More than 20 billion medical devices sold in the United States each year are sterilized using ethylene oxide (EtO), according to an agency statement from then-FDA Acting Commissioner Ned Sharpless, M.D. on October 25. EtO is the most common method of sterilization in the country, and as such, the closures of EtO facilities across the country are raising strong concerns among stakeholders. Last week FDA held a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee to discuss the “Reduction of Ethylene Oxide Sterilization Emissions for Medical Devices and Potential for Utilizing Other Sterilization Modalities”. Before as well as after the meeting, many organizations released statements about the issue, including excerpts of their planned testimony.
“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, M.D., Ph.D., president and CEO of ECRI Institute in a news release. “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. Without access to medical supplies, many surgeries and procedures would not be possible.”
“EPA’s data shows that ambient air levels of EtO are far higher than the proposed standard that some have used as justification to shutter sterilization facilities. This demonstrates that the standard is not a reliable or useful gauge for determining appropriate emission levels of EtO. As we continue to study EtO’s presence in our atmosphere, it’s important to remember that leading toxicologists and epidemiologists confirm that the communities surrounding these facilities are safe. We look forward to working with EPA, FDA and other stakeholders to find a reasonable solution to the issue of EtO use that will allow for the continued safe and responsible sterilization of needed medical devices.” – Scott Whitaker, president and CEO, AdvaMed
“I am concerned that should sterilization facility closures continue throughout the country without adequate warning or contingency planning, that patient safety will be at risk and unnecessary patient harm will occur,” said Kara Mascitti, M.D., infectious disease physician and Medical Director of Healthcare Epidemiology and Infection Prevention, St. Luke’s University Health Network, who testified during the FDA meeting. Her concerns covered three main areas:
- “Internalization of sterilization by hospitals and health systems would be prohibitive in terms of costs and logistics
- Inadequate sterilization would be catastrophic for patient care and threaten modern medicine as we know it
- Changes to sterilization methods must occur in a coordinated and systematic manner to minimize unintended consequences.”
“Based on primary research, we identified that most third-party EtO sterilization facilities are operating currently at 90 percent capacity. Using that statistic and two different calculations that identified that the average facility sterilizes 200 million units per year, we established that the excess sterilization capacity in the U.S. was approximately 1 billion units prior to any closures. Following the closure of Sterigenics in Illinois, Viant in Michigan, and Sterigenics in Georgia, the current excess capacity is 520 million units,” said Chaun Powell, group vice president, strategic supplier engagement, Premier, Inc. in testimony during the FDA panel. “The estimated capacity at Medline in Illinois and BD in Georgia is 550 million units. Simple math shows that if those two plants close, or any similarly sized plants close, we will exceed the excess sterilization capacity for current FDA-approved facilities in the U.S. Two more sterilization facility closures is our threshold and would not only send our healthcare supply chain into a tailspin, it would be catastrophic for patient care.”
“Given that the FDA mandates that medical device approval applications for [critical devices] contain appropriate data to support the required sterilization process, not only would a new process need to be developed, but the process would also need to be tested and validated in each medical device.” – letter sent by the American College of Cardiology, American Society for Gastrointestinal Endoscope, the Heart Rhythm Society, the Society for Cardiovascular Angiography and Interventions, the Society of Interventional Radiology and the Society of Thoracic Surgeons to the FDA panel.