SAPERO: a new tool for safety analyses in advanced radiotherapy

Abstract

Improving safety standards in advanced radiotherapy technologies, where historical experience is not sufficient due to innovation aspects, raises the need to perform studies using new tools that follow a holistic view of the process chain. Such studies are useful to identify additional critical elements compared to safety analyses carried out by classic tools. In this field, SAPERO (La SicurezzA del PazientE: tecniche avanzate ed innovative per la valutazione del rischio di eventi indesiderati all’interno del percorso assistenziale nel settore RadioterapicO) is a new assessment tool that allows to use integrated of Hierarchical Task Analysis (HTA); Failure Mode Effects and Criticality Analysis (FMECA); Cognitive Task Analysis (CTA); Human Error Assessment Reduction Technique (HEART). The methodological approaches have been suitably modified to address their operating in the medical sector under study. Some improvements have concerned the application of the fuzzy theory in FMECA and the use of a linguistic approach in HEART. In this paper, SAPERO application on a case study related to treatment procedures in helical tomotherapy performed at the radiotherapy department of ARNAS Civico hospital, Italy, is described. The results have allowed to provide suggestions aimed to improve the examined process.