human factors in medical device design.pdf

HUMAN FACTORS IN

MEDICAL DEVICE DESIGN

Michael Sheedy

SIMULATION AS A TOOL

Disclosure

Human Factors Engineering Definition

“application of knowledge about human behaviour, abilities, limitations, and

other characteristics related to the design of tools, devices, systems, tasks,

jobs, and environments to achieve adequate USABILITY” [ISO 62366:2007]

Also known as Usability Engineering

Human Factors in Design

Procedures

Physical Barriers

Information

Decisions

Poor Protocols

Faulty Equipment

Missing Information

Inadequate Supervision

Patient

Harmed

Human Factors and

Design Medical Devices

Purchasing Advice

Use Medical Devices

Simulation

Exploring the possiblities

“Being forced to confront the prospect of failure head-on – to study it, dissect it, tear apart all its components and consequences – really works.”

Human Factors Considerations

Food and Drug Administration. (2011). Applying Human Factors and Usability Engineering to Optimize Medical Device Design.

Draft Guidance for Industry and Food and Drug Administration Staff.

Identify Users

Engage all Stakeholders

Staff

Patients

Public

Involve them early on in design

User characteristics (e.g., functional capabilities, attitudes and behaviours)

that could impact the safe and effective use of the device

Ways in which users might use the device that could cause harm

USERS

NHS. (2010). Lessons from high hazard industries for healthcare. National Reporting and Learning Service Full Report.

Every User is Different

Elephant Path

USE ENVIRONMENT

CDHB Cardboard Hospital

Hardware Components

Switches, buttons and knobs

Information

Indicators, displays and alarms

Size

Labelling

User Manuals

DEVICE / INTERFACE

Food and Drug Administration. (2011). Applying Human Factors and Usability Engineering to Optimize Medical Device Design.

Draft Guidance for Industry and Food and Drug Administration Staff.

Information Perception

Where it goes wrong

Systems Approach

1. Cafazzo, J. A., & Olivier, S. (2012). Human Factors in Patient Safety: From Discovery to Design: The Evolution of Human Factors in Healthcare.

Healthcare Quarterly, 15 (1).

2. Dekker, S. (2011). Patient Safety: A Human Factors Approach. CRC Press.

“Tapestry of Strategies”

Substitution Myth

Technology removes error?

Creates new human work

1

2

Iterative Formative Evaluations

Evaluation using Simulation

Availability of the situation

Accessibility

Analysis

Heuristic Analysis

Failure Mode & Effects Analysis(FMEA)

Human Factors for Health Technology Safety: Evaluating & Improving the use of Health Technology in the Real World. Cassano-Piche, A. et. al.

Function and Task Analysis

Food and Drug Administration. (2011). Applying Human Factors and Usability Engineering to Optimize Medical Device Design.

Draft Guidance for Industry and Food and Drug Administration Staff.

Equipment Procurement

Pre-purchase evaluation

Identify Human Factors Problems

Tailor training to correct

Pat Baird, “Incident Data: Filling the Gaps, Identifying the Value, and Prioritizing Needed Information.” Presentation at the AAMI/FDA Infusion Device Summit, Oct. 6, 2010.

Why is it important?

Tracey-Jane Havill-Nelson

http://www.stuff.co.nz/national/health/10418956/IV-line-kills-woman-in-Christchurch

“IV line kills woman in Christchurch”

Central Venous Access Device

CVAD Changes

Images: Dr Hamish Gray

Recap

Users

Environment

Device/Interface

Reduce the risk of harm - Increased Patient Safety

“Making it easy to do the right thing.”

[Bromiley 2010]

Simulation is useful in all parts of the process

Acknowledgements

Shona McMillan

Dr Maggie Meeks

Chris Beasley

Dr Hamish Gray