Sterigenics won a temporary restraining order today against Cobb County, Ga., allowing it to resume normal operations at its Atlanta medtech sterilization plant for two weeks.
Oak Park, Ill.-based Sterigenics filed suit in U.S. District Court in Atlanta on Monday. The company temporarily shut the Atlanta plant on August 26 to voluntarily upgrade emission controls for ethylene oxide (EtO), the carcinogenic gas it uses 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 personal protective equipment for healthcare workers spurred the company and the FDA to pressure county officials to allow the plant to reopen.
Last week, county officials issued an order allowing the company to reopen the plant for 21 days to sterilize only PPE for healthcare workers to use during the COVID-19 pandemic.
“Sterigenics is pleased the court has granted our emergency request for a temporary restraining order
to allow us to fully resume the safe sterilization of medical products and supplies in Atlanta,” the company said in a statement emailed to Medical Design & Outsourcing. “This ruling enables Sterigenics to serve the urgent needs of health care workers and patients, without product limitation, as we begin the proceeding to establish our right to continue the safe operation of our longstanding facility in the interests of public health.”
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.