When looking at new designs, equipment or technology, it is helpful to use a failure-mode effects analysis (FMEA) to determine how to mitigate or eliminate risk factors. FMEA is a step-by-step approach that identifies possible failure modes in products, design, manufacturing or service.
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Failure is any defect that can cause harm or potential harm to a patient and modes are the way in which the failure can occur. Effects analysis studies the consequences of those failure modes. FMEAs are proactive methods of identifying failure modes.
Once potential failures are identified, they are prioritized according to likelihood and severity. For example, high severity/low likelihood would be lower priority than high severity/high likelihood. The purpose of the FMEA is to take actions to reduce failures that are high priorities.
An FMEA is most helpful when a process, product or service is being redesigned or designed in a new way; utilizing an existing process or product in a new way or in a modified way; or periodically throughout the life of the process, service or product.