FDA concerned about potential device shortages due to new EtO limits

Corrected on 21 May 2024*

Rural and vulnerable populations could be placed at risk as the US Environmental Protection Agency (EPA) imposes new limits on the use of ethylene oxide (EtO) for medical device sterilization, Ryan Ortega, regulatory policy advisor for the Office of Product Evaluation and Quality for the Center for Device and Radiological Health (CDRH), said on 17 May at a meeting sponsored by the Food and Drug Law Institute (FDLI).
 
Ortega also discussed some of the ways the US Food and Drug Administration (FDA) is working with manufacturers to explore alternative sterilization methods as well as some of the current challenges in choosing sterilization methods.
 
Ortega discussed the 2019 Illinois state EPA seal order which resulted in the closure of the Sterigenics facility in Willowbrook, IL, due to air quality issues and its high level of EtO emissions. The closure resulted in the temporary shortage of tracheostomy tubes, which had a significant impact on the neonatal population, Ortega added.
 
EPA issued a final rule on EtO emissions in March 2024 (RELATED: EPA finalizes rule to reduce EtO emissions from sterilization facilities, Regulatory Focus, 12 March 2024).
 
Ortega said that CDRH launched an innovation challenge in 2019 to help industry develop alternatives to EtO sterilization; the agency also convened an advisory committee meeting the same year to consider alternatives.
 
In May 2023, FDA launched the Radiation Pilot Program to allow companies that terminally sterilize single-use medical devices using gamma radiation or EtO to submit Master Files when making certain changes to sterilization sites, methods, or processes. In 2022, FDA launched the 510(k) EtO Sterility Change Master File Pilot.
 
More recently, FDA announced the formation of a “Tiger Team” comprised of CDRH lawyers and subject matter experts, as well as public health officials, to collaborate on solutions and mitigate the risk of shortages in the sterile supply chain.
 
Under its 510(k) modifications guidance, some changes in sterilization method may not require a new 510(k), such as changing from one established category A sterilization method to another. The 510(k) EtO Sterility Change Master File Pilot also enables device makers, under certain conditions, to change sterilization methods from EtO to a category B or novel method included in the master file pilot. For PMAs, manufacturers will still have to file a supplement if they choose a different sterilization method.
 
Ortega said that he is worried about the risk of a potential shortage of devices that are sterilized with EtO. “What if a major contract sterilizer – a big facility – what if they decide that the juice is not worth the squeeze anymore and they sunset their operations? There is a finite amount of sterilization capacity” at other facilities, he said.
 
He added that there are ways to increase the capacity of the existing facilities, but these changes are “incredibly complex and do not happen immediately.”
 
Ortega was asked to address some of the device-specific challenges with changing sterilization methods.
 
He responded that choosing a sterilization method is not as simple as it used to be. Ortega said that “things like material biocompatibility are not always straightforward. As a matter of fact, it can be very complex. The days of the device being made with one or two materials, a stainless-steel scalpel or a single polycarbonate arm brace, those days are pretty far behind us. Even today devices have multiple material types.” That complexity means that choosing a sterilization method is no longer so simple.
 
Traditionally, the choice of sterilization method was viewed as an “afterthought,” Ortega said, adding that manufacturers now should consider these issues in device development.
 
FDLI meeting

*A previous version of this story incorrectly stated certain facts pertaining to the Sterigenics facility seal order, the agency's 510(k) policies, and the 510(k) EtO Sterility Change Master File Pilot Program. Regulatory Focus regrets these errors.