Standard Practices
Last month’s column focused on how those working on UDI regulations have broadened their focus beyond the US, as countries and regions around the world are either implementing or readying their own versions of the regulation that requires application of unique device identifiers (UDIs) for medical devices. This month, I will provide some more updates from two of those efforts: Europe and Saudi Arabia, while exploring some questions about the need to go beyond just product identification standards to standardizing how UDIs are implemented.
Based on commentary from both speakers and attendees at a European UDI Forum in late April, it was clear how much the rest of the world appreciates the seminal work performed by the U.S. Food and Drug Administration (FDA) UDI team. Yet, because UDI regulations elsewhere are going beyond what the U.S. FDA required, we may also have an opportunity to learn from their experiences.
Standardizing implementation globally
One of the speakers, Terrie Reed, Sr. Advisor for UDI Adoption with the U.S. FDA, has been involved in the development of a new publication by the International Medical Device Regulatory Forum (IMDRF) that seeks to harmonize how UDI regulations are implemented to ease compliance challenges and maximize value from the use of UDIs. She and other members of the U.S. FDA UDI team contributed lessons learned and best practices gained from five years of real world experience. The guide is expected to be published by the end of May.
European update
Salvatore Scalzo with the European Commission, who plays a lead role on both the UDI regulation and the IMDRF application guide, provided the latest details on the European regulation. In addition to labelling their products with UDIs, medical device manufacturers will need to publish data about their products to a new section of the European Databank on Medical Devices (Eudamed). Eudamed was originally launched nearly a decade ago to provide a secure web-based portal for exchange of information provided by manufacturers with the European Commission. Scalzo believes the UDI section of Eudamed will be ready for manufacturers to begin publishing data by late May 2020 as they work toward the official deadline of November 25, 2021 (or sooner for products involved in a serious adverse event.) If Eudamed is not ready by next May, manufacturers will have a six-month extension. Scalzo emphasized that the UDI will be the key to access all data about a particular medical device across Eudamed, which will eventually include sections on clinical trials, performance studies and market surveillance. Unlike the U.S. UDI rule, the European Commission is also requiring all economic operators, including hospitals, to store data (ideally by electronic means) on the sale, receipt and usage of implantable medical devices.
Saudi Arabian update
Azzam Alothman with the Saudi Arabian FDA (sFDA) says he expects his country’s UDI database to be operational by the end of the year. The official sFDA UDI regulation has not yet been published but is expected soon. Like the European regulation, the Saudi rule will also require hospitals to capture and store data on data on implantable devices, but it also includes use of UDIs to control entry of products into the country, and to better protect against counterfeit products and better manage recalls. Alothman expects the database to be used by patients, hospitals and retailers.
The power of parsing
In the U.S., regulations by both the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services (CMS), respectively, have called for documentation of UDIs for implantable devices in electronic health records (EHRs). EHR vendors have met ONC certification requirements by demonstrating the ability to record the UDI and parse it into its specific parts: the device identifier (UDI-DI), such as a GS1 Global Trade Item Number (GTIN), a HIBCC Universal Product Number (UPN) or an ICCBBA ISBT 128, and the components of the production identifier (UDI- PI), which includes data such as lot, serial number, expiration date, manufacture date and/or distinct identification codes. EHRs must also include the UDI in the U.S. Core Data Set for Interoperability or USCDI (formerly known as the Common Clinical Data Set for Meaningful Use). To help ensure effective transfer of clinical and administrative data between software systems used in healthcare, Health Level Seven Fast Healthcare Interoperability Resource (HL7 FHIR) workgroups have been reviewing the core data, including UDI. While some originally thought it was sufficient to store and transmit the full UDI as a text string, UDI-related pilots have determined the need to not only parse the UDI but also be able to record, store and transmit the distinct parts of the UDI in structured fields, rather than as a lengthy text string that requires an additional decoder to understand. It’s the power of parsing that supports important downstream uses of UDI, including inclusion of these distinct data elements in recall notices, adverse event reporting, registries and claims.
It will be important to see if this change impacts the ability of healthcare providers and their IT systems to more effectively use UDIs for a variety of administrative and clinical purposes. Further, the experience of other regulators with more extensive UDI requirements could help answer a more fundamental question as to the value of more precise and in turn restrictive regulation vs. the level of flexibility that the U.S. FDA sought to offer when it issued its UDI rule. In the end, the real value of UDI can only be realized when the UDIs are used in practice and in technology systems. Exactly how best to accomplish that — through government mandate or multi-stakeholder collaboration— has yet to be determined.
