The end of June 2023 marks the last day industry stakeholders, community members, and public health leaders are able to submit comments for two separate proposals from the Environmental Protection Agency (EPA) on medical device sterilization using ethylene oxide (EtO): the National Emission Standards for Hazardous Air Pollutants (EPA-HQ-OAR-2019-0178-0154), and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act (NESHAP and FIFRA) covering the use of EtO for device sterilization (EPA-HQ-OPP-2013-0244-0044). The proposals are entrenched in controversy and have been since they were first announced in April 2023.
EPA says the implementation of new standards would reduce air emissions linked to heightened cancer risk. Through required use of advanced source monitoring methods to confirm pollution controls, and reduced amounts of the chemical applied to medical devices during the sterilization process, among other updates, the Agency says emissions would be cut by 80% per year, which would fall below its benchmark for elevated cancer risk. Technology would also be updated to monitor EtO in real-time down to 10 parts per billion, and if it surpasses that number, workers would be required to wear PPE. Companies would, under the proposals, need to slash concentrations used to sterilize medical devices down to 500 milligrams per liter for each cycle.
To achieve these upgrades, EPA estimated that the 86 United States sterilization facilities, which are owned by 46 different companies, would cumulatively need to spend $220 million in one-time capital investments as well as an additional $86 million a year in recurring operating and maintenance costs on equipment. However, the medtech industry seems steadfast in voicing its concerns about the proposed changes and how they could negatively impact patient care, supply, and suitability of sterilization. Submitting its comments to the proposals, the Advanced Medical Technology Association (AdvaMed) urged continued cooperation between industry and the Agency as regulations move forward; however, highlight the potential for massive interruption in patient care and access due to the changes in sterilization practices resulting in a reduction of capacity for life-saving devices. The medtech industry and EPA must continue working together to improve these two proposals because as written, we could see significant shortfalls and a risk to patient access resulting from a device sterilization capacity reduction of 30% to 50% nationwide,” said Scott Whitaker, AdvaMed president and CEO.
In a statement submitted to proposal No. EPA-HQ-OAR-2019-0178-0154, the American Association of Orthopaedic Surgeons (AAOS) echoed these concerns, noting that while it supports the notion that no single sterilization method is optimal for all applications, proposed processes to reduce EtO could “lead to delays in the completion of sterilization and turnover of surgical devices.”
AAOS president, Kevin J. Bozic, MD, MBA, FAAOS, who penned the statement, wrote “The AAOS recommends a risk-based approach to the regulation of sterilization. Any regulatory limitation of one sterilization method needs to be balanced against the available alternatives, its benefits, and its drawbacks for various orthopaedic [sic] device classes. There is also a need for it to be balanced against the ready supply of devices and procedures for patients in need today or in the near future.”
The Healthcare Industry Resilience Collaborative (HIRC), a non-profit association that includes leading healthcare providers, suppliers, and industry partners, also submitted comments to both proposals, highlighting that “supply chain disruptions harm patients.” In the statement, the collaborative urged the EPA to give weighted consideration to ensuring sufficient availability of high-quality medical technology with the understood concern of EtO emissions, including “balancing relative environmental risk against the benefit of availability of critical medical supplies and devices that require the same EtO sterilization.”
Currently, the chemical’s use for sterilization in the medtech industry is overarching. The FDA estimates EtO is used to sterilize about half of all medical equipment — roughly 50 million devices a day in the US — and for many devices, EtO is the only choice when other sterilization methods are harmful or ineffective. “Properly sterilized medical devices are a matter of public health,” according to the HIRC. “As recognized by the FDA, EtO has an important role to play in device sterilization. Currently, this sterilization method cannot be completely replaced by any other modality. Without fully implemented alternatives, we foresee serious risks impacting patient care if the proposed rule is implemented as written. Without flexibility and options in how mitigation is achieved, there is increased likelihood of potential facility shutdown, as well as constrained capacity and significant sterilization outages leading to unavoidable downstream impact to patient care.”
To preserve patient access and prevent supply shortages, AdvaMed’s proposal comments highlighted specific policies it recommended the EPA address. The Association reasoned that the proposal, as it stands, would result in an estimated total capacity reduction of 30% to 50% per site, and on more extreme cases, even upwards of 70%. AdvaMed also noted that sterilization facilities are not “one-size-fits-all” so using such an approach is not possible. Instead, the final determination, in their view, “must allow for flexibility to prevent any delays in lifesaving, life-enhancing, and timely patient care.” Revalidation may also be a large issue. The potential need for revalidation of millions of products, including extensive testing and change management with US and international regulatory bodies, would cut capacity sharply and disrupt supply.
With the commenting period now closing, the EPA is charged with read through the acquired comments from both proposals. Currently, a timeline for the proposal decision is unknown, and many companies are impatiently waiting for what the future of sterilization might hold.
REFERENCE: MD+DI (Medical Device and Design Industry); 27 JUN 2023; Katie Hobbins