FDA: Effective Sterilization in Manufacturing Needed to Prevent Shortages

Recent article cites major cause of issue

A recent article published on the Food and Drug Administration’s website stressed the need for manufacturers to ensure proper and safe sterilization of certain devices during the manufacturing process in order to avoid future shortages.

The article, written by Suzanne B. Schwartz, MD, MBA, Deputy Director of the Office of Strategic Partnerships and Technology Innovation and Acting Office Director, Center for Devices and Radiological Health (CDRH), and CAPT Elizabeth F. Claverie-Williams, MS, Microbiologist and Branch Chief, Infection Control Devices Branch, CDRH, reminds readers of the importance of utilizing ethylene oxide for sterilization before delivering the device to facilities. 

“Effective sterilization processes are critical to ensuring device safety, and manufacturers depend on this process,” the authors wrote. “And frequently there are no readily available processes today that can serve as alternatives to those that use ethylene oxide.”

The article also discusses concerns with the ethylene oxide sterilization process, and the actions taken by the FDA to improve this process. These include a current period of idea gathering from stakeholders, academics, and others in the industry that will run until October 15.


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