Dataset Information

Failure mode and effects analysis (FMEA) to enhance the safety and efficiency of Gamma Knife radiosurgery.

ABSTRACT: This risk analysis describes our Failure Mode and Effects Analysis (FMEA) for Gamma Knife stereotactic radiosurgery at our community hospital. During bi-monthly meetings over 5 months, our FMEA team mapped a detailed Gamma Knife process tree and identified potential failure modes, each were scored a Risk Priority Number (RPN) for severity, occurrence, detectability. In our process tree of 14 subprocesses and 177 steps, we identified 31 potential failure modes: 7 high scoring (RPN o150) and 3 modes (<150) selected by clinicians for mitigation strategies. Eighteen months later, rescoring of high-risk failure modes showed significant reduction in RPN scores, thus confirming the benefit of our FMEA mitigation strategies. Our study provides a roadmap to achieve high-quality Gamma Knife radiosurgery that can be utilized by new centers as a starting point for their quality management program. Five quality control documents were developed that can be customized by any Gamma Knife center.

SUBMITTER: Warnick RE

PROVIDER: S-EPMC7717097 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Failure mode and effects analysis (FMEA) to enhance the safety and efficiency of Gamma Knife radiosurgery.

Warnick Ronald E RE Lusk Amy R AR Thaman John J JJ Levick Elizabeth H EH Seitz Andrew D AD

Journal of radiosurgery and SBRT 20200101 2

This risk analysis describes our Failure Mode and Effects Analysis (FMEA) for Gamma Knife stereotactic radiosurgery at our community hospital. During bi-monthly meetings over 5 months, our FMEA team mapped a detailed Gamma Knife process tree and identified potential failure modes, each were scored a Risk Priority Number (RPN) for severity, occurrence, detectability. In our process tree of 14 subprocesses and 177 steps, we identified 31 potential failure modes: 7 high scoring (RPN o150) and 3 mod ...[more]

PMID: 33282465

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Project description:The Leksell GammaPlan software version 10 introduces a CT image-based segmentation tool for automatic skull definition and a convolution dose calculation algorithm for tissue inhomogeneity correction. The purpose of this work was to evaluate the impact of these new approaches on routine clinical Gamma Knife treatment planning. Sixty-five patients who underwent CT image-guided Gamma Knife radiosurgeries at the University of Pittsburgh Medical Center in recent years were retrospectively investigated. The diagnoses for these cases include trigeminal neuralgia, meningioma, acoustic neuroma, AVM, glioma, and benign and metastatic brain tumors. Dose calculations were performed for each patient with the same dose prescriptions and the same shot arrangements using three different approaches: 1) TMR 10 dose calculation with imaging skull definition; 2) convolution dose calculation with imaging skull definition; 3) TMR 10 dose calculation with conventional measurement-based skull definition. For each treatment matrix, the total treatment time, the target coverage index, the selectivity index, the gradient index, and a set of dose statistics parameters were compared between the three calculations. The dose statistics parameters investigated include the prescription isodose volume, the 12 Gy isodose volume, the minimum, maximum and mean doses on the treatment targets, and the critical structures under consideration. The difference between the convolution and the TMR 10 dose calculations for the 104 treatment matrices were found to vary with the patient anatomy, location of the treatment shots, and the tissue inhomogeneities around the treatment target. An average difference of 8.4% was observed for the total treatment times between the convolution and the TMR algorithms. The maximum differences in the treatment times, the prescription isodose volumes, the 12 Gy isodose volumes, the target coverage indices, the selectivity indices, and the gradient indices from the convolution and the TMR 10 calculations are 14.9%, 16.4%, 11.1%, 16.8, 6.9%, and 11.4%, respectively. The maximum differences in the minimum and the mean target doses between the two calculation algorithms are 8.1% and 4.2% of the corresponding prescription doses. The maximum differences in the maximum and the mean doses for the critical structures between the two calculation algorithms are 1.3 Gy and 0.7 Gy. The results from the two skull definition methods with the TMR 10 algorithm agree either within ± 2.5% or 0.3 Gy for the dose values, except for a 4.9% difference in the treatment times for a lower cerebellar lesion. The imaging skull definition method does not affect Gamma Knife dose calculation considerably when compared to the conventional measurement-based skull definition method, except in some extreme cases. Large differences were observed between the TMR 10 and the convolution calculation method for the same dose prescription and the same shot arrangements, indicating that the implementation of the convolution algorithm in routine clinical use might be desirable for optimal dose calculation results.

Project description:BACKGROUND:Gamma Knife radiosurgery (GKRS; Elekta AB) remains a well-established treatment modality for vestibular schwannomas. Despite highly effective tumor control, further research is needed toward optimizing long-term functional outcomes. Whereas dose-rate effects may impact post-treatment toxicities given tissue dose-response relationships, potential effects remain largely unexplored. OBJECTIVE:To evaluate treatment outcomes and potential dose-rate effects following definitive GKRS for vestibular schwannomas. METHODS:We retrospectively reviewed 419 patients treated at our institution between 1998 and 2015, characterizing baseline demographics, pretreatment symptoms, and GKRS parameters. The cohort was divided into 2 dose-rate groups based on the median value (2.675 Gy/min). Outcomes included clinical tumor control, radiographic progression-free survival, serviceable hearing preservation, hearing loss, and facial nerve dysfunction (FND). Prognostic factors were assessed using Cox regression. RESULTS:The study cohort included 227 patients with available follow-up. Following GKRS 2-yr and 4-yr clinical tumor control rates were 98% (95% CI: 95.6%-100%) and 96% (95% CI: 91.4%-99.6%), respectively. Among 177 patients with available radiographic follow-up, 2-yr and 4-yr radiographic progression-free survival rates were 97% (95% CI: 94.0%-100.0%) and 88% (95% CI: 81.2%-95.0%). The serviceable hearing preservation rate was 72.2% among patients with baseline Gardner-Robertson class I/II hearing and post-treatment audiological evaluations. Most patients experienced effective relief from prior headaches (94.7%), tinnitus (83.7%), balance issues (62.7%), FND (90.0%), and trigeminal nerve dysfunction (79.2%), but not hearing loss (1.0%). Whereas GKRS provided effective tumor control independently of dose rate, GKRS patients exposed to lower dose rates experienced significantly better freedom from post-treatment hearing loss and FND (P = .044). CONCLUSION:Whereas GKRS provides excellent tumor control and effective symptomatic relief for vestibular schwannomas, dose-rate effects may impact post-treatment functional outcomes. Further research remains warranted.

Dataset Information

Failure mode and effects analysis (FMEA) to enhance the safety and efficiency of Gamma Knife radiosurgery.

Publications

Failure mode and effects analysis (FMEA) to enhance the safety and efficiency of Gamma Knife radiosurgery.

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