Unique Device Identification (UDI): Evolution, Value Proposition and Implementation: A Provider Perspective
The U.S. Food and Drug Administration's Unique Device Identification (UDI) System Final Rule was published in the Federal Register on September 24, 2013. The rule requires the label and package of marketed devices to include UDI. For devices intended to be used more than once and reprocessed before each use, UDI must be directly marked on the device. UDI consists of a device identifier that identifies manufacturer and model and a production identifier that identifies lot number, serial number, expiration date, and/or date of manufacture. UDI establishes a standard format for medical device identification and the ability to track a device through distribution and use.
Compliance dates for adherence to the rule depend on class of device with highest risk devices being impacted first. UDI on labels and packages of Class III devices are required one year after the final rule and two years after the final rule for other implantable devices. UDI for other devices and direct marking will be required in a step-wise fashion 2-7 years after the final rule. The expected value of UDI use across health care is extensive and is inclusive of clinical, post-market surveillance and supply chain benefits.
There is not parallel regulation or meaningful incentive requiring UDI use at this time although there are ongoing national-level efforts to address this. Some hospitals are readying their systems for UDI use. Many hospitals are seeking information. Achieving full value of UDI across health care will require implementation and adoption of UDI in multiple areas as well as IT integration. Necessary is multi-stakeholder education and collaboration, research efforts focused on implementation and adoption, and leadership through knowledge and involvement.
From a supply chain perspective, expected value includes
- A standard for device documentation in supply chain IT systems
- Greater accuracy and efficiency in procurement
- Improved inventory and recall management
- Better charge capture
- Enhanced availability of device data
From a clinical perspective, expected value includes
- Greater patient safety and accuracy surrounding device use in clinical care
- A standard for device documentation in HIT systems
- Greater comprehensiveness and efficiency in device recalls
- Availability of enhanced data for internal assessment or post-market surveillance activities on devices
- Standard device-identifying information for health care providers and patients
From a post-market surveillance perspective, expected value includes
- Enhanced use of device data from EHR
- Standard device-identifying information in adverse event reports
- A standard for device-identifying data in clinical registries and research databases
- A standard identifier for devices across FDA data systems
- A standard identifier for device recalls
Impact of Barcode Scanning in Orthopedic Surgery (2012-present)
Peri-operative Total Hip and Knee Arthroplasty Implant Documentation and Identification Practices: Implications for Use of Unique Device Identification in Orthopedic Surgery (2011-12)
- Project conducted in collaboration with the Research Committee of the American Association of Hip and Knee Surgeons (AAHKS). Presented at the AAHKS 22nd Annual Meeting, November 2012 and Academy Health's Annual Research Meeting June 2013.
Wilson NA, Jehn M, York S, Davis CM. Revision Total Hip and Knee Arthroplasty Implant Identification: Implications for Use of Unique Device Identification 2012 AAHKS Member Survey Results. J Arthroplasty 2014; 29(2): 251-55.
Wilson, NA, Drozda, J. The Value of Unique Device Identification in the Digital Health Infrastructure, JAMA 2013; 309(20): 2107-8
Education & Other Publications:
The Final UDI Rule- The Clock is Now Ticking (vhatv), December 11, 2013
The FDA’s Unique Device Identification System Rule, (Bloomberg BNA), December 9, 2013
What Pacemaker is this? The Value of Unique Device Identification (KnowWPC). June 27, 2013
The Impacts of the FDA Unique Device Identification System (vhatv), December 12, 2012
The value of unique device identification across healthcare (white paper), December 2012
Unique Device Identification Across Health Care (HSRC-ASU Webinar), September 13, 2012
1. Brookings Institution Unique Device Identification Workshops & Webinars
- Accessing and Communicating Device Information: UDI as a Tool for Improved Patient and Provider Connectivity, March 18, 2013
- Improved Access to Device Information: What a UDI System Can Do for Patients and Consumers (webinar), Feb 26, 2013
- Unique Device Identification Expert Workshop 2: Identifying Steps for Implementation and Integration of UDI within Electronic Data Infrastructure of Care Delivery Sites, December 13, 2012
- The Value of Unique Device Identification for Health Care Systems and Providers (webinar), November 5, 2012
- Unique Device Identification Expert Workshop 1: Exploring the Opportunities and Challenges Associated with Capturing UDIs in Claims, October 15, 2012
- Unique Device Identification (UDI) Implementation Work Group Kick-Off, July 16, 2012
2. U.S. Food and Drug Administration
PROJECT TRUST: BUILDING PROVIDER-SUPPLIER RELATIONSHIPS IN THE HEALTH CARE SUPPLY CHAIN
Project trust was a multiphase study on building provider-supplier relationships in the health sector supply chain. Building on previous research, studied facilitators and barriers to good relationships.
Study Goals included:
- Describing the dynamic nature of multi-faceted relationships
- Identifying facilitators to good relationships
- Identifying barriers to good relationships
- Analyzing the impact of specific factors on facilitating good relationships
- Dedicated resources, commitment, trust, contracts, information sharing and collaboration
- Analyzing the impact of specific factors on barriers to good relationships
- Economic, clinical, dependency, organizational performance
- Providing guidance to hospitals, suppliers and intermediaries for building good provider-supplier relationships
Phase I of Project Trust: This survey study provided pilot data on hospital supply chain leaders’ perception of areas that impact building collaborative relationships with suppliers. Completed 2013
Phase II of Project Trust: Parallel survey studies aimed to understand the manufacturer and hospital supply chain perception of the importance of specific areas in facilitating good relationships. These areas include: dedicated resources, commitment, trust, contracts, information sharing and collaboration. The studies also aimed to understand the barriers that exist in building good relationships.
Findings from project trust are reported in Making the Case for Inter-Organizational Trust, April 2015 and have been presented at a variety of professional meetings and to corporate groups.
- Revision Total Hip and Knee Arthroplasty Implant Identification Practices: Implications for Use of Unique Device Identification
Principal Investigator: Natalia Wilson MD, MPH
This project investigated implant identification practices by orthopedic surgeons prior to revision total hip or knee arthroplasty (THA/TKA) within the context of unique device identification. Considered was methods used, time taken, percentage of cases when the failed implant could not be identified and cost and clinical impact.
Survey results highlighted the inadequacy of current documentation process to
comprehensively obtain device identification for failed implants in THA/TKA.
Survey results also highlighted surgeon and staff inefficiency and perceived clinical
and cost impact when components of the failed implant could not be identified
during pre-operative planning. The UDI Rule presents this opportunity for UDI use in patient care settings, across specialties, as standard practice for documentation of implantable devices.
- The Value of Unique Device Identification (UDI) Across Healthcare
The White paper discusses the Unique Device Identification (UDI) System Proposed Rule that was published by the U.S. Food and Drug Administration (FDA) on July 10, 2012. The UDI rule sets the foundation for use of UDI across healthcare and establishes a common language for medical devices. The potential benefits of UDI are many, including greater accuracy and efficiency in the procurement process, improved charge capture, a standard for device documentation in clinical care and post-market surveillance, enhancement of post-market surveillance activities, greater efficiency and comprehensiveness in recalls, and the ability to track a device across its lifecycle. Achieving the full value of UDI across healthcare will require implementation and adoption of UDI in multiple areas, including supply chain, clinical care, and post-market surveillance, as well as integration between these areas. Research, key constituent involvement, and education efforts are ongoing to address implementation and adoption of UDI across the healthcare industry.
- Corporate Governance and the Adoption and Diffusion of Health Information Technology within Integrated Delivery Systems
Principal Investigator: Michael Furukawa
While several previous studies have found “system affiliation” to be a significant and positive predictor of health information technology (IT) adoption, little is known about the association between corporate governance practices and adoption and diffusion of IT within integrated delivery systems (IDSs). Rooted in agency theory and research in corporate governance, this study examines the relationship between corporate governance practices (centralized decision rights and strategic alignment between business and IT strategy) and IT adoption, standardization, and innovation diffusion within U.S. IDSs. The methodology included Cross-sectional, retrospective analyses using data from the 2011 Health Information and Management Systems Society (HIMSS) Analytics Database on adoption within IDSs (n=485) is used to analyze the association between two corporate governance constructs (centralized decision rights and strategic alignment) and three IT constructs (adoption, standardization, and innovation) within IDSs for clinical and supply-chain IT. Multivariate fractional logit, probit, and negative binomial regressions are applied.
Some of the practical implications of the study include that while IT adoption and standardization are likely to benefit from corporate governance practices within IDSs, innovation is likely to be delayed. Additionally, corporate governance is not one-size-fits all and contingencies are important considerations.
- Supply Chain and Revenue Cycle Integration: Asset Management in the U.S. Hospital Systems.
As healthcare reform continues to place an emphasis on margin management within provider organizations, creating synergy between the supply chain and revenue cycle has increased in importance. In most provider organizations supply chain management (SCM) and revenue cycle operations function in silos, occasionally responding to anecdotal evidence to make improvements in the processes linking the two areas. Hospitals and health care systems that become proficient in managing the revenue environment achieve strategic advantage by reaching their financial goals and assuring a stream of revenues to support their clinical efforts. While the supply chain function has not traditionally been perceived as extending to revenue capture, it is increasingly clear that a linkage between supply chain and those aspects of the hospital that recover money for products used is indispensable for accurate, efficient and consistent cost recovery . This paper and supplemental tool were developed through literature reviews of research pertaining to revenue management, and interviews conducted with three health care systems that vary in size, mission, technology implementation, and efforts to achieve integration of supply chain and revenue cycle operations. While it is clear that technology applications are indispensable to successfully manage “supplies as assets” from point of order to recovery of funds, it is increasingly clear that an organization’s comprehensive intent to strategically manage its supply chain, as a flow of materials, information and funds, is indispensable to success.
- Value for Money: Supply Chain Strategies and Potential Contributions.
As the US health care system is challenged by changes brought about by health care reform and the difficult economic climate, achievement of “Value for Money (VFM)” has become an increasingly important concept depicting a health care system that seeks to achieve maximum benefit and quality for the funds it expends for both clinical and administrative services. This white paper, based on the 2011 Dissemination Conference HSRC-ASU, discusses seven factors pertaining to achieving value for money. The importance of both vertical and horizontal collaboration is stressed across health care providers, suppliers and intermediaries in achieving savings as well as improved clinical outcomes.
- Repositioning Supply Chain in the Health Care System. The paper contributes to the growing awareness of the importance of strategically managing the supply chain function and building a competent and capable supply chain management workforce. The paper reports on interviews with fourteen senior supply chain managers and 7 senior system leaders regarding the repositioning of supply chain into the executive suite of their systems. Key aspects of this repositioning include recognition and validation of repositioning by outside advisors, the touting and dissemination of the value of the supply chain function by senior system leadership, and system readiness for such repositioning. Also discussed are the principal attributes associated with the new breed of supply chain leaders. Included are their attainment of advanced education in business and supply chain management and their considerable skills in relationship management with internal and external channel partners such as group purchasing organizations and distributors.
- Physician Preference Item Management (PPIM). This research evaluated innovative strategies utilized at hospital systems for their management of physician preference items. During the 2008 HSRC-ASU Dissemination Conference, representatives of these identified hospital systems, consortium board members and guests, and other leading experts were brought together for a day-long conference to share strategy, discuss best practices for PPIM, and provide a platform for conceptualization of a cross-disciplinary clinical strategic sourcing center model for PPIM. In follow-up of this conference, a white paper was developed and disseminated.
- Hospital-Physician Gainsharing in Cardiology. This was the first rigorous analysis of the value that gainsharing brings to the health sector as a strategy to align hospital and physicians via incentives for standardization, process improvement and efficiency. The research was published in Health Affairs in 2008.
- Centralization of the Supply Chain Function. A case study and consultation on centralization of supply chain function was carried out in conjunction with Catholic Health Initiatives. "Alignment of CHI Materials Management Leaders" was presented at the International Research Study of Public Procurement, 3rd Workshop, Paris, France, in September 2007.
- Strategic Sourcing & Outsourcing Practices. This project targeted best practices in strategic sourcing and outsourcing from non-health care industries for adoption in health care organizations.
- Supply Metrics. The HSRC-ASU provided the research funding for the genesis of SCMetrixTM, a benchmarking and performance measurement tool. SCMetrixTM was subsequently spun-off and is now a joint venture between Arizona State University and the Association for Health Care Resources and Materials Managers.