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Cardiac device recalls may spur change in how companies report problems

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INDIANAPOLIS (AP) _ Joyce Tierney and her daughter, Heidi, were rolled off to surgery one morning two years ago, just days after learning they had the same serious heart condition.

They emerged with implanted defibrillators that brought their erratic heartbeats under control with periodic jolts of electricity.

All was well until June, when Joyce Tierney, of Montpelier, Ind., received sobering news: The 47-year-old mother of five was among nearly a quarter million Americans whose defibrillators have been recalled this year due to defects that could cause them to malfunction.

``I kept waking up in the middle in the middle of night thinking it was a bad dream or something,'' she said.

Since January, Indianapolis-based Guidant Corp. and the nation's two other primary defibrillator makers _ Fridley, Minn.-based Medtronic Inc. and St. Jude Medical Inc. of Little Canada, Minn. _ have issued recalls or safety warnings affecting about 214,000 defibrillators.

The volume of recalls has raised questions about regulatory oversight and how companies alert doctors and patients about potential defects.

Consumer advocacy groups contend the recalls highlight what they call the U.S. Food and Drug Administration's cumbersome, hands-off process for handling recalls of problematic medical devices and drugs. Advocacy groups have also voiced similar complaints about the National Highway Traffic Safety Administration's treatment of automobile safety recalls.

Dr. Sidney Wolfe, director of the health research group for the consumer watchdog group Public Citizen, said the FDA's recall process is flawed because it essentially relies on companies to tell the agency about potentially defective products.

``All too often, recalls are started late, are done dangerously slowly and even after they're done they aren't as complete as they should be,'' Wolfe said. ``The whole process goes on more slowly than it should.''

Guidant has acknowledged it waited three years before telling some 24,000 patients and their doctors about an electrical system defect with its Ventak Prizm 2 DR Model 1861, which was recalled June 17 and has been linked to two patient deaths.

FDA spokeswoman Julie Zawisza said the agency rarely orders recalls, preferring to work with companies to assess the risks posed by problems with a particular product.

``It's a judgment call, and sometimes it can be a very clear, bright line, where we have to tell people today or next week, or there's no need to notify people. But often there's not a bright line,'' she said.

That's little consolation to thousands of patients like Tierney, whose Guidant implant was swapped with a new Guidant model during outpatient surgery in June. Her daughter's defibrillator, also a Guidant model, was not one of those recalled.

Use of implanted defibrillators in the United States has grown from about 21,000 in 1995 to between 250,000 and 300,000 this year, largely because of advances in technology and surgical techniques, according to the Heart Rhythm Society, a nonprofit group of cardiac care specialists based in Washington.

The battery-powered implants are about the size of a mini-cassette tape. Wires extend from the device to the heart, shocking it back into a normal rhythm when an abnormal heartbeat is sensed.

However, in rare cases highlighted by this year's recalls, they can malfunction.

Emory Crawford Long Hospital in Atlanta has replaced about 75 Medtronic defibrillators this year and expects to replace an equal number of Guidant defibrillators, said Dr. Angel Leon, the hospital's chief of cardiology.

``It's just been almost like a perfect storm of recalls this year,'' he said.

Leon said many of his patients now ask about the devices' safety records, something that seldom happened before the recalls.

Fred McCoy, president of Guidant's Cardiac Rhythm Management division, said it is ``painful'' for the company to hear about post-recall distrust of the company's products

``These products are of strikingly high reliability,'' he said.

McCoy said the company's engineers have worked to identify solutions to ensure the safety and quality of its products. The company announced Aug. 1 that it had received FDA approval to relaunch its top-selling implantable defibrillator, the Contak Renewal 3, which was recalled June 24 because of a faulty switch.

Some politicians and regulators say such steps aren't enough.

Sen. Charles Grassley, R-Iowa, a frequent critic of the FDA, has requested copies of the FDA's annual post-approval reports for the recalled Guidant defibrillators. He also is sponsoring legislation to create a publicly accessible data bank of clinical trial information.

Next month, cardiac experts, the FDA and the medical device industry will gather in Washington to discuss ways to more quickly alert patients and their doctors about potential flaws.

Dr. Anne B. Curtis, president of the Heart Rhythm Society, which is helping plan the Sept. 16 gathering, said participants will also work on standards that outline when defective implantable defibrillators and pacemakers should be recalled.

Coming up with uniform guidelines will take three to six months, she said. It won't be easy, she said, because of the number of devices and the fact that most defects are extremely rare _ and in some cases may have no effect on a patient's health.

``The problem is that there are so many different devices, and so many different problems that could come up, and right now there is no set way of dealing with those,'' she said.

Mark Brager, spokesman for the Advanced Medical Technology Association, supports the push for guidelines.

His group represents about 1,300 medical device companies and will participate in next month's meeting.

``It would be best to have standardized guidelines as far as is possible, recognizing that all devices are different and all error situations are different,'' he said.
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