FDA considering additional regulatory actions to reduce duodenoscope risks
Editor's Note The Food & Drug Administration on April 16 announced it is considering additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes. The FDA is also working with manufacturers of disposable duodenoscopes that would make reprocessing…
FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples
Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…
FDA orders manufacturers to stop selling gynecologic mesh
Editor's Note The Food and Drug Administration (FDA) on April 16 announced that it had ordered manufacturers of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the US, immediately. The FDA has determined that manufacturers, Boston Scientific and Coloplast,…
FDA continues efforts to assess duodenoscope contamination risk
Editor's Note The Food & Drug Administration (FDA) on April 12 announced that it is taking steps to implement additional regulatory actions, including consulting with federal health experts, on how to reduce the risks of contamination and infections linked to duodenoscopes. The agency is also collaborating with manufacturers of disposable…
FDA issues statement on trach tube shortages
Editor's Note The Food & Drug Administration on April 12 issued a statement about the agency’s efforts to mitigate the shortage of Smiths Medical’s Bivona tracheostomy tubes, especially the pediatric tubes. The shortage is a result of the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and there…
FDA: Class I recall of Brainlab Spine & Trauma 3D Navigation Software
Editor's Note The Food & Drug Administration (FDA) on April 15 identified the recall of Brainlab's Spine & Trauma 3D Navigation Software as Class I, the most serious. The Software is being recalled because of the potential for incorrect information to display during surgery, which may prevent the surgeon from…
FDA to require label changes on how to safely decrease opioids in physically dependent patients
Editor's Note The Food & Drug Administration (FDA) on April 9 issued a Drug Safety Announcement saying it has received reports of serious harm in patients who are physically dependent on opioid pain medications and suddenly have them discontinued or rapidly decreased. Because of these reports, the FDA is requiring…
FDA issues statement on review framework for AI-based devices
Editor's Note The Food & Drug Administration (FDA) on April 2 issued a statement announcing steps toward a new, tailored review framework for artificial intelligence (AI)-based medical devices. AI and machine learning have the potential to transform the delivery of healthcare, with earlier disease detection, more accurate diagnoses, more targeted…
FDA addresses potential medical device, product shortages amid shutdown of sterilization facility
Editor's Note The Food & Drug Administration on March 26 said it will take steps to address potential medical product and device shortages because of the recent closure of a large contract sterilization facility, Sterigenics (Willowbrook, Illinois). Earlier this year, the Illinois Environmental Protection Agency issued an order to stop…
FDA issues Safety Communication on cybersecurity vulnerabilities in Medtronic cardiac devices
Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…
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