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Potentially Harmful Medical Devices Should Be Recalled When Safer Alternatives Are Developed, Public Citizen Tells FDA

Sept. 14, 2005

Potentially Harmful Medical Devices Should Be Recalled When Safer Alternatives Are Developed, Public Citizen Tells FDA

Man Implanted With Inferior Pacemaker Model

WASHINGTON, D.C. – Medical devices that have caused harm to patients or that raise a substantial likelihood of causing harm should be withdrawn from the market when another device is available that is equally or more effective but poses less risk, Public Citizen told the U.S. Food and Drug Administration (FDA) today.

In a letter sent to Daniel Schultz, the director of the FDA’s Center for Devices and Radiologic Health, Public Citizen petitioned the FDA to change its current system for such situations, which allows companies to delay removal of a flawed device as physicians continue to use the remaining inventory. This practice benefits the manufacturer, which can deplete its inventory of older, defective devices but leaves patients who receive these inferior products endangered.

The letter details the case of a patient who was given a St. Jude Medical pacemaker from a model series known to be inferior. The pacemaker was more likely to discharge prematurely due to a short circuit created during the manufacturing process.   Several months before the patient’s implantation, St. Jude received permission from the FDA to market a substitute pacemaker with the problem corrected. At the time of the implantation, St. Jude had already been distributing the corrected pacemaker for six weeks.  However, the patient was implanted with a pacemaker from the improperly manufactured series. Ironically, the patient’s new pacemaker was implanted to replace a pacemaker from the same series that had discharged prematurely due to the manufacturing problem. Ultimately, at least 180 pacemakers with depleted batteries were surgically removed from patients.

The case mirrors the scenario of recent news reports about a series of Guidant defibrillators that continued to be implanted even after improvements had been made to newer models to correct what was known to be a potentially fatal malfunction. Guidant knew that its product was potentially defective but did not remove it from the market, resulting in the death of a 21-year-old student. Additionally, the FDA knew about the defibrillator defect but took no action for months.

“If a safer, equally effective device exists, there is no reason why patients should be put at risk,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group and co-author of the letter. “The principle is simple: Patient safety should come before company profits.”

On Friday, the Heart Rhythm Society will sponsor a meeting of doctors, industry officials and FDA regulators in Washington, D.C., to discuss medical device performance, postmarketing surveillance and communicating risks to patients and doctors.

For a copy of Public Citizen’s letter, click here.