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DOI: 10.4338/ACI-2010-11-RA-0064
Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases
Correspondence to:
Publication History
received:
07 November 2010
accepted:
04 February 2011
Publication Date:
16 December 2017 (online)
Summary
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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Keywords
Electronic health records - information systems - mandatory reporting - medical errors - United States Food and Drug Administration
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Conflict of Interest
The authors declare that they have no conflicts of interest in the research.
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Correspondence to:
-
References
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- 2 Dearne K. Medicare glitch affects records. The Australian [Internet]. 2010 Apr 20 [cited 2010 Apr 25]; Available from: http://www.theaustralian.com.au/australian-it/medicare-glitch-affects-records/story-e6frgakx-1225855706275
- 3 MAUDE –Manufacturer and User Facility Device Experience [Internet]. [cited 2010 Apr 15]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
- 4 Koppel R, Kreda D. Health care information technology vendors’ "hold harm-less" clause: implications for patients and clinicians. JAMA 2009; 301 (12) 1276-1278.
- 5 Sittig DF, Classen DC. Safe electronic health record use requires a comprehensive monitoring and evaluation framework. JAMA 2010; 303 (05) 450-451.
- 6 Koppel R. Monitoring and evaluating the use of electronic health records. JAMA 2010; 303 (Suppl. 19) 1918 author reply 1918-1919.
- 7 Goodman KW, Berner ES, Dente MA, Kaplan B, Koppel R, Rucker D. et al. Challenges in ethics, safety, best practices, and oversight regarding HIT ven-dors, their customers, and patients: a report of an AMIA special task force. J Am Med Inform Assoc 2011; 18 (01) 77-81. doi:10.1136/jamia.2010.008946.
- 8 Norden L. Voting system failures: a database solution [Internet]. New York N Y.: Brennan Center for Justice; 2010 [cited 2010 Sep 20]. Available from: http://www.brennancenter.org/content/resource/voting_system_failures_a_database_solution
- 9 CFR –Code of Federal Regulations Title 21 [Internet]. [cited 2011 Jan 8]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1&subpartNode=21:8.0.1.1.3.5
- 10 FDA policy for the regulation of computer products. 11/13/89 (Draft) [Internet]. [cited 2011 Jan 28]; Available from: http://www.janosko.com/documents/FDA%20Policy%20Computer%20Products/FDAPolicyComputers1989.htm
- 11 MDR Database Search [Internet]. [cited 2010 Apr 20]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm?searchoptions=1
- 12 Medsun Reports [Internet]. [cited 2010 Apr 15]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/searchReport.cfm
- 13 MedSun: Medical Product Safety Network [Internet]. [cited 2010 Apr 15]; Available from: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm
- 14 Campbell EM, Sittig DF, Guappone KP, Dykstra RH, Ash JS. Overdependence on technology: an unintended adverse consequence of computerized pro-vider order entry. AMIA Annu Symp Proc 2007: 94-98.
- 15 Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2006; 13 (05) 547-556. doi:10.1197/jamia. M2042.
- 16 Sittig DF, Singh H. Eight rights of safe electronic health record use. JAMA 2009; 302 (10) 1111-1113.
- 17 DeVore SD, Figlioli K. Lessons premier hospitals learned about implementing electronic health records. Health Aff (Millwood) 2010; 29 (04) 664-667. doi:10.1377/hlthaff.2010.0250.
- 18 Han YY, Carcillo JA, Venkataraman ST, Clark RSB, Watson RS, Nguyen TC. et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics 2005; 116 (06) 1506-1512. doi:10.1542/peds.2005-1287.
- 19 Del Beccaro MA, Jeffries HE, Eisenberg MA, Harry ED. Computerized pro-vider order entry implementation: no association with increased mortality rates in an intensive care unit. Pediatrics 2006; 118 (01) 290-295. doi:10.1542/peds.2006-0367.
- 20 Linder JA, Haas JS, Iyer A, Labuzetta MA, Ibara M, Celeste M. et al. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf 2010; 19 (12) 1211-1215. doi:10.1002/pds.2027.
- 21 Dal Pan GJ. Commentary on "Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting" by Linder et al. Pharma-coepidemiol Drug Saf 2010; 19 (12) 1216-1217. doi:10.1002/pds.2050.
- 22 CCHIT [Internet]. [cited 2010 Apr 15]; Available from: http://www.cchit.org
- 23 Ambulatory EMR –Segment Profile –KLAS Helps Healthcare Providers by Measuring Vendor Performance [Internet]. [cited 2010 Apr 15]; Available from: http://www.klasresearch.com/Research/Segments/Default.aspx?id=3&evProductID=33609&ReturnURL=%2fResearch%2fSegments%2fDefault.aspx%3fid%3d3%26evProductID%3d33609
- 24 Jha AK, DesRoches CM, Campbell EG, Donelan K, Rao SR, Ferris TG. et al. Use of electronic health records in U. S. hospitals. N Engl J Med 2009; 360 (16) 1628-1638. doi:10.1056/NEJMsa0900592.
- 25 H.R.1 [111th]: American Recovery and Reinvestment Act of 2009 (Gov-Track.us) [Internet]. [cited 2011 Jan 14]; Available from: http://www.govtrack.us/congress/bill.xpd?bill=h111-1
- 26 Hsiao C, Beatty P, Hing E, Woodwell D, Rechtsteiner E, Sisk J. Products –Health E Stats –EMR and EHR Use by Office-based Physicians [Internet]. [cited 2011 Jan 14]; Available from: http://www.cdc.gov/nchs/data/hestat/emr_ehr/emr_ehr.htm
- 27 Shuren J. Testimony of Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health [Internet]. 2010 Available from: http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10741_910717_0_0_18/3Shuren_Testimony/022510.pdf
- 28 *ASTER Study [Internet]. [cited 2010 Aug 10]; Available from: http://www.asterstudy.com
- 29 Issue 42: Safely implementing health information and converging technologies | Joint Commission [Internet]. [cited 2010 Aug 7]; Available from: http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm
- 30 Federal Aviation Administration. Aeronautical information manual –official guide to basic flight information and ATC procedures [Internet]. 2010 Feb 11; Available from: http://www.faa.gov/air_traffic/publications/atpubs/aim/
- 31 Miller RA, Gardner RM. Recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Science Libraries, American Health Information Management Association, American Nurses Association. J Am Med Inform Assoc 1997; 4 (06) 442-457.
- 32 PSO Privacy Protection Center –Device or Medical/Surgical Supply, including HIT Device (Beta) [Internet]. [cited 2011 Jan 18]; Available from: https://www.psoppc.org/web/patientsafety/device-ormedical/surgical-supply-including-hit-device-beta
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