EPA Analysis: “EPA Does Not Have Methods to Estimate How Long [EtO Sterilization] Facilities Might Close”

FDA: “Very Worried” About Potential Product Shortfalls

AdvaMed Says “Patients Can’t Afford for the EPA to Sweep Those Concerns Under the Rug,” Cites Impact on Medtech Supply Chain

WASHINGTON, D.C. – AdvaMed, the Medtech Association, urges the Environmental Protection Agency (EPA) to heed concerns of medtech supply shortfalls under its proposed requirements on ethylene oxide (EtO) sterilization and consider the effects on patient care.

The EPA’s impact analysis of its regulation of EtO sterilization through the National Emission Standards for Hazardous Air Pollutants (NESHAP) cites the potential for medtech shortfalls as facilities implement the new requirements. However, in comments responding to questions in interagency review, the EPA appears to downplay the concern and suggests facility closures to install new equipment would be brief. Because EtO sterilization is at capacity, and a number of medtech devices can be sterilized only with EtO, taking facilities offline even briefly could cause major supply disruptions.

FDA Commissioner Robert Califf said in an April 28 article, “This issue is very much on the forefront for us. We are highly aware of it and we’re engaged in the discussions. I’m very worried.”

AdvaMed President and CEO Scott Whitaker said, “As we wrote to President Biden and have stated for years, the medtech industry welcomes updated regulations governing EtO sterilization because our industry is just as committed to employee and community safety as it is to improving and saving patients’ lives. However, EPA on one hand recognizes the challenges its proposals pose for the sterile medical technologies patients depend on. On the other hand, it dismisses or downplays the challenges. Patients can’t afford for the EPA to sweep those concerns under the rug. Our ability to serve patients depends on not only innovating medtech but also supplying safe, sterile medtech on time, in abundance, to healthcare providers when and wherever they need it.”

The EPA’s impact analysis of its NESHAP proposal says:

• “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.”

On whether there has been an assessment of time related to shutdowns and business disruptions, the Agency further responds in its interagency response: “EPA believes that these shutdowns typically last at least a week but may be longer if more work is needed. EPA does not have methods to estimate how long facilities might close or what the lost revenues might be. As such these costs are not included in the cost estimates.”

Sterilization facilities requiring new equipment must source the equipment, likely from a limited number of specialty suppliers unequipped to accommodate sudden high demand, install the equipment, and test it to ensure necessary sterility levels. Those factors could cause weeks or months of temporary shutdowns to implement the requirements, hindering sterile medtech supplies and patient care. EtO is used to sterilize 50 percent, or 20 billion, of medical devices in the United States each year. As the EPA notes, EtO sterilizes an estimated 95 percent of all surgical kits.

The thousands of pages of supporting documents, the complexity of the regulations, the shorter than usual timeframe for implementing such regulations (18 months versus three years), an equally complex regulation on handling EtO, and the public health implications of implementation all demand careful consideration.

Earlier, AdvaMed urged the EPA to double the amount of time for public comment on the rule, from 60 days to 120 days. In January, Whitaker wrote to President Biden outlining four principles for the EtO regulations, including the potential threat to patient care if facilities shut down and a call for “technology-neutral solutions” to meet new emissions targets. The medtech industry will comment formally on the proposed regulations.

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