The fight over plants that use ethylene oxide (EO) to sterilize medical devices is escalating across the country.
New proposed legislation in Illinois would ban the use of the carcinogenic gas by sterilizers by 2021 and by hospitals by 2022, according to reports by the Chicago Tribune. A legislative hearing on the bill is scheduled for this afternoon. A different state law passed in Illinois in June would have required Medline Industries to install a taller emissions stack on its sterilization plant in Waukegan, Ill., but the Waukegan City Council voted down the taller stack in September, the newspaper reported.
The Environmental Protection Agency is expected to update its EO regulations by March 2020. Georgia’s Environmental Protection Division (EPD) is considering strengthening its EO emissions standards, and Georgia is seeking a temporary restraining order to close a Becton Dickinson (NYSE:BDX) EO plant in Covington, Ga., where a leak of 54.5 lbs. of the gas went undetected for eight days in September. BD pledged in August to install $8 million worth of emissions-control equipment at its two Georgia EO plants, but the state alleges the company has been dragging its feet.
Medela (McHenry, Ill.), which makes breast pumps and other devices for nursing mothers and newborns, wrote a letter to Illinois statehouse speaker Michael Madigan last week, saying it “respectfully oppose(s) HB 3888 and HB 3885 because their restriction to EO use would lead to the inevitable elimination of EO sterilization in the state and will likely lead to further restrictions in other states. This process is essentially irreplaceable in its effectiveness to combat infection in hospital surgical settings, and is an essential step for Medela to support the most medically fragile in the Neonatal Intensive Care Unit (NICU).”
Medela said it made the Medline Waukegan plant its primary sterilization source after Illinois state regulators shut down Sterigenics’ EO plant in Willowbrook, Ill. in February. The Medline Waukegan plant now sterilizes “millions of pieces of medical devices” for Medela, the company said in the letter.
“While we do have backup suppliers in qualification, the capacity at remaining sterilizers is a major concern for Medela and many other medical device manufacturers dependent on this process,” the company said. “Medela serves more than 80% of U.S. hospitals and NICUs with sterile breast milk pumping kits, neonatal enteral feeding devices, sterile containers for breast milk and specialty feeding devices used in the NICU. Sterilization is the clinical standard of practice in the NICU to keep dangerous bacteria from appearing and affecting our most vulnerable infants.”
Medline has operated its surgical kit manufacturing and sterilization plant the same way in Waukegan for the past 25 years, company spokesman Jesse Greenberg said in an email to Medical Design & Outsourcing.
“We assemble and sterilize approximately 16,000 custom surgical kits per day at that facility,” Greenberg said. “In compliance with new Illinois regulations passed in 2019, Medline is installing additional, best-available technology controls that will capture and destroy 99.9% of the ethylene oxide used. Historically, we abated 99% of ethylene oxide in Waukegan. While legislators in Illinois consider an all-out ban on ethylene oxide during their veto session, Medline is working hard to educate lawmakers and the public about the risks to public health such a policy would cause, as recently stated by the FDA.”
EO is used to sterilize about 50% of all devices sold in the U.S. that require sterilization — more than 20 billion medical devices per year, according to the FDA. It is a preferred sterilant for devices made from certain polymers (such as plastic or resin), metals, or glass, and devices that have multiple layers of packaging or hard-to-reach crevices, because it has better penetration properties than other methods and is unlikely to damage products during the process. The agency issued a pair of innovation challenges in July to identify alternatives to EO and measures to reduce EO emissions. It is planning a public advisory committee meeting Nov. 6-7 to discuss how best to encourage innovation in medtech sterilization.
AdvaMed president & CEO Scott Whitaker said a shutdown of the Medline Waukegan plant “will likely have a direct and devastating effect on the patients who are served by 135 Illinois hospitals as well as millions of patients across the country who depend on the safe, clean and critical surgical devices Medline sterilizes — including the most vulnerable newborns in NICUs nationwide.”
On Friday, acting FDA Commissioner Dr. Ned Sharpless warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the permanent shutdown of the Sterigenics Willowbrook plant, a Becton Dickinson (NYSE:BDX) plant in Atlanta and efforts in Georgia to close a second BD plant in the city of Covington. Sterigenics voluntarily closed an EO plant in Atlanta in August to upgrade its emissions controls.
A group of 16 state-level medtech trade groups echoed the FDA’s concerns in a letter last week, as did AdvaMed and a group six medical societies.
“We appreciate Commissioner Sharpless for calling attention to the critical role ethylene oxide plays in protecting the health of millions of Americans who depend on sterile devices to keep them safe,” AdvaMed president and CEO Scott Whitaker said in a statement. “It cannot be overstated: Critical medical devices might not make it into doctors’ and surgeons’ hands if we aren’t careful as we have this important conversation about the true risk of these EtO sterilization plants.
“We absolutely understand why those who live around these plants are deeply concerned based on what they’ve heard and read. But leading toxicologists and epidemiologists are certain that media reports have been misleading, and that the communities surrounding these plants are safe. These experts need to be a much bigger part of the conversation within these neighborhoods and with policymakers.”
“The closure of medical device sterilization facilities will disrupt the health care supply chain in every state and territory in the US and cause serious public health consequences that will impact hundreds of thousands of vulnerable Americans across the country,” the state-level trade groups said. “Medical device sterilization techniques utilizing ethylene oxide (EtO) are essential to ensuring the safety of more than 20 billion medical devices every year, approximately 50% of all devices sterilized annually. Without this sterilization method, millions of patients simply will not have access to critical, life-saving and life-sustaining treatments.”
The coalition of state trade groups includes:
- BioForward Wisconsin.
- California Life Sciences Association (CLSA).
- Colorado BioScience Association.
- Florida Medical Manufacturers Consortium (FMMC).
- Georgia Bio.
- Healthcare Institute of New Jersey (HINJ).
- Indiana Health Industry Forum (IHIF).
- Medical Alley Association.
- Southeastern Medical Device Association (SEMDA).