FDA: B. Braun recalls blood administration sets
Editor's Note The Food & Drug Administration (FDA) on November 26 announced a voluntary recall by B. Braun Medical (Bethlehem, Pennsylvania) of 22 lots of blood administration sets. The recall was initiated because of the potential for leakage at the joint between the blood filters and tubing. This could force…
FDA approves first system for insertion of ear tubes with local anesthesia
Editor's Note The Food & Drug Administration (FDA) on November 25 approved a new system for the delivery of tympanostomy tubes into the eardrums of young children without using general anesthesia. The Tubes Under Local Anesthesia (Tula) System (Tusker Medical, Menlo Park, California) is the first ear tube delivery system…
FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…
FDA clears first duodenoscope with disposable elevator component
Editor's Note The Food & Drug Administration (FDA) on November 15 announced that it had cleared for marketing in the US the first duodenoscope with a sterile, disposable elevator component. The clearance of the Pentax Medical Video ED34-i10T2 duodenoscope represents a major step toward lowering the risk of infection in…
Sterilization trumps high-level disinfection for semicritical items
In the never-ending quest to improve patient care, we are always seeking better ways to process medical devices. Many leading experts now recommend transitioning from high-level disinfection (HLD) to sterilization for semicritical items. Semicritical items are instruments or objects that contact mucous membranes or nonintact skin of a patient, but…
FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System
Editor's Note The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious. The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device…
FDA: Class I recall of Abbott CentriMag Circulatory Support System
Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…
FDA clears Heartvista’s AI-assisted cardiac MRI tool
Editor's Note Heartvista (Los Altos, California) has obtained clearance from the Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted One Click autonomous MRI acquisition software for cardiac ischemia exams, the October 30 BioWorld MedTech reports. Integrated with existing MRI scanners, the software uses AI to guide image acquisition,…
FDA: ICU Medical recalls Lactated Ringer’s Injection, 0.9% Sodium Chloride Injection
Editor's Note The Food & Drug Administration on October 30 announced the nationwide recall by ICU Medical (San Clemente, California) of one lot of Lactated Ringer’s Injection, USP, and one lot of 0.9% Sodium Chloride Injection because of the presence of particulate matter. The affected lot numbers are: Lactated Ringer’s…
FDA: Class I recall of Ethicon Echelon Flex Endopath staplers
Editor's Note The Food & Drug Administration on October 30 identified the recall by Ethicon of its Echelon Flex Endopath staplers as Class I, the most serious. The recall was initiated because of failure of the staplers to completely form staples. As of October 3, 2019, seven serious injuries and one…
Free Daily News
- OR Business Management Conference, daily coverage begins
- Healthgrades names best hospitals for patient outcomes
- FDA announces Class 1 recall for ventilator system
- Research review: Nurse-led preoperative visits reduce anxiety, build trust
- Moody’s downgrades health insurance outlook as medical costs surge
- Criminalizing anesthesia errors has unintended consequences, experts warn
- FDA approves new non-opioid analgesic
- Legislation proposes to halt Medicare physician payment cuts
- Cigna ties executive pay to patient experience
- Proposed tax credit aims to bolster nurse preceptor ranks