Medical Device ID Proposal UnveiledFDA Would Create Database of Information
A long-awaited U.S. Food and Drug Administration proposed rule requiring unique identifiers on medical devices was published July 10 in the Federal Register.
While the rule aims to ease the collection and analysis of data about adverse health events and help detect counterfeit products, no patient information would be collected in a proposed new FDA database to help track the safety of these devices, the agency notes.
"The UDI [unique device identifier] database will capture static information about devices, for example, manufacturer, make, model and some other identifying attributes," says Jay Crowley, a senior advisor for patient safety at the FDA. "The database will not collect serial numbers or any patient information," he says. "Specific information like that would be collected in a patient's own e-health record."
Under the proposed rule, each unique device identifier would have to be provided in a plain-text version and in a form that uses automatic identification and data capture technology, such as bar codes. The FDA says the UDI would look like a medical label on the packaging of the device and contain information about the product including name, expiration date, reference and lot numbers, manufacturer, details about the item, an illustration of the item and bar code.
The UDI also would be required to be directly marked on some devices in certain categories for which the labeling requirement may not be sufficient. Those include products that remain in use for an extended period of time and devices that are used more than once.
The FDA says the UDI will enable users to look up information about the device from a Global Unique Device Identification Database. But the database will not contain any information about who uses a device.
Comments on the proposed rule are being accepted until Nov. 7, after which the FDA will draft a final version of the rule. But the FDA does not plan to put the rule into effect until 2019.
Long Time Coming
The FDA's proposed rule was a long time in the making. In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices.
The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.
The main reason why it's taken so long for FDA to craft the rule is that the agency collaborated with others, including medical industry players, to develop a plan, Crowley says.
"We were working with many stake-holders, including our global regulatory partners, to craft a proposal that properly balanced the benefits and costs and burden of implementation," he says. "For example, over about three years after the 2007 legislation, we conducted a number of pilots to better understand how UDI and the UDI database would work. Also, we worked with GHTF [Global Harmonization Task Force] to publish a guidance on UDI, which we just finalized and published last September," Crowley says.
Some industry insiders say the proposed 2019 effective date isn't soon enough.
"With this rule, we are one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices," says Blair Childs, senior vice president at Premier, a healthcare purchasing network, in a statement about the rule.
"Since we have already been waiting five years for UDI, patients can't wait until 2019 to have confidence that the devices implanted in their bodies are safe and effective," he adds.
When fully implemented, the FDA also expects the UDI to provide a number of other benefits, such as:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly;
- Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device;
- Enhance FDA analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries;
- Enable a post-market surveillance system to be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices;
- Help manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls;
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies;
- Lead to the possible development of a medical device identification system that is recognized around the world.