Sterigenics may reopen its Atlanta medtech sterilization plant for 21 days to sterilize personal protective equipment (PPE) needed by healthcare workers during the COVID-19 pandemic.
Cobb County officials announced the decision to allow the temporary reopening last night based on the county’s COVID-19 emergency declaration and conditional state approval of the results of negative-pressure air testing at the plant.
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.
While the plant has been closed, Sterigenics installed new controls to reduce EtO emissions “beyond already safe levels protecting employees and the community,” the company said on its website. “The Atlanta facility met or outperformed U.S. EPA and Georgia EPD regulations prior to the enhancements. Voluntary upgrades to the emission control system render it one of the most advanced sterilization facilities in the world in terms of capture and control of (EtO).”
“The limited emergency authorization, effectuated by the order, is only authorized due to the unprecedented challenge that we face,” Cobb County Commissioners chairman Michael Boyce wrote in last night’s order. “As of the date of this order, the greatest risk to the health, safety and welfare of society is the unabated spread of COVID-19 and the tremendous threat it places upon the healthcare system in the state of Georgia. Allowing the sterilization of critically needed PPE will assist in combating the exponential growth of COVID-19 and help equip our healthcare providers with the protection they need and deserve.”
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.
In a statement emailed to Medical Design & Outsourcing, Sterigenics said it will take immediate steps to resume sterilization of PPE, but it was not satisfied with the temporary reprieve.
“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,” the statement said. “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.”
Sterigenics added that it has invested “significant resources” to install voluntary upgrades to its emission control systems.
“Those enhancements have established our facility as one of the most advanced sterilization facilities in the world in terms of emission control, as demonstrated by our successful test on March 24, 2020. In addition, we have fully complied with the fire and safety review required by Cobb County, which is now in the county’s hands. That review required by the county further demonstrates that our facility is in compliance and safe,” the statement continued.” Sterigenics has met the demands of public officials by further enhancing a state-of-the-art facility that is safe. The only thing that remains is for the county to confirm that the facility may be re-opened for full operation to meet the urgent needs facing health care workers and patients. As we resume our operation on a limited basis, we are also working to fully resume all sterilization operations in the interest of protecting public health.”