Here is my two cents and a bit of a rant, Bill you got me going. I agree with Bill - just want to add my thoughts - it's a Class III Medical Device (meaning that they have classified this type of equipment as highly-regulated and high-risk) requiring a pre-market approval process. I personally think that prohibited is too strong of a word. Like Bill says the CAP has guidelines on how to utilized this technology for other processes such as primary diagnosis through the "laboratory developed test" route. I'm not sure what that FDA would do if they found out a lab was utilizing this technology for primary diagnosis or how that would affect billing capabilities, there is probably some risk associated with this approach. If you look at some of the FDA published guidelines many of them recommend the use of digital pathology.
There are many instruments currently on the market that have various 510K clearances for algorithms, digital reads, etc. The DPA website has all of this information on it and much more regarding WSI - www.digitalpathologyassociation.org. My impression of what CAP is saying - they are saying move forward with this technology and they have provided us with guidelines on how to do so. Bottom line this is technology that can improve patient care and we in the US are so far behind in implementing this technology to its fullest potential, like Bill says outside the US its used extensively for primary diagnosis. If you are afraid of the risk of primary diagnosis, use this technology for one of the many processes that Bill has listed below. It also can be a valuable resource to the histology lab in general, you can use it in QC, tracking control staining, in IHC protocol development, consistency of staining, etc. It's a great tool. Liz Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Premier Laboratory, LLC PO Box 18592 Boulder, CO 80308 (303) 682-3949 office (303) 682-9060 fax (303) 881-0763 cell l...@premierlab.com www.premierlab.com March 10, 2014 is Histotechnology Professionals Day Ship to Address: Premier Laboratory, LLC 1567 Skyway Drive, Unit E Longmont, CO 80504 -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of WILLIAM DESALVO Sent: Thursday, April 10, 2014 9:56 AM To: mtitf...@aol.com; histonet Subject: RE: [Histonet] Telepathology In the US, FDA has designated the WSI instruments as Class I and, to date, no company has received approval/clearance for use. Until the FDA issue is resolved, the use of WSI for primary diagnosis is prohibited. Outside the US, WSI can be used in all facets of pathology, including primary diagnosis, and is used extensively. That said, in the US, using WSI for pathology processes such as frozen section diagnosis, case consultation, special stain and IHC review, can occur because these processes do not produce a primary diagnosis. There are many other uses for WSI in pathology lab that make the consideration for use and implementation cost effective. CAP has released guidelines for validating WSI in the lab and there is the option to expand the use of WSI by using the "laboratory developed test" route. The best resource for WSI, in my mind, is the Digital Pathology Association (DPA) web site. I am a member and this group is dedicated to the advancement and education of WSI. Check out the web site William DeSalvo, BS HTL(ASCP) > To: histonet@lists.utsouthwestern.edu > From: mtitf...@aol.com > Date: Thu, 10 Apr 2014 08:14:23 -0400 > Subject: [Histonet] Telepathology > > > Victor Tobias asks about telepathology- > > I seem to remember there is a rule somewhere that primary diagnosis can only > be made using a glass slide. As to chapter and verse, I don't know. > > However there are reports in the literarature that it has been tried out for > F/S in Alaska and Finland. > > Michael Titford > USA Pathology > Mobile AL USA > _______________________________________________ > Histonet mailing list > Histonet@lists.utsouthwestern.edu > http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
