Module 16 2024

17/10/2024

The basics of risk evaluation

• The most used method of risk evaluation is the risk matrix

• Risk matrices can be used to assess design, manufacturing, usability and clinical hazards

• Each hazard is assigned a severity and occurrence value

• The severity and occurrence values are multiplied to produce a Risk Priority Number (RPN)

• The magnitude of the RPN is graded to determine if the risk is within acceptable limits

• Risk reduction methods are employed to minimize the likelihood of occurrence

• The RPN is recalculated based on the risk reduction methods employed

• All risks should be reduced As Low as Possible (ALAP)

• ISO14971 is the applicable harmonized standard

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The basics of risk evaluation

Scenario #1:

A Deep Brain Electrode used to record EEG (electroencephalogram) signals for localizing the area of the brain causing epileptic seizures has been reported to have an open circuit contact and a signal cannot be captured from that contact. The electrodes have 16 contacts each and 10 electrodes are implanted in the patient's brain during the localization procedure (160 separate contacts). Over the last year 1000 electrodes have been sold, treating 100 patients (10 electrodes per patient) and there have been 10 reported cases of open-circuit contacts.

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