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October 2, 2019

FDA seeks innovative ideas for medical device sterilization

FDA is currently running an innovation challenge to identify new sterilization methods and technologies that do not rely on ethylene oxide.

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The AGA Center for GI Innovation and Technology wants to make members aware of a new FDA public innovation challenge seeking to identify new sterilization methods and technologies that do not rely on ethylene oxide.

 

Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. However, there are concerns after the Illinois Environmental Protection Agency (EPA) issued an order in March 2019 to stop one of the largest sterilization facilities in the country due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility.

 

This public challenge provides an opportunity to identify new solutions that do not rely on ethylene oxide to ensure continued access to medical devices that are safely and effectively sterilized.

 

The deadline to submit an idea is Oct. 15, 2019. Winners will be announced in December 2019. More information is available on the FDA website.

 

 

Have an idea to submit? Share your submission plans with CGIT@gastro.org. We’ll consider your innovative idea for presentation at the 2020 AGA Tech Summit, June 3-6, in San Francisco.

 

 

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