Module 16 2022

05/09/2022

Risk

Benefit

Example  Vaginal Mesh 2000  Considered a great solution for pelvic organ prolapse.  However throughout

the 2000’s data began to demonstrate more and more corrective surgeries leading to life changing issues demonstrated worse than other therapeutic alternatives

 Further data

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Risk estimation

Risk control measures verified

Lifecycle Phase

Severity becomes clearer due to involvement of clinical specialists and more knowledge

Able to evaluate the severity of harm if available information relates to the device or characteristic

Design Development Pre-production Clinical investigation Commercialisation Production Transportation Storage Installation Use

Cannot estimate how likely it is to occur but can at least foresee hazards and from evaluation of data know potential frequencies

Estimates made based upon the strength of your control. Coupled with verification you should now be able to predict the likelihood of occurrence

about your design and intended use

Post market surveillance plan

Reprocessing Maintenance Repair

Considers the risks, residual risks and the quantitative assessments about likelihood and severity. The data and sources are established to inform the clinical evaluation, PMCF and post-production information

Risk 1

Probability = 1 in 10,000

Product changes Decommissioning Disposal

PMS Plan

Time

Signal detections, trending & post-production information

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