Upload
troy-landay
View
219
Download
0
Tags:
Embed Size (px)
Citation preview
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