The US FDA says the closing of a medical device sterilization facility in Illinois has led to a shortage of tracheotomy devices made for children. The agency is working with the manufacturer, Smiths Medical, to ensure the devices are back on the market as soon as possible.
The agency recently warned device-makers about possible downstream devices shortages after two major ethylene oxide sterilization facilities were closed or closing due to public safety. The chemical used to clean medical products is also dangerous in greater concentration to people in surrounding areas and was found to be present at higher levels around the facilities, requiring their closure under Environmental Protection Agency regulations