Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery
| Autor: | Fabrizio Dori, Roberto Miniati, Andrea Belardinelli, Guido Biffi Gentili, Saverio Grillone, Francesco Frosini |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Computer science Process (engineering) 030232 urology & nephrology Biomedical Engineering Biophysics Urology Health Informatics Bioengineering Biomaterials 03 medical and health sciences 0302 clinical medicine Risk analysis (business) medicine Humans Robotic surgery Reliability (statistics) Data collection business.industry General surgery Health technology Reproducibility of Results Robotics Equipment Design Failure mode effects and criticality analysis 030220 oncology & carcinogenesis General Surgery Urologic Surgical Procedures Laparoscopy Artificial intelligence business Information Systems |
| Zdroj: | Technology and health care : official journal of the European Society for Engineering and Medicine. 24(6) |
| ISSN: | 1878-7401 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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