FDA Warns of “Tipping Point” with Medical Device Supplies and EtO Facility Closures

Sterilization Shortage could have “Ripple Effect” Nationally

WASHINGTON, DC. – A top FDA official warned that additional closures of ethylene oxide (EtO) sterilization plants could lead to shortages of critical medical devices across the country.

“It’s kind of like a tipping point right now,” said Dr. Suzanne Schwartz, acting director of the Office of Strategic Partnerships & Technology Innovation at FDA’s Center for Devices and Radiological Health, to Georgia media on two recent closures of EtO sterilization plants and the possibility of future plant closures. “If there were to be any more closures then the likelihood is we will not only see spot or local shortages, it will have a ripple effect nationally.”

Last week, FDA released a statement expressing its concern about a “national shortage” of critical medical devices without EtO sterilization, noting: “this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”

AdvaMed President and CEO Scott Whitaker said: “FDA is right to point out the serious consequences to U.S. patients and the health care system should access to EtO be further limited. Make no mistake: without EtO sterilization, there will be a true health care crisis in this country as physicians and surgeons will not have access to critical medical devices. The importance of safe, sterilized medical devices to patient care must be emphasized as we continue to debate the true risk of this crucial sterilization method.”