Regular readers will recall my post earlier this year on the shutdown of a Sterigenics plant in Illinois using ethylene oxide to sterilize medical devices due to repeat environmental emissions of the sterilant, which is known to cause cancer. The shutdown continues and is expanding to other facilities, causing serious shortages of certain products (read an update here). The FDA has been working to help alleviate the shortages, and mid-year announced two Innovation Challenges to identify sterilization alternatives and reduce ethylene oxide emissions. Forty-six applications were received, and from these the FDA has selected 5 submissions for the sterilization alternatives challenge and 8 submissions for the emission reduction challenge. The FDA has encouraged the remaining applicants to consider using the standard mechanisms for approval of their technologies and to seek assistance from the Division of Industry and Consumer Education (DICE) for any questions. The purpose of the Challenge is to accelerate the development and approval of these new technologies to alleviate the current shortages and establish better and safer sterilization methods. Hopefully one outcome will be to help restore the operations at plants using ethylene oxide, although Sterigenics has alredy announced they will not reopen the Illinois plant.
Reach out to me if you want to know more or discuss your medical product development challenges.
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