Medical Device Safety

May 23, 2019
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.
May 13, 2019
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.
Apr 24, 2019
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
Apr 16, 2019
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.
Apr 12, 2019
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.
Feb 28, 2019
AHA's comment on the Food and Drug Administration’s draft guidance on blood glucose monitoring test systems for prescription point-of-care use.
Feb 4, 2019
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage.
Nov 30, 2018
The Food and Drug Administration today issued draft guidance describing the premarket studies that manufacturers should conduct for blood glucose monitoring systems intended for use in professional health care settings.
Nov 15, 2018
The Food and Drug Administration yesterday warned the health care community about complications that arise when pairing pain medications with intrathecal implanted pumps when the medications are not approved for use with those devices, which deliver medicine into spinal fluid.
Oct 17, 2018
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity…