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FDA asks Georgia to reopen Sterigenics plant, but hasn’t yet approached Illinois

Monday, Mar 23, 2020

* 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.

- Posted by Rich Miller        

8 Comments »
  1. - JB13 - Monday, Mar 23, 20 @ 1:32 pm:

    Maybe someone could ask the governor if he would be willing to ease the process a bit to let sterilization facilities open? Sterigenics is no saint in this (far from it), but PPE is in short supply and the FDA believes sterilization plants are a chokepoint. After all, the FDA did warn the public several times last year, but no one listened.


  2. - Jilted - Monday, Mar 23, 20 @ 1:53 pm:

    Sterigenics used this very arguement to stay open .said very few did this neccessary and vital operation. Your turn jb


  3. - Med Sense - Monday, Mar 23, 20 @ 2:14 pm:

    If we can close down the economy for the greater good of society, we can open the Sterigenics plan to help protect the doctors and nurses on the front lines. Hearing of hospitals systematically sending their employees to the ER to get tested for COVID-19. Most are not wearing protective gear. A bad plan and without gear an easy way of crumping the entire health system fast. The Governor should order Sterigenics back in business ASAP.


  4. - thechampaignlife - Monday, Mar 23, 20 @ 2:28 pm:

    Easy to say reopen the EtO facilities, but what about the folks who live nearby who will get cancer?


  5. - Da Big Bad Wolf - Monday, Mar 23, 20 @ 2:52 pm:

    If Sterigenics can prevent people from getting one horrible disease without giving people another horrible disease in the process (and if we can trust but verify) they should go for it.
    That’s all anyone wanted from them anyhow.


  6. - Maestro - Monday, Mar 23, 20 @ 3:27 pm:

    If asked to reopen after being give the corporate death penalty without trial (and based on mere trial lawyer junk science), Sterigenics will likely tell Pritzker/Illinois to go cram it with walnuts


  7. - Challenges Abound - Monday, Mar 23, 20 @ 3:45 pm:

    Allowing these two EtO sterilization facilities in Illinois to reopen would be the fastest way to possibly re-sterilize “used” PPE equipment to help alleviate some of the hospitals and Governor’s concern over PPE shortages. For the foreseeable future, the PPE shortages only get more challenging without additional sterilization capacity. If FDA/CDC ask, it will pose quite a quandary for our leaders.


  8. - 17% Solution - Monday, Mar 23, 20 @ 5:15 pm:

    ==If asked to reopen after being give the corporate death penalty without trial (and based on mere trial lawyer junk science)==
    That’s not what happened. Sterigenics was given many chances to get their act together. They lied about fixing their equipment. They got caught by the EPA. People died. It has only been a year ago, too soon to assume everyone forgot.


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