Human Factors Engineering and Patient Safety : Human Factors Engineering and Patient Safety Michigan Health & Safety Coalition – Annual Conference John Gosbee, MD, MS VA National Center for Patient Safety www.patientsafety.gov


Introductions: Introductions Mine Human factors engineering and healthcare specialist Adverse events and patient safety Curriculum for residents and students Invention and innovation Yours 2 minutes to meet your neighbor Your role and why you chose this break-out session


Objectives: Objectives Learn about human factors engineering to help improve Root Cause/Contributing Factors for RCAs Failure Modes/Causes for FMEAs Begin to understand the scope of HFE is beyond devices Work areas and entire buildings


Human Factors Engineering : Human Factors Engineering Interaction between human and system Dialogue between end-user and their tools Tools and concepts to help us with patient safety A short quiz to get us started


If someone painted all the stop signs in your town green, which statement is true?: If someone painted all the stop signs in your town green, which statement is true? a.      A few people would notice, but it would not increase accidents b.      It would have no effect c.      It would have a measurable effect with an increased accident rate d.      A few people who are day-dreaming would miss the signs, but not those that cared and were paying attention e.      Radio warnings and cautions to pay more attention would not help


HFE Quiz (cont.): HFE Quiz (cont.) Which blue knob controls the dial on the right? Why? Control Panel


Human Factors Model: Human Factors Model Senses - Vision - Hearing Psychomotor Hand - Feet Input Devices Buttons - Foot pedal Output - Color display - Sound INTERFACE


Radar Scope to Detect “enemy” ships: Radar Scope to Detect “enemy” ships


ECG Signal (Telemetry) Monitoring: ECG Signal (Telemetry) Monitoring


Performance Graph (curve): 100% 90% 80% 70% Time (hours) 1 2 3 4 Performance Performance Graph (curve)


Slide11: 100% 90% 80% 70% Time (hours) 1 2 3 4 Performance Performance Graph (curve)


How can we move the curve upwards? : How can we move the curve upwards? 100% 90% 80% 70% Time (hours) 1 2 3 4 Performance


Another Demonstration with a Patient Safety Twist: Another Demonstration with a Patient Safety Twist Look at the next slide Count the number of words in the paragraph that are repeated


Medical Device Correlation: Medical Device Correlation What does this phrase mean  “Telemetry Off” To a novice? To an expert?


What is this regulator used for?: What is this regulator used for? Write your answer down on paper


Demonstration: Stroop Test: Demonstration: Stroop Test Row 1 Row 2 Row 3


Slide17: Sources: Medical Mistake Left Newborn In Coma KITV-TV HONOLULU - A medical mistake at Tripler Army Medical Center has left a newborn baby in a coma with severe brain damage. Sources familiar with this case tell KITV 4 News that Tripler officials apologized to the family of a baby boy born there in January after he was mistakenly given carbon dioxide right after birth, instead of oxygen. The baby boy was born Jan. 14 at Tripler Army Medical Center during a scheduled cesarean section delivery, sources told KITV 4 News. They said medical personnel mistakenly gave him carbon dioxide immediately after birth instead of oxygen. Sources said the operating room may have been set up incorrectly.


Volunteer to Write Instructions: Volunteer to Write Instructions Starting from Peanut Butter Jar and Bag of Bread Ending with - peanut butter sandwich (two slices of bread) on the plate


The Normalization of Complexity: The Normalization of Complexity Healthcare workers compensate for complex, unclear workplaces and devices IV Pumps, for example Unclear or absent information or cues to understand how to accomplish desired goal Mastery of the complex becomes a normal strategy, without regard to reasonableness or necessity of complexity


Broad Impact of Human Factors Engineering: Broad Impact of Human Factors Engineering Aviation (since 1940’s) Nuclear Power Space flight Computer software and hardware (Xerox PARC 1970s) Consumer products (Palm Pilot, Snakelight) Railroad, motor vehicle, farm machinery, etc.


Human Factors Engineering and Your World: Human Factors Engineering and Your World Anesthesiology Design of alarms, monitors, and safety systems Emergency Medicine Design of decision-making tools and monitoring Surgery Design of hand tools and visualization devices (laparoscopy)


Healthcare “Systems”Range from the Simple to Complex: Healthcare “Systems” Range from the Simple to Complex Syringe, catheter bag and its tubing O2 cylinder, ECG machine, IV pump Code cart, anesthesia work station Hospital computer system MRI control room and suite ICU, ED, OR


Human Factors Engineering is about the whole system: Human Factors Engineering is about the whole system What’s the design of the training and education Labeling and instructions attached to device Policy and procedures? Information displays Pieces of paper Layout and structure of the room, layout of the floor, layout of the facility, overall environment


Design and Test of Written Documents: Design and Test of Written Documents Policies and procedures Steps to use a device Instructions or help screen for software It seems easy, but… Peanut butter sandwich making demo as an example


HFE and Patient Safety Lesson: HFE and Patient Safety Lesson Simple steps never are Learned intuition and assumptions Stereotypes Metaphors Iterative testing of instructions to work the bugs out


Learned intuition examples: Learned intuition examples Secretaries using computers Other examples?


Human factors engineering and patient safety case studies: Human factors engineering and patient safety case studies Code Cart drawer PCA pump


Baseline Drawer (“Laundry hamper”)Range = 2:43-3:58 min, Avg=3:07 min: Baseline Drawer (“Laundry hamper”) Range = 2:43-3:58 min, Avg=3:07 min Note the multiple orientations


Code Cart Drawer Fifth Version Range = :55-1:25 min, Avg=1:08: Code Cart Drawer Fifth Version Range = :55-1:25 min, Avg=1:08 Note the lack of labels for each spot


PCA: Interface Redesign – Univ. Toronto: PCA: Interface Redesign – Univ. Toronto Existing Design New Design


PCA: Programming Sequence Redesign: PCA: Programming Sequence Redesign Existing Design New Design


Usability Evaluation of a PCA Pump: Measurements: Usability Evaluation of a PCA Pump: Measurements Programming Errors Measured Quantity Severity Performance Measured Programming Time Task completion time Mental Workload Ratings  NASA-TLX


PCA Pump Errors - Results: PCA Pump Errors - Results New Interface 55% reduction in number of errors Zero errors in entering drug concentration Old interface 8 drug concentration errors were made 3 of these were not detected and were left uncorrected Mode Errors Old interface errors involved selecting the wrong mode (11 errors, 9 of which were eventually corrected With the new interface, only 3 such mode selection errors occurred, all of which were eventually corrected


Other Results: Other Results Task Completion Time 11/12 end-users faster with new interface Average 18% faster No difference in Subjective Workload Over 90% preference for new interface


How can we APPLY all of this theory?: How can we APPLY all of this theory? Set of principles If they are not followed, adverse events always will Set of guidelines If they are ignored, again, adverse events will occur We will present a short list of guidelines now


Human Factors Engineering Guidelines (Adapted from Nielsen, 1992): Human Factors Engineering Guidelines (Adapted from Nielsen, 1992) 1. Simple and Natural Dialogue 2. Speak the Users’ Language 3. Minimizing User Memory Load 4 . Consistency 5. Feedback 6. Clearly Marked “Exits” 7. Prevent Errors Good Error Messages Help and Documentation Readable and understandable labels and warnings


Simple and Natural Dialogue: Simple and Natural Dialogue Dialogue is between the user of a device and the device The device communicates to the person with: Physical shape, feel Labeling including symbols and words Characteristics of parts that connect to other devices or a person Environment can affect this dialog in the way that background noise makes hearing difficult


Prerequisites for simple natural dialogue: Prerequisites for simple natural dialogue How a device/process/workplace is designed needs to fit with the work done (fit glove to the hand) and the person doing it Because how specific users do their specific jobs gives you Insight into their “mental model” Understanding mismatch between the person and the system design


Take a look around us: Take a look around us


Clinical Example – Radioactivity Calculator Software: Clinical Example – Radioactivity Calculator Software Used to determine radioactivity of the “pellet” to be placed near the patient’s tumor This determines how long to leave it there during surgery Key data is the date field XX/XX/XX What date is 01/12/99?


Consistency: Consistency Controls that look the same act the same Displays or terms that look the same act the same Overall Refer to one item with the same name all the time Conversely, refer to different items with distinct names


Consistency: Consistency Location of controls Typewriter Brake pedal in car Defibrillator


Consistency: Examples from daily life: Consistency: Examples from daily life


Consistency: Clinical Example: Consistency: Clinical Example Your Examples? – testimonials


Feedback: Feedback Users want to know what is happening in terms they understand Device or system should indicate current status of the system Examples of feedback from your computer “Beep” when you do certain “bad” things “Thermometer” or “hourglass” display to indicate progress in task


Real world examples: Real world examples


Clinical Example – Defibrillator: Clinical Example – Defibrillator


Feedback – your examples : Feedback – your examples


Readable and understandable labels and warnings: Readable and understandable labels and warnings Seemingly easy to do…it’s not Thousands of examples, including our own earlier Caused by Jargon Complexity of most design processes Unneeded creativity


Clinical Example #1 – Cardiac Monitor: Clinical Example #1 – Cardiac Monitor This piece of tape says “On/Off”


Clinical Example #2 – Syringe: Clinical Example #2 – Syringe


Clinical Example – Syringe: Clinical Example – Syringe Syringe labeling on plunger, not syringe itself Harder to read with liquid in the syringe Not usual “measuring cup” model of figuring out volume in syringe


Your clinical examples : Your clinical examples


Conclusions and Next Steps: Conclusions and Next Steps HFE contains concepts that underlie patient safety Small group exercises Principles applied to many systems Usability testing method revealed! More resources follow this slide


AdvaMed Infusion Pump Working Group: AdvaMed Infusion Pump Working Group Usability Objectives for all future IV pumps Feeding off FDA and ANSO/AAMI 74 guidance Examples 90% min-trained users can turn on pump in 20 sec 85% min-trained can program basics in 5 min


HFE Web Resources: HFE Web Resources Wiklund M. Eleven Keys to Designing Error-Resistant Medical Devices. MD&DI. May 2002 pp. 86-90. http://www.devicelink.com/mddi/archive/02/05/004.html VA Web Site http://www.patientsafety.gov/hf.html FDA Web Site and Publications (free and good!) http://www.fda.gov/cdrh/humanfactors/ Human Factors Engineering and Medical Devices (“Do It By Design” & “Device Use Safety”)


Web Sites (more): Web Sites (more) Human Factors Society (HFES) Website: http://www.hfes.org/ Graduate programs in Human Factors Local Chapters of the Human Factors Society The Usability Professionals Association (UPA) Website: http://www.upassoc.org/index.html Local Chapters of the Usability Prof Association ACM-Special Interest Group on Computer-Human Interaction (SIGCHI) Website: http://sigchi.org/ Local Chapters of SIGCHI


Academia: Academia University of Wisconsin Series of courses for masters in HFE and patient safety Students from nursing, medicine, engineering HFE and BME key to research agenda http://www.engr.wisc.edu/ie/ University of Maryland Video analysis in OR and ED Alarms redesign HFE and BME key to DCERPS http://www.safetycenter.umm.edu/


Academia (cont.): Academia (cont.) University of Virginia Laparscopic Cholecystectomy – training, etc. http://www.sys.virginia.edu/hci/ University of Toronto PCA pumps Procurement Savings from one device investigation paid for expense of HF Expert for one year http://www.mie.utoronto.ca/labs/cel/research/pca.html http://www.mie.utoronto.ca/labs/cel/


Bibliography: Bibliography Gosbee JW. Introduction to the human factors engineering series. Joint Commission Journal on Quality and Safety. 2004; 30(4): 215-219. Gosbee JW, Anderson T. Human factors engineering design demonstrations can enlighten your RCA team. Quality & Safety in Health Care. 2003; 12: 119-121. http://qhc.bmjjournals.com/cgi/content/abstract/12/2/119?etoc Dumas, J. and Redish, G. (1993). A Practical Guide to Usability Testing. Norwood, NJ: Ablex. Nielsen, J. (1993) Usability Engineering. Boston: AP Professional. Rubin, J. (1994). Handbook of Usability Testing. New York: John Wiley & Sons, Inc.