Industry Says EPA Rule to Limit Ethylene Oxide Will Also Limit Access to Medical Care

Significant moves to limit amounts of the known human carcinogen ethylene oxide (EtO), commonly used to sterilize medical devices, will adversely affect delicate supply chains, making it difficult for hospitals to access devices needed to treat cardiac ailments, diabetes and Parkinson’s disease as well as medical supplies needed for surgery.

That’s the assertion of Anita M. Tuch, Medtronic’s vice president of Enterprise Risk & Facilities, who wrote a 24-page comment in response to the Environmental Protection Agency’s (EPA) proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Sterilization Facilities.

Tuch’s observations were among 90 public comments made in response to the proposed amendments, which would require an 80 percent reduction in EtO emissions from commercial sterilizers, businesses that are often located near residential areas, including schools and parks. While EtO usage has decreased over time, it continues to be the most widely used gaseous sterilization agent in the world, used to sterilize 50 percent — roughly 20 billion — medical devices in the U.S. annually.

EtO also “is uniquely capable of diffusing into and sterilizing difficult to reach areas of complex medical devices, such as pacemakers, defibrillators, catheters, and insulin pumps,” wrote Medtronic’s Tuch, adding that medical device sterilization is a tiny fraction of commercial use of EtO, representing just half of 1 percent of all commercial uses.

For Medtronic products, EtO remains the only validated method to ensure sterility without affecting the integrity and function of the device, said Tuch.

Read public comments here.

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