Medical Device Failure
Transcript: The need: The product of our case study is a defibrillator, which is a product that attempts to treat a heart that is afflicted with either Cardiac dysrhythmia, Ventricular fibrillation, or pulseless ventricular tachycardia, by dispensing thereputic doses of electricity to regulate the heartbeat. The Solution: A medical device company, Guidant LLC, created an Implantable Cardioverter Defrillator (ICD). This product was designed to be implanted in patients with a high risk for sudden cardiac death. The ICD can detect cardio abnormalities and correct them without need for an external defibrillator. What went wrong? Due to poor wiring, the ICD's would short circuit and arch, causing malfunctions that prevented the device from delivering its electric charge to the patient's heart. Prior to 2002, several failures occured in the Ventak Prizm AVT model. Guidant continued to market the product but ordered immediate and total redesign. They claimed that doing so would eliminate all risk. However, by May 30, 2005, two more deaths and 45 additional failures had occured. Upon further testing, Guidant discovered that its newer Contak Renewal Model had a high risk of failure On June 17, 2005, Guidant issued a recall of numerous defibrillator models 50,000 Americans were suddenly forced to live in fear of the inability to receive assistance in the event of heart failure A massive class-action suit was held against the company, headed by U.S. District Attorney Frank J. Magill The Justice Department forced Guidant to pay $296 million in damages and plea guilty for several misdimeanors for lying to the FDA BUT WAIT... THERES MORE In April 2010 U.S. District Court Judge Donovan Frank (that name just keeps popping up), heeding the requests of many affected by the case, ordered a harsher punishment for Guidant, claiming that the previous settlement did "not adequately address Guidant's history and the criminal conduct at issue". Frank suggested placing Guidant and its parent company, Boston Scientific, on probation, but couldn't say whether their executives would have criminal charges levied against them We say... The FDA needs stricter approval requirements and a more rigid system of testing. Stricter regulation would ensure patient safety and help promote the idea that consumers ought to be able to purchase as safe and reliable a product as possible Guidant: From Defibrillation to Disaster By Ben Robinson and Colin Shaffer