Editor's note: This article has been revised and updated to include an announcement from the Illinois EPA clearing Medline's sterilization plant to resume operations. The article has been further revised and updated to include additional comments from the state of Illinois regarding medical device sterilizers in the state. All the added information was received following publication.
An embattled Georgia ethylene oxide medical device sterilization plant has been cleared to reopen on a limited basis, to allow for more personal protective equipment to make its way to doctors, nurses, first responders and others on the front lines of the battle against COVID-19.
At the same time, an Illinois medical device sterilization plant that has been shut down since December has also received clearance from Illinois state regulators to resume operations.
Sterigenics plant, Cobb County, Ga.
| cobbcounty.org
However, a message released by a local Georgia government official hint at the prospects of further federal action to ramp up supplies of PPE and other medical gear needed in the fight against COVID-19, including potentially further steps to compel the opening of sterilization facilities at full strength.
On March 26, officials in Cobb County, Ga., released details of a message believed to be from the U.S. Department of Health and Human Services, forwarded to the county by Georgia Gov. Brian Kemp, criticizing Cobb County for standing in the way of efforts to increase stocks of needed medical supplies.
That post, on the Cobb County website, came a day after Cobb County had announced the county would allow embattled-medical device sterilizer Sterigenics to resume limited operations at its plant outside of Atlanta, but strictly for the purposes of sterilizing personal protective equipment (PPE). A host of hospital leaders and governors, including Illinois Gov. JB Pritzker, have repeatedly said more PPE, including masks, gowns and gloves, are desperately needed in the current crisis.
In 2019, actions by Pritzker and state and local officials in Georgia had resulted in the closure or reduction of operations of four sterilization plants, two in Illinois and two in Georgia.
The plants had been closed amid public outcry from a group of activists over concerns the plants’ use of ethylene oxide (EtO) created emissions which increased the risks of cancer and other maladies in the communities near the plants.
However, as COVID-19 has paralyzed the U.S. and much of the world, attention has refocused on the plants, which the medical device industry and the U.S. Food and Drug Administration have said are crucial to supplying hospitals and other health care providers with the sterile equipment they need.
On March 19, the FDA sent a letter to Gov. Kemp calling on the state and Cobb County to allow the Sterigenics plant, near Atlanta, to reopen. That letter was obtained and first published by The Cook County Record.
Within days, Cobb County and Georgia state officials had conducted testing on new emissions equipment at the Sterigenics facility. And on March 25, Cobb County Chairman Mike Boyce granted Sterigenics limited clearance to begin sterilization operations, but only for PPE and only for as long as Georgia remained under a declared emergency.
That declaration is scheduled to expire in about three weeks.
On March 26, however, Boyce’s office released a message, purportedly forwarded by Gov. Kemp’s office, from someone at the U.S. Department of Health and Human Services, blasting the county’s response to the FDA’s request and national need as insufficient. The Cobb County posting does not identify the author of the message, but the message references “the Secretary.” Alex Azar serves as HHS Secretary under President Donald Trump.
“…We don’t think that one county should be allowed to jeopardize the nation’s response to an unprecedented national pandemic,” the forwarded message said, according to excerpts posted on Cobb County’s website. “My understanding is that this particular plant represented 4% of the total U.S. capacity for Ethylene Oxide Sterilization. If it remains shuttered, there are national implications.
“Conversations on next steps from the Federal Government are occurring at the highest levels, should the situation not change,” the author of the forwarded message added.
According to the forwarded message, “the Secretary” was particularly displeased by the strict limits imposed by the county, including the decisions to restrict production to PPE.
“PPE was only about 20% of what was being sterilized at Sterigenics, and other items like catheters, syringes, IV sets and ventilator components like tubes, filters, and masks are critical to helping patients,” the message said.
Sterigenics had similarly criticized Cobb County’s decision, also noting the order does not allow them to sterilize the full range of health care equipment hospitals are seeking.
“… The County’s Order stating that Sterigenics can operate for only 21 days and only for the purpose of sterilizing PPE falls woefully short of the measures needed to protect public health, as well as the FDA’s request for assistance,” Sterigenics said in a prepared statement. “The Order also excludes sterilization of vital medical products and devices, including ventilator tubing, IV sets, catheters and many other medical products that are essential to patient care.
“Rather than engage with Sterigenics regarding an appropriate plan for the operation of its facility to protect the public, the County unilaterally issued an Order that omits necessary medical products at a critical time.”
In response to the federal criticism of his decision, Boyce simply said he “stands by his order.”
In the meantime, a sterilization facility operated by medical device maker Medline in the north Chicago suburb of Waukegan has received permission to resume full operations, according to a statement issued Friday evening, March 27, by the Illinois Environmental Protection Agency.
The IEPA said test results conducted on new emissions equipment Medline had installed were operational and allowed the facility to operate in compliance with strict new state EtO emissions rules.
"... The facility is authorized to resume full commercial sterilization operations," the IEPA said in the March 27 release.
Medline said the new emissions equipment cost $10 million.
“The investment in Waukegan is part of our dedication to the health and safety of Medline employees and our neighbors,” said Medline spokesperson Jesse Greenberg in a prepared statement. “Illinois is leading the nation with the most stringent ethylene oxide emission standards in the country. At this critical time for the national public health, we are gratified that we can help supply sterile medical equipment to Illinois healthcare professionals working on the frontlines and to clinicians battling COVID-19 across America.”
Medline said medical devices sterilized at the Waukegan plant "are used to treat patients with the coronavirus or prevent its spread." The items include PPE, including gowns and drapes, as well as medical devices like syringes, tubing and oxygenators.
The new state EtO rules that had kept Medline's plant offline for three months amid the COVID-19 outbreak were set in 2019 in a state law passed amid public pressure to compel the closure of a sterilization facility operated by Sterigenics in west suburban Willowbrook.
The Willowbrook Sterigenics facility has remained shuttered since February 2019, when the Pritzker administration first ordered it closed over emissions concerns. Sterigenics challenged that order, calling it illegal and unconstitutional. The company has noted repeatedly no government agencies have ever accused them of violating state or federal emissions rules.
Last summer, Sterigenics ultimately reached a deal with the Illinois Attorney General’s Office, which would have allowed them to reopen, subject to a raft of stringent emissions regulations and inspection requirements. However, the company ultimately said it was withdrawing from Illinois altogether, amid continued efforts by activists and certain state elected officials to block them from reopening, despite the settlement with the state government.
Both Sterigenics and Medline are the target of a host of personal injury lawsuits in Cook County Circuit Court over their use of EtO.
Following initial publication of this article, spokespeople for the Illinois state COVID response team issued a statement on Saturday night, March 28, concerning the status of the former Sterigenics facility in Willowbrook.
The statement said: "The Sterigenics facility in Willowbrook has not been in operation in over a year, and the company previously stated that its operations in Willowbrook are ceased permanently.
"The IEPA has received no requests from government entities or the company to explore any modification of the facility’s current status."