For months, officials have been warning of a looming shortage in the supply of a gas used in the sterilization of medical equipment. Now, that already stressed system has taken another massive hit from the new coronavirus infection, COVID-19.
At the heart of the issue is ethylene oxide (ETO). Across the country, states have been shutting down plants that produce ETO in response to concerns from local communities that the chemical, a known carcinogen, could contaminate the local environment. These closures have raised fears of shortages of necessary equipment for many medical procedures.
Now, the onslaught of COVID-19 is placing additional strain on the system, as medical providers ask for more protective gear and single-use instruments, which are often sterilized by ETO before initial use.
“Everyone approves of eliminating the emissions to keep people safe,” Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions LLC, in Lansdale, Pa, told Clinical Oncology News. “Taking ETO factories offline until enhanced safety goals could be achieved may have seemed smart at the time, but in hindsight with this pandemic, it may have inadvertently contributed to equipment shortages.”
To Use or Not to Use
The medical industry has been relying on ETO since the 1950s, as one of a handful of ways to sterilize medical devices and instruments that contain delicate materials, such as plastic, which can degrade in high heat. According to AdvaMed, the medical technology trade association, more than half of all medical devices—over 20 billion per year—are sterilized using ETO. These devices include gowns and drapes, syringes, surgical kits, catheters and ventilators.
However, exposure to ETO can lead to a host of health problems, such as cancer and neurologic issues. This, along with reports of leaks and explosions at ETO sterilization facilities, has put residents in areas close to ETO manufacturers on high alert, and facilities have been closing their doors.
In October, before the COVID-19 pandemic, the FDA warned that the recent closures of facilities in Georgia and Illinois could affect the supply of sterile medical devices (www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures). When the health care system became engulfed by the pandemic, demand for sterilized medical equipment soared.
Fortunately, in many fields, providers have rescheduled elective procedures, which eases the strain on the system, Dr. Muscarella said. But the demand for personal protective equipment (PPE) and single-use medical instruments—required to be sterile before first use, often by ETO—will remain high as long as the pandemic continues, he said. “You have a supply line that was already stressed because of efforts in some places to eliminate a process that’s commonly used in this country to sterilize this equipment,” Dr. Muscarella said.
Responding to a Crisis
In late March, the EPA said Georgia and the company BD had reached an agreement to temporarily increase the number of devices the company can sterilize during the pandemic at two ETO sterilization facilities. According to the agency, the company is installing new air emission controls to protect the local environment.
On March 27, the Illinois Environmental Protection Agency announced that Medline Industries could resume full commercial sterilization operations using ETO, after showing it had complied with local environmental regulations. According to Medline, the facility in Waukegan, Ill., produces and sterilizes more than 16,000 sterile surgical packs every day, which supply nearly 80% of the state’s urban and rural hospitals.
Medline’s Waukegan employees pack surgical kits prior to sterilization.
The EPA declined to comment, referring inquiries to other agencies, including the Illinois EPA (IEPA). A representative of the IEPA, Kim Biggs, told Gastroenterology & Endoscopy News the agency had been working with Medline to implement new protective measures. The facility has since been up and running, she said, and the state doesn’t have plans to increase capacity further.
“Medline is the only remaining commercial medical sterilizer in the state of Illinois, and they are now authorized to resume normal operations,” Ms. Biggs said. “IEPA has not been provided with any other proposals to increase use of ETO for medical equipment sterilization.”
Jesse Greenberg, a spokesperson for Medline, said in an interview that the Waukegan facility had been dark since late December, as it was working on the installation, testing and balancing of an updated emissions system to comply with the state’s new law that went into effect just before 2020. But now that it can resume normal operations, it is using the same process for surgical kit sterilization to decontaminate used face masks, including N95 respirators. “We just started this process and will be decontaminating 100,000 face masks per day, part of which will be handled in Waukegan,” he said. “Medline anticipates quickly escalating the number of face masks we decontaminate in a few weeks.”
Soumi Saha, PharmD, JD, the senior director of advocacy at Premier, a group purchasing organization for health facilities and providers, said the company was immediately “concerned about ETO sterilization capacity” once the COVID-19 pandemic hit. Seeing facilities open up and ramp up production has been a big relief, Dr. Saha said. “That’s opened up tremendous capacity in the U.S. to help sterilize PPE and other medical supplies that are being used to care for COVID-19 patients.” Ideally, that will continue, she added. “Our hope is the reopening of the facilities in Illinois and Georgia are not temporary, and that going forward, the FDA, EPA and CDC work together to collaboratively define acceptable ETO emissions and sterilization techniques, which will help ensure continued availability of sterile medical supplies.”
A spokesperson for the FDA said in an interview that although most endoscopes do not rely on ETO for reprocessing, the gas remains a vital part of infection prevention as a sterilizer of PPE used in surgical and other interventional procedures.“We are committed to working with state and local officials and industry to increase the supply of certain essential medical devices needed for health care personnel to protect against COVID-19 and to provide the best care to patients with COVID-19,” the spokesperson said.
Long term, the FDA is working to reduce the system’s reliance on ETO to sterilize equipment. Last year, the agency issued two challenges, designed to encourage innovators to develop alternative sterilization techniques and new ways to reduce ETO emissions. “We stand steadfast in our commitment to reduce over-reliance on ethylene oxide for medical device sterilization.”
For providers who are seeking to reuse filtering facepiece respirators such as N95 masks to address shortages, the CDC has recommended the use of other techniques, such as vaporous hydrogen peroxide and ultraviolet germicidal irradiation (www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html). A group at Duke University, in Durham, N.C., has reported safely decontaminating N95 face masks using vaporized hydrogen peroxide.
The FDA recently issued emergency authorization to another decontamination system developed by Battelle that also uses hydrogen peroxide. “With additional study, evidence may demonstrate that ETO is a viable decontamination method, which could place additional strain on ETO facilities in the country,” Dr. Saha said.
“There was a whole science behind reprocessing multiuse instruments, and now there’s a science developing around reprocessing PPE for front-line medical staff to wear during this pandemic,” Dr. Muscarella said. And there is much still to work out, he noted. “This is the big elephant in the room: If you’re reprocessing a single-use device, how many times can you safely reuse it?”
Many things keep Dr. Muscarella up at night lately, he said, one of which is how the sterilization landscape might be permanently changed by what happens during the pandemic. If providers are able to find ways to reuse single-use devices, why not keep doing it? “What I’m concerned about is that when this crisis ends, we may be incentivized to rewrite our policies in a way that tolerates lax practices,” Dr. Muscarella said. “We can’t let this become the new clinical norm. We need to assure we revert back when the crisis is resolved.”
—Alison McCook
Dr. Muscarella is the president of LFM Healthcare Solutions LLC, an independent safety and quality improvement company. His company has consulted for or received research sponsorship in the recent past from universities regarding endoscope-related infections, and from companies, including Ambu, that market ethylene oxide (ETO) and other low-temperature sterilization technologies, instrument cleaning products, disposable endoscopes and reusable equipment, among others.