Unique Device Identification System Research Articles

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

BackgroundThe 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.MethodsSemi-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.ResultsTwenty-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 ImplicationsDelineation 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.

Comparison of Medical Device Regulations in India, Japan and South Korea

Increased health awareness, a growing middle class, and government health efforts are projected to propel India's medical equipment market forward in the next years. With the publication of the Medical Device Rules in 2017, Indian authorities revised the medical device regulatory process. The devices included in the link are currently regulated medical devices and in vitro diagnostic devices, as well as their classifications. CLA (Central Licensing Authority) is in charge of all import device licencing, as well as manufacturing, loan, and wholesale licences for Class C and Class D medical devices.
 Because of its complicated registration process and linguistic obstacles, Japan is regarded one of the most difficult markets for overseas medical device producers. The Pharmaceutical and Medical Device Agency, which works in tandem with the MHLW (Ministry of Health and Labour Welfare), is in charge of reviewing drug and medical device applications in Japan. The Pharmaceuticals and Medical Devices Act is a federal law that regulates the sale of pharmaceuticals and medical devices. The Pharmaceuticals and Medical Devices Act, also known as the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, lays out the current PMDA (Pharmaceuticals and Medical devices Agency) laws in Japan.
 South Korea is one of the largest health-care markets in the Asia-Pacific region. Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety, formerly known as the Korea Food and Drug Administration. The Medical Device Act of 2015 governs current medical device laws in Korea. To access the South Korean Medical-Device-Market, you must first obtain marketing approval from the local Medical Device Authority, the Medical Device Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. With the MFDS notification No. 2020-29, the South Korean Ministry of Food and Drug Safety launched UDI (Unique Device Identification System) operations in 2018. Article 20 of the Medical Device Act and Article 54-2 of the Medical Device Act Enforcement Regulations make UDI compliance mandatory.

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

BackgroundThe 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.MethodsSemi-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.ResultsTwenty-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 ImplicationsThe 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.

Packaging Related Terms and Their Application in Unique Device Identification System

This article introduces the significance of packaging for the implementation of Unique Device Identification System (UDI system) and some key terms associated with it. It is further supported by analyzing the important role it plays in building a successful UDI system. This article provides a reference for the related stakeholders to meet the requirement and implement UDI system.

A rastreabilidade de dispositivos médicos implantáveis e o sistema único de identificação de dispositivos: um estudo bibliométrico

The aim was to systematize and analyze the national and international scientific production on the traceability of implantable medical devices and the use of the Unique Device Identification System in 126 academic articles. Data were retrieved from the Scopus database and analyzed using inferential statistics to reach conclusions about a larger group. Thus, the coefficient of determination and the chi-square test of adherence were adopted, using the Microsoft Excel® software and the R statistical program to assess the scientific production activity related to the terms’ traceability and unique identification of the device. A map was generated in the VOS software, which provided the analysis of the behavior parameters and some presentations of the results in the form of tables and graphs, examined according to descriptive statistics. It was found that there was theoretical and empirical growth in the field of traceability of implantable medical devices and in the use of the Unique Device Identification System.

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.

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.

New European medical device regulation: How the French ecosystem should seize the opportunity of the EUDAMED and the UDI system, while overcoming the constraints thereof

The European regulation governing the placing on the market of medical devices (MD) provides for the gradual and mandatory phasing-in, within the European Union, of a unique device identification (UDI) system and a European database (EUDAMED) aimed at improving traceability and transparency of the market. The deployment of these tools will have a significant impact on the stakeholders of the medical device world (companies, health institutions, healthcare professionals, competent authorities, etc.). A strengths/weaknesses/opportunities/threats (SWOT) analysis conducted among the think tank participants shows real support for the objectives but also distinguishes a great deal of issues relating to the implementation of these tools. An inventory of the current traceability tools and databases used in France was then carried out to measure the gaps between the requirements of the European regulation and the current situation revealing that EUDAMED and the UDI system will ultimately have to slot into a complex and poorly interoperable ecosystem. An essential first step to facilitate this integration will be to increase the number of educational, awareness-raising and information initiatives for the stakeholders concerned. Several other recommendations were put forward to support the implementation of EUDAMED and the UDI system in France and thus enable their promises to crystallise in the future.

Innovative Distribution Priorities for the Medical Devices Industry in the Fourth Industrial Revolution.

PurposeThis study aimed to set priorities for improving the medical device distribution structure and to suggest an innovative improvement plan for the distribution structure using the analytic hierarchy process (AHP) method, focusing on stakeholders in the medical device industry.MethodsThis study conducted a survey with 35 specialists using the AHP method, which is a multiple-criteria decisionmaking methodology, in order to set priorities for improvement plans to address the problems faced by the medical device distribution structure.ResultsThe AHP analysis showed that supply stability was the most important factor, followed by greater transparency, efficiency, smart supply, and cost reduction.ConclusionsIt is necessary to establish a stable supply system and manage crises through supply stability, as well as to provide opportunities for fair trade through greater transparency. As steps towards those goals, we propose establishing a unique device identification system, an information disclosure system, online distribution, and a group purchasing organization system in Korea.

Unique Device Identifier Database Integration for Clinical Engineers

Over the last several years, the US Food and Drug Administration has established the Unique Device Identification system. The US Food and Drug Administration has published several previous articles explaining the background for developing the system and helping hospitals adopt Unique Device Identification into their daily use. In this article, we provide background on the database where device identification information is stored and accessed, the Global Unique Device Identification Database (GUDID). We also explain several methods for accessing those data through the public portal, AccessGUDID, and describe efforts to integrate GUDID data into existing infrastructure using the GUDID application programming interfaces.

Evaluation of the unique device identification system and an approach for medical device tracking

BackgroundMost countries have different registration and tracking system, but unique device identification based approach was recently introduced in the USA. In 2013, FDA and EU released regulations about unique device identification system. In literature, there is not any study that compares the UDI legislations on the basis of the requirements. In addition to the legal requirements, establishing a UDI system in digital environment is very challenging. MethodsThis is a theory based study that includes information from healthcare industries and key points from UDI related legislations which are discussed. To visualize the design of the proposed system, the Dia program that contains the Unified Modeling Language (UML) components was used. ResultsImplementation of the UDI based tracking system is very difficult due to two reasons. First, the relevant legislations do not give detailed information on how UDI system will be implemented. Second, each type of medical device has difficulties due to UDI labeling. We have observed that the stakeholders in the medical devices sector in Turkey, especially the manufacturers, are not yet ready for UDI-based tracking. The current registry system is not effective to track medical devices and share data. ConclusionsTo overcome compliance problems, UDI requirements should be perfectly determined and subsequently related legislation should be established. Regarding these requirements, every country should introduce an action plan and include all sector stakeholders in that action plan. We suggest a model for medical device tracking to be able to use instead of the current registry system in Turkey.

The Food and Drug Administration's unique device identification system: better postmarket data on the safety and effectiveness of medical devices.

The Food and Drug Administration's unique device identification system: better postmarket data on the safety and effectiveness of medical devices.

Implementing Unique Device Identification in Electronic Health Record Systems

The United States Food and Drug Administration (FDA) has proposed creating a unique device identification (UDI) system for medical devices to facilitate postmarket surveillance, quality improvement, and other applications. Although a small number of health care institutions have implemented initiatives comparable with the proposed UDI system by capturing data in electronic health record (EHR) systems, it is unknown whether institutions with fewer resources will be able to similarly implement UDI. This paper calls attention to organizational, workflow, and technological challenges in UDI system implementation by drawing from the literature on EHR and clinical research systems implementation. Organizational challenges for UDI system implementation include coordinating multiple stakeholders to define UDI attributes and characteristics for use in EHRs, guiding organizational change within individual institutions for integrating UDI with EHRs, and guiding organizational change for reusing UDI data captured in EHRs. Workflow challenges include capturing UDI data in EHRs using keyboard entry and barcode scanning. Technological challenges involve interfacing UDI data between EHRs and surgical information systems, transforming UDI and related patient data from EHRs for research, and applying data standards to UDI within and beyond EHRs. We provide recommendations for regulations, organizational sharing, and professional society engagement to raise awareness of and overcome UDI system implementation challenges. Implementation of the UDI system will require integration of people, process, and technology to achieve benefits envisioned by FDA, including improved postmarket device surveillance and quality of care.

Postmarket surveillance of medical devices: current capabilities and future opportunities

Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide. Premarket evaluation of CIEDs cannot be expected to eliminate all performance defects. Robust postmarket surveillance systems are needed to promote patient safety and reduce harm. Challenges impacting existing surveillance mechanisms include underreporting of defects, low rates of return of explanted CIEDs, lack of integration of surveillance into normal workflow, underutilization of existing resources including registries, a lack of capacity of aging resources, multiple proprietary platforms that lack interoperability, and the unmet need for common data variables as well as newer methods to generate, synthesize, analyze, and interpret evidence in order to respond rapidly to safety signals. Long-term solutions include establishing a unique device identification system; promoting expanded use of registries for surveillance and post-approval studies; developing additional methods to combine evidence from diverse data sources; creating tools and implementing strategies for universal automatic, triggered electronic event reporting; and refining methods to rapidly identify and interpret safety signals. Protection from litigation and creation of financial and other incentives by legislators, regulators, payers, accreditation organizations, and licensing boards can be expanded to increase participation in device surveillance by clinicians and health care facilities. Research to evaluate the comparative effectiveness of surveillance strategies is needed. Interim solutions to improve CIED surveillance while new initiatives are launched and the system strengthened are also presented.

Beyond Indications

In September of this year, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health published a document entitled, “Strengthening Our National System for Medical Device Postmarket Surveillance.”1 In addition to summarizing the current process and mechanisms for monitoring medical devices after commercial approval, the document proposed the following specific actions to improve the efficiency and quality of postmarket surveillance of medical devices in the United States: > 1. Establish a unique device identification system and promote its incorporation into electronic health information; > > 2. Promote the development of national and international device registries for selected products; > > 3. Modernize adverse event reporting and analysis; and, > > 4. Develop and use new methods for evidence generation, synthesis, and appraisal. [1, p. 4] The intended focus of this initiative is laudable and much needed, as the current system, discussed in this journal earlier this year,2 is widely believed to be overly time consuming and expensive, and to place the United States at a competitive and technological disadvantage to many other countries. As with many of the investigational mechanisms used to assess new medical technologies, these initiatives are likely to lend themselves most easily to devices that are used widely and in relatively consistent applications. With the introduction and evolution of this forward thinking upgrade of the postmarket medical device surveillance system, let us hope that low-volume, off-label, and other marginal device use remains within its purview so that we can collectively move toward a better understanding and oversight of such device applications, as well as those with broader market applications. It is no secret that the majority of transcatheter interventions for congenital heart disease in the United States are performed with devices that are not …