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Monday, March 30, 2020

FDA: Sterilization plants needed to boost PPE supply vs COVID; activists question, resist call to reopen plants

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By Jonathan Bilyk | Mar 24, 2020

Stopsterigenics protest
Stop Sterigenics activists protest in August 2019 | Youtube screenshot

In the wake of a formal request to Georgia’s governor to reopen a shuttered medical device sterilization facility, officials from the U.S. Food and Drug Administration also met with representatives of a group of activists who have spearheaded a movement to close that facility and others the FDA believes are needed to produce equipment essential to protect doctors, nurses, first responders and others on the front lines of the fight against COVID-19.

However, in the days that followed the meeting, the activists, including leaders from an affiliated group based in the suburbs of Chicago, appear to have decided to continue to resist the call to reopen the facility, accusing Sterigenics, the company that owns the shuttered sterilization facility near Atlanta, which sterilizes gowns, masks and other protective gear and medical equipment, of attempting to “take advantage” of the nationwide health and economic crisis.

For nearly two years, activists with the group known as “Stop Sterigenics,” operating from chapters in Illinois and Georgia, have actively and loudly campaigned against the use of the gas known as ethylene oxide (EtO) to sterilize critical equipment and medical devices used in hospitals and other health care settings.

The activists launched their efforts in 2018, following the release of a federal assessment that linked EtO emissions from sterilization plants to increased cancer risk in the surrounding communities.

The anti-EtO campaign that began in Willowbrook in Chicago’s western suburbs eventually resulted in the closure of Sterigenics’ Willowbrook plant at the hands of the administration of Gov. JB Pritzker, and the shutdown of Sterigenics’ facility in Cobb County, Ga., at the behest of county officials there.

Also, another sterilization facility, operated by medical device maker Medline in Chicago’s northern suburb of Waukegan, also has been shut down since December, when the company took it offline voluntarily while it installed and tested new equipment to meet stringent new Illinois EtO limits.

Throughout that time, and particularly since mid-2019, the FDA and makers of medical equipment have warned continued efforts to shut down the sterilization plants over EtO emissions would lead to complications in the U.S. health care system. The FDA and medical device makers have repeatedly noted nearly half of all medical devices in the U.S., including PPE, is sterilized using EtO, and there is no viable substitute available now to replace EtO in sterilizing a large number of those devices, which would be damaged or not adequately sterilized by other sterilization methods. That, they said, increases danger for both patients and health care providers.

As the novel coronavirus outbreak has gripped the nation, the FDA has since noted those predictions have been borne out, as the sterilization plant closures have played a role in crimping the supply of personal protective equipment (PPE) needed by health care workers, paramedics and others responding to the national emergency.

On March 19, the FDA sent a letter to Georgia Gov. Brian Kemp, asking him to reopen the Cobb County Sterigenics plant to help alleviate the problem. The letter had been first obtained and published by The Cook County Record.

“Much of the PPE also requires certain sterilization,” said Commissioner of Food and Drugs Stephen M. Hahn, in the letter. “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.

“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.”

Sterigenics has also asked Cobb County officials to let it reopen its facility, saying it has at least 1 million PPE items awaiting sterilization, among a host of other medical devices used by hospitals to treat patients. The company said it has installed emissions control equipment, and is simply waiting on approval from bureaucrats in Cobb County and Georgia state government to let it begin sterilizing the needed PPE and other gear.

The company, for instance, claimed it sterilizes a quarter of all PPE used in the world, and asserted it had “developed a safe method for rapid mask sterilization in China” and that process “can be replicated in Atlanta.”

One day after FDA sent the letter to Gov. Kemp, the Stop Sterigenics group announced its leaders from Illinois and Georgia had been on “a call” with the FDA concerning the Cobb County Sterigenics plant, in a post to the group’s Facebook page.

The Illinois anti-Sterigenics leadership indicated in that post they would support their counterparts in Georgia “with whatever path they take.”

The Illinois group has been led publicly by lawyer Margie Donnell, of Westmont, and Sri Rao, of Willowbrook. 

The Georgia chapter is led by its president, Janet Rau.

On March 23, Stop Sterigenics Georgia announced their “path,” posting on their Facebook page a call to members to oppose any attempt to reopen Sterigenics, despite the FDA’s PPE request.

Cobb County announced on March 23 they would lift their months-long delay on allowing Sterigenics to begin testing their new emissions equipment. The county, however, stopped short of saying it would allow Sterigenics to reopen, according to a story published Monday evening by the Marietta Daily Journal.

The FDA declined to disclose what was discussed in the meeting with Stop Sterigenics, saying only “the FDA coordinates with multiple stakeholders on any impacts to medical device availability.”

The FDA also declined to state whether there would be further meetings with anti-EtO activists concerning official FDA communications to state and local authorities concerning the COVID-19 response effort.

According to the Marietta Daily Journal report, Rau said the FDA purportedly told the activists the “final decision” still lay with Gov. Kemp and Cobb County.

Rau and a Stop Sterigenics ally in the Georgia state legislature, Democratic State Rep. Erick Allen, also publicly questioned whether sterilization operations like those performed by Sterigenics were really needed for the PPE sought by the FDA and hospitals.

In a letter posted on his Facebook page, Allen asserted the FDA’s request amounted to improper federal “influence” in a matter involving “private business.”

He also asked whether the FDA has asked other states to similarly reopen other shuttered sterilization facilities.

In Illinois, political blogger Rich Miller at CapitolFax reported a spokesperson for Gov. Pritzker said Illinois had not yet received any such requests from the FDA regarding the state’s shuttered sterilization facilities.

Spokespeople for Illinois’ special COVID-19 response team did not reply to questions submitted Monday from the Cook County Record. Those included a question over what steps Illinois might take to assist sterilization facilities to meet the demand for PPE, identified by hospitals and others, including repeatedly by Gov. Pritzker himself during his daily COVID-19 press conferences and on appearances on national news programs, which he has used to routinely criticize the federal response to COVID-19 under President Donald Trump.

Gov. Pritzker has repeatedly said he would make increasing the supply of PPE available to Illinois health care workers and first responders among his top priorities during the COVID-19 crisis.

Despite a plea to construction businesses and other organizations to help meet the need for PPE, a spokesman for the Illinois Health and Hospital Association similarly did not respond to a question from the Cook County Record over whether the IHA would back a call to reopen sterilization plants in Illinois to help alleviate the need for PPE to protect health workers.

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Organizations in this Story

State of GeorgiaCobb CountyFood and Drug AdministrationSterigenicsIllinois Governor J.B. Pritzker

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