FDA Encourages Vaporized Hydrogen Peroxide for Medical Device Sterilization, Amid Ethylene Oxide Safety Concerns

A leak from a Sterigenics plant in Illinois resulted in a $400 million ethylene oxide exposure lawsuit settlement agreement last year for nearby residents, due to serious health risks

Federal regulators are calling for more widespread use of vaporized hydrogen peroxide to sterilize medical devices, amid growing concerns about the health and environmental risks of ethylene oxide, which has been linked to a number of high-profile leaks in recent years.

On January 8, the U.S. Food and Drug Administration (FDA) issued updated guidance, announcing that the agency is recategorizing vaporized hydrogen peroxide as an “established method of sterilization” for medical devices.

Medical devices marketed in the U.S. that require sterilization must contain directions on how to properly and safely sterilize them. The process must be approved by the FDA for the manufacturer to include the method in the sterilization directions.

Ethylene Oxide Risks

Ethylene oxide is the most common method of sterilization used in the United States. There are approximately 20 billion devices sold in the U.S every year that are required to be sterilized with ethylene oxide. That accounts for roughly 50% of the market share of medical devices that must be properly sterilized.

However, a series of large ethylene oxide leaks, and concerns about the medical device manufacturing industry’s reliance on the chemical, has raised concerns, leading the FDA to begin looking into and approving alternatives.

Massive ethylene oxide leaks from Sterigenics manufacturing facilities in Illinois resulted in a $408 million settlement last year for residents in surrounding communities. Two Baltimore-area spice plants were also at the center of controversy following ethylene oxide leaks in 2023. Research indicates the ethylene oxide leaks lead to higher cancer risks for residents in neighboring communities.

As a result, the FDA proposed new ethylene oxide standards intended to limit the risk of health side effects to communities and the environment.

Vaporized Hydrogen Peroxide

Vaporized hydrogen peroxide was initially categorized as an Established Category B method of sterilization, meaning the FDA evaluated the data on the method but could not come to a consensus for its standard use.

Following the numerous ethylene oxide leaks and health risks to residents, the FDA moved to revise the final guidance for sterilizing standards. The agency now recognizes vaporized hydrogen peroxide as an Established Category A method of sterilization.

This move is part of the FDA’s effort to reduce the use of ethylene oxide and improve the medical supply chain overall. It comes in addition to other efforts by the agency, including programs to support changes to sterilization techniques, encouraging the research of new sterilization strategies to reduce ethylene oxide emissions, and developing new sterilization methods.

Methods of sterilization currently approved by the FDA include moist heat, dry heat, ethylene oxide, radiation, and now vaporized hydrogen peroxide.

“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health. “Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages.”