Wall Street Journal: Faulty Devices

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FDA Plans ID-Tag System to Detect Faulty Devices

By THOMAS M. BUR T  ON    Wall Street Journal 4/26/12

The Food and Drug Administration is devising a new system for detecting malfunctions in medical devices that will tap medical and billing records from hospitals and insurance companies.

The system is designed to catch malfunctioning devices like the St. Jude Medical Inc. STJ +0.82% heart defibrillator wires recently linked to at least 20 deaths. The agency wants to assign a new bar-code-like identification number to medical devices.

Some Recent Recalls, Complaints

Medical-device flaws that led to the FDA's new surveillance system

            Medtronic defibrillator wires: Sprint Fidelis heart wires fractured in rare cases; patients died from inappropriate shocks and failure to shock. Recalled in 2007.

            Surgical vaginal mesh: Used for urinary incontinence, mesh led to serious complications, including scarring, infection and pain. More than 1,000 complaints by 2008.

            Metal hips: Tiny metal particles wore off, damaging bone and tissue, causing pain and sometimes requiring revision surgery. Two brands recalled in 2008 and 2010.

            St. Jude defibrillator wires: March 2012 study linked the Riata wire to 20 deaths, after product was recalled in December 2011.

Source: WSJ reports; FDA

It would use that number to search large databases of records that could include veterans' and other hospitals, as well as large insurance companies. That could potentially allow the agency to know more precisely the rate at which a device is failing, and which patients have devices prone to malfunctions. The FDA plans to provide further details of its system as early as Thursday.

"The unique identifier is the real game changer," said William H. Maisel, deputy director for science of the FDA's medical device center. "With that number and a medical database, you could see, for example, if the reoperation rate for a certain defibrillator has become statistically a high outlier."

The agency's idea for the identification number—called a "UDI," for unique device identifier—has been awaiting action for about 10 months by the White House Office of Management and Budget. A bipartisan group of senators wrote to OMB recently complaining that the FDA's proposed new rules on the provision weren't yet public. OMB said it doesn't comment on such matters.

The Premier Hospital Alliance, a 2,500-hospital chain, said it is eager to allow the FDA to use its medical database for device- and drug-safety purposes. "We will definitely cooperate and do whatever we can with the FDA once the UDI goes into effect," said Blair G. Childs, Premier senior vice president. The Department of Veterans Affairs didn't immediately comment.

The FDA and St. Jude have struggled in recent weeks to understand the scope of defects in the company's Riata defibrillator wire, called a "lead." The lead connects the life-saving defibrillator to the heart of a patient. The Riata lead has been known to malfunction and has been linked to 20 deaths in reports to the FDA. St. Jude officials maintain the Riata has no more malfunctions than other defibrillator leads created around the same time.

The device has since been recalled, but an estimated 79,000 Americans still have the Riata and Riata ST recalled leads implanted in their chests.

FDA officials say an individual doctor played a crucial role in alerting them to the problems with the Riata lead. The doctor, whom the agency didn't name, had a 23-year-old patient who died July 16, 2010. The young man had a defibrillator implanted, along with a Riata lead.

Defibrillators are designed to dispatch a powerful shock to the heart when the heartbeat goes lethally haywire. If the lead gets damaged, it can start dispatching powerful shocks when they're not needed.

That's what happened to this young patient, whose Riata lead became damaged and began shocking him, according to the doctor's report to the FDA. Doctors then put in a new Riata-class lead and a new defibrillator. But according to reports to the FDA from the doctor and St. Jude, the new lead became damaged and didn't work properly either. This time, when his heartbeat went awry, the needed shock was "truncated" and failed to revive the patient, the doctor and the company told the FDA.

FDA analysts grew intrigued. They asked St. Jude for more detail beginning that September. By later in the fall, agency officials said, they had become convinced that the failure of the Riata-class leads could represent a possible broader serious defect. In December 2010, St. Jude pulled the Riata and Riata ST silicone-coated leads off the market.

St. Jude said that only the first lead that was put in the patient was among those pulled from the market. They said the second lead put in the patient was not, and that its failure may have been caused by scraping against the other lead that was left inside the patient. Doctors sometimes leave leads inside patients since their removal can trigger complications.

FDA officials credit the young man's doctor for an especially detailed and vivid report that enabled the agency to focus on the Riata lead. His information presented to the FDA "shows the difference between a great report and a mandated report," said the FDA's Dr. Maisel.

"I suspect that the lead design cannot withstand the vigor of cardiac contraction of a young adult and should not be recommended for active persons," the doctor wrote to the FDA. "This lead design needs to be re-evaluated." St. Jude said it stopped selling that lead model in December 2010 and that "our current-generation leads have a different design and a newer, more abrasion-resistant insulation material."

Write to Thomas M. Burton at tom.burton@wsj.com

A version of this article appeared April 26, 2012, on page B3 in some U.S. editions of The Wall Street Journal, with the headline: FDA Plans ID-Tag System To Detect Faulty Devices.