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Ryan D. Lewis MD MHA Capstone Advisor: Ayse Gurses, PhD, Assistant Professor, Department of Anesthesiology and Critical Care Medicine The Johns Hopkins School of Medicine Can a Device-Use Checklist Reduce Medical Errors in the Operating Room? A Literature Review
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Overview Introduction Methodology Results Discussion Summary
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Device-Use Error Human Limitations (memory distraction) Device Complexity (multiple parts multiple steps) System Limitations (teamwork communication) Device-Use Error
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Devices Are Becoming More Complex Image Source: The Vein and Vascular Institute of Tampa Bay; tampavascularsurgeon.com
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Classification/Regulation FDA Device Classification Class I Class II Class III – highest risk IFUs
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Medical Errors Device-Related Errors Surgical Device Errors Complex-Invasive Surgical Device (CISD)Errors
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CISDs Image Source: Dr. Grobelney performs endovascular surgery; chicagovascularsurgery.com; Gore Neuroprotection System; touchcardiology.com
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CISDs 20 potential adverse events listed 60 (approx) procedural steps Image Source: The Gore Helex Septal Occluder; gore.com; The Helex Septal Occluder; scielo.br
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Checklists in Aviation Image Source: Wright brothers airplane, xtimeline.com
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Checklists in Aviation Image Source:Test flight of B-17; B-17 test flight crash How the pilot’s checklist came about, atchistory.org
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Image Source: Approved B-17F and G checklist, pilots duties in red, galbreath.net
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Could CISDs Benefit From Checklists? Image Source: Glass cockpit, amevoice.com; Printable wedding checklist, portaweddings.com; Robotic surgery, spectrum.ieee.org
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Methodology Literature search for articles relating to: Checklists in medicine, surgery, for surgical devices Device-related adverse events Distributed cognition theory Adverse events and memory/distraction Human error theory Instructions for use Others No articles found describing checklists for CISDs
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Results Description of the public health problem Magnitude of the problem Causes and determinants Prevention and intervention
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Magnitude of the Problem Medical Errors Device-Related Errors Surgical Device Errors Complex-Invasive Surgical Device (CISD)Errors 44,000-98,000/year = $24 billion 1 83.7/1000 hospital visits 2 ??? MAUDE/manufacturers database 1.To err is human: Building a safer health system - summary [Internet].; 1999. Available from: http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is- Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf.http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is- Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf 2.Gawande AA, Thomas EJ, Zinner MJ, Brennan TA. The incidence and nature of surgical adverse events in colorado and utah in 1992. Surgery. 1999 Jul;126(1):66- 75. = 1.5 jetliners crashing every day 1
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Causes and Determinants Lack of experience or competence with a procedure (53%) 1 Breakdown in communication (43%) Fatigue (33%) Interruptions/distractions during a procedure Inappropriate protocols 1. Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by surgeons at three teaching hospitals. Surgery. 2003 Jun;133(6):614-21.
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Human/System Limitations 7 ± 2 Image Source: James Reason’s Swiss cheese model, thereliabilityroadmap.com; Seven chunks plus or minus two, thelatherapistblogspot.com; Image of a person doing math with a paper and pencil,tamu-commerce.edu
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Prevention “Greater than 50% of surgical injuries are preventable” 1 1. Gawande AA, Thomas EJ, Zinner MJ, Brennan TA. The incidence and nature of surgical adverse events in colorado and utah in 1992. Surgery. 1999 Jul;126(1):66-75. Image Source: A central line placed in a patient, blog.timesunition.com
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Intervention Image Source:WHO Surgical Safety Checklist, who.int
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Discussion Checklists work Devices are becoming more complex Limitations of the literature Criticism of checklists Future studies
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Summary CISD-use errors occur at some undetermined rate The causes and determinants for surgical errors are likely the same for CISD-use errors A device-use checklist could be explored as an intervention
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