Georgia Permits Shuttered Sterilization Facility to Reopen to Help Fight Pandemic

Sterigenics is back in business in Georgia.
 
For the time being, anyway.
 
Last week, the Cobb County Board of Commissioners signed an emergency order that temporarily permits Sterigenics LLC to reopen its shuttered sterilization plant and begin sterilizing personal protective equipment (PPE) to combat the COVID-19 pandemic. The company apparently has 200 truckloads of PPE outside its Cobb County facility awaiting sterilization, according to the March 25 decree.
 
The order makes it clear that Sterigenics’ restart is only temporary; officials said the authorization to begin operations again was “due to the unprecedented challenge” of COVID-19. “This limited emergency authorization for sterilization of PPE…is granted so as to promote and secure the safety and protection of the civilian population during the public health emergency,” the order states. “This…authorization does not grant a right to perpetual operation, constitute a valid certificate of occupancy, or authorize continued sterilization upon the expiration or termination of the local Declarations of Emergency.”
 
Cobb County officials said Sterigenics completed a negative air pressure test of its facility on March 23, and a Georgia Environmental Protection Division (EPD) inspection concluded the system “appeared to be working as designed.” The limited use authorization restricts the amount of EO permitted on site and provides for immediate reporting of any incident at the facility.
 
Cobb County (an Atlanta suburb) granted Sterigenics permission to temporarily restart operations on the same day Georgia’s Environmental Protection Division (EPD) modified a legal settlement with Becton Dickinson and Company (BD) that allows the firm to sterilize more medical devices with ethylene oxide (EO). The amendment temporarily increases the number of medical devices BD is allowed to sterilize and allows BD to make temporary changes to its aeration time. This change increases the limits on product lots sterilized per month from 600 to 825 in Covington and from 603 to 685 in Madison and modifies the minimum heated aeration period for sterilized product from 24 to 20 hours at the Covington facility.  These changes are necessary, according to the EPD, to ensure hospitals have enough sterilized medical devices available to treat the influx of COVID-19 patients. The equipment sterilized at these facilities of specific concern include Foley catheter procedural trays, Foley catheters, PICC line catheters, and acute dialysis catheters.   
 
The changes to BD’s device sterilization load and aeration time also are temporary, set to expire within two weeks after the end of the coronavirus pandemic. BD is presently installing new, more effective pollution control devices at its Covington and Madison plants, which will reduce emissions and will be placed in operation as soon as installation is complete.   
 
“I commend the swift actions by Governor Kemp and the Georgia EPD taking the necessary steps to increase the nation’s capacity to sterilize critically needed life-saving medical equipment and protect our heroic healthcare workers and their patients. This federal, state and local collaboration is a great example of the whole of government approach we are taking to address COVID 19,” EPA Administrator Andrew Wheeler said on March 25. “While we must take into account the risks from emissions of ethylene oxide, and addressing those risks remains a major regulatory priority for the agency, it’s important to bear in mind those risks are linked to exposure over an entire lifetime—over a 70 year period – however, COVID-19 poses an immediate threat to our nation during this crisis.”
 
Both Sterigenics and BD and other sterilization companies have been at the center of a growing national controversy over the toxicity of EO emissions. A public outcry in Illinois prompted Sterigenics to completely close its facility there (in Willowbrook).