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Alerts for safety of heart device

by Medindia Content Team on Aug 20 2001 11:22 AM

Heart devices may go wrong sometimes.There has been a rise in the number of safety warnings concerning devices that regulate the heart rhythm.

Many depend on either a pacemaker or an implantable defibrillator to keep their heart beating rhythimically. However sophisticated and accurate devices they may be, sometimes they to do go wrong.

Researchers at Brigham and Women's Hospital in the US have surveyed safety warnings on heart devices issued by the Food and Drug Administration over a ten year period from 1990 to 2000. Over this time, there has been an increase of 49 per cent in patients fitted with a pacemaker or defibrillator. Fifty two warnings were issued covering nearly half a million pacemakers and nearly 120,000 defibrillators, which resulted in the recall of devices and supply of replacements. Most warnings were concerned with hardware malfunction and computer errors.

There was a sharp increase in the annual rate of warnings between 1995 and 2000. As the rate of manufacturing of devices increase, they are getting more complex and more chances to malfunction. Nevertheless, having a safety warning is a worry for the patient and supplying a replacement is costly. With the growing population, it is likely that more devices will be fitted and it is important that manufacturers make sure that they are reliable.


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