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; 4Outcomes Research, Mercy, Chesterfield, MO, USACorrespondence: Natalia A WilsonCollege of Health Solutions, Arizona State University, 500 N. 3rd St., Phoenix, AZ, 85004, USAEmail natalia.wilsonasu.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 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Wilson NA [verfasserIn] Tcheng JE [verfasserIn] Graham J [verfasserIn] Drozda JP Jr [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2021

Schlagwörter:	unique device identifiers implants implementation framework udi-enabled system implantable devices

Übergeordnetes Werk:	In: Medical Devices: Evidence and Research - Dove Medical Press, 2009, (2021), Seite 411-421
Übergeordnetes Werk:	year:2021 ; pages:411-421

Links:	Link aufrufen Link aufrufen Journal toc

Katalog-ID:	DOAJ062995650

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allfields	(DE-627)DOAJ062995650 (DE-599)DOAJ6cca7b7b52da4759a0b4eedb4736e191 DE-627 ger DE-627 rakwb eng R855-855.5 Wilson NA verfasserin aut Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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.wilsonasu.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 unique device identifiers implants implementation framework udi-enabled system implantable devices Medical technology Tcheng JE verfasserin aut Graham J verfasserin aut Drozda JP Jr verfasserin aut In Medical Devices: Evidence and Research Dove Medical Press, 2009 (2021), Seite 411-421 (DE-627)611726149 (DE-600)2520731-3 11791470 nnns year:2021 pages:411-421 https://doaj.org/article/6cca7b7b52da4759a0b4eedb4736e191 kostenfrei https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER kostenfrei https://doaj.org/toc/1179-1470 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2021 411-421
spelling	(DE-627)DOAJ062995650 (DE-599)DOAJ6cca7b7b52da4759a0b4eedb4736e191 DE-627 ger DE-627 rakwb eng R855-855.5 Wilson NA verfasserin aut Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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.wilsonasu.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 unique device identifiers implants implementation framework udi-enabled system implantable devices Medical technology Tcheng JE verfasserin aut Graham J verfasserin aut Drozda JP Jr verfasserin aut In Medical Devices: Evidence and Research Dove Medical Press, 2009 (2021), Seite 411-421 (DE-627)611726149 (DE-600)2520731-3 11791470 nnns year:2021 pages:411-421 https://doaj.org/article/6cca7b7b52da4759a0b4eedb4736e191 kostenfrei https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER kostenfrei https://doaj.org/toc/1179-1470 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2021 411-421
allfields_unstemmed	(DE-627)DOAJ062995650 (DE-599)DOAJ6cca7b7b52da4759a0b4eedb4736e191 DE-627 ger DE-627 rakwb eng R855-855.5 Wilson NA verfasserin aut Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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.wilsonasu.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 unique device identifiers implants implementation framework udi-enabled system implantable devices Medical technology Tcheng JE verfasserin aut Graham J verfasserin aut Drozda JP Jr verfasserin aut In Medical Devices: Evidence and Research Dove Medical Press, 2009 (2021), Seite 411-421 (DE-627)611726149 (DE-600)2520731-3 11791470 nnns year:2021 pages:411-421 https://doaj.org/article/6cca7b7b52da4759a0b4eedb4736e191 kostenfrei https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER kostenfrei https://doaj.org/toc/1179-1470 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2021 411-421
allfieldsGer	(DE-627)DOAJ062995650 (DE-599)DOAJ6cca7b7b52da4759a0b4eedb4736e191 DE-627 ger DE-627 rakwb eng R855-855.5 Wilson NA verfasserin aut Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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.wilsonasu.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 unique device identifiers implants implementation framework udi-enabled system implantable devices Medical technology Tcheng JE verfasserin aut Graham J verfasserin aut Drozda JP Jr verfasserin aut In Medical Devices: Evidence and Research Dove Medical Press, 2009 (2021), Seite 411-421 (DE-627)611726149 (DE-600)2520731-3 11791470 nnns year:2021 pages:411-421 https://doaj.org/article/6cca7b7b52da4759a0b4eedb4736e191 kostenfrei https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER kostenfrei https://doaj.org/toc/1179-1470 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2021 411-421
allfieldsSound	(DE-627)DOAJ062995650 (DE-599)DOAJ6cca7b7b52da4759a0b4eedb4736e191 DE-627 ger DE-627 rakwb eng R855-855.5 Wilson NA verfasserin aut Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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.wilsonasu.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 unique device identifiers implants implementation framework udi-enabled system implantable devices Medical technology Tcheng JE verfasserin aut Graham J verfasserin aut Drozda JP Jr verfasserin aut In Medical Devices: Evidence and Research Dove Medical Press, 2009 (2021), Seite 411-421 (DE-627)611726149 (DE-600)2520731-3 11791470 nnns year:2021 pages:411-421 https://doaj.org/article/6cca7b7b52da4759a0b4eedb4736e191 kostenfrei https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER kostenfrei https://doaj.org/toc/1179-1470 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2021 411-421
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author_browse	Wilson NA Tcheng JE Graham J Drozda JP Jr
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title_sort	advancing patient safety surrounding medical devices: a health system roadmap to implement unique device identification at the point of care
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title_auth	Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care
abstract	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.wilsonasu.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
abstractGer	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.wilsonasu.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
abstract_unstemmed	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.wilsonasu.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
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title_short	Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care
url	https://doaj.org/article/6cca7b7b52da4759a0b4eedb4736e191 https://www.dovepress.com/advancing-patient-safety-surrounding-medical-devices-a-health-system-r-peer-reviewed-fulltext-article-MDER https://doaj.org/toc/1179-1470
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