Rate in Recall of Medical Devices Increased Sharply in a Decade

Published By : 21 Mar 2014 | Published By : QYRESEARCH

A recent study has shown that the rate of recall of medical devices, things that are expected to have zero errors for obvious reasons, have increased to almost double of their rate of recall in the decade from 2003 to 2012. The report was published by the Food and Drug Administration bureau of the U.S. 

Recall of a product refers to the removal of a product from the market or correcting it and may also include complete refund against damages, in response to its defective nature.  

The report mentioned that the total number of recalls of medical devices, resulting from their defective working, was 604 in the year 2003, which rose to 1,190, almost double of the former. All these recalls were seen for devices that were defective enough to carry a sound probability of death. In fact, 57 cases from the 2012 statistic belonged to the Class I recall, a figure up by seven of what was observed in 2003. 

The report came as a result of an analysis carried out by the centre of medical devices of FDA for responding a report in 2011 by the Government Accountability Office. This report from the Government Accountability Office noted the issue of late recall of defective products from manufacturers since thousands of such products are already implanted in patients.   

An example of such defective devices that were very hard to retrieve were the Sprint Fidelis defibrillator wires or leads developed by Medtronic Inc. In the year 2007, these devices, which tended to fractures in some patients and also resulting to some deaths, were recalled by the company. But about 268,000 of them were already implanted in patients before the recall and many of them were also implanted at the time.  

A part of the number of recalls in 2012 curtailed from inspections by the FDA. Other recalls stemmed as a result of a workshop held in 2010 about reducing the radiations from exposure to X-rays and other imaging devices. It was the workshop that made hospitals even more wary of issues of high dosing and so, more flaws were discovered and reported.  

Though the recalls reflect a patient-centric, pro-active and more cautious approach towards quality and safety of their devices by manufacturers, it is also a fact that more rigorous regulations during the production of these devices would have easily avoided these recalls.  
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