ACCESS PACK EXPO XPRESS ONLINE TODAY
ACCESS PACK EXPO XPRESS ONLINE TODAY. Content is available on-demand through November 30th.
LEARN MORE

Counting Down the Top 10 Articles of 2019 - #6: FDA Comments on ETO Interruptions

We’re taking a look at the most-read Healthcare Packaging stories of 2019. At #6 is this article regarding FDA comments on potential device shortages in the wake of ETO sterilization, and potential next steps.

Hp 115086 Fda Stock Image 3

In our top 10 of 2019, we examine how the interruptions and closures of ETO sterilization facilities may impact medical device availability (article here). The FDA comments included some advice to device manufacturers—and a request that facilities don’t hoard devices—and highlighted the need for future innovation in sterilization techniques.


Acting FDA Commissioner Ned Sharpless MD issued an Oct. 25 statement on potential medical device supply chain effects due to interruptions in ethylene oxide (ETO) sterilization services.

“The recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia could affect the availability of some sterile medical devices used by health care delivery organizations and patients,” said Sharpless.

Many medical devices are sterilized with ETO, including those used for emergency and routine procedures. Unfortunately, at present, no “readily available processes or facilities” serve as an alternative to ETO sterilization…

Continue to the full article here

 

Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Take Quiz
Test Your Supply Chain Smarts
Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Unlock Learning Here
Discover Our Content Hub