The total number of defective medical device recalls in the past decade represents a significant increase, and it raises the question of whether more people are reporting issues or if there are simply more design defects putting patients at risk. Defective devices can injure patients and cause serious physical and mental repercussions when the device does not operate properly.
There are several reasons behind the increase recall numbers, according to Steve Silverman, director of the medical device compliance center at the FDA. Educational workshops and tough FDA inspections have increased the number of devices being pulled from the market, although many of these devices have already caused numerous patient problems long before they are officially recalled. Easier processes for reporting an increased belief in the importance of journaling problems early could be partly behind the increased recalls. However, the jump still raises overall concerns about device safety.
Since so many devices are recalled after being approved for the market, more attention may need to be given to the regulatory process that investigates and approves these products. Too many products are slipping through the cracks, putting patients at risk of serious injury. Software issues alone were one of the biggest reasons that a device was recalled from the market. Hence, manufacturers should also explore options for full testing of all software components. Better research and design investment in medical devices could help to reduce the number of recalled products as well as the numbers of patients who are hurt. The most commonly recalled medical devices are radiological, followed by cardiovascular, chemistry, and other hospital equipment devices.
If you or someone you know has been injured by a defective medical device, you need to report the problem to the FDA and consult with legal representation about your rights. Please contact an Illinois defective medical device attorney today.