June 18, 2005
Consumer Safety Alert: Heart Device Manufacturers Decide for Themselves When and If to Tell Public About Faulty Devices
According to a June 14th article in the NY Times, heart device manufacturers make their own decision when and if to inform the general public and doctors if a potentially life saving heart device like a defribrillator is faulty. There are no set guidelines and there is no close monitoring of these devise manufacturers even though they make outrageous profits. The article points out the recent death of a 21 year old student with an implanted defibrillator made by the Guidant Corporation. Unfortunately, patient safety is not the only concern of these companies. The potential loss of profits as well as the legal liability play huge roles in the company's evaluation of the benefits of disclosing a product flaw. Until there is closer monitoring, consumers are not safe.
