US device recalls double in a decade

According to the Wall St Journal, recalls of defective medical devices nearly doubled in the decade from 2003 through 2012. The findings come from a Food and Drug Administration report.

In 2012, the total number of recalls rose to 1,190 in 2012 - up from 604 in 2003.  The newspaper also reports that there was a significant increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these Class I recalls, compared with seven in 2003.

The analysis by the FDA's centre for medical devices came about, says the Wall St Journal, partly in reponse to a 2011 report by the government accountability office. This report found that recalls often happened too late for much to be done about the defects. In the case of implants, these would already be inside patients.

The Wall St Journal cites an example of a difficult to remove defibrillator wires of a Medtronic device that was recalled in 2007. In some of the patients, these fractured, leading to deaths. It is estimated that around 268,000 of them had been implanted in patients before the recall, and many of those still were implanted at the time. According to Medtronic, its system in which doctors' offices monitor patients remotely now provides an early warning if the device is about to fail.

Steve Silverman, director of the FDA medical device centre's office of compliance, told the Wall St Journal, that some of the recalls came from inspections by the agency.

He added that he wasn't able to provide numbers of devices or patients covered by the recalls, but that the rate of recall lags industry growth. The FDA said the numbers of medical devices increased by about 25% from 2008 through 2012.