What pathologists and the CAP can do to assist with PMA process

With recent news of the FDA classifying whole slide scanning systems as Class 3 devices and therefore requiring pre-market approval (PMA), I would propose an idea to my fellow pathologists and our professional college, the College of American Pathologists (CAP) to have a supporting role in these endeavors.

For the sake of argument, let's take 16,000 as the number of members of CAP.  If conservatively, 10% of its members contributed, say 2,000 cases to the organization, the CAP would have at its disposal over 3 million pathology cases.  For members, this may constitute a few days, week or month of accessions depending on the size of the laboratory operation.  Members would select accessions beginning the first week of December 2008 until enough cases were collected from that particular laboratory/group to contribute to the CAP.  This would likely require some cost to recut the cases and perhaps not all cases may be suitable from the standpoint of having enough diagnostic tissue, blocks sent to another institution and not returned, etc…Members of committees often contribute cases, control material and cytology slides for purposes of proficiency testing and validation.  This would involve more folks and create I think for the first time in CAP's history a slide repository from a cross section of laboratories across the country representing a wide variety of specimens, cases, tissue types, part types and slides.

Manufacturers and software companies can then make "withdrawals" from the slide bank, for say, 90 days to conduct studies evaluating glass slide versus digital diagnosis.  Someone may ask for 10,000 breast cases, 15,000 GI cases or a subset of gynecologic specimens for a specific intended use they are going to submit a PMA for.  Random number generators can be used to "shuffle" the cases selected for a particular request.

The CAP would could create a revenue stream as companies are charged processing and handling fees for the withdrawals or loans.  The cost of the "CAP Center for Slide Excellence" in terms of housing and cataloging millions of slides would be one factor for the CAP to consider among many others.

Vendors that do not return material in a timely fashion or in its original condition are charged according to pre-defined fees and may potentially risk being excluded from the priveledge of using the slide bank.

Pathologists in-turn perhaps are provided some form of renumeration for the time and effort to collect the slides and manage handling to the CAP slide bank.  Anonymous brief clinical histories and the referring diagnosis will be submitted along with the slides.  Although the referring diagnosis is I think of least importance here as seperate individuals and/or panels will establish the "ground truth" diagnosis the additional seperate microscope and digital reads are compared with.

In addition to costs for CAP and what likely revenue this could garner as well as the actual need for this product and service may be overstated in this simplified proposal.

Larger vendors that have access to large medical centers and universities may already have this kind of access with current clients or established beta partners.  Smaller vendors may have a greater need to access of a library of this type and could benefit from the diversity of cases that would be submitted from pathologists willing to contribute.  

This product and service would be open to anyone with the need to perform studies on the level of a PMA study but could also include other validation studies, proficiency testing, GME and CME material.  

No scanning of any shape or form would be done within the slide bank.  The slide bank is just that – a collection of slides that are loaned as substrate to be used on the specific device, platform, open system, closed system, etc… of the company or individuals making the request.

While this concept is not unique, as tissue banks and university laboratories may have for-profit ventures where tissue slices, cores or TMAs are made or clinical trials and supporting services are managed, care will have to be exercised by all parties to insure patient privacy and cost vs. expense are managed and exercised in a professional manner.

For the CAP and its pathologists members, we can assist industry colleagues recognizing the quality of material produced by CAP members and recognition by the CAP for offering this type of product and service on behalf of inventors and innovators.  Manufacturers are served by cost effective access to a large selection of cases as part of their investment in the PMA process.

I welcome your comments to this proposal