FDA/CDC Health Care Infections Control Practices Advisory Update on this FDA /CDC Health Care Infections Control Practices Advisory Committee at their meeting Thursday May 16. There was a presentation by FDA rep to the committee at 11 AM and a significant powerful public input presentation by the wife of a patient who died due to CRE from a contaminated scope in 2013 at 4 PM.
My take… The FDA rep said very little new at this meeting except that they did reference TSO3's study showing the ability of the VP4 to sterilize duodenscopes that was published recently in the AJIC (https://www.ajicjournal.org/article/S0196-6553(18)30915-5/fulltext…) The FDA rep simply restated the known problems and the latest data showing 5.4% bad bugs and 3.6% other bacteria on scopes processed according to their present recommendations and then she went over the recommendations from 2015, adding that they did not know if any supplemental reprocessing they had previously suggested was actually helping (except she did state that they do know that doing 2 x HLD was shown in studies not to be of benefit and that ETO seemed to help with outbreaks, but with the caveat that ETO is only available in 12% US hospitals and use is decreasing due to toxicity, cost, environmental issues, etc.) … IMHO, the is FDA dragging its feet big time before making any public statements… Until, IMHO, TSO3 can put out an official IFU for ERCP scopes (like the one they are working on with Fuji now) … Actually FDA rep even asked two (almost embarrassingly obvious) questions of the advisor panel 1) are panel members concerned about the ongoing problem of scope contamination?… to which panel members said 'You’re bloody right we are extremely concerned!! and the present situation is unacceptable' and 2) should new devices coming to market with 510k's have data to show they can be sterilized/decontaminated? … and the committee replied 'Yes! From now on!'… Other FDA comments were 3) the benefits of ERCP still outweigh the risks of infection ….to which the reply from a committee physician and others was 'but the present contamination issue is still unacceptable to our patients and to the public!!' FDA did mention they are working with 4) Alternative Sterilization Technologies (though the AJIC article by Molloy-Simard was mentioned in their slide, TSO3 was not specifically named, as per FDA practice of not identifying specific companies!) IMHO, TSO3 needs an OEM approved and recognized IFU like the one they are working on with Fuji for duodenoscopes before FDA will highlight them more publicly as a major solution to the problem. They did however mention that ETO has too many problems (too long, too toxic, only 12% hospitals have access, general movement to stop using ETO, and it is hard on scopes (but compatibility remains undefined)….and in post market studies that show continued contamination. It is also noted that HLD with peracidic acid (such as in the Steris 1E and ASP's soon to be marketed upgrade alternative to the Steris) have not been proven to make a breakthrough difference with contamination persisting despite using these systems and they acknowledged that HLD is also hard on scopes…
IMHO, this makes the IFU TSO3 is working on with Fuji even more important to get out publicly asap!!
The one relevant speaker was the woman who is on the TSO3 website giving her testimonial whose husband died with CRE in 2013 following ERCP in the Carolinas. She described his excruciating death over 4-6 months from superbug infection from the scope and how she has worked tirelessly as an advocate for terminal sterilization for the past 5 years. It seemed to me that the FDA and committee did not allow her to identify TSO3 as being the specific alternative technologies she was talking about for some internal ethical reason, but she stated that, as she and all of them at the meeting knew or should know, there is a terminal sterilization technology that exists to solve the problem and that she was at the first hospital in N. Dakota to start sterilizing ERCP scopes using this technology (the VP4) and that they continue to do so effectively and efficiently. And, she stated this solution is cost effective and time efficient and there should be no excuse for not adopting it. She thanked the committee for their continued highlighting of this problem and for keeping it at the top of their agenda, but she also implored the committee to recognize that a solution exists and to advocate for it on behalf of all patient and the public.
It seems to me this is just a political outreach committee that makes recommendations to Congress, and part of the behemoth of US government, but this presentation to them was personal and real. And, I believe the committee and teh FDA were listening. I hope she gives her presentation to the Senate Committee as well!
(I have been away. I have more to post regarding a new industry publication summarizing the present situation and recommending a broad move to sterilization for endoscopes by Dr. William Rutala from AJIC June 2019 Supplement, in which he finally recognizes the VP4 option and identifies it as being FDA approved. I will do this update shortly.)