ul and the ul logo are trademarks of ul llc © 2013 integrating human factors nto the r&d...

UL and the UL logo are trademarks of UL LLC © 2013

Integrating Human Factors nto the R&D Process

Presented at

Presented by

Michael Wiklund, PE, CHFP General Manager – Human Factors Engineering, UL-Wiklund

November 5, 2014

INTRODUCTION

My background

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Michael Wiklund, MS, PE

General Manager – Human Factors Engineering, UL

Certified Human Factors Professional

Professor, Tufts University

Author/Editor: Usability Testing of Medical Devices

Handbook of Human Factors in Medical Device Design

Designing Usability into Medical Products

Usability in Practice

Member:AAMI Human Factors Engineering Committee

IEC Human Factors Engineering Committee

Human factors specialists

Seek to optimize the quality of interaction between people and products, making them:

• Safe

• Effective

• Efficient

• Satisfying

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Participant did not notice drug injection pen was expired.

Credit: http://marylandepinephrineresourceschoolnurses.yolasite.com/resources/Epi%20pen%20demo.jpg

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Photo source: http://media.propertycasualty360.com/propertycasualty360/article/2013/01/08/ConctructionDefect_324-resize-380x300.jpg

To err is human

Photo source: http://www.justjared.com/photo-gallery/2586425/katie-holmes-suri-ice-cream-17/fullsize/

Source: http://www.langleyflyingschool.com/Photos/Safety%20Management%20System/car_err.JPG

To err when using a medical device can be harmful or deadly.

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1999: Deaths resulting from use errors involving medical devices = 10% of at least 45,000/year in the USA



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ROOT CAUSES

•Inadequate training •European format•Small text


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Participant programmed IV pump to deliver antibiotic fluid (“secondary” infusion) at “primary” rate intended for hydration fluid.

Credit: http://humanfactors.ca/wp-content/uploads/2011/06/Lab-CNursingWard1_6114383052-960x475.jpg

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Participant programmed IV pump to deliver antibiotic fluid (“secondary” infusion) at “primary” rate intended for hydration fluid.

Credit: http://humanfactors.ca/wp-content/uploads/2011/06/Lab-CNursingWard1_6114383052-960x475.jpg

POSSIBLE ROOT CAUSES

•Use of abbreviations•No confirmation•No prompt about IV bag height•Closed clamp•No dose limits

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Participant did not breathe out completely before taking puff from inhaler.

Credit: http://www.visualphotos.com/photo/2x3376353/man_using_inhaler_42-17590020.jpg

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Participant did not breathe out completely before taking puff from inhaler.

Credit: http://www.visualphotos.com/photo/2x3376353/man_using_inhaler_42-17590020.jpg


•Step not described during training•Step not illustrated in instructions

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Participant drew blood sample from fingertip still wet with disinfectant.

Credit: http://1.bp.blogspot.com/-pfZ60W9YpLo/ThYVUI5Ad-I/AAAAAAAAAME/6bpsNlSsaVI/s1600/Diabetes_3.jpg

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Participant drew blood sample from fingertip still wet with disinfectant.

Credit: http://1.bp.blogspot.com/-pfZ60W9YpLo/ThYVUI5Ad-I/AAAAAAAAAME/6bpsNlSsaVI/s1600/Diabetes_3.jpg


•Not taught to air dry finger during training•Instructions suggest using disinfectant, but don’t direct users to air dry finger

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Participant did not detect LVAD’s low battery alarm.

Credit: http://www.umcvc.org/sites/default/files/styles/large/public/JeromeWilson-DrToddKoelling.jpg?itok=xsgl8W_y

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Participant did not detect LVAD’s battery low alarm.

Credit: http://www.umcvc.org/sites/default/files/styles/large/public/JeromeWilson-DrToddKoelling.jpg?itok=xsgl8W_y


•Pizoelectric buzzer emits 3500 Hz signal; above threshold for older individuals with presbycussis•Parallel visual alarm is inconspicuous

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THE HUMAN FACTORS ENGINEERING IMPERATIVE

Imperative to apply HFE

• Today, FDA and other regulatory agencies expect medical devices to reflect good HFE.

• Applying HFE is a cornerstone of overall risk management.

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Timeline

1993: ANSI/AAMI HE48:1993 (design guidelines)

1995: Joint AAMI and FDA conference on HF

1996: Quality System Regulation (QSR); indirect requirements for HFE added

1997: End of “grace period” to incorporate HFE in medical device design process

1999: IOM report on medical error

2001: ANSI/AAMI HE74:2001 (HFE process standard)

2006: IEC 60601-1-6 collateral standard (AAMI HE74 is informative annex)

2007: ISO/IEC 62366:2007 (AAMI HE74 included as informative annex)

2008: EU adopts ISO/IEC 62366:2007 as basis for CE mark

2008: FDA’s HFE team moves into Office of Device Evaluation

2009: ANSI/AAMI HE75:2009 (HFE methods and design guidelines)

2011: FDA publishes draft HFE guidelines

2012: Adoption of 3rd edition of IEC 60601 by Europe and Canada

2013: Adoption of 3rd edition of IEC 60601 by USA

Quality System Regulation (Effective Date: June 1, 1997)

Subpart C -- Design Controls, § 820.30 Design controls. The need for human factors techniques or data in the design process is implicit in paragraphs c, f, and g of Section 820.3.

( c ) Design input: "Each manufacturer shall establish and maintain procedures to

ensure that the design requirements relating to a device are appropriate and

address the intended use of the device, including the needs of the users and

patient.”

( f ) Design verification: "Each manufacturer shall establish and maintain

procedures for verifying the design input. Design verification shall confirm that

the design output meets the design input requirements.”

( g ) Design validation:Design validation shall ensure that devices conform to

defined user needs and intended uses, and shall include testing of production

units under actual or simulated use conditions."

Key documents

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IEC 62366FDA’s Draft Guidance

Basic expectations

• Implement an HFE (UE) program

• Define intended users, use environments, potential hazards, potential use errors, and use-related risks

• Mitigate use-related risks

• Validate user interface designs, proving risk control measures work

• Document HFE activities and outcomes

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HFE Design History File (one example, partial, simplified)

• HFE program plan

• User profiles and use environment descriptions

• Function and task analysis

• Use-related hazard analysis

• Known problems analysis

• Use-related risk analysis (e.g., Use-FMEA); iterative

• User interface requirements

• Application specification, usability specification, and other documents (per IEC 62366)

• User interface design products (reflecting application of HFE principles)

• Formative evaluation plans and reports

• User interface verification report

• Summative usability test plan and report (to validate user interface)

• HFE Report

Standards apply to diverse medical devices

SAMPLE HFE TECHNIQUES AND END-PRODUCTS

Sample user profile: registered nurses

Nurse often multi-task, placing relatively heavy demand on their short-term memoryNurse often multi-task, placing relatively heavy demand on their short-term memory

Use environment description (sample)

Patient care areas might be brightly or dimly lit.Patient care areas might be brightly or dimly lit.

• “I’d like to be able to read the screen without a magnifying glass.”

• “The bG result should stand out from everything else. Make it big!”

• “You should be able to confirm the time and date so that you know the readings are being logged properly.”

• “The information labels don’t have to be as big.”

• “It shouldn’t have too few or too many controls. Too many controls would be intimidating.”

• “I want it to make a noise when I press a button so that I know it got my input.”

• “I want to know that the device is alive – awake – at all the times.”

• “Don’t let the screen time out too quickly.”

User needs – glucose meter

• Text (capital letters and numbers) shall be ≥14 point (5 mm).

• Blood glucose readout shall be ≥ 60 point (21 mm).

• Main screen shall include the time and date.

• Labels shall be visually subordinate to primary onscreen content.

• There shall be no more than 4 primary hardware controls used to navigate among screens.

• Device shall provide audible feedback in response to all button presses (user option).

• At least one visual element shall be constantly dynamic to indicate the display has not failed.

• Power-down screen after ≥ 2 minutes of inactivity.

Derived user requirements – glucose meter

Design concepts – glucose meter

Task analysis

Deconstruct an overall user interactions with a device into its myriad components: perceptions (P), cognitive processes (C), and actions (A). Yields: PCA analysis.

Sample flow diagram showing decisions and events

Source: http://www.pre-diabetes.com/wp-content/uploads/2012/02/9176220_s.jpg

Use errors derived from task analysis

• User inserts wrong test strip

• User inserts test strip in wrong orientation

• User inserts test strip in wrong port

• User damages test strip during handling

• User applies blood to wrong part of test strip

• User applies too much blood to test strip

• User applies too little blood to test strip

• User does not select re-test when prompted

• User does not remove used strip from meter

• User misreads the blood glucose readout

• User mistakes units of measure as mmol/L versus mg/dL

•

Sample risk mitigations

Advisory messageAudible feedbackClear instructionsColor codingConfirmation messageEmergency power cutoffFamiliar symbolLack of parting linesLarge labelInterlockNeedle guardNon-glare displayOrientation cue

Quick reference cardResistance forceSetting limitsShape codingSize codingSwitch coverTactile feedbackTextured gripTrainingWarning labelWarning lightWider pushbutton spacingCable/tube strain relief

Life of a use error

Life of a use error (continued)

Select a sample size (continued)

• Formative tests typically involve ≤12 participants, yielding excellent insights while preserving resources for additional tests.

• Summative tests typically involve either 15 participants per distinct user group, or 25 participants if the user population is relatively homogeneous (i.e., there is 1 distinct user group).

Operating room simulator

Hospital meeting room

Usability testing laboratory (at UL-Wiklund)

Sample use error report (abbreviated)

Did not attach needle securely

Task

5. Deliver 20 units of insulin.

Task priority

4 out of 16

Risk identifier(s)

Use-FMEA: Items 4.3, 16.1, 22.3

Potential harms

1 –Insulin underdose causes hyperglycemia. 2 – Needlestick injury causes pain and infection. 3 – Needle contamination causes local or systemic infection.

Occurrences

5 test participants committed this use error one or more times during 5 repeated injection trials. The use error occurred 8 times out of the 150 opportunities to err, yielding a use error rate of 5.3%.

Description

3 participants pressed the needle on to the injector but did not twist it to lock it in place. 2 participants initially twisted the needle to lock it in place, but then unlocked it when they removed the needle cap by means of a twisting rather than pulling motion.

Participant reported root causes

3 participants said they forgot to twist the needle to lock it in place. 2 participants speculated that they must have initially gripped the needle’s hub rather than the cap when removing the cap.

Root cause analysis

There is no visual feedback to distinguished a needle that is locked in place from one that is not. The needle cap gripping surface is adjacent to the needle gripping surface, making it vulnerable to unintended twisting during cap removal.

THE HFE REPORT

Excerpted from: Applying Human Factors and Usability Engineering to Optimize Medical Device Design

FDA’s guidance calls for an HFE/UE report

An HFE Report is like a court case.

•Opening statement about the manufacturer’s HFE efforts

•Presentation of HFE evidence and testimony (i.e., results of summative usability test)

•Closing argument that device is safe and effective

Analogy

HFE Report – Sections 1, 2, and 3

HFE Report – Sections 4, 5, and 6

HFE Report – Section 7

Device is adequately safe and effective for the intended users, its intended uses, and use environments.

Claim

BENEFITS AND COSTS

HFE benefits and costs

Benefits

•Faster time to market (regulatory approval)•Simpler user documentation and training•Increased sales related to better first impressions, ease of learning, and initial satisfaction•Reduced risk of recalls, products liability claims•Lower customer support demand•Extended marketability

Costs

•Possibly $250K-$500K for a moderately complex device

Return on investment (ROI)

•Could be the range of 5:1 to 10:1•ROI factors in the cost of lost sales due to a device’s comparatively poor usability, a reject submission to regulators, a recall, and a lawsuit.

Promise of a high ROI

HFE PRACTICE MODELS

Who takes the lead?

Initially:

•CEO (when inspired)

•Regulatory (when facing FDA pushback)

•Quality (when procedure driven)

Long-term:

•R&D (when properly integrated)

Briefly:

•Marketing (when seeking claims)

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Contracting for HFE services (outsourcing)

• HFE service broker (in-house)

• Engage consultants as needed

• Establish strategic relationship with a preferred HFE vendors

• Establish strategic relationship with multiple HFE vendors

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In-house capability (core competency)

• Establish a central HFE department that consults to project teams

• Embed HFE specialists within project teams

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CONCLUSION

Experience suggests…

• Today, HFE is a mandate rather than an option.

• HFE is cost-effective

• Existing staff can perform a substantial amount of HFE work, but specialists are needed at times

• HFE, if implemented in a timely manner, is not a paperwork exercise. It leads to better devices.

• HFE offers commercial advantages.

Contact information

UL – Wiklund R&D300 Baker Avenue, Suite 200

Concord, Massachusetts 01742 USA

Telephone: 001 (978) 371–2700

URL: www.ul.com/ul-hfe

Management team:

Michael WiklundGeneral Manager – Human Factors Engineering, E: [email protected]

Jonathan KendlerDesign Director – Human Factors Engineering, E: [email protected]

Allison StrochlicResearch Director – Human Factors Engineering, E: [email protected]

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