Dive Brief:

• AdvaMed warned the White House in a meeting August 8  that forthcoming regulations revising emission standards for ethylene production could endanger the medical device supply chain and patient safety if the Environmental Protection Agency effectively bans the use of ethylene oxide. The gas is used to sterilize more than half of medical devices.
• The Office of Management and Budget currently is reviewing a proposed rule on ethylene production, which has been sitting at its regulatory affairs office since July 12. Another proposed rule specifically addressing commercial ethylene oxide sterilizers was scheduled for release in July, but has not yet been received by OMB.
• Greg Crist, who represented AdvaMed at the meeting with administration officials, told MedTech Dive the trade lobby is concerned if new regulations rely on risk values found by EPA's ethylene oxide Integrated Risk Information System (IRIS) evaluation "it poses an imminent public health threat through shortages of medical devices that uses ethylene oxide for sterilization."

Dive Insight:

The meeting with the White House is the latest effort by the medical device industry to lobby the federal government to maintain access to ethylene oxide, a carcinogenic gas that EPA found to be linked to breast cancer, lymphoma and leukemia.

Following the closure of a major Sterigenics ethylene oxide sterilization plant in Willowbrook, Illinois, major medtechs including Boston Scientific, Medtronic and Smiths Medical had sterilization supply chains disrupted, resulting in millions in losses.

Sterigenics since has boosted its lobby spend from $40,000 per quarter in 2017 to $145,000 during the second quarter of 2019 on issues including the EPA IRIS program and ethylene oxide. And AdvaMed spent nearly $1 million lobbying in the second quarter on a number of issues including the use of ethylene oxide to sterilize medical devices.

A senior administration officer declined to detail a timeline for release of the pending proposed rule, telling MedTech Dive that historically, OMB does not comment on regulations under review.

In an interview, Crist, AdvaMed's executive vice president of public affairs, appeared to echo language from Sterigenics lobbying material spread on Capitol Hill earlier this year that called into question the IRIS report by raising concern over the naturally occurring concentration of ethylene oxide in ambient air monitoring.

"Whether a contract sterilizer is present or not, what ethylene oxide exist in the climate or in the atmosphere, what exists endogenously?" Crist said. "The second argument we made was on the limits of detection at those [IRIS] levels, does that technology at those levels exist?"

But public advocates and activists have called attention to emissions measurements around the Willowbrook facility after it closed as evidence that sterilization plants have a measurable affect on the communities they reside in.

Genna Reed, lead science and policy analyst at the Union of Concerned Scientists, wrote to EPA that emissions fell by 90% after the Illinois EPA forced it to close, "illustrating the direct relationship between the facility’s operations and ethylene oxide levels."  

Last month, FDA launched two innovation challenges to incentivize the invention of alternative medical device sterilization methods and to reduce ethylene oxide emissions, but it is unclear if the effort will yield progress ahead of the March 13, 2020, court-ordered deadline for the final rule for ethylene production.

According to an AdvaMed document shared during the White House meeting, the trade lobby warned administration officials of many devices sterilized with ethylene oxide that have "no acceptable alternative" if a ban on the gas is issued by EPA. The device industry would have to redesign multiple medical devices, a process that "could take several years and require lengthy regulatory approval," it argued.

"The direct impact of any elimination or severe restriction would potentially threaten the entire health care system, as low product inventories and severe backorders of sterile single-use devices could result, putting patients at risk," according to the document.