COVID-19 Further Complicates Existing Sterilization Problems
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,” said Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions LLC, an independent safety and quality improvement company in Lansdale, Pa. “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. 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.
Responding to a Crisis
In late March, the EPA said Georgia and the medical device company BD had reached an agreement to temporarily increase the number of items 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.
Subsequently, 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.
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, she 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.
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 overreliance 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 (https://bit.ly/ 3bqTCLT). A group at Duke University, in Durham, N.C., has reported safely decontaminating N95 face masks using vaporized hydrogen peroxide.
“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?”
Dr. Muscarella is uncertain 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,” he said. “We can’t let this become the new clinical norm. We need to assure we revert back when the crisis is resolved.”