The temporary closure of an Atlanta contract sterilization facility could potentially impact the medical device supply chain, FDA warned Friday.
The Sterigenics facility, which closed earlier this month, is implementing technology upgrades aimed at reducing ethylene oxide emissions. Sterigenics said it aims to complete construction by the first week of October.
In August, the EPD implemented an air quality monitoring program to measure EtO levels near sterilization facilities in suburban Atlanta. The agency expects to receive the results from the laboratory conducting the testing in early November.
The notice from FDA that it's actively working to determine if there will be medical device shortages echoes language the agency used in March after the closure of Sterigenics’ facility in Willowbrook, Illinois.
"The FDA is actively working with Sterigenics and its customers to determine if there will be any medical device shortages as a result of the Atlanta facility closure," FDA said in a statement Friday. "The FDA also reminds device manufacturers to reach out to the FDA if they are impacted by the temporary closure of the Sterigenics Atlanta contract sterilization facility and anticipate delays in distribution of devices to their customers as a result."
The closure of the Willowbrook plant resulted in tens of millions in lost revenue for major medical device companies like Medtronic and Boston Scientific.
Sterigenics said in a statement construction is expected to be completed in October, ahead of its initial estimates. The company is "working with customers to minimize the impact on the supply of vital sterile medical products to hospitals."
"We have determined that suspending sterilization operations, and the use of EO in those operations, throughout the duration of the work will enable us to further accelerate the installation of these enhancements and that doing so is the most efficient path to meeting the requests of all stakeholders," the company said.
EtO, a carcinogenic gas used to sterilize more than half of medical devices, has fallen under the scrutiny of community advocates across the country who argue sterilization facilities have not adequately controlled emissions, exposing local residents to levels of gas in excess of what the Environmental Protection Agency says is safe. Sterigenics and other commercial sterilizers are currently facing dozens of lawsuits that claim emissions from sterilization plants resulted in people living nearby developing cancer.
AdvaMed has tackled the threat to the device industry by ramping up lobbying on the issue, recently meeting with the White House to warn regulations on EtO under development at EPA could result in device shortages if the agency effectively bans use of the chemical.
In July, FDA launched dual innovation challenges aimed at the creation of alternative sterilization methods and the reduction of EtO emissions. The agency also scheduled a November two-day advisory committee meeting to discuss EtO sterilization of medical devices.
Clarification: This article has been updated to more accurately reflect the circumstances of the Sterigenics plant closure.