FDA prepares for possible device shortages after gas leaks lead to closure of sterilization plant

The FDA is working to prevent potential shortages of medical devices after the closure of an Illinois sterilization plant, which was due to a state environmental protection order.

In mid-February, the Illinois Environmental Protection Agency halted operations at the large Willowbrook facility, run by the contract sterilizer Sterigenics, after officials found unacceptably high levels of ethylene oxide gas in the air surrounding the premises.

Ethylene oxide is commonly used to sterilize many medical devices—about half of all of them, in fact, ranging from wound dressings to stents to surgery kits used in routine hospital procedures, according to the FDA—and it's especially useful in sterilizing components made of different materials, or that can’t be cleaned by steam.

The flammable, colorless gas is also used to help manufacture antifreeze, textiles, plastics, detergents and adhesives. Long-term exposure to higher levels can cause irritation, harm the central nervous system and increase the risk of certain types of cancers, according to the federal Environmental Protection Agency.

But effective sterilization and the prevention of infections is critical to the nation’s healthcare system, FDA Commissioner Scott Gottlieb said in an agency statement. "However, the FDA recognizes the environmental considerations that are currently impacting manufacturers’ ability to use this process," he said.

In response, the agency has been looking to secure alternative locations for the devices processed at the Willowbrook facility, and it is working directly with manufacturers to help them transition their products to another site or another method.

According to the FDA, Sterigenics listed 594 different types of devices that were sterilized with ethylene oxide gas at the plant, including sutures, clamps, knives, stents and needles, but the agency isn’t aware of any related device shortages at this time.

"There’s a risk that for some sterile packaged products that are already in distribution, existing supply may be diminished—or even depleted—as healthcare facilities use their inventory before alternative arrangements can be made accommodate the sterilization of new products coming off manufacturing lines," Gottlieb said. "This could lead to temporary or ‘spot’ shortages of some products until sterilization can be restored."

The FDA also noted that a separate facility—an ethylene oxide sterilization plant maintained by Viant in Grand Rapids, Michigan—is scheduled (PDF) to close later this year, following air quality issues raised by the Michigan Department of Environmental Quality. The Viant facility processes 46 types of devices, including catheters and surgical mesh.

The FDA is urging affected medical device manufacturers to begin assessing any potential downstream impacts of the closures on device distribution through their supply chain. The agency is also considering making devices available from other sources to avoid any interruptions.

In addition, the FDA has launched new efforts to encourage companies to develop new and improved sterilization technologies, and it's working with stakeholders to validate methods using lower levels of agents like ethylene oxide to reduce environmental exposure risks.

The agency plans to hold a public innovation challenge later this year, which could include new devices or modalities for sterilizing devices, and will host an advisory committee meeting on the topic. The FDA also launched a new webpage consolidating its information on ethylene oxide use.