Sterigenics has sued the government of a Georgia county to force a permanent reopening of the company’s Atlanta medtech sterilization plant.
Officials of Cobb County, Ga. recently gave Sterigenics permission to reopen the plant for 21 days to sterilize personal protective equipment for healthcare workers treating COVID-19 patients. Sterigenics had told county officials it has 200 truckloads of PPE outside its plant awaiting sterilization. Before the plant closed, it sterilized thousands of gowns and hundreds of thousands of IV tubing sets per day, as well as other essential products, according to the company.
Oak Park, Ill.-based Sterigenics temporarily shut the Atlanta plant on August 26 to voluntarily upgrade emission controls for ethylene oxide (EtO), the carcinogenic gas it used to sterilize medical devices. In September, Cobb County officials declared the Atlanta plant a “high-hazard” industrial facility that must meet stiffer fire safety regulations than it needed to under its previous designation as a storage facility.
But the spread of COVID-19 and the need for PPE spurred the company and the FDA to pressure county officials to allow the plant to reopen.
Sterigenics says the upgrades are complete and wants to the plant to resume normal operations.
“Cobb County officials have manufactured baseless certificate of occupancy claims in order to close a
longstanding, lawfully operating facility,” the company said in a news release. “The county’s actions are illegally prohibiting a facility that outperforms both state and federal regulatory standards from operating, preventing millions of essential and lifesaving medical products from reaching health care providers for use in patient care.”
Sterigenics maintains that the county’s stance that the plant only holds a certificate of occupancy for a storage facility is false and that it has complied with all fire and building codes that should allow it to resume normal operations.
The U.S. Department of Health & Human Services is also pressuring the county to allow the Atlanta plant to begin sterilizing more than just PPE. HHS Secretary Alex Azar said in a letter last week that the need for PPE will “extend significantly beyond” 21 days and that Sterigenics should be allowed to sterilize other items like catheters, syringes, IV sets and ventilator components like tubes, filters, and masks.
“We don’t think that one county should be allowed to jeopardize the nation’s response to an unprecedented national pandemic,” Azar wrote. “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.
“We hope you will use whatever communication channels you have to encourage the county to expand the decree to full production of all medical items and extend it until the nation’s threat and need is over,” Azar added. “Conversations on next steps from the federal government are occurring at the highest levels, should the situation not change.”
Boyce said he stands by his order. The county declined to comment directly on the lawsuit.
