July 25, 2007
Who are the Defibrillator Manufacturers?
Samaritan, Philips, Medtronic, Guidant, Heartsine, Defibtech Lifeline, and Zoll (among others) are names not known to the average person; as they are defibrillator manufacturers. Yet, they perform a very vital role in our modern society. While few people may know these companies, they certainly know their products: defibrillators.
These days, cardiac problems are a leading cause of early death in the United States. As a result, all kinds of defibrillators: automatic, implanted, portable etc. are incredibly important, and are used in hospitals, clinics, ambulances and a host of other locations.
Due to the critical importance of these machines, defibrillator manufacturers must be held to a high standard of quality control. They and their distributors are required to keep track of the locations of all of their products. Back in June of 2006, Guidant had to issue a recall for its PRIZM 2 DR 1861, CONTAK RENEWAL H135 and CONTAK RENEWAL H155 implantable models when it was revealed that they could short out and cause death or very serious injury. The fact that the company had known about the problem for three years did little to improve their public image. The company said that when it took into account all the mitigating factors, it felt that removing the defective defibrillators from people's chests posed a greater health risk than leaving them in place. After all, the company argued, the devices were scheduled for removal and replacement as part of their standard operating procedure.
And Guidant has not been the only defibrillator manufacturer forced to carry out a recall of their implantable devices. In recent years, Medtronic and St. Jude's Medical have had to do likewise. Harvard Medical School carried out a joint study with the Food and Drug Administration, looking into the rate of defects among implanted defibrillators. The results: they found that an increase in the number of reported defects, yet the number of replacements due to these same defects had decreased. This trend indicated that even though the incidents of malfunctions were going up, efforts at replacing the devices were not keeping pace with the problem. Only the future will tell as to whether or not the industry works harder at improving its image.
Filed under General by Mark Glazer
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