Implementing unique device identification in electronic health record systems: Organizational, workflow, and technological challenges

Medical Care

Volumn 52, Issue 1, 2014, Pages 26-31

  Campion, Thomas R ^a   Johnson, Stephen B ^a   Paxton, Elizabeth W ^b   Mushlin, Alvin I ^a,c   Sedrakyan, Art ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b Kaiser Permanente   (United States)

^c NEW YORK PRESBYTERIAN HOSPITAL   (United States)

Author keywords

electronic health records; medical devices; outcomes research; postmarket surveillance; public health

Indexed keywords

ARTICLE; CLINICAL RESEARCH; ELECTRONIC MEDICAL RECORD; ELECTRONIC PRESCRIBING; FOOD AND DRUG ADMINISTRATION; HUMAN; KEYBOARD; MEDICAL CARE; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; MEDICAL INFORMATION SYSTEM; MEDICAL SOCIETY; ORGANIZATIONAL DEVELOPMENT; PATIENT CODING; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; TOTAL QUALITY MANAGEMENT; UNIQUE DEVICE IDENTIFICATION; WORKFLOW;

AUTOMATIC DATA PROCESSING; ELECTRONIC HEALTH RECORDS; EQUIPMENT AND SUPPLIES; HUMANS; MEDICAL RECORD LINKAGE; PATIENT IDENTIFICATION SYSTEMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORKFLOW;

EID: 84890431739     PISSN: 00257079     EISSN: 15371948     Source Type: Journal    
DOI: 10.1097/MLR.0000000000000012     Document Type: Article

References (50)

1. Gross TP, Crowley J. Unique device identification in the service of public health. N Engl J Med. 2012;367:1583-1585
2. SteadWW, Lin HS. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions. The National Academies Press; 2009. Available at: Http://www.nap.edu/openbook.php?record-id = 12572
3. Chute CG, Cohn SP, Campbell Jr. A framework for comprehensive health terminology systems in the United States: Development guidelines, criteria for selection, and public policy implications. J Am Med Inform Assoc. 1998;5:503-510
4. Box TL, McDonell M, Helfrich CD, et al. Strategies from a nationwide health information technology implementation: The VA CART story. J Gen Intern Med. 2010;25(suppl 1):72-76
5. Paxton EW, Inacio MC, Kiley ML. The Kaiser Permanente implant registries: Effect on patient safety, quality improvement, cost effectiveness, and research opportunities. Perm J. 2012;16:36-44
6. Black D, Zimmerman A. Perfect order and beyond: BD and Mercy/ROi achieve far-reaching GS1 standards integration, 2011. Available at: Http://www.gs1us. org/BDMercystudy. Accessed November 1, 2012
7. Paxton EW, Inacio MC, Khatod M, et al. Kaiser Permanente National Total Joint Replacement Registry: Aligning operations with information technology. Clin Orthop Relat Res. 2010;468:2646-2663
8. Chaudhry B, Wang J, Wu S, et al. Systematic review: Impact of health information technology on quality, efficiency, and costs of medical care. Ann Intern Med. 2006;144:742-752
9. Blumenthal D, Tavenner M. The meaningful use regulation for electronic health records. N Engl J Med. 2010;363:501-504
10. Connolly C. Cedars-Sinai doctors cling to pen and paper. The Washington Post. Available at: Http://www.washingtonpost. com/wp-dyn/articles/A52384- 2005Mar20.html, 2005. Accessed July 1, 2013
11. Han YY, Carcillo JA, Venkataraman ST, et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics. 2005;116:1506-1512
12. Sittig DF, Ash JS, Zhang J, et al. Lessons from Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics. 2006;118:797-801
13. Nelson SJ, Zeng K, Kilbourne J, et al. Normalized names for clinical drugs: RxNorm at 6 years. J Am Med Inform Assoc. 2011;18:441-448
14. Baksi D. Integrating MPI and deduplication engines: A software architecture roadmap. Int J Med Inform. 2009;78:161-169
15. Huff SM, Rocha RA, McDonald CJ, et al. Development of the Logical Observation Identifier Names and Codes (LOINC) vocabulary. J Am Med Inform Assoc. 1998;5:276-292. Available at: Http://www.ncbi.nlm.nih. gov/pubmed/9609498
16. Cimino JJ. Desiderata for controlled medical vocabularies in the twentyfirst century. Methods Inf Med. 1998;37:394-403
17. Kuperman GJ, Reichley RM, Bailey TC. Using commercial knowledge bases for clinical decision support: Opportunities, hurdles, and recommendations. J Am Med Inform Assoc. 2006;13:369-371
18. Cimino JJ, McNamara TJ, Meredith T, et al. Evaluation of a proposed method for representing drug terminology. Proc AMIA Symp. 1999;1999:47-51
19. Peters L, Kapusnik-Uner JE, Bodenreider O. Methods for managing variation in clinical drug names. AMIA Annu Symp Proc. 2010;2010: 637-641
20. Sedrakyan A, Paxton EW, Phillips C, et al. The International Consortium of Orthopaedic Registries: Overview and summary. J Bone Joint Surg Am. 2011;93(suppl 3):1-12
21. Robertsson O, Mendenhall S, Paxton EW, et al. Challenges in prosthesis classification. J Bone Joint Surg Am. 2011;93(suppl 3):72-75
22. Lorenzi NM, Riley RT, Blyth AJ, et al. Antecedents of the people and organizational aspects of medical informatics: Review of the literature. J Am Med Inform Assoc. 1997;4:79-93
23. Lorenzi NM, Riley RT. Managing change: An overview. J Am Med Inform Assoc. 2000;7:116-124
24. Ash JS, Stavri PZ, Dykstra R, et al. Implementing computerized physician order entry: The importance of special people. Int J Med Inform. 2003;69:235-250
25. Embi PJ, Payne PR. Clinical research informatics: Challenges, opportunities and definition for an emerging domain. J Am Med Inform Assoc. 2009;16:316-327
26. Chute CG, Beck SA, Fisk TB, et al. The Enterprise Data Trust at Mayo Clinic: A semantically integrated warehouse of biomedical data. J Am Med Inform Assoc. 2010;17:131-135
27. Ash JS, Anderson NR, Tarczy-Hornoch P. People and organizational issues in research systems implementation. J Am Med Inform Assoc. 2008;15:283-289
28. Kahn MG, Kaplan D, Sokol RJ, et al. Configuration challenges: Implementing translational research policies in electronic medical records. Acad Med. 2007;82:661-669
29. Ohmann C, Kuchinke W. Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration. Methods Inf Med. 2009;48:45-54. Available at: Http:// www.ncbi.nlm.nih.gov/ pubmed/19151883
30. Prokosch HU, Ganslandt T. Perspectives for medical informatics. Reusing the electronic medical record for clinical research. Methods Inf Med. 2009; 48:38-44. Available at: Http://www.ncbi.nlm.nih.gov/pubmed/19151882
31. Rosenbloom ST, Denny JC, Xu H, et al. Data from clinical notes: A perspective on the tension between structure and flexible documentation. J Am Med Inform Assoc. 2011;18:181-186
32. Box TL. SILENT SIGNALS through the NOISE: Device surveillance efforts in the Veterans Health Administration and the Potential of Universal Device Identification, 2011. Available at: Http://www.fda. gov/downloads/ MedicalDevices/NewsEvents/WorkshopsConferences/ UCM272064.pdf. Accessed July 1, 2013
33. Emons MF. Unique device identification (UDI) for postmarket surveillance and compliance public workshop: Cerner, 2011. Available at: Http://www.fda.gov/ downloads/MedicalDevices/NewsEvents/Work shopsConferences/UCM272068.pdf. Accessed July 1, 2013
34. Poon EG, Keohane CA, Yoon CS, et al. Effect of bar-code technology on the safety of medication administration. N Engl J Med. 2010; 362:1698-1707
35. Greenberg CC, Diaz-Flores R, Lipsitz SR, et al. Bar-coding surgical sponges to improve safety: A randomized controlled trial. Ann Surg. 2008;247:612-616
36. Poon EG, Keohane CA, Bane A, et al. Impact of barcode medication administration technology on how nurses spend their time providing patient care. J Nurs Adm. 2008;38:541-549
37. Koppel R, Wetterneck T, Telles JL, et al. Workarounds to barcode medication administration systems: Their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc. 2008;15:408-423
38. Patterson ES, Cook RI, Render ML. Improving patient safety by identifying side effects from introducing bar coding in medication administration. J Am Med Inform Assoc. 2002;9:540-553
39. Ohsaka A, Kobayashi M, Abe K. Causes of failure of a barcode-based pretransfusion check at the bedside: Experience in a university hospital. Transfus Med. 2008;18:216-222
40. Ellner SJ, Joyner PW. Information technologies and patient safety. Surg Clin North Am. 2012;92:79-87
41. Melton GB. Biomedical and health informatics for surgery. Adv Surg. 2010;44:117-130
42. Minear MN, Sutherland J. Medical informatics -A catalyst for operating room transformation. Semin Laparosc Surg. 2003;10:71-78
43. Veillette CJ. ABJS Carl T. Brighton Workshop on Health Informatics in Orthopaedic Surgery: Editorial comment. Clin Orthop Relat Res. 2010;468:2561-2564
44. Mandl KD, Kohane IS. No small change for the health information economy. N Engl J Med. 2009;360:1278-1281
45. Gray GW. Challenges of building clinical data analysis solutions. J Crit Care. 2004;19:264-270
46. Roden DM, Pulley JM, Basford MA, et al. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Ther. 2008;84:362-369
47. Richesson RL, Krischer J. Data standards in clinical research: Gaps, overlaps, challenges and future directions. J Am Med Inform Assoc. 2007;14:687-696
48. Kush RD, Helton E, Rockhold FW, et al. Electronic health records, medical research, and the Tower of Babel. N Engl J Med. 2008;358:1738-1740
49. Marsolo K, Corsmo J, Barnes MG, et al. Challenges in creating an opt-in biobank with a registrar-based consent process and a commercial EHR. J Am Med Inform Assoc. 2012;19:1115-1118
50. CDRH Reports -National Medical Device Postmarket Surveillance Plan. Available at: Http://www.fda.gov/AboutFDA/CentersOffices/Officeof MedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm. Accessed July 8, 2013