FDA analyzes increased trend in recall of faulty medical devices

The Food and Drug Administration is charged with monitoring and managing the recall of any food and drink products, supplements, drugs and medical devices that could potentially cause illness or injury. Nowhere is this more crucial than with life-saving medical equipment that, when faulty, can instead become life-threatening.

The FDA has just released a 10-year trend analysis of recalls of defective medical devices. Recalls have been affected by the ongoing work the FDA does with manufacturers, which in recent years has led to:

  • Improved self-regulation by medical equipment companies.
  • Increased awareness of performance safety.
  • Better classification of types of equipment that are frequently recalled.

The data trends are dramatic but also somewhat reassuring. Total recall events, with single events sometimes affecting multiple products, numbered 604 in 2003 and almost doubled to 1,190 in 2012.

Class 1 is the sub-group of devices that have the potential to cause death, or at least serious injury or illness, when they malfunction. Examples are ventilators and defibrillators. Recalls of Class 1 equipment have increased from a low of seven in 2003 to a high of 57 almost a decade later.

Class 1 recalls increased from about 1 percent of all recall events in 2003 to closer to 5 percent in 2012, and the increase may have to do with the reclassification of many products to be included in the Class 1 category.

A recent example of the scale of some recalls is one that happened in December 2013. Ventilators, manufactured by a firm with its U.S. headquarters in Massachusetts, were found to have errors in the software that put them at risk of ceasing to work at crucial times in the treatment of patients. More than 16,000 units had already been distributed in the U.S. If you include sales to other countries, the total number of units distributed globally was more than 56,000.

The FDA’s increased vigilance over medical device manufacturers can only help medical care to become safer. Still, when machinery does fail, companies are liable to face legal action by affected patients and their families.

Source: Boston Business Journal, “Life-threatening medical device recalls up eightfold since 2003,” Don Seiffert, March 21, 2014