Failure Mode and Effects Analysis FMEA

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 within the healthcare organizations and developing those members into FMEA leaders, the FMEA team can examine every element of every system within the healthcare organization for possible errors and defects. 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.

3. FMEA's possible impact on preventing sentinel events

As of March 31, 2010, the ten most frequently reported sentinel events within U.S. healthcare organizations are: "wrong site surgery; suicide; operative/post-operative complication; delay in treatment; medical error; patient fall; unintended retention of a foreign body; assault, rape or homicide; perinatal death or loss of function; patient death or injury in restraints" (HealthLeaders Media, 2010). Choosing a couple examples of FMEA's possible impact on sentinel events: wrong site surgery can be reduced by examining surgical scheduling for potential failures and refining scheduling to avoid those failures, while treatment delays can be reduced by examining treatment scheduling and staffing within and among different departments for possible problems and refining those systems to avoid those problems. Interdisciplinary-team input, examination, foresight and refinement of a healthcare organization's systems is clearly effective in anticipating and avoiding sentinel incidents.