Dive Brief:

• AdvaMed is using the U.S. Environmental Protection Agency’s own assessment to push for changes to proposed safety rules on ethylene oxide sterilization.
• The EPA’s impact assessment report warns it is unclear how the changes will affect supply of reusable medical devices and that even a temporary drop in capacity could cause shortages.
• “Patients can’t afford for the EPA to sweep those concerns under the rug,” AdvaMed CEO Scott Whittaker said in a statement on the organization’s website on May 10. 

Dive Insight:

The EPA proposed stricter rules on the release of EtO into the environment last month in response to evidence that the chemical has caused cancer in people living close to sterilization facilities. If the actions cause sterilization facilities to close, they could cause shortages of medical devices. AdvaMed has said it is seeking to avoid that outcome and followed up its testimony before the EPA with another statement this week.

In the statement, AdvaMed cited three lines from the EPA’s own assessment of the impact of its plans to change the rules on EtO. 

• “EtO sterilization services are a critical input in the provision of safe medical devices and there is uncertainty in how the proposal could potentially affect the medical device supply chain.”
• “If the capacity of the industry were to potentially decline even temporarily due to the proposed rule, there could be increased risk of shortages for some devices.”
• “It should be noted, however, that there are no alternative sterilization methods for a substantial portion of medical devices and alternative modalities for highly EtO-dependent products are unlikely to be available in the near future.”

None of the cites lines were in the draft impact assessment that the EPA submitted for inter-agency review late last year. According to the marked-up document returned to the EPA, the review identified issues with sections on the impact of the proposals on capacity constraints.

Discussing the risk of shortages, a commenter wrote that “EPA has not elsewhere considered this cost of implementation,” adding that “these costs are minimized in the justification for an 18-month compliance period.” The comment called for the EPA to “do a complete consideration of the capacity reductions required to implement this rule on their timeline, and, as recognized elsewhere, the costs of facilities that will be unable to operate if they are unable to complete the compliance investments on time.”

Other comments in the marked-up document note that “the cost of closing a sterilization facility during upgrades for compliance does not appear in the [regulatory impact analysis],” and that “neither FDA nor industry” believe efforts to develop alternatives to EtO “can come to fruition before the anticipated compliance dates,” referencing the Food and Drug Administration.

In response to one of the comments, the EPA wrote that it “does not have methods to estimate which facilities would need to close to complete upgrades, how long those facilities might close, or what the lost revenues might be. As such these costs are not included in the cost estimates.”