The Obama Administration’s Office of Management and Budget has approved and released a long-awaited proposed rule on a unique device identification system for medical devices. The document was published in the July 10 Federal Register.
When finalized, the rule would require a unique device identifier (UDI) to be placed on device labels and packages. “Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology,” FDA said. “The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling.” It would also require device makers to submit information to a public database so patients and health professionals can obtain important information about a device’s use.
Certain devices, such as implantables and reprocessed devices, would be required to have the UDI directly on the device, according to the proposed rule. “These types of devices have physical characteristics, or characteristics of use, that significantly increases the probability that the device will become separated from its label, particularly when used over an extended period of time,” the agency said.
In June, CDRH Surveillance and Biometrics director Thomas Gross provided an update on surveillance activities, including ongoing activities in preparation for the UDI system. “A UDI database is under development as we speak,” he said. “It will undergo user acceptance testing over the next few months and we hope to have the database up and running by the spring of next year. UDI is a transformative piece of information and will have a tremendous impact on adverse event reporting and analysis, recalls, reduced medical errors, and enhanced use of health-related electronic data.”
Currently, CDRH is engaged with hospital systems to perform demonstration projects to build UDI best practices to streamline how they follow products in their institutions through the point of entry to the point of product use with a patient, Gross said. The Center is also partnering with CMS and the Office of the National Coordinator about incorporating UDI as a “meaningful use” parameter like drug use for reimbursement purposes. “One advantage UDI offers is that it will allow some harmonization across multiple older databases. The hope is UDI will be the common element that becomes a part of all the databases so they can be linked together in some way.”