Unique Device Identifiers for Medical Devices at 10 Years.

This Viewpoint discusses the next steps to realize the public health promise of using unique device identifiers in health information data and outlines the progress and challenges in implementation over the past 10 years.

Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.

Objectives: To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices. Design: Mixed methods, including a structured survey and semistructured interviews. Setting: Eight health systems participating in the National Evaluation System for health Technology research network within the USA. Participants: Individuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology and high-volume procedural area(s) in their health system. Main outcomes measures: Interview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analysed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted. Results: Thirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision-makers; organisational systems, culture and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices. Conclusions: UDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation.

Multi-institutional distributed data networks for real-world evidence about medical devices: building unique device identifiers into longitudinal data (BUILD).

Objectives: To support development of a robust postmarket device evaluation system using real-world data (RWD) from electronic health records (EHRs) and other sources, employing unique device identifiers (UDIs) to link to device information. Methods: To create consistent device-related EHR RWD across 3 institutions, we established a distributed data network and created UDI-enriched research databases (UDIRs) employing a common data model comprised of 24 tables and 472 fields. To test the system, patients receiving coronary stents between 2010 and 2019 were loaded into each institution's UDIR to support distributed queries without sharing identifiable patient information. The ability of the system to execute queries was tested with 3 quality assurance checks. To demonstrate face validity of the data, a retrospective survival study of patients receiving zotarolimus or everolimus stents from 2012 to 2017 was performed using distributed analysis. Propensity score matching was used to compare risk of 6 cardiovascular outcomes within 12 months postimplantation. Results: The test queries established network functionality. In the analysis, we identified 9141 patients (Mercy = 4905, Geisinger = 4109, Intermountain = 127); mean age 65 ± 12 years, 69% males, 23% zotarolimus. Separate matched analyses at the 3 institutions showed hazard ratio estimates (zotarolimus vs everolimus) of 0.85-1.59 for subsequent percutaneous coronary intervention (P = .14-.52), 1.06-2.03 for death (P = .16-.78) and 0.94-1.40 for the composite endpoint (P = .16-.62). Discussion: The analysis results are consistent with clinical studies comparing these devices. Conclusion: This project shows that multi-institutional data networks can provide clinically relevant real-world evidence via distributed analysis while maintaining data privacy.

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers.

Background: The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption. Methods: Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps. Results: Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy. Conclusions and Implications: Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.

Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care.

BACKGROUND: The US Food and Drug Administration's Unique Device Identification System Rule of 2013 mandated manufacturers to assign unique device identifiers (UDIs) to their medical devices. Most high-risk (Class III), moderate-risk (Class II) and implantable devices now have UDIs. To achieve the necessary next step for a comprehensive UDI-enabled system for patient safety, UDIs must be electronically documented during patient care, a process not routinely done. The purpose of this research was to study the implementation experiences of diverse health systems in order to develop a roadmap for UDI implementation at the point of care. METHODS: Semi-structured interviews were conducted with personnel at health systems that had implemented UDI for implantable devices in their cardiac catheterization labs or operating rooms. Interviews were audio-recorded, transcribed, and analyzed using the framework methodology of Ritchie and Spencer. Data interpretation involved development of a conceptual model and detailed recommendations for UDI implementation. An expert panel evaluated and provided input on the roadmap. RESULTS: Twenty-four interviews at ten health systems were conducted by phone. Participants described implementation steps, factors and barriers impacting implementation. Findings populated a UDI implementation roadmap, that includes Foundational Themes, Key Components, Key Steps, UDI Use, and Outcomes. CONCLUSIONS AND IMPLICATIONS: The UDI implementation roadmap provides a framework for health systems to address the necessary steps and multilevel factors that underpin UDI implementation at the point of care. It is intended to guide and advance routine electronic documentation of UDIs for devices used during clinical care, the critical next step for a comprehensive UDI-enabled system to enhance medical device safety and effectiveness for patients.

FDA Device Oversight From 1906 to the Present.

This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts by the FDA to strengthen device oversight and address areas of concern.

Patient perspectives on the need for implanted device information: Implications for a post-procedural communication framework.

BACKGROUND: Shared decision making and patient-centred communication have become part of pre-procedural decisions and perioperative care across medical specialties. However, gaps exist in patient communication about the implanted device received and the benefits in sharing information about their procedure and device. OBJECTIVE: To understand the patients' knowledge of identifying information for their implanted devices and perspectives on sharing their implanted device information. METHODS: Four focus groups were conducted with patients who had received a cardiac or vascular implanted device from one of the study sites within the previous 6 months. Data were transcribed and thematically analysed. RESULTS: Five themes emerged: lack of awareness of identifying information on implanted devices; value of information on implanted devices; varying trust with sharing device information; perceived risk with sharing device information; and lack of consensus on a systematic process for tracking implanted devices. DISCUSSION: Patients desire post-procedural information on their implanted device and a designated plan for longitudinal follow-up, but lack trust and perceive risk with broadly sharing their implanted device information. CONCLUSION: After receiving an implanted device, post-procedural patient communication needs to be expanded to include identifying information on the device including the unique device identifier, how long-term tracking will be supported and the process for notification in case of a problem with the device. This communication should also include education on how sharing device information supports patients' long-term health care, post-market safety surveillance and research. PATIENT OR PUBLIC CONTRIBUTION: The research team included members who were also patients with implanted devices.

Transmitting Device Identifiers of Implants From the Point of Care to Insurers: A Demonstration Project.

BACKGROUND: For implanted devices, an effective postmarket surveillance system does not exist. For medications, the Food and Drug Administration's Sentinel Initiative plays that role, relying mainly on drug codes in insurance claims. Unique device identifiers (UDIs) could play an analogous role for implants, but there is no mandate for providers to include UDIs in claims or for payers to record them. Objections have been raised to incorporating UDIs into claims based on a potential burden on providers. METHODS: To assess this purported barrier, we modified information systems at 2 provider-payer dyads to allow for the transmission of UDI data from provider to payer. In addition, to illustrate the potential benefit of including device data in claims, we used our data to compare rates of 90-day adverse events after implantation using the electronic health record (EHR) alone with the EHR plus claims. RESULTS: The software system modifications were modest and performed as designed. Moreover, the level of difficulty of their development and implementation was comparable to that associated with a typical new release of an existing system. In addition, our data demonstrated the ability of claims-based data plus EHR data to reveal a larger percentage of postprocedure adverse events than data from EHRs alone. CONCLUSIONS: Modifying information systems to allow for the transmission of UDI data from providers to payers should not impose a substantial burden on either. Implementation of a postmarket surveillance system based on such data in claims will require, however, the development of a system analogous to Sentinel.

UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim.

BACKGROUND: In response to problems with the current postmarket surveillance of medical devices, the U.S. Food and Drug Administration mandated device labelers to include a unique device identifier (UDI), composed of a device identifier (DI) and production identifier. Including the DI in insurance claims could be a potent method to monitor implanted devices, yet implementation has lagged because of questions of benefit and operational concerns. METHODS: To illustrate the potential benefit of including DIs in claims, rates of 90-day adverse events after implantation using an electronic health record (EHR) were compared with the EHR plus claims, which capture utilization outside that EHR's health system. To explore operations, we planned a pilot project to transmit the DI of implanted devices from the point of care to the claim at two provider/payer pairs. RESULTS: By querying claims plus EHR, estimated rates of patients with potential adverse events were as much as 3.75 times higher. For our pilot, our multistakeholder team identified and resolved the following five challenges: (1) capturing the DI at the point of care; (2) selecting a location for the DI on the claim form; (3) transmitting the DI to the claim form; (4) analyzing the claim forms received by the payer; and (5) verifying the quality of the transmitted information. CONCLUSIONS: Including DIs on claims could allow more complete data capture of adverse events for implanted devices than the EHR data. We overcame challenges in transmitting the DI to the claim with attention to planning and multistakeholder involvement.

Nurses' Perceptions of Implant Barcode Scanning in Surgical Services.

The US Food and Drug Administration's 2013 Unique Device Identification System Rule requires manufacturers to label devices with unique identifiers. Implantable devices are now shipped with unique identifiers, and many electronic health records have fields to incorporate them. Health policy changes have prompted hospital systems to assess implementation of implant barcode scanning systems to capture unique device identifiers. Project aims were to assess predictors of operating room nurses' acceptance of a new implant barcode scanning system, describe operating room nurses' perceptions of the system value, and identify operating room nurses' perceived gaps in system implementation. An online survey was disseminated to operating room nurses, and focus groups were conducted with orthopedic operating room nurses in an academic medical center that had recently implemented an implant barcode scanning system in surgical services. Predictors of barcode scanning acceptance included perceived usefulness for patient care, perceived ease of use, and perceived usefulness (self). Nurses perceived the system to be more accurate and valuable for patient safety. Perceived gaps in system implementation related to communication, completeness of the system, consistency in process, and training. Understanding nurse perceptions of new barcode scanning systems and engaging them in the implementation process are key areas for success and optimization of these systems.

Science of Health Care Delivery: An Innovation in Undergraduate Medical Education to Meet Society's Needs.

The purpose of this special article is to describe a new, 4-year Science of Health Care Delivery curriculum at Mayo Clinic School of Medicine, including curricular content and structure, methods for instruction, partnership with Arizona State University, and implementation challenges. This curriculum is intended to ensure that graduating medical students enter residency prepared to train and eventually practice within person-centered, community- and population-oriented, science-driven, collaborative care teams delivering high-value care. A Science of Health Care Delivery curriculum in undergraduate medical education is necessary to successfully prepare physicians so as to ensure the best clinical outcomes and patient experience of care, at the lowest cost.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%.

National projections of time, cost and failure in implantable device identification: Consideration of unique device identification use.

BACKGROUND: U.S. health care is responding to significant regulation and meaningful incentives for higher quality care, patient safety, electronic documentation and data exchange. FDA's Unique Device Identification (UDI) Rule, a relatively new regulation aligned with these goals, requires standard labeling of medical devices by manufacturers. This lays the foundation for UDI scanning and documentation in the electronic health record, expected to change the landscape of medical device identification and postmarket surveillance. METHODS: We developed national projections for time, cost and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA) using American Association of Hip and Knee Surgeons 2012 membership survey data, Nationwide Inpatient Sample 2011 data and THA/TKA demand projection data. RESULTS: Our projections suggest that cumulative surgeon time spent identifying failed implants could reach 133,000 h in 2030, representing opportunity to perform over 500,000 15 min established patient office visits. Staff time could reach 220,000 h with a cost of $3.3m. Failed implants that cannot be identified may be greater than 50,000 preoperatively and 25,000 intraoperatively in 2030. CONCLUSION: Study projections indicate significant time, cost and inability to identify failed implants, supporting need for improvement of implant documentation. FDA's UDI Rule sets the foundation for UDI scanning and documentation in the electronic health record, a process poised to serve as the standard system for device documentation.

Revision total hip and knee arthroplasty implant identification: implications for use of Unique Device Identification 2012 AAHKS member survey results.

FDA's Unique Device Identification (UDI) Rule will mandate manufacturers to assign unique identifiers to their marketed devices. UDI use is expected to improve implant documentation and identification. A 2012 American Association of Hip and Knee Surgeons membership survey explored revision total hip and knee arthroplasty implant identification processes. 87% of surgeons reported regularly using at least 3 methods to identify failed implants pre-operatively. Median surgeon identification time was 20 min; median staff time was 30 min. 10% of implants could not be identified pre-operatively. 2% could not be identified intra-operatively. UDI in TJA registry and UDI in EMR were indicated practices to best support implant identification and save time. FDA's UDI rule sets the foundation for UDI use in patient care settings as standard practice for implant documentation.

Professionalism in 21st century professional practice: autonomy and accountability in orthopaedic surgery.

Orthopaedic surgical practice is becoming increasingly complex. The rapid change in pace associated with new information and technologies, the physician-supplier relationship, the growing costs and growing gap between costs and reimbursements for orthopaedic surgical procedures, and the influences of advertising on the patient, challenge all involved in the delivery of orthopaedic care. This paper assesses the concepts of professionalism, autonomy, and accountability in the 21st century practice of orthopaedic surgery. These concepts are considered within the context of the complex value chain surrounding orthopaedic surgery and the changing forces influencing clinical decision making by the surgeon. A leading impetus for challenge to the autonomy of the orthopaedic surgeon has been cost. Mistrust and lack of understanding have characterized the physician-hospital relationship. Resource dependency has characterized the physician-supplier relationship. Accountability for the surgeon has increased. We suggest implant surgery involves shared decision making and "coproduction" between the orthopaedic surgeon and other stakeholders. The challenge for the profession is to redefine professionalism, accountability, and autonomy in the face of these changes and challenges.

Hip and knee implants: current trends and policy considerations.

This paper constitutes an analysis of the issues, relationships, emerging hospital strategies, and policy needs surrounding hip and knee implants. Demand for hip and knee replacements is rising annually, and growth is expected to be substantial. Costs are high, reaching $11 billion for hospitals in 2004 and $5 billion for Medicare in 2006. Relationships among stakeholders add complexity. Case studies reveal emerging strategies by hospitals for management of implants. Policy considerations include development of a national council for data and technology assessment, a national joint registry, price transparency, and incentives.