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COVID-19 | 3M Personal Protective Equipment (PPE) Info

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COVID-19 | 3M Personal Protective Equipment (PPE) Info

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2.21 CDC and Johns Hopkins Ebola (doffing) Gown Video

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2.21 CDC and Johns Hopkins Ebola (doffing) Gown Video

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Centers for Disease Control and Prevention (CDC)

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How to Safely Take off PPE, Selected Equipment: N95 and Gown

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2.20 CDC & Johns Hopkins Ebola (donning) Gown Video

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2.20 CDC & Johns Hopkins Ebola (donning) Gown Video

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Centers for Disease Control and Prevention (CDC)

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How to Safely Put on PPE, Selected Equipment: N95 and Gown

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2.19 CDC & Johns Hopkins Ebola (doffing) Coverall Video

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2.19 CDC & Johns Hopkins Ebola (doffing) Coverall Video

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Centers for Disease Control and Prevention (CDC)

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How to Safely Take off PPE, Selected Equipment: N95 and Coverall

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COVID-19: personal protective equipment use for non-aerosol generating procedures - GOV.UK

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COVID-19: personal protective equipment use for non-aerosol generating procedures - GOV.UK

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Guidance on the use of personal protective equipment (PPE) for non-aerosol generating procedures (APGs).

Details

This guidance covers the donning (putting on) and doffing (taking off) of personal protective equipment ( PPE) for non-aerosol generating procedures ( AGPs).

Guidance on donning and doffing PPE for aerosol generating procedures is also available.

Also refer to guidance on infection prevention and control for COVID-19.

This video shows how to safely don (put on) and doff (take off) the personal protective equipment ( PPE) for non-aerosol generating procedures ( AGPs), specific to COVID-19. This guidance outlines infection control for health and social care settings involving possible cases of COVID-19.

Please note that this guidance is of a general nature and that an employer should consider the specific conditions of each individual place of work and comply with all applicable legislation, including the Health and Safety at Work etc. Act 1974.

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COVID-19: personal protective equipment use for non-aerosol generating procedures

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We use cookies to collect information about how you use GOV.UK. We use this information to make the website work as well as possible and improve government services. Guidance on the use of personal protective equipment (PPE) for non-aerosol generating procedures (APGs).

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COVID-19: personal protective equipment use for aerosol generating procedures - GOV.UK

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COVID-19: personal protective equipment use for aerosol generating procedures - GOV.UK

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Stay at home

Only go outside for food, health reasons or work (but only if you cannot work from home)

If you go out, stay 2 metres (6ft) away from other people at all times

Wash your hands as soon as you get home

Do not meet others, even friends or family.

You can spread the virus even if you don't have symptoms.

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COVID-19: personal protective equipment use for aerosol generating procedures

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Only go outside for food, health reasons or work (but only if you cannot work from home) If you go out, stay 2 metres (6ft) away from other people at all times Wash your hands as soon as you get home Do not meet others, even friends or family.

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How are hospitals handling a PPE shortage? | Advisory Board

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How are hospitals handling a PPE shortage? | Advisory Board

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We will be keeping this resource updated on a rolling basis as new strategies and best practices are introduced. This checklist was last updated on May 12, 2020
A national shortage of personal protective equipment (PPE) is forcing U.S. health systems to deploy creative strategies to conserve and improvise alternatives to face masks, respirators, eye protection, and gowns, though their efficacy is unproven.

Here we've assembled a running list of strategies US health systems and hospitals are using to disinfect, reuse, and create their own PPE.
Many of the strategies below have not been FDA or NIOSH approved and should be used only as a last resort when standard PPE is unavailable. Consult CDC guidance before using any replacements for standard PPE.
Strategies to conserve FDA-compliant PPE

University of Nebraska Medical Center in Omaha, Nebraska, is sterilizing single-use respirators to last a week or longer using UV light. To sanitize the masks, staff place the N95s in paper bags and transport them to their disinfection room, where they hang the masks up on wires. Two UV light towers in the room decontaminate the masks within three to five minutes. After decontamination, staff return the masks to their original owners for reuse.

Duke Health in North Carolina is leveraging a method used for years in their biocontainment lab to sanitize N95s. The method uses specialized equipment to vaporize hydrogen peroxide. The gas permeates the layers of the mask to eliminate the virus without degrading the mask material. Duke researchers have confirmed the process does not affect fit and filtration of the masks.

Yale Medicine in Connecticut has repurposed a machine they typically use to fumigate hospital rooms with hydrogen peroxide to sanitize masks. The machine cleans the masks with hydrogen peroxide for about five hours, with additional time needed to extract the chemicals from the room and the masks. Based on preliminary research, the process killed three viruses similar to the novel coronavirus without affecting filtration. The recycled masks are being put in storage for now as backup if their hospitals experience an extreme shortage.

Baptist Health in Florida is sanitizing masks with a robot from Xenon Disinfection Services called the LightStrike. The machine cleans PPE using pulsed xenon ultraviolet light which disinfects each side of the mask for five minutes. Providers can then reuse the masks multiple times. The Xenon technology is currently in use at all four Baptist locations.

Atrium Health in North Carolina has moved their IV pumps and ventilator control panels out of the rooms COVID-19 patients are being treated in so that providers don't have to change PPE each time they need to adjust the machines. The strategy has allowed them to decrease PPE usage by 70% over the past several weeks.

Partners HealthCare in Massachusetts is using Battelle's CCDS Critical Care Decontamination System to sanitize up to 80,000 N95 respirators per day. The sanitization system uses a concentrated vaporized hydrogen peroxide cleaning method that allows staff to safely reuse N95s up to 30 times. The sanitization system received FDA emergency use authorization at the beginning of April. The sanitization site, one of four across the country, is set up in a former K-Mart store in Somerville, MA near the Partners HealthCare corporate headquarters.

Partners' Brigham and Women's Hospital in Massachusetts is conserving PPE using their "B-Protected Covid-19 Booth" for testing. Staff can swab patients from inside the closed plastic polycarbonate booth by placing their hands through the portholes into attached thick rubber gloves. Staff inside the booth do not have to wear any PPE. BWH hopes to scale the booths across their sites of care to retain PPE for Covid patient care.

Researchers at the University of Southern California in Los Angeles, California have devised a method to build a UV disinfection system to sanitize face shields using plastic storage boxes, a reflective coating, and UV-c bulbs. Researchers at the Keck School of Medicine released a publicly available paper detailing the efficacy of the disinfection system and instructions to build the UV-c disinfection devices using readily available resources they found at a hardware store.

Novant Health in North Carolina is expanding PPE's useful life by using a Bioquell decontamination machine to clean PPE with hydrogen peroxide. Leaders found they could clean 4,000 masks per day and get 30-40 uses from masks cleaned this way compared to the 3-4 uses before masks degrade when cleaned with UV light. With two of these devices purchased during SARS, Novant is using one at their biggest hospital and has the other rotating between their other facilities.

Emory Health in Georgia has developed a "warm zone model" on their inpatient nursing units to maintain staff safety while reducing PPE use and burn rates. To extend gown use, nurses cluster patient care to minimize the number of times they enter a patient's room. Their publicly-available implementation guidance covers workflow and staffing between zones, physical setup and equipment, and tasks each team member is responsible for.

Homemade PPE alternatives

Boston Children's in Massachusetts conducted a small pilot study in their Surgical Innovation Fellowship for a DIY, low-cost respirator mask alternative. The respirator, made from an anesthesia mask, ventilator inline bacterial or viral filter, and elastic straps, cost under three dollars to produce. Providers can disassemble and reuse the mask until it shows visible signs of wear or contamination. The respirator is not approved for use at Boston Children's at this time, though researchers say they will use the device should the need arise.

Providence Health in Washington had their infection and control quality experts create homemade face-shields using supplies from Home Depot, including military-grade vinyl, industrial tape, foam, and elastic. Last week, the team and administrative staff assembled 500 face shields to send to their Seattle hospital, and are currently testing a prototype facemask made from surgical wrap material. Local furniture manufacturer Kaas Tailored and Nordstrom are working with Providence to produce these PPE prototypes and share specs with other manufacturers who want to help as part of their " 100 Million Mask Challenge" campaign.

Henry Ford Health System staff in Michigan have turned to everyday items to fashion homemade face masks and shields as short-term PPE replacements as part of their Innovation Institute's challenge campaign. Staff created their prototyped mask with moisture wicking fabric, elastic bands, and air filter material, and they can wash the mask with a bleach cleaning solution for reuse. They made homemade face shields from materials including plastic sheets, elastic bands, and tongue depressors. Staff and volunteers plan to ramp up production of the homemade masks to 500-1,000 pieces per day to bridge the gap between their dwindling supply and their next shipment of standard supplies.

Deaconess Health System in Indiana posted a PDF template and video instructions for homemade fabric masks on their website along with directions for donating masks to hospitals in need. The system recognizes that providers should not use fabric masks to care for COVID-19 patients outside of a crisis situation, but says their orders for standard masks are on long back order. Providers can sterilize and reuse the masks as needed.

Cox Health in Missouri is working with Missouri State University researchers to 3D-print face shields made out from a non-assembled safety frames, zip ties, face shields and printed nosepieces. After they print the components, researchers use a laser cutter to fashion the clear face shields, and then snap all of the pieces together. Staff can disassemble and clean each component of the face shield. The directions for printing and assembling the shields are available on the Cox Health website.

Geisinger Health in Pennsylvania is 3D-printing replacement mask straps and clips for providers who have to reuse N95s multiple times. Their N95 sterilization process often causes their N95 straps to fail, so they have begun to make their own reusable straps and clips as a temporary solution to extend the life of their masks. The design files are publicly available at the linked site.

The Medical University of South Carolina in Charleston, South Carolina developed the "Self-Assembly Filtration for Emergencies (S.A.F.E) Cartridge System", a modular HEPA filtration system that fits onto disposable hospital masks and 3D printed respirator alternatives. The filtration cartridges are an experimental prototype, but passed standard N95 fit tests. The publicly available files to print the filtration system are available at the linked site.

An Atrium Health critical care physician fashioned a N95 mask alternative to use in case of a critical respirator shortage from an inline ventilator filter and CPAP parts. A video with a full explanation of how to make the N95/100 mask alternative is posted at the linked site.

UCSF Medical Center in California is using 3D-printed face shields built from a printed headband, rubber bands, and a repurposed sheet of plastic typically used to cover bound reports. Each shield costs under a dollar and takes just over an hour to manufacture. UCSF hopes to partner with local manufacturers to scale production of the shields so that they can have shields for every UCSF clinician in contact with Covid patients.

Mercy Health is dispatching staff who have latent capacity or weren't redeployed to care for Covid-19 patients to create 50,000 plastic face shields in a newly-created assembly line inside their Consolidated Services Center warehouse. The shields, assembled from foam insulation and plastic, are already being sent to hospitals across the Mercy system, and the process allows staff to receive regular income for alternate work.
Is your organization using a creative strategy to deal with PPE shortages that we should add to this list? Send Virginia Reid an email with a short description at ReidV@Advisory.com.

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How are hospitals handling a PPE shortage?

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We will be keeping this resource updated on a rolling basis as new strategies and best practices are introduced. This checklist was last updated on May 12, 2020 A national shortage of personal protective equipment (PPE) is forcing U.S.

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Cleaning and disinfection of environmental surfaces in the context of COVID-19

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Cleaning and disinfection of environmental surfaces in the context of COVID-19

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Overview

The purpose of this document is to provide guidance on the cleaning and disinfection of environmental surfaces in the context of COVID-19. This guidance is intended for health care professionals, public health professionals and health authorities that are developing and implementing policies and standard operating procedures (SOP) on the cleaning and disinfection of environmental surfaces in the context of COVID-19.

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Cleaning and disinfection of environmental surfaces in the context of COVID-19

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The purpose of this document is to provide guidance on the cleaning and disinfection of environmental surfaces in the context of COVID-19. This guidance is intended for health care professionals, public health professionals and health authorities that are developing and implementing policies and standard operating procedures (SOP) on the cleaning and disinfection of environmental surfaces in the context of COVID-19.

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Standard precautions: Waste management

According to WHO, about 85% of the total amount of waste generated by health care activities is general, non-hazardous waste. The remaining 15% is considered hazardous material that could be infectious, toxic or radioactive. Hazardous waste that is not managed properly presents a risk to hospital patients, health care personnel and the general public.

Standard precautions: Hand hygiene

Most health care-associated infections are preventable through good hand hygiene - cleaning hands at the right times and in the right way. The WHO Guidelines on hand hygiene in health care support hand hygiene promotion and improvement in health care facilities worldwide and are complemented by the WHO multimodal hand hygiene improvement strategy, the guide to implementation, and implementation toolkit, which contain many ready-to-use practical tools. This module has been prepared to help summarize the WHO guidelines on hand hygiene, associated tools and ideas for effective implementation.

Introduction to Go.Data - Field data collection, chains of transmission and contact follow-up

Go.Data is a field data collection platform focusing on case data (including lab, hospitalization and other variables though case investigation form) and contact data (including contact follow-up). This briefing package provides an orientation to the purpose, benefits and utilization of Go.Data, consisting of 7 modules with a narrated walkthrough of the key features of the Go.Data web-based platform and mobile application.

COVID-19: How to put on and remove personal protective equipment

This is a guide for healthcare workers involved in patient care activities in a healthcare setting. It aims to show the type of personal protective equipment or PPE needed to correctly protect oneself. Based on the current available evidence, the WHO recommended PPE for the care of COVID patients are CONTACT and DROPLET precautions, with the exception of aerosol producing procedures, which require CONTACT and AIRBORNE (hence, a respirator mask such as N95, FFP2, FFP3). Keeping in mind, PPE is part of a larger infection prevention and control bundle of measures and should be implemented as part of a multimodal strategy of management of COVID-19 patients. Only clinical staff who are trained and competent in the use of PPE should be allowed to enter the patient's room.

Severe Acute Respiratory Infection (SARI) Treatment Facility Design

Screening areas, treatment centres and community facilities are part of the strategic priorities for Severe Acute Respiratory Infection (SARI) outbreak preparedness, readiness and response. The SARI Facilities training package has been developed to meet the operational needs emerging with the COVID-19 pandemic. It provides a thorough understanding of the principles driving the design process of COVID-19 screening areas for health care facilities, community facilities and SARI treatment centres, including how to repurpose an existing building into a SARI treatment centre.

COVID-19: Operational Planning Guidelines and COVID-19 Partners Platform to support country preparedness and response

In order to assist UN country teams in scaling up country preparedness and response to COVID-19, WHO has developed these learning modules as a companion to the Operational Planning Guidelines to Support Country Preparedness and Response.

The training is intended:

For UN country teams (UNCTs)

For other relevant stakeholders, including partners, donors and civil society

To support national readiness and preparedness for COVID-19

To help countries increase their capacity to respond to COVID-19

To increase international coordination for response and preparedness

To streamline the process of coordinating resources and assessing country preparedness level

This learning package consists of 3 modules with videos and downloadable presentations.

Infection Prevention and Control (IPC) for novel coronavirus (COVID-19)

This course provides information on what facilities should be doing to be prepared to respond to a case of an emerging respiratory virus such as the novel coronavirus, how to identify a case once it occurs, and how to properly implement IPC measures to ensure there is no further transmission to HCW or to other patients and others in the healthcare facility.

This training is intended for healthcare workers and public health professionals, as it is focused on infection prevention and control.

Introduction to emerging respiratory viruses, including novel coronavirus

Coronaviruses are a large family of viruses that are known to cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).

A novel coronavirus (COVID-19) was identified in 2019 in Wuhan, China. This is a new coronavirus that has not been previously identified in humans.

This course provides a general introduction to COVID-19 and emerging respiratory viruses and is intended for public health professionals, incident managers and personnel working for the United Nations, international organizations and NGOs.

Clinical Care Severe Acute Respiratory Infection

This course includes content on clinical management of patients with a severe acute respiratory infection.

It is intended for clinicians who are working in intensive care units (ICUs) in low and middle-income countries and managing adult and pediatric patients with severe forms of acute respiratory infection (SARI), including severe pneumonia, acute respiratory distress syndrome (ARDS), sepsis and septic shock. It is a hands-on practical guide to be used by health care professionals involved in clinical care management during outbreaks of influenza virus (seasonal) human infection due avian influenza virus (H5N1, H7N9), MERS-CoV, COVID-19 or other emerging respiratory viral epidemics.

WHO-ICRC Basic Emergency Care: approach to the acutely ill and injured

Developed by WHO and ICRC, in collaboration with the International Federation for Emergency Medicine, Basic Emergency Care (BEC): Approach to the acutely ill and injured is an open-access training course for frontline healthcare providers who manage acute illness and injury with limited resources, focused on presentations of difficulty in breathing, shock, and altered mental status. Produced in response to requests from multiple countries and international partners, the BEC package includes a Participant Workbook and electronic slide decks for each module. Integrating the guidance from WHO Emergency Triage, Assessment and Treatment (ETAT) for children and the Integrated Management of Adult/Adolescent Illness (IMAI), BEC teaches a systematic approach to the initial assessment and management of time-sensitive conditions where early intervention saves lives. Available in English and Spanish.
WHO Medical Emergency Checklist
The WHO Medical Emergency Checklist is a modified version of the WHO Trauma Care Checklist designed for use in emergency units for patients with acute conditions such as severe difficulty in breathing. It reviews actions at two critical points to ensure that no life threatening conditions are missed and that timely, life-saving interventions are performed.

The adaptation of this checklist for medical emergency care was led by an expert group from the WHO global emergency care systems network. The WHO Medical Emergency Checklist is appropriate in any setting delivering emergency care, and can be easily adapted to local needs.
Resuscitation Area Designation Tool
The guidance on Resuscitation Area Designation describes a standardized approach to organize resuscitation areas and keep essential resources close at hand, ensuring the sickest patients in the emergency unit are clearly identified and receive needed care.

Health and safety briefing for respiratory diseases - ePROTECT

This course provides a general introduction to Acute Respiratory Infections (ARIs) and basic hygiene measures to protect against infection. By the end of the course, you should be able to describe basic information about ARIs including what they are, how they are transmitted, how to assess the risk of infection and list basic hygiene measures to protect against infection.

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According to WHO, about 85% of the total amount of waste generated by health care activities is general, non-hazardous waste. The remaining 15% is considered hazardous material that could be infectious, toxic or radioactive. Hazardous waste that is not managed properly presents a risk to hospital patients, health care personnel and the general public.

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Personal Protective Equipment (PPE) Burn Rate Calculator | CDC

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Personal Protective Equipment (PPE) Burn Rate Calculator | CDC

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Centers for Disease Control and Prevention

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The Personal Protective Equipment (PPE) Burn Rate Calculator (Version 2) [XLS - 2 MB] is a spreadsheet-based model that will help healthcare facilities plan and optimize the use of PPE for response to COVID-19. Non-healthcare facilities such as correctional facilities may also find this tool useful.

To use the calculator, enter the number of full boxes of each type of PPE in stock (gowns, gloves, surgical masks, respirators, and face shields, for example) and the total number of patients at your facility, if applicable. If your facility does not treat COVID-19 patients, leave "patients" row blank. The tool will calculate the average consumption rate, also referred to as a "burn rate," for each type of PPE entered in the spreadsheet. This information can then be used to estimate how long the remaining supply of PPE will last, based on the average consumption rate. Using the calculator can help your facility make order projections for future needs.
System Requirements

Windows* operating system (MS Windows 2000 or newer)

Microsoft Excel (MS Office 2000 or newer)

486 Pentium processor and at least 128MB RAM

2 MB of hard drive storage space

* MS Windows and Office is a copyrighted product produced by Microsoft Corporation, based in Redmond, WA. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
Instructions for Downloading
Before loading and starting the PPE Burn Rate Calculator, you may need to change Excel's security level. To do so:

1. Open a blank Excel spreadsheet.

2. Click Tools and then click Macro, choose Security.

3. Set Security Level to Medium.

4. Click OK.

5. Double-click and open PPE Burn Rate Calculator file.

6. When asked to Disable Macros or Enable Macros, click Enable Macros.

Downloading the Files
We recommend downloading and saving the PPE Burn Rate Calculator spreadsheet to your computer before opening the spreadsheet. Taking this step will open the spreadsheet in Excel rather than your web browser.

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tools to track personal protective equipment supply

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The Personal Protective Equipment (PPE) Burn Rate Calculator (Version 2) [XLS - 2 MB] is a spreadsheet-based model that will help healthcare facilities plan and optimize the use of PPE for response to COVID-19. Non-healthcare facilities such as correctional facilities may also find this tool useful.

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Infection Prevention and Control: 1. Role and structure of infection prevention and control programmes

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Infection Prevention and Control: 1. Role and structure of infection prevention and control programmes

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Take the chapter quiz before and after you read this chapter.
Open chapter quiz

First time? Register for free. Just enter your email or cell number and create a password.

Contents

Objectives

When you have completed this chapter you should:

Introduction to infection prevention and control programmes

1-1 What is infection prevention and control?

Infection prevention and control (IPC) is a discipline that aims to prevent or control the spread of infections in healthcare facilities and the community. IPC is a universal discipline with relevance to all aspects of healthcare.

It is part of every healthcare workers' duty of care to ensure that no harm is done to patients, visitors or staff. All healthcare workers require at least a basic understanding of IPC principles and practice.

Infection prevention and control is a discipline that aims to prevent or control the spread of infections in healthcare facilities and the community.

1-2 What is an infection prevention and control programme?

IPC programmes include activities, procedures and policies designed to reduce the spread of infections, usually within healthcare facilities. The primary goals of an IPC programme are:

To prevent susceptible patients acquiring pathogenic (disease-causing) micro-organisms

To limit the spread of antimicrobial resistant infections.

1-3 What is included in infection prevention and control programmes?

There are several components that are common to IPC programmes worldwide including:

Although the basic principles of IPC apply globally, each country and individual healthcare facility will need to adapt and add to the core elements based on their specific circumstances, e.g. differences in patient population, infectious disease profiles, and type of healthcare services delivered.

1-4 Why are infection prevention and control programmes needed?

Healthcare facilities are places where sick people congregate, creating many opportunities for micro-organisms to spread between patients, visitors and healthcare workers. Medical care is also becoming increasingly complex, with multiple, invasive procedures increasing the risk of developing healthcare-associated infections (HAI). Many of these infections (up to 70%) are preventable. Research has proven that IPC programmes can make healthcare safer and more affordable by preventing the suffering, loss of life and cost caused by healthcare-associated infection.

IPC programmes can make healthcare safer and more affordable by preventing the suffering, loss of life and cost caused by healthcare-associated infection.

1-5 Why are infection prevention and control programmes especially important in low-resource settings?

Many low-resource settings have a high burden of infectious diseases, including HIV and tuberculosis. IPC has a critical role to play in these settings to enhance patient safety and to avoid the use of scarce resources for the treatment of healthcare-associated infection.

1-6 What are the main activities of an infection prevention and control practitioner?

The main activities performed by the IPC practitioner include:

In many countries, the IPC practitioner has other duties such as seeing to occupational health or quality management. The term 'quality management' refers to all activities related to quality planning, assurance, quality control and improvement. In some cases, this may hamper their ability to perform all the required IPC activities. Since the aim is to prevent harm to patients and staff, IPC programmes often form part of a healthcare facility's quality management programme.

1-7 What are the key indicators for infection prevention and control programmes?

There are three key indicators that can be used to report on the impact of an IPC programme.

1. Compliance indicators: these rate how well local or national Department of Health guidelines are being followed, e.g. the percentage of handwash basins in a facility with soap, water and towels available.

2. Process indicators: these rate how well individuals follow facility-based guidelines, but may also include how many individuals were trained on local IPC policy implementation, e.g. the percentage of hand hygiene compliance; the number attending training on tuberculosis (TB) infection control.

3. Outcome indicators: these measure the outcome that IPC programmes are trying to prevent, healthcare-associated infection, e.g. the facility's infection rate from surgical site infections, urinary tract infections in catheterised patients and rates of antibiotic-resistant infections.

The key indicators of IPC programmes address compliance, process and outcome.

Structure and function of infection prevention and control programmes

1-8 What is the structure of infection prevention and control programmes at different levels?

The structure of IPC programmes varies from country to country. Many programmes have a central co-ordinating body situated within the national Department of Health or within the provincial (regional) healthcare administration. Each facility (both primary care clinics and hospitals) are then required to implement and adhere to the prescribed national or provincial IPC guidelines and policies. At individual facility level, the IPC programme should involve the facility management, the IPC committee and the IPC practitioner.

1-9 Who should take responsibility for the infection prevention and control programme?

Every healthcare worker (under the Duty of Care law) has responsibility for preventing harm to themselves, fellow staff, visitors and patients. However, the final authority and responsibility for IPC lies with the facility management. They may delegate this role to the IPC team, but must ensure that the right support structures are in place to ensure a functional and effective IPC programme.

Every healthcare worker has responsibility for preventing harm to themselves, fellow staff, visitors and patients.

1-10 What is an infection prevention and control team?

Ideally, an IPC team is made up of an IPC doctor and one or more IPC nurse practitioners, however, in some countries the IPC nurse practitioners function on their own. Preferably, an IPC doctor should be trained in infectious diseases, medical microbiology, public health or related specialities. The IPC nurse practitioner should be formally trained in IPC. The duties of the IPC team generally include:

Performing and reporting on surveillance for healthcare-associated infection

Investigating and advising on outbreak management

Providing a clinical advisory service for infection prevention-related issues

Revising and formulating policies

Providing regular in-service training in IPC for all healthcare workers

Auditing quality of care, high-risk procedures, and occupational injuries

Reporting to and advocating for improved standards of care with facility management

Liaising with all role players, e.g. laboratory, engineering, nursing, clinicians, sterile services, pharmacy, cleaning services, and the procurement division.

1-11 How many infection prevention and control nurse practitioners are needed?

Many countries provide guidance on how many IPC nurse practitioners (IPCNP) are required in order to deliver an effective IPC programme. This is reported as the beds per IPC nurse practitioner ratio. In well-resourced settings this is often one IPC nurse practitioner per 100 hospital beds, but in low-resource settings may be as low as one IPC nurse practitioner per 250 hospital beds. Owing to a lack of skilled staff, many countries may have only one IPC nurse practitioner per facility or per district. In low-resource settings, nursing staff in clinical units can be trained to fulfil some IPC practitioner functions (known as IPC link nurses).

In low-resource settings, the ratio of IPC nurse practitioners may be as low as one practitioner per 250 hospital beds or per facility.

1-12 What is an infection prevention and control committee?

An IPC committee is a multi-disciplinary group of healthcare facility staff who advise and assist with:

Management of the IPC programme

Policy development

Procurement issues

Patient safety

Risk identification

IPC training and education

Antimicrobial and disinfectant use

Surveillance of healthcare-associated infections.

The IPC committee usually consists of representatives from:

Facility management

Nursing management

Clinicians

The IPC practitioner or team

Quality management

Occupational health

Pharmacy

Cleaning services

Sterile services

Engineering department.

IPC committee meetings are usually held monthly or quarterly, with circulation of reports and meeting minutes to management and all other stakeholders in the facility.

1-13 What legislation supports infection prevention and control programmes?

Each country has its own legislation (laws) governing IPC. In South Africa these include: the Occupational Health and Safety Act; the National Health Act including the National Core Standards for Healthcare Establishments and the Healthcare Waste Act. There are several international documents that provide recommendations for IPC programmes, including those available from the World Health Organization (WHO) and Centers for Disease Control (CDC), amongst others (see addendum).

Education of healthcare workers

1-14 Why should healthcare workers be educated about infection prevention and control?

In many countries, there is insufficient emphasis on IPC in the undergraduate training of medical, nursing and allied health professionals. In addition, the clinical training facilities and senior staff often provide poor examples of IPC best practice to students. New guidelines, equipment, procedures and even new diseases result in a need for regular updates to the healthcare workers' IPC knowledge. Education is also important to address workers' concerns, fears, stigmas and incorrect assumptions regarding transmission or prevention of healthcare-associated infections.

1-15 Which categories of healthcare workers should be trained in infection prevention and control?

All healthcare workers require at least a basic understanding of IPC principles. Since different categories of workers may have different information needs, it is recommended that IPC training sessions be tailored to the specific target audience, e.g. medical staff versus cleaning services staff. Critical information to include is training on standard and transmission-based precautions (see chapter 3).

All healthcare workers require at least a basic understanding of IPC principles.

1-16 When and how often should healthcare workers be trained in infection prevention and control?

Ideally all new employees should receive induction (pre-employment) training in IPC. Annual refresher courses or short in-service training updates are recommended for all categories of healthcare staff.

1-17 Which education methods can be used to train staff in infection prevention and control?

The simplest and often most well-accepted format for training is face-to-face, small group teaching. This is, however, the most time-consuming teaching method, and may limit the number of staff that the IPC practitioner can educate. Incorporating short sessions into the weekly clinical schedule and utilising other staff for IPC education may be effective, e.g. using the sister-in-charge of a ward to give a demonstration on hand hygiene techniques at the morning ward handover rounds. Alternative methods include formal IPC courses, distance learning (including small-group, self-study and collaborative learning, video demonstrations and e-learning (online short courses).

1-18 Who should provide training of healthcare workers in infection prevention and control?

The responsibility of providing training in IPC usually falls to the IPC practitioner or IPC team. However, involvement of other senior healthcare workers is important as staff members are more likely to follow the advice of respected clinical leaders and colleagues. There may also be additional nursing staff appointed for clinical training at some facilities (called clinical co-ordinators). These clinical co-ordinators, as well as IPC link nurses, may be able to provide some IPC training to their colleagues.

Audits in infection prevention and control

1-19 What is an infection prevention and control audit?

An audit is an assessment of practice based on pre-determined criteria. Audits are used as a quality management tool to improve patient safety and standards of care. In IPC, audits are used to monitor and evaluate how well a facility or clinical area is complying with specified standards of good IPC practice. Before an audit can be started, each facility must decide which standards or policies their performance will be measured against. South Africa has introduced the National Core Standards for Healthcare Establishments document to be used as a reference for IPC and other quality of care audits.

Audits monitor and evaluate how well a facility or clinical area is complying with specified standards of good IPC practice.

1-20 What is the purpose of infection prevention and control audits?

The purpose of performing an audit is to check how real-life observed practice in a facility or clinical area compares with accepted best-practice or standards of care. After the audit is completed, feedback with suggestions of how to improve practice is given to all stakeholders. This important step must not be forgotten. After the suggested changes or improvements have been implemented, the facility or clinical area should be re-audited. This process is similar to a quality improvement cycle.

1-21 Who should conduct infection prevention and control audits?

The people performing the audit should preferably be very experienced in the practices that they will be auditing. IPC practitioners are well-placed to perform such audits, but need to be impartial when evaluating practice in their own facility. For national audits, it is better to get auditors who do not work at the facility being assessed, as they are more likely to notice problems with practice than an IPC practitioner who works in the facility. All audits should have the approval and support of facility management. Staff at the facility or clinical area being assessed should be informed prior to performing the audit, but the auditor should attempt not to interrupt clinical work or influence clinical practice during the assessment.

1-22 What is needed to conduct an audit on infection prevention and control practice?

Several elements must be considered before starting with an audit:

1-23 How and to whom should the audit findings be reported?

The audit outcome should be presented to stakeholders both in written and oral format. The written document should provide clear and understandable feedback with itemised and prioritised recommendations for improvements. It is best to give suggested timelines and assign individuals responsible for the implementation of the audit recommendations, as this keeps the facility or clinical area managers accountable. The various practices audited can be divided into categories for ease of reading. Compliance should be evaluated as shown below. The final outcome of the audit may be reported as a percentage score or a symbol.

Final score-sheet for IPC practice audit in Ward B, Hospital X

Date of audit: 13 March 2014

Auditors: Sister X and Doctor Y

Environmental cleaning

Hand hygiene

Sub-total score

Actual score of 6 out of possible score of 12 = 50%

1-24 What infection prevention and control audit tools are available?

There are many well-designed tools available online for a variety of IPC audits, from comprehensive IPC programme audits, to hand hygiene, environmental cleaning, antibiotic usage and sterilisation and disinfection audits.

Policy development in infection prevention and control

1-25 What is a policy?

A policy is a document that records 'a plan or a course of action intended to influence and determine decisions and action'. The purpose of a policy is to provide standard guidance on a particular topic, e.g. the National Department of Health policy on Tuberculosis-Infection Prevention and Control (TB-IPC); the facility policy on needlestick injury (NSI) management, the facility policy on isolation room usage.

The purpose of a policy is to provide standard guidance on a particular topic.

1-26 When is a policy needed?

Circumstances and practices in healthcare settings change often. There are several reasons for drafting or revising a policy including:

1-27 How are policies helpful in improving infection prevention and control?

From an IPC perspective, policies are useful for:

Assisting healthcare workers to understand practices (as an educational tool)

Supplying an agreed method of dealing with mishaps, e.g. needlestick injury or blood spills

Ensuring healthcare workers are held accountable for their actions (since policies explain the minimum standard of care expected).

1-28 Who should be involved in drafting IPC policies?

Policies are usually drawn up by the IPC team, on behalf of a facility's IPC committee or facility management. It is essential that all role players are consulted when the policy is being drafted. This ensures that staff have a sense of ownership of the policy and increases the chance that they will actually follow the policy recommendations.

1-29 What is involved in the process of drafting IPC policies?

Drafting or revising a policy should follow a specified process to ensure that the policy will be both evidence-based and acceptable to the facility staff. The steps involved in policy development include:

1-30 Which components should be included in a policy?

Every policy requires certain components including:

1-31 How should new IPC policies be communicated and implemented?

The process of communicating a new policy is much simpler if all stakeholders were consulted during the policy drafting process. Before launching the policy:

Make sure the policy is written in simple, understandable language

Ensure that all the resources are available to implement the policy

Pilot or test the draft policy before wide implementation.

Once the policy is finalised and approved, send out the final policy to all role players with a stated date for policy implementation. Call a meeting to go through the policy with all relevant role players.

Arrange for staff to be trained on the policy. Monitor the outcome of the new policy, providing opportunities for staff to report difficulties or request support for the implementation process. Make sure the policy is included in the infection control manual and that the document is easily accessible to staff.

1-32 What is a standard operating procedure (SOP)?

A standard operating procedure (SOP) is a written explanation of how to perform a practical task, e.g. how to clean a laryngoscope after use. SOPs are written using verbs or action words to describe the process, e.g. put on gloves and an apron, disassemble the laryngoscope, unscrew the light bulb, scrub the blade with soap and water. The instructions and steps should be very specific so that there is no uncertainty or confusion. The draft SOP should be produced after wide consultation with stakeholders. Once finalised and approved, the SOP should be prominently displayed in the appropriate place, e.g. hand hygiene posters at wash basins; urine testing SOP in sluice rooms.

A standard operating procedure (SOP) is a written explanation of how to perform a practical task.

1-33 When is a standard operating procedure needed?

Most SOPs are written for high-risk tasks where the potential negative consequences for an incorrect practice are serious. SOPs can also be used to simplify complicated processes by breaking a task down into steps. SOPs are also useful for induction training of new staff members.

1-34 What is a guideline?

Guidelines are usually written to provide standard recommendations for:

the treatment of a clinical condition, e.g. guidelines for the treatment of syphilis

management of a particular circumstance, e.g. guideline for the management of needlestick injuries.

The format resembles that of a policy or SOP.

Report writing in infection prevention and control

1-35 What is an infection prevention and control report?

Reports in IPC are used to document findings and facts about a particular situation (e.g. outbreaks), services (e.g. the IPC programme) or practices (e.g. hand hygiene compliance). The purpose of an IPC report is to share factual information and to provide recommendations for improvement.

The purpose of an IPC report is to share factual information and to provide recommendations for improvement.

1-36 What should be included in the report?

An IPC report may be simply written but should provide sufficient detail (both written and in graphs/figures) to allow the reader to understand the content. The following components are included in most reports:

Report: Investigation of an outbreak of Klebsiella pneumoniae sepsis on the Neonatal Unit

Summary

In January 2014, eight neonates were diagnosed with Klebsiella pneumoniae bloodstream infection. Molecular testing showed that the infections were related. Investigation of the outbreak revealed the source to be inadequately decontaminated ventilator tubing. Hospital management agreed to stop the practice of recycling used ventilator tubing. No further cases of Klebsiella pneumoniae sepsis have been reported to date.

Background

Klebsiella pneumoniae is a common neonatal pathogen which can cause bloodstream infections, pneumonia and meningitis. Outbreaks of Klebsiella pneumoniae sepsis in neonatal units are not infrequent. Poor hand hygiene, contaminated medication or equipment and inadequate environmental cleaning may be responsible for outbreaks with this pathogen.

Aims

To identify the cause of the outbreak.

Methods

Following identification of eight neonates with Klebsiella pneumoniae sepsis in the neonatal unit over four weeks an outbreak investigation was undertaken. The following methods were used:

A line list and Gannt chart were drawn up

Audits of hand hygiene compliance and environmental cleaning were conducted in the neonatal unit

Microbiological cultures (swabs) from equipment, surfaces and ventilator tubing were taken

Molecular analysis techniques (PCR sequencing) were used to determine if the bacterial isolates were related.

Findings

The line list revealed that ventilation was a common risk factor for all eight affected neonates.

Overall levels of hand hygiene were low (average 30%, 125 observations).

Environmental cleaning levels were acceptable (audit score 24/30 = 80% compliance).

Strain typing of the eight neonates and the six isolates from the ventilator tubing revealed a closely related strain, implying that the inadequately decontaminated tubing was the source of this outbreak. On inspecting the washer disinfector used to clean the ventilator tubing in the sterile services department, it was found to be outdated with a faulty temperature gauge.

Recommendations

1. The practice of recycling single-use items should be stopped with immediate effect.

2. The outdated washer disinfector in the sterile services department should be replaced.

3. Sterile services department staff should be re-trained on validation of decontamination.

4. Hand hygiene compliance in the neonatal unit should be reinforced.

Date of report: 21 February 2014

Investigation Team: Sr N Khumalo (IPC practitioner), Dr M Smith (Microbiology), Dr G Sithole (Neonatal Unit)

Occupational health and safety programmes

1-37 What is an occupational health and safety (OHS) programme?

OHS programmes aim to promote and protect the health and safety of all healthcare workers. In general the OHS programme should perform:

Pre-employment screening

Workplace safety and risk assessments

Surveillance and medical evaluations for occupational injuries and diseases

Immunisation for occupationally acquired diseases.

The IPC and OHS services at a facility should have a close working relationship, ensuring the safety of patients, visitors (IPC) and staff (OHS and IPC). In some low-resource settings, the responsibility for IPC and OHS are combined in a single IPC/OHS practitioner post. IPC and OHS work together to monitor for and prevent transmission of hazardous biological agents, e.g. tuberculosis (TB), blood-borne diseases (HIV, hepatitis B and C), among others.

Infection prevention and control and occupational health and safety services work together to ensure the safety of patients, visitors and staff.

1-39 Which diseases and activities of the occupational health and safety programme have relevance to infection prevention and control?

Particular programmes where IPC and OHS services should combine their efforts are:

1-40 How should needle-stick injuries be handled?

Every healthcare facility should have a needlestick injury (NSI) policy that is familiar and accessible to all staff and is regularly updated (at least every two years). Training on the NSI policy should be mandatory for all healthcare workers at pre-employment training or staff induction. The general procedures and principles that should be addressed in a NSI policy include:

Perform first aid (remove the sharp, wash the affected area with soap and running warm water, do not suck the wound).

For eye or mouth splashes, rinse out with lots of water (use eye washout kits if available).

Report the injury to a supervisor and to the occupational health service immediately.

Establish (where possible) the HIV, hepatitis B and C status of the source case.

Establish the injured healthcare worker's immunity to hepatitis B.

Establish the injured healthcare worker's HIV status and if HIV-positive, establish whether their CD4 and HIV viral loads have been checked within the last six months.

Provide post-exposure prophylaxis for HIV as soon as possible (preferably within 1-2 hours of the injury) and if necessary for hepatitis B.

Provide pre- and post-test counselling for the source patient and injured healthcare worker.

Provide regular follow-up, support and testing for HIV and hepatitis sero-conversion to healthcare workers exposed to blood-borne viruses.

Every healthcare facility needs a needlestick injury policy that is familiar and accessible to all staff.

1-41 How can needlestick injuries be prevented?

Healthcare workers should be educated never to recap used needles.

Used needles should be immediately discarded in a puncture-proof sharps box.

Sharps boxes should be located within arm's reach of a procedure.

Sharps boxes must be replaced when more than two-thirds full.

Case study 1

A new 1000-bed hospital is being built in a community with a high burden of tuberculosis (TB) and HIV. The hospital manager is busy recruiting staff to run the infection prevention and control programme.

1. What should the main goals of the IPC programme be?

The primary goals of the new hospital's IPC programme should be:

To prevent susceptible patients acquiring pathogenic (disease-causing) micro-organisms

To contain the spread of antimicrobial resistant infections.

2. How many IPC practitioners will the new hospital need?

Since this will be a large 1000-bed hospital with a heavy burden of infectious diseases, the hospital manager should allocate sufficient human resources to IPC. Ideally he should appoint an IPC team, including an IPC doctor and at least four IPC nurse practitioners (that is one for every 250 beds).

3. What activities should the hospital manager add to the job description of the IPC practitioners?

The daily duties of the IPC practitioners would include:

4. What other structure should the hospital manager create to assist the IPC team?

The manager should ensure that an IPC committee is formed as soon as possible after the hospital opens. An IPC committee is a multi-disciplinary group of healthcare facility staff who volunteer or are elected to advise and assist with management of the IPC programme. The manager should ensure that IPC committee meetings are held regularly with circulation of reports and meeting minutes to management and all other stakeholders in the facility.

Case study 2

A newly appointed IPC practitioner notices that staff at her clinic have limited understanding of and poor implementation of airborne isolation precautions for prevention of tuberculosis transmission. On questioning different categories of staff, she realises that they have had very little IPC education during their training and none at all since they started working at the clinic.

1. Why do these healthcare workers need training in IPC?

In many countries, there is insufficient undergraduate training in IPC for medical, nursing and allied health professionals. In addition, once they enter the workplace, healthcare workers often follow the poor or incorrect practices of senior colleagues. Over time new guidelines, equipment, procedures and even new diseases may arise, resulting in a need for regular in-service IPC training for healthcare workers.

2. Who should the IPC practitioner train?

All healthcare workers require at least a basic understanding of IPC, including TB-IPC principles. Since different categories of workers may have different information needs, it is recommended that IPC training sessions be tailored to the specific target audience. In the case of training on airborne isolation precautions for TB, every staff member who comes into contact with patients will need training, including cleaners, porters, nurses, doctors, radiographers and clinic reception staff.

3. When should staff members receive IPC training?

Ideally all new employees should receive induction (pre-employment) training in IPC. Annual refresher courses or short in-service training updates are recommended. In this case, the IPC practitioner may need to prioritise who is most at risk and then start training for this group first.

Case study 3

The facility manager requests the IPC practitioner to provide copies of all policies developed, audits performed and reports written in the last year. The IPC practitioner has to explain to the manager's secretary which documents to file under policies, audits and reports.

1. What is a policy and what are some examples of documents that could be included?

A policy is a document that provides standard guidance on a particular topic. The IPC practitioner submitted a new policy and several policies that were updated in the last year, including:

The facility policy on tuberculosis infection prevention and control (TB-IPC)

The facility policy on needlestick injury (NSI) management

The facility policy on isolation room usage.

2. What is an audit and what are some examples of audit reports that could be included?

An IPC audit is an activity performed to evaluate how well a facility or clinical area is complying with IPC standards. Examples of IPC audit reports that could be supplied to management include:

Annual facility-wide audits of hand hygiene compliance

Audits of compliance with healthcare waste management

Audits of environmental cleaning.

3. What is an IPC report and what are some examples of reports that could be included?

Reports in IPC are used to document findings and facts about a particular situation (e.g. outbreaks), services (e.g. the IPC programme) or practices (e.g. hand hygiene compliance). The IPC practitioner could submit reports on the following:

Outcome of outbreak investigations

Reports of healthcare-associated infection rates

Reports on training and education of staff in IPC.

Case study 4

A porter is carrying a sharps container and the lid which was loosely placed on top of the container falls off. All the sharps fall out and one needle and syringe which appears unused jabs him on the lower leg. The sharps container had been placed next to a patient who was having a fingerprick glucose test taken.

The porter should call his superior and report the incident immediately. He should then report to the occupational health department or officer, with the needle and syringe that caused the accident. The spillage should be cleared up by an experienced person in full protective equipment and with the appropriate brush and pan.

2. What should the occupational health officers do for him as a staff member?

Check his immunisation record and immune status. Take blood from the porter and from the source patient for HIV, hepatitis B and C and send for testing. If his immunisation is inadequate, fast track hepatitis B immunisation and start on HIV post-exposure prophylaxis (PEP) within two hours. If the source blood is HIV-negative then the PEP can be stopped. If the member of staff is HIV positive then his CD4 count and viral load should be checked.

3. What is the expected risk from this accidental needle stick injury?

This needle and syringe did not appear to have blood in it therefore the risk is less than if there had been blood in the needle and the barrel of the syringe. Nonetheless, it is essential that full precautions as described above be taken.

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1. Role and structure of infection prevention and control programmes

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Take the chapter quiz before and after you read this chapter. Open chapter quiz First time? Register for free. Just enter your email or cell number and create a password. When you have completed this chapter you should: Infection prevention and control (IPC) is a discipline that aims to prevent or control the spread of infections in healthcare facilities and the community.

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Infection prevention and control | First Steps | RCN

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Infection prevention and control | First Steps | RCN

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Infections, particularly those known as 'health care acquired infections' (HCAI or HAI) (which means that patients/clients acquire the infection while receiving care from health services), are one of the biggest challenges facing health services throughout the world.

There are many kinds of infections that patients/clients can acquire while accessing health care services. Some are associated with specific germs such as Clostridium difficile (you might hear this referred to as 'C.diff'), which causes diarrhoea. Others cause urinary, wound or chest infections. These can be caused by lots of different germs (usually bacteria) and can range from being very mild to serious - sometimes fatal - infections.

Our job as health care workers is to do everything we can to reduce passing (or 'transmitting') infection to patients, and from one patient to another. In this section, we'll look at some of the things we can do to help us avoid transmitting germs and therefore preventing infection - what we call 'standard infection control precautions'.

Standard infection control precautions include personal protective equipment and waste streams, which we will look at in this section. But central to standard infection control precautions is hand hygiene. It sounds very simple, but there's no doubt that learning how to perform hand hygiene and making sure you wash your hands 'as you should, when you should' are the most important things you can do to combat HCAI.

We will also explore in this section how infections are transmitted - the chain of infection.

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Infection prevention and control | First Steps

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Infections, particularly those known as 'health care acquired infections' (HCAI or HAI) (which means that patients/clients acquire the infection while receiving care from health services), are one of the biggest challenges facing health services throughout the world. There are many kinds of infections that patients/clients can acquire while accessing health care services.

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Break the Chain of Infection - Infection Prevention and You

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Break the Chain of Infection - Infection Prevention and You

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There are many different germs and infections inside and outside of the healthcare setting. Despite the variety of viruses and bacteria, germs spread from person to person through a common series of events. Therefore, to prevent germs from infecting more people, we must break the chain of infection. No matter the germ, there are six points at which the chain can be broken and a germ can be stopped from infecting another person. The six links include: the infectious agent, reservoir, portal of exit, mode of transmission, portal of entry, and susceptible host.

Infectious agent is the pathogen (germ) that causes diseases

Reservoir includes places in the environment where the pathogen lives (this includes people, animals and insects, medical equipment, and soil and water)

Portal of exit is the way the infectious agent leaves the reservoir (through open wounds, aerosols, and splatter of body fluids including coughing, sneezing, and saliva)

Mode of transmission is the way the infectious agent can be passed on (through direct or indirect contact, ingestion, or inhalation)

Portal of entry is the way the infectious agent can enter a new host (through broken skin, the respiratory tract, mucous membranes, and catheters and tubes)

Susceptible host can be any person (the most vulnerable of whom are receiving healthcare, are immunocompromised, or have invasive medical devices including lines, devices, and airways)

The way to stop germs from spreading is by interrupting this chain at any link. Break the chain by cleaning your hands frequently, staying up to date on your vaccines (including the flu shot), covering coughs and sneezes and staying home when sick, following the rules for standard and contact isolation, using personal protective equipment the right way, cleaning and disinfecting the environment, sterilizing medical instruments and equipment, following safe injection practices, and using antibiotics wisely to prevent antibiotic resistance. Learn 10 ways to protect patients.

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Break the Chain of Infection - Infection Prevention and You

# data[].attributes.attachment_link.description
There are many different germs and infections inside and outside of the healthcare setting. Despite the variety of viruses and bacteria, germs spread from person to person through a common series of events. Therefore, to prevent germs from infecting more people, we must break the chain of infection.

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Healthcare Respiratory Protection Resources | NPPTL | NIOSH | CDC

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Healthcare Respiratory Protection Resources | NPPTL | NIOSH | CDC

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The following categories are key requirements necessary for an effective hospital respiratory protection program. Click into each category to browse the related NIOSH information within.

The categories above are explained in-depth in the Hospital Respiratory Protection Program Toolkit. For more information, browse the NIOSH resources in each category, which includes NIOSH documents, infographics, videos, blog articles, journal articles, and more.

Page last reviewed:

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The following categories are key requirements necessary for an effective hospital respiratory protection program. Click into each category to browse the related NIOSH information within. The categories above are explained in-depth in the Hospital Respiratory Protection Program Toolkit. For more information, browse the NIOSH resources in each category, which includes NIOSH documents, infographics, videos, blog articles, journal articles, and more.

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Strategies for Optimizing the Supply of Isolation Gowns | CDC

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Strategies for Optimizing the Supply of Isolation Gowns | CDC

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Centers for Disease Control and Prevention

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Audience: These considerations are intended for use by federal, state, and local public health officials; leaders in occupational health services and infection prevention and control programs; and other leaders in healthcare settings who are responsible for developing and implementing policies and procedures for preventing pathogen transmission in healthcare settings.

Purpose: This document offers a series of strategies or options to optimize supplies of isolation gowns in healthcare settings when there is limited supply. It does not address other aspects of pandemic planning; for those, healthcare facilities can refer to COVID-19 preparedness plans.

Surge capacity refers to the ability to manage a sudden, unexpected increase in patient volume that would otherwise severely challenge or exceed the present capacity of a facility. While there are no widely accepted measurements or triggers to distinguish surge capacity from daily patient care capacity, surge capacity is a useful framework to approach a decreased supply of isolation gowns during the COVID-19 response. Three general strata have been used to describe surge capacity and can be used to prioritize measures to conserve isolation gown supplies along the continuum of care.

The following contingency and crisis strategies are based upon these assumptions:

1. Facilities understand their current isolation gown inventory and supply chain

2. Facilities understand their isolation gown utilization rate

3. Facilities are in communication with local healthcare coalitions, federal, state, and local public health partners (e.g., public health emergency preparedness and response staff) regarding identification of additional supplies

4. Facilities have already implemented other engineering and administrative control measures including:

Reducing the number of patients going to the hospital or outpatient settings

Excluding HCP not directly involved in patient care

Reducing face-to-face HCP encounters with patients

Excluding visitors to patients with confirmed or suspected COVID-19

Cohorting patients and HCP

Maximizing use of telemedicine

5. Facilities have provided HCP with required education and training, including having them demonstrate competency with donning and doffing, with any PPE ensemble that is used to perform job responsibilities, such as provision of patient care

Conventional Capacity Strategies
Use isolation gown alternatives that offer equivalent or higher protection.
Several fluid-resistant and impermeable protective clothing options are available in the marketplace for HCP. These include isolation gowns and surgical gowns. When selecting the most appropriate protective clothing, employers should consider all of the available information on recommended protective clothing, including the potential limitations. Nonsterile, disposable patient isolation gowns, which are used for routine patient care in healthcare settings, are appropriate for use by HCP when caring for patients with suspected or confirmed COVID-19. In times of gown shortages, surgical gowns should be prioritized for surgical and other sterile procedures. Current U.S. guidelines do not require use of gowns that conform to any standards.

Contingency Capacity Strategies
Selectively cancel elective and non-urgent procedures and appointments for which a gown is typically used by HCP Shift gown use towards cloth isolation gowns. .
Reusable (i.e., washable) gowns are typically made of polyester or polyester-cotton fabrics. Gowns made of these fabrics can be safely laundered according to routine procedures and reused. Care should be taken to ensure that HCP do not touch outer surfaces of the gown during care.
Consider the use of coveralls.

Laundry operations and personnel may need to be augmented to facilitate additional washing loads and cycles

Systems are established to routinely inspect, maintain (e.g., mend a small hole in a gown, replace missing fastening ties), and replace reusable gowns when needed (e.g., when they are thin or ripped)

Coveralls typically provide 360-degree protection because they are designed to cover the whole body, including the back and lower legs, and sometimes the head and feet as well. While the material and seam barrier properties are essential for defining the protective level, the coverage provided by the material used in the garment design, as well as certain features including closures, will greatly affect the protective level. HCP unfamiliar with the use of coveralls must be trained and practiced in their use, prior to using during patient care.
Use of expired gowns beyond the manufacturer-designated shelf life for training.
In the United States, the NFPA 1999 standardexternal icon specifies the minimum design, performance, testing, documentation, and certification requirements for new single-use and new multiple-use emergency medical operations protective clothing, including coveralls for HCP.
Use gowns or coveralls conforming to international standards.
The majority of isolation gowns do not have a manufacturer-designated shelf life. However, consideration can be made to using gowns that do and are past their manufacturer-designated shelf life. If there is no date available on the gown label or packaging, facilities should contact the manufacturer.

Current guidelines do not require use of gowns that conform to any standards. In times of shortages, healthcare facilities can consider using international gowns and coveralls. Gowns and coveralls that conform to international standards, including with EN 13795 and EN14126, could be reserved for activities that may involve moderate to high amounts of body fluids.
Cancel all elective and non-urgent procedures and appointments for which a gown is typically used by HCP.
Crisis Capacity Strategies

Extended use of isolation gowns.
Consideration can be made to extend the use of isolation gowns (disposable or cloth) such that the same gown is worn by the same HCP when interacting with more than one patient known to be infected with the same infectious disease when these patients housed in the same location (i.e., COVID-19 patients residing in an isolation cohort). This can be considered only if there are no additional co-infectious diagnoses transmitted by contact (such as Clostridioides difficile) among patients. If the gown becomes visibly soiled, it must be removed and discarded as per usual practicespdf icon .

Re-use of cloth isolation gowns.
Disposable gowns are not typically amenable to being doffed and re-used because the ties and fasteners typically break during doffing. Cloth isolation gowns could potentially be untied and retied and could be considered for re-use without laundering in between.

In a situation where the gown is being used as part of standard precautions to protect HCP from a splash, the risk of re-using a non-visibly soiled cloth isolation gown may be lower. However, for care of patients with suspected or confirmed COVID-19, HCP risk from re-use of cloth isolation gowns without laundering among (1) single HCP caring for multiple patients using one gown or (2) among multiple HCP sharing one gown is unclear. The goal of this strategy is to minimize exposures to HCP and not necessarily prevent transmission between patients. Any gown that becomes visibly soiled during patient care should be disposed of and cleaned.

Prioritize gowns.
Gowns should be prioritized for the following activities:

During care activities where splashes and sprays are anticipated, which typically includes aerosol generating procedures

During the following high-contact patient care activities that provide opportunities for transfer of pathogens to the hands and clothing of healthcare providers, such as:
Dressing, bathing/showering, transferring, providing hygiene, changing linens, changing briefs or assisting with toileting, device care or use, wound care

Surgical gowns should be prioritized for surgical and other sterile procedures. Facilities may consider suspending use of gowns for endemic multidrug resistant organisms (e.g., MRSA, VRE, ESBL-producing organisms).
Consider using gown alternatives that have not been evaluated as effective.
When No Gowns Are Available

In situation of severely limited or no available isolation gowns, the following pieces of clothing can be considered as a last resort for care of COVID-19 patients as single use. However, none of these options can be considered PPE, since their capability to protect HCP is unknown. Preferable features include long sleeves and closures (snaps, buttons) that can be fastened and secured.

Disposable laboratory coats

Reusable (washable) patient gowns

Reusable (washable) laboratory coats

Disposable aprons

Combinations of clothing: Combinations of pieces of clothing can be considered for activities that may involve body fluids and when there are no gowns available:

Long sleeve aprons in combination with long sleeve patient gowns or laboratory coats

Open back gowns with long sleeve patient gowns or laboratory coats

Sleeve covers in combination with aprons and long sleeve patient gowns or laboratory coats

Reusable patient gowns and lab coats can be safely laundered according to routine procedures.

Laundry operations and personnel may need to be augmented to facilitate additional washing loads and cycles

Systems are established to routinely inspect, maintain (e.g., mend a small hole in a gown, replace missing fastening ties) and replace reusable gowns when needed (e.g., when they are thin or ripped)

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Audience: These considerations are intended for use by federal, state, and local public health officials; leaders in occupational health services and infection prevention and control programs; and other leaders in healthcare settings who are responsible for developing and implementing policies and procedures for preventing pathogen transmission in healthcare settings.

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COVID-19: Strategies for Optimizing the Supply of PPE | CDC

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COVID-19: Strategies for Optimizing the Supply of PPE | CDC

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Centers for Disease Control and Prevention

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Personal protective equipment (PPE) is used every day by healthcare personnel (HCP) to protect themselves, patients, and others when providing care. PPE helps protect HCP from potentially infectious patients and materials, toxic medications, and other potentially dangerous substances used in healthcare delivery.

PPE shortages are currently posing a tremendous challenge to the US healthcare system because of the COVID-19 pandemic. Healthcare facilities are having difficulty accessing the needed PPE and are having to identify alternate ways to provide patient care.

CDC's optimization strategies for PPE offer options for use when PPE supplies are stressed, running low, or absent. Contingency strategies can help stretch PPE supplies when shortages are anticipated, for example if facilities have sufficient supplies now but are likely to run out soon. Crisis strategies can be considered during severe PPE shortages and should be used with the contingency options to help stretch available supplies for the most critical needs. As PPE availability returns to normal, healthcare facilities should promptly resume standard practices.

Key Concepts

HCP and facilities-along with their healthcare coalitions, local and state health departments, and local and state partners-will have to work together to develop strategies that identify and extend PPE supplies, so that recommended PPE will be available when needed most. When using PPE optimization strategies, training on PPE use, including proper donning and doffing procedures, must be provided to HCP before they carry out patient care activities.

All U.S. healthcare facilities should begin using PPE contingency strategies now.

Maximize use of engineering controls, such as barriers and maintained ventilation systems, and administrative controls, such as altering work practices to minimize patient contacts.

Cancel elective and non-urgent procedures/appointments.

Reserve PPE for HCP and replace PPE normally used for source control with other barrier precautions such as tissues.

Use re-usable PPE that can be reprocessed.

Use PPE beyond the manufacturer-designated shelf life for training.

Consider allowing HCP to extend use of respirators, facemasks, and eye protection, beyond a single patient contact.

U.S. healthcare facilities experiencing PPE shortages may need to consider crisis capacity strategies, which must be carefully planned before implementation. The effectiveness of crisis strategies is uncertain and they may pose a risk for transmission between HCP and patients.

Consider using intact PPE that is beyond the manufacturer-designated shelf life for patient care activities.

Carefully prioritize PPE use for selected care activities. This could include reserving sterile gowns and gloves for urgent sterile patient procedures, such as surgery, and reserving respirators for aerosol-generating procedures and patient care with airborne transmitted disease risks, like tuberculosis, measles, and varicella.

If no commercial PPE is available, carefully consider if alternative approaches will reduce the risk of HCP exposure and are safe for patient care.

As PPE becomes available, healthcare facilities should promptly resume standard practices.

Guidance

Emergency Use Authorization (EUA) of Respiratory Protective Devices

On February 4, 2020, the HHS Secretary declared that circumstances exist to justify the authorization of emergency use of additional respiratory protective devices in healthcare settings during the COVID-19 outbreak. The FDA is providing frequent updates for manufacturers, facilities, and local/state jurisdictions about Emergency Use Authorizations (EUA) for respirators and other types of personal protective equipment. The FDA has issued EUAs to authorize all NIOSH approved particulate-filtering air purifying respirators (APRs)external icon to be used in healthcare settings, including all NIOSH approved filtering facepiece respirators, elastomeric APRs, powered air purifying respirators, expired NIOSH-approved filtering facepiece respirators, and respirators that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system. The authorized decontamination systems are listed on the FDA EUA website. In addition, non-NIOSH-approved disposable filtering facepiece respirators within the context of the posted EUAexternal icon are permitted for use as well.

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Personal protective equipment (PPE) is used every day by healthcare personnel (HCP) to protect themselves, patients, and others when providing care. PPE helps protect HCP from potentially infectious patients and materials, toxic medications, and other potentially dangerous substances used in healthcare delivery.

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1.9. IPC WHO (updates often)

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Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected

This is the first edition of guidance on infection prevention and control (IPC) strategies for use when infection with a novel coronavirus (2019-nCoV) is suspected. It has been adapted from WHO's Infection prevention and control during health care for probable or confirmed cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection, based on current knowledge of the situation in China and other countries where cases were identified and experiences with severe acute respiratory syndrome (SARS)-CoV and MERS-CoV.

- Access the publication (19 March 2020)

Infection Prevention and Control for the safe management of a dead body in the context of COVID-19

This interim guidance is for all those, including managers of health care facilities and mortuaries, religious and public health authorities, and families, who tend to the bodies of persons who have died of suspected or confirmed COVID-19.

- Access the publication (24 March 2020)

IPC guidance for long-term care facilities in the context of COVID-19

The objective of this interim guidance is to provide guidance on Infection Prevention and Control in Long-Term Care Facilities (LTCF) in the context of COVID-19 to prevent COVID-19-virus from entering the facility, spreading within the facility, and spreading to outside the facility. This guidance is for LTCF managers and corresponding IPC focal persons in LTCF.

- Access the publication (21 March 2020)

Consideration for quarantine of individuals in the context of containment for coronavirus disease (COVID-19)

The purpose of this document is to offer guidance to Member States on quarantine measures for individuals in the context of COVID-19. It is intended for those responsible for establishing local or national policy for quarantine of individuals, and adherence to infection prevention and control measures.

- Access the publication (19 March 2020)

Health workers exposure risk assessment and management in the context of COVID-19 virus

This tool is to be used by health care facilities that have either cared for or admitted COVID-19 patients; it is to be completed for all health workers who have been exposed to a confirmed COVID-19 patient in a health care facility. It will help determine the risk of COVID-19 virus infection of all HCWs who have been exposed to a COVID-19 patient and then provides recommendations for appropriate management of these HCWs, according to their infection risk.

Find below the links to the template for collecting the data contained within the tool and a corresponding data dictionary to facilitate the collection of this data.

- Access the tool (19 March 2020)

- Access to the data template

- Access to the data dictionary

Rational use of personal protective equipment for coronavirus disease (COVID-19)
This document summarizes WHO's recommendations for the rational use of personal protective equipment (PPE) in health care and home care settings, as well as during the handling of cargo; it also assesses the current disruption of the global supply chain and considerations for decision making during severe shortages of PPE. This updated version includes a section on considerations for decision making processes and a summary of temporary measures in the context of severe PPE shortage.

- Access the publication (6 April 2020)

Advice on the Use of Masks

This document provides advice on the use of masks in communities, during home care, and in health care settings in areas that have reported cases of COVID-19. It is intended for individuals in the community, public health and infection prevention and control (IPC) professionals, health care managers, health care workers (HCWs), and community health workers. This updated version includes a section on Advice to decision makers on the use of masks for healthy people in community settings.

- Access the publication (6 April 2020)

Home care for patients with suspected novel coronavirus (nCoV) infection presenting with mild symptoms and management of contacts

WHO has developed this rapid advice note to meet the need for recommendations on the safe home care for patients with suspected novel coronavirus (2019-nCoV) infection presenting with mild symptoms and public health measures related to management of asymptomatic contacts.

- Access the publication (17 March 2020)

Q&A on infection prevention and control for health care workers caring for patients with suspected or confirmed 2019-nCoV
Are boots, impermeable aprons, or coverall suits required as routine person protective equipment (PPE) for healthcare workers (HCW) caring for patients with suspected or confirmed 2019-nCoV infection? Can disposable medical face masks be sterilized and reused? Do patients with suspected or confirmed 2019-nCoV need to be hospitalized if they have mild illness? Here you will find answers to these and other questions related to infection prevention and control for health care workers caring for patients with suspected or confirmed 2019-nCoV.

Water, sanitation, hygiene and waste management for COVID-19
This interim guidance is the second edition and supplements existing IPC documents by referring to and summarizing the latest evidence on COVID-19 in water supplies and sanitation and highlights WHO guidance on water, sanitation, hand hygiene and health care waste which is relevant for viruses (including coronaviruses). It is written in particular for water and sanitation practitioners and providers.

- Access the publication (23 April 2020)

Guide to local production of WHO-recommended Handrub Formulations
Part A is intended to guide a local producer in the actual preparation of the formulation.

Part B contains important safety and cost information and incorporates information from the WHO Guidelines on Hand Hygiene in Health Care (2009).

- Access the publication (Revised April 2010)

For any questions related to COVID-19 and infection prevention and control (IPC), please contact: WHEipc@who.int

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This is the first edition of guidance on infection prevention and control (IPC) strategies for use when infection with a novel coronavirus (2019-nCoV) is suspected.

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1.8. IPC UK gov.

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12.24. PPE shortage considerations

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HSE has examined the use of FFP2 respirators as an alternative to Type IIR surgical face masks in non-surgical settings

if risk assessment identifies a need for FFP2 respirators the user must be face fit tested to ensure they are providing the intended level of protection

in circumstances where a lower level of user protection is required, such as that provided by a surgical mask, an FFP2 worn without a face fit test will offer protection similar to the levels from a surgical face mask

this is a pragmatic approach for times of severe shortage of respiratory protective equipment (RPE), FFP2 respirators being used in this way will not be carrying out the function they were designed to perform

all healthcare settings are reminded that where their risk assessment has identified the requirement for a tight-fitting respirator users must pass a face fit test for that respirator model before it can be used

employers and users of respirators need to be assured protective equipment is protecting the wearer

Note: Surgical masks may sometimes be used for source control, if feasible and if the mask can be tolerated by the individual; for example, a surgical mask worn by a patient with COVID-19 during transfer within a hospital. When an FFP2 respirator needs to be used in place of a surgical mask for this specific purpose, it should an unvalved FFP2 respirator (that is, no exhale valve).

2. Background to 17 April 2020 advice

This document aligns with current evidence and Centers for Disease Control ( CDC) and World Health Organization ( WHO) guidance on optimising the supply of personal protective equipment ( PPE) and the use of PPE when in short supply.

The Health and Safety Executive ( HSE) has reviewed the options outlined in this document. Where there are acute shortages of PPE, and where it is safe to do so, it approves the sessional and reuse of PPE.

Some of the PPE in the NHS COVID-19 Ensemble is designated by the manufacturers as being single use. However, the HSE recognises that some compromise is needed to optimise the supply of PPE in times of extreme shortages. It has agreed that the use as outlined in this document is appropriate within health and safety legislation and provides appropriate protection for health and care workers.

These are exceptional circumstances and do not reflect HSE's standard approach. HSE expects Trusts to have an agreed action plan to support implementation which includes a consideration of all measures to manage usage effectively.

In addition, documentation of how any re-use will be managed (recognising that some PPE is personal, for example FFP3/FFP2 respirators) and should include a record of systems of work to manage how integrity checks and decontamination processes are being carried out. It should also recognise that certain equipment (for example gloves and aprons) cannot be reused.

Organisations should ensure healthcare workers are appropriately hydrated during prolonged use and trained to recognise dehydration, fatigue and exhaustion while wearing PPE.

Further work on validating methods to safely reprocess masks and fluid repellent gowns is under way and future updates will be circulated when available.

3. Purpose and scope of this document

This document aims to highlight the sessional use and reuse of PPE when there are severe shortages of supply.

The considerations are to ensure that health and care workers are appropriately protected from COVID-19, where items of PPE are unavailable, and should be considered as temporary measures until the global supply chain is adequate to meet the UK's needs.

The reuse of PPE should be implemented until confirmation of adequate re-supply is in place.

These take into account the following important principles that should already be in place for all health and care delivery:

1. Only urgent or emergency face-to-face contacts in the health and social care setting.

2. Where an individual has a multi-drug resistant or other key pathogen, transmission-based infection prevention control precautions should apply to prevent cross transmission to other individuals.

Sessional use: by one health or care worker during one shift while working. Clinical areas should include all ward areas. In hospitals, leaving a ward area to continue to care or transfer a patient, the same PPE can be worn. Face masks/respirators, gowns/ coveralls and eye protection should only be changed when taking a break or when visibly contaminated or damaged.

Reuse: using the same item again, with appropriate precautions, by the same healthcare worker.

Alternatives to standard PPE: recommended where there is a crisis or short supply.

4. Medical masks

4.1 Fluid repellent surgical face masks (FRSM) and disposable respirators (FFP3/ FFP2/ N95)

This excludes re-usable respirators, that can be re-used according to manufacturer's instructions.

FFP3/FFP2/N95 respirators have a large capacity for the filtration and retention of airborne contaminants. Sessional use or re-use over the course of a day in health or social care, would not approach anywhere near that capacity.

Sessional use

The use of masks for one HCW to use in one work area. This is currently recommended in the UK Infection Prevention and Control guidance.

it should be disposed of if it becomes moist, damaged, visibly soiled

the duration (number of hours) of sessional use is dependent on local (for example, heat, activity length, shift-length) and individual factors. In practice, this may vary from 2 to 6 hours

if masks are touched or adjusted, hand hygiene should be performed immediately

if the mask is removed for any reason (for example, upon exiting the ward area, taking a break or completing a shift), they are disposed of as clinical waste, unless they can be safely reused as outlined below

Resuse

Important requirements are as follows:

the mask should be removed and discarded if soiled, damaged, or hard to breathe through

masks with elastic ear hooks should be re-used (tie-on face masks are less suitable because they are more difficult to remove)

hand hygiene should be performed before removing the face mask

face masks should be carefully folded so the outer surface is held inward and against itself to reduce likely contact with the outer surface during storage

the folded mask should be stored between uses in a clean sealable bag/ box which is marked with the person's name and is then properly stored in a well-defined place

hand hygiene should be performed after removing the face mask

some models of PPE cannot be physically reused as they deform once being donned and do not go back to original condition (meaning it would be difficult to re-don and achieve a fit check). Fit checks should be performed each time a respirator is donned if it is reused

Alternatives to standard PPE

There is insufficient evidence to consider homemade masks or cloth masks in health and care settings.

5. Gowns and coveralls

Fluid repellent hospital gowns or coveralls are indicated for use for the care of patients in high risk areas, where aerosol generating procedures ( AGPs) are being performed.

There are 3 main options that can be considered as alternatives if gowns are not available:

1. Reserve disposable, fluid repellent gown or coveralls for AGPs and surgical procedures.

2. Disposable, non-fluid repellent gowns or coveralls with a disposable plastic apron for high-risk settings and AGPs with forearm washing once gown or coverall is removed.

3. Reusable (washable) surgical gowns or coveralls or similar suitable clothing (for example, long-sleeved laboratory coat, long-sleeved patient gown or industrial coverall) with a disposable plastic apron for AGPs and high-risk settings with forearm washing once gown or coverall is removed. These would need to be washed in a hospital laundry and capacity for hospital laundries may need to be increased.

5.1 Sessional use

This is the use of gowns or coveralls for healthcare workers ( HCWs) to use for higher risk clinical areas. This is currently recommended in the UK Infection Prevention and Control guidance.

If the gown or coverall becomes visibly soiled, it must be disposed as infectious waste (followed by hand hygiene, donning of a new gown, and appropriate donning of new gloves).

The following important factors would safely reduce gown usage over a session but organisations should develop an implementation and action plan suitable to their organisation:

1. Label all higher risk area bays, single rooms, corridors, treatment rooms and nurses' stations as 'clinical' areas within a specific hospital area. Limit 'non-clinical' areas to staff kitchen/rest areas and changing room.

2. Once gown or coverall is donned, the gown/coverall should remain on the staff member until their next break. Plastic aprons and gloves should be changed between patients (with the notes from aprons highlighted below).

3. Staff should doff the gown or coverall only when going from the clinical to non-clinical area of the ward, or if they are leaving the ward for a break.

4. If leaving a higher risk area/theatre ward with a patient to transfer them to another area staff should retain their gown or coverall and other PPE.

5. Teams that assist with turning and moving patients ("proning teams"), allied health professionals and other teams should retain gowns or coveralls on sessional basis, changing gloves/aprons between patients/residents and performing hand hygiene.

Consider shifting disposable gowns or coveralls to reusable options, retaining disposable gowns only for high risk AGPs.

If there are no available disposable gowns or coveralls, consider the use of gown alternatives including:

reusable gowns

reusable (washable) laboratory coats

reusable (washable) long sleeved patient gowns

reusable coveralls

Capacity for hospital laundering service should be considered if using these items.

6. Eye Protection

Goggles provide barrier protection for the eyes. They should fit snuggly over and around the eyes or personal prescription lenses, be indirectly-vented (to prevent penetration of splashes or sprays) and have an anti-fog coating to help maintain clarity of vision. The lens is made of plastic, commonly polycarbonate and there is an adjustable elastic strap to allow snug fit around the eyes. Goggles used for healthcare applications are typically reusable.

Visors provide barrier protection to the facial area and related mucous membranes (eyes, nose, lips) and are considered an alternative to goggles. Visors should be used if AGP aerosol-generating procedure is performed. They should cover the forehead, extend below the chin, and wrap around the side of the face. Visors are available in both disposable and reusable options.

Sessional use

This is currently recommended in the UK Infection Prevention and Control guidance.

The goggles or face shield should be removed upon exiting the ward area per standard practice.

Reuse

This is currently recommended in the UK Infection Prevention and Control guidance, where the eye protection is not relabelled as single use only.

If in extremely short supply, single use only items could be re-used in a similar way as re-usable items.

The standard method of cleaning is to use a detergent product either combined/ sequentially with a decontamination product as agreed by the local infection prevention and control ( IPC) specialists.

They should be rinsed thoroughly to remove any residual detergent or cleaning product and left to dry.

Products will degrade over time with repeated cleaning, particular the anti-fog component and will need to be resupplied regularly.

This guidance relates to examination gloves used for clinical care of COVID-19 patients. These gloves are available in a variety of materials, are single use and must be disposed of after each use. Non-powdered, nitrile gloves are the most commonly recommended for healthcare.

7.1 Additional considerations

Do not use double gloves for care of suspected or confirmed COVID-19 patients.

Sessional use or of reuse examination gloves for clinical care should be avoided.

These are indicated for use when there is risk of splashes or sprays to protect clothes, where gowns are used on a sessional basis or where the gowns are not fluid resistant.

Re-use of aprons is not recommended.

9. Associated legislation

Please note that this guidance is of a general nature and that an employer should consider the specific conditions of each individual place of work and comply with all applicable legislation, including the Health and Safety at Work etc. Act 1974.

10. Consensus statement

It is the consensus view of Health Protection Scotland, Public Health Wales, and Public Health Agency Northern Ireland that current advice remains extant; that is, single use PPE should not be reused/reprocessed and that reusable PPE should be reprocessed in accordance with the manufacturer's instructions.

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Considerations for acute personal protective equipment (PPE) shortages

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HSE has examined the use of FFP2 respirators as an alternative to Type IIR surgical face masks in non-surgical settings if risk assessment identifies a need for FFP2 respirators the user must be face fit tested to ensure they are providing the intended level of protection in circumstances where a

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2.18. CDC & Johns Hopkins Ebola (donning) Coverall Video

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Centers for Disease Control and Prevention (CDC)

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How to Safely Put on PPE, Selected Equipment: N95 and Coverall

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2.17. CDC

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Centers for Disease Control and Prevention (CDC)

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Demonstration of Donning (Putting On) Personal Protective Equipment (PPE)

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2.16. NHS don&doff (non aerosol related)

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COVID-19: Donning and doffing of Personal Protective Equipment in Health and Social Care Settings

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2.15. NHS training video (doffing)

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COVID-19: Removal and disposal of Personal Protective Equipment (PPE)

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12.23. WHO on PPE

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7.13. Decon&Reuse webinar by N95

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N95 Decontamination & Reuse Webinar | N95DECON & MGB

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12.22. Webinar on PPE

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WHO-CED COVID19 Critical Topic Webinar: Masks, Respirators and face shields - YouTube

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12.21. WFSA resources

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COVID-19 Information for Low Resource Settings

This site is intended to provide resources for anesthesia providers working in a limited-resource setting caring for patients with COVID-19. If there is any topic you would like to see included or useful information (including pictures) you would like to share please contact us at advocacy@wfsahq.org

Keeping you and your patient safe

Creative low-resource solutions to creating barriers to protect the anesthesia provider during intubation and extubation:

Physician well-being - Selected resources relating to wellbeing and psychological support during the COVID-19 pandemic.

Perioperative Care

COVID-19 Anesthesia specific tools:

COVID-19 Intraoperative Checklist - To be used in conjunction with the WHO SSCL to minimize healthcare provider exposure when operating on a COVID-19(+) or suspected patient:

Critical/Intensive Care

Management of Severe COVID-19 Disease - Guidelines developed by Kenya Society of Anaesthesiologists, Critical Care Society of Kenya, and the Respiratory Society of Kenya on the management of the patient with COVID-19.

CPR Modifications for suspected or confirmed COVID-19 Patients:

Simulation

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COVID-19 Information for Low Resource Settings

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COVID-19 Information for Low Resource Settings This site is intended to provide resources for anesthesia providers working in a limited-resource setting caring for patients with COVID-19.

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12.20. Surgical patient checklist. Includes PPE and team issues

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12.19.

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12.1

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As the Covid-19 pandemic escalates, many governments worldwide are advocating for the mandatory use of face masks in public.

When President Cyril Ramaphosa addressed the nation on 23 April, he indicated that the use of face masks in public - during all lockdown levels - would be mandatory.

And if you can't find one, you can certainly make one, but be sure to take the advice of scientists in a recent study.

Six researchers from the Argonne National Laboratory and the University of Chicago recently conducted a study and found that two simple but important features can help to stop the spread of the new coronavirus, officially named SARS-CoV-2.

These include that the mask should have multiple layers, and mixing up the fabrics. They suggest this works best to filter particles and add that an improper mask fit can seriously reduce the protection it offers.

The study was published in ACS Nano Publications.

The study

The researchers began their study by taking a variety of common fabrics, including cotton, chiffon, silk, flannel, various synthetics, and their combinations, and proceeded to test them in laboratory conditions.

Their aim was to investigate the materials' mechanical and electrostatic filtration properties. Mechanical filtration refers to the fabric physically catching the particles, whereas electrostatic-based filtration keeps the aerosols inside the static environment, explains ScienceAlert.

"Overall, we find that combinations of various commonly available fabrics used in cloth masks can potentially provide significant protection against the transmission of aerosol particles," the researchers explain.

The process involved the use of an aerosol mixing chamber to sample the number of aerosols in the air, an article by ScienceAlert explains. The paper shows an illustration of the experiment, along with specific information on the fabrics used.

After the first step, they passed the particles through each of the fabrics and sampled the air that penetrated the fabric, and tested for a large range of aerosolised particle sizes. Although scientists are still on the fence on whether such tiny particles can cause infection, ScienceAlert further explains that ensuring the material can filter out the smallest scale of particles is a good way to ensure larger particles will also be blocked.

Ruining the entire effort

In addition to mixing up the material, the team also found that layering multiple materials, also known as "hybrid" fabrics, successfully filtered a large majority of the particles.

"We speculate that the enhanced performance of the hybrids is likely due to the combined effect of mechanical and electrostatic-based filtration," the researchers explained.

However, although making your own mask may be a quick and cheap method, the researchers cautioned that even if you get the above techniques right, wearing your mask incorrectly can ruin the entire effort - and can increase the risk of being infected with the virus.

As part of their experiment, the team poked small holes in the fabrics they were testing, and the results were surprising.

"Our studies also imply that gaps (as caused by an improper fit of the mask) can result in over a 60% decrease in the filtration efficiency," they explained.

The World Health Organization (WHO) offers simple tips for getting this right:

Before wearing your mask, ensure your hands were cleaned with alcohol-based hand sanitiser, or washed thoroughly with soap and water.

Make sure to cover both your mouth and nose with the mask.

Take care to check for any gaps between your face and the mask, as there shouldn't be any.

Avoid touching your mask while using it.

In the event that you do touch your mask, clean your hands as stated above.

When removing your mask, remove it from behind and do not touch the front of it.

Once done, clean your hands thoroughly.

Of course, face masks are effective only when used in combination with frequent handwashing, notes WHO. More importantly, wash your face mask regularly, as this is just as important as wearing it correctly, in order to prevent the spread of the Covid-19 virus.
READ | Coronavirus in SA: All the confirmed cases READ | Coronavirus morning update: Why lockdown was eased, 1 million cases in US, and experts speak out on BCG READ | Isolation during coronavirus pandemic a trigger for depression
Image: Getty/Anna Blazhuk

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If you're making a DIY face mask, these are the best materials to use according to science

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As the Covid-19 pandemic escalates, many governments worldwide are advocating for the mandatory use of face masks in public. When President Cyril Ramaphosa addressed the nation on 23 April, he indicated that the use of face masks in public - during all lockdown levels - would be mandatory.

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12.2. use of cloth to get great filtration

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If the fit is right, face masks made of a combination of high thread-count cotton and natural silk fabric or a chiffon weave can effectively filter out aerosol particles, researchers report.

In the wake of the COVID-19 pandemic, the US Centers for Disease Control and Prevention recommends that people wear masks in public. Because N95 and surgical masks are scarce and should go to health care workers, many people are making their own coverings out of fabric.

"There is a huge interest and need for homemade cloth masks, but we found little data on how good various fabrics are as filters for masks," says senior author Supratik Guha, professor with the Pritzker School of Molecular Engineering at the University of Chicago and a scientist at the Argonne National Laboratory.

"According to these results, it's possible to get very good filtering with commonly available fabrics, but the wearer only gets maximum protection if the fit is very close to your face."

COVID-19 is thought to spread mainly through respiratory droplets created when an infected person coughs, sneezes, speaks, or breathes. Guha and his colleagues wanted to study the ability of common fabrics, alone or in combination, to filter out aerosols similar in size to respiratory droplets. So Guha-in regular times, a leading scientist in microelectronics and materials for quantum information-quickly rigged up an experimental setup with his colleagues to test combinations of fabrics that can be bought at fabric and retail stores.

The experiments took place in two plexiglass boxes connected by a tube. In one chamber, the team created a cloud of particles and blew them toward the tube, which was covered by different combinations of cloth. Mike Schmoldt and Greg Moss, environmental safety experts at Argonne who specialize in respirator testing and the effects of aerosol particles, used laboratory-grade scientific instruments to measured the number and size of particles in the chambers before and after passing through the fabric.

According to their results, one layer of a tightly woven cotton sheet, combined with two layers of polyester-based chiffon-a sheer fabric often used in evening gowns-filtered out the most aerosol particles (80% to 99%, depending on particle size). Substituting the chiffon with natural silk or a polyester-cotton flannel, or simply using a cotton quilt with cotton-polyester batting, produced similar results.

Though the study does not attempt to replicate real-world conditions, the findings are a useful guide. The researchers point out that tightly woven fabrics, such as cotton, can act as a mechanical barrier to particles, whereas fabrics that hold a static charge, like certain types of chiffon and natural silk, can serve as an electrostatic barrier. The electrostatic effect serves to suck in and hold the tiniest particles, which might otherwise slip through holes in the cotton. This is key to how N95 masks are constructed.

However, Guha adds, even a small gap reduced the filtering efficiency of all masks by half or more, emphasizing the importance of a properly fitted mask.

Fabrics that did not do well included standard polyester and spandex with more open weave. In general, Guha says, fabric with tighter weaves-with fewer gaps between the strands of yarn-worked better.

"This is some of the first methodical data I've seen on homemade masks. It's very helpful to have some idea of how the different types of fabric perform," says Emily Landon, executive medical director of infection prevention and control at the University of Chicago Medicine. "I was also pleasantly surprised by how effective some of the homemade masks can be in the right conditions."

Landon notes that the advice to wear homemade masks while out in public is intended primarily to protect others from your own respiratory droplets, and that universal adoption of this recommendation will go a long way to make everyone safer. In that case, any mask is better than none.

The research appears in . Partial funding came from the US Department of Defense Vannevar Bush Fellowship. The researchers used the US Department of Energy's Center for Nanoscale Materials user facility at Argonne National Laboratory.
Source: University of Chicago

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Combine cotton and silk for the best homemade mask - Futurity

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If the fit is right, face masks made of a combination of high thread-count cotton and natural silk fabric or a chiffon weave can effectively filter out aerosol particles, researchers report. In the wake of the COVID-19 pandemic, the US Centers for Disease Control and Prevention recommends that people wear masks in public.

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12.3. OSHA Guidance on permitted use of expired and used facemasks

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12.4. PPE module

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12.5. Brace to fix the surgical mask

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We're facing a global shortage of N95 masks. N95 masks are difficult to manufacture. ASTM surgical masks -the kind hospitals have plenty of- are still available but do not seal tightly to the face, creating the risk of exposure to COVID-19 particles.

We developed the Surgical Mask Brace. It allows a surgical mask to seal better - turning a shortage of masks into an abundance.

CDC/NIOSH is our golden standard, but we don't have 45 days to wait. We've been working to validate it ourselves in the meantime while we wait for CDC.

Fix The Mask mission is to quickly supply safe masks in the fight against COVID-19. Our ex-Apple mechanical engineers designed the surgical mask brace to improve the sealing of surgical masks.

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We're facing a global shortage of N95 masks. N95 masks are difficult to manufacture. ASTM surgical masks -the kind hospitals have plenty of- are still available but do not seal tightly to the face, creating the risk of exposure to COVID-19 particles. We developed the Surgical Mask Brace.

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12.6.

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European Centre for Disease Prevention and Control

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Find ECDC resources on preparedness and prevention and control measures of COVID-19, such as guidance and technical reports for patient and case management, personal protective equipment, preventive measures.

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12.7. Identify and utilize PPE infographic

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12.8. dos-and-donts-of-masks.pdf

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12.9. PPE conservation management sourcing from JAMA

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12.10. PPE Sourcing Conservation and Management JAMA

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12.11. ECDC microcourse on PPE

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12.12. Audio: Reusing Face Masks and N95 Respirators COVID19  AMA Ed Hub

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Infection prevention and control and preparedness for COVID-19 in healthcare settings - second update

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Infection prevention and control and preparedness for COVID-19 in healthcare settings - second update

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12.13.

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European Centre for Disease Prevention and Control

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COVID-19

At the end of December 2019, Chinese public health authorities reported several cases of acute respiratory syndrome in Wuhan City, Hubei province, China. The disease is now referred to as coronavirus disease 2019 (COVID-19), and the causative virus is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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Infection prevention and control and preparedness for COVID-19 in healthcare settings - second update

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This document aims to provide guidance to EU/EEA healthcare facilities and healthcare providers on infection prevention and control (IPC) measures for the management of suspected and confirmed cases of COVID-19 infection in healthcare settings, including long-term care facilities. It also offers guidance on the management of specimens at laboratories in the EU/EEA.

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12.14. PPEs and decontam devices FDA Emergency Use Authorizations

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Industry Hotline: Coronavirus COVID-19 Diagnostic Tests and Shortages

For Industry Questions: COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for masks and respirators

Contact our toll-free line 24 hours a day: 1-888-INFO-FDA , choose option *

Or Email:

Date EUA Issued

Manufacturer

Diagnostic (Letter of Authorization)

Technology

Authorized Setting(s)1

Authorization Documents2

Other Documents/

03/20/2020

Cepheid
Xpert Xpress SARS-CoV-2 test
Molecular

H, M, W

HCP, Patients, IFU for Labs,
IFU for Point-of-Care
Letter Granting EUA Amendment(s) (April 28, 2020)

03/19/2020

DiaSorin Molecular LLC
Simplexa COVID-19 Direct assay
Molecular

H, M

03/16/2020

Laboratory Corporation of America (LabCorp)
COVID-19 RT-PCR Test
Molecular

H

HCP, Patients, EUA
Summary, IFU-Home Collect
Letter Granting EUA Amendment(s) (April 14, 2020)

03/13/2020

Thermo Fisher Scientific, Inc.
TaqPath COVID-19 Combo Kit
Molecular

H

Letter Granting EUA Amendment(s) (March 24, 2020)
Letter Granting EUA Amendment(s) (April 20, 2020)

Date EUA Issued

Laboratory

Letter Granting Inclusion under EUA

EUA Summary

Other Documents

03/31/2020

Yale New Haven Hospital,
Clinical Virology Laboratory
SARS-CoV-2 PCR test EUA Summary
None

On September 27, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Chembio Diagnostic Systems, Inc.'s DPP Zika IgM Assay System for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel) and fingerstick whole blood, EDTA venous whole blood, or EDTA plasma (each collected alongside a patient-matched serum specimen) specimens collected from individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high or moderate complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after onset of symptoms or risk of exposure, respectively. Where there are reactive results from the DPP Zika IgM Assay System, confirmation of the presence of anti-Zika IgM antibodies requires additional testing, as described in the Scope of the Letter of Authorization (Section II) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.

In response to Chembio Diagnostic Systems, Inc.'s request, on February 6, 2018 FDA concurred with the modifications to the authorized Instructions for Use for the DPP Zika IgM Assay System to (1) replace the liquid form of the goat anti-human IgG antibodies and heterophilic antibody (HA) interference blocker for treatment of the specimen with the dehydrated form of the reagents placed in the DPP Zika IgM Assay System device, (2) expand the kit storage range from 2 to 8 °C to 2 to 30 °C, and (3) replace the DPP Zika IgM Sample Buffer and DPP Zika IgM Running Buffer vials by a single vial that is labeled DPP Zika IgM Buffer.

In response to Chembio Diagnostic Systems, Inc.'s request, on August 3, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the DPP Zika IgM Assay System to correct some typographical and formatting errors.

On November 21, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Abbott's RealTi m e Zika assay for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Positive results are indicative of current infection.

In response to Abbott Molecular Inc.'s request, on January 6, 2017 FDA concurred with the modification to the authorized Abbott RealTime ZIKA assay Kit Fact Sheets to include EDTA whole blood as an authorized specimen type. FDA also concurred with the related updates to the Instructions for Use and the Fact Sheets for the Abbott RealTime ZIKA assay that reflect the addition of EDTA whole blood.

On September 23, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Vela Diagnostics USA, Inc.'s Sentosa SA ZIKV RT-PCR Test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Positive results are indicative of current infection.

On June 17, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Hologic, Inc.'s Aptima Zika Virus assay for the qualitative detection of RNA from Zika virus in human serum and plasma specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

In response to Hologic Inc.'s request, on September 7, 2016 FDA concurred with the revision to add processed urine (collected alongside a patient-matched serum or plasma specimen) as an authorized specimen under the emergency use authorization of the Aptima Zika Virus Assay issued on June 17, 2016. The Instructions for Use and Fact Sheets also have been updated to incorporate these revisions, and the Pregnant Women and Patient Fact Sheets were combined into one Patient Fact Sheet.

In response to Hologic, Inc.'s request, on April 12, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the Aptima Zika Virus assay to (1) extend the stability of processed urine specimens, (2) clarify storage and stability of serum and plasma specimens, and (3) improve the overall clarity and accuracy of the document. FDA also concurred with minor updates to the authorized Aptima Zika Virus assay Fact Sheets that were requested by FDA.

In response to Hologic, Inc.'s request, on March 8, 2018 FDA concurred with the request to add processed whole blood K2EDTA (collected alongside a patient-matched serum or plasma specimen) as an authorized specimen under the emergency use authorization of the Aptima Zika Virus Assay issued on June 17, 2016. FDA also concurred with the related updates to the Instructions for Use and the Fact Sheets for the Aptima Zika Virus assay that reflect the addition of processed whole blood K2EDTA (collected alongside a patient-matched serum or plasma specimen).

On May 13, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of altona Diagnostics RealStar Zika Virus RT-PCR Kit U.S. for the qualitative detection of RNA from Zika virus in serum or urine (collected alongside a patient-matched serum specimen) from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

In response to altona Diagnostics GmbH's request, on October 31, 2016 FDA concurred with the revision to add the MagNA Pure 96 Instrument (Roche) and the NucliSENS easyMAG Instrument (bioMérieux) and their respective extraction chemistry/reagents as authorized extraction methods under the emergency use authorization of the RealStar Zika Virus RT-PCR Kit U.S. issued on May 13, 2016. The Instructions for Use and Fact Sheets have been updated to incorporate these revisions, and the Pregnant Women and Patient Fact Sheets were combined into one Patient Fact Sheet.

In response to altona Diagnostics GmbH's request, on March 6, 2017 FDA concurred with the following revisions to the emergency use authorization of the RealStar Zika Virus RT-PCR Kit U.S. issued on May 13, 2016: (1) update the Instructions for Use and Fact Sheets to include EDTA plasma as an authorized clinical specimen; and (2) update the Instructions for Use to include results of the FDA Reference Material testing with the RealStar Zika Virus RT-PCR Kit U.S.

On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.'s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests.

In response to Focus Diagnostics, Inc.'s request to amend this EUA, on October 7, 2016 FDA reissued the April 28, 2016, EUA in its entirety with the Focus Diagnostics, Inc.'s requested amendments incorporated. The amendments to the Zika Virus RNA Qualitative Real-Time RT-PCR Test: (1) allow use of a commercially sourced inactivated Zika virus as a positive control material in addition to the Zika virus strain FLR (live virus); (2) allow the addition of urine (when collected alongside a patient-matched serum specimen) as an authorized specimen type; (3) update the Instructions for Use with the results of the FDA Reference Material sensitivity studies; (4) combine the Pregnant Women and Patient Fact Sheets into one Patient Fact Sheet; and (5) enable, as described in Section IV (Conditions of Authorization) of this letter, certain changes or additions to be made by Focus Diagnostics, Inc. in consultation with, and with concurrence of, the Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The authorized Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.

In response to Quest Diagnostics Infectious Disease, Inc. request, on April 11, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling and Fact Sheets for the Zika Virus RNA Qualitative Real-Time RT-PCR test to update the company name.

On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside a patient-matched serum specimen from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., recent history of travel to geographic regions during a period of active Zika virus transmissions at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health response), by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Where there are positive or equivocal results from the Zika MAC-ELISA, confirmation of the presence of anti-Zika IgM antibodies requires additional testing by CDC, or by authorized laboratories in consultation with CDC, using the CDC-issued algorithm.

In response to CDC's request to amend this EUA, on June 29, 2016 FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments incorporated. The amendments: (1) update the language for the CDC Zika virus clinical and epidemiological criteria; (2) update the language related to additional testing of positive or equivocal test results using the CDC algorithm; (3) allow use of Zika COS-1 Recombinant Antigen (CDC catalog #AV0005) as Zika Viral Antigen in addition to Lyophilized Zika Vero E6 Tissue Culture Antigen (CDC catalog #AV002 or AV003); and (4) as described in Section IV. Conditions of Authorization of this letter, enable certain changes or additions to be made by CDC in consultation with, and with concurrence by, FDA's Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.

In response to CDC's request on November 15, 2016, FDA concurred with the modification to the CDC algorithm for results confirmation of the Zika MAC-ELISA as outlined in the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection (revised). The Instructions for Use and Fact Sheets remain unchanged by this request.

In response to CDC's request, on December 6, 2016 FDA concurred with the modification to the authorized Zika MAC-ELISA Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016. The Instructions for Use remains unchanged by this request.

In response to CDC's request, on May 3, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Zika MAC-ELISA to (1) add the DynexTechnologies, Inc.'s Agility and DSX systems as acceptable automated instruments for use with the Zika MAC-ELISA, (2) add language recommending an additional negative human serum control be run once daily, (3) include a limitation concerning the use of the Hennessey detecting antibody conjugate 6B6C-1 in conjunction with the Vero E6 antigen when testing infant serum, and (4) update contact information. FDA also concurred with minor updates to the authorized Zika MAC-ELISA Fact Sheet for Healthcare Providers.

In response to CDC's request, on July 31, 2017 FDA concurred with the interim update to the Instructions for Use labeling for the CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) to provide additional acceptance criteria designed to enhance the precision and accuracy of the assay across all testing laboratories. The CDC communication to Zika Testing Laboratories has been appended to the front of the currently posted Zika MAC-ELISA IFU document.

In response to CDC's request, on April 16, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Zika MAC-ELISA to (1) include a standardized negative control serum and calibration control serum reagent set as one of the materials provided by CDC, (2) include use the Flavivirus group-specific conjugate MAB 6B6C-1/HRP with the Zika MAC-ELISA in CDC laboratories only, (3) integrate the previously granted test result acceptance criteria designed to enhance the precision and accuracy of the assay across all testing laboratories, (4) remove the Hennessey conjugate as a recommended detecting antibody conjugate, and (5) update the specimen handling and safety precautions.

In response to CDC's request, on September 26, 2018 FDA concurred with the modifications to include a minor update to improve clarity.

On March 17, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, and chikungunya virus in human sera or cerebrospinal fluid (collected alongside a patient-matched serum specimen), and for the qualitative detection of Zika virus RNA in urine and amniotic fluid (each collected alongside a patient-matched serum specimen). The assay is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health investigation). Testing is performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).

In response to CDC's request, on September 21, 2016, FDA concurred with the following revisions to the emergency use authorization of the Trioplex Real-time RT-PCR Assay issued on March 17, 2016: (1) include a large volume (up to 1.0 mL) nucleic acids extraction option for use with the authorized automated MagNA Pure 96 instrument for authorized specimens; (2) add two automated extraction instruments, the MagNA Pure Compact and the BioMerieux easyMAG instruments, for nucleic acid extraction from the appropriate clinical specimen types using the appropriate small and/or large volume extraction options per specimen type; and (3) add whole blood (EDTA) as an authorized specimen for the qualitative detection and differentiation of RNA from Zika virus, Dengue virus, and chikungunya virus. The Instructions for Use and Fact Sheets also have been updated to incorporate these revisions, and the Pregnant Women Fact Sheet and Patient Fact Sheet were combined into one Patient Fact Sheet.

In response to CDC's request, on January 12, 2017, FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to (1) clarify the volume of lysis buffer preferred for use with the authorized easyMAG extraction instrument, (2) add a singleplex reaction option for the Trioplex rRT-PCR, and (3) clarify the expected positive control values/ranges in the Trioplex Positive Control package insert.

In response to CDC's request, on March 1, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to include the results of the FDA Reference Material testing with the Trioplex rRT-PCR and to correct some typographical errors. FDA also concurred with some minor modifications to the authorized Trioplex rRT-PCR Fact Sheets.

In response to CDC's request, on April 6, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to (1) add the QuantStudio Dx Real-Time PCR instrument for use with the Trioplex rRT-PCR, (2) correct some typographical errors, and (3) make some revisions to improve clarity.

On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors by qualified laboratories. In response to CDC's request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013, EUA in its entirety with the CDC-requested amendments incorporated. The amendments authorize the expanded use of the CDC assay to include testing persons who may not be exhibiting signs and symptoms associated with MERS-CoV infection, but who meet certain epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated as part of a public health investigation). The EUA amendments also include a new fact sheet for contacts of MERS cases and revisions/updates to the instructions for use and fact sheets for patients and health care professionals. This device will be distributed by CDC to qualified laboratories.

On July 17, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012, in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors for the presumptive detection of MERS-CoV, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and similarly qualified non-U.S. laboratories. In response to altona Diagnostics GmbH's request to amend this EUA, on February 12, 2016 FDA reissued the July 17, 2015 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments authorize the expanded use of the RealStar MERS-CoV RT-PCR Kit U.S. to include the in vitro qualitative detection of genomic RNA from MERS-CoV in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-Co V cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated). The amendments also include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases and revisions to the Instructions for Use, and Fact Sheets for Health Care Providers and Patients.

On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. This device will be distributed by CDC to the public health and other qualified laboratories.

In response to CDC's request to amend this EUA, on March 27, 2018 FDA reissued the April 22, 2013, EUA in its entirety with the CDC-requested amendments incorporated. The amendments: (1) update nucleic acid extraction options authorized for use with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A(H7) [Eurasian Lineage] Assay; (2) provide users with additional guidance on reporting/referring presumptive positive results to CDC; and (3) as described in Section IV. Conditions of Authorization of this letter, enable certain changes or additions to be made by CDC in consultation with, and with concurrence by, FDA's Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.

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For Industry Questions: COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for masks and respirators Contact our toll-free line 24 hours a day: 1-888-INFO-FDA , choose option * Or Email: Date EUA Issued Manufacturer Diagnostic (Letter of Authorization) Technology Authorized Setting(s)1 Authorization Documents2 Other Documents/ 03/20/2020

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12.15. Using Equipment Sterilizer for masks FDA emergency auth

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Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers | FDA

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Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers | FDA

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12.16.

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The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits (scrubs), may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.

The following conservation strategies for use by health care organizations and personnel are categorized for a range of needs and supply levels and are intended to assist health care organizations as they determine operating procedures during the COVID-19 outbreak. These strategies do not cover N95 respirators and are not limited to use in the care of patients infected with COVID-19. The FDA's conservation strategies are intended to augment, and not intended to replace, specific controls and procedures developed by health care organizations, the Centers for Disease Control and Prevention ( CDC), or CDC's Healthcare Infection Control Practices Advisory Committee ( HICPAC) to aid in infection prevention and control.

Conservation Strategies

For surgical masks and gowns, health care providers follow these strategies based on the supply levels of their health care organization.

Gowns that provide lower level barrier protection, ANSI/AAMI PB70 Level 1 and 2, are considered non-surgical isolation gowns. Gowns that provide higher level barrier protection, ANSI/AAMI PB70 Level 3 and 4, are considered surgical gowns or surgical isolation gowns.

Conventional Capacity Strategies (supply levels are adequate to provide patient care without any change in routine practice)

Use FDA-cleared surgical masks and gowns according to labeling and federal, state, and local requirements.

Employ engineering and administrative controls following CDC and HICPAC guidelines to reduce the need for surgical masks while minimizing risks to health care providers and patients.

Specifically, for gowns, consider:

Implementing the use of reusable gowns instead of disposable single use gowns.

Using ANSI/AAMI PB70 standard Level 3 or 4 gown (that is, sterile surgical isolation gowns) for surgery/invasive procedures with a medium to high risk of contamination.

Using non-sterile

Isolation gowns for routine care of patients that are suspected or confirmed to be infected with COVID-19.

Contingency Capacity Strategies (limited supply levels may change patient care, but may not have a significant impact on patient care and health care provider safety)

During times of limited access to surgical masks, facilities could consider having health care providers continue to wear the same surgical mask (i.e., extended use), remove only used gloves and gowns , and perform hand hygiene between treating patients with the same infectious disease diagnosis or exposure who are maintained in a confined area. If the mask, gloves, or gowns become contaminated, replace them.

For training, use gowns that are beyond the manufacturer-designated shelf life, if available.

Prioritize the use of gowns and surgical masks by the type of activities required for patients. If there are shortages of gowns, they should be prioritized for aerosol-generating procedures (such as suctioning, nebulizer treatments, and other respiratory treatments or procedures), care activities where splashes and sprays are anticipated, and high-contact patient care activities that provide opportunities for transfer of pathogens to the hands and clothing of health care providers. Examples of high-contact patient care activities requiring gown use include: dressing, bathing/showering, transferring, providing hygiene, changing linens, changing briefs or assisting with toileting, device care or use, or wound care.

Crisis or Alternate Strategies (may need to be considered if surgical mask or gown demand exceeds the supply)

If Surgical Masks and/or Gowns Are Running Low

Using ANSI/AAMI PB70 standard Level 1 or 2 gown (that is, sterile non-surgical isolation gowns) for surgery/invasive procedures with a low risk of contamination.

Extend the use of single use gowns for health care providers without changing the gown between patients with the same infectious disease diagnosis or exposure who are maintained in a confined area. If the gown becomes contaminated, replace it.

Use surgical masks and/or gowns that meet CDC recommendations and/or ANSI standards for fluid resistance and bacterial filtration efficiency.

Prioritize the use of unexpired FDA-cleared surgical masks for health care providers in procedures where it is important to protect the health care provider and/or the patient from risk of exposure to blood and body fluids.

Use surgical masks beyond the manufacturer-designated shelf life in a setting where there is a lower risk of transmission(e.g., non-surgical). The user should visibly inspect the product prior to use and, if there are concerns (such as degraded materials or visible tears), discard the product.

Re-use surgical masks during care for multiple patients where they are used to protect the health care provider from an activity with low transmission risk (such as dispensing medications) and thus do not create a risk to the health care provider or patient. If the mask becomes contaminated, replace it.

Be aware that counterfeit masks and gowns may be on the market, especially during this time of increased demand.

If No Surgical Masks and/or Gowns Are Available, see CDC's Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids
NIOSH and OSHA have issued standards and recommendations for protective clothing based on fluid barrier properties.

FDA Actions

The FDA is collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid any widespread shortages of these products.

On March 25, 2020, the FDA issued the guidance, Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency. This guidance provides a policy to help expand the availability of surgical apparel for health care professionals during the COVID-19 public health emergency.

The FDA will continue to keep health care providers, manufacturers, and the public informed if new or additional information becomes available.

Reporting Problems to the FDA

The FDA encourages users and facilities who are concerned about distribution of a medical product, or anticipates a potential or actual shortage, to notify the FDA. For potential or actual supply issues, email information to the FDA at deviceshortages@fda.hhs.gov.

The FDA also encourages health care providers to report any adverse events or suspected adverse events experienced with gowns or surgical masks.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, please see FAQs on Shortages of Surgical Masks and Gowns, contact deviceshortages@fda.hhs.gov or, for general questions, the Division of Industry and Consumer Education (DICE).

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Surgical Mask and Gown Conservation Strategies - Letter to Healthcare

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The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits (scrubs), may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.

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12.17.

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2.1 reuse and conservation
guidance ACE + DICE

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We have the following resources for use in your facility related to COVID-19, for use during PPE shortages. We will continue to update as often as we can as the situation changes, so be sure to refresh your browser. Please give us feedback here.

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COVID-19 Conserving PPE | Emory School of Medicine

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We have the following resources for use in your facility related to COVID-19, for use during PPE shortages. We will continue to update as often as we can as the situation changes, so be sure to refresh your browser. Please give us feedback here.

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11.1.

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This course is also available in the following languages:

Overview: The hands of health care workers (HCWs) play a critical role in keeping patients safe. If HCWs do not clean their hands at the right moments, using the proper methods, they can transmit infection-causing microorganisms through their hands from one patient to another. Performing hand hygiene at key moments is an important health care intervention. Hand hygiene reduces the transmission of microorganisms (including those that are antibiotic-resistant), increases patient safety, and decreases health care-associated infection (HAI). Effective, timely hand hygiene is a cornerstone of infection prevention and control.

Learning objectives: By the end of this course, participants should be able to:

describe hand hygiene as a critical component of infection prevention and control;

identify the 5 Moments for Hand Hygiene;

discuss glove use and hand hygiene during patient care activities;

demonstrate the correct way to wash hands with soap and water according to the WHO-recommended method;

demonstrate the correct way to perform hand hygiene with an alcohol-based handrub (ABHR) according to the WHO-recommended method; and

discuss key issues and considerations of hand hygiene in a health care facility.

Course duration: Approximately 1 hour.

Certificate: A Record of Achievement will be issued to participants who receive at least 70% on the post-test. You have an unlimited number of attempts to meet the threshold. Participants who receive a Record of Achievement can also download an Open Badge for this course. Click here to learn how.

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Most health care-associated infections are preventable through good hand hygiene - cleaning hands at the right times and in the right way. The WHO Guidelines on hand hygiene in health care support hand hygiene promotion and improvement in health care facilities worldwide and are complemented by the WHO multimodal hand hygiene improvement strategy, the guide to implementation, and implementation toolkit, which contain many ready-to-use practical tools.

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2.2 PPE infographics

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COVID19 PPE - Image Based Medical Reference

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Find 'COVID19 PPE' images on GrepMed. GrepMed uses images to help clinicians find the information they need to make better decisions at the bedside. GrepMed crowdsources high yield and up-to-date algorithms, decision aids, checklists, guidelines, differentials, point of care ultrasound (POCUS), physical exam clips and more from the best clinicians and medical educators around the world.

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0.1 Cleaning reusable PPE

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11.2.

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2.3. HCP don + doff

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2.4. doffing infographics

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COVID19 Checklist Doffing - Image Based Medical Reference

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Find 'COVID19 Checklist Doffing' images on GrepMed. GrepMed uses images to help clinicians find the information they need to make better decisions at the bedside. GrepMed crowdsources high yield and up-to-date algorithms, decision aids, checklists, guidelines, differentials, point of care ultrasound (POCUS), physical exam clips and more from the best clinicians and medical educators around the world.

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2.5.  User Seal Check

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7.1 N95DECON scientific consortium for data-driven study of N95 FFR decontamination

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N95DECON - A scientific consortium for data-driven study of N95 FFR decontamination

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A scientific consortium for data-driven study of N95 filtering facepiece respirator decontamination

N95DECON is a volunteer collective of scientists, engineers, clinicians, and students from universities across the US as well as other professionals in the private sector. N95DECON seeks to review, collate, publish, and disseminate scientific information about N95 decontamination to help inform decisions about N95 decontamination and reuse.

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N95DECON - A scientific consortium for data-driven study of N95 FFR decontamination

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A scientific consortium for data-driven study of N95 filtering facepiece respirator decontamination N95DECON is a volunteer collective of scientists, engineers, clinicians, and students from universities across the US as well as other professionals in the private sector. N95DECON seeks to review, collate, publish, and disseminate scientific information about N95 decontamination to help inform decisions about N95 decontamination and reuse.

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3.1

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7.2. FDA on decontamination

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Background | Project Description | Project Outcomes | Accomplishments | Additional Reading

Performer: Battelle Memorial Institute

Project leader: William Richter

Contract value: $435,285

Project dates: August 2014 - July 2016

Background

While everyone else exits, they rush in. Protecting the health and safety of first responders and health care workers is an essential part of planning for public health emergencies. Personal protective equipment (PPE) items such as respirators, protective clothing, and eye protection are standard supplies.

One of many preparedness and response challenges is ensuring adequate supplies of this protective equipment during an emergency, when responders may need to don additional protective gear or replace used equipment more rapidly as they treat an increased number of patients.

One type of respirator routinely used to protect workers from biological hazards is known as an N95 filtering facepiece respirator (FFR, pictured). These respirators protect the wearer by filtering contaminants from the air. Currently, these respirators must be discarded after one use, but in emergency response circumstances such as an emerging infectious disease (pandemic influenza, for example) or intentional release of a biological threat agent, reuse of these respirators may be necessary to maintain adequate supplies.

Project Description

To investigate the potential for reusing respirators in emergency situations, FDA awarded an 18-month contract to Battelle Memorial Institute. Battelle conducted tests to evaluate the feasibility of using a commercially available hydrogen peroxide vapor technology to decontaminate N95 respirators.

Based on recommendations from an interagency respirator equipment working group known as Project BREATHE, this pilot-scale testing evaluated respirators during and after as many as 50 decontamination cycles. The testing examined the ability of hydrogen peroxide vapor to decontaminate respirators, and it determined whether the respirators maintained their structure and function after multiple decontamination cycles.

Project Outcomes

The project addressed three areas related to decontamination of N95 respirators:

Optimizing decontamination parameters

Evaluating the impact of repeated decontamination cycles on functional performance of the respirators

Assessing efficacy of repeated decontamination for up to 50 cycles

This project demonstrated the feasibility of FFR decontamination and reuse, and established testing methods for future investigation of additional decontamination technologies-important steps in ensuring continued and sustainable protection of our nation's health workers, responders and patients during public health emergencies.

Accomplishments (updated April 2020)

This project offered a comprehensive pilot-scale study that evaluated the efficacy of hydrogen peroxide vapor (HPV) for decontamination of N95 respirators against a single organism using the Bioquell Clarus C HPV decontamination system. The study measured filter efficiency, fit, and differential pressure after exposure to up to 50 decontamination cycles. This study:

Established the parameters of the HPV decontamination cycle to ensure a 6-log reduction in organism viability

Evaluated the mechanical integrity and performance of the N95 FFR following exposure to up to 50 cycles of HPV decontamination

Confirmed that decontamination was still achieved even after 50 repeated cycles of biological aerosol exposure/HPV decontamination

The project successfully demonstrated the feasibility of a test approach to evaluate FFR reuse and establish testing methods for future investigation of additional decontamination technologies. This information is being used to support development of decontamination systems for the COVID-19 response.

For example, on March 28, 2020, FDA issued an EUA for the Battelle CCDS Critical Care Decontamination System for use in decontaminating compatible N95 respirators during the COVID-19 public health emergency. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators by authorizing these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.

This project was funded through the MCMi Regulatory Science Extramural Research program.

Related Links

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Investigating Decontamination and Reuse of Respirators

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Background | Project Description | Project Outcomes | Accomplishments | Additional Reading Performer: Battelle Memorial Institute Project leader: William Richter Contract value: $435,285 Project dates: August 2014 - July 2016 While everyone else exits, they rush in. Protecting the health and safety of first responders and health care workers is an essential part of planning for public health emergencies.

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7.3. research on mask decontam

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Centers for Disease Control and Prevention

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Disposable filtering facepiece respirators (FFRs) are not approved for routine decontamination and reuse as standard of care. However, FFR decontamination and reuse may need to be considered as a crisis capacity strategy to ensure continued availability. Based on the limited research available, ultraviolet germicidal irradiation, vaporous hydrogen peroxide, and moist heat showed the most promise as potential methods to decontaminate FFRs. This document summarizes research about decontamination of FFRs before reuse.
Reusing disposable filtering facepiece respirators (FFRs) has been suggested as a crisis capacity strategy to conserve available supplies for healthcare environments during a pandemic. Strategies for FFR extended use and reuse (without decontamination of the respirator) are currently available from CDC's National Institute for Occupational Safety and Health (NIOSH).

The surfaces of an FFR may become contaminated while filtering the inhalation air of the wearer during exposures to pathogen-laden aerosols. The pathogens on the filter materials of the FFR may be transferred to the wearer upon contact with the FFR during activities such as adjusting the FFR, improper doffing of the FFR, or when performing a user-seal check when redoffing a previously worn FFR. A study evaluating the persistence of SARS-CoV-2 (the virus that causes COVID-19) on plastic, stainless steel, and carboard surfaces showed that the virus is able to survive for up to 72-hours [1]. One strategy to mitigate the contact transfer of pathogens from the FFR to the wearer during reuse is to issue five respirators to each healthcare worker who may care for patients with suspected or confirmed COVID-19. The healthcare worker will wear one respirator each day and store it in a breathable paper bag at the end of each shift. The order of FFR use should be repeated with a minimum of five days between each FFR use. This will result in each worker requiring a minimum of five FFRs, providing that they put on, take off, care for them, and store them properly each day. Healthcare workers should treat the FFRs as though they are still contaminated and follow the precautions outlined in our reuse recommendations. If supplies are even more constrained and five respirators are not available for each worker who needs them, FFR decontamination may be necessary.

Decontamination and subsequent reuse of FFRs should only be practiced as a crisis capacity strategy. At present, FFRs are considered one time use and there are no manufacturer authorized methods for FFR decontamination prior to reuse. On March 28, 2020, FDA issued an Emergency Use Authorization (EUA) permitting the Battelle Decontamination Systemexternal icon at Battelle Memorial Institute to be authorized for use in decontaminating "compatible N95 respirators." The FDA websiteexternal icon should be checked to determine if other EUAs have been issued since the posting of this crisis capacity strategy guidance. Only respirator manufacturers can reliably provide guidance on how to decontaminate their specific models of FFRs. In absence of manufacturer's recommendations, third parties may also provide guidance or procedures on how to decontaminate respirators without impacting respirator performance. Decontamination might cause poorer fit, filtration efficiency, and breathability of disposable FFRs as a result of changes to the filtering material, straps, nose bridge material, or strap attachments of the FFR. CDC and NIOSH do not recommend that FFRs be decontaminated and then reused as standard care. This practice would be inconsistent with their approved use, but we understand in times of crisis, this option may need to be considered when FFR shortages exist.

An effective FFR decontamination method should reduce the pathogen burden, maintain the function of the FFR, and present no residual chemical hazard. The filter media in NIOSH-approved respirators varies by manufacturer. The ability of the respirator filter media to withstand cleaning and disinfection are not NIOSH performance requirements. The NIOSH's National Personal Protective Technology Laboratory (NPPTL) and other researchers have investigated the impact of various decontamination methods on filtration efficiency, facepiece fit of FFRs, and the ability to reduce viable virus or bacteria on the FFRs. This research is summarized below.

Because ultraviolet germicidal irradiation (UVGI), vaporous hydrogen peroxide (VHP), and moist heat showed the most promise as potential methods to decontaminate FFRs, researchers, decontamination companies, healthcare systems, or individual hospitals should focus current efforts on these technologies. Specifically, the effectiveness of using these methods should be explored further with specific FFR models based on the manufacturers' support to better understand the impact on the respirator performance, including filtration and fit. The respirator manufacturer should be consulted about the impact of the method on their respirators prior to considering the use of any method.

When information from the manufacturer or a third-party is available showing that respirators can be successfully decontaminated without impacting respirator performance, then FFRs decontaminated following those recommendations can be worn for any patient care activities.

In the absence of guidance or when information is available that a respirator cannot be decontaminated without negatively impacting the performance, respirators may still be decontaminated. However, given the uncertainties on the impact of decontamination on respirator performance, these FFRs should not be worn by HCPs when performing or present for an aerosol-generating procedure.

No current data exists supporting the effectiveness of these decontamination methods specifically against SARS-CoV-2 on an FFR. Other pathogens may also be present on FFRs and there is only limited data available for other pathogens. Further work is needed to assure SARS-CoV-2 and other pathogens are inactivated. Therefore, even after decontamination, these FFRs should be handled carefully.

HCPs should take the following precautionary measures prior to using a decontaminated FFR:

Clean hands with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the FFR.

Avoid touching the inside of the FFR.

Use a pair of clean (non-sterile) gloves when donning and performing a user seal check.

Visually inspect the FFR to determine if its integrity has been compromised.

Check that components such as the straps, nose bridge, and nose foam material did not degrade, which can affect the quality of the fit, and seal.

If the integrity of any part of the FFR is compromised, or if a successful user seal check cannot be performed, discard the FFR and try another FFR.

Users should perform a user seal check immediately after they don each FFR and should not use an FFR on which they cannot perform a successful user seal check.

Table 1 provides a summary of the crisis standards of care decontamination recommendations.

Table 1. Summary of crisis standards of care decontamination recommendations

Method

Manufacturer or third-party guidance or procedures available

Recommendation for use after decontamination

Additional use considerations

Ultraviolet germicidal irradiation (UVGI)

Yes

Can be worn for any patient care activities

Clean hands with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the FFR.

Avoid touching the inside of the FFR.

Use a pair of clean (non-sterile) gloves when donning and performing a user seal check.

Visually inspect the FFR to determine if its integrity has been compromised.

Check that components such as the straps, nose bridge, and nose foam material did not degrade, which can affect the quality of the fit, and seal.

If the integrity of any part of the FFR is compromised, or if a successful user seal check cannot be performed, discard the FFR and try another FFR.

Users should perform a user seal check immediately after they don each FFR and should not use an FFR on which they cannot perform a successful user seal check.

Vaporous hydrogen peroxide (VHP)

Ultraviolet germicidal irradiation (UVGI)

No

Can be worn for patient care activities except when performing or present for an aerosol generating procedure

Vaporous hydrogen peroxide (VHP)

Table 2 provides a summary of the decontamination methods evaluated in the referenced literature and the reported effect of each method on FFR performance.
Table 2. Summary of the decontamination method and effect on FFR performance

Method

Treatment level

FFR filtration performance

FFR fit performance

Other observations

References

Vaporous hydrogen peroxide (VHP)

Battelle report: Bioquell Clarus C HPV generator: The HPV cycle included a 10 min conditioning phase, 20 min gassing phase at 2 g/min, 150 min dwell phase at 0.5 g/min, and 300 min of aeration.

Bergman et. al.: Room Bio-Decontamination Service (RBDS™, BIOQUELL UK Ltd, Andover, UK), which utilizes four portable modules: the Clarus® R HPV generator (utilizing 30% H ₂O ₂), the Clarus R20 aeration unit, an instrumentation module and a control computer. Room concentration = 8 g/m ³, 15 min dwell, 125 min total cycle time.

Passed

FFR fit was shown to be unaffected for up to 20 VHP treatments cycles using a head form

Degradation of straps after 30 cycles (Battelle report)

3, 4

Ultraviolet germicidal irradiation (UVGI)

0.5-950 J/cm ²

Passed

90-100% passing rate after 3 cycles depending on model

2, 3, 7, 8, 9, 10

Table 3 provides a summary of the decontamination methods used, the treatment levels assessed, the microbes tested, and the antimicrobial efficacy as reported in the literature.
Table 3. Summary of decontamination method antimicrobial efficacy

Method

Treatment level

Microbe tested

Antimicrobial efficacy

References

Vaporous hydrogen peroxide (VHP)

Battelle report: Bioquell Clarus C HPV generator: The HPV cycle included a 10 min conditioning phase, 20 min gassing phase at 2 g/min, 150 min dwell phase at 0.5 g/min, and 300 min of aeration.

Bergman et. al.: Room Bio-Decontamination Service (RBDS™, BIOQUELL UK Ltd, Andover, UK), which utilizes four portable modules: the Clarus® R HPV generator (utilizing 30% H ₂O ₂), the Clarus R20 aeration unit, an instrumentation module and a control computer. Room concentration = 8 g/m ³, 15 min dwell, 125-min total cycle time.

Kenney personal communication: Bioquell BQ-50 generator: The HPV cycle included a 10 minute conditioning phase, 30-40 min gassing phase at 16 g/min, 25 min dwell phase, and a 150 min aeration phase.

Geobacillus stearothermophilus spores

T1, T7, and phi-6 bacteriophages

>99.999%

3, 4, 6

Ultraviolet germicidal irradiation (UVGI)

Influenza A (H1N1)
Avian influenza A virus (H5N1),
low pathogenic
Influenza A (H7N9),
A/Anhui/1/2013
Influenza A (H7N9),
A/Shanghai/1/2013
MERS-CoV
SARS-CoV
H1N1
Influenza A/PR/8/34
MS2 bacteriophage

99.9% for all tested viruses

12, 13, 14

Vaporous hydrogen peroxide, ultraviolet germicidal irradiation, and moist heat are the most promising decontamination methods. If FFR decontamination is considered, these methods do not appear to break down filtration or compromise the FFR; however, many of these methods can only be used for limited times.

Vaporous hydrogen peroxide

Investigations into VHP decontamination of FFRs provides evidence of minimal effect to filtration and fit while demonstrating 99.9999% efficiency in killing bacterial spores. VHP did not reduce the filtration performance of the ten N95 FFR models tested while showing a 6-log reduction in Geobacillus stearothermophilus spores [2-4]. In a report prepared by Battelle Memorial Institute, the 3M 1860 FFR was shown to maintain filtration performance for 50 treatment cycles of VHP, also referred to as HPV by some decontamination system manufacturers, using the Clarus ® R HPV generator form Bioquell (utilizing 30% H ₂O ₂). Additionally, FFR fit was shown to be unaffected for up to 20 VHP treatments cycles using NPPTL's Static Advanced Headform [4, 5]. Strap degradation occurred after 20 treatment cycles. Kenney et al., co-contaminated 3M 1870 FFRs with three bacteriophages, T1, T7, and Phi 6, and decontaminated the FFRs using VHP generated from the Bioquell's BQ-50 system. The VHP treatment was shown inactivate >99.999% of all phages which was below the limit of detection [6]. Viscusi et al. found that 9 FFR models (three particulate N95, three surgical N95 FFRs and three P100) exposed to one cycle of VHP treatment using the STERRAD 100S H ₂O ₂ Gas Plasma Sterilizer (Advanced Sterilization Products, Irvine, CA) had filter aerosol penetration and filter airflow resistance levels similar to untreated models; however, Bergman et al. found that three cycles of VHP treatment using the STERRAD 100S H ₂O ₂ Gas Plasma Sterilizer negatively affected filtration performance [2, 3]. Bergman et al. measured acceptable filtration performance for six FFR models (three particulate and three surgical FFRs) that received three cycles of VHP treatment using the Clarus ® R HPV generator (utilizing 30% H ₂O ₂) [3]. VHP is a promising method with a potential for high capacity throughput, but certain VHP systems, such as the Clarus ® R HPV generator, may be more compatible with FFR decontamination.

Ultraviolet germicidal irradiation

UVGI is a promising method but the disinfection efficacy is dependent on dose. Not all UV lamps provide the same intensity thus treatment times would have to be adjusted accordingly. Moreover, UVGI is unlikely to kill all the viruses and bacteria on an FFR due to shadow effects produced by the multiple layers of the FFR's construction. Acceptable filtration performance was recorded for eleven FFR models exposed to various UV doses ranging from roughly 0.5-950 J/cm ² and UVGI was shown to have minimal effect on fit [2, 3, 7, 8, 9, 10]. Heimbuch et al. tested filtration and fit of 15 FFRs and found no adverse effects to FFR performance [11]. Lindsley et al. reported a reduction of the durability of materials of the FFRs for doses ranging from 120-950 J/cm ²; however, an approximate inactivation of 99.9% of bacteriophage MS2, a non-enveloped virus, and H1N1 influenza A/PR/8/34 were achieved with much lower doses of approximately 1 J/cm 2 [12-14]. Heimbuch et al. tested the performance of 1 J/cm ² of UVGI against Influenza A (H1N1), Avian influenza A virus (H5N1), Influenza A (H7N9) A/Anhui/1/2013, Influenza A (H7N9) A/Shanghai/1/2013, MERS-CoV, and SARS-CoV and reported virus inactivation from 99.9% to greater than 99.999% [11]. UVGI is harmful. Proper precautions are required to avoid UVGI exposure to skin or the eyes.

Moist heat

Moist heat, consisting of 60°C and 80% RH caused minimal degradation in the filtration and fit performance of the tested FFRs [3, 9, 10]. Heimbuch et al. disinfected FFRs contaminated with H1N1 using moist heat, of 65°C and 85% RH, and achieved a minimal of 99.99% reduction in virus [14]. One limitation of the moist heat method is the uncertainty of the disinfection efficacy for various pathogens.

Steam treatment

Steam treatment may be a suitable approach for decontaminating FFRs. The limited number of studies for steam report minimal effect on FFR filtration and fit performance and a minimum 99.9% reduction in H1N1 and bacteriophage MS2 [14, 15]. Fisher et al. used microwave steam bags, designed for disinfecting infant feeding equipment, to decontaminate six FFR models and achieved 99.9% inactivation of MS2 bacteriophage. Filtration performance of all tested FFRs scored above NIOSH certification requirements. Three FFRs were further evaluated for three cycles of steam exposure and demonstrated no change in filtration performance [15]. Bergman et al. also demonstrated acceptable filtration performance after three cycles of exposure to microwave generated steam [3]. Microwave generated steam had little effect on FFR fit after exposure to up to three cycles of steam [9, 10]. Using microwaves to produce steam to decontaminate FFRs is not without limitations. Not all microwaves are constructed the same and some are more powerful than others. The effect of higher power microwaves on FFRs is unknown. Furthermore, the metal nosebands of FFRs may cause arcing, sparks inside the microwave oven, during exposure to microwaves.

Liquid hydrogen peroxide

Liquid hydrogen peroxide showed no effect of FFR filtration performance [3, 7]. Bergman et al. evaluated six FFRs for filtration performance after a 30-minute submersion in 6% hydrogen peroxide. All six FFR models tested demonstrated no changes in filter performance after three cycles of decontamination. FFR fit and disinfection efficacy were not assessed for this method.

Table 4 provides a summary of the decontamination methods evaluated for each FFR model. This table does not serve to confirm that the decontamination method was effective for each FFR model. This table serves to alert the reader about the availability of more information about the decontamination methods for specific FFR models in the literature.
Table 4. Decontamination methods evaluated for each FFR model

Autoclaving and the use of disinfectant wipes are not recommended as crisis strategies as they may alter FFR performance.

Autoclave, dry heat, isopropyl alcohol, soap, dry microwave irradiation and bleach

Decontamination using an autoclave, 160°C dry heat, 70% isopropyl alcohol, microwave irradiation and soap and water caused significant filter degradation to both FFRs and particle penetration levels did not meet the levels that NIOSH would allow for approval. Decontamination with bleach caused slight degradation in filtration performance and created an odor that would not be suitable for use [2, 7].

Disinfectant wipes

Heimbuch et al. evaluated biological decontamination efficacy and filtration penetration following aerosol exposure of mucin or viable Staphylococcus aureus [18]. Following aerosol exposure, respirators were cleaned with three types of wipes: hypochlorite, benzalkonium chloride (BAC), or nonantimicrobial. Particle penetration following cleaning yielded mean values <5%. The highest penetrations were observed in FFRs cleaned with BAC wipes. The BAC wipe caused one sample of FFRs to exceed 5% penetration. Filter penetration following various decontamination methods was shown in this study to vary based on the decontamination method and the model of FFR.

Ethylene oxide is not recommended as a crisis strategy as it may be harmful to the wearer.

Ethylene oxide (EtO) was shown to not harm filtration performance for the nine tested FFR models [2, 3, 7]. All tests were conducted for one hour at 55˚C with EtO gas concentrations ranging from 725 to 833 g/L. Six models that were exposed to three cycles of 736 mg/L EtO all passed the filtration performance assessment [3]. Data is not available for the effect that EtO treatment may have on FFR fit. However, EtO treatment does not cause visible physical changes to the appearance of FFRs [2, 3]. A serious concern about using EtO for decontamination of large numbers of FFRs is throughput, since relatively long aeration cycles are needed to ensure removal of highly toxic EtO gas [2]. Any use of ethylene oxide (EtO) should be accompanied by studies to ensure no off-gassing into the breathing zone of the wearer as EtO is carcinogenic and teratogenic. Chronic inhalation of EtO has been linked to neurologic dysfunction and may cause other harmful effects to the wearer [16]. EtO should be used in accordance with Occupational Safety and Health Administration standard 29 CFR 1910.1047 [17].

Hospitals may have other decontamination capabilities on-hand that may be feasible. For example, photodynamic inactivation of pathogens using methylene blue plus visible light exposure is used to treat blood products and there is interest in using the method to decontaminate PPE. There is currently no data to evaluate the effect of this method on FFR filtration and fit [19].

1. van Doremalen, N., et al., Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. J New England Journal of Medicine, 2020.

2. Viscusi, D.J., et al., Evaluation of five decontamination methods for filtering facepiece respirators. Annals of occupational hygiene, 2009. 53(8): p. 815-827.

3. Bergman, M., et al., Evaluation of Multiple (3-Cycle) Decontamination Processing for Filtering Facepiece Respirators. Journal of Engineered Fibers and Fabrics, 2010. 5(4): p. 33-41.

4. Battelle. Final Report for the Bioquell Hydrogen Peroxide Vapor (HPV) Decontamination for Reuse of N95 Respirators. 2016; Available from: https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/investigating-decontamination-and-reuse-respirators-public-health-emergenciesexternal icon .

5. Bergman, M.S., et al., Development of an advanced respirator fit-test headform. Journal of Occupational and Environmental Hygiene, 2014. 11(2): p. 117-125.

6. Kenney, Patrick, et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv (2020).

7. Viscusi, D.J., King, W.P., Shaffer, R.E., Effect of decontamination on the filtration efficiency of two filtering facepiece respirator models. Journal of the International Society for Respiratory Protection, 2007. 24: p. 93-107.

8. Lindsley, W.G., et al., Effects of ultraviolet germicidal irradiation (UVGI) on N95 respirator filtration performance and structural integrity. Journal of Occupational and Environmental Hygiene 2015. 12(8): p. 509-517.

9. Bergman, M., et al., Impact of Three Cycles of Decontamination Treatments on Filtering Facepiece Respirator Fit. Journal of the International Society for Respiratory Protection, 2011. 28(1): p. 48-59.

10. Viscusi, D.J., et al., Impact of three biological decontamination methods on filtering facepiece respirator fit, odor, comfort, and donning ease. Journal of Occupational and Environmental Hygiene, 2011. 8(7): p. 426-36.

11. Heimbuch, B.K. and D. Harnish. Research to Mitigate a Shortage of Respiratory Protection Devices During Public Health Emergencies. 2019; Available from: https://www.ara.com/news/ara-research-mitigate-shortage-respiratory-protection-devices-during-public-health-emergenciesexternal icon

12. Fisher, E.M. and R.E. Shaffer, A method to determine the available UV‐C dose for the decontamination of filtering facepiece respirators. Journal of Applied Microbiology, 2011. 110(1): p. 287-295.

13. Mills, D., et al., Ultraviolet germicidal irradiation of influenza-contaminated N95 filtering facepiece respirators. American Journal of Infection Control, 2018. 46(7): p. e49-e55.

14. Heimbuch, B.K., et al., A pandemic influenza preparedness study: use of energetic methods to decontaminate filtering facepiece respirators contaminated with H1N1 aerosols and droplets. American Journal of Infection Control, 2011. 39(1): p. e1-e9.

15. Fisher, E.M., J.L. Williams, and R.E. Shaffer, Evaluation of microwave steam bags for the decontamination of filtering facepiece respirators. PLoS One, 2011. 6(4).

16. Rutala, W.A. and D.J. Weber. Guideline for disinfection and sterilization in healthcare facilities, 2008. 2008; Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/.

17. Occupational Safety and Health Administration. Ethylene oxide: 29 CFR 1910.1047

18. Heimbuch, B.K., et al., Cleaning of filtering facepiece respirators contaminated with mucin and Staphylococcus aureus. American Journal of Infection Control, 2014. 42(3): p. 265-270.

19. Eickmann, M., et al., Inactivation of Ebola virus and Middle East respiratory syndrome coronavirus in platelet concentrates and plasma by ultraviolet C light and methylene blue plus visible light, respectively. Transfusion, 2018. 58(9): p. 2202-2207.

20. 3M. Disinfection of Filtering Facepiece Respirators. Technical Bulletin 2020; Available from: https://multimedia.3m.com/mws/media/1816576O/disinfection-of-disposable-respirators-technical-bulletin.pdf.external icon

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Disposable filtering facepiece respirators (FFRs) are not approved for routine decontamination and reuse as standard of care. However, FFR decontamination and reuse may need to be considered as a crisis capacity strategy to ensure continued availability. Based on the limited research available, ultraviolet germicidal irradiation, vaporous hydrogen peroxide, and moist heat showed the most promise as potential methods to decontaminate FFRs.

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1.1 several types of training, info

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emDOCs.net - Emergency Medicine Education

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COVID-19 is here. While one of our primary goals is to provide the best patient care we can during this pandemic, we must also care for ourselves. This includes ensuring we safely evaluate and manage patients. The recommendations concerning Personal Protective Equipment (PPE) keeps changing. What's the most up to date information concerning use of PPE in the ED for COVID-19? Lets review together!

Background

To understand PPE, first we need to cover transmission. COVID-19 transmission can occur via droplet transmission and contact transmission primarily, similar to influenza. The risk of transmission via respiratory droplet primary occurs with coughing and is approximately 6 feet. ¹

Contact is another common means of transmission. This type is often overlooked but vital to prevention. Basically a droplet coughed by a patient lands on a surface. The viral particles persist, depending on the surface. A recent study found viral particles persisted on copper for 4 hours, cardboard for 24 hours, steel for up to 3 days, and plastic for up to 3 days. ²

Airborne route transmission may occur with procedures that result in aerosolization. These particles may remain aloft for 3 hours, though this is controversial. Airborne precautions require the use of an N95 mask, compared to a surgical mask. Currently, the World Health Organization (WHO) and Canadian guidelines recommend airborne precautions for procedures that are aerosol-generating. These include nebulizer therapy, endotracheal intubation, noninvasive positive pressure ventilation (NIPPV), high flow nasal cannula (HFNC), CPR, bag-mask ventilation, cricothyrotomy or tracheostomy, and bronchoscopy. While the CDC previously recommended using airborne precautions for all patients with suspected COVID-19, currently providers caring for patients not undergoing an aerosol-generating procedure may use droplet precautions. ³

Prevention

With these points in mind, let's move to prevention. The first goal is hand hygiene, whether washing with soap and water for 20 seconds or alcohol-based hand sanitizer (60-95% alcohol). Personally, we recommend you remove any ring, jewelry and watch before working clinically.

The face, including eyes, nose, and mouth, should not be touched. While this is extremely difficult, wearing a mask may assist you in remembering not to touch the face.

Cleaning of environmental surfaces on a routine basis, including medical equipment, with a 70% ethanol or 0.5% sodium hypochlorite solution is recommended.

Limit the providers entering the room, and also try to limit contact with the patient. One provider who is able to assess the patient, perform a history and exam, and test if needed is recommended. Speaking through a glass door or using a phone to obtain a history can limit exposure.

Masks

From JAMA Network

Surgical/Medical Mask

A surgical mask is loose fitting mask that should be worn by the patient and provider caring for the patient (not performing an aerosol-generating procedure).

Unfortunately there have been significant shortages in masks, both surgical and N95. A recent study evaluated medical masks, cloth masks, and standard practice. Authors found cloth masks were associated with higher rates of infection (cloth mask 7.8% vs. medical mask 4.8% for clinical respiratory infection, cloth mask 2.3% vs. medical mas 0.2% for influenza like illness, and cloth mask 5.4% vs. medical mask 3.3% for laboratory confirmed viral infection). ⁴

Respirator Mask

A N95 mask is tight fitting that prevents inhalation of smaller particles. However, this mask is not helpful in children or those with beards. In this situation, the provider should wear a power air purifying respirator (PAPR). These should be worn for aerosol generating procedures, such as intubations.

N95 masks are not resistant to oil (denoted by 'N') and remove at least 95% of airborne particles that are 0.3 microns or larger. The coronavirus is approximately 0.06-0.14 microns in size, but these particles are typically found in droplets of much greater size. N95 masks can provide protection against particles 0.08-0.2 microns in size based on one study. ⁵

Can you reuse an N95 that has been sterilized in some manner? There is a means of using ultraviolet germicidal irradiation (UVGI). This inactivates microorganisms but can also degrade the mask material, decreasing its effectiveness in filtering particles. There is not consistent or reliable way of determining the number of safe reuses unfortunately. One study found filter penetration increased by up to 1.25% after one UVGI application, though resistance to flow was unchanged. ⁶ If times become dire, you can also make your own respirator mask if necessary with supplies at the hospital:

A second respirator mask is a PAPR, which should be worn by providers with beards and certain types of facial hair ( CDC recommendation). A PAPR should be cleaned and disinfected if utilized. It is important to refer to the make / model of the specific PAPR at your institution so you are aware of all the details.

PPE

Contact precautions = a waterproof gown + gloves.

Droplet precautions = contact precautions + surgical mask + eye protection (goggles or disposable face shield).

Airborne precautions are similar but include respiratory mask such as N95 or a PAPR in place of a surgical mask. A hair cover or hood should also be used for aerosol-generating procedures with a N95.

For intubation, we recommend the following if able: N95 with surgical mask over it (later step controversial to some with limited PPE) or PAPR, goggles surrounding the eyes or face shield, bunny suit with hood or disposable fluid proof gown, 2 pairs of gloves (1 pair underneath sleeves of gown and 1 over the under layer that are longer cuffed). If a hooded suit is unavailable, use a sterile disposable cap. A clear plastic drape should be placed over the equipment and patient during intubation, along with use of video laryngoscopy. This may reduce aerosol and droplet contamination.

Shoe covers are NOT recommended, as they increase risk of exposure during removal.

How do you don and doff your PPE?

These steps are essential to reducing the risk of contact transmission. The hardest component is removing the gear, and there are many ways where this goes wrong. The best technique is to have a partner assist you in both donning and doffing utilizing a checklist. A tear away gown and gloves that go over the sleeve are advised.

The CDC has a great handout that takes you through step by step for donning:

The CDC also has two methods for doffing. Of note, we only demonstrate one, in which the gown and gloves are removed in the first step. Make sure to sanitize before step 1 below, as well as between each step if able. Make sure to dispose of the gown, gloves, and if disposable, the eye protection, within the room. The face mask should be removed outside the room.

Here is a great handout from the IBCC courtesy of Josh Farkas:

A fixed gown with a tie at the back of the neck is more difficult. You can use double gloves as well, with removing the top layer of gloves first before removing anything else.

This video from NETEC walks you through donning and doffing (donning begins at 5:00 and doffing at 11:14):

Sunnybrook Hospital also has a great video:

Many centers are having issues with PPE supplies. The CDC has recommendations pertaining to optimizing PPE supplies: https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html

Post Shift Decontamination

Lauren Westafer and Mizuho Morrison have a great set of tips for decontamination after shift to protect our loved ones:

Pearls:

1. Limit exposure to the patient (limited number of providers in the room) and remove watches and jewelry on the upper extremities before starting your shift.

2. Use a constructed checklist and a partner to assist in donning and doffing.

3. If no partner is available, use a checklist and don and doff in front of a mirror if able.

4. Ensure the cuff is tucked into the gloves. The gloves should cover the gown, and there should be no gaps. Longer cuffed gloves are preferable, as they allow you to remove the gown and gloves in a single motion.

5. Aerosol generating procedures are high risk. Wear a respiratory mask with hood or cap.

6. Sanitize before donning and before each step when doffing. Clean your gloved hands before doffing (We recommend in between steps of the doffing process).

7. Have a decontamination process when you leave your shift (to include cleaning your phone and badge).

Thanks for reading, and please comment if you have found ways of reusing PPE or tips in donning and doffing PPE. Let's all learn together so we are safe and healthy as we deal with this pandemic!
References:

1. del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. Published online February 28, 2020. doi:10.1001/jama.2020.3072

2. Van Doremalen N, Morris DH, Holbrook MG, et al. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl Jour Med. DOI: 10.1056/NEJMc2004973

3. Coronavirus Disease 2019. https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html

4. MacIntyre CR, Seale H, Dung TC, et al. A cluster randomised trial of cloth masks compared with medical masks in healthcare workers. BMJ Open. 2015;5(4):e006577. Published 2015 Apr 22. doi:10.1136/bmjopen-2014-006577

5. Lee SA, Grinshpun SA, Reponen T. Respiratory Performance Offered by N95 Respirators and Surgical Masks: Human Subject Evaluation with NaCl Aerosol Representing Bacterial and Viral Particle Size Range. Annals of Occupational Hygiene. 2008;52(3):177-185.

6. Lindsley WG, Martin SB Jr, Thewlis RE, et al. Effects of Ultraviolet Germicidal Irradiation (UVGI) on N95 Respirator Filtration Performance and Structural Integrity. J Occup Environ Hyg. 2015;12(8):509-517.

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Personal Protective Equipment (PPE) Pearls - COVID-19 - emDOCs.net - Emergency Medicine Education

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COVID-19 is here. While one of our primary goals is to provide the best patient care we can during this pandemic, we must also care for ourselves. This includes ensuring we safely evaluate and manage patients. The recommendations concerning Personal Protective Equipment (PPE) keeps changing.

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1.2. TRAINING DESIGN
PPE training in Australia

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1.3. brief guidance on selection, donning doffing

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1.4. informational slide deck from CDC 2010

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The resources on this page are intended to promote patient safety and increase the safety of the healthcare work environment through improved use of personal protective equipment (PPE) by healthcare personnel.

See Strategies to Optimize the Supply of PPE and Equipment for additional information.

Guidelines

Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007 pdf icon [PDF - 3.80 MB] This document is intended for use by infection control staff, healthcare epidemiologists, healthcare administrators, nurses, other healthcare providers, and persons responsible for developing, implementing, and evaluating infection control programs for healthcare settings across the continuum of care.

Guidelines for Infection Control in Healthcare Personnel, 1998 pdf icon [PDF - 1.04 MB]
This guideline is designed to provide methods for reducing the transmission of infections from patients to healthcare personnel and from healthcare personnel to patients.

Additional healthcare infection control guidelines are at the HICPAC Publications page.

Slides

Guidance for the Selection and Use of Personal Protective Equipment in Healthcare Settings

CDC has developed this slide set for use by staff development, infection control, and occupational health personnel for training healthcare personnel on how to select and use personal protective equipment PPE to protect themselves from exposure to microbiological hazards in the healthcare setting.

Available Formats for download:

Posters

Sequence for Donning and Removing Personal Protective Equipment

This poster demonstrates the sequence for donning and removing PPE. The poster provides key instructions to reinforce safe practices and are intended to limit the spread of contamination.
English Version, 8.5″ x 11″ size pdf icon [PDF - 2.85 MB]
Protecting Healthcare Personnel from HIV

National Clinicians Post-Exposure Prophylaxis Hotline (PEPline)external icon
Hotline providing clinicians with guidance on managing occupational exposures to HIV, viral hepatitis, and other bloodborne pathogens. Open 9 a.m. - 2 a.m. EST, seven days a week.

Retired Guidance and Resources

The following guidance and resources have been retired and are included on this webpage for historic and reference purposes only. These are no longer considered current CDC guidance.

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The resources on this page are intended to promote patient safety and increase the safety of the healthcare work environment through improved use of personal protective equipment (PPE) by healthcare personnel. See Strategies to Optimize the Supply of PPE and Equipment for additional information.

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3.2. British Medical Journal

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7.4. UV decontamination

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As COVID-19 continues to ravage global populations, the world is singularly focused on finding ways to battle the novel coronavirus. That includes the UC Santa Barbara's Solid State Lighting & Energy Electronics Center (SSLEEC) and member companies. Researchers there are developing ultraviolet LEDs that have the ability to decontaminate surfaces -- and potentially air and water -- that have come in contact with the SARS-CoV-2 virus.

"One major application is in medical situations -- the disinfection of personal protective equipment, surfaces, floors, within the HVAC systems, et cetera," said materials doctoral researcher Christian Zollner, whose work centers on advancing deep ultraviolet light LED technology for sanitation and purification purposes. He added that a small market already exists for UV-C disinfection products in medical contexts.

Indeed, much attention of late has turned to the power of ultraviolet light to inactivate the novel coronavirus. As a technology, ultraviolet light disinfection has been around for a while. And while practical, large-scale efficacy against the spread of SARS-CoV-2 has yet to be shown. UV light shows a lot of promise: SSLEEC member company Seoul Semiconductor in early April reported a "99.9% sterilization of coronavirus (COVID-19) in 30 seconds" with their UV LED products. Their technology currently is being adopted for automotive use, in UV LED lamps that sterilize the interior of unoccupied vehicles.

It's worth noting that not all UV wavelengths are alike. UV-A and UV-B -- the types we get a lot of here on Earth courtesy of the Sun -- have important uses, but the rare UV-C is the ultraviolet light of choice for purifying air and water and for inactivating microbes. These can be generated only via human-made processes.

"UV-C light in the 260 -- 285 nm range most relevant for current disinfection technologies is also harmful to human skin, so for now it is mostly used in applications where no one is present at the time of disinfection," Zollner said. In fact, the World Health Organization warns against using ultraviolet disinfection lamps to sanitize hands or other areas of the skin -- even brief exposure to UV-C light can cause burns and eye damage.

Before the COVID-19 pandemic gained global momentum, materials scientists at SSLEEC were already at work advancing UV-C LED technology. This area of the electromagnetic spectrum is a relatively new frontier for solid-state lighting; UV-C light is more commonly generated via mercury vapor lamps and, according to Zollner, "many technological advances are needed for the UV LED to reach its potential in terms of efficiency, cost, reliability and lifetime."

In a letter published in the journal ACS Photonics, the researchers reported a more elegant method for fabricating high-quality deep-ultraviolet (UV-C) LEDs that involves depositing a film of the semiconductor alloy aluminum gallium nitride (AlGaN) on a substrate of silicon carbide (SiC) -- a departure from the more widely used sapphire substrate.

According to Zollner, using silicon carbide as a substrate allows for more efficient and cost-effective growth of high-quality UV-C semiconductor material than using sapphire. This, he explained, is due to how closely the materials' atomic structures match up.

"As a general rule of thumb, the more structurally similar (in terms of atomic crystal structure) the substrate and the film are to each other, the easier it is to achieve high material quality," he said. The better the quality, the better the LED's efficiency and performance. Sapphire is dissimilar structurally, and producing material without flaws and misalignments often requires complicated additional steps. Silicon carbide is not a perfect match, Zollner said, but it enables a high quality without the need for costly, additional methods.

In addition, silicon carbide is far less expensive than the "ideal" aluminum nitride substrate, making it more mass production-friendly, according to Zollner.

Portable, fast-acting water disinfection was among the primary applications the researchers had in mind as they were developing their UV-C LED technology; the diodes' durability, reliability and small form factor would be a game changer in less developed areas of the world where clean water is not available.

The emergence of the COVID-19 pandemic has added another dimension. As the world races to find vaccines, therapies and cures for the disease, disinfection, decontamination and isolation are the few weapons we have to defend ourselves, and the solutions will need to be deployed worldwide. In addition to UV-C for water sanitation purposes, UV-C light could be integrated into systems that turn on when no one is present, Zollner said.

"This would provide a low-cost, chemical-free and convenient way to sanitize public, retail, personal and medical spaces," he said.

For the moment, however, it's a game of patience, as Zollner and colleagues wait out the pandemic. Research at UC Santa Barbara has slowed to a trickle to minimize person-to-person contact.

"Our next steps, once research activities resume at UCSB, is to continue our work on improving our AlGaN/SiC platform to hopefully produce the world's most efficient UV-C light emitters," he said.

Other research contributors include Burhan K. SaifAddin (lead author), Shuji Nakamura, Steven P. DenBaars, James S. Speck, Abdullah S. Almogbel, Bastien Bonef, Michael Iza, and Feng Wu, all from SSLEEC and/or the Department of Materials at UC Santa Barbara.

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vitamin d; workplace health; medical imaging; nature; extreme survival; drought; optics; graphene; consumer electronics

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Ultraviolet LEDs prove effective in eliminating coronavirus from surfaces and, potentially, air and water

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As COVID-19 continues to ravage global populations, the world is singularly focused on finding ways to battle the novel coronavirus. That includes the UC Santa Barbara's Solid State Lighting & Energy Electronics Center (SSLEEC) and member companies.

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4.1

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As nurses, we are taught and retaught each year how to manage personal protective equipment (PPE) and the importance of a good seal with our N95 respirator. Suddenly, in the past week, we are expected to take most of what we have learned and throw it away. Not the PPE, exactly, just our ingrained practice. For most of us who've been around for a while, these relaxed standards make us uncomfortable to the point of not feeling safe.

Additionally, the CDC standards for optimizing PPE supplies include extending the use of this equipment beyond the manufacturer's expiration date. No need to worry about a Joint Commission survey to ding you on those expired masks, we need all the supplies we can get during a national crisis.

There is a lot of information circulating these days, and while it's imperative that nurses stay informed and educated, information overload is overwhelming. Here are the CDC standards for most PPE, broken down into bite-sized pieces, but still based on the CDC and OSHA standards:

Masks & N95 Respirators

Face masks and N95 respirators may be reused until they are visibly soiled, or it is difficult to breathe through them. Carefully remove and store your mask and respirator when not in use. Always perform hand hygiene before donning and before doffing to minimize contaminating the device.

Masks

It may be worn continuously until visibly soiled or moist from respirations.

It should be carefully folded so that the outer surface is held inward and against itself to reduce contact with the outer surface during storage. The folded mask can be stored between uses in a clean, sealable paper bag or breathable container.

N95 Respirators

It may be worn continuously up to 8 hours or reused as long as the inside of the respirator remains clean, and you're able to breathe easily through it.

It should be stored between uses in a clean, sealable paper bag or breathable container.

I'll briefly mention that the CDC does list as a last resort, using a scarf or bandana as a protective barrier when nothing else is available. Yet it is literally the last-ditch after all other options and resources are exhausted, and they admit there is no science behind it.

RELATED: How Do Nurses Protect Themselves from Highly Infectious Patients?

RELATED: Is a KN95 Respirator Safe to Use?

Eye Protection

When face shields are not available, use reusable safety glasses or goggles.

How to Clean Eye Protection Equipment

1. While wearing gloves, carefully wipe the inside, followed by the outside of the face shield or goggles using a clean cloth saturated with neutral detergent solution or cleaning wipe.

2. Carefully wipe the outside of the face shield or goggles using a wipe or clean cloth saturated with EPA-registered hospital disinfectant solution.

3. Wipe the outside of face shield or goggles with clean water or alcohol to remove residue.

4. Fully dry (air dry or use clean absorbent towels).

5. Remove gloves and perform hand hygiene.

RELATED: Standard Precautions, Transmission Based, Surgical Asepsis: NCLEX-RN

Paper and plastic gowns can be reused as long as they are not visibly soiled. Alternatives to paper or plastic gowns include patient gowns, disposable lab coats, and disposable coveralls.

How to Remove a Gown for Reuse

While wearing clean gloves, carefully untie the gown and remove it by gently pulling forward at the sleeves. Hang the gown in an open area and avoid having the gown come in contact with other garments.

Organizations across the globe are scrambling to enact contingency, emergency, and surge policies that they never believed they would need (or didn't even have). Nurses must advocate for ourselves, our colleagues, our patients, and our communities (in that order) to reduce the contagion. Stay informed and stay committed to protecting yourself with the supplies you have on hand.

Quick Guide to Donning and Doffing PPE

This infographic gives a basic overview of how to safely don and doff PPE equipment such as masks, gowns, eye protection, and gloves in the proper order.

Taken from: http://publichealth.lacounty.gov/acd/docs/CoVPPEPoster.pdf

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Healthcare is a Team Sport

The "Human Good" Throughout the Nation - Nurses' Views From the Frontlines of COVID-19

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COVID-19: A Cough Is a Cough... Until it's Not

EXTERNAL PPE RESOURCES

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How to Reuse Personal Protective Equipment (PPE) || RegisteredNursing.org

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As nurses, we are taught and retaught each year how to manage personal protective equipment (PPE) and the importance of a good seal with our N95 respirator. Suddenly, in the past week, we are expected to take most of what we have learned and throw it away.

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3.3. intubation guidance

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1.5. WHO master info deck

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1.6. 2016 general WHO guidance

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4.2. process tips storage decontam

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0.2 Respirator seal check

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0.3 PPE infographic

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0.4 Masks recommendation from MOH

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0.5 PPE guidelines

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4.3. Mask storage, reuse

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9.1 PPE assesment

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Across Massachusetts, public health officials and others are working to secure personal protective equipment (PPE) to ensure the safety of health care providers and others working directly with Covid-19 patients. N95 respirators and face masks, which are regulated by the U.S. government, have been in short supply, leading some entities and states, including the Commonwealth of Massachusetts, to secure KN95 respirators as an alternative. KN95 respirators are regulated by the Chinese government under specifications similar to N95 respirators in the U.S., and have been approved for emergency use in some circumstances by the FDA. (N95 respirators seal against the face and protect the wearer from small-particle aerosols in the environment. Face masks are not form-fitting but protect both the wearer and those around them from splashes and exchanges of large droplets.) To try to gauge the effectiveness of the respirators in the state's stockpile, public health officials turned to the Massachusetts Manufacturing Emergency Response Team () initiative for help rapidly analyzing materials and products. At MIT, Professor Gregory Rutledge is part of that initiative; he has donated the services of his lab, which includes specialized equipment to generate and analyze aerosols, to test the filtration efficiency and breathability of materials used, or proposed for use, in respirators or masks.
Rutledge spoke with MIT News about the testing his lab is conducting, why he got involved, and the early gap his testing helped to fill. He described how entities may use this kind of data to inform decision-making and , such as that issued by the Massachusetts Department of Public Health () and the Massachusetts Emergency Management Agency () on April 24. However, he cautioned against drawing overly broad conclusions, noting that early analyses such as his involve certain limitations.

Q: Governor Charlie Baker referenced MIT's testing of KN95 respirators in his briefing on Tuesday, and news reports have referred to those tests. Can you describe the testing your lab conducted and what you found?

A: Our lab has long been interested in the fabrication and application of nanofibrous nonwoven materials prepared by a technique called "electrospinning." One of the most promising applications of such materials is as high-efficiency particulate air (HEPA) filters. In our research, we had previously shown that such nanofibrous filters could shift the maximum peneterating particle size (MPPS, or size of particle most likely to pass through a filter) below 100 nanometers and remove over 99 percent of these particulates. To demonstrate this, we generate an airborne aerosol of salt particles between 20 and 300 nanometers, and then measure what percent of them are removed by the filter as the air passes through it, a property called the "filtration efficiency." At the same time, we measure the pressure drop across the filter, which characterizes the resistance to airflow.

When the Covid-19 crisis first hit the news, there was a lot of concern over the scale of the threat, and the lack of either sufficient stockpiles or domestic manufacturing capacity to meet the demand for PPE, notably N95 respirators, over the coming weeks and months. Almost immediately, hospitals around the area and the nation were scrambling to find enough of these devices to protect their staff and patients. There was a lot of discussion around suitable alternatives, including respirators that had been certified for use elsewhere but not in the U.S., such as KN95 respirators from China.

Like the N95 respirator, KN95s are supposed to remove at least 95 percent of solid particulates below 300 nanometers, exactly the range of aerosols of interest to our lab. Unfortunately, there was also some evidence from Europe, which was a few weeks ahead of the U.S. in the pandemic, that the quality control for some KN95 respirators was not as good as it could be, leading to recalls, such as one in the Netherlands. Nevertheless, the manufacturing capacity for respirators is very strong in China, so in my view it was a logical place for the Commonwealth to look for suitable alternatives.

It soon became apparent that the Commonwealth wanted to do its own quality control of the KN95s it was receiving. In my lab, we were already testing filtration efficiency and pressure drop for alternative filter materials being considered by hospitals as ways to protect health care workers and patients. With the help of AFFOA [a manufacturing innovation institute headquartered in Cambridge] and the M-ERT, we began testing the materials used in the KN95 respirators procured by the Commonwealth from a variety of manufacturers, donations, etc.

To be clear, a respirator like an N95 or a KN95 has to satisfy a number of criteria, including the ability to form a seal against the face, and we are in no position to certify an N95 or equivalent; that full capacity resides with the federal government. However, high filtration efficiency and low pressure drop are essential properties without which the respirator cannot perform. These two criteria are ones my group has been able to review upon request by the Commonwealth.

Over the past two weeks, our lab has tested - in triplicate - over 40 different KN95s from the MEMA stockpile, at the request of the Department of Public Health. We can compare their performance in our test to that of certified N95 respirators and quickly distinguish those that might pass the N95 certification from those that would not. The latter group is still valuable in noncritical situations, but it is important to know that health care workers and first responders on the front line of the pandemic are getting the best available protection. So far, about a third of the KN95s we've tested appear to perform as advertised.

Q: Why is your lab at MIT involved in testing materials?

A: The battle against Covid-19 may be a marathon in the end, but in the first few weeks during which the goal was to "flatten the curve," it has been a race against time. Everyone wants to do their part, but it is difficult to do the right thing in the absence of reliable information. This is the argument for testing. Unfortunately, the organizations that normally certify respirators for N95 performance are few and far between, and they were already experiencing long lead times due to the national scale of the pandemic. It was within this context that we realized the preliminary information we could provide on filtration efficiency and inhalation resistance could help inform the decision-makers and help them to provide the greatest protection to the largest number of people.

We felt it was essential that we ramp up as quickly and responsibly as we could to meet demand in a very dynamic situation, while at the same time ensuring that the results we provided were reliable and validated over time. In doing so, I believe we helped buy time while additional testing capacity has come on-line around the state, at MIT Lincoln Laboratory, the U.S. Army Combat Capabilities Development Command (CCDC) in Natick, and, very soon, at the University of Massachusetts at Lowell. These several labs provide complementary capabilities in testing for filtration efficiency, liquid penetration (for surgical masks), and other requirements of PPE.

I hope to be clear that our testing is not the equivalent of the official national testing conducted by the National Institute for Occupational Safety and Health (NIOSH). Likewise, we do not provide official certification or validation. However, the initial testing data we collect enables public health officials and other decision-makers to proceed with some light while they wait for the NIOSH processes to complete.

Q: What kind of reports do you provide when asked to conduct tests? How might entities use the data or information you provide?

A: MIT, through my lab's efforts in coordination with colleagues at AFFOA and Lincoln Laboratory, is donating its testing capabilities in response to the Covid-19 pandemic, and the results are provided "as is." While we cannot reproduce exactly the test protocols specified by NIOSH for filtration efficiency and inhalation resistance, the aerosol generated to challenge the respirator material and the conditions under which the test is performed are designed to mimic as closely as possible that which would be performed by an FDA-approved precertification facility, subject to the constraints of our equipment and the demands of the current crisis.

We only test the filtration material itself, not the design of the respirator or its "fit" to the face, nor any valves or other ancillary components. In the case of fabricated respirators such as the KN95s, our testing serves as a check against faulty or fraudulent materials of construction and offers guidance for the selection, procurement, and distribution of these devices. In other instances, our data have been used by innovation teams to develop new designs for respirators, and by manufacturers to re-engineer their product lines to increase the domestic supply chain for respirators. Such designs often deviate in significant ways from the conventional N95 we know today, and require a longer timeline to develop. We offer the flexibility to analyze such designs under different conditions of use, and we are building a database of materials performance evaluations that may subsequently be mined for filtration and flow resistance characteristics for use by the broader community of PPE developers.

Q: What have you learned from engaging in this voluntary effort over the past couple of weeks?

A: I have been most impressed by the enthusiasm and commitment with which students at MIT and the doctors, clinicians, scientists, and engineers with whom they collaborate dropped what they were doing to address shortfalls in PPE across the board, in very short timeframes. Projects to mass produce components as simple as a face shield or as complex as a ventilator are other examples. The students in the lab, working long hours in uncertain times, are the stars in most of these efforts. This crisis has galvanized a host of grassroots actvities that have moved quickly, often in parallel but toward a common set of goals. To some extent, my role has been to help channel that effort into the most productive avenues.

Q: What do you think public health officials and first responders should be most aware of?

A: Unlike the average academic, those who are on the front lines of this pandemic are trained to make decisions on a daily basis, and to make them quickly. But to make good decisions, they need good information, and they need it rapidly but responsibly. We are here to help inform those decisions as best we can with timely, reliable data.

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Q&A: Gregory Rutledge on initial testing of KN95 respirators for public health officials

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Across Massachusetts, public health officials and others are working to secure personal protective equipment (PPE) to ensure the safety of health care providers and others working directly with Covid-19 patients. N95 respirators and face masks, which are regulated by the U.S.

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6.1 PPE training failures 2018 study

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7.5. Portable UV decontam

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7.6. Using idle resources for inexpensive, scalable, accessible UV sterilization

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7.7. H2O2  decontam

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7.8. H2O2 Decontamination

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Personal Protective Equipment (PPE) decontamination for reuse

DELIVERING CRITICAL EQUIPMENT TO HOSPITAL SYSTEMS

The Battelle CCDS Critical Care Decontamination System™ addresses the current shortage of critical Personal Protective Equipment (PPE) across the United States. Battelle CCDS™ is designed to work on N95 respirators for the removal of the novel coronavirus (SARS-CoV-2).

How does it work?

Battelle CCDS™ can decontaminate thousands of N95 respirators using concentrated, vapor phase hydrogen peroxide. The respirators are exposed at the validated concentration level to decontaminate biological contaminants, including the SARS-CoV-2. Battelle CCDS ™ can decontaminate the same respirator multiple times without degrading N95 respirator performance.

Regulatory, safety & efficacy

Battelle CCDS™ draws on decades of research and is grounded on an FDA study Battelle completed following a 2016 contagion. Battelle is currently conducting research to validate that other equipment, including surgical masks and ventilator components, can be decontaminated using this process.

How do healthcare systems use Battelle CCDS™?

Healthcare systems will collect worn N95 respirators each day in accordance with an approved procedure, and the PPE will be labeled with a barcoded serial number for tracking the chain-of-custody throughout the decontamination process. This procedure ensures that the hospital system receives its own respirators back.

CCDS™ Information & Instructions

Check out the documents below for information on how your healthcare system or personnel can use the Battelle CCDS Critical Care Decontamination System™

Click on the image of the document to the left for information about the preparation and collection of compatible N95 respirators for decontamination by Battelle using the Battelle CCDS Critical Care Decontamination System™.

Click on the image of the document to the left for information about the preparation of compatible N95 respirators for decontamination by Battelle using the Battelle CCDS Critical Care Decontamination System™

Click on the image of the document to the left to review this fact sheet. The fact sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated N95 or N95-equivalent respirators. These respirators have been decontaminated using the Battelle CCDS Critical Care Decontamination System™

Click on the image of the document to the left to review the U.S. Food and Drug Administration's Emergency Use Authorization (EUA) for the use of the Battelle CCDS Critical Care Decontamination System™ in decontaminating compatible N95 or N95-equivalent respirators for reuse by healthcare personnel to prevent exposure to pathogenic biological airborne during the COVID-19 pandemic.

Overview and Reports

The Battelle CCDS™ Process

Rapid Response & Pandemic Mitigation Capabilities

Battelle's rapid response capabilities and pandemic mitigation are in alignment with U.S. Pandemic Task Force requests to provide immediate front-line support and public health workforce enablement, predictive analytics, lab capabilities and capacity, and innovative platforms for ensuring global health security.

Frontline Support

Public Health Workforce Enablement

Predicting Disease Spread

Modeling & Characterization

Lab Support & Testing

Biodefense & Emerging Infectious Disease Expertise

Global Health Security

Linking Commercial & Government to Scale Biotech

Contact a Battelle Expert Today

STAY CONNECTED WITH BATTELLE

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Battelle CCDS Critical Care Decontamination System for PPE Decontamination

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long-arrow-pointing-to-left linkedin twitter facebook mail Personal Protective Equipment (PPE) decontamination for reuse DELIVERING CRITICAL EQUIPMENT TO HOSPITAL SYSTEMS The Battelle CCDS Critical Care Decontamination System™ addresses the current shortage of critical Personal Protective Equipment (PPE) across the United States. Battelle CCDS™ is designed to work on N95 respirators for the removal of the novel coronavirus (SARS-CoV-2).

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7.9. UV decontamination
UV light method shows promise for sanitizing N95 masks
BioOptics World

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2.6. NHS video training (donning)

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COVID-19: Donning of Personal Protective Equipment (PPE)

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4.4. storage based decon

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4.5.

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How to Save PPE and Reduce Exposure, HIPAA Relaxes

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In today's episode, emergency physicians Amy Cho and Jason Adler break down novel ways to limit use of PPE while at the same time minimizing contact ...

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11.3.. Testing info

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2.7. donning inforgraphics

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COVID19 Checklist Donning - Image Based Medical Reference

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Find 'COVID19 Checklist Donning' images on GrepMed. GrepMed uses images to help clinicians find the information they need to make better decisions at the bedside. GrepMed crowdsources high yield and up-to-date algorithms, decision aids, checklists, guidelines, differentials, point of care ultrasound (POCUS), physical exam clips and more from the best clinicians and medical educators around the world.

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7.10. UV decontamination

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7.11. Batelle H202 method

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Gov. Charlie Baker on Saturday visited a site where medical-grade masks will be sterilized on a massive scale, a facility he's touted as a major help to Massachusetts' health care workers facing the possibility of being without adequate protective equipment as they treat coronavirus patients.

Speaking outside the facility, Baker announced that two coronavirus testing facilities, at Gillette Stadium and the Big E Fairground, are expanding access to grocery store and supermarket workers, including ones who aren't presenting symptoms. He also announced the activation of up to 3,000 more members of the Massachusetts National Guard to help in the state's coronavirus response, bringing the total to 5,000.

The majority of his remarks were about the need in Massachusetts for Battelle's mask-cleaning machines to "keep more masks in use and ... sustain our personal protective equipment supply." But he also said his administration is working every day to increase the supply of medical equipment as well.

"We're still working channels on additional N95 masks. We think this is a terrific tool to help us create a much longer shelf life and useful life for an N95 mask, but we're looking for more of those," he said.

The machines together can decontaminate up to 80,000 N95 masks per day, allowing doctors, nurses, EMTs and others to reuse them. It's made by Battelle and was brought to Massachusetts in a partnership between the Ohio company, Partners HealthCare and the City of Somerville, where it's located.

The facility consists of four trailers, each named after a different sports team, that can each sterilize masks around the clock, said Chris Coburn, the chief innovation officer at Partners HealthCare. Dozens of regional health care providers and other organizations that are using masks can deliver their used masks to the facility for cleaning and will have them returned in new packaging.

N95 masks are a crucial tool in the fight against the deadly new coronavirus, as they are designed with a close fit around the face and can filter out all but the tiniest airborne particles. But they're in short supply as medical workers and first responders around the world use them to prevent themselves from being infected.

Last month, Massachusetts scrambled to acquire enough to keep its front-line workers safe and found itself competing against all other U.S. states and the federal government, leading to New England Patriots owner Rober Kraft's purchase and import of more than 1 million masks from China -- an act that left Baker emotional.

Between acquiring the shipment and the Battelle machine, which will be able to clean those masks for reuse up to eight times, he said last Friday, "you start to feel like you're creating a little bit of a comfort for a lot of people who had been uncomfortable."

Baker was on Saturday's tour by Lt. Gov. Karyn Polito and Somerville Mayor Joseph Curtatone, whom Baker credited for securing the machine's arrival to the state. On Saturday, Massachusetts reported that it has seen 22,860 coronavirus cases and 686 deaths so far in the outbreak, which is expected to ramp up in the coming weeks.

Download our free mobile app for iOS or Android to get the latest breaking news and in-depth coverage of COVID-19.

The machine was assembled in an empty former K-mart store near Assembly Row in Somerville. It was just the fourth Battelle mask decontamination site to be announced in the country, though others have since been added.

The machine uses vaporized hydrogen peroxide to clean masks for several hours, according to Battelle. The company said Friday that it will eliminate per-mask cleaning charges to health care providers under a new, $400 million federal contract, showing that "good things happen sometimes when people work together," Baker said Saturday.

The machines leave masks "absolutely safe from a bacterial and a viral perspective," said Dr. Paul Biddinger, medical director for Emergency Preparedness at Partners HealthCare, who called the sterilization an "extraordinary opportunity to continue to protect our health care workforce."

Health care workers are also seeking another important tool in the fight against coronavirus: ventilators, which are necessary to keep the most critical patients breathing but are in drastically short supply given the high demand nationwide.

Massachusetts has so far only received 200 of the 1,000 it requested from the federal stockpile, Baker said.

"The message we got from the feds was that we would receive ventilators on an incremental basis," he said. "So far, they're living up to that. They gave us 100. They gave us another 100. They've committed another 200."

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battelle ccds critical care decontamination system

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Coronavirus in Mass.: Baker Tours Mask-Cleaning Facility, Adds Testing for Grocery Workers

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Gov. Charlie Baker on Saturday visited a site where medical-grade masks will be sterilized on a massive scale, a facility he's touted as a major help to Massachusetts' health care workers facing the possibility of being without adequate protective equipment as they treat coronavirus patients.

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7.12. Decontamination Xenex tech

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Intense pathogen killing power in just 5 minutes

LightStrike Germ-Zapping Robots is the first disinfection system of its kind to deliver intense germicidal action from 200-315nm. It's a user friendly robot that's intensely pathogen deadly.

How intense is it? The LightStrike Germ-Zapping Robots deliver up to 4,300x more germicidal UV pathogen killing intensity than UV-C mercury vapor* and can disinfect an entire patient room in as little as 20 minutes​

From the power of our technology, to our rigorous scientific approach - intensity is what sets us apart. It's why Intensity Matters.

*Data on file for the model X5 LightStrike Robot

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LightStrike™ Germ-Zapping™ Robots - Xenex

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Intense pathogen killing power in just 5 minutes LightStrike Germ-Zapping Robots is the first disinfection system of its kind to deliver intense germicidal action from 200-315nm. It's a user friendly robot that's intensely pathogen deadly. How intense is it?

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0.6 Tz training

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10.1

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As more and more low-income countries report COVID-19 infections, there are urgent concerns of whether health systems will be able to cope. One particular worry is whether health workers will be protected at the frontlines of diagnosing and treating infected patients. Across the world, doctors, nurses, community health workers, and others are at elevated risk of infection and mortality. They are also a crucial asset to battling the pandemic. In Europe, infections among medical staff have already generated worker shortages. In low-income countries, health workers are scarce even in good times: the average low-income country has 0.2 physicians and 1 nurse per 1,000 people, compared to 3 and 8.8 in high-income countries. And while shortages of protective equipment and materials have become a major issue in high-income countries, the picture is bleaker in low-income countries

The Ebola crisis demonstrated both the importance of protecting health workers and the struggle health systems of low-income countries face in providing adequate protective equipment and infection prevention to protect their health workforces. Health workers are disproportionally at risk of infection and death, and, without adequate protective equipment, Ebola killed 8 percent of health workers in Liberia and about 7 percent in Sierra Leone. In addition to causing substantial loss of life, that deprived these health systems of a crucial asset to fight the current pandemic (and future ones).

Many health systems lack basic infection prevention and personal protective equipment

Using data from recent facility surveys ( Service Provision Assessments), we examined the availability of basic infection prevention (BIP) materials and personal protective equipment (PPE) in health facilities in seven low- and low-middle income countries.

We use a shortened list of BIP consisting of four items: guidelines for infection prevention, pourable water and soap or hand disinfectant, surface disinfectant, and a waste bin. Per World Health Organization (WHO) guidance, PPE also consists of four items for those in direct contact with patients: gloves, face masks, gowns or aprons, and eye protection. These survey measures capture general availability but not whether supplies are adequate in quantity or quality, so they give an overly optimistic picture of facilities' preparedness.

The prospects for protecting health workers are grim, especially for lower-level facilities such as clinics and health centers that often serve as the first point of contact with the health system (Figure 1). Across the seven countries, hospitals have an average of 3.1 out of the 4 items that make up each of BIP and PPE, whereas lower-level facilities average just 2.3 BIP items and 2 PPE items. Tanzanian and Haitian hospitals are the best equipped with BIP and PPE items respectively, while Nepalese hospitals are the least well-equipped in both items of the seven countries.
Figure 1. Availability of basic infection prevention materials and personal protective equipment in seven countries
The data for Bangladesh, DRC, Haiti, Nepal, Senegal, and Tanzania are nationally representative, whereas the Afghanistan sample covers seven urban areas; all estimates use facility sampling weights

Availability of specific items is highly variable (see tabulations for each item here). Among the BIP items, handwashing items and surface disinfectants were available in almost all hospitals but only in about 80 percent of lower-level facilities, while guidelines for infection prevention were frequently missing. Of the PPE items, gloves were available in almost all hospitals and in 9 out of 10 lower-level facilities. Face masks were generally available in hospitals but not non-hospitals: less than a third of clinics and health centers in Bangladesh, the Democratic Republic of Congo (DRC), Nepal, and Tanzania had any face masks. Eye protection was the least available item, present in an average of 37 percent of hospitals and 9 percent of clinics and health centers across the seven countries.

Plans to protect the health workforce are deficient or absent in many low-income countries

Even where inventory of key protective gear and infection prevention is available, it is unclear how health systems will be able to cope with increased demand for these items once infections rise. Most of the countries we reviewed score low on preparedness dimensions that are relevant to the health workforce, according to external evaluations on International Health Regulations (IHR), a set of international rules to prevent the spread of diseases (see Table 1). Most countries have an applied epidemiology training program in place and some human resources available to implement the IHR core capacity, but are lacking on other measures. Despite the DRC's experience with the Ebola outbreak, the country still scored low on the most dimensions of preparedness, including medical countermeasures and personal deployment and risk communication plans.
Table 1. Selected capabilities to implement International Health Regulations (IHR) with regards to protecting the health workforce (range from 1 = "no capacity" to 5 = "sustainable capacity")
Source: WHO Joint External Evaluations. Haiti has completed a plan but it is not yet available online while Nepal has not created a plan.

Countries are struggling to improve infection control and provide workers with protective equipment

As high-income countries scramble to source crucial supplies like face masks-with calls to nationalize equipment producers or direct stimulus spending to invest this sector-low-income countries face even tougher choices. Their budgets are more limited, and they lack many local producers and have inefficient and insecure supply chains, with a substantial reliance on donors and multilaterals for procurement. Bangladesh's large textile industry began production of nearly half a million pieces of PPE to be distributed to its health facilities last week, but this scale of production is not replicable in other low-income settings. The World Bank's $12 billion support package might provide much-needed resources to purchase protective equipment and prop up basic infection control, though there are already concerns about price increases, hoarding, market manipulation, black markets and competition with high-income countries for these items.

Donors and multilaterals have not yet responded at sufficient scale

The global response to the looming health workforce crisis in low-income settings has been limited so far. WHO estimates that some 89 million masks and 76 million gloves may be needed in the coming months, and has called on manufacturers of PPE to boost production by 40 percent. Yet so far shipments of PPE to low-income countries are but a fraction of what's needed: WHO has so far dispatched 0.5 million PPE sets; UNICEF has dispatched 4.3 million gloves, 100,000 N95 respirators and other PPE; philanthropist Jack Ma is donating 100,000 masks and 1,000 protective suits to each country in Africa, as well as 1.8 million masks to 10 Asian countries. It won't be nearly enough.

These shortages in protective equipment and materials reflect the situation before the arrival of COVID-19 in any of these low-income countries. An inability to protect healthcare workers will not only lead to needless loss of lives, but also deplete already-stretched health systems. We can't afford low-income countries to go through an experience like that of Liberia and Sierra Leone during the Ebola epidemic. To effectively fight COVID-19 in low-income countries-and hence globally-the international community needs to step up now to protect frontline health workers.

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Health Systems in Low-Income Countries Will Struggle to Protect Health Workers from COVID-19

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As more and more low-income countries report COVID-19 infections, there are urgent concerns of whether health systems will be able to cope. One particular worry is whether health workers will be protected at the frontlines of diagnosing and treating infected patients.

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2.8. CDC don&doff training

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PPE Donning and Doffing: CDC Sequence for COVID 19

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6.2- UV check

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UV lamps are commonly used within the healthcare and food industry to help teach best practise hand washing technique to help improve infection control and reduce cross contamination.
Below you'll see a list of products we manufacture and supply for hand hygiene training. If you'd like to discuss your particular process requirements with a member of our team please call 0121 423 2000 or contact us.

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UV light hand hygiene training - UV glow box and UV glow lotion

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UV lamps are commonly used within the healthcare and food industry to help teach best practise hand washing technique to help improve infection control and reduce cross contamination. Below you'll see a list of products we manufacture and supply for hand hygiene training.

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1.7. general info deck on IPC and PPE (old)

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principles of infection control and personal protective equipment

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Principles of Infection Control and Personal Protective Equipment - ppt download

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Learning Objectives Demonstrate knowledge of the principles of infection control Recognize gaps in infection control infrastructure Recognize ways to address gaps in infection control infrastructure in different situations Demonstrate proper selection and use of personal protective equipment At the end of this presentation, you should be able to: Demonstrate knowledge of the principles of infection control based upon known routes of transmission of infectious agents.