Medical Device Safety
Cordis Corporation recently recalled 25,000 catheters used to visualize and measure parts of the vascular system, due to the potential for their marker bands to move or dislodge during procedures. The Food and Drug Administration has identified this as a Class I recall due to the potential for…
The Food and Drug Administration reported 55 injuries and one death involving an infusion pump and vital signs monitoring system.
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.
In light of closures and potential closures of certain facilities that use gas ethylene oxide (EtO) to sterilize medical devices prior to their distribution and use, the Food and Drug Administration (FDA) is concerned about the future availability of medical devices and possible medical device…
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.