use and disclose the protected health information of individuals who are Armed Forces personnel for activities deemed necessary by appropriate military command authorities to assure the proper execution of the military mission, if the appropriate military authority has published by notice in the Federal Register the following information:

(A) Appropriate military command authorities; and

(ii) Separation or discharge from military service. A covered entity that is a component of the Departments of Defense or Homeland Security may disclose to the Department of Veterans Affairs (DVA) the protected health information of an individual who is a member of the Armed Forces upon the separation or discharge of the individual from military service for the purpose of a determination by DVA of the individual's eligibility for or entitlement to benefits under laws administered by the Secretary of Veterans Affairs.

(iii) Veterans. A covered entity that is a component of the Department of Veterans Affairs may use and disclose protected health information to components of the Department that determine eligibility for or entitlement to, or that provide, benefits under the laws administered by the Secretary of Veterans Affairs.

(iv) Foreign military personnel. A covered entity may use and disclose the protected health information of individuals who are foreign military personnel to their appropriate foreign military authority for the same purposes for which uses and disclosures are permitted for Armed Forces personnel under the notice published in the Federal Register pursuant to paragraph (k)(1)(i) of this section.

(2) National security and intelligence activities. A covered entity may disclose protected health information to authorized federal officials for the conduct of lawful intelligence, counter-intelligence, and other national security activities authorized by the National Security Act ( 50 U.S.C. 401, et seq.) and implementing authority (e.g., Executive Order 12333).

(3) Protective services for the President and others. A covered entity may disclose protected health information to authorized Federal officials for the provision of protective services to the President or other persons authorized by 18 U.S.C. 3056 or to foreign heads of state or other persons authorized by 22 U.S.C. 2709(a)(3), or for the conduct of investigations authorized by 18 U.S.C. 871 and 879.

(4) Medical suitability determinations. A covered entity that is a component of the Department of State may use protected health information to make medical suitability determinations and may disclose whether or not the individual was determined to be medically suitable to the officials in the Department of State who need access to such information for the following purposes:

(i) For the purpose of a required security clearance conducted pursuant to Executive Orders 10450 and 12968;

(ii) As necessary to determine worldwide availability or availability for mandatory service abroad under sections 101(a)(4) and 504 of the Foreign Service Act; or

(iii) For a family to accompany a Foreign Service member abroad, consistent with section 101(b)(5) and 904 of the Foreign Service Act.

(5) Correctional institutions and other law enforcement custodial situations -

(i) Permitted disclosures. A covered entity may disclose to a correctional institution or a law enforcement official having lawful custody of an inmate or other individual protected health information about such inmate or individual, if the correctional institution or such law enforcement official represents that such protected health information is necessary for:

(A) The provision of health care to such individuals;

(B) The health and safety of such individual or other inmates;

(C) The health and safety of the officers or employees of or others at the correctional institution;

(E) Law enforcement on the premises of the correctional institution; or

(F) The administration and maintenance of the safety, security, and good order of the correctional institution.

(ii) Permitted uses. A covered entity that is a correctional institution may use protected health information of individuals who are inmates for any purpose for which such protected health information may be disclosed.

(6) Covered entities that are government programs providing public benefits.

(ii) A covered entity that is a government agency administering a government program providing public benefits may disclose protected health information relating to the program to another covered entity that is a government agency administering a government program providing public benefits if the programs serve the same or similar populations and the disclosure of protected health information is necessary to coordinate the covered functions of such programs or to improve administration and management relating to the covered functions of such programs.

(i) Is a State agency or other entity that is, or contains an entity that is:

(ii) Discloses the information only to:

(A) The National Instant Criminal Background Check System; or

(A) Discloses only the limited demographic and certain other information needed for purposes of reporting to the National Instant Criminal Background Check System; and

(B) Does not disclose diagnostic or clinical information for such purposes.

[ 65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53270, Aug. 14, 2002; 78 FR 5699, Jan. 25, 2013; 78 FR 34266, June 7, 2013; 81 FR 395, Jan. 6, 2016]

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45 CFR § 164.512 - Uses and disclosures for which an authorization or opportunity to agree or object is not required.

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§ 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required. A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section.

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Our state laws require certain deaths to be report such as a accidental, homicade, suicide, sudden/or suspicious death in nature it needs to notifiy to the medical examiner or the coroner . Also, after the physician examined the patient , the physician noted the patient had several bruises , so this links to suspicious death could be elder abuse but also because reporting serious occurence or death to restraint.

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Hospitals must report deaths related to use of restraints or seclusion to CMS.

(2014, May 9). Hospital Restraint/Seclusion Deaths to be Reported Using the Centers for Medicare and Medicaid Services (CMS) Form CMS-10455, Report of a Hospital Death Associated with Restraint or Seclusion. https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-14-27-

Wesley Glen and the hospital must report the death to the FDA and the manufacturer of the faulty medical device.

(2023, August 16). Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities. https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities

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If the faulty device is determined to be the cause of death, the manufacturer can be held liable for the death.

(2019, March 7). Medical Device Defects Leading to Products Liability Lawsuits. Justia . https://www.justia.com/products-liability/types-of-defective-product-cases/medical-devices/

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Certain serious health conditions may require the use of complex medical devices. However, many patients have been injured by flaws in these products, which can consist of manufacturing defects, design defects, or errors in marketing a device. These claims often have arisen from products such as hip implants, transvaginal mesh and other contraceptive devices, and products designed to prevent heart attacks, such as stents and defibrillators. Injured patients can bring a products liability claim against a manufacturer or another party associated with a flawed medical device that caused their injuries.

Manufacturing Defects

An error in making a specific medical device can cause problems that are not otherwise present in the product line. Also, a medical device can be damaged en route to a consumer, which means that someone else in the chain of distribution may be responsible. Manufacturing defect claims are usually based on strict liability, which means that you need to prove only that there was a defect and that it caused your harm.

Design Defects

These types of cases can be more complex because they allege that the entire line of a product is inherently defective. Perhaps the manufacturer failed to account for a certain risk in its blueprint, or perhaps it failed to anticipate the device breaking down over time. In many situations, a plaintiff will need to show that there was a safer alternative design possible that would not have imposed a much greater cost.

Sometimes a manufacturer intentionally conceals a potential problem with a device, or it may be reluctant to recall a defective line of devices and lose the profits from them. Knowingly allowing consumers to buy and use a defective medical device can support a punitive damages award in addition to compensatory damages.

Marketing Defects

Medical devices may need to be used in a specific way to ensure the patient's safety. If the manufacturer fails to provide appropriate warnings regarding the dangers of a device, or if it does not thoroughly instruct consumers on its safe use, it may be liable under a theory of failure to warn. Sometimes doctors, hospitals, and other health care providers also may be liable for recommending that a patient use a certain device without giving them proper instructions on how to use it.

Whom to Sue

Manufacturers, distributors, and suppliers tend to be the main defendants in these cases. You can sue any of these entities for releasing a defective device to the market. Since a substantial amount of money probably will be at stake, you should expect the case to be prolonged and hard-fought. You will need expert testimony to describe the defect in the device and how it caused your injuries. These sophisticated claims are often best handled with the assistance of an attorney.

Other parties in the pharmaceutical industry also may bear some of the fault. If the manufacturer used an outside laboratory to check the safety of a device, the laboratory may be sued if it failed to conduct tests properly. Also, sales representatives of the manufacturer may be independently liable if they glossed over certain risks of a device or recommended it to doctors for inappropriate uses.

Health care providers that were involved in recommending a device to patients may be sued under a medical malpractice theory. Doctors have responsibilities to inform their patients of potential risks and give them instructions on how to use a device. In some cases, hospitals and clinics also may bear some fault.

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Medical Device Defects Leading to Products Liability Lawsuits

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Injured patients can bring claims against manufacturers, distributors, or health care providers when they are injured by manufacturing, design, or marketing defects in medical devices.

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We do not have a report from the medical examiner or coroner as to the cause of death. Glen Senior Living Facility, the hospital where the patient was last treated, and the manufacturer may all be at fault or partially at fault.

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Your Legal Duty - Reporting Elder and Dependent Adult Abuse

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When elder abuse occurs in a medical facility, it must be reported to law enforcement. In California, failure to report elder or dependent adult abuse in long-term health care facilities is a crime.

(2011, February 18). Your Legal Duty - Reporting Elder and Dependent Adult Abuse. https://oag.ca.gov/sites/all/files/agweb/pdfs/bmfea/yld_text.pdf

A mitigation plan for preventing similar events to the one detailed in this assignment from occurring in the future must incorporate policies requiring mandatory reporting of misconduct or abuse of patients to authorities, so that an investigation can be conducted. Staff who fail to report abuse must be disciplined and possibly prosecuted.

Staff must be trained to understand misconduct towards patients and their responsibility to report, and to recognize signs and how to report suspected abuse. The facility must have a policy of thoroughly investigating all reports of abuse or other misconduct.

The facility should record all medical devices and medications prescribed to its patients, and keep apprised of all FDA alerts regarding medical device or other medical products. The facility may consider adoption of an EHR system which can send medical device alerts, in general and for patients in the facility who are prescribed recalled devices.

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The manufacturer is responsible for notifying hospitals of medical device alerts or recalls.

(2023, August 16). Recalls, Corrections and Removals (Devices). https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

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Center for Devices and Radiological Health

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Recalls, Corrections and Removals (Devices)

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Info related to recall of medical devices, corrections and removals; regulations and Federal Register notices.

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Mileen San Juan

The mitigation plan moving forward would be the following:

1. Initiate an in house investigation to determine the sequence of events and interview all the medical staff that were included in the patient's care.

2. Review and ensure that all the policies and procedures of the hospital are being implemented and in place,

3. Re-educate all the staff on company policies and procedures that have a connection on the events after the investigation results have been determined.

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Moving forward the hospital would need to implement a better plan to notify it's patients that receive devices that are alerted for defects or malfunctioning to prevent patient injury and/or death.

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Mileen San Juan

This question will only be answered after the investigation of the medical examiner and coroner's office. If the cause of death is because of the defect of defibrillator (medical device) and the manufacturer did not report to FDA then they are at fault. If the cause of death is due to care negligence or abuse it would need further investigation within the hospital. This is case to case basis we cannot conclude anything without the results of the investigation.

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There would need to be more information in the cause of the patient's death to determine who is at fault.

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If a death is attributable to a medical device such as a defibrillator, there is a mandatory reporting requirement per the Medical Device Reporting (MDR) regulation (21 CFR Part 803). The death must be reported to the FDA’s Safety Information and Adverse Event Reporting Program or MedWatch, and to the manufacturer.

(2023, July 27). Medical Device Reporting (MDR): How to Report Medical Device Problems. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

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Overview of Medical Device Reporting

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See " Medical Device Reporting for User Facilities," a guidance document issued by the FDA.

Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.

Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Voluntary Malfunction Summary Reporting Program

The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 ( 82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, ( 83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 ( 83 FR 40973):

1. Any reportable malfunction associated with a 5-day report under § 803.53(a).

2. If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.

3. The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:

Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.

Where there was a high level of uncertainty regarding device risk.

Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.

Where there were ongoing signals or other safety-related investigations for the device.

These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).

1. The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.

Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

2. The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.

In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.

Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.

Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:

The firm's name, address, registration number

The contact person's name, telephone number, and email address

Complete device identification and description, including product code and review panel

A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any

As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status

Voluntary Medical Device Reporting

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.

How to Report a Medical Device Problem

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

Find information and instructions for mandatory device reporting at:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:

To Report an Emergency

If you have identified a public health emergency, you may use the following contact information to alert the FDA:

FDA Office of Crisis Management, Emergency Operations Center

Submitting Medical Device Reports for Devices Licensed as Biological Products

While most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.

Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 - Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Searching Medical Device Reports

The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 - 1996 and reports received under the Alternative Summary Reporting Program from 1999 - April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.

Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.

Contact

For general questions, please contact the Division of Industry and Consumer Education (DICE).

Additional Resources

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Medical Device Reporting (MDR): How to Report Medical Device Problems

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Requirements for reporting medical device problems, including malfunctions and adverse events (serious injuries or deaths) associated with medical devices.

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The device manufacturer has liability if the patient's death is caused directly by the medical device.

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Under federal rules, hospitals have 10 days to report serious device-related injuries to the device's manufacturer and to notify both the manufacturer and the FDA about any deaths that may have resulted.

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The manufacturer of the device and the FDA are responsible for notifying the hospital that a medical device in use may cause harm to patients.

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Hospitals must report to CMS any death that occurs while a patient is restrained or in seclusion for behavior management, or when it is reasonable to assume that a patient's death is the result of restraint or seclusion.

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A covered entity may disclose protected health information to a coroner or medical examiner for the purpose of identifying a deceased person, determining a cause of death, or other duties as authorized by law.

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Mileen San Juan

The manufacturer may or may not have the liability, it depends on the results of the investigation. if the medical device has any malfunction or defects that the manufacturer did not report to FDA then the manufacturer has a liability. If they have reported any problem on the medical device and FDA ddi not disseminate the information to the hospitals using that certain medical device they will not be at fault.

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Overview of Medical Device Reporting

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See " Medical Device Reporting for User Facilities," a guidance document issued by the FDA.

Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.

Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Voluntary Malfunction Summary Reporting Program

The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 ( 82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, ( 83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 ( 83 FR 40973):

1. Any reportable malfunction associated with a 5-day report under § 803.53(a).

2. If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.

3. The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:

Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.

Where there was a high level of uncertainty regarding device risk.

Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.

Where there were ongoing signals or other safety-related investigations for the device.

These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).

1. The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.

Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

2. The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.

In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.

Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.

Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:

The firm's name, address, registration number

The contact person's name, telephone number, and email address

Complete device identification and description, including product code and review panel

A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any

As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status

Voluntary Medical Device Reporting

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.

How to Report a Medical Device Problem

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

Find information and instructions for mandatory device reporting at:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:

To Report an Emergency

If you have identified a public health emergency, you may use the following contact information to alert the FDA:

FDA Office of Crisis Management, Emergency Operations Center

Submitting Medical Device Reports for Devices Licensed as Biological Products

While most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.

Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 - Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Searching Medical Device Reports

The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 - 1996 and reports received under the Alternative Summary Reporting Program from 1999 - April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.

Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.

Contact

For general questions, please contact the Division of Industry and Consumer Education (DICE).

Additional Resources

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Medical Device Reporting (MDR): How to Report Medical Device Problems

# data[].attributes.attachment_link.description
Requirements for reporting medical device problems, including malfunctions and adverse events (serious injuries or deaths) associated with medical devices.

# data[].attributes.body
The hospital is required to report the patient's death to the medical examiner/coroner to determine an actual cause of death due to any of these circumstances 1) the death was unexpected and no medical cause can be determined; 2) the decedent was not under the care of a physician for any disease which could reasonably be expected to cause death; or 3) the death might be a public health hazard.

# data[].attributes.body
Moving forward the hospital would need to implement a better plan to notify it's patients that receive devices that are alerted for defects or malfunctioning due to patient injury and or death.

# data[].attributes.body
I think the manufacturer of the device is at fault, due to the device being defective. The circumstances of the patient being elderly and at a senior living would make it difficult to communicate the device alert to the patient.

# data[].attributes.body
I would need more information to determine who is responsible for the death of the patient.

# data[].attributes.body
Because the patient's death was suspicious and sudden in nature, the hospital had to report the patient's death to the medical examiner/coroner. The fact that the 75-year-old patient had multiple bruises around his body and had a cardiac defibrillator implant which may have caused his sudden death, is what warranted an investigation. It is within the state's laws that certain deaths and specific personal health information regarding the patient are to be released to the medical examiner/coroner. The state laws having to do with reporting suspicious deaths don't conflict with HIPAA. That is because such disclosures are allowed without authorization.

# data[].attributes.body
The device manufacturer has liability if the patient's death is caused directly by the medical device.

# data[].attributes.body
The manufacturer must report to the FDA any injury or death that the device contributed and must maintain records. They also must submit a specified follow-up.

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Overview of Medical Device Reporting

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See " Medical Device Reporting for User Facilities," a guidance document issued by the FDA.

Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.

Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Voluntary Malfunction Summary Reporting Program

The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 ( 82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, ( 83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 ( 83 FR 40973):

1. Any reportable malfunction associated with a 5-day report under § 803.53(a).

2. If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.

3. The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:

Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.

Where there was a high level of uncertainty regarding device risk.

Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.

Where there were ongoing signals or other safety-related investigations for the device.

These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).

1. The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.

Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

2. The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.

In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.

Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.

Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:

The firm's name, address, registration number

The contact person's name, telephone number, and email address

Complete device identification and description, including product code and review panel

A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any

As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status

Voluntary Medical Device Reporting

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.

How to Report a Medical Device Problem

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

Find information and instructions for mandatory device reporting at:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:

To Report an Emergency

If you have identified a public health emergency, you may use the following contact information to alert the FDA:

FDA Office of Crisis Management, Emergency Operations Center

Submitting Medical Device Reports for Devices Licensed as Biological Products

While most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.

Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 - Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Searching Medical Device Reports

The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 - 1996 and reports received under the Alternative Summary Reporting Program from 1999 - April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.

Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.

Contact

For general questions, please contact the Division of Industry and Consumer Education (DICE).

Additional Resources

# data[].attributes.attachment_link.title
Medical Device Reporting (MDR): How to Report Medical Device Problems

# data[].attributes.attachment_link.description
Requirements for reporting medical device problems, including malfunctions and adverse events (serious injuries or deaths) associated with medical devices.

# data[].attributes.body
Mileen San Juan

If the death was attributed to the defibrillator, the hospital is responsible in reporting to FDA the death since their is a medical device involved.

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Christina Lalani, MD, 1 Elysha M. Kunwar, BA, 2 Madris Kinard, MBA, 3 Sanket S. Dhruva, MD, MHS, 4 , 5 , 6 , 7 and Rita F. Redberg, MD, MSc 4 , 6 , 8

Key Points

Question

When a medical device adverse event report in the US Food and Drug Administration Manufacturer and User Facility Device Experience database describes a patient death, how often is that report classified as injury, malfunction, other, or missing instead of death?

Findings

In this study and manual review of a random sample of 1000 adverse event reports that were selected using a natural language processing algorithm to identify patient deaths, the percentage of reports classified as injury, malfunction, other, or missing (instead of death) was 23% (95% CI, 20%-25%).

Meaning

Many adverse event reports for medical devices that involve a patient death are classified in categories other than death, and as the US Food and Drug Administration only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

Abstract

Importance

In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death.

Objective

To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died.

Design, Setting, and Participants

In this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device.

Exposures

Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death.

Main Outcomes and Measures

Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death.

Results

The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%).

Conclusions and Relevance

Many of the findings of this study suggest that many medical device adverse event reports in the FDA's MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

This study examines the percentage of medical device adverse event reports submitted to the Us Food and Drug Administration's Manufacturer and User Facility Device Experience database that were not classified as death even though the patient died.

Introduction

Before marketing, the clinical trial evidence supporting medical device approval is often limited; postmarket surveillance provides additional evidence on safety and effectiveness.1,2,3 For the highest-risk (class III) medical devices, the US Food and Drug Administration (FDA) requires premarket approval and the submission of clinical data for the agency to review. However, premarket approval is often based on a single, small, nonrandomized study with a short period of follow-up.1 Examples of class III medical devices are ventricular assist bypass devices, deep brain stimulators, and coronary drug-eluting stents. Class II (usually moderate-risk) devices typically receive clearance based on substantial equivalence to an existing device; the submission of clinical data are not required.4 Thus, postmarket surveillance allows for longer-term follow-up of a larger and more diverse group of patients than those enrolled in premarket trials.2,5

Passive surveillance is the primary source of safety signals for medical device safety communications.6 Manufacturers, distributers, and health care facilities are required to submit adverse events to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.6,7,8,9 Others (eg, physicians, hospitals, and patients) can submit reports, but such voluntary reports are submitted infrequently.10

The individuals or organizations reporting adverse events to MAUDE choose whether to report them as malfunction, injury, death, or other. The FDA requires that reports be classified as death if the device "may have caused or contributed to a death," or if the cause of death is unknown.11 If a report in which a patient dies is not classified as death (eg, is reported instead as a device malfunction), the identification of safety signals may be delayed. Although the FDA must review all reports classified as death, it does not routinely review all reports that are classified as injury or malfunction.10

A prior report from our research group12 showed high rates of miscategorization of deaths as malfunctions or injuries for 2 high-risk cardiac devices, the Sapiens 3 aortic valve (Edwards Lifesciences) and the MitraClip (Abbott Vascular), a device used for transcatheter mitral valve repair. In this study, we expand on our earlier article by examining adverse event reports for all medical devices in MAUDE to determine how often a death was reported in a category other than death.

Methods

Data Source

We reviewed adverse event reports in MAUDE from its inception on December 31, 1991, to April 30, 2020. Given that MAUDE is a publicly accessible database that stores only deidentified information, this study was exempt from institutional review board approval. We used a proprietary software (Device Events) that exports MAUDE data into an interface that can be used to navigate the FDA database.13 The software uses a natural language processing algorithm to help identify reports in which there was a death. The natural language processing algorithm searches the free text in reports for terms such as patient died, patient expired, could not be resuscitated, and time of death, which are likely to be associated with death. The algorithm allows for plural and past tense versions of words (eg, death includes deaths and die includes died). The algorithm also excludes reports with selected phrases that are unlikely to be associated with death (eg, patient passed out should be excluded, although the term patient passed should not be excluded).

Contents of MAUDE Adverse Event Reports

The terms included in a MAUDE report include report ID, date of event, date of manufacturer receipt, date of report, date FDA received report, report type, report source, reporter occupation, company name, product code, device name, device brand name, and device generic name. Reporters must also complete an unstructured free text box to provide a more detailed event description. The report type refers to whether the adverse event reporter classified the patient event outcome as a death, malfunction, injury, other, or did not classify the report (missing). The report source describes whether a report was submitted by a user facility, manufacturer, voluntary reporter, or distributor. The Device Events software added a term for the device class (class I-III) associated with the report by matching the device product code with the appropriate class of the device.

Search Query

We included MAUDE reports with at least 1 of 70 terms that were associated with death. As our interest was in the reporting of deaths in categories other than death, we then limited the data set to reports in which the outcome was classified as injury, malfunction, other, or missing and manually reviewed selected reports.

Primary Outcome

The primary outcome was the percentage of reports in which the patient's ultimate outcome was death, but the report had not been classified as death by the reporter. One of 2 authors (C.L. and E.M.K.) read the report descriptions to determine if a death occurred.

Statistical Analysis

We reviewed the event descriptions for a simple random sample of up to 50 injury, malfunction, other, and missing reports for each of the 70 terms for descriptions of a patient death ( Figure ). We selected all random samples by assigning a random number to each report in Microsoft Excel and selecting the reports with the 50 lowest assigned numbers. If there were fewer than 50 total reports for a given term, we reviewed all reports.

We calculated the percentage of reports in which a death was identified in the narrative among all reviewed reports (ie, all reports among those classified as injury, malfunction, other, or missing). If there were no reports in which the patient's ultimate outcome was death, the search term was removed from analysis; 8 terms were removed for this reason, leaving 62 terms.

For each term, we determined the confidence interval for the percentage of these reports that were classified not as death but as injury/malfunction/other/missing despite a patient death in the full data set based on the percentage of death reports calculated from our manual review. We used the epitools package in the R statistical software (R Foundation) to calculate an exact binomial proportion confidence interval. We then determined the number of reports (in multiples of 50) to be reviewed to ensure a confidence interval width of less than 5% for the estimate for the true percentage of these death reports. We calculated 95% confidence intervals, which resulted in statistical significance for P  < .05. This calculation was performed by assuming that the estimated percentage of reports in which a patient death occurred but the death was classified as injury/malfunction/other/missing instead of death in a random sample of 50 reports for a given term would generalize to the entire population of reports. For example, if all 50 of 50 manually reviewed reports (100%) for a given term were determined to have a patient outcome of death, the estimated percentage of such death reports was considered to be 100%, and approximately 100 reports would have to be reviewed to ensure a confidence interval at least as narrow as 95% to 100% for the true percentage. If the total number of reports that needed to be reviewed was greater than the total number of reports for a given term, all reports were reviewed, and an exact percentage was calculated. We reviewed all reports for 44 of 62 terms (71.0%). We estimated the total number of death reports that were classified in other categories for each of the 18 terms, for which we calculated confidence intervals by multiplying the estimated percentage of reports with deaths that were classified in other categories for the manually reviewed random sample of reports by the total number of reports that were classified as injury, malfunction, other, or missing.

To estimate the total number of reports of deaths that were classified in categories other than death, we also reviewed a random sample of 1000 reports from the full data set (138 996 reports in categories other than death). We counted the number of reports with death classified in other categories from this manually reviewed random sample of 1000 reports and applied that percentage to the overall sample (138 996 reports). We defined the percentage of missed deaths as the number of reports in which a patient's outcome was classified as injury/malfunction/other/missing (ie, not as death), but in which the patient had died, divided by the total number of reports with the outcome of patient death.

Results

Sample Characteristics

The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death ( Figure and Table 1 ). Most reports (162 147 [55.9%]) were submitted for class III devices; 116 358 (40.1%) were for class II devices. Of the reports, 50.1% were received by the FDA between January 2015 and April 2020. Nearly all reports were submitted by manufacturers (95.9%). There was more than 1 term associated with death, such as expired, could not be resuscitated, and pt passed in 52.8% of reports. There was no specified reporter occupation for 139 436 reports (48.1%); when specified, the most frequent reporter occupation was physician (58 787 [20.3%]), which likely refers to either physicians reporting adverse events to manufacturers or physicians employed by manufacturers. The most common product codes among all adverse event reports were ventricular (assist) bypass, with 38 708 reports; dialysate concentrate for hemodialysis (liquid or powder), with 25 261 reports; and transcervical contraceptive tubal occlusion device, with 14 387 reports.

Table 1.

Characteristic

No. (%)

Report type

Death

151 145 (52.1)

Injury

77 516 (26.7)

Malfunction

58 025 (20.0)

Other/missing

3455 (1.2)

Device class

I

7399 (2.6)

II

116 358 (40.1)

III

162 147 (55.9)

Undetermined

4237 (1.5)

Year of report receipt by FDA

Before 1995

1161 (0.4)

1995-1999

11 467 (4.0)

2000-2004

13 198 (4.5)

2005-2009

24 675 (8.5)

2010-2014

94 170 (32.5)

2015-April 2020

145 377 (50.1)

Missing

93 (0.0)

Report source

Manufacturer

278 251 (95.9)

User facility

6172 (2.1)

Voluntary

4778 (1.6)

Distributor

940 (0.3)

Reporter occupation

Unspecified a

139 436 (48.1)

Physician

58 787 (20.3)

Health care personnel b

41 329 (14.2)

Attorney

26 314 (9.1)

Nurse

10 965 (3.8)

Patient, patient family, or caregiver

6757 (2.3)

Risk manager

4792 (1.7)

Medical equipment company technician/representative

1538 (0.5)

Service/testing personnel

223 (0.1)

Device product code c

DSQ: ventricular (assist) bypass

38 708 (13.3)

KPO: dialysate concentrate for hemodialysis (liquid or powder)

25 261 (8.7)

HHS: transcervical contraceptive tubal occlusion device

14 387 (5.0)

NIQ: coronary drug-eluting stent

11 296 (3.9)

LWS: implantable cardioverter-defibrillator (non-CRT)

10 006 (3.4)

MVK: wearable automated external defibrillator

9273 (3.2)

DTB: permanent pacemaker electrode

8332 (2.9)

MIH: system, endovascular graft, aortic aneurysm treatment

6562 (2.3)

DTK: filter, intravascular, cardiovascular

5777 (2.0)

LZG: pump, infusion, insulin

5005 (1.7)

Reports in Which the Patient Died but Which Were Not Classified as Death

For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. Of the 70 natural language processing terms, 62 (88.6%) were associated with deaths that were categorized in other categories. We reviewed a total of 7951 reports for all terms. The reports for 44 (71.0%) of the terms were reviewed in full because of small sample sizes. For the 18 terms with sample sizes that were large enough to calculate confidence intervals, the term death(s) was associated with the highest total number of reports in which the patient died but had been classified as injury/malfunction/other/missing (instead of death). For the term death(s), the percentage of such reports not classified as deaths was 12% (95% CI, 9%-14%) based on our review of a random sample of 600 reports containing the term death(s), suggesting that approximately 13 156 reports with this term had deaths that were classified in other categories. Of the 62 terms, 17 (27.4%) had an estimated percentage of 100%, which means that every time that term was used, the patient had died, even though the reporter had not classified the report as death ( Table 2 ).

Table 2.

Term

Total No.

No.

% of Reports that were classified as death (with 95% CI when calculated)a

Reports

Nondeath reports

Reports reviewed

Reports in which the patient had died

Missed Deaths

In the random sample of 1000 reports that were not classified as death, the overall percentage of missed deaths, defined as the percentage of all deaths that were classified in other categories, was 17% (95% CI, 16%-19%). The term with the highest percentage of missed deaths among the 44 terms reviewed in full was unreported cause of death, with a total of 5 reports and a 60% missed death rate ( Table 3 ). The term with the highest percentage of missed deaths among the 18 terms reviewed partially was patients died, which had a missed death percentage of 70% (95% CI, 69%-70%).

Table 3.

Term

Total No.

No.

% of Missed death reports (with 95% CI when calculated)a

Reports

Nondeath reports

Reports reviewed

Deaths that were not classified as deaths

Discussion

We found that a large percentage of adverse event reports in the FDA's MAUDE database that involved a patient death were classified in categories other than death by the reporter. The classification chosen by the reporter is vital, as the FDA must review all adverse events reported as deaths, which is not the case for the other reporting categories.10 Per FDA instructions, reports of a device malfunction or injury that include a patient death should be reported as death if the death may be associated with the device malfunction or if the cause of death is unknown.11 However, it is possible that manufacturers or other reporters do not classify the patient outcome as death if they do not believe that the death was definitively caused by the device.

The MAUDE database allows for the identification of safety signals for medical devices that are repeatedly associated with serious adverse events. Accurate reporting of patient deaths allows the FDA to pursue investigations to determine if there is cause for concern, notify clinicians, and, when appropriate, take regulatory actions to protect patient safety.14 Thus, it is essential that all deaths be classified and reported appropriately as deaths. There is a disclaimer on the MAUDE database that states, "Submission of a medical device report and the FDA's release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event."7

Our findings suggest that the FDA could improve the identification of fatalities among patients with medical devices by using search terms, such as decedent and pt expired, within reports to help identify patterns and clusters of reports that are associated with higher rates of patient death. Using a natural language processing algorithm, as in our study, could help streamline the full review of reports that are more likely to be associated with patient death at a time when the numbers of medical devices and adverse event reports are substantially increasing.14,15 Future studies could evaluate other terms or consider using a machine learning algorithm (with the terms in our study or others) to allow for more rapid evaluation of reports to identify patient deaths, such as has been explored for drug adverse event reporting.16

Currently, manufacturers report, and thus choose, the reporting category for more than 95% of adverse event reports. There is an inherent conflict with manufacturers being the primary reporters, as it may not be in their interest to facilitate identification of serious problems with their own devices in a timely manner. There have been multiple instances of delays by manufacturers in reporting serious malfunctions and deaths that were associated with medical devices, as well as complete failures to report.17,18,19 As a result, it seems likely that more patients have been unknowingly treated with devices that turned out to be dangerous than would have been the case if reporting had not been delayed. Some examples of delayed reporting of adverse events associated with implantable cardioverter-defibrillator leads include delays by St Jude Medical17 and Medtronic.18 In another reporting failure, between 2002 and 2013, 32 000 women reported adverse events associated with Essure (Conceptus), a medical device used for permanent birth control, to the manufacturer, yet the FDA only received 1023 events (3.2%) during that period from the manufacturer.13,19 Bard received multiple warning letters following inspections in 2014 and 2015 that cited multiple failures, including a failure to comply with the medical device reporting regulations by misreporting patient deaths that were associated with vena caval filters as malfunctions.20 For these reasons, physicians, hospitals, and patients should submit reports directly to the FDA instead of or in addition to reporting through the manufacturer. The FDA could facilitate such reporting by making a freely available user-friendly mobile application that patients and physicians could use to report adverse events directly to the agency.

Limitations

Our study has limitations. We performed a manual review of a subset of adverse event reports. Specifically, we reviewed all of the reports for 44 of the 62 terms that were associated with death reports in categories other than death and used random samples with narrow confidence intervals (<5% confidence interval width) to create estimates of misclassified reports and missed deaths that were associated with the other 18 terms. As we only included reports that contained at least 1 term that was likely to be associated with a death and not all reports in the MAUDE database, our findings likely underestimate the actual number of deaths that were not classified as death, even when the patient died.

Conclusions

Many deaths in persons with medical devices are reported to the FDA as adverse events in categories other than death. Our findings suggest that the FDA's adverse event reporting form should be revised to make it even clearer that if the cause of death in a patient with a medical device is unknown, as it often is,21 it still should be reported in the category of death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

References

13. Device Events . Improve patient outcomes & reduce risk through better information. Accessed April 16, 2021. https://www.deviceevents.com

Articles from JAMA Internal Medicine are provided here courtesy of American Medical Association

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Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death

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When a medical device adverse event report in the US Food and Drug Administration Manufacturer and User Facility Device Experience database describes a patient death, how often is that report classified as injury, malfunction, other, or missing instead ...

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Under federal rules, hospitals have 10 days to report serious device-related injuries to the device's manufacturer and to notify both the manufacturer and the FDA about any deaths that may have resulted.

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The manufacturer of the device and the FDA are responsible for notifying the hospital that a medical device in use may cause harm to patients.

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If the defibrillator is attributed to the patients death it is the hospitals responsibility to report it to the medical examiner, coroner, and the FDA.

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Overview of Medical Device Reporting

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See " Medical Device Reporting for User Facilities," a guidance document issued by the FDA.

Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.

Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Voluntary Malfunction Summary Reporting Program

The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 ( 82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, ( 83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 ( 83 FR 40973):

1. Any reportable malfunction associated with a 5-day report under § 803.53(a).

2. If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.

3. The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:

Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.

Where there was a high level of uncertainty regarding device risk.

Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.

Where there were ongoing signals or other safety-related investigations for the device.

These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).

1. The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.

Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

2. The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.

In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.

Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.

Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:

The firm's name, address, registration number

The contact person's name, telephone number, and email address

Complete device identification and description, including product code and review panel

A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any

As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status

Voluntary Medical Device Reporting

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.

How to Report a Medical Device Problem

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

Find information and instructions for mandatory device reporting at:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:

To Report an Emergency

If you have identified a public health emergency, you may use the following contact information to alert the FDA:

FDA Office of Crisis Management, Emergency Operations Center

Submitting Medical Device Reports for Devices Licensed as Biological Products

While most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.

Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 - Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Searching Medical Device Reports

The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 - 1996 and reports received under the Alternative Summary Reporting Program from 1999 - April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.

Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.

Contact

For general questions, please contact the Division of Industry and Consumer Education (DICE).

Additional Resources

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Medical Device Reporting (MDR): How to Report Medical Device Problems

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Requirements for reporting medical device problems, including malfunctions and adverse events (serious injuries or deaths) associated with medical devices.

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Mileen San Juan

The one responsible for notifying the hospital that a medical device in use may cause harm to patients is the FDA (Food and Drug Administration). They are responsible to protect the public in ensuring the safety, effectiveness and security of the medical device.

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Overview of Medical Device Reporting

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See " Medical Device Reporting for User Facilities," a guidance document issued by the FDA.

Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.

Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Voluntary Malfunction Summary Reporting Program

The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 ( 82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, ( 83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 ( 83 FR 40973):

1. Any reportable malfunction associated with a 5-day report under § 803.53(a).

2. If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.

3. The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:

Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.

Where there was a high level of uncertainty regarding device risk.

Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.

Where there were ongoing signals or other safety-related investigations for the device.

These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).

1. The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.

Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

2. The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.

In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.

Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.

Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:

The firm's name, address, registration number

The contact person's name, telephone number, and email address

Complete device identification and description, including product code and review panel

A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any

As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status

Voluntary Medical Device Reporting

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.

How to Report a Medical Device Problem

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

Find information and instructions for mandatory device reporting at:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:

To Report an Emergency

If you have identified a public health emergency, you may use the following contact information to alert the FDA:

FDA Office of Crisis Management, Emergency Operations Center

Submitting Medical Device Reports for Devices Licensed as Biological Products

While most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.

Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 - Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Searching Medical Device Reports

The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 - 1996 and reports received under the Alternative Summary Reporting Program from 1999 - April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.

Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.

Contact

For general questions, please contact the Division of Industry and Consumer Education (DICE).

Additional Resources

# data[].attributes.attachment_link.title
Medical Device Reporting (MDR): How to Report Medical Device Problems

# data[].attributes.attachment_link.description
Requirements for reporting medical device problems, including malfunctions and adverse events (serious injuries or deaths) associated with medical devices.

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Hospitals must report to CMS any death that occurs while a patient is restrained or in seclusion for behavior management, or when it is reasonable to assume that a patient's death is the result of restraint or seclusion.

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Hospitals must report to CMS any death that occurs while a patient is restrained or in seclusion for behavior management, or when it is reasonable to assume that a patient's death is the result of restraint or seclusion.

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Hospitals must report to CMS any death that occurs while a patient is restrained or in seclusion for behavior management, or when it is reasonable to assume that a patient's death is the result of restraint or seclusion.

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A covered entity may disclose protected health information to a coroner or medical examiner for the purpose of identifying a deceased person, determining a cause of death, or other duties as authorized by law.

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A covered entity may disclose protected health information to a coroner or medical examiner for the purpose of identifying a deceased person, determining a cause of death, or other duties as authorized by law.

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The hospital is required to report the patient's death to the medical examiner/coroner to determine an actual cause of death due to any of these circumstances 1) the death was unexpected and no medical cause can be determined; 2) the decedent was not under the care of a physician for any disease which could reasonably be expected to cause death; or 3) the death might be a public health hazard.

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The hospital is required to report the patient's death to the medical examiner/coroner to determine an actual cause of death due to any of these circumstances 1) the death was unexpected and no medical cause can be determined; 2) the decedent was not under the care of a physician for any disease which could reasonably be expected to cause death; or 3) the death might be a public health hazard.

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The additional required reporting must be done by Wesley Glen and the hospital in regard to the patient’s death, they need to report the death from restraints to CMS because of Conditions of Participation right's rule. It must be documented in the patient’s health record the date and time that the death was reported. It must be recorded in the internal log/system within 7 days of death key health Information. And lastly, it should be reported to FDA since there is a medical device involved.

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A manufacturer and/ or importer is required to report any informations they learn about their devices that may cause death or serious injury. There is a Manufacturer and User Facility Device Experience (MAUDE) database with information on reported devices. Wesley Glen should notify the hospital of the device when the patient is transferred there.

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Overview of Medical Device Reporting

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See " Medical Device Reporting for User Facilities," a guidance document issued by the FDA.

Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.

Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Voluntary Malfunction Summary Reporting Program

The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 ( 82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, ( 83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual Medical Device Report (MDR) or VMSR.

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 ( 83 FR 40973):

1. Any reportable malfunction associated with a 5-day report under § 803.53(a).

2. If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or similar device marketed by the manufacturer must be submitted as an individual report until the recall is terminated.

3. The FDA has determined that individual MDR reporting is necessary to address a public health issue for certain devices. Examples of situations where the FDA has determined that individual reporting is necessary to address a public health issue include:

Where the device was reusable and represented a high risk of infection if not adequately reprocessed. Appendix E of the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance," identifies device types associated with such risks.

Where there was a high level of uncertainty regarding device risk.

Where malfunction events were potentially attributed to complex failure modes and root causes were not well understood.

Where there were ongoing signals or other safety-related investigations for the device.

These are examples of situations where individual malfunction reporting data are needed in place of summary information to understand malfunction events and the causes of those events. Public health issues may involve a specific individual device or multiple devices (for example, all devices of the same type).

1. The FDA has determined that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

Where there has been a failure to comply with applicable MDR requirements under 21 CFR Part 803 or a failure to follow the conditions of the VMSR program.

Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

2. The reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to the FDA for that device.

In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. The FDA periodically assesses the eligibility of product codes for the VMSR program.

Eligibility Status: The status of a given device product code for summary reporting under the VMSR program is listed in the CDRH Product Classification Database.

Eligibility Requests: If a manufacturer would like to request, under 21 CFR 803.19(b), that the FDA consider whether a given device product code should be eligible for the VMSR program, they can email their request to MDRPolicy@fda.hhs.gov, with the following information:

The firm's name, address, registration number

The contact person's name, telephone number, and email address

Complete device identification and description, including product code and review panel

A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any

As part of the justification for the request, it is helpful to provide a copy of any prior FDA correspondence regarding device eligibility status

Voluntary Medical Device Reporting

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.

How to Report a Medical Device Problem

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

Find information and instructions for mandatory device reporting at:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:

To Report an Emergency

If you have identified a public health emergency, you may use the following contact information to alert the FDA:

FDA Office of Crisis Management, Emergency Operations Center

Submitting Medical Device Reports for Devices Licensed as Biological Products

While most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) is also responsible for the regulation of certain medical devices.

Currently, CBER is designated the lead center in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures. For more information unique to IVDs, see Overview of IVD Regulation.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 - Medical Device Reporting. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products.

Searching Medical Device Reports

The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

There are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 - 1996 and reports received under the Alternative Summary Reporting Program from 1999 - April 2019 are not available in MAUDE. In the spirit of promoting public transparency, the FDA posted Alternative Summary Reporting (ASR) data and Device Experience Network (DEN) reports on the MDR Data Files page.

Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.

Contact

For general questions, please contact the Division of Industry and Consumer Education (DICE).

Additional Resources

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Medical Device Reporting (MDR): How to Report Medical Device Problems

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Requirements for reporting medical device problems, including malfunctions and adverse events (serious injuries or deaths) associated with medical devices.

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Mileen San Juan

The medical examiners and the coroners have the right to receive patient information needed to investigate a case, HIPAA specifically defines exemption to them thru (45 CFR § 164.512(g)(1)) (17) and other relevant exemptions.

As stated, "45 CFR § 164.512—Uses and disclosures for which an authorization or opportunity to agree or object is not required.

A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity’s information and the individual’s agreement may be given orally."

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It is critical for medical examiner and coroner (ME/C) offices to obtain the medical history as part of the investigation of their cases; Medical examiners and coroners have broad statutory authority to investigate deaths falling within their jurisdiction. Most hospitals and clinics will comply with requests from ME/C for the electronic health records. However, lawyers in some medical systems automatically respond to not allow such disclosures based upon Title II of the Health Insurance Portability and Accountability Act of 1996 (HIPAA or the Kennedy-Kassebaum Act) ( 1)-they are naive. Somewhat analogously, some have mistakenly claimed during the COVID-19 pandemic that HIPAA prevents disclosure of vaccination status ( 2).

HIPAA consists of five Titles that encompass insurance, medical spending account, and group health plan regulations among other things ( 3). HIPAA includes the Privacy Rule (45 CFR 160 and 164) and the Security Rule (45 CFR 160, 162, and 164) that protect the confidentiality (nondisclosure) and security of Protected Health Information (PHI) ( 4 - 6). Electronic communications are of particular concern and HIPAA's security rules apply specifically to electronic transactions ( 7), but the privacy rules apply to PHI in "any form or medium"-including paper records, as well as electronic records, faxes, emails, exchanges in phone conversations, and face-to-face talk. The U.S. Department of Health and Human Services (HHS) Office for Civil Rights enforces the Privacy Rule ( 8); penalties were strengthened in 2009 in Subtitle D of the HITECH Act ( 9).

Protected Health Information is individually identifiable health information that relates to the past, present, or future physical or mental health or condition of an individual, that is linked to the specific person, and is transmitted or maintained in electronic media or any other form, with certain specific exceptions, such as in education and employment records ( 10). There are 18 identifiers that must be removed for deidentification ( 11). Originally HIPAA did not apply to deceased patients, but this was specifically changed and now it applies for 50 years following the death of a patient ( 12).

HIPAA confers a certain set of national "health information rights," as well as a requirement for notice of these rights, to all patients. Specifically, these rights include: 1) a right of access to records, 2) a right to amend the records to correct errors or to enter statements of disagreement, 3) a right to receive an accounting of uses and disclosures of records, 4) a right to request restrictions on access to or additional protections of particularly sensitive data, and 5) a right to prevent certain reasonable "additional" types of use and disclosure. The HITECH Act gives patients a right to request electronic copies of their record; entities generally have 30 days to respond. Patients may complain of violations of their HIPAA rights to an entity's Privacy Officer and, if not satisfied, to the HHS Office of Civil Rights or to state-level agencies.

There are three major categories of health information uses and disclosures: 1) no permission required, 2) oral permission required, and 3) written permission required. The no permission required category is the largest and pertains to treatment, payment, and other core health care operations (TPO). Beyond TPO, there are other broad categories of data that do not require specific disclosure, such as information related to public health and health system oversight activities, reporting about victims of abuse, neglect, or domestic violence, content for judicial and administrative proceedings, and activities related to "specialized governmental functions." Oral permission is allowed for disclosures such as inclusion or exclusion from facility directories, as well as uses and disclosures to friends and family involved in the person's care. Specific written authorization is needed for research, marketing, and fundraising. As a general rule, if a person has a right to make a health care decision, then that person has a right to control information associated with that decision.

Health care workers have three personal legal obligations: 1) to use or disclose PHI only for legitimate, work-related purposes, 2) to limit use or disclosure to only the minimum necessary information to achieve the work-related purposes, and 3) to exercise reasonable and appropriate caution to protect the PHI.

HIPAA applies to "covered entities" as defined by the HHS. Covered entities include: 1) health plans, 2) health care clearinghouses (such as billing services), and 3) health care providers that electronically transmit PHI ( 13, 14). Medical examiner and coroner offices are not covered entities. Covered entities must maintain compliance with HIPAA guidelines. HIPAA permits covered entities to disclose PHI to business associates that may not be covered entities through business associate agreements that require no further disclosure from the business associate ( 15). Business associates are generally defined as a person or organization (other than a member of a covered entity's workforce) using or disclosing individually identifiable health information to perform or provide functions, activities, or services for a covered entity ( 5, 16).

HIPAA specifically defines exemptions, where the consent of the patient is not required. These specifically exempt coroners and medical examiners (45 CFR § 164.512(g)( 1)) ( 17), and other relevant exemptions including disclosures where required by law and for public health purposes ( 18), law enforcement purposes ( 19), funeral home directors, organ and tissue donations, and some types of research:

45 CFR § 164.512-Uses and disclosures for which an authorization or opportunity to agree or object is not required.

A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity's information and the individual's agreement may be given orally.

(a) Standard: Uses and disclosures required by law.

1. A covered entity may use or disclose protected health information to the extent that such use or disclosure is required by law and the use or disclosure complies with and is limited to the relevant requirements of such law.

2. A covered entity must meet the requirements described in paragraph (c), (e), or (f) of this section for uses or disclosures required by law.

(b) Standard: Uses and disclosures for public health activities -

(1) Permitted uses and disclosures. A covered entity may use or disclose protected health information for the public health activities and purposes described in this paragraph to:

(i) A public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions; or, at the direction of a public health authority, to an official of a foreign government agency that is acting in collaboration with a public health authority;

(ii) A public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect;

(iv) A person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading a disease or condition, if the covered entity or public health authority is authorized by law to notify such person as necessary in the conduct of a public health intervention or investigation; or

(f) Standard: Disclosures for law enforcement purposes. A covered entity may disclose protected health information for a law enforcement purpose to a law enforcement official if the conditions in paragraphs (f)(1) through (f)(6) of this section are met, as applicable.

(1) Permitted disclosures: Pursuant to process and as otherwise required by law. A covered entity may disclose protected health information:

(i) As required by law including laws that require the reporting of certain types of wounds or other physical injuries, except for laws subject to paragraph (b)(1)(ii) or (c)(1)(i) of this section; or

(ii) In compliance with and as limited by the relevant requirements of:

(A) A court order or court-ordered warrant, or a subpoena or summons issued by a judicial officer;

(B) A grand jury subpoena; or

(C) An administrative request, including an administrative subpoena or summons, a civil or an authorized investigative demand, or similar process authorized under law, provided that:

(1) The information sought is relevant and material to a legitimate law enforcement inquiry;

(2) The request is specific and limited in scope to the extent reasonably practicable in light of the purpose for which the information is sought; and

(3) De-identified information could not reasonably be used.

(2) Permitted disclosures: Limited information for identification and location purposes. Except for disclosures required by law as permitted by paragraph (f)(1) of this section, a covered entity may disclose protected health information in response to a law enforcement official's request for such information for the purpose of identifying or locating a suspect, fugitive, material witness, or missing person, provided that:

(i) The covered entity may disclose only the following information:

(B) Date and place of birth;

(C) Social security number;

(D) ABO blood type and rh factor;

(F) Date and time of treatment;

(G) Date and time of death, if applicable; and

(H) A description of distinguishing physical characteristics, including height, weight, gender, race, hair and eye color, presence or absence of facial hair (beard or moustache), scars, and tattoos.

(ii) Except as permitted by paragraph (f)(2)(i) of this section, the covered entity may not disclose for the purposes of identification or location under paragraph (f)(2) of this section any protected health information related to the individual's DNA or DNA analysis, dental records, or typing, samples or analysis of body fluids or tissue.

(3) Permitted disclosure: Victims of a crime. Except for disclosures required by law as permitted by paragraph (f)(1) of this section, a covered entity may disclose protected health information in response to a law enforcement official's request for such information about an individual who is or is suspected to be a victim of a crime, other than disclosures that are subject to paragraph (b) or (c) of this section, if:

(i) The individual agrees to the disclosure; or

(ii) The covered entity is unable to obtain the individual's agreement because of incapacity or other emergency circumstance, provided that:

(A) The law enforcement official represents that such information is needed to determine whether a violation of law by a person other than the victim has occurred, and such information is not intended to be used against the victim;

(B) The law enforcement official represents that immediate law enforcement activity that depends upon the disclosure would be materially and adversely affected by waiting until the individual is able to agree to the disclosure; and

(C) The disclosure is in the best interests of the individual as determined by the covered entity, in the exercise of professional judgment.

(4) Permitted disclosure: Decedents. A covered entity may disclose protected health information about an individual who has died to a law enforcement official for the purpose of alerting law enforcement of the death of the individual if the covered entity has a suspicion that such death may have resulted from criminal conduct.

(5) Permitted disclosure: Crime on premises. A covered entity may disclose to a law enforcement official protected health information that the covered entity believes in good faith constitutes evidence of criminal conduct that occurred on the premises of the covered entity.

(6) Permitted disclosure: Reporting crime in emergencies.

(i) A covered health care provider providing emergency health care in response to a medical emergency, other than such emergency on the premises of the covered health care provider, may disclose protected health information to a law enforcement official if such disclosure appears necessary to alert law enforcement to:

(A) The commission and nature of a crime;

(B) The location of such crime or of the victim(s) of such crime; and

(C) The identity, description, and location of the perpetrator of such crime.

(ii) If a covered health care provider believes that the medical emergency described in paragraph (f)(6)(i) of this section is the result of abuse, neglect, or domestic violence of the individual in need of emergency health care, paragraph (f)(6)(i) of this section does not apply and any disclosure to a law enforcement official for law enforcement purposes is subject to paragraph (c) of this section.

(g) Standard: Uses and disclosures about decedents -

(1)  Coroners and medical examiners. A covered entity may disclose protected health information to a coroner or medical examiner for the purpose of identifying a deceased person, determining a cause of death, or other duties as authorized by law. A covered entity that also performs the duties of a coroner or medical examiner may use protected health information for the purposes described in this paragraph.

(2)  Funeral directors. A covered entity may disclose protected health information to funeral directors, consistent with applicable law, as necessary to carry out their duties with respect to the decedent. If necessary for funeral directors to carry out their duties, the covered entity may disclose the protected health information prior to, and in reasonable anticipation of, the individual's death.

(h) Standard: Uses and disclosures for cadaveric organ, eye or tissue donation purposes. A covered entity may use or disclose protected health information to organ procurement organizations or other entities engaged in the procurement, banking, or transplantation of cadaveric organs, eyes, or tissue for the purpose of facilitating organ, eye or tissue donation and transplantation.

(i) Standard: Uses and disclosures for research purposes -

(1) Permitted uses and disclosures. A covered entity may use or disclose protected health information for research, regardless of the source of funding of the research, provided that:

(i) Board approval of a waiver of authorization. The covered entity obtains documentation that an alteration to or waiver, in whole or in part, of the individual authorization required by § 164.508 for use or disclosure of protected health information has been approved by either:

(A) An Institutional Review Board (IRB), established in accordance with 7 CFR lc.107, 10 CFR 745.107, 14 CFR 1230.107, 15 CFR 27.107, 16 CFR 1028.107, 21 CFR 56.107, 22 CFR 225.107, 24 CFR 60.107, 28 CFR 46.107, 32 CFR 219.107, 34 CFR 97.107, 38 CFR 16.107, 40 CFR 26.107, 45 CFR 46.107, 45 CFR 690.107, or 49 CFR 11.107; or

...

[bold highlights added]

Independent forensic pathologists and organizations contracted to perform medicolegal death investigations for jurisdictions operate under color of law and would probably fall under the "Coroner and Medical Examiner" exemption. Private forensic pathology consultants and consultation services performing private consultations would probably not be exempt, although they may gain access by consent or legal process; but they would not be "covered entities."

Coroner offices and a few medical examiner offices have subpoena power that help the situation where a medical system refuses release of the records.

It is important to recognize that many states may have their own privacy laws, often covering specific types of data (such as data on mental health treatment, HIV, sexually transmitted infections, genetic tests, and substance abuse), that supplement the federal HIPAA laws that could also potentially impact disclosure ( 20, 21). Furthermore, constraints also flow from nongovernment sources on medical institutions, such as through certification by The Joint Commission (formerly known as JCAHO), and providers through their professional codes of ethics.

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HIPAA and Access to Medical Information by Medical Examiner and Coroner Offices

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Often, medical staff and sometimes their attorneys mistakenly believe that HIPAA prevents disclosure of medical records to medical examiner and coroner offices. Medical examiner and coroner government offices are not covered entities. Moreover, HIPAA ...

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HIPAA and Access to Medical Information by Medical Examiner and Coroner Offices

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Medical examiners and coroners have the right to receive medical information needed to investigate the case without authorization and may have subpoena powers to collect such information. Medical examiners and coroners are not covered entities. Under HIPAA, patient information disclosure is permitted to law enforcement, public health, and medical examiners and coroners.

Weedn V. W. (2022). HIPAA and Access to Medical Information by Medical Examiner and Coroner Offices. Academic forensic pathology, 12(3), 83–89. https://doi.org/10.1177/19253621221102039

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The hospital will need to report:

1.Name and address

2.Age

3.Marital status

4. Ethnicity

5.Onset of cause of death

6.Place, mode, and manner of injury

7.Place of death

8.Time of death

9.Location of body

10.Information regarding restraints, the defibrillator, and bruising

11.Name of staff reporting, date, and time

12. Name of physician whom pronounced the death.

Wesley Glen Senior Living Facility will need to report:

1. The use of restraints

2.The defibrillator

3. The bruises

4.Information regarding hospitalization

5.Any occurrences

6.Any injury determined by a physician

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(a) Each licensee shall furnish to the licensing agency such reports as the Department may require, including, but not limited to, the following:

(1) A written report shall be submitted to the licensing agency and to the person responsible for the resident within seven days of the occurrence of any of the events specified in (A) through (D) below. This report shall include the resident's name, age, sex and date of admission; date and nature of event; attending physician's name, findings, and treatment, if any; and disposition of the case.

(A) Death of any resident from any cause regardless of where the death occurred, including but not limited to a day program, a hospital, en route to or from a hospital, or visiting away from the facility.

(B) Any serious injury as determined by the attending physician and occurring while the resident is under facility supervision.

(C) The use of an Automated External Defibrillator.

(D) Any incident which threatens the welfare, safety or health of any resident, such as physical or psychological abuse of a resident by staff or other residents, or unexplained absence of any resident.

(2) Occurrences, such as epidemic outbreaks, poisonings, catastrophes or major accidents which threaten the welfare, safety or health of residents, personnel or visitors, shall be reported within 24 hours either by telephone or facsimile to the licensing agency and to the local health officer when appropriate.

(3) Fires or explosions which occur in or on the premises shall be reported immediately to the local fire authority; in areas not having organized fire services, within 24 hours to the State Fire Marshal; and no later than the next working day to the licensing agency.

(b) The licensee shall notify the Department, in writing, within thirty (30) days of the hiring of a new administrator. The notification shall include the following:

(1) Name and residence and mailing addresses of the new administrator.

(2) Date he/she assumed his/her position.

(3) Description of his/her background and qualifications, including documentation of required education and administrator certification.

(A) A photocopy of the documentation is acceptable.

(c) Any change in the chief corporate officer of an organization, corporation or association shall be reported to the licensing agency in writing within fifteen (15) working days following such change. Such notification shall include the name, address and the fingerprint card of the new chief executive officer, as required by Section 87355, Criminal Record Clearance.

Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections 1569.1,1569.2, 1569.31, 1569.312, 1569.616 and 1797.196, Health and Safety Code.

1. Change without regulatory effect renumbering former section 87561 and former section 87560, subsection (c) to new section 87211 filed 3-5-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 10).

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Cal. Code Regs. Tit. 22, § 87211 - Reporting Requirements

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(a) Each licensee shall furnish to the licensing agency such reports as the Department may require, including, but not limited to, the following: (1) A written report shall be submitted to the licensing agency and to the person responsible for the resident within seven days of the occurrence of any of the events specified in (A) through (D) below.

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HHS, OIG: HOSPITAL REPORTING OF DEATHS RELATED TO RESTRAINT AND SECLUSION

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Because of signs of abuse including injuries, this death might be considered a suspicious death, which must be examined by the medical examiner or coroner.

This death also constitutes a serious occurrence or death related to restraint or seclusion, which is required to be reported. Since the patient is over 60 years of age, this case might also be considered abuse of the elderly, which requires reporting as well.

H.H.S, O. I. G. (2006, September 11). Hospital Reporting of Deaths Related to Restraint and Seclusion (OEI-09-04-00350; 09/06).

https://oig.hhs.gov/oei/reports/oei-09-04-00350.pdf

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Mileen San Juan

The hospital is required to report this patient's death to the medical examiner/coroner because there is an incident of sudden or suspicious death. The expired patient was physically abusive to himself and others, the unexpected death of the patient needs to be investigated since he was sedated and restraint after 15 hours.

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Coroner/Medical Examiner Laws

Is medical death investigation system centralized, county-based, or district-based?
County-based. Cal. Gov't Code § 24010.

If centralized, in which department or agency is the system housed?
Not applicable.

Does the state system have a coroner, medical examiner, or coroners and medical examiners?
Coroners and medical examiners. Notwithstanding any other provision of law, the board of supervisors may by ordinance abolish the office of coroner and provide instead for the office of medical examiner, to be appointed by the said board and to exercise the powers and perform the duties of the coroner. Cal. Gov't Code § 24010 [Title 3, Government of Counties].

Notwithstanding the provisions of Section 24300, in counties of the 11th class, the board of supervisors by ordinance may consolidate the duties of certain of the county offices, in one or both of these combinations:

(a) County clerk, assessor, and recorder.

(b) Sheriff, coroner, and public administrator.

Cal. Gov't Code § 24304.1.

"In practice" notes
None.

Is there a state medical examiner?
No.

If so, what is the state medical examiner's role?
Not applicable.

In what department or agency is the state medical examiner's office located?
Not applicable.

Are there deputies?
Every county or district officer, except a supervisor or judicial officer, may appoint as many deputies as are necessary for the prompt and faithful discharge of the duties of his office. Cal. Gov't Code § 24101.

If so, what are the deputies' roles?
If the coroner is absent or unable to attend, the duties of his office may be discharged by any of his deputies with like authority and subject to the same obligations and penalties as the coroner. Cal. Gov't Code § 27530.

What are the qualifications for deputies?
Unspecified.

Is the coroner or medical examiner position elected?
Coroners: appointed or elected
Medical examiners: appointed

[T]he board of supervisors may by ordinance abolish the office of coroner and provide instead for the office of medical examiner, to be appointed by the said board and to exercise the powers and perform the duties of the coroner. Cal. Gov't Code § 24010.

(a) Except as provided in subdivision (b), the county officers to be elected by the people are the treasurer, county clerk, auditor, sheriff, tax collector, district attorney, recorder, assessor, public administrator, and coroner.

(b) Except for those officers named in subdivision (b) of Section 1 of Article XI of the California Constitution, any county office that is required to be elective may become an appointive office pursuant to this subdivision. In order to change an office from elective to appointive, a proposal shall be presented to the voters of the county and approved by a majority of the votes cast on the proposition . . .

Cal. Gov't Code § 24009.

If so, how many years is the term of office?
Unspecified.

What are the qualifications specified by law? The medical examiner shall be a licensed physician and surgeon duly qualified as a specialist in pathology. Cal. Gov't Code § 24010.

What types of deaths are required to be investigated?
It shall be the duty of the coroner to inquire into and determine the circumstances, manner, and cause of all violent, sudden, or unusual deaths; unattended deaths; deaths where the deceased has not been attended by either a physician or a registered nurse, who is a member of a hospice care interdisciplinary team . . . in the 20 days before death; deaths related to or following known or suspected self-induced or criminal abortion; known or suspected homicide, suicide, or accidental poisoning; deaths known or suspected as resulting in whole or in part from or related to accident or injury either old or recent; deaths due to drowning, fire, hanging, gunshot, stabbing, cutting, exposure, starvation, acute alcoholism, drug addiction, strangulation, aspiration, or where the suspected cause of death is sudden infant death syndrome; death in whole or in part occasioned by criminal means; deaths associated with a known or alleged rape or crime against nature; deaths in prison or while under sentence; deaths known or suspected as due to contagious disease and constituting a public hazard; deaths from occupational diseases or occupational hazards; deaths of patients in state mental hospitals serving the mentally disabled and operated by the State Department of State Hospitals; deaths of patients in state hospitals serving the developmentally disabled and operated by the State Department of Developmental Services; deaths under such circumstances as to afford a reasonable ground to suspect that the death was caused by the criminal act of another; and any deaths reported by physicians or other persons having knowledge of death for inquiry by coroner. . . The coroner shall have discretion to determine the extent of inquiry to be made into any death occurring under natural circumstances and falling within the provisions of this section . . . For the purpose of inquiry, the coroner shall have the right to exhume the body of a deceased person when necessary to discharge the responsibilities set forth in this section. Cal. Gov't Code § 27491.

What types of deaths are required to be autopsied?
[T]he coroner shall, within 24 hours, or as soon thereafter as feasible, perform an autopsy in any case where an infant has died suddenly and unexpectedly. However, if the attending physician desires to certify that the cause of death is sudden infant death syndrome, an autopsy may be performed at the discretion of the coroner. If the coroner performs an autopsy pursuant to this section, he or she shall also certify the cause of death . . . Cal. Gov't Code § 27491.41.

For purposes of inquiry the coroner shall, within 24 hours or as soon as feasible thereafter, where the suspected cause of death is sudden infant death syndrome and, in all other cases, the coroner may, in his or her discretion, take possession of the body, which shall include the authority to exhume the body, order it removed to a convenient place, and make or cause to be made a postmortem examination or autopsy thereon, and make or cause to be made an analysis of the stomach, stomach contents, blood, organs, fluids, or tissues of the body . . . The coroner shall have the right to retain only those tissues of the body removed at the time of the autopsy as may, in his or her opinion, be necessary or advisable to the inquiry into the case, or for the verification of his or her findings . . . Nothing in this section shall be deemed to prohibit the discretion of the coroner to conduct autopsies upon any victim of sudden, unexpected, or unexplained death or any death known or suspected of resulting from an accident, suicide, or apparent criminal means, or other death, as described in Section 27491. Cal. Gov't Code § 27491.4.

Does the state require that pathologists perform the autopsies?
No.

Disclaimer: Information available on this website that was not developed by the Centers for Disease Control and Prevention (CDC) does not necessarily represent any CDC policy, position, or endorsement of that information or of its sources. The information contained on this website is not legal advice; if you have questions about a specific law or its application you should consult your legal counsel.

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Coroner/Medical Examiner Laws Is medical death investigation system centralized, county-based, or district-based? County-based. Cal. Gov't Code § 24010. If centralized, in which department or agency is the system housed? Not applicable. Does the state system have a coroner, medical examiner, or coroners and medical examiners? Coroners and medical examiners.

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Yes, if the death is an accident, suspicious, a homicide, or suicide there will be an investigation. The medical examiner/coroner have the right to information needed to investigate the case.

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§ 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required.

A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity's information and the individual's agreement may be given orally.

(a) Standard: Uses and disclosures required by law.

(b) Standard: Uses and disclosures for public health activities -

(ii) A public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect;

(iii) A person subject to the jurisdiction of the Food and Drug Administration (FDA) with respect to an FDA-regulated product or activity for which that person has responsibility, for the purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity. Such purposes include:

(A) To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations;

(B) To track FDA-regulated products;

(C) To enable product recalls, repairs, or replacement, or lookback (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of lookback); or

(D) To conduct post marketing surveillance;

To conduct an evaluation relating to medical surveillance of the workplace; or

(B) The protected health information that is disclosed consists of findings concerning a work-related illness or injury or a workplace-related medical surveillance;

(vi) A school, about an individual who is a student or prospective student of the school, if:

(A) The protected health information that is disclosed is limited to proof of immunization;

A parent, guardian, or other person acting in loco parentis of the individual, if the individual is an unemancipated minor; or

(c) Standard: Disclosures about victims of abuse, neglect or domestic violence -

(iii) To the extent the disclosure is expressly authorized by statute or regulation and:

(2) Informing the individual. A covered entity that makes a disclosure permitted by paragraph (c)(1) of this section must promptly inform the individual that such a report has been or will be made, except if:

(ii) The covered entity would be informing a personal representative, and the covered entity reasonably believes the personal representative is responsible for the abuse, neglect, or other injury, and that informing such person would not be in the best interests of the individual as determined by the covered entity, in the exercise of professional judgment.

(d) Standard: Uses and disclosures for health oversight activities -

(i) The health care system;

(ii) Government benefit programs for which health information is relevant to beneficiary eligibility;

(iii) Entities subject to government regulatory programs for which health information is necessary for determining compliance with program standards; or

(iv) Entities subject to civil rights laws for which health information is necessary for determining compliance.

(i) The receipt of health care;

(ii) A claim for public benefits related to health; or

(iii) Qualification for, or receipt of, public benefits or services when a patient's health is integral to the claim for public benefits or services.

(e) Standard: Disclosures for judicial and administrative proceedings -

(ii) In response to a subpoena, discovery request, or other lawful process, that is not accompanied by an order of a court or administrative tribunal, if:

(C) The time for the individual to raise objections to the court or administrative tribunal has elapsed, and:

No objections were filed; or

(A) The parties to the dispute giving rise to the request for information have agreed to a qualified protective order and have presented it to the court or administrative tribunal with jurisdiction over the dispute; or

(B) The party seeking the protected health information has requested a qualified protective order from such court or administrative tribunal.

(A) Prohibits the parties from using or disclosing the protected health information for any purpose other than the litigation or proceeding for which such information was requested; and

(i) As required by law including laws that require the reporting of certain types of wounds or other physical injuries, except for laws subject to paragraph (b)(1)(ii) or (c)(1)(i) of this section; or

(ii) In compliance with and as limited by the relevant requirements of:

(A) A court order or court-ordered warrant, or a subpoena or summons issued by a judicial officer;

(B) A grand jury subpoena; or

(C) An administrative request, including an administrative subpoena or summons, a civil or an authorized investigative demand, or similar process authorized under law, provided that:

The information sought is relevant and material to a legitimate law enforcement inquiry;

The request is specific and limited in scope to the extent reasonably practicable in light of the purpose for which the information is sought; and

De-identified information could not reasonably be used.

(i) The covered entity may disclose only the following information:

(A) Name and address;

(B) Date and place of birth;

(C) Social security number;

(D) ABO blood type and rh factor;

(E) Type of injury;

(F) Date and time of treatment;

(G) Date and time of death, if applicable; and

(H) A description of distinguishing physical characteristics, including height, weight, gender, race, hair and eye color, presence or absence of facial hair (beard or moustache), scars, and tattoos.

(ii) Except as permitted by paragraph (f)(2)(i) of this section, the covered entity may not disclose for the purposes of identification or location under paragraph (f)(2) of this section any protected health information related to the individual's DNA or DNA analysis, dental records, or typing, samples or analysis of body fluids or tissue.

(3) Permitted disclosure: Victims of a crime. Except for disclosures required by law as permitted by paragraph (f)(1) of this section, a covered entity may disclose protected health information in response to a law enforcement official's request for such information about an individual who is or is suspected to be a victim of a crime, other than disclosures that are subject to paragraph (b) or (c) of this section, if:

(6) Permitted disclosure: Reporting crime in emergencies.

(i) A covered health care provider providing emergency health care in response to a medical emergency, other than such emergency on the premises of the covered health care provider, may disclose protected health information to a law enforcement official if such disclosure appears necessary to alert law enforcement to:

(A) The commission and nature of a crime;

(B) The location of such crime or of the victim(s) of such crime; and

(C) The identity, description, and location of the perpetrator of such crime.

(g) Standard: Uses and disclosures about decedents -

(i) Standard: Uses and disclosures for research purposes -

(A) An Institutional Review Board (IRB), established in accordance with 7 CFR lc.107, 10 CFR 745.107, 14 CFR 1230.107, 15 CFR 27.107, 16 CFR 1028.107, 21 CFR 56.107, 22 CFR 225.107, 24 CFR 60.107, 28 CFR 46.107, 32 CFR 219.107, 34 CFR 97.107, 38 CFR 16.107, 40 CFR 26.107, 45 CFR 46.107, 45 CFR 690.107, or 49 CFR 11.107; or

Does not have any member participating in a review of any project in which the member has a conflict of interest.

(A) Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research;

(B) Documentation, at the request of the covered entity, of the death of such individuals; and

Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;

(B) The research could not practicably be conducted without the waiver or alteration; and

(iv) Review and approval procedures. A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures, as follows:

(A) An IRB must follow the requirements of the Common Rule, including the normal review procedures ( 7 CFR 1c.108(b), 10 CFR 745.108(b), 14 CFR 1230.108(b), 15 CFR 27.108(b), 16 CFR 1028.108(b), 21 CFR 56.108(b), 22 CFR 225.108(b), 24 CFR 60.108(b), 28 CFR 46.108(b), 32 CFR 219.108(b), 34 CFR 97.108(b), 38 CFR 16.108(b), 40 CFR 26.108(b), 45 CFR 46.108(b), 45 CFR 690.108(b), or 49 CFR 11.108(b)) or the expedited review procedures ( 7 CFR 1c.110, 10 CFR 745.110, 14 CFR 1230.110, 15 CFR 27.110, 16 CFR 1028.110, 21 CFR 56.110, 22 CFR 225.110, 24 CFR 60.110, 28 CFR 46.110, 32 CFR 219.110, 34 CFR 97.110, 38 CFR 16.110, 40 CFR 26.110, 45 CFR 46.110, 45 CFR 690.110, or 49 CFR 11.110);

(B) A privacy board must review the proposed research at convened meetings at which a majority of the privacy board members are present, including at least one member who satisfies the criterion stated in paragraph (i)(1)(i)(B)(2) of this section, and the alteration or waiver of authorization must be approved by the majority of the privacy board members present at the meeting, unless the privacy board elects to use an expedited review procedure in accordance with paragraph (i)(2)(iv)(C) of this section;

(C) A privacy board may use an expedited review procedure if the research involves no more than minimal risk to the privacy of the individuals who are the subject of the protected health information for which use or disclosure is being sought. If the privacy board elects to use an expedited review procedure, the review and approval of the alteration or waiver of authorization may be carried out by the chair of the privacy board, or by one or more members of the privacy board as designated by the chair; and

(j) Standard: Uses and disclosures to avert a serious threat to health or safety -

(A) Is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and

(ii) Is necessary for law enforcement authorities to identify or apprehend an individual:

(2) Use or disclosure not permitted. A use or disclosure pursuant to paragraph (j)(1)(ii)(A) of this section may not be made if the information described in paragraph (j)(1)(ii)(A) of this section is learned by the covered entity:

(4) Presumption of good faith belief. A covered entity that uses or discloses protected health information pursuant to paragraph (j)(1) of this section is presumed to have acted in good faith with regard to a belief described in paragraph (j)(1)(i) or (ii) of this section, if the belief is based upon the covered entity's actual knowledge or in reliance on a credible representation by a person with apparent knowledge or authority.

(k) Standard: Uses and disclosures for specialized government functions -

(1) Military and veterans activities -

(i) Armed Forces personnel. A covered entity may use and disclose the protected health information of individuals who are Armed Forces personnel for activities deemed necessary by appropriate military command authorities to assure the proper execution of the military mission, if the appropriate military authority has published by notice in the Federal Register the following information:

(A) Appropriate military command authorities; and

(ii) Separation or discharge from military service. A covered entity that is a component of the Departments of Defense or Homeland Security may disclose to the Department of Veterans Affairs (DVA) the protected health information of an individual who is a member of the Armed Forces upon the separation or discharge of the individual from military service for the purpose of a determination by DVA of the individual's eligibility for or entitlement to benefits under laws administered by the Secretary of Veterans Affairs.

(iii) Veterans. A covered entity that is a component of the Department of Veterans Affairs may use and disclose protected health information to components of the Department that determine eligibility for or entitlement to, or that provide, benefits under the laws administered by the Secretary of Veterans Affairs.

(iv) Foreign military personnel. A covered entity may use and disclose the protected health information of individuals who are foreign military personnel to their appropriate foreign military authority for the same purposes for which uses and disclosures are permitted for Armed Forces personnel under the notice published in the Federal Register pursuant to paragraph (k)(1)(i) of this section.

(2) National security and intelligence activities. A covered entity may disclose protected health information to authorized federal officials for the conduct of lawful intelligence, counter-intelligence, and other national security activities authorized by the National Security Act ( 50 U.S.C. 401, et seq.) and implementing authority (e.g., Executive Order 12333).

(3) Protective services for the President and others. A covered entity may disclose protected health information to authorized Federal officials for the provision of protective services to the President or other persons authorized by 18 U.S.C. 3056 or to foreign heads of state or other persons authorized by 22 U.S.C. 2709(a)(3), or for the conduct of investigations authorized by 18 U.S.C. 871 and 879.

(4) Medical suitability determinations. A covered entity that is a component of the Department of State may use protected health information to make medical suitability determinations and may disclose whether or not the individual was determined to be medically suitable to the officials in the Department of State who need access to such information for the following purposes:

(i) For the purpose of a required security clearance conducted pursuant to Executive Orders 10450 and 12968;

(ii) As necessary to determine worldwide availability or availability for mandatory service abroad under sections 101(a)(4) and 504 of the Foreign Service Act; or

(iii) For a family to accompany a Foreign Service member abroad, consistent with section 101(b)(5) and 904 of the Foreign Service Act.

(5) Correctional institutions and other law enforcement custodial situations -

(i) Permitted disclosures. A covered entity may disclose to a correctional institution or a law enforcement official having lawful custody of an inmate or other individual protected health information about such inmate or individual, if the correctional institution or such law enforcement official represents that such protected health information is necessary for:

(A) The provision of health care to such individuals;

(B) The health and safety of such individual or other inmates;

(C) The health and safety of the officers or employees of or others at the correctional institution;

(E) Law enforcement on the premises of the correctional institution; or

(F) The administration and maintenance of the safety, security, and good order of the correctional institution.

(ii) Permitted uses. A covered entity that is a correctional institution may use protected health information of individuals who are inmates for any purpose for which such protected health information may be disclosed.

(6) Covered entities that are government programs providing public benefits.

(ii) A covered entity that is a government agency administering a government program providing public benefits may disclose protected health information relating to the program to another covered entity that is a government agency administering a government program providing public benefits if the programs serve the same or similar populations and the disclosure of protected health information is necessary to coordinate the covered functions of such programs or to improve administration and management relating to the covered functions of such programs.

(i) Is a State agency or other entity that is, or contains an entity that is:

(ii) Discloses the information only to:

(A) The National Instant Criminal Background Check System; or

(A) Discloses only the limited demographic and certain other information needed for purposes of reporting to the National Instant Criminal Background Check System; and

(B) Does not disclose diagnostic or clinical information for such purposes.

[ 65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53270, Aug. 14, 2002; 78 FR 5699, Jan. 25, 2013; 78 FR 34266, June 7, 2013; 81 FR 395, Jan. 6, 2016]

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45 CFR § 164.512 - Uses and disclosures for which an authorization or opportunity to agree or object is not required.

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§ 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required. A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section.

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In the event that Wesley Glen is at fault for the patient's death due to elder abuse, employees would be interviewed and any surveillance footage would be reviewed. A more stringent hiring process would be implemented to ensure that employees hold professional ethics and codes of conduct.

For the hospital, a review and update of processes to address medical alerts would be performed. The aim would be to improve response time and take urgent action as quickly as possible.

For the manufacturer, a review of development and assembly procedures should be performed to fix any errors discovered. The manufacturer should also improve on reporting practices to ensure the fastest response from facilities using their devices.

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More information is required before determining who is at fault. A complete autopsy report would be needed. Wesley Glen, the hospital, and the manufacturer could each be at fault for different reasons:

Wesley Glen - may be at fault due to potential elder abuse as seen by the patient's bruising, which could have caused more issues within the patient's body that were not immediately detected.

Hospital - may be at fault for not immediately addressing the implanted device, which was possibly defective.

Manufacturer - may be at fault for producing and distributing defective implant devices.

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The device manufacturer may have liability depending on a number of factors; for example, negligence could be found if the manufacturer knowingly distributed defective devices.

However, there could have been an error made during implantation, implying user error. The manufacturer also did notify the hospital as required when a defect was noticed with the devices.

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In the event that the defibrillator contributed to the patient's death, the hospital would be required to report the death to the FDA. The FDA is responsible for ensuring the public's safety when using medical devices.

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The FDA is responsible for notifying the hospital of possible harm from a medical device. The FDA would receive notice of defects from facilities and manufacturers and would then pass that information on to any facilities where defective medical devices were distributed.

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Wesley Glen and the hospital must additionally report the following:

Death of the patient within 24 hours after removal from restraint should be reported to the CMS regional office (42 CFR 482.13(e))

Medical device reporting - the physician found a cardiac defibrillator implanted during the last inpatient visit, which might have been a factor in the patient's death (45 CFR 164.512(b))

Details on the bruising found on the patient's body to aid in potential investigations

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Yes, medical examiners and coroners do have the right to receive patient information needed to investigate a case. They may also hold subpoena powers to obtain this information. In states that require the reporting of suspicious deaths, doing so doesn't conflict with HIPAA because authorization isn't required for public health and law enforcement purposes.

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The hospital is required to report the patient's death because it happened suddenly and unexpectedly. The cause of death is not immediately apparent and thus may be considered suspicious, especially with the presence of bruising on the patient's body. Moreover, according to regulations (42 CFR 482.13(e)), to maintain Medicare requirements, the hospital is required to report deaths that occur within 24 hours after a patient has been removed from restraints - in this case, the patient died 15 hours after getting restraints removed.

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The mitigation plan moving forward is to conduct an internal investigation. This would include determining how the patient sustained the various bruises. I would provide my staff members with the training and education of restraints, proper documentation of care given and patient's behavior, and behavioral intervention. Lastly, I would ensure that the patient’s family is in communication and are updated with any information in concern with their loved one’s death.

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Further investigation must be done to determine who is at fault for the patient’s death. This is due to the circumstances which surrounded the patient's death such as the restraints, bruises, and cardiac defibrillator.

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The device manufacturer may have liability if it was determined to be the cause of death. The cardiac defibrillator is supposed to meet safety standards and provide the patient with clear instructions pertaining to the device. If there were to be any safety issues, the manufacturer must address the problem immediately. If any of those were not followed, there are chances of the manufacturer being liable for the death and can result in legal action being taken against them.

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If the death was attributed to the defibrillator, the hospital must report it to the authorities that deal with the safety of medical devices. In addition to that, the hospital must have their own policies and procedures to follow for reporting the death in such a manner.

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The medical device manufacturer must be responsible for notifying the hospital if it may cause harm to the patients. They must notify the hospitals and/or providers to ensure that the patients are informed and safe. An alert was given pertaining to the cardiac defibrillator; therefore, the manufacturers must have found an issue and promptly notified the hospital.

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The additional reporting that must be done by Wesley Glen and the hospital is to report to their state health department and to CMS in which is a federal agency.

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The medical examiners and coroners have the right to receive patient information needed to investigate a case. A medical examiner is given the responsibility to investigate suspicious deaths by the government. The patient’s death may be deemed suspicious due to the circumstances; therefore, the medical examiners and coroners have the right.