Last week FDA Commissioner Scott Gottlieb, M.D., issued a statement on how the agency is working to prevent medical device shortages following the closure of the Sterigenics facility.
FDA included a link to the 594 types of medical devices that Sterigenics listed as undergoing EtO sterilization at the Willowbrook plant, and thus those could be impacted by the shutdown.
“…The FDA has been working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility in order to mitigate potential product supply issues. We’re taking steps to prevent patient harm from potential device shortages that could delay or disrupt critical care. At the same time, we’re undertaking new efforts to encourage innovative and improved sterilization options.” – Scott Gottlieb, M.D., FDA
However, the device shortage issue has become a bit more serious with the news that another contract EtO sterilizer, Viant Medical, Inc., will be shutting down its Grand Rapids, MI facility after being hit with several violation notices from the Michigan Department of Environmental Quality (MDEQ). According to a document released by MDEQ, its investigation of Viant found EtO emission levels associated with the facility to be “higher than expected”.
The FDA statement also includes a link to a copy of the letter from Viant Medical about the issue and the fact that the sterilization facility will be shut down “because that work is not part of our core business.”
According to the FDA, 46 types of medical devices (here’s the list of devices) could be affected by the facility shut down.
Gottlieb emphasized that FDA is monitoring shortages that could be related to the facility closings and is working with industry to find new ways to sterilize medical devices. “About half of all sterilized medical devices undergo sterilization using ethylene oxide. In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices,” said Gottlieb.
Read the full statement from Gottlieb.
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