Federal regulators, medical device manufacturers, and sterilization companies are working on urgent measures to reduce the amount of ethylene oxide used in medical device sterilization processes without causing further shortages of sterile medical supplies.
If you live anywhere near a medical device sterilization plant, you likely know by now about ethylene oxide, the chemical gas commonly used to sterilize pre-packaged medical supplies. In 2016, the U.S. Environmental Protection Agency (EPA) wrapped up an exhaustive 10-year study of ethylene oxide’s effects on human health. Researchers found the gas is 30 times more likely to cause certain cancers than scientists previously thought.
The EPA notified state regulators about the risks. In 2018, the agency issued the results of its National Air Toxins Assessment (NATA) study, an evaluation of the health risks posed by airborne releases of toxins. The report flagged 109 census areas throughout the U.S. where residents are living under an elevated threat of cancer and other health problems posed by airborne toxins. Researchers found most of the risks were driven by just one chemical: ethylene oxide.
State regulators failed to share this information with the affected populations. It wasn’t until media outlets such as The Intercept, Georgia Health News, and Web MD reported on the ethylene oxide hazards that communities became informed.
The public outcry forced ethylene oxide producers and major sterilization companies to suspend operations, enhance safety controls, or shut down altogether, triggering a shortage of everything from pacemakers to vascular stents to wound-care dressings.
These shortages have pushed the U.S. to the “cusp of a major medical logistical failure,” one physician told MedTechDive, and they’re the reason for the federal government’s regulatory action.
In a statement, the U.S. Food and Drug Administration (FDA) said it is taking measures to address the over-reliance on ethylene oxide in single-use medical device sterilization processes and other commercial operations. At the same time, the agency is “advancing innovation in medical device sterilization techniques to reduce reliance on ethylene oxide.”
One of these steps involves accelerating both the development and review of new sterilization techniques, including “expediting approvals of certain changes that medical device manufacturers make to ethylene oxide sterilization methods, processes and facilities,” the FDA said.
The agency said it also chose 12 participants to work directly with the FDA in “Innovation Challenges” that would accelerate the development and review of sterilization technology innovations and reduce ethylene oxide emissions to as close to zero as possible.
FDA regulators are also meeting with company officials to reduce the amount of paper and packaging used in sterilized device packaging. To become sterilized, single-use medical devices must be sealed in carefully designed gas-permeable packages. The packaged devices are then locked in a chamber where ethylene oxide gas enters the packaging.
Medical devices sealed with a large amount of paper and packaging increase the sterilization chamber load, thereby requiring the use of more ethylene oxide.
“The FDA will continue in our steadfast commitment to develop solutions to avoid potential device shortages and encourage new, innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health,” the agency said.