FDA reports sterilization challenge progress as EPA takes aim at EtO emissions

The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.  Those innovation challenges are making “encouraging progress,” FDA said, with some facilities cutting EtO emissions by an estimated 20% to 35%.  “In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range,” the FDA said in a news release in August 2022.

Manufacturers and sterilization companies that have worked with the FDA on reduction efforts include Abbott, Andersen Scientific, BD, DMB Apparatebau, Medtronic, Sterigenics, Steris and Taiwan Advanced Sterilization Technologies.  Alternative sterilization methods under consideration for certain types of medical devices include vaporized hydrogen perozide, supercritical carbon dioxide and nitrogen dioxide.  The FDA selected NovaSterilis, Noxilizer, Steris and Stryker’s TSO3 from 24 innovation challenge applicants to work with the agency on these efforts.  Some device manufacturers are working with contract sterilizers to validate new or different methods as well as the feasibility for scaling up, FDA said.

Another EtO reduction effort is the FDA’s EtO Sterilization Master File Pilot Program, which lets premarket approval (PMA) holders of high-risk devices change sterilization processes and facilities.  The pilot now includes 11 sites and 28 Class III devices (those that “sustain or support life, are implanted, or present potential unreasonable risk of illness or injury”), the FDA said.  Med-tech organizations have also expressed interest in the FDA’s new 510(k) master file pilot program.  “While signs of innovation are promising, other methods of sterilization cannot currently replace the use of EtO for many devices,” the FDA said.  “To that end, we are equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.  Our supply chain program is ready to work with industry to help prevent and mitigate potential shortages due to reduced supply of certain ethylene oxide sterilized medical devices.”

The FDA’s most recent report of an EtO facility closure was the June 2021 closure of Steril Milano facilities in Italy.  The FDA said that the company falsified records for years, leading to voluntary device recalls by at least 10 med-tech firms.

EtO is used to sterilize more than 20 billion medical devices every year, equal to about half of all devices that require sterilization.  The gas is the most commonly used sterilization method thanks to its ability to permeate packaging at relatively low temperatures and kill bacteria and viruses that could cause life-threatening infections.

REFERENCE:  Medical Design and Outsourcing; 04 AUG 2022; Jim Hammerand

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