Session Item

Intraoperative electron radiotherapy (IOERT) is a technique enabling to deliver a high dose of ionizing radiation in a single session directly to the surgically exposed organ or tumor bed with the use of a mobile accelerator. Due to the specific features of the treatment procedure using an intraoperative accelerator compared to a conventional linear accelerator or performing only tumor resection, it is necessary to develop a dedicated risk analysis and management program. The purpose of this study was to develop risk management recommendations for IOERT that would apply to three types of accelerators.

Two types of accelerators for IOERT are currently used clinically in Poland (Mobetron, IntraOp and Novac11, Sordina), while the third (IntralineIOERT, HITEC ZdAJ) built by the National Centre for Nuclear Research in Poland, is being prepared for clinical use. In intraoperative radiotherapy procedure, actions are taken that are not taken in radiotherapy carried out using conventional therapeutic devices or only performing tumor resection operations. These differences mean that for intraoperative therapy a detailed risk analysis is necessary. Irradiation using that method can be performed only at a specific time, associated with the surgery, which significantly affects the existing risks. From the various methods presented in the literature, the authors of this study focused on the FMEA (Failure Mode and Effects Analysis) method. It is often used due to its universality and possibility of use for various cases of risk analysis. The method consists in establishing the causal relationships of errors in various processes, successively eliminating sources of errors and minimizing the risk associated with them

The authors divided the study into several parts required by ISO 1497; 2012 and ISO 31000; 2009. First, the identification of hazards was discussed, then attention was paid to the possibilities of risk assessment, and ended with a description of how to document and manage risk. As part of the case study, the authors noticed unique, distinctive risks that do not occur when working in the operating room, but are related only to the IOERT procedure. An example may be mechanical damage to both equipment and people in the operating room by a moving device or inability to carry out the procedure in the absence of cooling, or or exposure of persons to radiation.

It was possible to propose risk management stages, as well as a way of documenting the risk management procedure, for a specific therapeutic method which is IOERT therapy using mobile accelerators.