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Judge, Georgia County OK Medical Sterilizer Use in Pandemic (1)

April 8, 2020, 11:58 PMUpdated: April 9, 2020, 4:08 PM

A federal judge says a medical sterilizer company in suburban Atlanta can continue indefinitely to use carcinogenic ethylene oxide to clean critically needed medical equipment.

And Cobb County acknowledged after the ruling Wednesday that it has agreed to let Sterigenics resume normal operations using the dangerous chemical throughout the course of the pandemic, as long as emergency orders are in place.

Judge William M. Ray II of the U.S. District Court for the Northern District of Georgia signed an order Wednesday that allows Sterigenics U.S. LLC to continue sterilizing protective gloves, gowns, and masks, as well as medical equipment like catheters and intravenous pumps, tubes, and syringes. The order supersedes the one issued April 1, which only allowed the Illinois-based medical sterilizer company to resume normal activities until mid-April.

The judge’s latest order, coupled with the county’s statement, means the facility could continue to clean the equipment as health care workers scramble to overcome equipment shortages.

“The County has mutually agreed with Sterigenics to maintain the status quo under the existing Temporary Restraining Order (TRO) while the ongoing pandemic health crisis and emergency orders are in place,” the county said in a statement.

Sterigenics said: “We are pleased the Court has entered the order to continue the safe sterilization of vital medical products and devices at our Atlanta facility.”

Since the coronavirus outbreak, hospitals and clinics have found themselves short of sterilized medical equipment.

Ray has said he will continue to weigh the complaints that Sterigenics lodged March 30 against Cobb County’s Nicholas Dawe, the fire marshal, and Kevin Gobble, the chief building manager. But his order Wednesday allows the company to operate fully at least until the lawsuit is settled.

Ethylene Oxide Dangers

The company alleged Cobb County illegally prevented it from using its plant to “provide FDA-approved sterilizations for essential medical products,” which it says are needed to fight the coronavirus pandemic.

Ethylene oxide is found naturally in ambient air, but prolonged exposure to higher concentrations can harm the brain and nervous system, and potentially cause cancer.

“The County stands behind the work exhibited by our Fire Marshal and Chief Building Official in their continued efforts to protect the County’s public from potential hazards and harms regardless of origin,” county spokesman Ross Cavitt said in an email. “Public Safety has always and will remain the County’s focus regarding this issue.”

Sterigenics’ lawsuit stemmed from Cobb County’s March 25 order that allowed the company—which had been shut down since August over the ethylene oxide issue—to temporarily reopen, but at first only to sterilize masks, gowns, and gloves. The March 25 order didn’t let the company use ethylene oxide to sterilize IV sets, catheters, and syringes, as the company had demanded and later received permission to do.

State regulators told Sterigenics on April 1 that it can continue to operate with the upgraded emissions controls it already has installed to capture fugitive releases of ethylene oxide into the nearby community. Sterigenics said it’s continuing to operate its plant safely while preparing to test the pollution controls under protocols set by the Georgia Environmental Protection Division.

The case is Sterigenics U.S. LLC v. Cobb County, Ga., N.D. Ga., No. 20-01382, 4/8/20.

(Updated last paragraph with the current status of Sterigenics operations in Georgia.)

To contact the reporter on this story: Amena H. Saiyid in Washington at asaiyid@bloombergenvironment.com

To contact the editors responsible for this story: Gregory Henderson at ghenderson@bloombergenvironment.com; Chuck McCutcheon at cmccutcheon@bloombergenvironment.com

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