UDI: good first step, but what next?
The recent ruling from the FDA requiring medical device companies to include unique device identification on all products will allow regulators to track goods, monitor them for safety and expedite recalls. This news comes as more nontraditional medical devices become mainstream, forcing regulators to implement a system to improve patient safety by increasing the quality of information in medical device adverse reports.
It’s unusual to see a software platform get classified as a Class II device, as was the case with the one Verizon Wireless created for chronic disease management. Though the device is not intended for use in clinical settings, the decision was based on the type of data collected and how it relates to patient safety and monitoring. With this ruling, Verizon must implement a quality management system to conduct post-market surveillance throughout the lifespan of the product to ensure it is being used the way it is intended and to keep up with the FDA’s quality system regulations.
Currently, most medical device manufacturers – traditional and otherwise – have their own processes for monitoring products and are using proprietary identifiers to do so. Implementing an additional system to assign a unique number to the device – the UDI – by everyone in the value chain, then properly labeling said products, could result in a costly and challenging endeavor.
Without the proper technology to aid the transition, it will be easy for data used in both internal and external transactions to be affected, as well as the physical packaging and labeling of devices. Companies that are quick to comply with the FDA’s new ruling for UDI compliance by adopting a technology that will capitalize on streamlined operations and improved traceability will be at an advantage to their counterparts who struggle to find a solution.
Unfortunately, the FDA left a small window for companies to implement and comply with the final ruling. After waiting six years for the UDI ruling to pass, all labels and packages of Class III medical devices – the most critical class – and devices licensed under the Public Health Service Act must bear a UDI by Sept. 24, 2014, just one year after the final FDA rule was published.
While the turnaround time for critical devices to comply with the FDA’s ruling is tight, the final date for required Class I devices to be labeled with a UDI is Sept. 24, 2020. This means patients and healthcare providers could wait more than five additional years to ensure all devices are accounted for within the global unique device identification database, called GUDID.
The GUDID, though several years out from being fully populated, will be accessible to the public, inclusive of all healthcare providers, insurers and patients. This ultimately means that any and all healthcare personnel could look up device information and put it into the electronic health record of a given patient, and at the same time, insurers and peers can do the same in their records. The FDA’s decision to make the GUDID available to the public shows the organization’s commitment to protect end users.
In theory, by 2020, any user or administrator of a medical device can look up the device information with relative ease to determine if any issues have been reported, or to track adverse events and warnings from the field. It is also possible for the GUDID to be fully populated in advance of 2020, which would be ideal from a healthcare provider’s perspective.
The point-of-use availability of GUDID is a step in the right direction for public health and safety; however, there is still much room for improvement. When compared to another data management system – air traffic control, for instance – where users are able to access near real-time information, it is evident that GUDID could benefit from something similar.
This presents a technology opportunity from the consumer side, as the current database requires a user to manage internal information. A more efficient method would be for the GUDID to couple with EHR systems to push information to patients whose medical devices may have been compromised, with a smartphone app sending an SMS text once a recall is issued.
Healthcare providers could benefit from the same notification, plus receive a list of all patients affected by the recall. Such apps could be developed quickly, however, and GUDID is still in an infant stage, so this solution may be available before we know it.
Additionally, not all healthcare facilities use the same data structure for managing a patient’s electronic health records. Until there is a common standard adopted by all EHR systems for patient information, healthcare providers will not be able to reap the maximum benefits of GUDID.
Potential improvements aside, the FDA’s final UDI ruling and imminent compliance by medical device manufacturers will prove beneficial to healthcare providers as well as patients. Healthcare providers will enjoy the time and cost savings as a result of GUDID, since information about all medical devices will be readily available.
Devices that have been recalled will be easily and quickly identified, resulting in improved patient safety while using any device or application to treat or diagnose a disease/condition. UDI and GUDID may not be the end-all solution, but they are definitely a step in the right direction.