Dive Brief:
- FDA announced Tuesday it plans to hold an advisory committee meeting Nov. 6-7 to discuss ethylene oxide sterilization of medical devices and the risks associated with infections stemming from reprocessed duodenoscopes.
- The dual-topic expert panel will be tasked with discussing how to reduce ethylene oxide emissions from the medical device sterilization process without putting device sterility at risk. It will also tackle recommendations on how to reduce the risk of infection from reprocessed duodenoscopes, coming shortly after FDA told providers and manufacturers to transition to products with disposable parts.
- The medical device industry has been actively lobbying Congress and the White House, warning limiting access to ethylene oxide, used to sterilize more than half of medical devices, could potentially cause device shortages. But numerous lawsuits filed by cancer patients against sterilizers claim the carcinogenic gas has not been adequately controlled, and the Environmental Protection Agency is in the process of developing updated regulations on the chemical.
Dive Insight:
The two-day public meeting will likely garner attention from the Illinois congressional delegations, which have called on FDA to evaluate alternatives to ethylene oxide after the February closure of a major Sterigenics sterilizing plant in a Chicago suburb.
The advisory panel appears to be timed to evaluate submissions to FDA's two innovation challenges launched in July. Those challenges aim to incentivize the creation of alternative sterilization methods and ways to reduce ethylene oxide emissions.
FDA said comments submitted to the public docket before Oct. 21 will be provided to the advisory committee. The docket will remain open until Dec. 6.
Background materials for the meeting will be made public at least two business days before the advisory committee panel, according to FDA.
The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee meeting, which FDA says will be livestreamed, will be held at the DoubleTree by Hilton in Gaithersburg, Maryland.
