Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases
Open accessAbstract
BACKGROUND: The US FDA has been collecting information on medical devices involved in significant adverse advents since 1984. These reports have been used by researchers to advise clinicians on potential risks and complications of using these devices. OBJECTIVE: Research adverse events related to the use of Clinical Information Systems (CIS) as reported in FDA databases. METHODS: Three large, national, adverse event medical device databases were examined for reports pertaining to CIS. RESULTS: One hundred and twenty unique reports (from over 1.4 million reports) were found, representing 32 manufacturers. The manifestations of these adverse events included: missing or incorrect data, data displayed for the wrong patient, chaos during system downtime and system unavailable for use. Analysis of these reports illustrated events associated with system design, implementation, use, and support. CONCLUSION: The identified causes can be used by manufacturers to improve their products and by clinical facilities and providers to adjust their workflow and implementation processes appropriately. The small number of reports found indicates a need to raise awareness regarding publicly available tools for documenting problems with CIS and for additional reporting and dialog between manufacturers, organizations, and users.
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A few studies have attempted to quantify and classify EHR-related safety concerns by mining patient safety incident reporting databases.
“A few studies have attempted to quantify and classify EHR-related safety concerns by mining patient safety incident reporting databases.18 29–31”
From An analysis of electronic health record-related patient safety concerns (2014) · cites this paper as [18]
Rapid adoption of electronic health records has revealed potential safety concerns related to EHR design, implementation, and use.
“In particular, rapid adoption of electronic health records (EHRs) has revealed potential safety concerns related to EHR design, implementation, and use.12 17–21”
From An analysis of electronic health record-related patient safety concerns (2014) · cites this paper as [18]
Previous studies have largely used isolated event reports without benefit of an independent human factors and informatics investigation to analyze safety concerns in the EHR.
“Previous studies have largely used isolated event reports without benefit of an independent human factors and informatics investigation to analyze safety concerns in the EHR.”
From An analysis of electronic health record-related patient safety concerns (2014) · cites this paper as [18]
Increasing adoption of electronic health records has revealed potential safety implications related to EHR design, implementation, and use.
“the increasing adoption of electronic health records (EHR) has revealed potential safety implications related to EHR design, implementation, and use.”
From Exploring the sociotechnical intersection of patient safety and electronic health record implementation (2014) · cites this paper as [12]
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Cites
Use of Electronic Health Records in U.S. Hospitals
Jha, A. K., DesRoches, C. M., Campbell, E. G., Donelan, K., Rao, S. R., Ferris, T. G., Shields, A., Rosenbaum, S., & Blumenthal, D. (2009) · New England Journal of Medicine · doi:10.1056/nejmsa0900592 · Cited by 1,473 · see citing works
Han, Y. Y., Carcillo, J. A., Venkataraman, S. T., Clark, R. S. B., Watson, R. S., Nguyen, T. C., Bayir, H., & Orr, R. A. (2005) · Pediatrics · doi:10.1542/peds.2005-1287 · Cited by 1,149 · see citing works
Types of Unintended Consequences Related to Computerized Provider Order Entry
Campbell, E. M., Sittig, D. F., Ash, J. S., Guappone, K. P., & Dykstra, R. H. (2006) · Journal of the American Medical Informatics Association · doi:10.1197/jamia.m2042 · Cited by 823 · see citing works
Self-citationDel Beccaro, M. A., Jeffries, H. E., Eisenberg, M. A., & Harry, E. D. (2006) · Pediatrics · doi:10.1542/peds.2006-0367 · Cited by 181 · see citing works
Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems
Miller, R. A., & Gardner, R. M. (1997) · Journal of the American Medical Informatics Association · doi:10.1136/jamia.1997.0040442 · Cited by 101 · see citing works
Koppel, R., & Kreda, D. (2009) · JAMA · doi:10.1001/jama.2009.398 · Cited by 99 · see citing works
Eight Rights of Safe Electronic Health Record Use
Sittig, D. F. (2009) · JAMA · doi:10.1001/jama.2009.1311 · Cited by 85 · see citing works
Self-citationCampbell, E. M., Sittig, D. F., Guappone, K. P., Dykstra, R. H., & Ash, J. S. (2007) · PubMed Central · Cited by 83 · see citing works
Self-citationSafe Electronic Health Record Use Requires a Comprehensive Monitoring and Evaluation Framework
Sittig, D. F. (2010) · JAMA · doi:10.1001/jama.2010.61 · Cited by 76 · see citing works
Self-citationSecondary use of electronic health record data: spontaneous triggered adverse drug event reporting
Linder, J. A., Haas, J. S., Iyer, A., Labuzetta, M. A., Ibara, M. A., Celeste, M., Getty, G., & Bates, D. W. (2010) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.2027 · Cited by 66 · see citing works
Goodman, K. W., Berner, E. S., Dente, M. A., Kaplan, B., Koppel, R., Rucker, D., Sands, D. Z., Winkelstein, P., & for the AMIA Board of Directors (2011) · Journal of the American Medical Informatics Association · doi:10.1136/jamia.2010.008946 · Cited by 62 · see citing works
Lessons Premier Hospitals Learned About Implementing Electronic Health Records
DeVore, S. D., & Figlioli, K. J. (2010) · Health Affairs · doi:10.1377/hlthaff.2010.0250 · Cited by 43 · see citing works
Monitoring and Evaluating the Use of Electronic Health Records
Koppel, R. (2010) · JAMA · doi:10.1001/jama.2010.590 · Cited by 13 · see citing works
Pan, G. J. D. (2010) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.2050 · Cited by 7 · see citing works
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Kim, M. O., Coiera, E., & Magrabi, F. (2017) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocw154 · Cited by 263 · see citing works
An analysis of electronic health record-related patient safety concerns
Meeks, D. W., Smith, M. W., Taylor, L., Sittig, D. F., Scott, J. M., & Singh, H. (2014) · Journal of the American Medical Informatics Association · doi:10.1136/amiajnl-2013-002578 · Cited by 207 · see citing works
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Sittig, D. F., & Singh, H. (2012) · New England Journal of Medicine · doi:10.1056/nejmsb1205420 · Cited by 204 · see citing works
Self-citationUsing FDA reports to inform a classification for health information technology safety problems
Magrabi, F., Ong, M.-S., Runciman, W., & Coiera, E. (2012) · Journal of the American Medical Informatics Association · doi:10.1136/amiajnl-2011-000369 · Cited by 193 · see citing works
Current challenges in health information technology–related patient safety
Sittig, D. F., Wright, A. T., Coiera, E. W., Magrabi, F., Ratwani, R. M., Bates, D. W., & Singh, H. (2018) · Health Informatics Journal · doi:10.1177/1460458218814893 · Cited by 173 · see citing works
Self-citationSingh, H., & Sittig, D. F. (2016) · BMJ Quality & Safety · doi:10.1136/bmjqs-2015-004486 · Cited by 167 · see citing works
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Sittig, D. F. (2011) · Archives of Internal Medicine · doi:10.1001/archinternmed.2011.327 · Cited by 167 · see citing works
Self-citationVan de Velde, S., Heselmans, A., Delvaux, N., Brandt, L., Marco-Ruiz, L., Spitaels, D., Cloetens, H., Kortteisto, T., Roshanov, P., Kunnamo, I., et al. (2018) · Implementation Science · doi:10.1186/s13012-018-0790-1 · Cited by 156 · see citing works
Karlsson, L. O., Nilsson, S., Bång, M., Nilsson, L. E., Charitakis, E., & Janzon, M. (2018) · PLoS Medicine · doi:10.1371/journal.pmed.1002528 · Cited by 120 · see citing works
An analysis of electronic health record–related patient safety incidents
Palojoki, S., Mäkelä, M., Lehtonen, L., & Saranto, K. (2016) · Health Informatics Journal · doi:10.1177/1460458216631072 · Cited by 108 · see citing works
Meeks, D. W., Takian, A., Sittig, D. F., Singh, H., & Barber, N. (2014) · Journal of the American Medical Informatics Association · doi:10.1136/amiajnl-2013-001762 · Cited by 91 · see citing works
Self-citationRonquillo, J. G., & Zuckerman, D. M. (2017) · Milbank Quarterly · doi:10.1111/1468-0009.12278 · Cited by 81 · see citing works
Kushniruk, A. W., Bates, D. W., Bainbridge, M., Househ, M. S., & Borycki, E. M. (2013) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2012.12.006 · Cited by 74 · see citing works
Sittig, D. F., Ash, J. S., & Singh, H. (2014) · PubMed · Cited by 72 · see citing works
Self-citationMartin, G., Ghafur, S., Cingolani, I., Symons, J., King, D., Arora, S., & Darzi, A. W. (2019) · The Lancet Digital Health · doi:10.1016/s2589-7500(19)30057-3 · Cited by 49 · see citing works
Magrabi, F., Ong, M.-S., Runciman, W. B., & Coiera, E. W. (2011) · PubMed Central · Cited by 48 · see citing works
Safety huddles to proactively identify and address electronic health record safety
Menon, S., Singh, H., Giardina, T. D., Rayburn, W. L., Davis, B. P., Russo, E. M., & Sittig, D. F. (2016) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocw153 · Cited by 48 · see citing works
Self-citationPalojoki, S., Pajunen, T., Saranto, K., & Lehtonen, L. (2016) · JMIR Medical Informatics · doi:10.2196/medinform.5238 · Cited by 46 · see citing works
Creating an Oversight Infrastructure for Electronic Health Record–Related Patient Safety Hazards
Singh, H., Classen, D. C., & Sittig, D. F. (2011) · Journal of Patient Safety · doi:10.1097/pts.0b013e31823d8df0 · Cited by 45 · see citing works
Self-citationEdwards, P., & Warm, D. (2012) · Applied Clinical Informatics · doi:10.4338/aci-2012-03-ra-0010 · Cited by 38 · see citing works
Electronic health record–related safety concerns: A cross‐sectional survey
Menon, S., Singh, H., Meyer, A. N. D., Belmont, E., & Sittig, D. F. (2014) · Journal of Healthcare Risk Management · doi:10.1002/jhrm.21146 · Cited by 29 · see citing works
Self-citationRights and responsibilities of users of electronic health records
Sittig, D. F., & Singh, H. (2012) · Canadian Medical Association Journal · doi:10.1503/cmaj.111599 · Cited by 28 · see citing works
Self-citationResilient practices in maintaining safety of health information technologies
Smith, M. W., Ash, J. S., Sittig, D. F., & Singh, H. (2014) · Journal of Cognitive Engineering and Decision Making · doi:10.1177/1555343414534242 · Cited by 26 · see citing works
Self-citationThe impact of electronic records on patient safety: a qualitative study
Scantlebury, A., Adamson, J., Watt, I. S., Sheard, L., Cairns, P. A., & Wright, J. (2016) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-016-0299-y · Cited by 28 · see citing works
Connor, M. J., Jr., Marshall, D. C., Moiseenko, V., Moore, K. L., Cerviño, L., Atwood, T. F., Sanghvi, P. R., Mundt, A. J., Pawlicki, T. A., Recht, A., et al. (2016) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2016.08.050 · Cited by 25 · see citing works
de Velde, S. V., Roshanov, P. S., Kortteisto, T., Kunnamo, I., Aertgeerts, B., Vandvik, P. O., & Flottorp, S. A. (2015) · Implementation Science · doi:10.1186/s13012-016-0393-7 · Cited by 25 · see citing works
Lei, J., Guan, P., Gao, K., Lu, X., Chen, Y., Li, Y., Meng, Q., Zhang, J., Sittig, D. F., & Zheng, K. (2013) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2013.10.006 · Cited by 22 · see citing works
Self-citationNdabu, T., Mulgund, P., Sharman, R., & Singh, R. K. P. G. (2021) · JMIR Human Factors · doi:10.2196/21884 · Cited by 19 · see citing works
Intelligent Simulation Model To Facilitate EHR Training.
Mohan, V., Scholl, G., & Gold, J. A. (2015) · PubMed Central · Cited by 18 · see citing works
Palojoki, S., Saranto, K., & Lehtonen, L. (2017) · Health Informatics Journal · doi:10.1177/1460458217720400 · Cited by 17 · see citing works
Kang, H., Wang, J., Yao, B., Zhou, S., & Gong, Y. (2018) · JAMIA Open · doi:10.1093/jamiaopen/ooy042 · Cited by 16 · see citing works
Emergency Department Workload and Crowding During a Major Electronic Health Record Breakdown
Wretborn, J., Ekelund, U. E. G., & Wilhelms, D. (2019) · Frontiers in Public Health · doi:10.3389/fpubh.2019.00267 · Cited by 16 · see citing works
Lyon, R., Jones, A., Burke, R. A., & Baysari, M. T. (2023) · Applied Clinical Informatics · doi:10.1055/s-0043-1768995 · Cited by 14 · see citing works
Martin, G., Arora, S., Shah, N., King, D., & Darzi, A. W. (2019) · Health Informatics Journal · doi:10.1177/1460458219854602 · Cited by 13 · see citing works
Establishment of a medical device adverse event management system for hospitals
Sun, J. S., Pan, J., Jin, Y., Zhang, Q. Y., Lv, Y., & Feng, J. (2022) · BMC Health Services Research · doi:10.1186/s12913-022-08830-5 · Cited by 13 · see citing works
Incidence and cost of medications dispensed despite electronic medical record discontinuation
Baranowski, P. J., Peterson, K. L., Statz-Paynter, J. L., & Zorek, J. A. (2015) · Journal of the American Pharmacists Association · doi:10.1331/japha.2015.14154 · Cited by 13 · see citing works
SAFER Electronic Health Records
Sittig, D. F., & Singh, H. (2015) · Apple Academic Press eBooks · doi:10.1201/b18371 · Cited by 11 · see citing works
Self-citationMedical device vulnerability mitigation effort gap analysis taxonomy
Holdsworth, J., Glisson, W. B., & Choo, K. R. (2017) · Smart Health · doi:10.1016/j.smhl.2017.12.001 · Cited by 10 · see citing works
Perspectives and Uses of the Electronic Health Record Among US Pediatricians
Doberne, J., Redd, T. K., Lattin, D., Yackel, T. R., Eriksson, C. O., Mohan, V., Gold, J. A., Ash, J. S., & Chiang, M. F. (2016) · Journal of Ambulatory Care Management · doi:10.1097/jac.0000000000000167 · Cited by 10 · see citing works
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Vošner, H. B., Železnik, D., & Kokol, P. (2018) · Informatics for Health and Social Care · doi:10.1080/17538157.2018.1525734 · Cited by 10 · see citing works
Labkoff, S. E., & Sittig, D. F. (2017) · Applied Clinical Informatics · doi:10.4338/aci-2017-02-ie-0032 · Cited by 6 · see citing works
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Reese, T. J., Kawamoto, K., Fiol, G. D., Weir, C. R., Tonna, J. E., Segall, N., Nesbitt, P., Waller, R. G., Borbolla, D. A., Moretti, E., et al. (2017) · IEEE International Conference on Healthcare Informatics (ICHI) · doi:10.1109/ichi.2017.64 · Cited by 3 · see citing works
Adelsberger, S., Setzer, A., & Walkingshaw, E. (2018) · International Symposium on Principles and Practice of Declarative Programming (PPDP) · doi:10.1145/3236950.3236962 · Cited by 2 · see citing works
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Magrabi, F., Ong, M., & Coiera, E. W. (2016) · Springer eBooks · doi:10.1007/978-3-319-31123-4_2 · Cited by 2 · see citing works
Analysis of Medical Device Recalls Owing to Output Information from Software
Kitawaki, R., Umezu, M., Iwasaki, K., & Kasanuki, H. (2016) · doi:10.14982/rsmp.6.281 · Cited by 2 · see citing works
Mason-Blakley, F., Weber, J. H., Lu, L., Price, M., & Roudsari, A. (2015) · IEEE International Conference on Healthcare Informatics (ICHI) · doi:10.1109/ichi.2015.7 · Cited by 2 · see citing works
Crossing Boundaries : Transferring eHealth services across the Northern Periphery
Pesola, U.-M. (2013) · KTH Publication Database DiVA (KTH Royal Institute of Technology) · Cited by 2 · see citing works
Castro, G. M. (2014) · ProQuest Demo Repository · Cited by 2 · see citing works
Patel, M., Parton, S., & Aitken, E. (2022) · Patient Safety · doi:10.33940/data/2022.6.4 · Cited by 1 · see citing works
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Ganio, M. C., Forrey, R. A., Lopez, B. R., & Barreto, J. S. (2016) · American Journal of Health-System Pharmacy · doi:10.2146/ajhp150257 · Cited by 1 · see citing works
Ronquillo, J. G., & Zuckerman, D. M. (2017) · Annals of Internal Medicine · doi:10.7326/l17-0050 · Cited by 1 · see citing works
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Sittig, D. F., & Singh, H. (2015) · Apple Academic Press eBooks · doi:10.1201/b18371-5 · Cited by 1 · see citing works
Self-citationRadcliffe, M. J., & Roukis, T. S. (2023) · Foot & Ankle Surgery Techniques Reports & Cases · doi:10.1016/j.fastrc.2023.100344 · Cited by 1 · see citing works
Cochran, G., Brown, J. L., Yu, Z., Gordon, A. J., Frede, S. M., Hardy, C. J., Castora‐Binkley, M., Homsted, F. A. E., Marsch, L. A., Holtyn, A. F., et al. (2024) · Addiction Science & Clinical Practice · doi:10.1186/s13722-024-00514-1 · Cited by 1 · see citing works
What are the most common medical errors/mistakes associated with EMR use?
Jackson, R. M., & Gill, C. A. (2019) · Evidence-Based Practice · doi:10.1097/ebp.0000000000000371 · Cited by 1 · see citing works
Clarke, A. (2015) · White Rose eTheses Online (University of Leeds, The University of Sheffield, University of York) · Cited by 1 · see citing works
Myers, R. B., Jones, S. L., Sittig, D. F., Meeks, D. W., Takian, A., Singh, H., Barber, N., Smith, M. W., Taylor, L., & Scott, J. (2015) · Apple Academic Press eBooks · doi:10.1201/b18371-3
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Sittig, D. F., Singh, H., Menon, S., Meyer, A. N. D., & Belmont, E. (2015) · Apple Academic Press eBooks · doi:10.1201/b18371-2
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Rose, E. A. (2016) · Springer eBooks · doi:10.1007/978-3-319-31123-4_15
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Sittig, D. F., & Singh, H. (2015) · Apple Academic Press eBooks · doi:10.1201/b18371-8
Self-citationGurley, A. L., Tanch, J., Portelli, D. C., Priebe, C. J., Berube, J. A., Dieffenbach, A., Harris, R., Jalal, M., Sayles, S., Smulling, A. J., et al. (2020) · IEEE International IOT, Electronics and Mechatronics Conference (IEMTRONICS) · doi:10.1109/iemtronics51293.2020.9216436
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Sittig, D. F., Singh, H., & Longhurst, C. (2015) · Apple Academic Press eBooks · doi:10.1201/b18371-4
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Kumar, S., & Tian, E. J. (2018) · Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature · doi:10.3410/f.733847354.793552066
Virginio, L. A., & dos Reis, J. C. (2024) · Journal of Health Informatics · doi:10.59681/2175-4411.v16.iespecial.2024.1283
Improving Patient Safety Maturity in Healthcare Organizations Using Information TechnologyPreprint
Virginio, L. A., & dos Reis, J. C. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5074006
- Authors
- Myers, R. B., Jones, S. L., & Sittig, D. F.
- Affiliations
- Houston Methodist (US)
- The University of Texas System (US)
- Corresponding author
- Sittig, D.F.
- Venue
- Applied Clinical Informatics
- Publisher
- Georg Thieme Verlag KG
- Published
- 2011
- Volume
- 02
- Issue
- 01
- Pages
- 63-74
- ISSN
- 1869-0327 (ISSN-L)
- PMC
- PMC3175794
- OpenAlex
- W2159072650
- Cited by
- 67
- References
- 14
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 1 · 2020: 1 · 2019: 4 · 2018: 7 · 2017: 6 · 2016: 11 · 2015: 14 · 2014: 5 · 2013: 4 · 2012: 3
- FWCI
- 8.20
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Applied Clinical Informatics (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. National Library of Medicine (R56LM006942)
- Topics
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- clinical information systems, adverse events, medical device safety, FDA adverse event reports, downtime, data errors, system design and implementation, clinical workflow, health information technology
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