Front Page NYT This Morning: Superbugshttps://www.nytimes.com/2019/04/06/health/drug-resistant-candida-auris.html?action=click&module=Top%20Stories&pgtype=Homepage
A friend of mine's infant son just died from a similar candida infection in his blood following heart surgery. The issue of superbugs, including drug resistant fungii, is a staggering public health problem as you can see from this article. And, the problem is not just limited to scopes, but scopes have problems that the FDA, CDC, and other regulatory bodies are only beginning to address. How many scopes have been tested to check for contamination with this 'new' strain of candida? Any? Scopes that have been high level disinfected in an older AER or processed with HLD liquid chemical 'sterilzation' are to be hung and stored in cabinets to dry. What is the level of contamination of those cabinets? Does anyone really want to find out? Is anything less than terminal sterilizaton capable of truly decontaminating these scopes and preventing recontamination before their next use? To quote, for example, from the FDA "There are several limitations with liquid chemical sterilization. Although the rinse water is treated to minimize any bioburden, it is not sterile. Because the rinse water is not sterile, devices rinsed with this water cannot be assured to be sterile. Furthermore, devices cannot be wrapped or adequately contained during processing in a liquid chemical sterilant. This means that there is no way to maintain sterility once devices have been processed."
A terminally sterilized scope such as one processed in a VP4 is wrapped sterile for use either immediately or in days or weeks when it is needed. It is not hung in a cabinet. The list of resistant bacteria on scopes is huge and growing, but included CRE, c. difficile, pseudomonas, candida. Single use scopes will play a role in helping with these problems, but their potential use is quite limited. Thankfully, companies with foresight like Fuji appear to be working with TSO3 to improve existing standards of practice with scope manufacturer endorsed IFU's, and a manufacturer is working with TSO3 on the design of a new line of scopes.
ETO for terminal sterilization remains touted as a partial solution, but it continues to have issues of toxicity, carcinogenicity, cost, limited availability, and now environmental issues have resulted in the EPA closing one of the largest industrial ETO facilities in the US with another facility planned for closure later this year, possibly resulting in shortages of single use items in hospitals across the continent. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/ucm634204.htm
AAMI and FDA and other regulatory bodies are definitely recommending moving toward sterilization of endoscopes, particularly flexible endoscopes that are used in semi-critical and definitely for all critical procedures. But, why are they moving so slowly? Why has it taken AAMI four years to come up with new standards for reprocessing of endoscopes? In coming months, the AAMI and others will demand even greater adherence to new improved sterilization standards than even Canada has already adopted. Yet, why are presentations made by some 'experts' in the field at industry meetings still discussing only how to do a better job of cleaning and reprocessing scopes in HLD machines when these have been shown time and time again to be inadequate? Might it be that the industry, including doctors and hospitals, and so called 'expert' consultants in reprocessing each have vested financial interests (in doing more scope procedures as cheaply and quickly as possible) (or, in representing the interests of the reprocessing AER, HLD or scope company that pays them for their 'expertise' and presentations at conferences)?
Though they have changed the wording from 'should be sterilized' to all endoscopes used in critical procedures 'shall be sterilized', might the industry be loathe to create another expense for the health care providers? At what cost to patients and their families who are contaminated and injured? As TSO3 illustrates in their ad, which hospital would you go to for a scope procedure, the one that sterilizes or the one that does not?
TSO3's technology will play a major role in meeting the surging demand for sterilization, particularly of flexible endoscopes.
And, I have a funeral to attend.