Is Software the & #039;Weak Link & #039; in Medical Device Safety?

Software is a weak link for medical devices, according to Stericycle Expert Solutions' second-quarter recall index. The report found software issues to be the top cause of medical device recalls for the 13th straight quarter . "As we become increasingly reliant on AI and data collection, software becomes an even bigger vulnerability for patients, physicians, and wrongdoers," said Chris Harvey, director of recall solutions at Stericycle. "If the software that is used to operate a device is inadequate, how can we be sure that it is protected from cybersecurity vulnerabilities? Add to that the fact that companies have only recently been laser-focused on mitigating cyber threats associated with medical devices. It's a recipe for disaster." 383882ae-20ea-46e1-80cf-0edc74ab800d.png   Cybersecurity Crime in Medtech – The Threat Is Real  As MD+DI recently reported, cybersecurity threats in medtech are really scary. In late June, FDA reported that due to cybersecurity vulnerabilities identified in Medtronic's MiniMed 508 and MiniMed Paradigm insulin pumps, a hacker could potentially connect wirelessly to a nearby device and change the pump's settings. This could allow a person to over-deliver insulin to the patient, leading to low blood sugar, or to stop insulin delivery, leading to high blood sugar and a buildup of acids in the blood. The MiniMed recall does&A...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news