RE:RE:RE:RE:RE:RE:RE:RE:pre CC newsThere seems to be little doubt that the industry is headed to terminal sterilization for all, or nearly all, scopes according to the dozen infectious disease specialists, heads of reprocessing and sterilization, as well as infection control officers with whom I have spoken. The big question, of course, is when. Don't forget: until the recent FDA approval of extended claims for the VP4 the FDA did not recognize that many if not most complex scopes simply could be sterilized. Now, the FDA, the CDC, the Department of Health, and other administrators and government regulatory agencies at least have an option on the table that they can openly discuss.
There is no question that leading industry and health care providers will move to sterilization before this is mandated through change to the Spaulding Classification for scopes: they don't like risk and injuring patients through contaminated scopes, and the costs of litigation of a single injured or even exposed patient probably far exceeds the cost of a new VP4 sterilizer, though the existing class action suits have yet to be settled, of course, so we don't have an exact number yet. A hospital, HMO, physican out-patient facility, or Health Region could buy a dozen or two VP4's for the litigation cost of every death caused by this industry nightmare, (see Terlune's latest LATimes article). And, if you could tell your patients that you just invested $150,000+ US in a new technologcal advance in sterilization, the VP4, for their upcoming colonoscopy to done with a STERILE scope, don't you think patients (and your facility PR people) might like to hear this and don't you think this might lead patients to have their procedure with you rather than with another competing facility that does not offer a sterile scope? That is why I will be very interested to hear of any strategic placements of VP4's during the upcoming cc or pr's. In the US, the market, and the lawyers, will be the first movers.
Demand will be slow at first, but then overwhelming. The FDA will, IMHO, be slow to demand change due to the inability of many health care providers to make the rapid change and for TSO3 to initially meet demand, and due to the medical-legal implications, ("you mean to tell this Court that the FDA told you to sterilize and you knew their was the VP4 option available, and yet you continued to use inadequate high level disinfection procedures...and my client's mother, Mrs. Smith, contracted a preventable infection and died?!?!" "No further questions, Your Honour.")
Some analysts don't talk about this obvious blue sky future because it is an evolving space just confronted with a disruptive technology and the implications are not easy to quantify in a table. But, the implications are obviously huge.