Heart pump recall, lack of donor organs create concern for heart failure patients
Editor's Note The lack of available hearts for transplantation combined with the recent recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) “makes the current therapy landscape for heart failure much more dire,” according to a May 20 report in Medical Device Network. The recall of the device, which…
FDA medical device Class 1 recalls trend upward
Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. According to the report, Anne Reid, program director of the Office…
FDA announces class 1 recall for disposable biopsy needle kit
Editor's Note Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy…
Joint replacement manufacturer recalls products after FDA packaging warning
Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…
Catheter sterility concerns prompt Class 1 FDA recall for surgery trays
Editor's Note The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death. According to the April 24 FDA notice, the recall is due to sterility concerns with the…
FDA announces class 1 recalls for premixed embolic, infusion pump software
Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…
FDA warning: unapproved topical analgesics potentially dangerous
Editor's Note The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture,…
Universal Recall Platform Alliance centralizes supply disruption communications, calls for members
Editor's Note Medical recall software developer Notisphere is spearheading a collaborative effort among healthcare organizations to address inefficiencies with the recall alert communication process, reduce burdens on providers, speed regulatory compliance achievement by suppliers, and enhance patient safety. As noted in the company’s March 29 announcement, the Universal Recall Platform…
FDA updates warning about plastic syringes made in China
Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…
Session: Imminent supply chain disruptors—What's your business continuity plan?
Editor's Note “Can cost and resiliency co-exist?” Michael Schiller, CMRP, executive director (interim) of the Association for Healthcare Resources and Materials Management—a professional membership group of the American Hospital Association—asked this session’s audience on the last day of the OR Business Management Conference. “They can co-exist,” he said, “but resiliency…
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