ARTICLE SUMMARY:
The agency has issued two recent safety alerts on devices. Excerpted from Pathways’ Picks February 5: Trump Transition Updates, Digital Health Picks, and More.
Diabetes devices. FDA warned patients who rely on a smartphone to deliver critical safety alerts related to continuous glucose monitors, insulin pumps, and automated insulin dosing systems that alerts are not always being delivered or not being heard, and in some cases this may have contributed to serious harm. In a February 5 safety alert, the agency urged patients to regularly check alert settings, especially following a software or hardware update. FDA says it is working with diabetes device manufacturers to ensure that smartphone alert configurations of their devices are carefully evaluated and that settings in smartphones and mobile medical apps are continuously tested.
Patient monitors. FDA and the Cybersecurity and Infrastructure Security Agency issued safety communications January 30 disclosing vulnerabilities in two patient monitor devices—the Contec CMS8000 and the Epsimed MN-120 made by Contec Medical Systems. Government researchers analyzing firmware on the devices discovered an embedded “backdoor function,” which suggests the device could have been or could be compromised. The FDA alert suggests the device might be remotely controlled by an unauthorized user and warns that personally identifiable information is gathered by the system.
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