0. 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

1. 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”
“Clinical World”
Functional
Inputs
Functional
Outputs
Medical Benefit
Medical
Device
Time
Patient
Patient
User (Operator)

2. Environmental Disturbances
Focus on Patients
Risk Management takes the idealized functional input/output diagram and identifies potential problems:
“Engineering World”
“Clinical World”
Environmental Disturbances
Functional
Inputs
Functional
Outputs
Medical Benefit
Medical
Device
Time
Patient
Use Errors
Patient
Failure Modes
User (Operator)
Hazards
Harm
“Risk Management”

3. International Standard for Medical Device Risk Management
ISO 14971, 2nd edition:
Medical Devices – Application of Risk Management to Medical Devices (2007)
ISO is required by …
USA - Food and Drug Administration
European Union - Medical Device Directive 93/42/EEC

4. 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”
“Clinical World”
Environmental Disturbances
Functional
Inputs
Functional
Outputs
Medical Benefit
Medical
Device
Patient
Time
Patient User Other person
Use Errors
Patient User Other person
Failure Modes
User (Operator)
"Causes“
Hazards
Harm
“Risk Management”

5. Risk Acceptability criteria
Standardized Risk Matrix 3 1 9 2 5
High Risk
Medium Risk
Low Risk
Risk Management is a decision-making process

6. Standards that support Risk Management
Environmental disturbances
Functional Inputs
  
Medical Device
Functional Outputs
Patient, Medical Device Users, Other persons
Operator
  
“Usability Engineering” IEC 62366
“Equipment Safety” IEC
“Risk Management” ISO 14971

7. IEC , 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 Industry Challenges:
Standard is long and unwieldy
Some requirements are difficult to fully understand
Standard was recently amended (2012 July)

8. Risk Management Challenge
Complicated medical systems are:
Difficult to fully analyze
Not fully covered by safety standards

9. Summary
Risk Mgmt standard ISO ensures that medical device risks are acceptable
ISO is relatively straightforward and practical
Risk management can be difficult for complicated systems
“Equipment safety” standard IEC ensures that minimum equipment safety requirements are met
IEC is difficult to fully understand