FDA Requires Duodenoscope Makers to Conduct Safety Studies

After Personal Injuries Associated with Duodenoscopes, FDA Requires 3 Manufacturers to Conduct Post-Market Safety Studies After several hospitals in the US reported superbug infections in patients after duodenoscope procedures, the FDA has investigated the potential causes of the infection spread, and recently ordered three major duodenoscope … [Read more...]

Superbug Outbreaks Linked to Medical Manufacturing Problems

FDA Finds Link Between Manufacturing Problems in Medical Equipment and Superbug Outbreaks at Hospitals The Food and Drug Administration (FDA) has sent warning letters to medical manufacturers after finding a link between last year’s superbug outbreaks at some major hospitals, and problems in the design or manufacturing process of the medical … [Read more...]

FDA Knew That Medical Devices Prone to Spreading Superbug

Medical Devices Prone to Spreading Superbug and FDA Knew Experts in hospital-acquired infections say that the Food and Drug Administration, which approves new drugs and medical devices, knew about problems cleaning a device called a duodenoscope, which has been at the center of Superbug outbreaks at UCLA and Seattle, among others. Allegedly, the … [Read more...]

DePuy Orthopedics Pay $2.5 Billion To Settle Defective Device Lawsuits

DePuy Orthopedics Agrees to Pay $2.5 Billion in Hip Implant Settlement DePuy Orthopedics, a subsidiary of much-maligned medical manufacturer Johnson & Johnson, has agreed to waive its “walk-away rights,” which has finalized the company’s settlement payment in its all-metal hip replacement lawsuit. DePuy will pay $2.5 billion to settle … [Read more...]

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