TS03 Inc Trust Units TSTIF

Need to Update Spaulding Classification Advised Sept 2016

[echo2]

Preventing Device-Related Healthcare-Associated Infections

ISSUES AND OUTCOMES FROM THE SEPTEMBER 2016 FORUM, MEDICAL TECHNOLOGY AND HAIs 

https://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/Summits/161227_AAMI_HAI_Forum_Report.pdf

Generally, this industry led forum put together a meeting summary that contains a general discussion of how slow a bureaucracy can be to adapt to problems and contains very little of interest as over 100 specialists and representatives supposedly met to discuss. However, Dr. Rutala did do a presentation recommending consideration of updating the Spaulding Classification for some devices, such as GI scopes and bronchoscopes, to be sterilized (critical not just semi-critical) instead of only using what is proving to be relatively ineffective high level disinfection protocols:

"William A. Rutala, PhD, MPH, CIC, director of hospital epidemiology at UNC Health Care in Chapel Hill, NC, emphasized that risks associated with managing increas- ingly sophisticated technology demand an evaluation of the e cacy of current process- ing protocols. According to Spaulding’s Classi cation, which speci es how an object will be disinfected depending on its intended use, healthcare facilities use high-level disinfection to process semi-critical devices (i.e., devices that contact mucous membranes or non-intact skin, but do not enter sterile cavities of the body). Rutala suggested that high-level disinfection may not be appropri- ate for endoscopes, based on years of failures. He instead recommended sterilizing devices that pose a signi cant or potentially signi - cant infection risk, such as gastrointestinal endoscopes and bronchoscopes. "

The lead feet that the CDC, FDA, industry, lawyers, and others are wearing as they are apparently trying to run to catch up to the problem of HAI's related to scopes is evident. And, this probably goes a long way to explain the delay TSO3 is experiencing in getting their submission for further extended claims completed to the FDA for more scopes, especially duodenoscopes. Once this submission is done and FDA is forced to admit to the availability of a practical, effective, and efficient solution, i.e., the VP4 Sterizone low temperature sterilizer, the game and the playing field will fundamentally be changed, to the benefit of TSO3 shareholder and company employees as well as to the benefit of patients in the US.

Also, I don't see any reference for Cash's claim that Trump knows what a superbug is let alone has a strong interest in promoting a prompt solution to this problem. Would love to see a link. Thanks.