FDA Should Increase Oversight to Prevent Cardiac Device Defects

The Food and Drug Administration needs to do much more to prevent cardiac device defects that result in a recall. The Government Accountability Office has just released a report which chides the federal agency for its oversight failures.

According to the report, cardiac devices account for some of the most frequent medical device recalls initiated by the Food and Drug Administration. The results were based on an audit of data from 2005 to 2009. According to the data, there were 3,510 medical device recalls during this period of time. Out of these, cardiovascular medical devices were the most frequently recalled devices.

There were a total of 532 recalls linked to cardiovascular devices, accounting for more than 15% of all recalls during this period of time. Four percent of the total recalls during this time were classified as class I recalls. These are some of the most serious recalls, and are only issued when there is a serious risk of injury or death from the use of the device. Cardiac devices accounted for about 31% of all class I recalls issued during this time. In all, there were 40 class I recalls for cardiac devices.

Cardiac devices were followed by radiological devices, which accounted for 484 recalls during the study period.

The Government Accountability Office says that the Food and Drug Administration reacts on a case-by-case basis to cardiac device safety. What the agency needs to do is increase oversight, and use the data that it collects to prevent any safety issues before they arise. The agency has plenty of data available, and a complete and through analysis of this data would help the agency to understand the underlying causes of the cardiac device recalls, equipping it to prevent these in the future.

The Indiana product liability attorneys at Montross Miller Muller Mendelson and Kennedy, LLP represent persons injured through the use of defective products across Indiana.