The use of Ethlyene Oxide (EtO) in the sterilization of medical devices has been under debate for years, dating back to 2019 when the US Food and Drug Administration (FDA) announced its Innovation Challenges to industry. Challenge 1 was to identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide and as a result, the FDA selected four participants and five submissions to participate. Challenge 2 was to develop strategies or technologies to reduce emissions to as close to zero as possible, under which the FDA selected eight participants.
Since that time and with nearly half of the medical device sterilization being done through EtO, the Environmental Protection Agency (EPA), amidst public concern, has been deliberating on a rule to amend air toxics standards for ethylene oxide commercial sterilization, estimating to reduce EtO emissions by more than twenty tons per year. The EPA and the medtech industry have been discussing the impact amendments to the standards would have on the availability of the medical device supply chain and the overall survival of many medical companies while maintaining a responsibility to safeguard public health.
The medtech industry is interested in working in a partnership with the federal government while maintaining the appropriate time to allow companies to be able to make the needed changes, implement adequate technologies for emissions removal, and limit or negate the need for Premarket Approval (PMAs).
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