AdvaMed: EPA Proposals Create Significant Risk of a Healthcare Crisis

In comments filed with the Environment Protection Agency (EPA) today, AdvaMed, the Medtech Association, called for continued cooperation between the industry and the agency as the regulations covering medical device sterilization using ethylene oxide (EtO) move forward. AdvaMed said if the proposals are finalized as written, the United States will see a massive interruption in patient care and access because of a 30 percent to 50 percent reduction in sterilization capacity for life-saving devices.

“As we review these EPA proposals, it’s important to remember that we come to these discussions as partners, not as adversaries,” said AdvaMed President and CEO Scott Whitaker. “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 percent to 50 percent nationwide.” 

AdvaMed pointed to specific policies that EPA must address in the proposals to preserve patient access to the medtech necessary for timely care, including:

• Capacity reduction. The proposals as drafted will result in an estimated total capacity reduction at sterilization facilities of 30 percent to 50 percent per site and even upwards of 70 percent or more for some facilities. This will likely result in a significant disruption to patient care and risk a public healthcare crisis. AdvaMed conducted an industry gap analysis to meaningfully assess impact and the risk to critical sterile infrastructure of the proposals.
• Sterilization facilities are not uniform operations. There is no “one-size-fits-all” approach to the medtech industry and sterilization. Any final determination must allow for flexibility to prevent any delays in lifesaving, life-enhancing, and timely patient care.
• Revalidation. Millions of products would require revalidation, including extensive testing and change management with U.S. and worldwide regulatory submissions. This in turn would also cut capacity sharply and disrupt the supplies of critical medical technology needed for patient care.
• Some elements of the two proposals are conflicting or make implementation technically impossible. Careful analysis is needed of the interplay between EPA’s proposed rule and its proposed interim registration decision to ensure workable rules that can be reasonably implemented.
• No consideration of background levels of EtO. Ethylene oxide is in the air from many sources, but neither EPA action takes this into account. Background concentration must be considered in meaningful risk assessment.
• Flawed risk assessment. EPA’s risk assessment model is fundamentally flawed, relies on a single study, and ignores recommendations by the National Academies of Science, among others.
• Technical feasibility. The EPA proposals in certain cases call for technology that either does not exist or is in limited supply, exacerbating capacity decreases and patient care and access delays to sterile medtech.
• Timeframe is not feasible. The proposed rules’ implementation timeframe of 18 months is impossible to meet and will exacerbate critical infrastructure shortages.

About ethylene oxide:

EPA issued two separate proposals earlier this year, the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act (NESHAP and FIFRA) covering the use of EtO for device sterilization. EtO-sterilized devices can be found in many healthcare procedures, from a standard blood draw during an annual physical to a complex surgical procedure such as open-heart surgery. The process is used to sterilize half, or 20 billion, of all medical devices in the United States each year. It is the only effective, viable sterilization method for many medical devices. Sterilization is at capacity, and any regulations that reduce capacity, even temporarily, would have serious implications for patient care.

The AdvaMed comments can be viewed here and here.