Mar 15, 2024 - Health

New curbs on medical device sterilizer ease fears of shortages

Illustration of a hand with scissor cutting emissions from a smoke stack

Illustration: Sarah Grillo/Axios

New federal restrictions on a cancer-causing chemical that's essential for sterilizing medical devices may have balanced out long-running concerns about protecting public health without choking the medical supply chain.

  • But the tradeoffs won't entirely go away until scientists can create a reliable alternative to ethylene oxide, the odorless gas that's been the subject of numerous civil claims and lawsuits.

Why it matters: EtO, as it's known, is one of the most effective tools for sterilizing medical devices that are moisture- or heat-sensitive and can't be decontaminated by steam sterilization. It's used on about half of the medical devices in the U.S.

Driving the news: A final rule released Thursday brought measured praise from health care organizations for the way they would cut the amount of EtO coming from commercial sterilizers by an estimated 90% while extending compliance timelines compared with the proposed standards.

  • The standards reflect FDA suggestions and should protect medical supply chains, agency spokesperson Audra Harrison said.
  • But the FDA will be "closely monitoring the medical device supply chains" to make sure access isn't compromised, and it encourages manufacturers to sound the alarm if there are disruptions, she added.

The agency in January updated guidance to device makers and listed vaporized hydrogen peroxide as an alternate sterilization method.

  • "As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health," said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health.
  • Alternatives would not only address concerns about environmental health but ease dependence on chemical plants in Texas that produce a lot of the EtO supply and have been vulnerable to weather-related disruptions.

Catch up quick: EPA proposed the emissions standards last April following years of litigation around the risk EtO poses to people living near sterilization facilities.

  • The final standards will give certain sterilizers up to four years to come into compliance with the new standards, as opposed to the originally proposed 18 months. The final rule also reversed a plan to require sterilizers to obtain specific operating permits.
  • Sterilizers will still have to monitor their emissions and submit reports to regulators.

What they're saying: Medical device companies are still reviewing the rule, but it seems "like we're heading in the right direction," said Scott Whitaker, CEO of the trade group AdvaMed.

  • "I'll give the EPA a lot of credit," Whitaker said. "They rolled out an initial draft rule that would have been problematic in a massive way. But they were willing to sit down and listen to all parties as we kind of worked through this."
  • Premier, which runs a group purchasing organization for health systems, believes the final standards are a good compromise between health concerns and supply chain realities, said senior vice president Soumi Saha.

Environmental groups also applauded the final standards, though some said the rule falls short by extending the compliance timeline and removing a requirement that sterilizers receive extra permits.

  • "Today's announcement is a critical step toward rectifying the injustices faced by those who have been most impacted by EtO pollution," Sierra Club senior attorney Zachary Fabish said in a statement.

What we're watching: How quickly scientists can create and scale additional options for keeping medical devices sterile.

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