The Food and Drug Administration (FDA) is proposing a new system to better track medical devices after they have been cleared for use. The plan allows patients, doctors, regulators and consumer advocates access to information about specific products in an effort to improve patient safety.
The need for such a plan was highlighted by the 2010 recall of a hip replacement system. The device, made by Johnson & Johnson subsidiary DePuy Orthopaedics, was made of all-metal parts and designed to be more durable than traditional hip implants, which are made of plastic or ceramic parts.
Hip implants are made to last 20 years or more, but mounting complaints of failures with the DePuy metal-on-metal devices were showing an alarming number of the hip implants were failing after just 5 years or less. It was difficult for the FDA to track the problems or even notify people who received the devices because there is no medical device registry in the United States.
The proposed tracking system for medical devices assigns a Unique Device Identifier, or UDI, to each device that provides basic information, such as the name of the manufacturer, the type of device, the model and an expiration date. It could also include a batch or lot number to help identify devices in the event of a recall. Information will be stored in a UDI database that is accessible to the public; however, no identifying patient information would be included.
The FDA says the system will help the agency identify problems with devices more quickly and allow them to more rapidly remove harmful devices. The agency will take public comment on the proposal for the next 120 days.
Source: Post Bulletin