Search

Your search keyword '"Tcheng, James E"' showing total 975 results
Start Over Author "Tcheng, James E"
975 results on '"Tcheng, James E"'

1. Contributors

Author

Ackerman, Michael J., primary, Adedinsewo, Demilade A., additional, Akbilgic, Oguz, additional, Al-Falahi, Zaidon, additional, Alkhatib, Deya, additional, Alkhouli, Mohamad, additional, Awerbach, Jordan D., additional, Axelrod, David M., additional, Baker, G. Hamilton, additional, Bashir, Mohamad, additional, Bond, Raymond, additional, Bos, J. Martijn, additional, Brisk, Robert, additional, Brown, Sherry-Ann, additional, Butler, Liam, additional, C. Chang, Anthony, additional, Camara, Oscar, additional, Chou, Timothy, additional, Davis, Matthew, additional, Dearani, Joseph A., additional, Dorraki, Mohsen, additional, Doukky, Rami, additional, Druz, Regina, additional, Ehwerhemuepha, Louis, additional, Ernst, Zachary, additional, Feaster, William, additional, Feeny, Albert K., additional, Fernandez-Campos, Beatriz A., additional, Fisher, Michael, additional, Flores, Mona G., additional, Franklin, Wayne J., additional, Frederickson, Abby, additional, Gaffar, Sharib, additional, Gates, Darren, additional, Gearhart, Addison, additional, Gerke, Sara, additional, Gomez, Javier, additional, Goto, Shinichi, additional, Grutter, Giorgia, additional, Hall, E. Kevin, additional, Jacobs, Jeffrey P., additional, Jefferies, John L., additional, Jegatheeswaran, Anusha, additional, Jenkins, Kathy, additional, Jone, Pei-Ni, additional, Kouzehkonan, Vahid Ghodrati, additional, Kumar, S. Ram, additional, Lai, Wyman, additional, Laussen, Peter C., additional, Lei, Howard, additional, Leta, Ruben, additional, Liao, Zhibin, additional, Limon, Alfonso, additional, Lopez-Jimenez, Francisco, additional, Lopuszko, Aleksandra, additional, Maher, Kevin, additional, Marano, Rachel, additional, Mattia, Donald, additional, McEneaney, David, additional, McMahon, Colin J., additional, Mesana, Thierry, additional, Moras, Patrizio, additional, Moreno, Tatiana, additional, Moustafa, Abdel Hakim, additional, Nafee, Tarek, additional, Nag, Nitish, additional, Nahar, Jai, additional, Nguyen, Hoang H., additional, Olajide, Olufemi, additional, Overman, David M., additional, Paul Finn, J., additional, Ramirez, Jessily P., additional, Rayan, David, additional, Recto, Mitch, additional, Reddy, Charitha D., additional, Sengupta, Partho P., additional, Shamavu, Ketemwabi Y., additional, Silversides, Candice K., additional, Soliman, Elsayed Z., additional, St Louis, James D., additional, Sun, Louise Y., additional, Tan, Sven, additional, Tandon, Animesh, additional, Tcheng, James E., additional, Toscano, Alessandra, additional, Tozzi, Alberto Eugenio, additional, Tran, Tu Hao, additional, Trivedi, Bhavya, additional, Tsang, Wendy, additional, Tseng, Andrew S., additional, van den Hengel, Anton, additional, Verjans, Johan W., additional, and Young, Krista, additional

Published
2024
Full Text
View/download PDF

3. Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways “LEAN” working group

Author

Black, James H., 3rd, Buckley, Donna, Velezis, Martha, Eldrup-Jorgensen, Jens, Serratore, Nina D., Gutierrez, Jorge A., Whatley, Eleni, Marmor, Rebecca A., Bertges, Daniel J., Tcheng, James E., Royce, Sara, Malone, Misti, Farb, Andrew, Secemsky, Eric A., Parikh, Sahil A., Smale, Joshua, Jaff, Michael R., White, Roseann, Wilgus, Rebecca W., and Krucoff, Mitchell W.

Published
2023
Full Text
View/download PDF

4. Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions

Author

Samant, Saurabhi, Bakhos, Jules Joel, Wu, Wei, Zhao, Shijia, Kassab, Ghassan S., Khan, Behram, Panagopoulos, Anastasios, Makadia, Janaki, Oguz, Usama M., Banga, Akshat, Fayaz, Muhammad, Glass, William, Chiastra, Claudio, Burzotta, Francesco, LaDisa, John F., Jr., Iaizzo, Paul, Murasato, Yoshinobu, Dubini, Gabriele, Migliavacca, Francesco, Mickley, Timothy, Bicek, Andrew, Fontana, Jason, West, Nick E.J., Mortier, Peter, Boyers, Pamela J., Gold, Jeffrey P., Anderson, Daniel R., Tcheng, James E., Windle, John R., Samady, Habib, Jaffer, Farouc A., Desai, Nihar R., Lansky, Alexandra, Mena-Hurtado, Carlos, Abbott, Dawn, Brilakis, Emmanouil S., Lassen, Jens Flensted, Louvard, Yves, Stankovic, Goran, Serruys, Patrick W., Velazquez, Eric, Elias, Pierre, Bhatt, Deepak L., Dangas, George, and Chatzizisis, Yiannis S.

Published
2023
Full Text
View/download PDF

9. Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions

Author

Bertges, Daniel J., White, Roseann, Cheng, Yu-Ching, Sun, Tianyi, Ramkumar, Niveditta, Goodney, Philip P., Wilgus, Rebecca W., Lottes, Aaron E., Smale, Joshua A., Drozda, Joseph, Raska, Melanie, Heise, Ted, Jones, W. Schuyler, Tcheng, James E., Eldrup-Jorgensen, Jens, Sedrakyan, Art, Malone, Misti L., Marinac-Dabic, Danica, Thatcher, Robert, Morales, Pablo, Krucoff, Mitchell W., and Cronenwett, Jack L.

Published
2021
Full Text
View/download PDF

10. Multispecialty Enterprise Imaging Workgroup Consensus on Interactive Multimedia Reporting Current State and Road to the Future: HIMSS-SIIM Collaborative White Paper

Author

Roth, Christopher J., Clunie, David A., Vining, David J., Berkowitz, Seth J., Berlin, Alejandro, Bissonnette, Jean-Pierre, Clark, Shawn D., Cornish, Toby C., Eid, Monief, Gaskin, Cree M., Goel, Alexander K., Jacobs, Genevieve C., Kwan, David, Luviano, Damien M., McBee, Morgan P., Miller, Kelly, Hafiz, Abdul Moiz, Obcemea, Ceferino, Parwani, Anil V., Rotemberg, Veronica, Silver, Elliot L., Storm, Erik S., Tcheng, James E., Thullner, Karen S., and Folio, Les R.

Published
2021
Full Text
View/download PDF

15. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Author

Fitter, Heather D., Illoh, Kachikwu, Cavanaugh, Kenneth J., Jr., Scirica, Benjamin M., Irony, Ilan, Brown Kichline, Rachel E., Levine, Jonathan G., Park, Anna, Sacks, Leonard, Szarfman, Ana, Unger, Ellis F., Wachter, Lori Ann, Zuckerman, Bram, Mitchel, Yale, Peddicord, Douglas, Shook, Thomas, Kisler, Bron, Jaffe, Charles, Bartley, Rhonda, DeMets, David L., Mencini, MariJo, Janning, Cheri, Bai, Steve, Lawrence, John, D’Agostino, Ralph B., Sr., Pocock, Stuart J., Hicks, Karen A., Mahaffey, Kenneth W., Mehran, Roxana, Nissen, Steven E., Wiviott, Stephen D., Dunn, Billy, Solomon, Scott D., Marler, John R., Teerlink, John R., Farb, Andrew, Morrow, David A., Targum, Shari L., Sila, Cathy A., Thanh Hai, Mary T., Jaff, Michael R., Joffe, Hylton V., Cutlip, Donald E., Desai, Akshay S., Lewis, Eldrin F., Gibson, C. Michael, Landray, Martin J., Lincoff, A. Michael, White, Christopher J., Brooks, Steven S., Rosenfield, Kenneth, Domanski, Michael J., Lansky, Alexandra J., McMurray, John J.V., Tcheng, James E., Steinhubl, Steven R., Burton, Paul, Mauri, Laura, O’Connor, Christopher M., Pfeffer, Marc A., Hung, H.M. James, Stockbridge, Norman L., Chaitman, Bernard R., and Temple, Robert J.

Published
2018
Full Text
View/download PDF

16. Improving Heart Failure Therapeutics Development in the United States: The Heart Failure Collaboratory

Author

O’Connor, Christopher M., Psotka, Mitchell A., Fiuzat, Mona, Lindenfeld, JoAnn, Abraham, William T., Bristow, Michael R., Canos, Daniel, Harrington, Robert A., Hillebrenner, Matt, Jessup, Mariell, Malik, Fady I., Solomon, Scott D., Stockbridge, Norman, Tcheng, James E., Unger, Ellis F., Whellan, David J., Zuckerman, Bram, and Califf, Robert M.

Published
2018
Full Text
View/download PDF

21. Predictors of outcome of percutaneous excimer laser coronary angioplasty of saphenous vein bypass graft lesions

Author

Bittl, John A, Sanborn, Timothy A, Yardley, David E, Tcheng, James E, Isner, Jeffrey M, Chokshi, Saurabh K, Strauss, Bradley H, Abela, George S, Walter, Paul D, Schmidhofer, Mark, Power, John A, and Registry, The Percutaneous Excimer Laser Coronary Angioplasty

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cardiovascular, Atherosclerosis, Heart Disease, Cancer, Evaluation of treatments and therapeutic interventions, 6.4 Surgery, Aged, Angioplasty, Balloon, Coronary, Angioplasty, Balloon, Laser-Assisted, Atherectomy, Coronary, Combined Modality Therapy, Coronary Angiography, Coronary Artery Bypass, Coronary Disease, Embolism, Female, Follow-Up Studies, Forecasting, Graft Occlusion, Vascular, Humans, Logistic Models, Male, Middle Aged, Myocardial Infarction, Recurrence, Saphenous Vein, Stents, Survival Rate, Treatment Outcome, Ulcer, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

A total of 495 patients underwent treatment with excimer laser angioplasty for 545 saphenous vein graft stenoses. Clinical success was achieved in 455 of 495 patients (92%), as indicated by < or = 50% residual stenosis at every target lesion and no complication during hospitalization. At least 1 in-hospital complication occurred in 30 of 495 patients (6.1%): death (1.0%), bypass surgery (0.6%), and Q-wave (2.4%) or non-Q-wave (2.2%) myocardial infarction. Relative risk analysis showed that ostial lesions (n = 65) tended to have higher clinical success (success rate = 95%, adjusted odds ratio [OR] = 2.1 [95% confidence interval (CI) 0.62, 6.88]; p = 0.24) and lower complications (complication rate = 0%, OR = 0.10 [CI 0.01, 0.79]; p = 0.03) than lesions in the body of the vein graft. Lesions > 10 mm (n = 131) had lower success (success rate = 84%, OR = 0.30 [CI 0.16, 0.56]; p = 0.001) and higher complications (complication rate = 12%, OR = 3.3 [CI 1.6, 6.6]; p = 0.004) than discrete lesions. Lesions in small vein grafts < 3.0 mm (n = 76) tended to have increased success (success rate = 94%, OR = 1.55 [CI 0.70, 3.44]; p = 0.39) and lower complications (complication rate = 2.2%, OR = 0.31 [CI 0.10, 0.94]; p = 0.03). Thus, excimer laser-facilitated angioplasty has the most favorable outcome for discrete lesions located at the ostium of all grafts and in the body of smaller saphenous vein grafts.(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1994

22. Acute complications of excimer laser coronary angioplasty: A detailed analysis of multicenter results

Author

Baumbach, Andreas, Bittl, John A, Fleck, Eckart, Geschwind, Herbert J, Sanborn, Timothy A, Tcheng, James E, Arsch, Karl RK, and Registries, The Coinvestigators of the US and European Percutaneous Excimer Laser Coronary Angioplasty

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Atherosclerosis, Clinical Research, Heart Disease - Coronary Heart Disease, Cardiovascular, Heart Disease, Acute Disease, Adult, Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary, Angioplasty, Balloon, Laser-Assisted, Chi-Square Distribution, Coronary Disease, Europe, Female, Humans, Incidence, Logistic Models, Male, Middle Aged, Multivariate Analysis, Postoperative Complications, Registries, United States, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThe aim of this study was to document and analyze the incidence and consequences of complications of excimer laser coronary angioplasty.BackgroundExcimer laser coronary angioplasty has been reported to be a safe and feasible alternative or adjunct to conventional balloon angioplasty, but serious and unique complications have been observed.MethodsData on 1,595 interventions of excimer laser coronary angioplasty in 1,521 patients were analyzed, using a merged data base from the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) registries.ResultsProcedural success was achieved in 89.3% of interventions. Stand-alone laser angioplasty was performed in 17.8% of interventions. Complications included dissection (22.0%), vasospasm (6.1%), filling defects (4.8%), abrupt reclosure (6.1%), embolization (2.3%), perforation (2.4%), arrhythmia (0.7%) and aneurysm formation (0.3%). Major complications were non-Q wave myocardial infarction (2.3%), Q wave myocardial infarction (1.0%), coronary artery bypass grafting (3.1%) and death (0.7%). Logistic regression analysis revealed correlation between dissections and the use of larger catheter size (p = 0.0005), high energy per pulse levels (p = 0.0001 for native vessels), lesion length > 10 mm (p = 0.001) and presence of a side branch (p = 0.01). The incidence of perforations was higher in women (p = 0.004), in treatment of total occlusions (p = 0.02) and in the presence of a side branch (p = 0.03). Fatal complications were correlated with patients with multivessel disease (p < 0.0001), patients with acute myocardial infarction (p = 0.0009) and older patients (> 70 years old, p = 0.004). The incidence of major complications decreased after performance of 50 laser angioplasty procedures at one institution (p = 0.02).ConclusionsThis analysis defines both the learning curve and the profile of complications for excimer laser angioplasty and provides insight into the selection of appropriate patients and proper performance of the procedure.

Published
1994

23. The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises – Roadmap for Implementation of the Clinically Integrated Supply Chain

Author

Tcheng, James E, Nguyen, Miriam V, Brann, Helen W, Clarke, Patricia A, Pfeiffer, Maureen, Pleasants, Jane R, Shelton, Gregory W, and Kelly, Joseph F

Subjects
Evidence and Research [Medical Devices], implementation roadmap, Methodology, Biomedical Engineering, Medicine (miscellaneous), clinical documentation, interoperability, unique device identifier, health care economics and organizations, supply chain, medical devices
Abstract

James E Tcheng,1 Miriam V Nguyen,1 Helen W Brann,1 Patricia A Clarke,1 Maureen Pfeiffer,1 Jane R Pleasants,2 Gregory W Shelton,1 Joseph F Kelly1 1Department of Medicine, Duke University Hospital and Health System, Durham, NC, USA; 2Strategic Marketplace Initiative, Westborough, MA, USACorrespondence: James E TchengDuke University Hospital and Health System, Hock Plaza Suite 403, 2424 Erwin Road, Durham, NC, 27705, USATel +1 919 668-8796Email tchen001@mc.duke.eduAbstract: Documentation and tracking of supplies, equipment and medical devices is central to operational, financial, and clinical aspects of safe, efficient, and effective patient care. The labeling of medical devices with a unique device identifier (UDI) creates the opportunity to tightly integrate device information across health information systems by using the UDI as the index “source of truth”. Across 3 hospitals of the Duke University Health System, we executed a comprehensive implementation of UDI-based device and supply information management in our cardiac catheterization and electrophysiology laboratories. Following are our key insights. Implementing a UDI-centric environment is a complex undertaking requiring integration of information systems, management processes, and clinical workflows involving leadership, inventory management, supply chain, clinical and billing teams. Implementation involves the domains of procedure documentation, electronic health records (EHRs), charge capture and billing, and interface and information technology systems, including information systems vendors. Replacing manual processes with electronic messages is not simply an exercise in programming information systems – successful execution requires orchestrated re-engineering of clinical and operational workflows. Our initiative resulted in a more efficient and effective supply chain, eliminated operational and clinical documentation errors, automated the posting of device implant data to the EHR, reduced clinician burden, improved charge capture, and produced a substantial financial benefit, with return on investment recognized in well under 1 year. We believe our stepwise approach to accomplishing a clinically integrated supply chain can serve as a roadmap for other healthcare enterprises to follow.Keywords: unique device identifier, medical devices, supply chain, clinical documentation, implementation roadmap, interoperability

Published
2021

25. ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization Laboratory: A Report of the American College of Cardiology Clinical Quality Committee

Author

Sanborn, Timothy A., Tcheng, James E., Anderson, H. Vernon, Chambers, Charles E., Cheatham, Sharon L., DeCaro, Matthew V., Durack, Jeremy C., Everett, Allen D., Gordon, John B., Hammond, William E., Hijazi, Ziyad M., Kashyap, Vikram S., Knudtson, Merrill, Landzberg, Michael J., Martinez-Rios, Marco A., Riggs, Lisa A., Sim, Kui Hian, Slotwiner, David J., Solomon, Harry, Szeto, Wilson Y., Weiner, Bonnie H., Weintraub, William S., and Windle, John R.

Published
2014
Full Text
View/download PDF

27. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Author

Hicks, Karen A., Mahaffey, Kenneth W., Mehran, Roxana, Nissen, Steven E., Wiviott, Stephen D., Dunn, Billy, Solomon, Scott D., Marler, John R., Teerlink, John R., Farb, Andrew, Morrow, David A., Targum, Shari L., Sila, Cathy A., Hai, Mary T. Thanh, Jaff, Michael R., Joffe, Hylton V., Cutlip, Donald E., Desai, Akshay S., Lewis, Eldrin F., Gibson, C. Michael, Landray, Martin J., Lincoff, A. Michael, White, Christopher J., Brooks, Steven S., Rosenfield, Kenneth, Domanski, Michael J., Lansky, Alexandra J., McMurray, John J.V., Tcheng, James E., Steinhubl, Steven R., Burton, Paul, Mauri, Laura, O’Connor, Christopher M., Pfeffer, Marc A., Hung, H.M. James, Stockbridge, Norman L., Chaitman, Bernard R., and Temple, Robert J.

Published
2018
Full Text
View/download PDF

32. Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

Author

Wilson,Natalia A, Tcheng,James E, Graham,Jove, Drozda,Joseph P, Wilson,Natalia A, Tcheng,James E, Graham,Jove, and Drozda,Joseph P

Abstract

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, researc

Published
2022

38. ACCF/AHA 2011 Key Data Elements and Definitions of a Base Cardiovascular Vocabulary for Electronic Health Records: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards

Author

Weintraub, William S., Karlsberg, Ronald P., Tcheng, James E., Boris, Jeffrey R., Buxton, Alfred E., Dove, James T., Fonarow, Gregg C., Goldberg, Lee R., Heidenreich, Paul, Hendel, Robert C., Jacobs, Alice K., Lewis, William, Mirro, Michael J., and Shahian, David M.

Published
2011
Full Text
View/download PDF

41. Prognostic Impact of Blood Transfusion After Primary Angioplasty for Acute Myocardial Infarction: Analysis From the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) Trial

Author

Nikolsky, Eugenia, Mehran, Roxana, Sadeghi, H. Mehrdad, Grines, Cindy L., Cox, David A., Garcia, Eulogio, Tcheng, James E., Griffin, John J., Guagliumi, Giulio, Stuckey, Thomas, Turco, Mark, Fahy, Martin, Lansky, Alexandra J., and Stone, Gregg W.

Published
2009
Full Text
View/download PDF

42. Effect of operator and institutional volume on clinical outcomes after percutaneous coronary interventions performed in Canada and the United States: A brief report from the Enhanced Suppression of the Platelet glycoprotein IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) study

Author

Madan, Mina, Nikhil, Janarthan, Hellkamp, Anne S., Pieper, Karen S., Labinaz, Marino, Cohen, E.A., Buller, Christopher E., Cantor, Warren J., Seidelin, Peter, Ducas, John, Carere, Ronald G., Natarajan, Madhu K., Conor O'Shea, J., and Tcheng, James E.

Published
2009
Full Text
View/download PDF

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

Author

Wilson,Natalia A, Tcheng,James E, Graham,Jove, Drozda Jr,Joseph P, Wilson,Natalia A, Tcheng,James E, Graham,Jove, and Drozda Jr,Joseph P

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.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 provid

Published
2021

44. The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises – Roadmap for Implementation of the Clinically Integrated Supply Chain

Author

Tcheng,James E, Nguyen,Miriam V, Brann,Helen W, Clarke,Patricia A, Pfeiffer,Maureen, Pleasants,Jane R, Shelton,Gregory W, Kelly,Joseph F, Tcheng,James E, Nguyen,Miriam V, Brann,Helen W, Clarke,Patricia A, Pfeiffer,Maureen, Pleasants,Jane R, Shelton,Gregory W, and Kelly,Joseph F

Abstract

James E Tcheng,1 Miriam V Nguyen,1 Helen W Brann,1 Patricia A Clarke,1 Maureen Pfeiffer,1 Jane R Pleasants,2 Gregory W Shelton,1 Joseph F Kelly1 1Department of Medicine, Duke University Hospital and Health System, Durham, NC, USA; 2Strategic Marketplace Initiative, Westborough, MA, USACorrespondence: James E TchengDuke University Hospital and Health System, Hock Plaza Suite 403, 2424 Erwin Road, Durham, NC, 27705, USATel +1 919 668-8796Email tchen001@mc.duke.eduAbstract: Documentation and tracking of supplies, equipment and medical devices is central to operational, financial, and clinical aspects of safe, efficient, and effective patient care. The labeling of medical devices with a unique device identifier (UDI) creates the opportunity to tightly integrate device information across health information systems by using the UDI as the index “source of truth”. Across 3 hospitals of the Duke University Health System, we executed a comprehensive implementation of UDI-based device and supply information management in our cardiac catheterization and electrophysiology laboratories. Following are our key insights. Implementing a UDI-centric environment is a complex undertaking requiring integration of information systems, management processes, and clinical workflows involving leadership, inventory management, supply chain, clinical and billing teams. Implementation involves the domains of procedure documentation, electronic health records (EHRs), charge capture and billing, and interface and information technology systems, including information systems vendors. Replacing manual processes with electronic messages is not simply an exercise in programming information systems – successful execution requires orchestrated re-engineering of clinical and operational workflows. Our initiative resulted in a more efficient and effective supply chain, eliminated operational and clinical documentation errors, automated the posting of device implant data to the EHR, reduced clinicia

Published
2021

Catalog

Books, media, physical & digital resources
See catalog results