Medical Device Sterilization

Sterilized medical products are critical to healthcare. Poor or incomplete sterilization can lead to transmission of infectious diseases or compromised patient health. One sterilization method is via ethylene oxide (EtO), a common gas that kills microorganisms at low temperatures. For many medical devices, EtO sterilization is the only method that effectively sterilizes and does not damage a device during the sterilization process. Should regulatory policy or actions limit or abolish the use of EtO as a sterilization agent, the negative effect on healthcare providers and patients would be profound.

HIDA recommends a thoughtful approach that considers the impact on the delivery of healthcare nationwide. Any changes to EtO policies must include a realistic and feasible plan to anticipate and address any potential product disruptions and patient care. Disruption at even a single sterilization facility can have a magnified impact across the country as devices sterilized in one facility support patient care in all 50 states.

HIDA Resources

• Medical Device Sterilization Frequently Asked Questions (FAQ)
• EtO Comments Extension Request – NESHAP
• EtO Comments Extension Request –FIFRA

Government Statements & Resources

FDA

• FDA Continues Efforts To Support Innovation In Medical Device Sterilization
• FDA Letter Asking To Reopen Sterigenics Facility For Sterilization Of Critical PPE–March 19, 2020 (PDF)
• Federal Register: Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program
• FDA Director Statement On New Steps To Advance Innovation In Medical Device Sterilization With Ethylene Oxide
• FDA Announces Participants In ‘Innovation Challenge’ To Reduce Ethylene Oxide Emissions
• FDA Announces Participants In Initiative To Identify New Sterilization Methods And Technologies
• FDA Actions to Advance Medical Device Sterilization
• FDA Commissioner Statement on Concerns with Medical Device Availability Due to Certain Sterilization Facility Closures
• Medical Devices: Standards and Conformity Assessment Program
• Ethylene Oxide Sterilization for Medical Devices

EPA

• EPA Launches Community Engagement Efforts On New Ethylene Oxide Risk Information
• EPA Moves Forward on Suite of Actions to Address Ethylene Oxide
• Agency Actions on Ethylene Oxide
• Frequent Questions: Health Information About Ethylene Oxide
• Regulations for Ethylene Oxide
• Ethylene Oxide Emissions Standards for Sterilization Facilities: National Emission Standards for Hazardous Air Pollutants

CDC

• Ethylene Oxide “Gas” Sterilization