AAMI News December 2019

FDA to Focus on Lowering Ethylene Oxide Emissions

AAMI Ethylene Oxide Sterilization Training

January 14–17, 2020
Arlington, VA

This training is geared to participants who are experienced in working with an established ethylene oxide sterilization process but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The combination of a classroom lecture with real-life scenarios helps to illustrate concepts and situational analyses.

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The Food and Drug Administration (FDA) recently convened a public advisory committee to comment on the feasibility of potential strategies to reduce or eliminate environmental ethylene oxide (EtO) emissions from industrial medical device sterilization.

The Nov. 6–7 public advisory committee meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee came on the heels of three high-profile EtO sterilization plant shutdowns in the U.S. The loss of capacity led to concerns about shortages of sterilized devices and highlighted the challenges of managing EtO emissions.

The meeting in Gaithersburg, MD, brought together government officials as well as experts in industry, healthcare, materials science, and public health advocacy. Topics included the potential medical device shortages that could result from sterilization plant closures, the impacts of regulatory changes or limited availability of EtO on industry and healthcare delivery organizations, alternative methods for medical device sterilization, and the public health impact of long-term exposure to high levels of EtO in the environment.

After two days of discussion, it became clear that there is no one type of product or procedure that will take the place of EtO sterilization, and that the FDA’s focus should be on finding better, safer ways to use EtO.

“It’s important that we work together to address this challenge to not only to limit emissions of EtO in the air, but to also ensure the safety of medical devices and equipment,” said Mike Koerber, deputy director of the Environmental Protection Agency (EPA) Office of Air Quality Planning and Standards, who announced plans to move forward on a suite of actions to address EtO emissions.

EtO stakeholders are challenged by two competing priorities: If EtO emissions from sterilization facilities are not kept in check,
elevated and long-term exposure to the gas in ambient air and water can lead to higher rates of cancer; however, if EtO sterilization is limited by tougher regulations or by further plant closures, it is very likely the U.S. will experience a country-wide shortage of clean and safe medical devices.

Most stakeholders recommended FDA work to reducing EtO emissions

Several stakeholders shared the opinion that the FDA should develop strategies to reduce EtO emissions, not replace EtO sterilization methods altogether.

Phil Cogdill, director of quality sterilization and microbiology at Medtronic, provided the FDA panel with an industry viewpoint of sterility assurance and optimizing EtO sterilization. During his presentation, Cogdill pointed out that EtO is used to sterilize about half of all medical devices worldwide, and that of the medical devices that recommend EtO sterilization, only 2% have validated an alternative method for sterilization. Rather than look at different sterilization modalities, Cogdill, immediate past chair of the AAMI Board of Directors and past cochair of the AAMI Industrial Ethylene Oxide Sterilization Working Group, recommended that industry with the FDA and EPA find ways to reduce the amount of EtO gas used during sterilization while maintaining the safety and efficacy of medical devices.

For example, Cogdill suggested device manufacturers use materials that can be sterilized by modalities other than EtO and reduce paper packaging, which would lower the amount of EtO needed for sterilization and the amount of residual EtO absorbed by paper. He also urged industry to consider moving from a conservative EtO sterilization approach to an optimized cycles (biological indicator/bioburden) approach.

“Changes to the sterilization process are difficult to make and take time to implement responsibly,” said Cogdill. “This includes time for validation and testing over the lifetime of each device. This is even more complex for nontraditional methods of sterilization for which there are no nationally recognized standards.”

Mark Leahy, from the Medical Device Manufacturers Association, said that, according to a survey of member companies, the loss of a primary sterilization facility would likely cause device shortages. He encouraged the validation of “new methods of using less EtO to sterilize devices effectively while working in parallel to investigate alternatives to EtO sterilization for the long term.”

Providing a healthcare delivery organization’s perspective was Kara Mascitti, a physician from St. Luke’s University Health Network.

“I urge the FDA to work collaboratively with all stakeholders to develop a coordinated, cohesive, and systematic approach to addressing the concerns with EtO while carefully considering the unintended negative consequences that sterilization facility closures would have on patient care,” Mascitti said. “We can change, and perhaps should change, the status quo, but we must be thoughtful in how we make that change.”

Participants also discussed potential alternatives to EtO sterilization. However, during panel deliberation, advisory committee voting chair Frank Lewis, executive director emeritus of the American Board of Surgery, said these alternative sterilization methods are subject to “significant technical restrictions either in terms of the materials they are compatible with or the infrastructure to utilize them will take several more years.”

In the end, the panel recommended the FDA not move to replace EtO in the short term, but to work with state governments to reduce the possibility of sterile medical device shortages and find new ways to use less EtO, and to use it more responsibly.

Reducing Risk of Infections from Reprocessed Duodenoscopes

On the second day of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee meeting, an open public hearing discussed reducing the risk of infections from improperly reprocessed duodenoscopes.

According to Shani Haugen, a microbiologist in the Center for Devices and Radiological Health at the  Food and Drug Administration (FDA), human factors data from an FDA postmarket surveillance study showed that reprocessing instructions should be strengthened. Too often, such instructions are difficult for reprocessing staff to comprehend and follow.

Following presentations from several stakeholders, the panel decided to recommend continued incremental improvements to boost the safety of reprocessed duodenoscopes over more substantial changes to duodenoscope design and reprocessing methods.