Medical Device Worries: More Government Oversight Coming to Ensure Heart Defibrillator Wires Are Safe
By Dean I Weitzman, Esq. on April 10th, 2012
The alleged failure of some tiny heart defibrillator wires that help to keep ill heart patients alive have led to the deaths of 20 patients and are raising the ire of doctors who are calling on the U.S. Food and Drug Administration (FDA) to have tighter oversight over such medical devices, according to a story in The Wall Street Journal (WSJ).
Some doctors are asking the FDA to strengthen safety reporting requirements for such medical devices after a recent report about the concerns was published in the medical journal, Heart Rhythm, the WSJ reported. The medical journal, which is published by the Heart Rhythm Society, reported that 20 deaths had been linked to the failure of heart defibrillator wires made by St. Jude Medical. The wires are surgically implanted under the skin of patients and are designed to send a perfectly timed electrical jolt to the heart when needed to help regulate a patient’s heartbeat.
Problems can apparently occur over time as the thin wire leads deteriorate under the skin and can cause ill-timed jolts which can lead to death, according to the story.
“The leads are susceptible to damage because the heart’s regular pounding can stress a lead over time and, in rare instances, cause it to fail,” the WSJ reported. “In 2007, Medtronic Inc. pulled from the market a brand of wire that sometimes fractured and has been linked to at least 13 deaths out of more than 200,000 implanted.”
Last month the journal Heart Rhythm released its report that connected St. Jude Medical’s Riata and Riata ST heart wires to 20 patient deaths.
Interestingly, though, the FDA doesn’t today have a mandatory monitoring system for such devices that would require medical device makers to report problems with their devices, the WSJ story reported.
Instead, “to track safety problems with medical devices, the FDA relies in large part on a safety program in which about 300 hospitals voluntarily report when devices malfunction,” the paper reported. “Since that system isn’t mandatory, it is difficult for the FDA to get an early handle on how frequently a device is failing and how urgently to warn patients and doctors, heart specialists say.”
That’s what some doctors want to change. They want the FDA to devise ways to monitor device safety more carefully so that patient safety is increased, according to the WSJ story. “Doctors say the FDA’s current system has failed to gauge the risks of faulty heart-defibrillator wires, and they want the FDA to ensure that hospitals report when such devices malfunction. Under the current system, federal requirements call for hospitals to report when these devices fail, but they don’t uniformly do so, doctors say. Instead, the agency relies extensively on voluntary reports from a few hundred hospitals.”
The FDA is working on just such a program, the story said, and is working to “unveil a more rigorous safety-monitoring program that could more quickly remove faulty devices from the market. Among the agency’s ideas is to assign each medical device a unique number that will make it easier to track device malfunctions.”
St. Jude Medical stopped selling the involved devices and electrical leads back in December 2010 due to safety concerns, according to an Associated Press story in The Washington Post, but they are still implanted in 79,000 patients in the U.S. and 49,000 patients abroad. “The company stopped selling Riata leads because of evidence the coating over the wires could wear and break down over time. The company said the issue has been corrected in its currently sold Durata leads, which are insulated with polyurethane, instead of silicone.”
St. Jude Medical denies that there are problems with its devices or wires, according to a story on the RTTNews Financial Wires Web site.
After the Heart Rhythm Society’s study was published, St. Jude Medical asked that the report be retracted, but the Society refused the request, according to a story on the Web site of the Massachusetts Medical Devices Journal.
For patients, this situation is certainly worth following closely , especially if you have ever been or continue to be under the care of a doctor for a medical condition and have been treated with such device implants.
Your ongoing care is critical to your health and if technical problems arise over time, you have the right to be made aware of the difficulties and potential dangers so that your doctor and you can monitor your safety.
That’s where a strengthened FDA device monitoring system would be a huge boon for patients around the nation. We applaud such efforts and encourage the FDA to continue to make moves in that direction so that patients always have the latest and most critical information about medical devices that are improving their lives.
If you have concerns about medical devices that you are using then we stand ready here at MyPhillyLawyer to speak with you and help you as you navigate the medical system.
Everyone should have all the facts about such devices when they are installed and maintained in our bodies. If you are not satisfied with your medical case management or are having medical problems due to the devices, contact us for a consultation.
When Winning Matters Most, call MyPhillyLawyer.