The FDA said today that it will hold an advisory meeting on November 6 and November 7, 2019, to discuss the role of ethylene oxide (EO) sterilization of medical devices in public health, as well as the risks of the sterilization process.
The general hospital and personal use devices panel of the FDA’s medical devices advisory committee will conduct the meeting to help the agency provide advice and make recommendations on the use of the carcinogenic sterilant gas.
The advisory panel will explore methods to reduce EO emissions from the sterilization process without compromising sterility or medical devices processing. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes, which have been implicated in patient deaths due to contamination.
In February, the Sterigenics Willowbrook, Ill. medical device sterilization plant was shut down after the Illinois Environmental Protection Agency cited excessive emissions. The shutdown affected medtech giants like Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), as well as medium-sized and smaller firms such as Teleflex (NYSE:TFX), Arthrex and ArthroCare.
In July, the FDA issued challenges to find new sterilization approaches, including identifying alternatives to EO and asking for input on reducing EO emissions. Later that month, medical device sterilization plants in two Atlanta suburbs came under scrutiny when they reportedly emitted thousands of pounds of the cancer-causing gas into the air in excess of federal environmental limits.