Clearly, the improved benefit outweighed the risk, and the device was ultimately cleared for use by FDA. The benefit was that the mortality rate was 70% without the use of the device. This risk was considered unacceptable until measured against the benefit. One of the dramatic examples of the use of risk-benefit evaluation was the original mechanical heart, which had an associated mortality rate of 40% when it was used. It would be up to regulators to ask the question, but you should not move product forward if the benefit does not outweigh the risk or until further risk reduction could be made. The product should not be put on the market if the benefit does not outweigh the risk in a documented benefit-risk analysis. The requirement of controlling risk allowed the use of “benefit” as an alternative method of releasing a product when a residual risk was evaluated as “unacceptable.” Residual risk is that risk remaining after risk controls are applied, so, in this case, all possible risk controls were applied, and the residual risk still could not reach acceptable levels. The Evolution Of The Terms “Benefit” And “Risk” In ISO 14971ĭiscussion of the term “benefit” first appeared in the first edition of ISO 14971, which appeared in 2000. The second article covered production and post-production information. The first article in this series covered the risk acceptability criteria and policy. Few changes in the process resulted, but this article covers the change in the process for benefit-risk covered in Clause 8 of the standard. The standard and the technical report were reorganized and clarifications of the concepts of medical device risk management were included in the two documents. This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance on the medical device risk management standard.
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