FDA Under Pressure to Improve Oversight of Cardiac Devices

The defects of cardiac defibrillator leads – like those of the St. Jude Riata line of products or Medtronic’s Sprint Fidelis or Quattro – have pushed doctors who rely on these products’ safety to question the method by which they reached the U.S. market.

According to a Wall Street Journal report this week, doctors fed up and frustrated with the constant problem caused by faulty defibrillator leads, the wires connecting implanted cardiac defibrillators to the heart, has left doctors questioning their better judgement and their patients fearing for their lives.

More than 79,000 people still rely on a St. Jude Riata defibrillator lead to deliver life-saving shocks to their heart or to keep their heart beating in rhythm. The Riata leads have been recalled by the Food and Drug Administration but building evidence suggests they probably should have never reached the market in the first place.

A cardiologist with Minneapolis Heart Institute told WSJ.com the Riata lead failures are a classic example of the flawed process which got them approved for use. The Riata line of leads, the Riata and Riata ST models, are responsible for at least 22 deaths in the U.S., but because of the Food & Drug Administration’s (FDA) flawed process for approving and then tracking these devices, that number could be higher and the risk of serious injuries or death could be greater to patients.

The FDA said it will unveil a new system for reporting medical device failures and will be based on a unique number given to each product. This “more rigorous” program for monitoring new devices once they hit the market could lead to quicker recalls once problems are noticed. Many believe delays in the demanding recalls along with the agency’s flawed device approval systems puts countless people at risk of serious injuries unnecessarily. Thousands of people likely received a Sprint Fidelis or Riata defibrillator lead on their cardiac defibrillator after the FDA had already received numerous reports of their failures.

Unlike some European countries which have registries or databases to track medical device failures or successes, the FDA does not have such a system, making it difficult and requiring hours of cumbersome research to determine a product’s safety. Often, doctors will rely on what they read in medical journals or what they’re told by sales people representing the devices for the latest information on a device’s safety.

The FDA does have a rudimentary system for accepting adverse event reports from doctors or patients regarding faulty medical devices or drugs. It does require the makers of these devices or drugs to immediately report any incidents which suggest a device poses a serious risk of injury or death to a patient but history has proven that these companies are unlikely to make those reports in a timely manner.

Doctors and patients, those experiencing the problems first-hand, have no such system or clear channel for reporting these problems. Currently, the FDA relies on a voluntary system including 300 hospitals across the country for reporting problems they’ve encountered with medical devices. Again, it’s just a voluntary system so the information gathered by it may not be an accurate representation of a device’s overall safety. That system failed to identify any clear problems with the Riata devices.

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