The U.S. Food and Drug Administration (FDA) may soon require manufacturers of medical devices and supplies to apply unique device identification (UDI) mechanisms to individual items so they can be automatically tracked and traced in the supply chain. The agency is also urging companies to file reports electronically whenever an item is involved in an adverse event. Currently, such reports are filed in paper format and must then be manually entered into a computerized system.
Although not directly connected, the two efforts are related. Both are intended to improve the collection of critical information regarding medical devices, ranging from infusion pumps to latex gloves, and both could help drive the adoption of radio frequency identification.
More than a year ago, the FDA began investigating how a UDI system might help automate the collection of information about various devices, such as the manufacturer, make and model, unique attributes, serial numbers, identifying lot and manufacturing numbers, and expiration dates (see FDA Seeks ID System for Medical Devices and Supplies). In addition, a UDI system could be used to facilitate product recalls, improve the consistency of medical device reports (MDRs) and identify device incompatibilities or potential allergic reactions. Such a system would rely on automatic-identification technologies, including RFID and serialized bar codes.
In late September, the Food and Drug Administration Amendments Act of 2007 was signed into law, charging the FDA with establishing a UDI system. Once implemented, the system will require that a label bearing a unique identifier be placed directly on a device, unless an alternative location (such as on the device’s packaging) is specified by the FDA, or unless an exception is made for a particular device or group of devices. The unique identifier must be able to identify the equipment and supplies throughout their distribution and use.
While the law does not specify a deadline, the FDA’s Center for Devices and Radiological Health (CDRH) is “working diligently” to develop draft regulations to implement the new requirements, says Jay Crowley, CDRH’s senior advisor for patient safety.
The act also does not specify any technologies. “Congress gave us latitude,” Crowley says, adding that flexibility is important because of the broad array of medical devices. “It allows for the UDI to be on the device itself, or on the box or packaging. It also gives us flexibility to exempt devices or device types that we don’t think need to be included under this specific regulation. And we will try and remain as technology-agnostic, or technology-neutral, as possible. With RFID, I see that being useful for devices in hospitals, such as infusion pumps, but that technology probably doesn’t make much sense for a box of gloves.”
CDRH oversees the current MDR requirements of the Federal Food Drug & Cosmetic Act. The MDR system is designed to help the agency more easily identify patterns in adverse events of medical devices, such as device-related deaths. Currently, the reports come primarily from manufacturers and user facilities such as hospitals. For instance, user facilities are required to file a report whenever an adverse event occurs that might be connected to a patient death.
The electronic Medical Device Reporting (eMDR) process is an optional electronic filing component of the required MDR. Electronic filing would enable CDRH to more quickly review and act on the reports, says Indira Konduri, eMDR project manager with CDRH, because “it takes time to get these reports into the system. Also, we’d be able to save [on] the costs associated with manual entry.” CDRH receives hundreds of thousands of such reports each year (in 2005, it received more than 200,000), all of which are filed manually.
CDRH has developed two methods to submit reports electronically. The first, designed for reports to be submitted one at a time, leverages an XML-based application that can be downloaded from the Web. The second, for batch filings, requires some software coding; to that end, CDRH is offering a detailed implementation guide containing technical specifications.
The eMDR rules do not call for any automated identification mechanisms. However, each filing must include information specific to the device involved in the event, including its model number, lot number, expiration date and serial number.
The UDI system has the potential to ensure that the device-specific information is consistent and detailed enough to help narrow efforts in the event of a recall. “I can see a link between UDI and eMDR,” Konduri says. “Suppose a device is truly defective and recalls need to be done. If, for example, we have more specific information about the device, we can narrow down on lot numbers and find out if there’s just one device involved, or an entire lot. UDI makes the information more helpful.”
CDRH is encouraging device manufacturers to begin testing eMDR by either downloading the XML-based application or following the technical guide for software coding to allow electronic filing of batch reports. The agency is now conducting pilots and is already receiving electronic reports from at least one company.
What’s more, CDRH is working on a draft rule to make it mandatory for MDRs to be submitted electronically. The draft is not yet complete, and will first have to go through a normal process of soliciting comments and revisions before it is adopted, which may happen in 2008.