To ensure the consistency of medical assessments, Medical Safety decides and establishes the criteria for a complaint. This is necessary because there are different treatment and risk profiles within a medical diagnosis. For example, a report of Endophthalmitis is a serious event. But how is the severity of a bacterial infection determined? A bacterial infection of the central cornea with a positive culture for pseudomonas has a greater severity than a bacterial infection of the conjunctiva without corneal involvement. By having a criterion, Medical Safety classifies complaints accurately and consistently. The criterion helps in the evaluation of cases with limited information. For example, reports of “chemical burn” would be considered more serious than reports of “irritation.” By establishing adverse event reporting criteria, Medical Safety effectively evaluates complaints in a consistent manner. This increases the reliability of complaint trends and analysis and helps medical safety monitor the safety profile of products. At pre-established time intervals, Medical Safety compares complaints and post-market sales to identify trends in complaint reporting and combinations of unexpected product events. Medical Safety does this using statistical and descriptive analyses. Three examples of reporting and trending methods that can be used include: Empirical Bayes Geometric Mean (EBGM), U-Chart,
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