Medical Device Safety
The Food and Drug Administration should study potential alternatives to ethylene oxide for sterilizing medical devices, but a solution could be at least a decade away, experts told an FDA advisory panel at a meeting this week on the issue.
The Food and Drug Administration today recommended medical device manufacturers, health care providers and patients take certain actions to reduce the risk that a remote attacker could exploit a set of cybersecurity vulnerabilities to control a medical device or prevent it from functioning.
To reduce risk of patient infection, the Food and Drug Administration recommends health care facilities transition to using duodenoscopes with disposable components.
Medtronic has recalled certain MiniMed insulin pumps due to cybersecurity risks, and will provide alternative pumps to the estimated 4,000 U.S. patients using the pumps, the Food and Drug Administration announced yesterday.
The Joint Commission yesterday recommended that health care organizations review cleaning and disinfection instructions for tonometers and other ophthalmology devices to ensure that they are reprocessed appropriately.
The Food and Drug Administration last week alerted health care providers and patients that batteries in certain Medtronic implantable pacemakers and cardiac resynchronization therapy pacemakers may drain more quickly than expected without warning.
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
The Food and Drug Administration today ordered manufacturers to immediately stop selling and distributing surgical mesh products for transvaginal repair of pelvic organ prolapse in the U.S.
Updated preliminary results from studies to better understand how duodenoscopes are reprocessed in real-world settings continue to show higher than expected contamination rates after reprocessing, the Food and Drug Administration announced today.
AHA's comment on the Food and Drug Administration’s draft guidance on blood glucose monitoring test systems for prescription point-of-care use.