On November 1, 2019 Crain’s Chicago Business published an op-ed “It’s time for Illinois to protect residents from this cancer-causing agent” by Nancy C. Loeb.
Ms. Loeb’s misleading op-ed included a number of misstatements on the use of Ethylene Oxide (EO) for medical device sterilization that need to be corrected.
In her op-ed, Ms. Loeb states “there are several other methods for sterilizing medical equipment”, and provides a link to a FDA Sterilization Guidance document. But this claim and the link to the FDA is misleading. The FDA clearly addresses the possibility of alternative sterilization methods in an October 25th statement from FDA Acting Commissioner Norman Sharpless:
“It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”
In addition, the concern about trace ethylene oxide from these plants is misguided and unsupported by science. EO sterilization plants go above and beyond federal law, using the best available technology to destroy and abate EO emissions. Toxicologists confirm that the air around these plants poses no threat to public health whatsoever.
This summer Governor Pritzker signed into law the most restrictive limits on Ethylene Oxide emissions, requiring companies to install the most advanced pollution control equipment available.
Despite passing this legislation, Illinois lawmakers are considering additional legislation (HB 3888 and SB 0557) that could effectively close the remaining EO sterilization facilities in Metro-Chicago which may quickly lead to real harm for Illinois patients and patients throughout the Midwest.
The FDA’s October 25th statement alerts the public and policy makers about the FDA’s growing concerns about the future availability of sterile medical devices and impending medal devise shortages related to the closure of facilities in Illinois and Georgia.
Without adequate availability of EO sterilization facilities, the FDA anticipates national shortages of surgical kits used in emergency and routine procedures along with other critical devices including feeding tubes used in neonatal intensive care units, drug-elating cardiac stents, catheters, shunts and other implantable devices. This statement and the potential impact of passing legislation that could close these facilities was not included in Ms. Loeb’s op-ed.
Illinois already passed legislation this year to address emissions from EO sterilization facilities and the chemical is fundamentally safe at very low levels of exposure which occur every day from a variety of other sources.
Additional legislation is not needed, and it could pose a real threat to Hospitals and patients in Illinois.