Young Sends Letter to EPA Administrator Outlining Concerns with Impact of Proposed Rules on Supply of Sterilized Medical Equipment
WASHINGTON – U.S. Senator Todd Young (R-Ind.) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael Regan outlining concerns related tonew rules on ethylene oxide (EtO), a sterilizer for medical equipment.
The EPA recently published proposals under two separate programs that would significantly impact the use of EtO – emission standards under the Clean Air Act, and restrictions on use under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). If these proposed rules are finalized, they will jeopardize the supply of sterilized medical equipment.
In his letter, Senator Young wrote, “A reduction in sterilization capacity could pose a significant risk of inadequate medical products being delivered to healthcare professionals and patients during crucial time periods. In such scenarios, healthcare facilities might be forced to limit the provision of certain treatments due to the scarcity of properly sterilized equipment, resulting in delayed medical care, increased patient suffering, and a higher risk of adverse patient outcomes.”
Full text of the letter can be found here and below:
Washington, DC 20004
RE: Docket ID EPA–HQ–OAR–2019–0178; U.S. Environmental Protection Agency Proposed National Emission Standards for Hazardous Air Pollutants—Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review
Dear Administrator Regan:
I’m writing to request that the Environmental Protection Agency (EPA) reconsider its proposed regulations that would restrict the use of Ethylene Oxide (EtO): 1) the proposed National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review (Docket ID: EPA-HQ-OAR-2019-0178); and 2) the notice of availability for Pesticide Registration Review; Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide (Docket ID No. EPA-HQ-OPP-2013-0244). While likely well-intentioned, these proposed regulations have underestimated the far-reaching implications for our medical device supply chain, the added cost burden on patients, and the necessity for effective interagency coordination that such impactful changes would require.
In the proposed regulation, EPA acknowledges that EtO sterilizes approximately half of all medical devices each year, or about 20 billion devices, including 95% of all surgical kits. While the U.S. Food and Drug Administration (FDA) is consistently challenging the industry to explore alternative sterilization methods and use less EtO, general consensus suggests that ethylene oxide sterilization may be the only method that successfully sterilizes without causing any harm to the device throughout the sterilization process. Consequently, the potential for extensive disruption in our medical device supply chain is evident, which could instigate a public health crisis of unprecedented scale. As noted by FDA, “EtO facilities in the United States typically run 24/7 with facilities operating at maximum capacity. Thus, when EtO facilities close (even temporarily), there are downstream implications for the medical device supply chain.”
According to EPA, there are currently 86 EtO sterilization facilities operating within the U.S., 24 of which are owned by various small businesses. The Small Business Administration, in its comments to EPA, warned that these proposed actions might result in a substantial number of small entities exiting the commercial sterilization market, which could negatively affect small medical device manufacturers and patients who rely on sterilized medical devices.
A reduction in sterilization capacity could pose a significant risk of inadequate medical products being delivered to healthcare professionals and patients during crucial time periods. In such scenarios, healthcare facilities might be forced to limit the provision of certain treatments due to the scarcity of properly sterilized equipment, resulting in delayed medical care, increased patient suffering, and a higher risk of adverse patient outcomes.
EPA, in its proposed NESHAP and Preliminary Information Document, acknowledges that these regulations could decrease commercial sterilizer capacity, reducing the supply of medical devices and escalating sterilization costs. These cost increases will inevitably pass from sterilizers to medical device manufacturers, then to hospitals, and finally to patients. Moreover, due to market conditions, manufacturers of commodity devices like syringes may be unable to transfer price increases to healthcare facilities, increasing the likelihood of ceasing domestic operations for these products. Such an outcome would also increase our reliance on foreign sources and heighten vulnerabilities in our public health supply chains.
During the interagency review of the draft, other agencies voiced similar concerns about the risks to the medical supply chain. EPA acknowledged that the expedited compliance timeline in its proposed regulations could cause multiple facilities to close simultaneously, necessitating heightened coordination to mitigate adverse impacts on the medical device supply. Yet, when questioned about who would facilitate this crucial coordination, EPA admitted that mechanisms are presently “unknown,” suggesting the responsibility could fall to FDA.
We cannot take the risk that EPA’s actions will inadvertently disrupt patient care. The intricacies of the U.S. healthcare system, particularly its reliance on the continuous operation of commercial sterilizers, demand that EPA and FDA coordinate efficiently and proactively. A reactive approach or waiting for a crisis to manifest is not an option.
Therefore, I urge EPA, in coordination with FDA, to undertake a thorough risk assessment regarding sterilization capacity from both the NESHAP and the proposed EtO pesticide registration. Additionally, I urge EPA to work collaboratively with other agencies, particularly FDA, to create a robust strategy to provide affordable, domestic supply in all parts of the United States. Reproposing the NESHAP and pesticide management standards to strike a balance between public health risks and potential access limitations to medical devices may be necessary.
Furthermore, while environment controls are important, they shouldn’t overshadow the significance of patient health and healthcare affordability. These interrelated goals emphasize the need for enhanced interagency coordination to address potential supply chain and patient health risks associated with these proposed changes. To that end, it is imperative that FDA has sufficient time to conduct a thorough risk assessment of EtO sterilization capacity constraints and ascertain that neither EPA proposal would contribute to a shortage of life-saving and life-sustaining medical products.
Thank you for your consideration and I look forward to your prompt attention to this matter.
United States Senator
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