Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility. The FDA has been closely monitoring the situation and working with device manufacturers affected by the closure to minimize any impact to patients who need access to these medical devices.
Source: Food and Drug Administration - Category: American Health Source Type: news