In Defective Medical Devices

Those seeking medical treatment in Nashville put their trust in the health care community when it comes to life-saving medical devices. However, data collected by the U.S. Food and Drug Administration shows a steep rise in the recall of defective devices, which has almost doubled between 2003 and 2012.

The Wall Street Journal reports that overall, defective device recalls have risen dramatically, with 1,190 devices recalled in 2012 as compared to the 604 recalls issued in 2003. Additionally, the most serious type of recalls initiated by the agency have also showed a marked increase. Known as Class 1 recalls, this action is undertaken when the defective device in question conveys a reasonable probability of death.

The reasons for this increase are still being debated by both the FDA as well as manufacturers of such devices. The agency itself points to workshops that made medical practitioners aware of potential device issues which led to an upsurge in reporting. Others claim that manufacturers have adopted a more proactive approach towards patient safety. Despite these claims, many in the industry feel that a more comprehensive regulatory process is the best defense against defective devices doing harm to patients.

According to the FDA, there are two types of recalls pertaining to medical devices. Voluntary recalls are initiated by the manufacturer when a device is found to violate FDA regulations. This entails removing the defective device or undertaking corrective measures for those devices that have been distributed to patients. Should a manufacturer refuse to participate in a voluntary recall, the FDA will then initiate a mandatory recall of those devices thought to pose a health risk. A mandatory recall halts the distribution of problem devices and instructs the medical community to discontinue use.   

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