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.
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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 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
Center for Disease Control and Prevention: Ethylene Oxide “Gas” Sterilization
12/4 | Viant To Cease Ethylene Oxide Sterilization At Michigan Plant By Year’s End
11/20 | New Congressional Task Force Formed To Pressure U.S. EPA To Adopt New EtO Rules
11/25 | FDA Launches Pilot To Speed New Ethylene Oxide Sterilization Methods
11/13 | Bill Phasing Out Ethylene Oxide In Densely Populated Areas Of Illinois Fails In Committee
11/8 | State Representative To Introduce Ethylene Oxide Legislation In General Assembly
11/8 | Ethylene Oxide Plant Closures Put Us On ‘Cusp Of A Major Medical Logistical Failure’
11/7 | ECRI Institute Opposes Proposed Ban Of Ethylene Oxide (EtO) Sterilization Operations
11/7 | EPA Proposes Drastic Cuts To EtO Emissions Nationwide
11/5 | How Can Medtech Overcome Its Ethylene Oxide Sterilization Crisis?
10/28 | Illinois House Committee Sees Partisan Split On Ethylene Oxide Votes
10/25 | BD Warns Of International Device Shortages In EtO Plant Legal Filing
10/25 | FDA Warns Of Device Shortages Again Due To Sterilization Plant Closures
Josh Babb »
Director, Government Affairs