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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. Medical Device Risk Management: Practical Overview & Challenges. Focus on Patients.

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Medical Device Risk Management: Practical Overview & Challenges

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  1. Aruna Ranaweera, PhD Corporate Process Owner – Design Controls & Risk Management Stryker Corporation October 2, 2012 – San Francisco, CA Medical Device Risk Management: Practical Overview & Challenges

  2. Focus on Patients Manufacturer’s viewpointThe 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)

  3. 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 Patient Use Errors Failure Modes User (Operator) Harm Hazards “Risk Management”

  4. 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

  5. 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 Patient User Other person Use Errors Failure Modes User (Operator) Harm Hazards "Causes“ “Risk Management”

  6. Risk Acceptability criteria Standardized Risk Matrix Risk Management is a decision-making process

  7. Standards that support Risk Management Environmental disturbances    Functional Inputs Medical Device Patient,Medical Device Users, Other persons Functional Outputs Operator    “Usability Engineering”IEC 62366 “Risk Management”ISO 14971 “Equipment Safety”IEC 60601-1

  8. 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: • Standard is long and unwieldy • Some requirements are difficult to fully understand • Standard was recently amended (2012 July)

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

  10. 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

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