Hi MedifyI'm not sure if FDA ever did engage the infection...

Hi Medify

I'm not sure if FDA ever did engage the infection control community at the May HICPAC meeting, but in the wake of the ethylene oxide dramas that played out earlier in the year (to which you kindly drew our attention back in April), FDA seems to have moved things along through other means.

On 15 July, FDA launched two innovation challenges to "incentivize the creation of alternative medical device sterilization methods and methods to reduce ethylene oxide (EtO) emissions" involving a call for submissions to the FDA by 15 October (see: https://www.medtechdive.com/news/fda-launches-innovation-challenge-to-boost-ethylene-oxide-sterilization-alt/558859/ ).

Then, a few days ago, the FDA announced it plans to hold an advisory committee meeting on 6 and 7 November (which will be open to the public) to discuss ethylene oxide sterilization of medical devices and the risks associated with infections stemming from reprocessed duodenoscopes. The news outlet reporting the FDA announcement opined that "the advisory panel appears to be timed to evaluate submissions to FDA's two innovation challenges launched in July". The news outlet also expected the meeting to: "garner attention from the Illinois congressional delegations, which have called on FDA to evaluate alternatives to ethylene dioxide after the February closure of a major Sterigenics sterilizing plant in a Chicago suburb" (see: https://www.medtechdive.com/news/fda-sets-november-ethylene-oxide-sterilization-duodenoscope-safety-advisor/562129/)

The Federal Register notice of the advisory committee meeting and the terms of public involvement (https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-19079.pdf) was published a few days ago on 4 September.

It will be interesting to see whether PO3 (and/or NAN) participate in the FDA submission process, or whether they are happy keep their focus respectively on more immediate business priorities.

zeno9