Generally, failure scenarios can be prioritized by the severity of each hazard. At this stage, there is often insufficient detail to evaluate hazard likelihood accurately. However, comparisons may be made with similar devices and their histories in the medical device reports. An evaluation revealing severe hazard potential may prompt a radical change in the conceptual design. There is considerable flexibility at this early design stage.
Major changes can make the device inherently safer at minimal cost.
For example, if use of a chemical was determined to be a significant hazard, other less-toxic chemicals or a diluted form of the original chemical might be a reasonable mitigating measure. During prototype development, more detailed hazard and risk analysis can be performed. At this stage of design, process and mechanical drawings are available, and the basic process operations have been defined. For example, the transfer of 100 ml of saline solution from a bulk container to a blending container could be one step of the process for preparation of intravenous solutions. Less None Reverse Part of As well as Other than Table I. Guide words used to determine deviations from design intent.