ECRI Institute Opposes Proposed Ban of Ethylene Oxide (EtO) Sterilization Operations

PLYMOUTH MEETING, PA—ECRI Institute, the nation’s leading independent, non-profit patient safety organization, opposes a total ban of commercial ethylene oxide (EtO) sterilization because it could result in widespread shortages of sterile medical devices. More than fifty percent of all sterile medical devices purchased in the United States are sterilized with EtO.

“Even a partial ban on ethylene oxide could cripple the delivery of healthcare in the United States as critical medical-surgical supplies would suddenly become unavailable,” said Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute.

Hospitals around the country began reporting medical device shortages after a large Illinois-based sterilization plant closed due to state environmental pressures. Legislators in Illinois are currently considering an outright ban on EtO sterilization. These actions follow a 2016 report by the Environmental Protection Agency (EPA) regarding possible health risks from EtO emissions.

“While environmental health concerns certainly need to be addressed, legislators and the public should be aware that an ethylene oxide ban could severely impact the safe delivery of healthcare,” said Schabacker. “Without access to medical supplies, many surgeries and procedures would not be possible.”

For more than 50 years, the medical device industry has relied on ethylene oxide to sterilize temperature- and moisture-sensitive disposable medical devices, such as syringes, IV bags, and wound dressings, and lifesaving devices, such as stents and catheters. These medical device materials and packaging were developed for EtO sterilization. ECRI Institute knows of no safe alternative commercial sterilization methods that could immediately replace EtO at this time.

This topic is under discussion at the Food and Drug Administration (FDA) public advisory committee meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee, November 6-7, 2019.

To learn more, contact ECRI Institute at clientservices@ecri.org, (610) 825-6000, or visit www.ecri.org.

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About ECRI Institute
ECRI Institute is an independent, nonprofit organization improving the safety, quality, and cost effectiveness of care across all healthcare settings. The combination of evidence-based research, medical device testing, and knowledge of patient safety makes ECRI uniquely respected by healthcare leaders and agencies worldwide. For more than 50 years, ECRI Institute has had an unwavering dedication to transparency and strict conflict-of-interest policies. The organization has earned a reputation as the trusted voice of unbiased, research-based assurance for tens of thousands of members around the world using its solutions to minimize risk and improve patient care.

ECRI Institute has the only medical device testing labs in North America and the Asia Pacific where biomedical engineers conduct hands-on independent device testing for safety and human factors usability. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services.

Visit www.ecri.org and follow @ECRI_Institute to learn more.

For more information, contact:
Laurie Menyo, Director of Strategic Communications
(610) 825-6000, ext. 5310
lmenyo@ecri.org