August 02, 2023
🏖 Hope you're enjoying your time away from Capitol Hill! We have some light summer reading for you on medical device sterilization rules.
- Keep scrolling for a bonus scoop from Peter!
- We'll be back next week, or earlier if there's something you need to know.
1 big thing: A chemical of concern
Photo illustration: Aïda Amer/Axios. Photo: Taylor Glascock/Bloomberg via Getty Images
Ethylene oxide — a substance used for sterilizing medical devices — is at the center of a dogfight over protecting public health while also preserving a supply chain, Maya and Axios Pro Energy's Jael Holzman write.
Why it matters: A chemical helping to keep Americans alive may also be making people sick, creating a situation that's sent lawmakers scrambling and pitted federal officials against the industries they regulate.
Driving the news: The EPA in April proposed new commercial standards for ethylene oxide, or EtO, including new emissions restrictions for sterilization facilities and chemical plants.
- EPA's moves are based on risk assessments, including a 2016 report finding with "high" confidence that ethylene oxide is "carcinogenic to humans."
- Like PFAS, this odorless gas has become the subject of many civil claims and was at the center of a Trump-era dust-up over alleged suppression of science.
Between the lines: Stakeholders are facing an uncomfortable truth: This chemical's pretty hard to get rid of right now.
- EtO has numerous uses, but crucially helps sterilize half of all medical devices in the U.S. each year, according to an FDA spokesperson.
- AdvaMed, a medical device lobbying group, and other industry outfits say EPA's proposals would cause "critical shortages" of medical devices.
Threat level: Chemicals trade representatives in D.C. have aimed at EPA's science and a chemicals program known as IRIS, as well as broadcasting EtO's myriad uses, including in EV batteries.
- The American Chemistry Council is involved in an ongoing legal challenge to a 2020 rule to reduce EtO emissions that questions the viability of the 2016 risk assessment's findings.
Yes, but: Darya Minovi, a senior analyst at the Union of Concerned Scientists, is optimistic that FDA can find alternative sterilization methods.
- "We should value the health of the people who live near these facilities a little bit more than our system has," Minovi told Jael.
- An FDA spokesperson, meanwhile, says that "while signs of innovation are promising, other methods of sterilization cannot currently replace the use of EtO for many devices."
The intrigue: The EtO fight has sparked visceral reactions from allies and foes in Congress.
- The fight against EtO has been led primarily by lawmakers from Illinois, home to a high-profile EtO exposure site.
- Rep. Brad Schneider created a bipartisan EtO task force in 2019 with former Rep. Jody Hice and recently wrote in support of EPA's proposed regulations with Sens. Tammy Duckworth and Dick Durbin.
- "This is not a binary choice between making sure we have medical devices, medical products and clean air. We're able to do both," Schneider told Axios.
What we're watching: House appropriators included language in the Interior-Environment bill that would restrict EPA from using funds to create new standards for EtO emissions until FDA certifies that the action won't cause a medical device shortage.
2. When health crises collide
Photo illustration: Aïda Amer/Axios. Photo: Mark Black/Chicago Tribune/Tribune News Service via Getty Images
Medical device makers and health care providers want to move away from using ethylene oxide to sterilize devices — but they say it's not that simple, Maya writes.
Why it matters: Because eliminating EtO is expected to take so long, federal regulators must weigh the risks and benefits of using EtO at its current scale.
Where it stands: In April, FDA announced a radiation sterilization pilot program to help companies find better ways to sterilize medical devices.
- FDA has launched other initiatives to reduce EtO reliance, including one program that has allowed some facilities to cut emissions as much as 35%, the agency said.
- But no alternatives can sterilize devices at the scale of EtO at this point, according to the agency.
The process of finding new sterilization methods shouldn't be rushed, said AdvaMed CEO Scott Whitaker.
- "We're better off taking our time and getting the science right rather than rushing to something," Whitaker told Maya.
- Industry groups feel there's a clear path forward. "EPA's estimated health risks are based on maximum emission levels for hypothetical and unlikely exposure scenarios; permanent and fatal outcomes to actual people can happen in minutes without adequate medical supplies," the Medical Device Manufacturers Association wrote in a comment letter to EPA.
The other side: Consumer and environmental advocates say industry should've expected EPA's regulations, and the rules provide more than enough time to come into compliance with new standards.
- Illinois passed a law in 2019 requiring sterilization facilities to significantly reduce EtO emissions. Facilities that fail emissions tests must close and get state approval before reopening.
- The state "has demonstrated that there are steps companies can take to make sure to continue operating and make sure that the air their employees and their neighbors are breathing is safe," Rep. Brad Schneider told Maya.
- Illinois temporarily shut down a sterilization facility in 2019 over EtO emissions concerns, resulting in the shortage of a particular breathing tube for children. But that's after FDA had warned that 594 types of medical equipment could be in short supply because of the shutdown.
The bottom line: EtO regulation highlights the importance — and difficulty — of solving one public health issue without creating another one.
- "You have to take what you've got now, think about how to make it safer as is, and think about what alternative might be developed that would be even safer beyond that," said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association.
3. Scoop: Watch for House health action in September
Illustration: Brendan Lynch/Axios
House GOP leadership wants three committees to work out their differences on health care legislation over the August recess so that a bill could potentially come to the floor in September, sources tell Peter.
Why it matters: The move could advance significant health care legislation aimed at at least somewhat lowering costs for drugs and medical visits, while drawing the ire of the PBM and hospital industries.
Driving the news: Energy and Commerce, Ways and Means and Education and Workforce have all marked up their own versions of legislation on price transparency, PBMs and hospital billing.
- The goal now is to merge those measures.
- The E&C and Education and Workforce measures were bipartisan, while the Ways and Means bill was GOP-only.
Caitlin Owens contributed to this report.
Thank you for reading Axios Pro Policy, and thanks to editors Chuck McCutcheon and Adriel Bettelheim and copy editor Brad Bonhall.
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