Presentation: Medical Device Risk Management

Report
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 Patients
Manufacturer’s viewpoint
The intended use/purpose of a medical device can be depicted using an
idealized functional input/output diagram:
“Engineering World”
Functional
Inputs
Functional
Outputs
Medical
Device
User (Operator)
“Clinical World”
Medical Benefit
Time
Patient
Patient
Focus on Patients
Risk Management takes the idealized functional input/output diagram and
identifies potential problems:
“Engineering World”
Functional
Inputs
Environmental
Disturbances
“Clinical World”
Functional
Outputs
Medical Benefit
Medical
Device
Use Errors
Time
Patient
Failure Modes
Patient
User (Operator)
Hazards
“Risk Management”
Harm
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 Hazards
In addition to patients, Risk Management also focuses on medical device
users and other people who are exposed to hazards
If the medical benefit outweighs the risks (associated with harm) then the
device is considered suitable for commercialization
“Engineering World”
Functional
Inputs
Environmental
Disturbances
“Clinical World”
Functional
Outputs
Medical Benefit
Patient
Medical
Device
Use Errors
Time
User (Operator)
"Causes“
Patient
User
Other person
Patient
User
Other person
Failure Modes
Hazards
“Risk Management”
Harm
Risk Acceptability criteria
PROBABILITY of
OCCURRENCE of HARM
Standardized Risk Matrix
High
O5
Moderate
O4
Low
O3
Remote
O2
Negligible
O1
3
1
9
High Risk
3
2
Medium Risk
Low Risk
5
S0
S1
S2
S3
S4
S5
None
Limited
Temporary or
Reversible
Intervention
Required
Permanent
Impairment
Death
SEVERITY of HARM
Risk Management is a
decision-making process
Standards that support Risk Management
Environmental
disturbances
Functional
Inputs
  
Medical Device
Operator
  
Functional
Outputs
Patient,
Medical Device Users,
Other persons
“Usability Engineering”
“Equipment Safety”
“Risk Management”
IEC 62366
IEC 60601-1
ISO 14971
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)
1.
Risk Management Challenge
Complicated 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
1.

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