Failure Mode and Effects Analysis (FMEA) Description of FMEA

As applied to the healthcare industry, "Failure Modes and Effects Analysis" (FMEA) is a proactive process for assessing risks of patient injury by anticipating possible system failures and prioritizing them (Davis, Riley, Gurses, Miller, & Hansen, 2008, p. 1). Rather than reviewing a past incident of failure, FMEA teams focus on processes and ask, "How could these systems fail?" (Davis, Riley, Gurses, Miller, & Hansen, 2008, p. 1). Originally developed in 1949 by the U.S. Military (V. Bulletin Solutions, Inc., 2011) and then adopted by the business world, FMEA consists of 2 types of analysis:

Process FMEA, which assumes that the product works and examines the process for possible defects and their possible effects;

b. Design FMEA, which assumes that the process works and examines the product for possible defects and their possible effects (Reiling, Knutzen, & Stoecklein, 2003).

FMEA's Usefulness to Improve Healthcare Organizations in the Context of Risk Management

According to the Institute of Medicine's comprehensive report, "To Err Is Human," avoidable medical errors annually kill 44,000-98,000 hospital patients (Reiling, Knutzen, & Stoecklein, 2003). Consequently, anticipating and eliminating those avoidable medical errors is a high priority in healthcare and the generally-described advantages of FMEA are attractive. Also, due to the various functions performed within a healthcare organization, the "inter-disciplinary team" approach is the ideal (Smith, 2007). Drawing on the expertise of members from different departments/professions...

The advantages of the inter-disciplinary FMEA team in healthcare are significant: it uses the combined knowledge of the inter-disciplinary team; it enhances the process' quality, reliability and safety; it employs a logical, methodical process for determining areas of concern; it lowers the cost and time involved in the process; it provides documentary bases and tracking for the team's activities; it assists the healthcare organization in pinpointing Critical-To-Quality aspects; it sets a starting point for comparison and creates historical documentation; it enhances patient safety and satisfaction with the healthcare organization (Smith, 2007, p. 2).
In its original non-medical business forms, FMEA is admittedly too complex for healthcare organizations (Reiling, Knutzen, & Stoecklein, 2003). However, in a 2001-2002 pilot program, St. Joseph's Community Hospital in West Bend, WI teamed with American Society for Quality, an expert from General Motors and architecture / construction representatives. That interdisciplinary team modified FMEA, simplifying and tailoring the system to the healthcare profession by, for example, reducing FMEA's complex numerical scoring system to a far simpler system of low, medium or high risk of potential failure (Reiling, Knutzen, & Stoecklein, 2003). Consequently, it is possible to use an integrated, simplified FMEA hybrid that speaks to the healthcare industries' unique needs and systems.

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