FDA: Antivirus Crashed Diagnostic Tool During Heart Procedure

The FDA reported that improperly configured antivirus software on a Merge Hemo Programmable Diagnostic Computer triggered an hourly scan during a heart catheterization, causing the monitor to lose communication with the patient data module and go blank for about five minutes until reboot; the vendor recommends excluding medical images and patient data from scans and the FDA reiterates guidance for incorporating cybersecurity risk management into medical device design and post-market processes.