The Value of Unique Device Identifiers in Plastic Surgery

Aston, Jeffrey W.; Howarth, Ashley L.; Wilson, Natalia; Mahabir, Raman C.

doi:10.1093/asj/sjy210

Cited by 6 publications

(12 citation statements)

References 3 publications

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“…Once a standard record (the UDI) has been electronically established, 4,5 these patient-level device data are available, alone or in aggregate, for clinical, safety surveillance, research, and regulatory purposes. 6,7 Documented UDIs have important clinical uses. UDI availability from a patient's prior procedure supports clinician decision-making before a revision procedure, such as selection of the replacement implant and instrumentation for removal of the failed implant.…”

Section: Introductionmentioning

confidence: 99%

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

Wilson¹,

Tcheng²,

Graham³

et al. 2021

MDER

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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 UDIenabled 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.

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Section: Introductionmentioning

confidence: 99%

“…Additionally, the absence of policy requiring health systems to use UDIs has contributed to slow progress. 7,11,[14][15][16][17] Both of these factors are significant impediments to achieving the goal of a comprehensive UDI-enabled system for patient safety.…”

Section: Introductionmentioning

confidence: 99%

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

Wilson¹,

Tcheng²,

Graham³

et al. 2021

MDER

Self Cite

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“…The UDI is presented on the device label as a bar code or radio frequency identification label [24]. The information provided by the UDI may be linked to a database for the purpose of complementarity and can thus ensure MD traceability [25].…”

Section: Active Monitoringmentioning

confidence: 99%

“…-Lack of clarity of requirements for manufacturers to implement UID, lack of knowledge and understanding of its value among providers, funding problem,barriers to inter-connectivity between health information systems and lack of a standardized EED system [24,25].…”

Section: The Unique Device Identifiermentioning

confidence: 99%

Development and implementation of a system for medical devices monitoring in Morocco

et al. 2021

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Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a multidimensional vigilance system to monitor medical devices in Morocco. Methods : The study is based on a systemic review selected by the PRISMA method for the period between [2011-2021] and on the Scopus, Pubmed, Science direct and Web of science databases. Results: A preliminary analysis of the data identified some challenges such as under-reporting and lack of standardization of adverse reaction coding, standard nomenclature problem for international trade, lack of clarity of requirements for manufacturers, and insufficient regulation and significant incentives for the use of unique device identifiers. Recommendations for a more effective national system are put for ward which address the regulation and computerization of the system for the development of medical devices monitoring mechanisms.

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“…The UDI can be scanned during a patient procedure and documented in the patient's electronic health record where it is available for multiple uses such as sharing with the patient, implant identification in clinical care and aggregation with other device data for post‐market safety surveillance and research. 29 The European Union has also mandated a UDI System through its Medical Device Regulations with dates of compliance starting in 2021. 30 The aim of the work reported here was to answer the following research questions: (a) Are patients aware of identifying information for their implanted device including the UDI?…”

Section: Introductionmentioning

confidence: 99%

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

Wilson

Reich

Graham

et al. 2021

Health Expectations

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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.

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The Value of Unique Device Identifiers in Plastic Surgery

Cited by 6 publications

References 3 publications

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

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

Development and implementation of a system for medical devices monitoring in Morocco

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

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