Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care
Natalia A Wilson, 1 James E Tcheng, 2 Jove Graham, 3 Joseph P Drozda Jr 4 1College of Health Solutions, Arizona State University, Phoenix, AZ, USA; 2Duke University School of Medicine and Health System, Durham, NC, USA; 3Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA;...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2021-11-01
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| Series: | Medical Devices: Evidence and Research |
| Subjects: | |
| Online Access: | https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER |
| _version_ | 1818743888480829440 |
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| author | Wilson NA Tcheng JE Graham J Drozda JP Jr |
| author_facet | Wilson NA Tcheng JE Graham J Drozda JP Jr |
| author_sort | Wilson NA |
| collection | DOAJ |
| description | Natalia A Wilson, 1 James E Tcheng, 2 Jove Graham, 3 Joseph P Drozda Jr 4 1College of Health Solutions, Arizona State University, Phoenix, AZ, USA; 2Duke University School of Medicine and Health System, Durham, NC, USA; 3Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA; 4Outcomes Research, Mercy, Chesterfield, MO, USACorrespondence: Natalia A WilsonCollege of Health Solutions, Arizona State University, 500 N. 3rd St., Phoenix, AZ, 85004, USAEmail natalia.wilson@asu.eduBackground: 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.Keywords: unique device identifiers, implants, implementation framework, UDI-enabled system, implantable devices |
| first_indexed | 2024-12-18T02:35:34Z |
| format | Article |
| id | doaj.art-6cca7b7b52da4759a0b4eedb4736e191 |
| institution | Directory Open Access Journal |
| issn | 1179-1470 |
| language | English |
| last_indexed | 2024-12-18T02:35:34Z |
| publishDate | 2021-11-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Medical Devices: Evidence and Research |
| spelling | doaj.art-6cca7b7b52da4759a0b4eedb4736e1912022-12-21T21:23:47ZengDove Medical PressMedical Devices: Evidence and Research1179-14702021-11-01Volume 1441142171021Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of CareWilson NATcheng JEGraham JDrozda JP JrNatalia A Wilson, 1 James E Tcheng, 2 Jove Graham, 3 Joseph P Drozda Jr 4 1College of Health Solutions, Arizona State University, Phoenix, AZ, USA; 2Duke University School of Medicine and Health System, Durham, NC, USA; 3Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA; 4Outcomes Research, Mercy, Chesterfield, MO, USACorrespondence: Natalia A WilsonCollege of Health Solutions, Arizona State University, 500 N. 3rd St., Phoenix, AZ, 85004, USAEmail natalia.wilson@asu.eduBackground: 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.Keywords: unique device identifiers, implants, implementation framework, UDI-enabled system, implantable deviceshttps://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDERunique device identifiersimplantsimplementation frameworkudi-enabled systemimplantable devices |
| spellingShingle | Wilson NA Tcheng JE Graham J Drozda JP Jr Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care Medical Devices: Evidence and Research unique device identifiers implants implementation framework udi-enabled system implantable devices |
| title | Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care |
| title_full | Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care |
| title_fullStr | Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care |
| title_full_unstemmed | Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care |
| title_short | Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care |
| title_sort | advancing patient safety surrounding medical devices a health system roadmap to implement unique device identification at the point of care |
| topic | unique device identifiers implants implementation framework udi-enabled system implantable devices |
| url | https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER |
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