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BD, State Of Georgia Agree To Allow EtO Sterilization Plant To Keep Operating, Averting Potential Device Shortage

Executive Summary

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.

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Risk Of Sterilization Plant Shutdowns Across US Sends Shockwave Through Industry

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.

Industry, AJC Duke It Out In Georgia Over Ethylene Oxide Risk

While AdvaMed has remained relatively quiet over the recent closures of ethylene oxide (EtO) sterilization facilities, the medical device industry advocacy group is taking on critics in Georgia, where two facilities have been paused to upgrade their operations to reduce EtO emissions. Critics – including the Atlanta Journal-Constitution’s editorial board – say the chemical is associated with increased risk for cancer for nearby residents, but AdvaMed and its supporters say there’s no evidence to back that up.

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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