Ethylene oxide (EtO) gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads of devices at one time. [Photo courtesy of the FDA]
The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities.The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.
Those innovation challenges are making “encouraging progress,” FDA said, with some facilities cutting EtO emissions by an estimated 20% to 35%.
“In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range,” the FDA said in a news…