A recent push from the Food and Drug Administration to find alternatives to ethylene oxide, a gas used to sterilize about 50% of the nation’s medical devices, is challenged by the lack of substitutes and the industry’s huge reliance on the gas.
The FDA has asked the industry to bring forward new processes that can effectively sterilize medical devices amid renewed concerns that ethylene oxide is harmful to workers and surrounding communities, after an Illinois sterilization facility run by Sterigenics closed.
The Illinois Environmental Protection Agency forced the plant to stop operations in February when it was prohibited from using ethylene oxide after high emissions of the gas were found. While effective at cleaning medical devices, it’s considered a human carcinogen and has been tied to some instances of cancer.
Sterigenics declined to comment.
The FDA said the proposed methods must be able to do all that ethylene oxide can do. Therefore the agency asked for submissions of sterilizing agents compatible with lots of different packing materials and fabrics as well as able to sterilize large volumes of devices.
Ethylene oxide is a low-temperature gas so it’s able to sterilize wound dressings and gowns as well as plastics and complex devices like pacemakers without causing damage to the products. It can also sterilize in bulk.
The deadline to submit alternatives to the FDA closes Oct. 15 and a review period runs until Nov. 16.
In light of FDA’s scrutiny, devicemakers are exploring alternatives to ethylene oxide, said Greg Crist, spokesman for AdvaMed, which represents the medical technology industry. Manufacturers recognize that the gas is harmful to people, but it’s difficult to find another method that is as effective. For instance, hydrogen peroxide is commonly mentioned as an alternative because it’s a very good germ killer. The problem is it hasn’t been used before to sterilize large fleets of devices, said Chris Lavanchy, engineering director of the health services group at the ECRI Institute, a not-for-profit focused on the safety of medical technologies and practices. Crist also said hydrogen peroxide can’t penetrate some materials.
The hospital industry supports finding alternatives to ethylene oxide but emphasizes how much it relies on the gas right now. The closure of the Sterigenics plant in Illinois briefly led to shortages in breathing tubes.
“We can’t just stop using it,” said Nancy Foster, vice president of quality and patient safety at the American Hospital Association. Until sufficient alternatives are available, Foster said devicemakers must do all they can to ensure they’re using the gas safely.
Devicemakers are examining how to reduce the amount of ethylene oxide currently in use, Crist said. There may be opportunities to lower emissions by using materials that are less difficult to penetrate. Right now, ethylene oxide sterilizes devices in cardboard, which requires a lot of the gas, he said.
The FDA is also interested in ways to slash emissions. Along with its inquiry for alternatives to the gas, it’s also seeking methods “to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.”
