AdvaMed Statement on Goffman Nomination to Lead EPA’s Office of Air and Radiation

By Friday, March 1, the Environmental Protection Agency is expected to finalize its regulation for the ethylene oxide (EtO) sterilization of 20 billion, or half, of all medical devices in the United States each year. AdvaMed President and CEO Scott Whitaker released the following statement:

In testimony today before the U.S. House of Representatives Committee on Small Business, Dr. Lishan Aklog urged Congress and the executive branch to consider the dire consequences for patients and medtech innovation if proposals further regulating the most prevalent method of sterilizing medical technology go forward without significant changes.

In testimony today before a key congressional subcommittee hearing, AdvaMed, the Medtech Association, called for a balance in the proposed regulations of the method used to sterilize 20 billion, or half, of all medical devices in the United States each year. The Environmental Protection Agency (EPA) is proposing restrictions of ethylene oxide (EtO) that if finalized as written, would cause severe interruptions in patient care and access to sterile medical technology. An industry analysis predicts a 30 percent to 50 percent reduction in sterilization capacity for life-saving devices and as much as 70 percent in some cases. 

Scott Whitaker, president and CEO of AdvaMed, recently chatted with Joe Mullings, chairman and CEO of The Mullings Group, about the impact of the medtech industry and the importance of connections.

Ethylene oxide sterilization ensures billions of pieces of medical technology are sterile for patients in every medical setting, in surgical procedures from c-sections to knee replacements.

According to a senior toxicologist in a RealClearPolicy op-ed, the EPA draws unreasonable conclusions about the health risks of the ethylene oxide used to sterilize medical technology.

 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.

AdvaMed, the Medtech Association, today welcomed the U.S. Environmental Protection Agency (EPA) extension of 15 more days for public comment on two proposed updates to regulations governing the use of ethylene oxide (EtO) to sterilize half of all medical technology in the United States each year. Even more time would have been preferable, as the regulations could cause shortfalls of critical medtech supplies, AdvaMed said.