Sterilization Facility Shutdown Sparks Device Shortage

Matt Haller put up a good fight.

But he was no match for the cancer that sprouted in his stomach and ravaged his entire body, eventually reducing him to a skeletal 100 pounds. In his final days on Earth, Haller found joy in the simple things: travel memories, family time, and confessions from total strangers.

The latter perhaps brought him the most joy (aside from his wife and 4-year-old son), as those persons unknown helped validate Haller’s concerns about the public health hazards of a medical device sterilization plant in his suburban Chicago neighborhood.

“I couldn’t be happier,” Haller, 45, told CBS television station WBBM days before his March 16 death. “It’s what it’s all about for me now. Whistleblowers, come forward. Tell your story. Tell us what you know, and let’s fight. Let’s fight for this community. Please.”

And come forward they did, spilling tales of excessive gas emissions and routine safety shortcuts at the Willowbrook, Ill.-based facility owned by Sterigenics, a global provider of sterilization solutions and consulting services. Whistleblowers (mostly former employees) spoke of numerous ethylene oxide (EtO) leaks at the plant and said the firm frequently released EtO residue into the public sewer system.

“They just figured we would just go along with orders,” former worker Mike Morales told WBBM in February.

Sterigenics, however, denied the whistleblowers’ allegations, calling them “false” and “misleading” in a Feb. 22 statement to WBBM. That statement also refutes Morales’ accusation about dumping EtO residue into sewers. “Sterigenics never intentionally allowed EO to be released in any illegal manner and any reporting that implies otherwise is simply wrong,” the company contended. “…allegations of dumping waste into the sewer are at best a mischaracterization of an authorized process of discharging certain waste materials into the sanitary sewer for treatment at municipal waste treatment facilities. This process was not only authorized but also disclosed to the local sanitation district. Importantly, this authorized practice no longer takes place.”

Maybe not, but federal lawmakers and local residents are nevertheless gunning for a criminal investigation into the company and the permanent closure of its sterilization plant. In mid-February, the Illinois Environmental Protection Agency (IEPA) shut Sterigenics’ Willowbrook facility down after testing showed high concentrations of ethylene oxide in downwind residential neighborhoods; the company called the move “indefensible,” particularly since the IEPA acknowledged that Sterigenics complied with applicable environmental regulations at the time of the shutdown, including the National Emission Standard for Hazardous Air Pollutants. Nevertheless, since the closedown, average detectable gas levels have fallen by 50 percent and in some instances, as much as 97 percent, according to the U.S. Environmental Protection Agency (EPA).

Sterigenics’ operations have been under state and federal microscopes for nearly two years now, as environmental officials attempt to determine the potential health risks of ethylene oxide, an easily absorbed carcinogen. Last summer, the EPA estimated the cancer risk along one census track near the Sterigenics facility to be more than nine times higher than the national average. An Illinois Department of Public Health (IDPH) report released in March drew a similar conclusion, finding higher-than-expected rates of certain cancers in women and girls living in west suburban Willowbrook. Although the report cited other studies linking EtO to breast cancer, lymphomas, and leukemia, it also acknowledged differences and inconsistencies in results between genders, across the study area, and among cancer types. Additionally, the IDPH analysis noted that “none of the three lymphohematopoietic cancers that previous studies have found to be associated with EtO…were found to be increased in either males or females.”

Not surprisingly, Sterigenics used those inconsistencies to disarm its critics. “…given the numerous ‘differences and inconsistencies’ highlighted in the report, it is unreasonable to use the findings as evidence of any link between EtO, Sterigenics, and the incidence of cancer in the Willowbrook area,” the company said in a March 29 statement. “The misinformation regarding EtO and Sterigenics has unnecessarily caused fears among the Willowbrook community and resulted in a shutdown of our Willowbrook facility, causing serious negative consequences for the patients who rely on the critical medical products and devices sterilized there.”

Negative consequences, indeed: The sudden plant closure left device makers scrambling to avoid product shortages over the last two months. Larger OEMs coped better in the crisis than their smaller counterparts, largely because they work with multiple sterilization providers and can adequately compensate for the loss. Medtronic and BD, for example, found alternative sterilization services, though the former still braced for “supply challenges” in its surgical innovations business.

Small and midsized firms, on the other hand, ran into some trouble: MedGyn fell behind in aspiration kit deliveries, French contrast agent manufacturer Guerbet forecast limited availability of several power injectors, and Cardinal Health reported a five-month gap in the availability of its Kendall ACCU-TRACE intrauterine catheter.

The crisis took a turn for the worse on April 12 when the FDA linked the shutdown to the shortage of a tracheostomy tube made by Smiths Medical. FDA executives said the company is currently using an alternative sterilization facility, and they expected the Bivona tube shortage to be alleviated the week of April 22.

“While there are other FDA-cleared silicone tracheostomy tubes for pediatric patients, there may not be enough available to adequately cover the shortage,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We recognize the challenges this shortage imposes…and are working to limit the impact to patients by helping the company quickly move their sterilization to another facility.”

That move can’t come soon enough for Smiths Medical and its Bivona patients.

Too bad it couldn’t have come in time for Matt Haller.