The company found that some common cleaning methods weren’t enough to fully sterilize certain urological endoscopes, and is issuing new instructions for use to ensure the devices will be safe.
Some urological endoscopes from Karl Storz GmbH & Co. KG. could pose an infection risk to patients if users follow current reprocessing instructions, the US Food and Drug Administration announced in a 4 April letter to health care providers.
The letter says the reprocessing failures were discovered after the agency asked Karl Storz to validate its flexible urological endoscope...
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Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
