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Medical Device Risk Management: Practical Overview & Challenges Aruna Ranaweera, PhD Corporate Process Owner – Design Controls & Risk Management Stryker.

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Presentation on theme: "Medical Device Risk Management: Practical Overview & Challenges Aruna Ranaweera, PhD Corporate Process Owner – Design Controls & Risk Management Stryker."— Presentation transcript:

1 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

2 Focus on Patients Manufacturers viewpoint The intended use/purpose of a medical device can be depicted using an idealized functional input/output diagram: Medical Device Medical Device Patient User (Operator) Functional Inputs Functional Outputs Patient Medical Benefit Time Engineering World Clinical World

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

4 International Standard for Medical Device Risk Management ISO 14971, 2 nd 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

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 Medical Device Medical Device Patient User Other person User (Operator) Functional Inputs Functional Outputs 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

6 Risk Acceptability criteria Standardized Risk Matrix High Risk Medium Risk Low Risk Risk Management is a decision-making process

7 Standards that support Risk Management Equipment Safety IEC Risk Management ISO Medical Device Functional Inputs Functional Outputs Operator Patient, Medical Device Users, Other persons Usability Engineering IEC Environmental disturbances

8 IEC , 3 rd edition (2005) Ensures that devices meets minimum safety requirements, but does not address all risks Requires a robust Risk Management process per ISO IEC Industry Challenges: 1.Standard is long and unwieldy 2.Some requirements are difficult to fully understand 3.Standard was recently amended (2012 July)

9 Risk Management Challenge Complicated medical systems are: 1.Difficult to fully analyze 2.Not fully covered by safety standards

10 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


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