There is a national shortage of tracheostomy tubes, including ICU Medical's Bivona tubes, and the dearth is more likely to affect pediatric patients because there are few alternative products, the FDA said Oct. 31.
Tracheostomy tubes are used in surgical procedures that slice into a person's trachea to create an airway. To offset the shortage, the FDA recommended sanitizing and reusing the tubes up to five times for pediatric sizes and up to 10 times for adult sizes. The agency also suggested providers employ "conservation strategies" and ask their suppliers about other FDA-approved options.
The struggle to obtain raw materials is causing the shortage.
"While there are other FDA-cleared tracheostomy tubes for pediatric patients, there may not be enough available to adequately mitigate the shortage," the agency said. "The FDA is working closely with manufacturers and other stakeholders to help quickly resolve supply challenges and support availability of these critical devices for patients who need them."
The FDA tapped HHS' Administration for Strategic Preparedness and Response to help manufacturers secure more raw materials and boost the product's supply.
On the same day, the FDA also warned of a shortage of Philips Invivo MRI breast biopsy grid plates and recommended healthcare workers to consider "alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures." The grid plates are in short supply because of shipment delays and the shortage is expected to last through 2022.