A Systems Engineering Approach to Risk Management

Wed, Sept 30 | 8:45 a.m.–10:00 a.m.

Jason Amaral VP, Program Management and Systems Engineering

Thoratec Corporation

© 2015 Association for the Advancement of Medical Instrumentation www.aami.org

Thoratec HeartMate II LVAS Components

Why add a Systems Engineering

Approach?

Approaches are systemic

“HFE areas of special importance relate to …the role of humans in complex systems…”

“…to enable the early identification of hazards and hazardous situations in complex medical devices and systems…”

“…increasingly, medical devices are being combined with other equipment … to create systems...”

complex

pacemaker

Dimensions of complexity

Diverse Users

Multiple Environ-ments

Various Times

Different Geo-

graphies

Tech Eco-

System

OR ICU

clinic home

hotel

car plane

day night

summer winter

alone crowds

outside bathroom

submerged

dry

cold

hot

US

Europe

foreign language electrical voltage

developing country

Canada

Asia time zones to doctor

ICD infusion pump consumer electronics

ventilator

pool

altitude

snow

industrial equipment

asleep

caregiver

cardiologist

patient

nurse

friend

TSA agents

stranger

bio tech EMT

surgeon

anxious

dark

intimacy

weekend

noise

duration of support

Complexity

children

primary doctor

VAD coordinator

spouse

police firemen

vacation

pets

restaurant poor sight

arthritis

hearing

school

literacy

education

weight height

rain

EMI glare

train

dusty

medicated

happy

holiday

standards of care replacement parts unreliable power (outage)

humidity

with caregiver

exercising

help line operator grandchild 911 horseback

bike

nursing home

Mexico

RV

elderly

international waters (cruise)

lightning

church

work

wireless communications

morning city/rural

laser

oxygenator

CRT

acute cv support

EP

dialysis

cath lab

packaging and transit

daylight savings time

beach

motorcycle

Divide and conquer Electrical Engineering Mechanical Engineering Ergonomics

Cord Capture Clip Visual Task Workstations

ANSI/AAMI HE75: Human factors engineering – Design of medical devices 60601-1: Medical Electrical Equipment

Analyze system elements

?

Emergent system properties

Water droplet blue Fir0002/Flagstaffotos

Dependence on environment

Snowflakes by Wilson Bentley, 1902.

Safety is emergent

Rainy Day Textures valleysinthevinyl.com

Summary • A systemic approach is implicit in guidelines…

– …but complexity creates implementation challenges • “Divide and conquer” makes the work tractable…

– … but can miss emergent safety risks • Systems engineering provides key tools to support

a holistic approach, such as – Focus on interfaces and interdependencies – Consideration of diverse users, environments, use

cases, and system components – Evaluation of dynamic change and human/machine

controls – Architecture and appropriate system decomposition – TRLs and appropriate program timeline commitments – Configuration management and system integration