AAMI & FDA Summit on Infusion Devices. Standardization of the User Interface October 5 th, 2010

Transcription

1 AAMI & FDA Summit on Infusion Devices Standardization of the User Interface October 5 th, 2010 Alan Ravitz Peter Doyle 1

2 Presentation Objectives Identify the user interface as an important domain in the Systems Engineering approach to total product lifecycle Identify prevalent user interface issues for large volume infusion pumps Propose some concepts for improvement 2

3 Systems Engineering Phases and Processes Capabilities Improvement Needs Definition Operational Data Collection Lessons Learned Test & Evaluation Product Development & Production Support System Lifecycle User involvement Thru Out Prototype Development Performance Demonstration Critical Field Experiments Data Collection Mission Performance Analysis Enabling Science & Technology Hypothesis, Concept Development Trade offs, Experiments Modeling/Simulation

4 User Interface as One Systems Engineering Domain Impacting Safety Patient Safety User Interface Device Design Human Behavior Patient Care Environment A combination of concept of operation/employment, engineering, training, usability testing and other interventions will lead to improved patient safety 4

5 Good User Interface Design Addresses Factors That Shape Performance User Interface Device Design Menus Buttons Dials Knobs Read outs Handles, Grasps Other software, mechanical, physical, etc interfaces Human Behavior Workload Proficiency Stress reactions Other human response actions Patient Care Environment ER, ICU, etc Home Lighting Distractions (noise, etc) Other physical, mechanical, etc characteristics Device Design, Human Behavior, & Patient Care Environment are not mutually exclusive 5

6 User Interface Study Combined Clinical and Systems Engineering Expertise Analyzed hardware, software, usability and training issues affecting the user interface Task analysis of nurses use of 2 large volume pumps Reduced tasks to smallest steps for 4 use cases Interviewed SMEs & held round table discussions Conducted field observations on units Literature review A sample of issues identified are presented herein Issues identified pertain to many pumps, the ones pictured are used as examples only 6

7 User Interface Issues: Labeling Medication description on pump may vary with format and content of IV bag labels and pharmacy/ emar documentation, promoting errors. Would be advisable if the pump descriptions mirrored those used by the hospital, including standard of unit for each drug Phenylephrine 200/270 Potassium Chloride Potassium CI Central 7

8 Hardware Design Hardware design enables incorrect tubing installation Improper removal of cassette may result in unrestricted flow* NOT ** 8

9 Control Design (1) Control dimension and spacing contribute to errors in stressful environments Standardize keypad configurations (e.g. number placement) Telephone pattern Calculator pattern Keyboard 9

10 Control Design (2) Decimal point positions vary across pumps Improved feedback cues for use of decimal (e.g. different colored display background or different tone for decimal) Norepinephrine 0.2 mcg/kg/min. Norepinephrine 2 mcg/kg/min. 10

11 Control Design (3) Control labeling to match environmental conditions Keypad requires backlighting* Control of input errors Consider design in which pump talks to Provider Order Entry (POE) to get programming information. * Wetterneck et. al

12 Association of Controls to Display Association of "soft" controls with soft display labels not optimized, e.g. where select channel? 12

13 Functional Grouping of Controls Cues to associate controls to display information not optimized: Nurses: Use of color is confusing 13

14 Display of Information (1) Nurses must wait 8 sec. to see drug name and concentration scroll sometimes insufficient info re: concentration Dose is more important than rate, display dose not rate Lighting and distance affect display readability [a) Upper display readable from ~94" and middle display ~63". Distance to door is greater. 14

15 Display of Information (2) Pressure history not provided for fluid delivered Provide more intuitive indication of degree of occlusion Ability to display the infusion site for DERS mode - would help prevent delivery of drug to wrong site Select line type then lumen e.g. Hickman > red port OR Hickman > white port 15

16 Display of Information (3) Insufficient cues to distinguish between similar drug names Use Tall Man letters per pharmacy practice * PENTObarbital PHENObarbital Visual indication of battery status not provided at all times - only when it alarms Provide indication of battery status at all times * Wetterneck et. al

17 Wrong Concentration: Common Error Drugs lists showing multiple concentrations may be shown on more than one screen user selects the closest one on the first screen Show same drugs with multiple concentrations on the same screen OR Use strong cues to indicate there are other options e.g. More prompt Evaluate placing most frequently used solutions at top of menu lists* Best: Select drug first, then concentration options * Wetterneck et. al

18 Wrong Dose (1) Failure to enter new patient profile for new patient may result in incorrect drug delivery, e.g. failure to power the pump down or to select new profile Consider controls in DERS mode to prevent exceeding DERS limit by hanging the same drug on two pumps with the same processor * Wetterneck et. al

19 Wrong Dose (2) Prompt to enter rate or VTBI before dose: Wrong rate calculation can result in the wrong dose RNs enter dose in the rate field massive errors Do not display rate option in drug calculation mode List Dose option first Nurses can hang the same drug on two pumps with the same processor Need controls in DERS mode to prevent pump processor from allowing this 19

20 Wrong Dose (3) Sufficient information not provided to make decisions dose entered is not displayed Dose exceeds DERS limit of 300 mcg/h. Proceed? Yes No 20

21 Wrong Rate (1) Errors in drug calculations If calculations are not already automated, avoid the need for user to do the math 150 mg Amiodarone in 100 ml diluent over 10 mins. is what rate/hr.? Input Sequence: Select Amiodarone Dose 150 mg VTBI 100 ml Time 10 min. 21

22 Wrong Rate (2) No maximum rate feature for bolus dosing for specific drugs* Provide maximum rate feature for bolus dosing? * Wetterneck et. al

23 Meds Delivery Timing, Delays and Efficiency (1) Power up cycle can be slow, delays administration of critical meds Power up cycle should be quick for rapid administration of critical meds Input of data for user recognition delays startup Evaluate value of biometrics for user recognition (e.g. fingerprint as done with Pyxis) 23

24 Meds Delivery Timing, Delays and Efficiency (2) Menus do not include options to select smaller bag sizes so timing of alerts is accurate for those bag volumes Timely notification needed for preparation of subsequent medication bags Automate status on hung fluid usage to pharmacy so pharmacy can process the next bag earlier. A delayed start option would greatly assist RN workflow 24

25 Meds Delivery Timing, Delays and Efficiency (3) Sequences to correct programming errors may delay drug delivery. Entering a wrong digit may require multiple reprogramming steps Optimize the protocol for making corrections to avoid the need to restart the whole programming sequence 25

26 Error Checking (1) Widely held myth: A DERS is a dose-checker DERS purpose is to prevent gross programming errors by checking against extreme limits DERS does not take weight, renal function or other factors into account Viewing the pump display to verify which medication is being delivered can be deceptive (e.g. drug programmed does not match bag) One of the more common errors Barcoding or networking POE to pump could provide check 26

27 Error Checking (2) Need for more control of programming checks by second RN Examine feasibility of requiring 2 separate entries for double checks - each RN to program the pump and the 2 entries must match Procedural controls to assure 5 rights are reliably adhered to are not always sufficient Consider a barcoding solution 27

28 Error Checking (3) A range of patient profiles is available across hospital units, enabling use of drug library options which are not advisable for certain units. Consider limiting profiles based on input of unit code Requires wireless updates to be feasible Errors in weight-based calculations Errors in weight-based calculations could be reduced if weight were acquired via network with patient bed This enables other errors requiring control 28

29 Alarms (1) Lack of notification when audio alarm is locked out/prevented from sounding Alarm volume changes affect signal tone (pitch) Only one alarm signal is provided for alarms of different criticality Different alert tone desired for problems with vasoactive drug administration 29

30 Alarms (2) Timing for "Callback" notification is after, not prior to completion of infusion. Must program VTBI less than bag contents to KVO. Screen test and alarm test functions not provided 30

31 Opportunity Exists to Identify Additional User Interface Issues Issues identified herein are but a sample of issues found Analyze additional tasks Anesthesia use Maintenance Develop concepts for innovations & enhancements that address workflow and environment issues Integration of pumps with other hospital systems, and resultant interface challenges Extend systems engineering efforts to additional stakeholders and other pump devices

32 References Valdez, R.S. and Brennan, P. F., Industrial and Systems Engineering and Health Care: Critical Areas of Research, AHRQ Publication No EF September 2009 Wetterneck, T.B., Skibinski, K.A., Roberts, T.L. Kleppin, S.M., Schroeder, M.E., Enloe, M., Rough, S.S., Hundt, A.S. and Carayon, P. Using failure mode and effects analysis to plan implementation of smart i.v. pump technology. Am J Health-Syst Pharm Vol 63 Aug 15,

33 THANK YOU Team members Dean Calcagni MD, JHU APL Michael Dawson, RN, NC I Peter A. Doyle PhD, JHH Ayse Gurses, PhD, JHH Annette Perschke, DPN, RN, CRRN Julius Pham MD, JHH Peter Pronovost, MD, JHH Alan Ravitz, MS JHU APL Melinda Sawyer, RN Nawshin Sultana, UMBC Rhonda Wyskiel, RN, NCIII Betsy Zink, RN, NC III

34 Integrated Systems Engineering Involves stakeholders from all domains More thorough requirements analysis process Requirements are tracked, assuring inclusion throughout the design and evaluation processes Benefits: Ensure intuitive, less error-prone operator interfaces Design repeatable, fail-safe physical setups Pumps integrated into the wider medication administration enterprise (provider orders, pharmacy & supply, documentation and maintenance) 34