In July 2001, the United States Joint Commission on Accreditation of Health care Organizations adopted a new leadership standard that requires department heads in health care organizations to perform at least one Failure Mode and Effects Analysis (FMEA) every year. This proactive approach to error prevention has proven to be highly effective in other industries, notably aerospace, but remains untested in acute care hospitals. For several reasons, the intensive care unit (ICU) potentially is an attractive setting for early adoption of FMEA; however, successful implementation of FMEA in ICUs is likely to require strong, effective leadership and a sustained commitment to prevent errors that may have occurred rarely or never before in the local setting. This article describes FMEA in relation to critical care medicine and reviews some of the attractive features together with several potential pitfalls that are associated with this approach to error prevention in ICUs.