FDA announces new coding system for medical devices

Defective medical devices and products are very dangerous and can cause serious injury or death to hospital patients and consumers. Unfortunately, it seems like there is no shortage of these defective products on the market, including hip replacements, vaginal mesh products and pacemakers.

That is why the Food and Drug Administration announced earlier this month that it will begin requiring all medical devices used and sold in the United States to carry a unique barcode. The hope is that the identifying code will make it easier to locate medical devices that have been recalled or deemed dangerous to consumers.

It is believed that the unique device identifiers could help to reduce medical errors by allowing doctors to better determine if devices are counterfeit or have been recalled. A senior policy analyst for advocacy group for patients called Consumer Union said she welcomed the policy change, but called it “long overdue.”

In fact, the FDA’s proposal comes a full five years after Congress required devices to carry the codes. Part of the reason it may have taken so long for the FDA to adopt the policy could be the cost it will pass down to United States companies. FDA officials told Reuters the policy could cost companies about $550 million to implement over the next decade.

This is good news for hospital patients and consumers in Massachusetts and the rest of the nation. We have been dealing with many recalls and dangerous medical products lately, so hopefully this new coding system will make it easier for the FDA to identify when products pose a risk so that they can be quickly taken off the market.

Source: NJ.com, “Medical devices will begin getting special codes to help improve patient safety,” Susan Todd, July 3, 2012