Human Factors and Medical Device Accidents. Presented by Frank R. Painter, MS, CCE University of Connecticut

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1 Human Factors and Medical Device Accidents Presented by Frank R. Painter, MS, CCE University of Connecticut 1

2 Human Factors & User Errors A perfectly designed device will be easy to use and no one will make mistakes with it A poorly designed device will be difficult to use and be prone to mistakes Why blame users for mistakes using poorly designed devices? 2

designed device will be difficult to use and be prone to

3 Users are part of medical device systems Device User Device-User System 3

4 Use Error v. User Error If an error is made with a device that is working the way it was designed, the error has been called a user error It might not be the fault of the USER so we now call these USE errors USE errors are not considered to be someone s fault, but the fault of the system (equipment, policies, communications, staffing, etc.) 4

the error has been called a user error It might not be the fault of the USER so we

5 Culture of Blame If the device works, the problem must be the user If something went wrong, it must be the user If a mistake was made, let s find out who did it 5

6 The Right Focus Individual accountability NOT the focus Not What should we have done to prevent this from having occurred? Focus is on improving systems How can we prevent this in the future? 6

7 Fix the System Find out what really happened Root Cause Analysis (ask why, why, why?) Change the system the staff operates in so errors are less likely Better policies Clearer procedures More training Improved communications Better designed equipment Less chaotic environment 7

) Change the system the staff operates in so errors are less likely

8 8

9 Fires during defibrillation... Typically caused by insufficient paddle contact with subsequent arcing in the presence of oxygen-enriched environments. Paddle charring 9

10 Infusion Pump Free-Flow Incidents 10

11 Electrosurgical units... Continue to be implicated in patient burns and fires. From Principles of Electrosurgery, Valleylab,

12 Non-Invasive BP Systems Misconnection that seemed right became a embolism death 12

13 ECG Cable Misconnection resulting in electrocution 13

14 Think Systems 1. Reduce or eliminate threats to patient safety 2. Plug the holes 3. Strengthen the slices 14

15 Complex Patient-User-Machine- Environmental Interface 15

16 Complex Patient-User-Machine- Environmental Interface 16

17 17

18 Human factors is... a discipline concerned with the design of tools, machines, and systems that take into account human capabilities, limitations, and characteristics. * Its fundamental goals in design are to: minimize / eliminate workplace injuries and hazards; minimize user and system-related errors; maximize worker and workplace efficiency and productivity. Like clinical and biomedical engineering, it is also a very interdisciplinary and systems-focused science. * J. Gosbee, Human factors engineering and patient safety, Qual Safe Health Care,

19 Historical Background... Human factors (then experimental psychology) was originally applied to problems of military aviation near the end of WWII because of: Poor usability and standardization of cockpits Original designs ignored normal limitations on human perception and cognition, especially under stress. 19 Adapted from L. Hettinger, et al.

military aviation near the end of WWII because of: Poor usability and standardization

20 NAVAL AVIATION MISHAP RATE Class A Mishaps/100,000 Flight Hours 776 aircraft destroyed in FY Angled Carrier Decks Naval Aviation Safety Center NAMP est RAG concept initiated NATOPS initiated aircraft destroyed in 1996 Squadron Safety program System Safety Designated Aircraft ACT HFC s Fiscal Year

est. 1959 RAG concept initiated NATOPS initiated 1961 39 aircraft destroyed in 1996

21 Human Factors Engineering Recognizing problems - what we should know: User preference does not necessarily indicate safety and effectiveness. Poor design greatly increases likelihood of errors. Device User Interface is where errors happen 21

22 Evaluating already purchased devices: Has training been slow and arduous? Only a few staff members seem able to use the device? Staff refuses to use the device? Many reports of - no problem found? Installation of accessories difficult? Alarms and batteries fail often? Incorrect accessories sometimes are installed? Displays difficult to read or understand? Controls poorly located or labeled? Alarms difficult to hear or overly annoying? Device operation is illogical and confusing? 22

23 Human Factors and Medical Device Design... Infusion Pumps: Frequent complaints of broke, won t stop beeping, why is it doing that, may suggest problems with design not the user. 23

24 Human Factors and Medical Device Design... Labeling Problems: 24

25 Evaluating Devices Before Purchase Determine if manufacturer conducted human factors / usability testing of the device. Check with staff and other facilities about predecessor models made by this manufacturer. Check with other facilities that may be using the new model. Check published evaluations of the model. Request a trial period prior to actual purchase. 25

26 Creating a culture of patient safety... Treat every adverse event, injury, accidental death as a precious learning opportunity Seek to identify the active failures and latent conditions - within the system that contributed to the event. DO NOT JUST MANAGE THE LAST ERROR Eliminate the tendency to blame 26

Karlene H. Roberts, PhD. Haas School of Business University of California Berkeley, CA 94720 USA E-mail: Karlene@haas.berkeley.edu

Karlene H. Roberts, PhD. Haas School of Business University of California Berkeley, CA 94720 USA E-mail: Karlene@haas.berkeley.edu When anyone asks me how I can best describe my experience in nearly forty