FDA Reports 97% Increase in Recalls of Defective Medical Devices
Last week the U.S. Food and Drug Administration released a report of medical device recalls covering Fiscal Years 2003 through 2012. The report found a significant increase in recalls of dangerous or defective medical devices during that time period. In fact, the number of recalls almost doubled.
The Medical Device Recall Report is a detailed, 20-page report packed with information regarding medical device recalls over the ten-year subject period. The report is an outgrowth of a 2011 Government Accountability Office (GAO) recommendation that FDA enhance its oversight of medical device recalls and a 2012 directive from Congress to routinely assess and proactively identify defective medical devices.
The report found that the most frequent causes for the recalls are defective device design, defective software design, and the use of non-conforming material or other component issues.
The number of recalls grew from 604 in 2003 to 1,190 in 2012. While this 97% increase is scary enough, a more troubling aspect of the report is the type of devices which are responsible for that growth. The FDA classifies medical devices three ways:
- Class I – there is a reasonable probability that use of or exposure to the device will cause serious negative consequences or death
- Class II – the device may cause temporary or reversible consequences
- Class III – the device, while defective and in need of recall, is not likely to cause adverse health consequences
When broken down by classification, one sees that recalls of Class I devices increased a whopping 714% over the ten-year period. Recalls for Class II devices increased by 127%. Meanwhile, recalls for Class III devices – those not likely to cause any actual harm – actually fell by 34%. The greatest number of recalled devices were Class II devices, which is why the overall increase is 97% when all the numbers are factored in together.
Although they contained the smallest number of recalls overall, Class I recalls grew from one percent of total recalls in FY03 to five percent in FY12. It is also important to note that one recall may include more than one product, type, model or device. Although the number of recalls increased from 604 in FY03 to 1,190 in FY12, the actual number of defective devices included in those recalls rose from 1,044 to 2,475.
In general, about eight months seems to elapse from the time a medical device manufacturer becomes aware of the need to recall a device before the FDA posts a recall classification and gives notice to the public. The report shows that this alarming time lag has been increasing over time.