EtO Transition Challenges Highlighted During Device Sterilization Town Hall

During a recent virtual town hall, FDA staff divulged there are currently no fully adequate substitutes for ethylene oxide (EtO), a chemical used to sterilize half of all medical devices in the U.S., and which can also cause an increased risk of various cancers.

The town hall occurred as the Environmental Protection Agency (EPA), which has labeled EtO emissions carcinogenic, works to complete a final rule governing commercial sterilization using EtO by March 1, while device stakeholders have asserted that the EPA’s proposed limitations would be detrimental to their industry and cause harm for patients using these sterilized devices.

The FDA, which has been seeking to balance device-using patient concerns with broader public health and environmental worries over use of EtO sterilization, estimates that 50 percent of all medical devices, or 20 billion, are sterilized using EtO each year.

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