FDA FINALLY LOOKS TO TIGHTEN CYBER SECURITY ON MEDICAL DEVICES
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By: Kelda Doherty
At the Rheingold firm, litigation for people injured by medical devices is a larger part of our practice. The Food and Drug Administration is planning on tightening its safety standards for medical devices ranging from hospital monitoring equipment to those devices implanted in patients such as pacemakers. The plan is a result of concerns over cyber security breaches which could interfere with the operation of such devices. Breaches can occur due to malware such as computer viruses and can cause machines to slow down or shut off completely.
This is cause for serious concern as important machines such as fetal monitors and X-ray viewers and CT scans, when interfered with, can cause serious harm to patients and jeopardize their recovery. We are glad the FDA is looking into this, but our firm knows there are many other problems with medical devices which are probably more urgent-90,000 recalled DePuy ASR XL hip implants, 20,000 recalled Stryker Rejuvenate/ABG II implants, and the list seems to grow every day.