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Use of failure modes, effects, and criticality analysis to compare the vulnerabilities of laparoscopic versus open
Edoardo Guida1, Ubaldo Rosati, Alessio Pini Prato
1From the *Pediatric Surgery Department, Giannina Gaslini Institute, University of Genoa; †Quality Control Office, Giannina Gaslini Institute; and ‡DINOGMI, Pediatric Department, Giannina Gaslini Institute, University of Genoa, Genoa, Italy.
Purpose:
To measure the feasibility of using FMECA applied to the surgery and then compare the vulnerabilities of laparoscopic versus open appendectomy by using FMECA.
Methods:
The FMECA study was performed on each single selected phase of appendectomy and on complication-related data during the period January 1, 2009, to December 31, 2010. The risk analysis phase was completed by evaluation of the criticality index (CI) of each appendectomy-related failure mode (FM). The CI is calculated by multiplying the estimated frequency of occurrence (O) of the FM, by the expected severity of the injury to the patient (S), and the detectability (D) of the FM.
Results:
In the first year of analysis (2009), 177 appendectomies were performed, 110 open and 67 laparoscopic. Eleven adverse events were related to the open appendectomy: 1 bleeding (CI: 8) and 10 postoperative infections (CI: 32). Three adverse events related to the laparoscopic approach were recorded: 1 postoperative infection (CI: 8) and 2 incorrect extractions of the appendix through the umbilical port (CI: 6). In the second year of analysis (2010), 158 appendectomies were performed, 69 open and 89 laparoscopic. Four adverse events were related to the open appendectomy: 1 incorrect management of the histological specimen (CI: 2), 1 dehiscence of the surgical wound (CI: 6), and 2 infections (CI: 6). No adverse events were recorded in laparoscopic approach.
Conclusion:
FMECA helped the staff compare the 2 approaches through an accurate step-by-step analysis, highlighting that laparoscopic appendectomy is feasible and safe, associated with a lower incidence of infection and other complications, reduced length of hospital stay, and an apparent lower procedure-related risk.
Insights
Failure Mode, Effects, and Criticality Analysis (FMECA) demonstrated laparoscopic appendectomy is safer than open surgery. This risk analysis showed fewer complications and a lower overall risk for the laparoscopic approach.
Area of Science:
- Surgical Risk Assessment
- Medical Device Safety
- Quality Improvement in Healthcare
Background:
- Appendectomy is a common surgical procedure with potential complications.
- Comparing surgical approaches is crucial for patient safety and outcomes.
- Risk assessment methodologies can identify vulnerabilities in surgical procedures.
Purpose of the Study:
- To assess the feasibility of applying Failure Mode, Effects, and Criticality Analysis (FMECA) to appendectomy.
- To compare the surgical risks and vulnerabilities between laparoscopic and open appendectomy using FMECA.
Main Methods:
- FMECA was applied to distinct phases of appendectomy procedures.
- Complication data from January 2009 to December 2010 were analyzed.
- Criticality Index (CI) was calculated for each failure mode (FM) based on Occurrence (O), Severity (S), and Detectability (D).
Main Results:
- In 2009, open appendectomy had 11 adverse events (e.g., bleeding, infection), while laparoscopic had 3 (infection, incorrect extraction).
- In 2010, open appendectomy had 4 adverse events (e.g., wound dehiscence, infection), with no adverse events reported for laparoscopic appendectomy.
- Laparoscopic appendectomy demonstrated a lower Criticality Index for adverse events compared to open appendectomy.
Conclusions:
- FMECA provides a robust method for comparing surgical approaches.
- Laparoscopic appendectomy is a feasible and safe alternative to open appendectomy.
- The laparoscopic approach is associated with a reduced incidence of complications, shorter hospital stays, and lower overall procedure-related risk.
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