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Status Included in Release
Created by David McElroy
Created on Aug 27, 2018

Failure Mode Effects Analysis (FMEA) within Healthcare Product

Implement the HFMEA within the healthcare product

A five-step process is used by interdisciplinary teams to proactively evaluate a health care process. Specifically designed for use by health care professionals, the process offers users analytical tools such as flow diagramming, decision trees, and prioritized scoring systems. The tools enable the user to proactively identify vulnerabilities and deal with them effectively.

The process streamlines hazard analysis steps found in a traditional Failure Mode and Effect Analysis procedure — an analytical process often used by engineers to identify potential failures of individual components and subsystems.

HFMEA includes health care-specific definitions for severity, probability, and detectability. It is a systematic engineering-based approach used to identify system vulnerabilities and correct problems before they occur.

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