Got A Better Idea? US FDA Seeks Help Tackling Ethylene Oxide Troubles
Regulators are reaching out to industry and the public-at-large for ideas that would help develop new sterilization methods that could reduce or replace the need for ethylene oxide used to treat difficult-to-clean medical devices. They are also looking for ways to reduce the risk and environmental impact of the sterilizing agent.
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While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.
BD, State Of Georgia Agree To Allow EtO Sterilization Plant To Keep Operating, Averting Potential Device Shortage
The state’s environmental regulators agreed on 28 October to allow Becton Dickinson to continue sterilizing medical devices using ethylene oxide (EtO) as long as the company continues to make modifications to their sterilization plants in the state, and limit the number of devices they sterilize. The agreement may have averted a serious medical device shortage across the US.
The US FDA is asking stakeholders to weigh in on a common device sterilization procedure and the contagion risks of reprocessed duodenoscopes ahead of a November panel meeting.