Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability.

BACKGROUND AND PURPOSE: Industrial companies use failure mode and effect analysis (FMEA) to improve quality. Our objective was to describe an FMEA and subsequent interventions for an automated intraoperative electron radiotherapy (IOERT) procedure with computed tomography simulation, pre-planning, and a fixed conventional linear accelerator. MATERIAL AND METHODS: A process map, an FMEA, and a fault tree analysis are reported. The equipment considered was the radiance treatment planning system (TPS), the Elekta Precise linac, and TN-502RDM-H metal-oxide-semiconductor-field-effect transistor in vivo dosimeters. Computerized order-entry and treatment-automation were also analyzed. RESULTS: Fifty-seven potential modes and effects were identified and classified into 'treatment cancellation' and 'delivering an unintended dose'. They were graded from 'inconvenience' or 'suboptimal treatment' to 'total cancellation' or 'potentially wrong' or 'very wrong administered dose', although these latter effects were never experienced. Risk priority numbers (RPNs) ranged from 3 to 324 and totaled 4804. After interventions such as double checking, interlocking, automation, and structural changes the final total RPN was reduced to 1320. CONCLUSIONS: FMEA is crucial for prioritizing risk-reduction interventions. In a semi-surgical procedure like IOERT double checking has the potential to reduce risk and improve quality. Interlocks and automation should also be implemented to increase the safety of the procedure.

The accuracy of EGSnrc, Geant4 and PENELOPE Monte Carlo systems for the simulation of electron scatter in external beam radiotherapy.

Three widely used Monte Carlo systems were benchmarked against recently published measurements of the angular distribution of 13 MeV and 20 MeV electrons scattered from foils of different atomic numbers and thicknesses. Source and geometry were simulated in detail to calculate electron fluence profiles 118.2 cm from the exit window. Results were compared to the measured fluence profiles and the characteristic angle where the fluence drops to 1/e of its maximum value. EGSnrc and PENELOPE results, on average, agreed with measurement within 1 standard deviation experimental uncertainty, with EGSnrc estimating slightly lower scatter than measurement and PENELOPE slightly higher scatter. Geant4.9.2 overestimated the characteristic angle for the lower atomic number foils by as much as 10%. Retuning of the scatter distributions in Geant4 led to a much better agreement with measurement, close to that achieved with the other codes. The 3% differences from measurement seen with all codes for at least some of the foils would result in clinically significant errors in the fluence profiles (2%/4 mm), given accurate knowledge of the electron source and treatment head geometry used in radiotherapy. Further improvement in simulation accuracy is needed to achieve 1%/1 mm agreement with measurement for the full range of beam energies, foil atomic number and thickness used in radiotherapy. EGSnrc would achieve this accuracy with an increase in thickness of the mylar sheets in the monitor chamber, PENELOPE with a decrease in thickness.