The FDA has unveiled its final rule for a new and hopefully more efficient and effective way of monitoring medical devices. The system is called the Unique Device Identification System, or UDI. The FDA hopes that the new system will more consistently identify medical devices.
The benefits the FDA hopes to see include:
- improving the quality of information in adverse event reports
- allowing the FDA to identify problems with medical devices more quickly
- recalling defective medical devices more efficiently, thereby better protecting public health
There are two parts to the UDI. Firstly, device manufacturers will have to assign a unique device identifier to each device. These numbers will be submitted to a database called the Global Unique Device Identification Database, which will be a source to reference all devices.
In order to roll the system out smoothly, manufacturers of high risk devices will be required to comply first. These Class III devices will have to comply with the system within a year. Examples of Class III devices include heart defibrillators, heart valves, and other life-saving technologies. Class II devices (moderate risk devices) must comply within 3 years, while low risk devices must comply within 5 years.
Other countries have long had device identification systems, and have therefore been able to identify problems with devices earlier than we have in the United States. These countries include Australia and Canada, which both identified problems with metal-on-metal hip implants long before the FDA did.
However, even though there are many positives to implementing such a system, the medical device manufacturers themselves point to the fact that compliance itself is not a simple task: the compliance itself is expensive, requiring new training for employees, modifications to software, and changes of device labels. In addition, making sure everyone in the health care system complies is no easy task either. From hospitals, to physicians, to insurance companies, in order for the system to be effective, there must be total compliance.
While the system will not be functional immediately, the FDA has taken an important and much-awaited step towards better patient safety with medical devices. The number of patients that have suffered life-changing consequences after receiving metal-on-metal hip implants alone is enough to warrant a better way to track the success and failure of medical devices.
Have you suffered serious injury as a result of a medical device? You are not alone. Every year tens of thousands of patients suffer serious side effects as a result of medical devices such as metal on metal hip implants, heart defibrillators, and heart valves. If you or a loved one have been injured, a defective device attorney from Kirkendall Dwyer LLP can give you the immediate answers you need and help you recover compensation for your injuries.