Failure Mode and Effect Analysis

The Detroit Medical Center (DMC) in Michigan has successfully used FMEA to identify and mitigate a number of patient safety issues throughout its health system. One such endeavor was initiated as a result of a nationally publicized event concerning “gaps” in the recall process involving Olympus bronchoscopes at a major teaching hospital. The failure of a recall notice to be delivered from a teaching hospital’s loading dock area to the clinical areas where the bronchoscopes were used on patients led to contaminated bronchoscope use in patients and subsequent nosocomial infection. Prompted by this report and the potential for use of recalled equipment and drugs in patients if the recall process fails, Tammy S. Lundstrom, M.D., and associated staff at DMC prioritized their current recall process for FMEA. DMC’s “recall-FMEA” is based on internal near-miss data and/or events that have been reported in the media from throughout the United States or from other event databases, such as JCAHO Sentinel Event Alerts or Institute for Safe Medication Practices.

DMC’s recall-FMEA team is composed of staff from stakeholder departments, including logistics, pharmacy, operating room, invasive procedure areas, materials management, environment of care, epidemiology, purchasing, and respiratory therapy. A core group was chosen to perform the actual FMEA with input from affected areas. Criteria considered for inclusion in the recall-FMEA team included:

  • People who have experience with the recall process;

  • People who regularly perform steps in the recall process;

  • People who have no experience with the process (a reality check);

  • A subject matter expert (procurement personnel in charge of recall process);

  • Quality department facilitator.

DMC gathered relevant information related to the recall process, including current internal procedures/policies/guidelines related to recalls, a search for any external or professional society guidelines and best practices, development of a professional organization resource list, and interviews of key staff and departments regarding the current process.

Next, DMC developed a process flow chart. Because the recall process itself is such a huge undertaking, the team narrowed the scope of the FMEA to include only that part of the process related to internal departmental responses to recall notices, with the understanding that once this FMEA was completed, the scope would be expanded. Likely failure modes were identi-

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