UDI Standards Guide

Global Regulators Promote UDI Standardization with New Guide The International Medical Device Regulators Forum (IMDRF) has just released a proposed UDI Application Guide for public comment.¹ The guide provides specifications for regulatory authorities and manufacturers to develop standardized UDI systems that can work together as part of a worldwide system. The guide also provides implementation guidance for stakeholders ranging from suppliers to healthcare providers. According to the new UDI Application Guide “The benefit and purpose of a UDI system will only be realized if healthcare stakeholders integrate and obtain value in their systems from UDIs and data in associated unique device identification databases. This guide is therefore also intended to assist all relevant stakeholders within the healthcare supply chain and clinical care systems to gain a better understanding of their role and impact on the UDI system.”² For IMDRF, a voluntary group consisting of representatives from 10 medical device regulatory authorities around the world, the proposed application guide is a step toward global harmonization of UDI data—and avoiding a situation where each regulatory authority implements and manages their local UDI system differently. “UDIs are not only going improve the Food and Drug Administration’s (FDA's) system for device recalls but also have the potential to facilitate the collection of more and better data on the safety and efficacy of medical technologies on a global scale,” said Joe Lewelling, vice president of emerging technologies and health IT at AAMI.³ Lewelling also pointed out that “If the data in the U.S. are translatable to what’s being collected in Europe, China, and other countries, and vice versa, then we’re going to have a lot more data about safety and effectiveness. And we’re also going to be able to learn much earlier when there are problems with devices in the field that require corrective actions.”⁴ The UDI Application Guide outlines the essential elements of a UDI system and other considerations, such as UDI placement on a device, as well as describes the components of a well-implemented UDI database and how data should be handled within that database. The fundamental elements of a UDI system, according to IMDRF, include:

• Standardized unique device identifiers
• Placement of UDIs in human-readable and AIDC (automatic identification and data capture) formats on package labels and, in some cases, on the device itself
• Submission of core UDI data elements to a UDI database
• Setting of appropriate transitional and implementation arrangements to ensure a smooth UDI system implementation⁵

The FDA began requiring UDIs for many medical devices in 2015, but announced in a January guidance document that it was delaying enforcement for low-risk Class I and unclassified medical devices for at least two years, depending on the device, in order to focus on “existing implementation challenges” for higher-risk devices.⁶ Under the European Union’s Medical Device Regulation, UDI labelling requirements are being phased in beginning with high-risk Class III devices in 2021 and ending with Class I devices in 2025. The China Food and Drug Administration is also working on implementing a UDI system. “The United States is the only jurisdiction with a formalized and implemented UDI system, and while it isn’t perfect, it did push our industry into action and transformed UDI from concept to reality,” said Lena Cordie, president of Qualitas Professional Services.⁷ Cordie also stated that “The benefits of UDI will be fully realized when implemented and used by all stakeholders—from manufacturers entering quality data, to integration of UDI in electronic data sources throughout the healthcare system, including supply chain, electronic health records, and registries, to accessibility by patients.”⁸ The International Medical Device Regulators Forum has had the goal of establishing a globally harmonized, unique device identification (UDI) system for medical devices years. This new guide is a giant step forward toward the attainment of that goal. This is great news for you, your staff and your entire healthcare facility. With the full implementation of the UDI Application Guide, you’ll finally have the ability to know the manufacturer of every medical device in your facility. Armed with this new, powerful information, you’ll be able to quickly react to product recalls and alerts, thus greatly improving patient safety! 1. IMDRF website: http://www.imdrf.org/consultations/cons-udi-system-180712.asp 2. http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-udi-system-n48-180712.pdf 3. AAMI’s website www.aami.org 4. Op. Cite. 5. IMDRF website: http://www.imdrf.org/consultations/cons-udi-system-180712.asp 6. FDA website www.fda.gov 7. Qualitas Professional Services website: http://qualitasproserv.com/services/udi/ 8. Op. Cite.