On October 30, 2019, the Illinois House of Representatives voted to approve legislation that would effectively ban the use of ethylene oxide, which is a chemical used for sterilizing the majority of medical devices found in hospital operating rooms and other health care settings. In moving forward with the legislation, Illinois lawmakers rejected warnings from federal health care regulators and medical device and surgical tool manufacturers that the measure would lead to shortages of properly sterilized health care tools. To lawmakers, however, the legislation is necessary in response to emission concerns from medical device sterilization plants in Illinois linked to an increased risk of cancer in those living nearby.
The legislation still must win approval in the Illinois State Senate and then be signed by Gov. J.B. Pritzker who has already committed to signing ethylene oxide restrictions passed by the state’s General Assembly.
The Illinois legislation comes on the heels of the decision by medical device sterilizer Sterigenics to withdraw from Illinois amid an uproar over allegations ethylene oxide emissions from its plant in suburban Willowbrook elevated the cancer risk in that town and surrounding communities. Other medical companies operating in Illinois have warned that if the new law is ultimately passed, they will also be forced to close their facilities, thereby placing the sterilized health care products supply chain at risk.
Opponents of the legislation include six doctors’ groups, including the American College of Cardiology, the Society of Interventional Radiology, American Society for Gastrointestinal Endoscopy, Society for Thoracic Surgeons, Heart Rhythm Society and Society for Cardiovascular Angiography & Interventions, which all signed a letter to the FDA warning of shortages of key surgical tools, pacemakers, cardiac catheters, stents and “other supplies and equipment used in the care of cardiovascular patients.” According to the six doctors’ groups, the supply of these devices relies heavily on ethylene oxide “for proper sterilization to ensure patient safety.”