April 15, 2012

Doctors Demand Better Heart Device Risk Measures

by Levin & Perconti

The Wall Street Journal posted a story this week on the growing concern surrounding the safety of heart devices like defibrillators. The story focused on the push by many doctors to get the U.S. Food and Drug Administration to enact tougher safety standards as it relates to reporting. Our Illinois medical malpractice lawyers discussed the basics of this issue in a post yesterday.

The spur for the potential change in FDA practices are faulty wires in certain heart defibrillators. Defibrillators are small battery-powered devices that generate currents when a cardiac arrhythmia is detected. The purpose is prevent harm to those patients who are at risk of suffering sudden cardiac death due to ventricular fibrillation. The devices are placed under the skin in the shoulder and then connected by wire to the heart. This allows the jolt to be sent to the heart when necessary to correct the faulty heartbeat. However, when not working properly, it can place the patient at extreme risks.

Unfortunately, new concerns have been raised after a series of different companies have had devices identified that fail at higher than reasonable rates. The latest failure involves defibrillators with wires that become exposed. According to reports in the journal Heart Rhythm, one kind of defibrillator has been linked to 20 deaths. These are the Riata and Riata ST heart wires made by St. Jude Medical. Our Illinois medical malpractice attorneys know that this is a particularly harmful device error because the exposed wires that have life-threatening consequences while removing the wires is not possible with extreme risks to the patient. In many ways it is a no-win situation. The wires at issue in this latest situation are still implanted in 79,000 patients across the country.

Therefore, experts are hoping for increased FDA oversight to catch these faulty devices before they are ever implanted in a patient’s body. Doctors explain that the current FDA system is broken. There are haphazard reporting requirements, because hospitals do not uniformly agree on when to report a failure or not. As a result, the reports generally only come from a small group of volunteer hospitals. This system leads to many problems slipping through the cracks, allowing more patients to be given the product and ultimately harmed by it.

The FDA has heard the criticism and taken most of it to heart. A deputy director for the agency’s center for medical devices has explained that the FDA “would concur that the current efforts are not constructed to identify underperforming products in the marketplace.”

That is why the FDA is planning to introduce a more rigorous monitoring program so that problem devices can be identified as soon as possible and pulled from the market. The new system will include assigning each device a unique tracking number. The tracking will allow for easier collection of cumulative data to figure out the failure rates for each product. Each medical malpractice attorney who has worked with patients that have suffered severe harm as a result of these products is likely aware of the need for better safety protocols on this front.

See Our Related Blog Posts:

Hip Implant Producers Ordered to Conduct More Research

Defective Medical Implants Suggest More Oversight Necessary