Ethylene oxide regulation: when environmental regulation and the medical device supply chain clash

In the U.S., the availability of medical devices may soon be clashing with environmental protection efforts.

Ethylene oxide (EtO) is a colorless and typically odorless gas. In manufacturing, it is used to sterilize medical devices. 

However, proximity to these sterilization facilities has also been associated with an increase in lifetime cancer risk. When people breathe in this gas over the course of many years, without even knowing it, they are likely increasing their risk of developing blood and breast cancers.

Image: Unsplash
Image: Unsplash

As a result of these findings, the U.S. Environmental Protection Agency (EPA) has prioritized addressing EtO emissions’ impacts on public health over the past few years.

However, as EtO sterilization facilities face closures as a result of the agency’s newest proposed regulation, the medical device industry is warning against the potential negative impacts on the supply chain — and eventually on patient care.

How might the medical device industry be impacted by EtO regulation?

This past summer, the EPA published a list of EtO emission offenders, which included 23 commercial sterilization facilities run by big medtech players like Becton Dickinson, Edwards Lifesciences, and Medtronic. The sites included on this list were classified by the agency as ones that pose a risk to nearby communities due to their high EtO emissions.

Medical device trade association, the Advanced medical Technology Association (AdvaMed), swiftly responded to this publication in August. AdvaMed President and CEO Scott Whitaker put out a statement cautioning that shutting down these facilities could disrupt the medical device supply chain.

This is because, for many devices, EtO is currently the only known safe and effective sterilization method currently available. Approximately half of all medical devices in the U.S. are treated with EtO annually.

So, as the EPA acts to reduce EtO emissions, the U.S. Food and Drug Administration (FDA) has been looking to identify alternative sterilization methods.

Now, the EPA has completed its review of existing EtO emissions standards and submitted its proposed regulation to the Office of Management and Budget for review. 

Again, AdvaMed has responded, this time in a public letter to the White House. In it, Whitaker praises the action to update EtO emissions standards, noting the fact that the last agency update of sterilization facility emissions standards was in 2006.

However, once again, the trade association asked President Biden to to consider potential disruptions to medical device production when evaluating the regulation. 

“With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage of facilities could harm patient access to health care,” Whitaker wrote. “EtO sterilization is at capacity. With 80 percent of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-operative care.”

Whitaker also made specific reference how a previous closure of an Illinois facility amid environmental concerns led Smiths Medical to experience a temporary shortage of tracheostamy tubes.

Can innovation help address this problem?

Long-term readers of MedTech Pulse will not be surprised to learn that medical device shortages are a big concern of ours in the industry. Just take a look at our recent feature on the European MDR process.

Like Whitaker, we share appreciation for the long-overdue update in EtO emissions standards. With cancer risk significantly elvated due to an exposure to this chemical in the air, it is common sense for government agencies to step in and protect public health.

However, we also share concern about disruptions to the medical device supply chain if regulation is enforced without guardrails. 

Our hope is that the FDA’s prioritization of unearthing new sterilization protocols for the impacted medical devices bears fruit.

We also encourage our industry to take up this torch. Given the dual public health concerns of decreasing cancer risk and preventing potential medical device shortages, we believe the development of more environmentally-friendly sterilization methods is a potent area for research and innovation.

We are reminded of the recent announcement of University of Michigan researchers developing a new PVC recycling method — which may help make medical device manufacturing more sustainable in the future. Our hope is that, while we pursue a minimally-disruptive pathway to curbing EtO emissions, such research brings us closer to a healthier future for the medtech industry.

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