Following the Seal Order issued by the Illinois EPA to shutdown Sterigenics operations on February 15, CDRH is alerting medical device manufacturers that there may be a potential impact to device supply. The problem surrounds the shutdown of the Sterigenics facility in Willowbrook, Illinois, which sterilizes products using ethylene oxide (EtO). The Illinois EPA found alarming levels of EtO emissions in the surrounding residential and commercial areas—“2.1 micrograms per meter3 and 9.1 micrograms per meter3, respectively”—according to a news release from the EPA. These emissions have been a significant cause for concern for some time, as discussed in a recent article in the Chicago Tribune. EtO is an EPA-classified carcinogen and its emissions have been linked to cancer—most specifically lymphoma, leukemia, and stomach and breast cancer, according to the National Cancer Institute.
How does the Sterigenics facility shutdown affect medical device manufacturers? Approximately 90% of the products sterilized at this particular facility are medical devices, according to the FDA. Although the agency is unaware of medical device shortages connected to this issue, it “believes that more than 100 manufacturers and hundreds of devices may be affected,” according to an FDA statement. It is contacting manufacturers who may be affected by the Sterigenics Willowbrook facility shutdown. CDRH has advised that PMA holders who are affected and plan to use a different facility for product sterilization submit a 180-day site change supplement. 510(k) holders with the same intentions generally do not need to submit a new 510(k), the agency states. In addition, if device manufacturers anticipate a potential device supply shortage, they are urged to report the shortage or supply issue to FDA.
How is Sterigenics responding? The company has called the Illinois EPA’s actions “indefensible”, stating that it is compliance with all state permits and regulations. “Unilaterally preventing a business that is operating in compliance with all state permits and regulations from carrying out its vital function sets a dangerous precedent. The Illinois EPA’s decision will place the health and lives of thousands of patients who rely on the critical medical products sterilized at Willowbrook at risk,” according to a Sterigenics statement released on February 15. Sterigenics has released several statements in defense of the recent developments affecting the company facility. In response to an email sent by CBS Chicago investigative reporter Dave Savini, the company called the EPA’s air sampling “flawed” and stated that people living in Willowbrook have been misinformed for months about how Sterigenics uses EtO to sterilize medical devices. “EO is the only method approved by the Food and Drug Administration (“FDA”) to sterilize millions of critical medical devices. Without sterilization of these devices, individuals needing medical care would face life-threatening infection. By complying with and going above and beyond what the regulations require, the Sterigenics Willowbrook facility safely uses EO and provides a vital service to patients in Illinois and across the country,” according to the Sterigenics statement dated February 1.