Even as demand remains high for masks, gowns and other gear to protect health care workers battling COVID-19, a battle is raging over the fate and role of sterilization plants that federal officials believe are essential to help stem the pandemic.
That battle now appears to focus on the use of the chemical known as ethylene oxide to decontaminate N95 respirator masks in high demand and short supply for doctors, nurses and others in hospitals on the front lines of the COVID-19 fight.
While activists assert the use of ethylene oxide (EtO) would put health care workers at risk, the nation’s leading maker of N95 masks, 3M, says it believes there are better alternatives to EtO decontamination.
However, federal regulators say the process will help boost supplies of personal protective equipment (PPE) in the current COVID-19 response effort. And sterilizers point to studies showing concerns over “residual” traces of EtO are unfounded, and, for some kinds of masks, there is no real alternative methods of decontamination.
The battle is the continuation of a longstanding legal and regulatory fight that dates back to 2018.
At that time, groups of activists in Chicago’s suburbs and, later, in Georgia, partnered with trial lawyers to launch a coordinated attack in public opinion, in politics and in the courts, against businesses which operate plants that use ethylene oxide (EtO) to sterilize PPE and medical devices.
The public outcry arose over concerns the plants’ use of EtO created emissions which increased the risks of cancer and other maladies in the communities near the plants. Those fears centered on the release of a report from the federal Agency for Toxic Substances and Disease Registry, which linked an increased cancer risk to EtO emissions from sterilization plants.
The effort gained support in Springfield, particularly from Illinois Gov. JB Pritzker, and in Atlanta, resulting in actions taken to close or reduce operations at four sterilization plants, two in each state.
Sterilization plant operators have also been targeted by a slew personal injury lawsuits. Sterilizers have argued they never violated any federal or state rules, and the lawsuits represent an improper attempt to use the courts to rewrite emissions rules set by lawmakers and regulators.
However, amid the COVID-19 pandemic that has paralyzed the U.S. and much of the world, the U.S. Food and Drug Administration and many in the health care sector have flipped the script, pushing for some of the sterilization plants to be reopened to help meet demand for PPE and other sterilized medical devices needed to combat the pandemic.
In late March, that pressure helped to reopen two key plants, which had been left shuttered for months as state and local officials in Illinois and Georgia took their time in signing off on testing of emissions control equipment installed at the demand of the state and local governments.
In Illinois, state regulators allowed Medline to reopen its sterilization facility in north suburban Waukegan.
And in Georgia, sterilization company Sterigenics secured a federal court order blocking officials in Cobb County from restricting operations at its plant outside Atlanta. Sterigenics had asserted in its court filing those county officials were acting in league with anti-EtO activists, led by the group known as Stop Sterigenics, which was birthed in Chicago’s western suburbs.
Sterigenics’ former plant in the Chicago suburb of Willowbrook – the plant initially targeted by anti-EtO activists - has remained closed, with no plans to reopen.
Medline spokesman Jesse Greenberg said his company’s Waukegan plant has traditionally sterilized surgical kits and other gear used in operating rooms.
However, with elective procedures and most surgeries cancelled throughout much of the U.S., Greenberg said Medline has asked the FDA for a special permit, known as an Emergency Use Authorization (EUA), to allow the company to instead use its facilities to decontaminate used N95 masks, surgical masks and other protective gear.
He noted demand for masks and PPE has soared, increasing three-fold over typical years and requiring mask makers and sterilizers to send out many millions more masks this year, including N95 respirator masks, surgical masks and procedural masks.
While such masks would normally be considered single-use and disposable, and thus not regulated as sterile, high demand for the special respirator masks amid the pandemic has created a shortage. That, in turn, has spurred a push to secure federal approval to decontaminate the masks, allowing them to be reused in large quantities.
The plans by Medline and potentially others to use EtO to decontaminate masks for reuse spurred public calls earlier this month by anti-EtO activists, urging the FDA to prohibit the proposed practice.
They said they believed decontaminating the masks with EtO would result in “residual EtO left on the masks” which would then be inhaled by health care workers and first responders, placing them at risk.
The activists, echoing a statement from manufacturer 3M, said they believed other, alternative methods of decontamination would be safer and equally effective. They also pointed to a statement from the Centers for Disease Control, which noted the need for "long aeration cycles" to ensure "residual EtO" is removed from the masks.
Medline, however, said the concerns are unfounded.
“We believe that there is no residual EtO on an N95 once it reaches a customer,” Greenberg said.
Other studies have also indicated far less concern over the presence of EtO on decontaminated masks.
The use of EtO to decontaminate N95 masks was studied in 2009 and 2010 by researchers who predicted a shortage of PPE, and particularly respirator masks, during an infectious disease pandemic.
In one study, published in the Annals of Occupational Hygiene, researchers called the use of EtO to decontaminate masks one of “the most promising” means of decontaminating the masks for reuse. They noted no concerns over residual EtO on the masks, noting they were “aerated” for four hours.
In another study, published in the Journal of Occupational and Environmental Hygiene, researchers specifically said “no residual (EtO) was detected in any of the respirators or respirator components” on decontaminated masks.
Greenberg said Medline believes alternative decontamination methods could also damage surgical masks or procedural masks, while EtO would not.
Greenberg noted Medline’s findings have been backed by a number of hospitals, who believe the FDA’s EUA approval is needed to boost supplies of masks and other PPE.
“Medline shared the filtration performance of the masks after running them through worst case sterilization cycles as well as the residual data that demonstrates the masks are both safe and provide the protection our end users need,” wrote an administrator at Integris Health in Oklahoma City, in a letter written to the FDA to support Medline's EUA request.
Administrators at Scotland Health Care System in Laurinburg, N.C., also said their health system held no concerns over residual EtO, and said they believed alternative methods of mask decontamination “do not address many types of masks nor the scale that we feel we need at this moment.”
Greenberg told the Cook County Record Medline has not yet begun decontamination, but is collected used N95 masks and other masks for potential decontamination. He said the company is inspecting the masks for damage that would render them unable to decontaminated. To this point, 60% of more than 1 million used masks collected and sorted by Medline are passing inspection.
In response to questions from the Cook County Record, a spokesperson for the FDA said the agency has not yet approved any EUA requests for EtO mask decontamination.
However, the FDA spokesperson said the agency “continues to assess and re-assess supply chain concerns around essential medical devices, like respirators, and will pursue every possible avenue to help increase supply of the protective gear needed for responding to the COVID-19 pandemic.”
“... In the context of the COVID-19 pandemic response, the need for respirators is outpacing the supply,” an FDA spokesperson said in a written statement. “Therefore, strategies must be explored that can address the needs faced during contingency and crisis situations. One of the ways FDA is helping facilitate access to more respirators is by issuing (EUAs) authorizing the emergency use of decontamination systems that allow for the reuse of N95 and N95 equivalent respirators when certain criteria are met.”
The spokesperson did not respond to direct questions from the Cook County Record concerning alleged health concerns over “residual” EtO on decontaminated face masks, or whether the FDA has any concerns over the use of EtO.
However, the FDA did publicly push state officials in Georgia to reopen EtO sterilization plants there to boost PPE production.
And the federal agency has repeatedly voiced concerns over how the closure of such plants could restrict the U.S. health care supply chain, and particularly the supply of key medical devices, including PPE.