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Digital technology is now available for pathologic microscopy.

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The Philips IntelliSite Pathology Solution (PIPS) is the first ever digital pathology system approved by the FDA for cancer diagnosis.  It is a whole-slide imaging (WSI) system that allows medical practitioners to view and interpret slides using digital technology instead of a conventional microscope.  The system utilizes hardware and software to scan biopsied tissue and digitize images at 400 times magnification. The digital data generated can be shared easily and used for decision-making by providers.

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View product details at the IntelliSite product page.

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View details of Philips IntelliSite Ultra Fast Scanner

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This high throughput bright field slide scanner is designed...

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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology.  April 12, 2017.

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The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.

"The system enables pathologists to read tissue slides digitally in order to make diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope," said Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "Because the system digitizes slides that would otherwise be stored in physical files, it also provides a streamlined slide storage and retrieval system that may ultimately help make critical health information available to pathologists, other health care professionals and patients faster."

Pathologists are medical doctors who specialize in understanding the cause and development of a disease or condition. In pathology, biopsied tissues are mounted onto glass slides and stained for viewing and evaluation. The PIPS uses proprietary hardware and software to scan and digitize conventional surgical pathology glass slides prepared from biopsied tissue at resolutions equivalent to 400 times magnification. These digitized images can then be reviewed and interpreted by pathologists.

The FDA reviewed the data for the PIPS through the de novo premarket review pathway, a regulatory pathway for devices of a new type with low- to moderate-risk that are not substantially equivalent to an already legally marketed device. The FDA evaluated data from a clinical study of approximately 2,000 surgical pathology cases using tissue from multiple parts of the body (anatomic sites). Results of the study found that clinical interpretations (diagnoses) made based on the PIPS images were comparable to those made using glass slides.

In this authorization, the FDA is establishing special controls that must be met to assure the digital imaging system's precision, reliability, and clinical relevance. The risks associated with use of this technology are similar to that of the use of conventional light microscopy. These special controls are necessary to provide reasonable assurance of safety and effectiveness for this digital imaging system.

The FDA permitted marketing of the Philips IntelliSite Pathology Solution to Philips Medical Systems Nederland B.V.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA allows marketing of first whole slide imaging system for digital pathology

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The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.

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The National Cancer Institute (2017) predicts 22 million new cancer diagnoses in the next 20 years, and the incidence continues to rise.  In addition, the increase in ordering of biopsies puts a strain on pathologists, who as a profession are recently declining in numbers (Granzow, 2017).  To meet the demand, pathologists must work more efficiently.  Although many medical professionals have long benefitted from digital imaging technologies, until this year, pathologists in the U.S. were still limited to working with traditional light microscopes and physically handling and storing slides.

On April 12, 2017, the Food and Drug Administration (FDA) made the decision to approve the marketing of the Philips IntelliSite Pathology Solution (PIPS) system for the review and interpretation of biopsied tissue.  This system is the first of its kind, but Granzow (2017) expects the industry to grow to 100% digitization in this country.  The PIPS system allows users to create, manage, store, and review samples of biopsied tissue.  This will allow pathologists to streamline their workflow and eliminate issues with handling and retrieving samples (which currently occupies 13% of their time), and may increase productivity by 18% (Stratman, Drogowski, & Ho, 2011).

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Allows sharing of data with experts in other locations for the most accurate diagnosis.

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Philips Digital Pathology Solution Envisioned Workflow

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Philips Digital Pathology Solution envisioned workflow

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Designed around the needs of pathologists, Philips offers an integrated Digital Pathology Solution. The solution comprises of the Philips Ultra Fast Scanner (UFS) and the Philips Image Management System (IMS). The Philips IMS is an automated system for viewing, analysis and presentation of Whole Slide Images (WSIs), grossing images and reports.

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ARTICLE in Medical Laboratory Observer Online

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ARTICLE in Medical Laboratory Observer Online

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Medical Laboratory Observer Online is a peer-reviewed journal.  Author Russell Granzow is the General Manager of Philips Digital Pathology Solutions.  August 2017.

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NEWS STORY in the Journal of the American Medical Association: Digitized Surgical Slides

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NEWS STORY in the Journal of the American Medical Association: Digitized Surgical Slides

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Author Rebecca Voelker is the associate managing editor of JAMA's Medical News & Perspectives section. May 16, 2017.

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I think that digitized images are the wave of the future, and it seems almost surprising that pathologists in this day and age are still spending time preparing samples and working with standard microscopes.  I am surprised that until now, we have been measuring pathological features without the digitized technology available in other modes like ultrasounds, CT scans, and MRIs.  According to Granzow (2017), Phillips met the stringent requirements of the FDA by conducting a study on 2,000 cases to demonstrate that the images produced by the PIPS system are not inferior to those produced by standard light microscopes.  I think that as long as a digital system is capable of producing images of equal quality, the choice is obvious.

Digital pathology systems can eliminate the mess of a desk full of slides, loss of productivity time from having to locate and pull up another slide under the microscope, and the human error of possibly examining the wrong patient’s specimen.  The ability to share information from the findings in real time with other practitioners anywhere in the world will help ensure a timely and accurate diagnosis.  Even if the initial upload times are long and artifacts are occasionally present, I think that the technology will continue to improve, and digital pathology is unquestionably a step in the direction of progress, with benefits to providers and patients alike.

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Quicker handling time.  No need to walk to another part of the building to find slides because they are stored efficiently in the system.

Quality digital images.

Ability to quickly move from case to case and slide to slide.  Fast transition time.

Collaboration.  Easy to share images with other users and experts worldwide.

Real time screen sharing and interactive multi-viewer case discussion function allows others to participate regardless of location.

Clean desks.  No contamination of work areas with tissue samples and slides.

Ability to magnify slides and digitally mark and measure images without using a ruler.

Patient safety.  Barcode scan ensures that practitioner is viewing the correct patient’s tissue sample.

Ability to open and compare multiple slides at once.

Ability to work from home or remote locations.

Images easy to use for presentations, research, and education.

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Nursing informatics is “a specialty that integrates nursing science, computer science, and information science to manage and communicate data, information, knowledge, and wisdom in nursing practice” (McGonigle & Mastrian, 2018, p. 7). This digital pathology system provides a new way to communicate important clinical information about a patient’s tissue and cancer status through standardized, digitally measurable and quantifiable data.  Specimens are scanned into a processing system that relays information to medical personnel and enables them to share data and make decisions about a patient’s plan of care.

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CONS:

Expense of purchasing new system.

Length of time to scan images in initial upload.

Large files.

Learning curve for personnel using novel technology which operates differently than a light microscope.

Potential for heterogenicity and artifacts in image scans.

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Abels, E., & Pantanowitz, L. (2017). Current state of the regulatory trajectory for whole slide imaging devices in the USA. Journal of Pathology Informatics, 8, 23. https://doi.org/10.4103/jpi.jpi_11_17

Doss, W. (2017, April 14). FDA approves first digital pathology system for diagnostic use. Radiology Business. Retrieved from http://www.radiologybusiness.com/topics/policy/fda-approves-first-digital-pathology-system-diagnostic-use

Granzow, R. (2017). Digital pathology for primary diagnostic use. Medical Laboratory Observer, 49(8), 58-60.

IntelliSite Ultra Fast Scanner digital pathology slide scanner. (2017). Retrieved October 4, 2017, from https://www.philips.co.uk/healthcare/product/HCNOCTN442/intellisite-ultra-fast-scanner.html

McGonigle, D., & Mastrian, K. G. (2018). Nursing informatics and the foundation of knowledge (4th ed.). Burlington, MA: Jones & Bartlett Learning.

National Cancer Institute. (2017). Cancer statistics. Retrieved from https://www.cancer.gov/about-cancer/understanding/statistics

Stratman, C., Drogowski, L., & Ho, J. (2011). Digital pathology in the clinical workflow: A time and motion study [PowerPoint slides]. Retrieved from http://www.slideserve.com/limei/digital-pathology-in-the-clinical-workflow-a-time-motion-study-pathology-visions

U.S. Food and Drug Administration. (2017). FDA allows marketing of first whole slide imaging system for digital pathology. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552742.htm

Voekler, R. (2017, May 16). Digitized surgical slides. Journal of the American Medical Association, 317(19), 1942. https://doi.org/10.1001/jama.2017.5540

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Measurements can be digitally quantified.  Images can be easily shared in presentations and for education.

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Multiple slides can be pulled up on the screen at once for comparison.