FDA works on creating ID system for medical devices, supplies
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 allow CDRH more quickly to 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. Note that the eMDR rules do not call for any automated identification mechanisms, but 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 holds the promise of ensuring 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 either by downloading the XML-based application or by 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. 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.
