| Life Saver Poses a Threat to Life |
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Urvashi Khanna, 24x7 Updates
Implanted cardioverter defibrillators, or ICDs, and pacemakers that shock an irregularly beating heart into normal rhythm were "directly responsible" for 61 deaths out of nearly 3 million implants between 1990 and 2002, according to a report from the Food and Drug Administration released on Friday. The report also revealed that 4,225 defibrillators had failed between 2000 and 2003, about as many as those that failed in the previous 10 years. It is believed as the design of defibrillators is becoming more sophisticated, rate of failure is also rising.
It is noticed that the ICD malfunction replacement rate trendeddown during the first half of the 1990s but increased during the latter half. More than 50 percent of the ICD malfunctions occurred during the last three years of the study. The increase in malfunctions of heart defibrillators may be a result of "increased complexity of these devices, manufacturing challenges posed by device complexity, or increased reporting by physicians", said the FDA
The FDA said on its Web site that the higher percentage of failures may be a result of design changes that made the devices smaller -- they are now the size of a stopwatch -- while their computer memory was increased and their power maintained.
Although the study states that the reason for failure is unclear, the fact that Guidant, a leading manufacturer of defibrillators, did not make public for three years a potential problem with some of its ICDs remains undisputed. The implantable devices can develop an internal short circuit without warning, resulting in a failure to deliver a shock when needed.
In the recall notice, the FDA advised patients to discuss with their doctors the advisability of replacing their defibrillators. But, yesterday, a number of physicians said they do not have all the information they need to make those decisions.
"We’ve gotten no real guidance from industry, the FDA or the academic community about when" to take the devices out, said Eric N. Prystowsky, director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital in Indianapolis. "We’re told to use our judgment, but there’s huge confusion." The event, sponsored by the Hearth Rhythm Society, is the start of discussions on how to better monitor and report problems.
At the meeting, experts debated how much information device makers and the FDA should release and when. Some questioned if the agency had enough resources.
"I think the FDA can do a better job," said Thomas Gross, head of post-market device surveillance at the FDA. "There are gaps in the system."
One such gap is getting devices returned when there is a problem, or when a patient dies. Some experts called for a new system that would require all devices to be registered when they are implanted.
Another hurdle is getting more doctors to report problems to the FDA voluntarily.
Many panelists recognized the industry’s tarnished image and growing public distrust, but they argued that the devices’ benefits outweighed any risks.
A number of patients at the meeting told mixed stories of how the devices changed their life.
Zina Lewis, a 38-year-old nurse who first received a Guidant pacemaker at age 14, said companies should be more forthcoming with data.
"The recent corporate behavior has made many of us feel like ticking time bombs," she said.
But 29-year old Matthew Noble, who received a Guidant implant at age 17 and now works for the company, praised his defibrillator for saving his life countless times.
Just this year, the nation’s three leading defibrillator makers — Indianapolis-based Guidant, Fridley-based Medtronic and Little Canada-based St. Jude Medical — have issued recalls or safety warnings affecting more than 200,000 defibrillators.
The industry’s trade organization, AdvaMed, emphasized that the failures reported in Maisel’s data are "from earlier generations of devices" and do not reflect the "increasing reliability" of newer devices. The trade group also emphasized — as did a number of doctors and regulators — that the devices are overwhelmingly effective and save hundreds of thousands of lives. While the meeting did not result in the adoption of any immediate changes, many said during the proceeding that they expected policy changes such as standardizing the ways that data about heart device failure are collected, reviewed and communicated to physicians and patients. The aftermath of media attention and recalls were key factors in prompting the conference, which is examining how to improve the system for detecting d
efective medical devices and getting the word out to doctors and patients. Meanwhile, the FDA has "already begun to better coordinate our pre- and post-market regulation of these devices, to strengthen the link between how these products are approved and how they are monitored after clinical use,". Pacemaker problems since 1990 have dropped, they also found, to a mean annual rate of 4.6 replacements per 1,000 implants compared with 20.7 per 1,000 for defibrillators.
The US health watchdog agency said it is now considering if it is necessary to demand additional information from manufacturers, and is planning for more effective communications with physicians and patients when problems arise.
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