Failure modes and effects analysis for ocular brachytherapy.

PURPOSE: The aim of the study was to identify potential failure modes (FMs) having a high risk and to improve our current quality management (QM) program in Collaborative Ocular Melanoma Study (COMS) ocular brachytherapy by undertaking a failure modes and effects analysis (FMEA) and a fault tree analysis (FTA). METHODS AND MATERIALS: Process mapping and FMEA were performed for COMS ocular brachytherapy. For all FMs identified in FMEA, risk priority numbers (RPNs) were determined by assigning and multiplying occurrence, severity, and lack of detectability values, each ranging from 1 to 10. FTA was performed for the major process that had the highest ranked FM. RESULTS: Twelve major processes, 121 sub-process steps, 188 potential FMs, and 209 possible causes were identified. For 188 FMs, RPN scores ranged from 1.0 to 236.1. The plaque assembly process had the highest ranked FM. The majority of FMs were attributable to human failure (85.6%), and medical physicist-related failures were the most numerous (58.9% of all causes). After FMEA, additional QM methods were included for the top 10 FMs and 6 FMs with severity values > 9.0. As a result, for these 16 FMs and the 5 major processes involved, quality control steps were increased from 8 (50%) to 15 (93.8%), and major processes having quality assurance steps were increased from 2 to 4. CONCLUSIONS: To reduce high risk in current clinical practice, we proposed QM methods. They mainly include a check or verification of procedures/steps and the use of checklists for both ophthalmology and radiation oncology staff, and intraoperative ultrasound-guided plaque positioning for ophthalmology staff.

Evaluation of impact of an external breast shield (FlexiShield) in electronic brachytherapy for breast IORT: A phantom study.

PURPOSE: To investigate Axxent (iCAD, Inc., San Jose, CA) electronic brachytherapy balloon deformation and its dosimetric impact because of an external flexible shield (FlexiShield [FS]; iCAD, Inc.). METHODS AND MATERIALS: Prostheses breast tissue phantom overlaid three spherical balloon applicators to simulate three clinical scenarios depending on minimum skin-to-balloon surface spacing (SS): balloon with SS of 2 cm, 1 cm, and balloon with 1 cm SS and touching the chest wall. Two sets of megavoltage CT (MVCT) scans were obtained with or without FS for 15 different sizes of balloons. For 45 pairs of MVCT scans, balloon deformation was measured in superior-inferior (dSI) dimension on coronal and sagittal planes and anterior-posterior (dAP) and lateral (dLAT) dimensions on the equatorial plane of balloon. SS was also compared. A treatment plan was made on each MVCT scan. Doses at four balloon surface points and skin were compared. Conformity index value was also compared to evaluate three-dimensional dose distribution. Clinically, 20 Gy was prescribed to the surface of balloon. RESULTS: Balloon deformation was observed with compression in SI and AP dimensions and expansion in lateral dimension. Average SI compression was 0.5 mm. Average dLat - dAP was 2.4 mm, which resulted in elevated point doses at AP dimension by 10.8% of prescribed dose and reduced point doses at lateral dimension by 4.6%. FS decreased SS by 1.8 mm, increasing skin dose by 1.2 Gy, on average. Conformity index value was decreased from 0.922 to 0.908, on average. CONCLUSIONS: This phantom study demonstrates that use of skin shielding during breast intraoperative radiation therapy can cause balloon deformation and SS reduction, resulting in dosimetric changes that are disregarded in current practice.