Pressure mounts to reopen Sterigenics Ga. plant to address pandemic

Under pressure from the FDA, officials in Cobb County, Ga., may allow Sterigenics to reopen a medical device sterilization plant sooner than expected to address the coronavirus pandemic.

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.

On March 17, the company asked county officials to let it reopen the plant so it could resume sterilizing products needed to care for coronavirus patients and protect healthcare workers. For example, Sterigenics said more than 1 million protective gowns previously sterilized at the Atlanta facility are awaiting sterilization before they can be used.

Then FDA commissioner Dr. Stephen Hahn asked Georgia Gov. Brian Kemp in a letter on March 19 to allow the plant to reopen to sterilize personal protective equipment (PPE) needed by healthcare workers and patients.

“Due to the recent challenges with the closure of some commercial sterilizers, such as the Sterigenics facility located in Cobb County, the supply of critical PPE during the COVID-19 outbreak has been further limited,” Hahn wrote. “FDA is asking for your assistance in helping to increase the supply of PPE to help protect against COVID-19 by working with Sterigenics to allow for the appropriate sterilization of PPE.”

Cobb County officials said yesterday that they will allow Sterigenics to begin negative air-pressure testing at the plant, but warned that the test “does not involve the use of ethylene oxide and is not a prelude to the facility re-opening.”

“We recognize that Sterigenics could assist the community in combating COVID 19,” said county manager Rob Hosack in a statement on the county’s website. “However, several critical steps must be completed before Sterigenics can safely reopen and comply with fire safety codes and other county ordinances as has been shared with Sterigenics.”

Sterigenics may conduct this testing in the next few days, the results of which will go to the state Environmental Protection Division officials who will then analyze the results, Hosack added. The county is also awaiting the results of a third-party expert’s investigation into Sterigenics’ operation and how the facility can comply with the latest fire codes.

“We understand the gravity of the current situation,” Hosack said, “but we also need to ensure the safety of our residents and with that in mind we need to carefully move forward.”

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 (Environmental Protection Division) 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).”

Sterigenics noted last week that more than 1 million protective gowns previously sterilized at the Atlanta facility are awaiting sterilization before they can be used. The company also said that it developed a safe method for rapid mask sterilization in China at the request of the Chinese government, and that it can replicate that solution in Atlanta. 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.

“Sterigenics looks forward to completing the negative air pressure test at our Atlanta facility which we are confident will demonstrate the effectiveness of the enhancements we have installed to our emissions control systems,” the company said in an email to Medical Design & Outsourcing. We are committed to moving quickly to finalize the remaining requirements in order to safely resume sterilization of vital medical products, including IV sets, breathing tubes, personal protective equipment and other items required in the battle against COVID-19.”

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