CAP Today has just published what I consider to be the definitive article on the latest ruling by the FDA on digital pathology (see: Regulators scanning the digital scanners). It was written by Karen Titus. Here's an excerpt from the lead paragraphs:
A recent panel on whole-slide imaging launched a clear message from the Food and Drug Administration: The agency views WSI systems as Class III medical devices and plans to regulate them as such....While the FDA’s decision was clear, the next steps are anything but. Vendors, pathologists, the FDA, and the Centers for Medicare and Medicaid Services could head in any number of directions next, but they won’t be moving swiftly....Depending on one’s view, the news will slow efforts to bring WSI for primary diagnosis into U.S. laboratories, with some vendors looking to Europe for regulatory relief; have virtually no impact on large vendors, who, while not necessarily enamored of the FDA’s decision, concede it’s one they can live with; kill the market completely; choke innovation among vendors, especially component makers; possibly put laboratories in jeopardy if they try to validate these systems as laboratory-developed tests under CLIA; or encourage laboratories to use WSI for other, already approved purposes, readying themselves for the inevitable day when whole-slide imaging transforms surgical pathology. What most agree on is that for the first time, the FDA, which regulates the vendor portion of the vendor-laboratory equation, has “put a stake in the sand regarding digital pathology,” says David Wilbur, MD, professor of pathology, Harvard Medical School, and chair, CAP Technology Assessment Committee.
I tend to favor more the "stake in the heart" than the "stake in the sand" view. While the speciality of radiology is enjoying the benefits of nearly total digital conversion (see: Software for Comparing Changes in Pulmonary Nodule Size on Chest X-Rays), pathology will be muddling along for perhaps five years without the benefits of digital pathology such as image portability and the development of large image archives.
Keith Kaplan, who blogs over at the Digital Pathology Blog, has made his views on this issue quite clear. In his recent blog note, he cleverly copies Karen's article form CAP Today and then embellishes it with his own tropes in boldface (see: Regulators regulating digital scanners). I suggest that you turn first to Keith's blog to get a "twofer" -- the CAP Today article plus Keith's funny and insightful comments. He treads where the CAP would not venture. Here is the way he launches his note:
The FDA has about 1 million pages that are surprisingly easy to navigate on their website including a "How to Classify Your Device Page". If I am reading this correctly, microscopes are Class I devices, as are colposcopes to diagnose cervical dysplasia and cancer, [and] ditto for stethoscopes [and] holders for artificial heart valves....(roman numerals should only be used for really important things like Super Bowls).....Defibrillators...are Class 2! 360 joules of energy that could save your life in a moment or cause death if you do not respond to the TV "CLEAR!". And a slide scanner is Class 3 because? Oh, image quality, right. Apparently the FDA didn't look through the microscope I used today. It was like rice crispies were stuck to the lenses.
By classifying slides scanners as Class III devices, the FDA completely ignores the interposition of the highly-trained brain of the pathologist between the screen image and the dictated report that is sent to the clinician. As Keith points out and according to the FDA, a malfunctioning defibrillator, a Class II device, apparently does not pose as serious a threat to life and limb as a whole slide image scan.
To achieve some balance in this note, I need to add that some significant minority of pathologists may be cheering for the FDA on the sidelines. The introduction of digital pathology for primary diagnosis will require a large capital investment and a significant amount of retraining on their part. However, the majority of our ancestors might have voted down the wheel if they has been asked for their opinion at the time. Too many shell necklaces and too much ox-cart-retraining required.
I guess that I can continue to use my classic example of pathologist foreplay for a while: "Please pass me the next slide."
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