RE:Another endoscope sterilizer recallThis has been an ongoing saga with this inadequate washer disinfection system and company for years, or since 2007, and since 2012 they were to stop selling their units but could continue to service them as they tried to show that they had made changes to meet FDA requirements. Obviously, the company did not do what they stated they would. The institutions still using these washers, totaling approximately 2800 units, will be in the immediate market for a solution. It is incumbent upon Getinge and TSO3 to let it be known as best they can, even though the submission for extended claims has not yet been made, that they have a sterilizer, the VP4, that will solve these institutions problems, and not allow these institutions to think that they just need to go out and purchase another inadequate washer from another manufacturer that will just need next year to by replaced by a VP4.
The big issue is obvious: when will the FDA decide for the US population that they can and need to transition their recommendations to terminal sterilization of scopes and put an end to this lack of standardization in the processing of scopes and the resulting inadequate quality of care? This is why the FDA should be working with and monitoring TSO3's progress to make extended claims for not just for these difficult duodenoscopes but for all scopes in the US market. They were so slow to give initial approval for the VP4 as a new category of low temperature sterilizer that they are certainly well aware of its potential. They just need the complex submission, paper work, and data to be completed so that they can move forward.
This whole issue remains charged, medicolegally, with the FDA behind the 8 ball. Once they officially have TSO3's data and confirm that the most prevalent and used duodenoscopes as well as most other scopes can be terminally sterilized, it will, of course, be their responsibility to issue advisories and recommendations regarding the new VP4 technology. My bet remains that TSO3 does not want to make press statements regarding the capabilities of the VP4 as this could be seen as prejudging the FDA process of extended claims approval, but I do hope that TSO3 will issue some statements before the FDA submission is made.
Not only will the VP4 be a new standard of care, it will be the ONLY sterilizer that can make these extended claims, just as it is the only one in Canada making claims for complex scopes with up to 8 channels. And, should there turn out to be some scopes that cannot be sterilized, as is possible, with the FDA mandating a new standard of care, these minor players in the scope manufacturing business will be obsolete and out of this business, but this should not make the FDA drag its bureaucratic feet. I am not sure how often the FDA mandates a standard of care that only one company is capable of meeting, but creating a virtual monopoly for TSO3 is not their problem, ensuring a high quality of patient care is. TSO3 will simply be the lucky recipient of an enormous growing market (that just increased today by 2800) in which they are the only viable player. TSO3 will soon be taking deposits on VP4 units for delivery as soon as the units can be manufactured, as the demand will soon outstrip the ability to make enough units.
I just hope TSO3 gets this submission done with even greater haste and care than previously envisioned. I know they are working hard on it. They must work harder, and faster. The slow moving bureaucracy must focus its attention and the submission and consideration of paper work must, for the good of our patients, be completed as expeditiously as possible. There is a problem to solve and the VP4 can solve it!
(The selling by TD over the last couple of days is beyond ridiculous. It is an insult to all of those who have spent years dedicating themselves to creating and getting this marvelous new VP4 sterilizer to market for the benefit of our patients.)
WKH
Thanks for the information! Here is the link to the FDA's statement:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472605.htm