title: Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Frosini
authors.affiliation: Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Miniati
authors.affiliation: Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy.
authors.forename: Saverio
authors.initials: S
authors.lastname: Grillone
authors.affiliation: Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Dori
authors.affiliation: Department of Information Engineering, School of Engineering, University of Florence, Florence, Italy.
authors.forename: Guido Biffi
authors.initials: GB
authors.lastname: Gentili
authors.affiliation: Innovation and Planning Area, Head Management, Florence Teaching Hospital AOU-Careggi, Florence, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Belardinelli
mesh_terms: D004867:Equipment Design / Q000592:standards*; D013502:General Surgery / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000295:instrumentation* / Q000379:methods; D015203:Reproducibility of Results; D012371:Robotics / Q000295:instrumentation* / Q000379:methods / Q000592:standards*; D013520:Urologic Surgical Procedures / Q000295:instrumentation* / Q000379:methods*
keywords: FMECA; HTA; Robotic surgery