Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers
Natalia A Wilson,1 James E Tcheng,2 Jove Graham,3 Joseph P Drozda Jr4 1College of Health Solutions, Arizona State University, Phoenix, AZ, USA; 2Department of Medicine, Duke University School of Medicine, Durham, NC, USA; 3Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA; 4M...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-06-01
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| Series: | Medical Devices: Evidence and Research |
| Subjects: | |
| Online Access: | https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-barriers-strategi-peer-reviewed-fulltext-article-MDER |
| _version_ | 1811332036366958592 |
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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 Jr4 1College of Health Solutions, Arizona State University, Phoenix, AZ, USA; 2Department of Medicine, Duke University School of Medicine, Durham, NC, USA; 3Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA; 4Mercy Research, Mercy, Chesterfield, MO, USACorrespondence: Natalia A Wilson, College of Health Solutions, Arizona State University, Phoenix, AZ, USA, Email natalia.wilson@asu.eduBackground: The 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.Methods: Semi-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.Results: Twenty-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 Implications: Delineation 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.Keywords: unique device identifier, FDA, implementation barriers, implementation strategies, information technology systems, device manufacturer responsibilities |
| first_indexed | 2024-04-13T16:29:44Z |
| format | Article |
| id | doaj.art-8af56f406e6b41cbb0405afb943e5ffb |
| institution | Directory Open Access Journal |
| issn | 1179-1470 |
| language | English |
| last_indexed | 2024-04-13T16:29:44Z |
| publishDate | 2022-06-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Medical Devices: Evidence and Research |
| spelling | doaj.art-8af56f406e6b41cbb0405afb943e5ffb2022-12-22T02:39:36ZengDove Medical PressMedical Devices: Evidence and Research1179-14702022-06-01Volume 1517718676097Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device IdentifiersWilson NATcheng JEGraham JDrozda JP JrNatalia A Wilson,1 James E Tcheng,2 Jove Graham,3 Joseph P Drozda Jr4 1College of Health Solutions, Arizona State University, Phoenix, AZ, USA; 2Department of Medicine, Duke University School of Medicine, Durham, NC, USA; 3Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA; 4Mercy Research, Mercy, Chesterfield, MO, USACorrespondence: Natalia A Wilson, College of Health Solutions, Arizona State University, Phoenix, AZ, USA, Email natalia.wilson@asu.eduBackground: The 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.Methods: Semi-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.Results: Twenty-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 Implications: Delineation 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.Keywords: unique device identifier, FDA, implementation barriers, implementation strategies, information technology systems, device manufacturer responsibilitieshttps://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-barriers-strategi-peer-reviewed-fulltext-article-MDERunique device identifierfood and drug administrationimplementation barriersimplementation strategiesinformation technology systemsdevice manufacturer responsibilities |
| spellingShingle | Wilson NA Tcheng JE Graham J Drozda JP Jr Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers Medical Devices: Evidence and Research unique device identifier food and drug administration implementation barriers implementation strategies information technology systems device manufacturer responsibilities |
| title | Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers |
| title_full | Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers |
| title_fullStr | Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers |
| title_full_unstemmed | Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers |
| title_short | Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers |
| title_sort | advancing patient safety surrounding medical devices barriers strategies and next steps in health system implementation of unique device identifiers |
| topic | unique device identifier food and drug administration implementation barriers implementation strategies information technology systems device manufacturer responsibilities |
| url | https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-barriers-strategi-peer-reviewed-fulltext-article-MDER |
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