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.