In a recent announcement, the U.S. Food and Drug Administration (FDA) provided updates on various topics related to healthcare and medical devices. Here are the key highlights:
Oxygenator Device Recall: The FDA issued a letter to healthcare providers and facilities regarding a recall notice by Getinge/Maquet for Quadrox Oxygenators. The letter includes recommendations for healthcare providers, updates on the FDA’s actions to address the issue, and contact information for reporting any issues with oxygenators.
Expanded Indication for Inspire UAS System: The FDA approved an expanded indication for the Inspire Medical Systems’ Inspire Upper Airway Stimulation (UAS) System. The device, which is an implantable nerve stimulator, is now indicated for adult patients with moderate to severe Obstructive Sleep Apnea (OSA) with an apnea hypopnea index (AHI) baseline of 100 and a body mass index (BMI) level of 40. The device helps maintain an open airway during sleep.
Updates to Medical Device Shortages List: The FDA updated its Medical Device Shortages List webpage, including the removal of certain devices from the list, changes to estimated shortage durations for some devices, and the discontinuation of certain devices. The FDA provides information on how it determines when to remove product codes from the device shortage list.
New Tests for Alzheimer’s Disease: The FDA cleared for marketing the Elecsys Total-Tau Cerebral Spinal Fluid (CSF) and Elecsys ß-Amyloid (1-42) CSF II tests for the detection of amyloid plaques, which are abnormal accumulations of β-amyloid in the brain. These tests are intended to be used in conjunction with other clinical assessments to help healthcare providers determine whether a patient has Alzheimer’s disease (AD).
Report on Drug Shortages: The FDA sent its Report on Drug Shortages for Calendar Year 2022 to Congress. The report summarizes major actions taken by the agency to prevent or mitigate drug shortages in the U.S. Despite challenges related to quality issues, capacity constraints, and increased demand due to the COVID-19 pandemic, the FDA helped prevent 222 potential shortages during the year.
2023 Science Forum: The FDA will host the 2023 Science Forum on June 13-14. The virtual event will feature talks from FDA science experts under eight topics related to regulatory science discoveries. The forum is open to the public, and attendees can access downloadable content and participate in virtual poster sessions.
Overall, the FDA’s recent updates cover a range of important topics, including medical device recalls, expanded indications for sleep apnea treatment, drug shortages, and advancements in regulatory science. These updates reflect the agency’s efforts to ensure the safety, effectiveness, and security of healthcare products and address emerging challenges in the industry.
