AdvaMed Comments on FDA Statement on Potential Device Shortages

FDA: “Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage”

WASHINGTON, D.C. – AdvaMed released a statement on FDA’s announcement today that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization plants and the possibility of future plant closures.

The FDA said in its statement: “Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: 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: “We appreciate Commissioner Sharpless for calling attention to the critical role ethylene oxide plays in protecting the health of millions of Americans who depend on sterile devices to keep them safe. It cannot be overstated: Critical medical devices might not make it into doctors’ and surgeons’ hands if we aren’t careful as we have this important conversation about the true risk of these EtO sterilization plants.

“We absolutely understand why those who live around these plants are deeply concerned based on what they’ve heard and read. But leading toxicologists and epidemiologists are certain that media reports have been misleading, and that the communities surrounding these plants are safe. These experts need to be a much bigger part of the conversation within these neighborhoods and with policymakers.”