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FDA takes steps to expedite innovation in ethylene oxide sterilization
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.
Quality Advisory: Ethylene Oxide Sterilization of Medical Devices
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 shortages. In addition to background on the issue, this advisory highlights potential alternatives to EtO, including the advantages and disadvantages of each, as well as a resource to identify companies that sterilize instruments and equipment in the U.S.
FDA meeting examines potential solution to sterilization facility closures
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.
FDA alerts providers, others to medical device cyber vulnerability
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.
FDA recommends using duodenoscope with disposable components
To reduce risk of patient infection, the Food and Drug Administration recommends health care facilities transition to using duodenoscopes with disposable components.
FDA: Certain Medtronic insulin pumps recalled due to cybersecurity risk
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.
Joint Commission issues advisory on disinfecting ophthalmology devices
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.
FDA: Batteries in certain Medtronic pacemakers may deplete early
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.
FDA proposes regulatory changes to improve surgical stapler safety
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
FDA orders surgical mesh for pelvic procedure off the market
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.