Unfounded scare over Sterigenics results in shortage of breathing tubes for children
A medical breathing tube most suitable for children is in short supply due to the shutdown of the Sterigenics plant in Willowbrook, the Food and Drug Administration (FDA) said in a statement.
“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., the FDA’s director of the Center for Devices and Radiological Health said. “We recognize the challenges this shortage imposes for these pediatric patients who need access to new tubes now, and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility.”
The Illinois EPA shut down the Sterigenics plant in February due to trace levels of ethylene oxide (EtO), used in the plant to sterilize medical equipment, detected in the air near the plant. News reports have characterized EtO as a cancer causing chemical, but company officials and air quality experts have repeatedly said that the minimal levels of EtO detected in the Willowbrook area pose no danger to residents. Use of EtO, moreover, is the only approved sterilization method for many medical devices.
“For many medical devices, sterilization with ethylene oxide may be the only method that properly sterilizes and does not damage the device during the sterilization process,” FDA spokesperson Stephanie Caccomo told the DuPage Policy Journal. “Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide.”
Caccomo said the agency is working with medical device manufacturers to “quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility in order to mitigate potential product supply issues.”
The FDA hopes to have the tubes available again the week of April 22.