Realizing the Full Potential of Medical Device Registries
October 30, 2020
Registries serve a unique role in public health. However, there remain key hurdles to fully realizing the potential of registries to improve medical device research and safety.
Registries track what medical device a patient receives, and can be established by a variety of stakeholders, from manufacturers and IDNs to medical societies like the American College of Cardiology (ACC). Registries can provide key post-market information on medical device performance to manufacturers, providers, and the FDA. These data are critical to evaluating the safety of medical devices, particularly when, as Pew points out, “there is significant design variation in a class of products (e.g., hip implants are made from different materials and come in different sizes).
But there are challenges. For example, if a hospital is registering a patient’s pacemaker with the ACC’s National Cardiovascular Data Registry, it is possible that:
- The hospital does not have accurate or complete device data feeding the EHR and as such has trouble finding the patient’s correct device information.
- The registry has outdated or incorrect device information, precluding the hospital from finding a patient’s device in the registry.
Both of these points of failure have overlapping causes and possible solutions. One solution is the adoption of Unique Device Identifiers (UDI) by registries and providers alike.
UDIs are intended to provide clarity on which specific device is being used, along with key pieces of information about the device, like its description and categorization. If a hospital is recording a device’s UDI in the patient’s electronic health record (EHR), it will know exactly what device a patient has. If a registry is using UDI, they will be able to offer better data to whomever is registering the patient, for example a hospital. Further, the UDI contains a “production identifier” that includes an item’s serial number, lot number, and expiration date, meaning that if there are adverse events with a device, it is possible to quickly track the problem.
The FDA has also considered how to promote a national system of coordinated registry networks to enable research across registries, with linkages to other sources of patient data like EHRs and patient-reported outcomes. UDI and standards for interoperability are foundational for reaching any such vision.
A crucial next step in promoting the use of UDI to improve registries’ data quality and outcomes research is for the Centers for Medicare and Medicaid Services to mandate that UDI be included on claims forms.Until then, new developments in scanning and mapping medical device data are making it possible for hospitals and registries to meaningfully adopt UDI today.