Defective Medical Devices: A Year in Review
Last year, the U.S. Food and Drug Administration (FDA) issued recalls of defective or dangerous medical products at the rate of about five per month, on average, for a total of 60 recalls in 2014. This list of recalls only includes the most serious device recalls where there is a reasonable chance that use of the product could result in serious health problems or death. A more exhaustive list of last year’s recalls would require a thorough search of the FDA’s Medical Device Recalls database.
The recalled devices covered a wide range of products and health issues. Some general categories of product failures included the following:
- Computer software glitches which could cause loss of power or faulty readings in everything from glucose meters to ventilators and infusion pain pumps
- Parts that tended to detach or break off
- Unsterile equipment potentially contaminated with bacteria, viruses or mold
- Product labels which promoted unproven medical claims
Although it can be frightening to know how many defective medical products are out there, it is good to know there is a watchdog agency hopefully catching these devices before they cause serious harm to too many people. The best way to stay informed about medical device recalls is to sign up for an e-mail alert whenever the FDA Medical Device Safety and Recalls webpage is updated. For other safety recalls related to contaminated food, dangerous drugs, defective household products, automobiles, and more, visit www.recalls.gov, where you can sign up for alerts from various agencies, including the FDA and the Consumer Products Safety Commission.