Implementing Unique Device Identification in Electronic Health Record Systems

Campion, Thomas R.; Johnson, Stephen B.; Paxton, Elizabeth W.; Mushlin, Alvin I.; Sedrakyan, Art

doi:10.1097/mlr.0000000000000012

Cited by 20 publications

(14 citation statements)

References 18 publications

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“…Registries are critically important for uniquely identifying devices, as almost none of the nation's electronic health records at this time can automatically uniquely identify a device and link it to the outcome data of individual patients 27 . Similarly, very limited national data exist that can be used to identify medical devices and link them to patient outcomes within claim systems 27 . Large U.S. and international registries might be very attractive in this context and potentially could meet the needs of the FDA and regulators worldwide.…”

Section: Other Icor Studies Of Devices and Outcomesmentioning

confidence: 99%

National and International Postmarket Research and Surveillance Implementation

Sedrakyan

Paxton

Graves

et al. 2014

The Journal of Bone and Joint Surgery

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Section: Other Icor Studies Of Devices and Outcomesmentioning

confidence: 99%

National and International Postmarket Research and Surveillance Implementation

Sedrakyan

Paxton

Graves

et al. 2014

The Journal of Bone and Joint Surgery

Self Cite

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“…The objective of the reported study was to understand the experiences of health systems that had implemented UDI at the POC in order to develop a set of practical recommendations for health system implementation, building on prior work [18][19][20] and advancing the field. Implantable devices were the focus because they are higher risk, discussion of all devices would impact the level of detail possible in interviews, and a roadmap for higher risk devices could serve as a model for broad UDI implementation.…”

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

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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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“…Technology can increase quality if used wisely for education and training, has a very important meaning for well-being. The results showed that technology-based instructional greatly helped students understand instruction [40]. Instructional online has become an acceptable part and is even expected to facilitate a more effective instructional [42].…”

Section: Introductionmentioning

confidence: 96%

Distance Instructional Strategies and Learning Motivation towards Learning Outcome of the Study Al-Qur'an in Situation a COVID-19 Pandemic

Rohman¹,

Aziz²,

Imran³

et al. 2020

ujer

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Distance education is a set of instructional and instructional strategies for connecting people who have learning needs with the resources needed to meet those needs. The purpose of this study was to determine the effect of distance instructional strategies and learning motivation on learning outcomes of the Qur'an study of the concept of taqwa in a COVID-19 pandemic situation. Experimental research used a quantitative approach. 64 students were divided into two groups. The group was given the treatment of distance instructional through digital media online and the other group with distance instruction through e-books offline. The results of the study were obtained by Significant 0.001 < 0.05, to shows that there are differences in learning outcomes with online digital media instructional strategies to learning outcomes of students who are treated with offline e-book instructional strategies and obtained by Significant 0.003 < 0.05, it means that there is a difference in learning between students who have high learning motivation and student learning outcomes who have low learning motivation. The implication is that distance instructional is dependent on internet network. If students are in rural areas, it will be difficult to implement because many factors for example, infrastructure is not yet available, students from economically disadvantaged circles who didn't have smartphones, or the cost to purchase internet quota expensive.

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Implementing Unique Device Identification in Electronic Health Record Systems

Cited by 20 publications

References 18 publications

National and International Postmarket Research and Surveillance Implementation

National and International Postmarket Research and Surveillance Implementation

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

Distance Instructional Strategies and Learning Motivation towards Learning Outcome of the Study Al-Qur'an in Situation a COVID-19 Pandemic

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