* Atlanta Journal-Constitution…
The federal Food and Drug Administration sent a letter to Gov. Brian Kemp this week urging Georgia to allow a controversial sterilization plant in Cobb County to reopen amid the ongoing COVID-19 pandemic.
Sterigenics, near Smyrna, has been shuttered since summer. It is one of a handful of facilities permitted to use the carcinogenic gas ethylene oxide to sterilize single-use medical devices.
The letter, which was obtained and published by the Cook County Record in Illinois, cites the current shortage of “personal protective equipment” (PPE) such as gowns, respirators, masks, and gloves as a compelling reason to allow the plant to resume operations.
“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,” it reads. “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.”
* Cook County Record…
Amid a sustained threat of continued legal and regulatory action from the state, activists and trial lawyers, Sterigenics opted not to attempt to reopen the Willowbrook facility, despite reaching a deal with the Illinois Attorney General’s office that should have allowed it to do so, subject to emissions controls and other requirements even more strict than those set in Illinois’ new EtO law.
At the same time, a sterilization facility operated by medical device maker Medline in suburban Waukegan also remained offline, after Medline voluntarily pulled the plug on the sterilization facility late last year to meet new EtO emissions standards set by a new Illinois state law in 2019, in response to concerns over Sterigenics’ alleged actions.
In a statement, the FDA declined to answer whether it had sent a similar request to the state of Illinois concerning its shuttered EtO plants.
However, the agency said: “In the face of this rapidly evolving National Public Health Emergency, there is increased need for certain essential medical devices that require sterilization. We understand that sterile PPE are rapidly falling in short supply. Therefore, the FDA is seeking assistance from state and local governments as well as from facilities to increase the supply of PPE needed for healthcare personnel to protect against COVID-19.”
I asked the governor’s office if the FDA has made a similar request of Illinois and was told it has not heard from the agency about this.