The Real Goal of Medical Device Safety Surveillance

A defibrillator that locks-up after delivering the first shock causes delay in treatment which can result in serious injury or death. A needle-free closed system used to deliver chemotherapy drugs could release tiny plastic particles in a patient’s blood stream which can cause blockage. A pacemaker fails due to an unpredictable circuit error which can result in a life-threatening situation. These are just a few examples of Class 1 recalls recently announced by the FDA in a span of just a few weeks.

Risk ManagementNaveen AgarwalMarch 5, 2019Medical Device SafetyComment

FDA Wants You to Take a STeP in the Right Direction

Recently, the FDA has taken 2 major steps to encourage innovation in medical devices. The first is finalizing guidance on the Breakthrough Device Program, which will enable accelerated approval of innovative medical devices that more effectively diagnose or treat life-threatening or irreversibly debilitating conditions.

Regulatory ComplianceNaveen AgarwalJanuary 7, 2019patient safety, FDA, STeP, STeP Program FDA, Medical Device SafetyComment