Affiliations: [a] Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy | [b] Innovation and Planning Area, Head Management, Florence Teaching Hospital AOU-Careggi, Florence, Italy
Correspondence:
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Corresponding author: Francesco Frosini, Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy. E-mail:francesco.frosini@unifi.it
Abstract: OBJECTIVES: The following study proposes and tests an integrated
methodology involving Health Technology Assessment (HTA) and Failure Modes,
Effects and Criticality Analysis (FMECA) for the assessment of specific
aspects related to robotic surgery involving safety, process and technology. METHODS: The integrated methodology consists of the application of
specific techniques coming from the HTA joined to the aid of the most
typical models from reliability engineering such as FMEA/FMECA. The study
has also included in-site data collection and interviews to medical
personnel. RESULTS: The total number of robotic procedures included in the
analysis was 44: 28 for urology and 16 for general surgery. The main
outcomes refer to the comparative evaluation between robotic, laparoscopic
and open surgery. Risk analysis and mitigation interventions come from FMECA
application. CONCLUSIONS: The small sample size available for the study
represents an important bias, especially for the clinical outcomes
reliability. Despite this, the study seems to confirm the better trend for
robotics' surgical times with comparison to the open technique as well as
confirming the robotics' clinical benefits in urology. More complex
situation is observed for general surgery, where robotics' clinical benefits
directly measured are the lowest blood transfusion rate.
