Last month, the U.S. Food and Drug Administration (FDA) proposed a policy which, if adopted, could significantly increase the oversight and safety of the medical device industry. Under the proposal, each individual device would receive its own identification number, allowing medical professionals and manufacturers to better track defective products, determine the cause of the problems and alert other patients who are using the same device.
Currently, most consumer products are able to be tracked individually through the barcodes that are scanned when they are sold or distributed. The same protection is not available for medical devices, despite the fact that they are often implanted internally and carry a significant risk of illness, injury or even death if they should happen to malfunction.
And malfunction they do, as has been made quite clear in recent years. For example, New Jersey-based Johnson & Johnson is currently defending against thousands of products liability and personal injury lawsuits filed by patients who suffered debilitating pain and injury when their metal-on-metal artificial hips or vaginal mesh implants failed.
Under the new proposal, each such product would have an individual identification number. So if and when a product fails, the manufacturer can track it to determine whether the problem is a unique malfunction or a design defect, and alert others who may be affected by the issue.
Following a 120-day public comment period, the FDA will determine whether to implement the proposal. If it is adopted, the proposal will take effect six months after the comment period closes.
If you or a loved one has been injured by a dangerous or defective medical device, please contact Breslin & Breslin for a free consultation.
Source: Reuters, "US plans IDs to track medical device safety," Anna Yukhananov, July 3, 2012