Introduction
In recent years, both legislation and US Food and Drug Administration (FDA) policy have placed an increasing emphasis on the use of real-world evidence (RWE) to support evaluations of medical device safety and effectiveness, including for regulatory decision making.1 2 RWE is clinical evidence synthesised from data captured from sources other than traditional clinical research. Real-world data (RWD) sources that can contribute to RWE include, but are not limited to, electronic health records (EHRs), insurance claims and registries.3 RWD have several advantages compared with traditional research data sources: they are ubiquitously available, less expensive and available for more diverse patient populations than usually represented in clinical trials.4 5
To drive the quality and efficiency in use of RWD for medical device evaluation, FDA established the National Evaluation System for health Technology Coordinating Centre (NESTcc).6 NESTcc leverages its research network collaborators to generate high-quality RWE to inform medical device decision-making by regulators, payors and clinicians, for the ultimate benefit of patient safety and quality of care.7–9 A fundamental necessity to support this work is that medical devices must be accurately identified and linked to the patients in whose care they are used.
Key legislative steps in this direction were the 2007 FDA Amendments Act and then the 2012 FDA Safety and Innovation Act, which mandated FDA to publish regulations to establish a system where unique device identifiers (UDIs) would be available for medical device identification.10 11 A key impetus was significant medical device-related adverse events.7 12 Subsequently, FDA published the 2013 UDI System Rule, which mandated a distinct code on the label and packaging of medical devices marketed in the USA.13 14 The UDI contains both a device identifier, which includes the manufacturer’s name and the model of the specific device; and a production identifier, which includes, as available, the lot and serial number, manufacturing date and expiration date. Manufacturers have complied with this mandate and most moderate and high-risk devices are labelled with an UDI.
However, for the UDI to be leveraged for RWE generation, it must be integrated into structured fields within electronic health information technology (IT) systems—primarily EHRs—when a medical device is used in a patient’s care. UDI integration is a critical step in ensuring these data are available for transmission to research databases and in claims forms, thus available for downstream use. Limited availability of UDIs in RWD has been cited as a significant data challenge in generating RWE.15–17 Although the Office of the National Coordinator for Health Information Technology requires inclusion of the UDI for implantable medical devices for EHR certification, with an appropriate field, there is no mandate for hospitals to populate this field.18 While some health systems have delineated the value of this integration clinically and operationally for their organisation and have implemented UDI capture into health IT systems at the point-of-care,19 20 unfortunately many have not21 in the setting of organisational, workflow and IT challenges.22
Understanding how health systems perceive the value of UDI and choose to implement it as a structured data element within an EHR is an essential next step to support strategies to increase the availability of medical device data for RWD-based studies. Prior research on health systems that had implemented UDI for implantable devices informed a roadmap for health system implementation as well as barriers, strategies and next steps.21 23 This project sought to build on this work and characterise the current state of UDI implementation and use in a focused group of health systems, those affiliated with NESTcc. Ultimately, these findings are intended to inform a playbook for UDI implementation in NESTcc health system network collaborators and for broader use by health systems, to support advancement of RWE on medical devices.