FDA Acknowledges Shortage of Breathing Tubes Due to Sterilization Shutdown

FDA acknowledged on Friday that there is a temporary shortage of a type of tracheostomy tube manufactured by Smiths Medical, a device that many high-risk kids and some adults depend on to help them breathe. As MD+DI reported on April 9, the shortage of the Bivona trach tubes is the direct result of a sterilization plant in Illinois being shut down. At that time, FDA had not yet commented on this shortage, although the agency had warned of potential shortages due to the closure and the planned closure of a similar facility in Michigan. Smiths Medical previously sent the tracheostomy tubes to Sterigenics' Willowbrook, IL facility for ethylene oxide (EtO) sterilization, but the Illinois EPA recently issued a seal order at that facility after finding dangerously high levels of the gas in the air around the facility. Viant Medical, another contract sterilizer, also plans to close its EtO sterilization facility in Grand Rapids, MI after receiving attention from the Michigan Department of Environmental Quality for air quality issues. According to Smiths Medical, Bivona tubes can be cleaned and sanitized at home for up to 10 re-insertions for adult sizes or up to five times for neonatal and pediatric sizes. "I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them a...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Source Type: news