Press Releases

AdvaMed: EPA Proposals Create Significant Risk of a Healthcare Crisis

Association Calls for Working Together to Ensure Patient Access

WASHINGTON, D.C. – 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:

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.