TY - JOUR
T1 - Exploring unique device identifier implementation and use for real-world evidence
T2 - A mixed-methods study with NESTcc health system network collaborators
AU - Dhruva, Sanket S.
AU - Ridgeway, Jennifer L.
AU - Ross, Joseph S.
AU - Drozda, Joseph P.
AU - Wilson, Natalia A.
N1 - Funding Information:
This project was supported by a research grant from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology (NEST), an initiative funded by the U.S. Food and Drug Administration (FDA) through grant 1U01FD006292-01. Its contents are solely the responsibility of the authors and do not necessarily represent the official views nor the endorsements of the Department of Health and Human Services or the FDA. While MDIC provided feedback on project conception and design, the organisation played no role in collection, management, analysis and interpretation of the data The research team, not the funder, made the decision to submit the manuscript for publication. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organisation imply endorsement by the United States Government.
Funding Information:
SSD receives research support from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology Coordinating Center (NESTcc), Greenwall Foundation, National Institute for Health Care Management, Arnold Ventures and Department of Veterans Affairs. JSR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the MDIC as part of the NESTcc, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, JSR is an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. JPD has received research support from Medtronic and Johnson & Johnson. His non-dependent son is an employee of Boston Scientific. NAW has received research support from the MDIC as part of the NESTcc, Patient-Centered Outcomes Research Institute, U.S. Food and Drug Administration, Johnson & Johnson, and Medtronic; serves on advisory committees for the AIM North America UDI Advisory Committee, Association for Health Care Resource reports consulting for Arizona State University’s Center for Healthcare Delivery and Policy, Mass General Brigham; and had purchased stock options in Vitreos Health. The remaining author has nothing to disclose.
Funding Information:
This project was supported by NESTcc, an organisation with a network of research collaborators focused on generating RWE for medical device testing, approval and monitoring. The study team included investigators with expertise in UDI implementation, medical device evaluation, use of RWD, and qualitative methods. The study team met with NESTcc leadership monthly.
Publisher Copyright:
© This manuscript's contents are solely the responsibility of the authors and do not necessarily represent the official views nor the endorsements of the Department of Health and Human Services or the FDA.
PY - 2023/1/23
Y1 - 2023/1/23
N2 - 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.
AB - 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.
KW - Device Evaluation
KW - Devices
KW - Process Assessment (Health Care)
KW - Real World Evidence
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U2 - 10.1136/bmjsit-2022-000167
DO - 10.1136/bmjsit-2022-000167
M3 - Article
AN - SCOPUS:85146904149
SN - 2631-4940
VL - 5
JO - BMJ Surgery, Interventions, and Health Technologies
JF - BMJ Surgery, Interventions, and Health Technologies
IS - 1
M1 - A8
ER -