Medical Device Regulation: Time to Improve Performance

Medical devices have made a significant contribution to helping patients enjoy longer lives of higher quality. However, numerous weaknesses in their premarket evaluation and post-market surveillance have sometimes left patients worse off from faulty devices. For example, the Sprint Fidelis implantable cardioverterdefibrillator lead (Medtronic, Minneapolis, Minnesota) was approved by the United States Food and Drug Administration (FDA) in 2004. Three years after its approval and subsequent rapid dissemination, this device’s high propensity to fracture was finally recognized; first by independent cardiologists and then the FDA and the manufacturer, which voluntarily recalled the device. At least several patient deaths have been attributed to this problem [1,2]. More than 268,000 patients worldwide have been implanted with this device and have had to choose between risky removal of the defective leads or living with uncertainty of death due to a faulty device. The Sprint Fidelis tragedy exemplifies the need for rigorous and transparent post-market surveillance so that problems with approved devices can be rapidly detected.