Medical device sterilisation issues

Our cobber across the way on the PO3 thread, cadence1 has drawn attention to an issue unfolding in the US regarding health issues linked to sterilisation of medical devices using ethylene oxide, by contract device sterilisation companies Sterigenics in Illinois and Viant Medical in Michigan. The story is linked at: https://www.medtechdive.com/news/sterilizer-plant-shutdown-prompts-fda-action-on-device-shortages/551392/ .

Ethylene oxide is used internationally to sterilise around 50% of medical devices. So the above linked story is a big deal and our friends on the PO3 thread are sensing opportunities, not least because of the following comments from the FDA: "Given the environmental risks associated with ethylene oxide, FDA said, it has begun to explore the validation of methods that would use lower levels of agents like ethylene oxide, or new sterilization agents or processes altogether. "

Well the crew over at PO3 may well be justified in sensing opportunities, but so too might NAN shareholders, given that trophon technology is now recognised as an environmentally benign industry standard for high level ultrasound probe disinfection in the US, with potential application to a range of other medical devices. Then there's the new non trophon disinfection product(s) which are apparently moving through regulatory consideration and towards commercial release in the not too distant future.

Whatever these new NAN disinfection products might be, it certainly sounds promising that given the ethylene oxide issues currently plaguing the medical device sterilisation market in the US, the FDA is now expressing interest in exploring validation of new medical device sterilisation agents or processes.

zeno9