The U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers recommending providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy due to the shortage of Philips Invivo MRI breast biopsy grid plates or other Philips Invivo MRI coil disposables.
The agency also issued a safety communication to alert patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited.
The FDA said it's working closely with manufacturers and other stakeholders to quickly help resolve supply challenges and support availability of these critical devices for patients who need them. People who use these tubes, including caregivers and health care providers, should consider the FDA’s recommendations listed in the safety communication.
