1. FMECA Failure Mode Effects Criticality Analysis Systematic & proactive approach to preventing failures before they occur Completed prior to implementation of a new system, or redesign of a system in early stage of development Systems or processes already in place.

2. FMECA not so new Used in high risk industries like aerospace (since 1960’s), chemical processing, nuclear, and airline industries Added to JC standards in 2001 requiring healthcare organizations to proactively address patient safety using system safety tools like FMEA Used in Healthcare to focus on what could go wrong, before it does

3. Various Adaptations for Healthcare Many variations available for use in complex systems like Healthcare Simple fill in the blank templates like “QI Macros” are available I have no financial interest in this product or company

4. Components of FMECA Identify known or potential failures Analyze the way the process/sub process can fail or the manner in which the failure occurs (failure mode) Determine effect of the failure mode Estimate severity & probability of each mode/effect combination Evaluate how to reduce/eliminate risk of failure

5. Getting Started Select a project of common interest or severity, one that will be supported by leadership (resource heavy) Select team specifically designated for the project, cross-functional & multidisciplinary, and disband after project completed Designate impartial facilitator

6. Determine boundaries for the project Flowchart or review how existing product/process works if applicable Brainstorm potential failure modes – determining all the ways each process/sub process could fail Identify potential causes of each failure mode List potential effects of each failure mode on the patient Assign Risk Codes (RPI) for each potential failure-mode effect combination

7. Develop Actions or Countermeasures to reduce risk Re-assign Risk Codes if/after implementation of countermeasures Assign responsibility for actions Re-assess for “slippage”

8. Example of FMECA Patient to ED at unknown hospital requires rapid sequence intubation post MVA Medication given Patient’s secretions clog filter No alarms heard RN hears gurgling sound and responds Patient rescued