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…
FDA issues warning letters to two breast implant manufacturers
Editor's Note The Food & Drug Administration (FDA) on March 19 issued warning letters to two breast implant manufacturers (Mentor Worldwide LLC of Irvine, California, and Sientra, Inc of Santa Barbara, California) for failing to comply with post-approval study requirements. All manufacturers of approved silicone gel-filled implants are required to…
FDA: Class I recall of Cook Medical’s Transseptal Needle
Editor's Note The Food and Drug Administration on March 18 identified the recall by Cook Medical Inc (Bloomington, Indiana) of one lot of its Transseptal Needles as Class I, the most serious. The recall was initiated because of a manufacturing error that resulted in some needle tips missing the back…
FDA: Hospira recalls 8.4% Sodium Bicarbonate Injection
Editor's Note The Food and Drug Administration (FDA) on March 15 announced the recall by Hospira, Inc (a Pfizer company) of three lots of its 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL). The recall was initiated because of the presence of particulate matter, confirmed as glass. The…
FDA: Guardian Pharmacy ordered to stop producing sterile compounded drugs
Editor's Note The Food & Drug Administration on March 12 announced that a federal judge entered a consent decree against Guardian Pharmacy Services (Dallas, Texas) to stop the company from producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic (FD&C)…
FDA issues letter on risks linked with staplers, implantable staples
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a letter to alert healthcare providers about an increasing number of medical device reports on surgical staplers for internal use and implantable surgical staples. The most common reported problems include opening of the staple line, malformation of staples,…
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