Slide 1

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

Slide 2

Overview Introduction Methodology Results Discussion Summary

Slide 3

Device-Use Error Human Limitations (memory distraction) Device Complexity (multiple parts multiple steps) System Limitations (teamwork communication) Device-Use Error

Slide 4

Devices Are Becoming More Complex Image Source: The Vein and Vascular Institute of Tampa Bay; tampavascularsurgeon.com

Slide 5

Classification/Regulation FDA Device Classification Class I Class II Class III highest risk IFUs

Slide 6

Medical Errors Device-Related Errors Surgical Device Errors Complex-Invasive Surgical Device (CISD)Errors

Slide 7

CISDs Image Source: Dr. Grobelney performs endovascular surgery; chicagovascularsurgery.com; Gore Neuroprotection System; touchcardiology.com

Slide 8

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

Slide 9

Checklists in Aviation Image Source: Wright brothers airplane, xtimeline.com

Slide 10

Checklists in Aviation Image Source:Test flight of B-17; B-17 test flight crash How the pilots checklist came about, atchistory.org

Slide 11

Image Source: Approved B-17F and G checklist, pilots duties in red, galbreath.net

Slide 12

Could CISDs Benefit From Checklists? Image Source: Glass cockpit, amevoice.com; Printable wedding checklist, portaweddings.com; Robotic surgery, spectrum.ieee.org

Slide 13

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

Slide 14

Results Description of the public health problem Magnitude of the problem Causes and determinants Prevention and intervention

Slide 15

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

Slide 16

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.

Slide 17

Human/System Limitations 7 2 Image Source: James Reasons 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

Slide 18

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

Slide 19

Intervention Image Source:WHO Surgical Safety Checklist, who.int

Slide 20

Discussion Checklists work Devices are becoming more complex Limitations of the literature Criticism of checklists Future studies

Slide 21

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