FDA of device shortages because of sterilization facility closures

Editor's Note

The Food and Drug Administration (FDA) on October 25 released a statement warning of possible device shortages because of interruptions in ethylene oxide (EO) sterilization services due to facility closures in Illinois and Georgia.

In the statement, the acting FDA Commissioner, Ned Sharpless, noted that “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.”

EO is used to sterilize about 50% of more than 20 billion sterile devices sold in the US each year.

The FDA is holding a public advisory committee meeting November 6-7, 2019, to discuss how best to encourage innovation in medical device sterilization.

The FDA is also continuing to collaborate with the Environmental Protection Agency to enforce clean air regulations and ensure that facilities protect the public from the risks associated with EO.