FDA Appears Focused on Ethylene Oxide

Before they can be marketed as “sterile,” many medical devices are sterilized by the device manufacturer or contract sterilizer using ethylene oxide before they are delivered to healthcare facilities.

A new FDA Voices entry titled “Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing” is now available.

The entry is co-written by Suzanne B. Schwartz, M.D., M.B.A., 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, M.S., Microbiologist and Branch Chief, Infection Control Devices Branch, CDRH.

The FDA is particularly aware of issues relating to sterilization during manufacturing – and the potential device shortages that can occur if there are problems during this process. So, the FDA is working to help ensure this process is carried out in a safe and effective manner.

One topic of interest discussed in the piece is ethylene oxide. This is a hot topic of discussion in health care circles. On Monday, the U.S. Food and Drug Administration (FDA) announced two Innovation Challenges to encourage the development of new approaches to device sterilization. The challenge submission period ends October 15. Find out more about the challenges here.

As the FDA Voices entry states “The issue of ethylene oxide emissions and potential medical device shortages is a serious one. As the FDA works with industry and stakeholders, the hope is that challenging them to present effective, efficient, and innovative solutions will help the agency prevent medical device shortages due to sterilization issues in the future.”

The FDA Voices entry is available online at fda.gov.