AdvaMed: “We place the highest priority on the safety of our communities, employees, and the millions of patients we serve.”

WASHINGTON, D.C. – This week, medtech leaders from across the country testified during an open hearing hosted by the U.S. Environmental Protection Agency (EPA) on the Agency’s proposed rule affecting 86 commercial sterilizers. The hearing included testimony on the safety and efficacy of ethylene oxide as a sterilizer of medical devices, the impact the proposed rule would have on patient health, and the misrepresentation of the threat facing communities near these facilities. Watch the full hearing from day one here, day two here, and day three here.

The use of EtO for the sterilization of medical devices is safe:

“The use of EtO for the sterilization of medical equipment has been and will continue to be safe and is subject to stringent regulations. … We place the highest priority on the safety of our communities, employees, and the millions of patients we serve.”

          —Khatereh Calleja, AdvaMed

“Sterilization facilities undertake exhaustive efforts to ensure public safety by capturing and destroying more emissions than required. They strive to eliminate any contribution, however minuscule, to the perception that carefully controlled medical device sterilization is anything but safe for employees, neighbors, and communities.”

          —Dean Paranicas, HealthCare Institute of New Jersey

EtO’s critical role in healthcare:

“EtO sterilization is crucial for preventing infection in patients undergoing surgical procedures and other medical treatments.”

          —Khatereh Calleja, AdvaMed

“Americans are admitted to the hospital 33.4 million times and visit doctors’ offices a billion times per year. This care requires billions of pieces of sterile medical equipment. … Ethylene oxide’s 80 years of proven effectiveness means this method of sterilization sterilizes approximately 50% of all medical devices.”

          —John Conrad, Illinois Biotechnology Innovation Organization

“Medical device sterilization is only one half of 1% of all commercial EtO use but represents an enormous impact on healthcare accessibility and patient outcomes.”

          —Ashley Haltom, Center for Global Health Innovation and Georgia Bio

“While medical device sterilization accounts for only half of 1% of all commercial EtO use, it sterilizes half of all medical technology, or nearly 20 billion devices, in the United States each year. It is the only effective viable sterilization method for heat- or moisture-sensitive materials.”

          —Winthrop Thurlow, the MedTech Association, New York

Alternative medical device sterilization methods for many devices do not exist:

“EtO is the only available sterilization option due to materials of construction, compatibility, and its ability to sterilize at low temperatures among other factors. … EtO is generally not the cheapest [sterilization] method, but rather the only method for sterilizing many devices.”

          —Christopher Klosen, Ethylene Oxide Sterilization Association

“However, until the best alternative can be identified, according to the FDA, ‘other methods of sterilization cannot currently replace the use of EtO for many devices.’”

          —Rob Owen, Bio Nebraska

“Over the past 80 years EtO has become one of the most common ways to sterilize medical devices, and for many of them, it is the only viable one. Many products otherwise would be rendered unusable by other sterilization methods.”

          —Dean Paranicas, HealthCare Institute of New Jersey

The EPA is misrepresenting the risks associated with EtO emissions: 

“The EPA uses a worst-case scenario estimate and modeling of EtO’s risk by its own estimation. The EPA states an elevated risk of continuous exposure over seven years for 24 hours a day, a highly unlikely scenario that has the potential to create confusion.”

          —Khatereh Calleja, AdvaMed

“This assessment is deeply flawed and has caused public alarm by erroneously concluding EtO as carcinogenic, at levels at or well below background air concentrations across the country. … EPA relied on only a narrow subset of the available data, conducted a flawed analysis, and dismissed other data that contradicted its evaluation.”

          —Christopher Klosen, Ethylene Oxide Sterilization Association

The proposed rule’s potential harm to patient access: 

“Because EtO sterilization is already at capacity, closure of even a few sterilization facilities could cause supply shortfalls. This would have grave consequences for patients and could create a dire health crisis that the proposed rule fails to contemplate.”

          —Kelvyn Cullimore, BioUtah

“Currently, EtO facilities are operating at capacity. Disruptions or closing of these facilities would result in a lack of access to medical products—syringes, vials, surgical instruments—could all be affected.”

          —Michael Morton, Medical Alley, Minnesota

“Sterilization, as we all know, is at capacity, meaning that long shutdowns or permanent closures would significantly disrupt patient access to sterile medical devices. This would be disastrous to patient safety, the daily practice of medicine, and overall public health United States.”

          —Rob Owen, Bio Nebraska

“With EtO sterilization at capacity nationally, any long shutdowns or permanent closures would significantly disrupt access to sterile medical devices, which will be disastrous to patient safety and overall public health in the United States.”

     —Dean Paranicas, HealthCare Institute of New Jersey

EPA should extend the proposed comment period and implementation timeline:

“The medtech industry is seeking an additional 60 days for public comment for 120 days total, consideration of a technology-neutral approach for both proposals, an examination of the existing background EtO levels, and EPA recognition of the supply chain disruptions that could cause a public health crisis if left unchecked.”

          —Khatereh Calleja, AdvaMed

“Many of the requirements come with unreasonable timelines because the technology and equipment are not currently available. … In all cases, these regulatory actions have the potential to cause a national healthcare crisis.”

          —Christopher Klosen, Ethylene Oxide Sterilization Association

“Regarding NESHAP and FIFRA, we note that these include more than 1,000 pages of highly technical information, and we strongly recommend that the time period for careful review and comment be extended.”

          —Michael Morton, Medical Alley, Minnesota

“We need a longer comment period, an 18-month implementation timeline would create sheer chaos in our industry, and certainly will deliver shortages and healthcare outcomes that do not correspond in line with the risk.” —John Ray, Florida Medical Manufacturers Consortium.