Medical Device Risk Management: Practical Overview & Challenges

Aruna Ranaweera, PhD

Corporate Process Owner – Design Controls & Risk Management

Stryker Corporation

October 2, 2012 – San Francisco, CA

Focus on PatientsManufacturer’s viewpoint

The intended use/purpose of a medical device can be depicted using an idealized functional input/output diagram:

MedicalDevice

Patient

User (Operator)

FunctionalInputs

FunctionalOutputs

Patient

Medical Benefit

Time

“Engineering World” “Clinical World”

Focus on Patients

Risk Management takes the idealized functional input/output diagram and identifies potential problems:

MedicalDevice

Patient

User (Operator)

FunctionalInputs

FunctionalOutputs

Patient

Medical Benefit

Time

“Engineering World” “Clinical World”

Environmental Disturbances

Use Errors

Hazards Harm

Failure Modes

“Risk Management”

International Standard for Medical Device Risk Management

ISO 14971, 2nd edition:

Medical Devices – Application of Risk Management to Medical Devices (2007)

ISO 14971 is required by …

USA - Food and Drug Administration

European Union - Medical Device Directive 93/42/EEC

People Exposed to HazardsIn addition to patients, Risk Management also focuses on medical device users and other people who are exposed to hazards

MedicalDevice

Patient User Other person

User (Operator)

FunctionalInputs

FunctionalOutputs

Time

“Engineering World” “Clinical World”

Environmental Disturbances

Use Errors

Hazards Harm

Failure Modes

"Causes“

“Risk Management”

If the medical benefit outweighs the risks (associated with harm) then the device is considered suitable for commercialization

Patient User Other person

Patient

Medical Benefit

Risk Acceptability criteria

Standardized Risk Matrix

O5

O4

O3

O2

O1S0 S1 S3 S4 S5

None LimitedIntervention

RequiredPermanentImpairment

Death

S2

Temporary orReversible

SEVERITY of HARM

PROB

ABILI

TY o

f OC

CURR

ENCE

of H

ARM

High

Moderate

Low

Remote

Negligible

High Risk

Medium Risk

Low Risk

Risk Management is a decision-making process

3 1

9 3 2

5

Standards that support Risk Management

“Equipment Safety”IEC 60601-1

“Risk Management”ISO 14971

Medical Device

Functional Inputs

Functional Outputs

OperatorPatient,

Medical Device Users, Other persons

“Usability Engineering”IEC 62366

Environmental disturbances

IEC 60601-1, 3rd edition (2005)

Ensures that devices meets minimum safety requirements, but does not address all risks

Requires a robust Risk Management process per ISO 14971

IEC 60601-1 Industry Challenges:

1. Standard is long and unwieldy

2. Some requirements are difficult to fully understand

3. Standard was recently amended (2012 July)

Risk Management ChallengeComplicated medical systems are:

1. Difficult to fully analyze

2. Not fully covered by safety standards

Summary

Risk Mgmt standard ISO 14971 ensures that medical device risks are acceptable

• ISO 14971 is relatively straightforward and practical

• Risk management can be difficult for complicated systems

“Equipment safety” standard IEC 60601-1 ensures that minimum equipment safety requirements are met

• IEC 60601-1 is difficult to fully understand