Developing Medical Software: Pitfalls and Prophylactics. Elliot Jaffe Seminar in Computer Assisted-Surgery, Medical Robots and Medical Imaging Fall 2002. Outline. Why should you be worried? Case Study: Therac-25 US Government Guidelines. What? Me worry?.
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Seminar in Computer Assisted-Surgery, Medical Robots and Medical Imaging
Linac: North Oakland Medical Center
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Simplified fault tree diagram for an infusion pump
FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
Subsystem/Name: DC motor P = Probabilities (chance) of Occurrences
Model Year/Vehicle(s): 2000/DC motor S = Seriousness of Failure to the Vehicle
D = Likelihood that the Defect will Reach the customer
R = Risk Priority Measure (P x S x D)
1 = very low or none 2 = low or minor
3 = moderate or significant 4 = high 5 = very high or catastrophic