When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

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Challenge

High volume of data... and differing opinions.

A client's product is utilized on critically ill patients in intensive care units. As a result, comorbidities and adverse events during the use of the device are inevitable. There were more than a thousand customer complaints and hundreds of serious adverse events reported to public databases for the subject device and comparative devices. Notified body findings on the previous clinical evaluation reports and internal conflict over the requirements added to the confusion.

Solution

Creating a common language across data sources.

The R&Q team worked to collate and link the reported events with the published literature and internal risk assessments. Each report needed to be examined and dissected to determine where the risks were from the device and where they were a natural consequence of the patient condition. Collating the data under a common language allowed the R&Q team to focus on the most safetycritical areas of the product's performance. Working with the clinical and regulatory groups of the client, each of the issues identified by the notified body was dissected and solutions were reached based on the most current regulatory guidance.

Results

Conclusive report showed benefits greater than risks.

The final report showed the linkage between accepted clinical research, the internal risk assessment, customer feedback, CAPAs, recalls, and publicly reported adverse events. The overall conclusion was that the benefit the device provided outweighed the potential risks of the device and no postmarket clinical followup was required. The client clinical representative was able to approve the report.

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