In April 2014, The Pew Charitable Trusts supported a study by The Workgroup for Electronic Data Interchange Foundation (The WEDI Foundation) on unique device identification. The WEDI Foundation, formed in 2004, is a multi-stakeholder charitable non-profit dedicated to scientific research and education in order to foster the improvement of administrative and clinical healthcare information exchange.
Medical technology and devices deliver remarkable advances in the health and care of individuals; however, the full risks and effectiveness of medical devices are not completely known because of the lack of a robust postmarket surveillance system in the United States. Without an effective system to gather and share the unique identification of devices, conducting recalls or understanding device performance is difficult.
To address this problem, the U.S. Food and Drug Administration (FDA) is establishing the new unique device identifier (UDI) system, which will provide each device with a unique number corresponding to its make, model, and other clinically relevant information, such as lot number and expiration date. Manufacturers of high-risk implantable devices will begin including the UDI on product packaging in September 2014. In a phased approach over the next several years, labels on virtually all devices will be required to contain the UDI. The true benefits will be realized with the capture and transmission of UDI throughout healthcare to evaluate device performance and conduct device recalls.
The medical device postmarket surveillance system should quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance, including the clinical benefits and risks of marketed devices, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices (FDA, 2012). Unfortunately, the current system does not accomplish any of these objectives.
To address this challenge, WEDI conducted a series of meetings involving multiple stakeholders from the healthcare industry to discuss the many facets of postmarket surveillance with particular focus on the transmission of UDI from providers to payers. The focus of these discussions was high-risk implanted devices only1. UDI transmission is not cost-effective, nor necessary, for all devices. Only those devices that are prone to failure and would cause substantial harm to patients should have the UDI transmitted. High-risk, implanted medical devices fit that definition.
The outcome of the discussions was recognition that a hybrid approach would be the optimum solution to enable the UDI to become an integral component of the postmarket surveillance system in the United States.
This hybrid approach would include:
- Developing provider system capabilities to capture and electronically integrate the UDI into their internal systems so the UDI is available within their clinical systems, supply chains, and administrative systems
- Implementing reporting registries to consolidate device information, including UDI, from facilities
- Adding UDI as an optional field, via a situational rule to the ASC X12N standards, to enable providers and payers to transmit and use the UDI of high risk implants on a voluntary basis
- Deploying pilots with support of the Food & Drug Administration (FDA) that test and demonstrate UDI being transmitted between the critical entities (e.g., provider to payer, provider to registry, etc.) to evaluate the transmission methods.
1 Refers to non-dental devices