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Title: SU-G-TeP4-05: An Evaluation of a Low Dose Rate (LDR) Prostate Brachytherapy Procedure Using a Failure Modes and Effects Analysis (FMEA)

Abstract

Purpose: The aim of the study is the application of a Failure Modes and Effects Analysis (FMEA) to access the risks for patients undergoing a Low Dose Rate (LDR) Prostate Brachytherapy Treatment. Methods: FMEA was applied to identify all the sub processes involved in the stages of identifying patient, source handling, treatment preparation, treatment delivery, and post treatment. These processes characterize the radiation treatment associated with LDR Prostate Brachytherapy. The potential failure modes together with their causes and effects were identified and ranked in order of their importance. Three indexes were assigned for each failure mode: the occurrence rating (O), the severity rating (S), and the detection rating (D). A ten-point scale was used to score each category, ten being the number indicating most severe, most frequent, and least detectable failure mode, respectively. The risk probability number (RPN) was calculated as a product of the three attributes: RPN = O X S x D. The analysis was carried out by a working group (WG) at UPMC. Results: The total of 56 failure modes were identified including 32 modes before the treatment, 13 modes during the treatment, and 11 modes after the treatment. In addition to the protocols already adopted inmore » the clinical practice, the prioritized risk management will be implanted to the high risk procedures on the basis of RPN score. Conclusion: The effectiveness of the FMEA method was established. The FMEA methodology provides a structured and detailed assessment method for the risk analysis of the LDR Prostate Brachytherapy Procedure and can be applied to other radiation treatment modes.« less

Authors:
;  [1]
  1. University of Pittsburgh Medical Center, Pittsburgh, PA (United States)
Publication Date:
OSTI Identifier:
22649468
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; BRACHYTHERAPY; DOSE RATES; HAZARDS; PROSTATE; RATS; RISK ASSESSMENT

Citation Formats

Cheong, S-K, and Kim, J. SU-G-TeP4-05: An Evaluation of a Low Dose Rate (LDR) Prostate Brachytherapy Procedure Using a Failure Modes and Effects Analysis (FMEA). United States: N. p., 2016. Web. doi:10.1118/1.4957130.
Cheong, S-K, & Kim, J. SU-G-TeP4-05: An Evaluation of a Low Dose Rate (LDR) Prostate Brachytherapy Procedure Using a Failure Modes and Effects Analysis (FMEA). United States. doi:10.1118/1.4957130.
Cheong, S-K, and Kim, J. 2016. "SU-G-TeP4-05: An Evaluation of a Low Dose Rate (LDR) Prostate Brachytherapy Procedure Using a Failure Modes and Effects Analysis (FMEA)". United States. doi:10.1118/1.4957130.
@article{osti_22649468,
title = {SU-G-TeP4-05: An Evaluation of a Low Dose Rate (LDR) Prostate Brachytherapy Procedure Using a Failure Modes and Effects Analysis (FMEA)},
author = {Cheong, S-K and Kim, J},
abstractNote = {Purpose: The aim of the study is the application of a Failure Modes and Effects Analysis (FMEA) to access the risks for patients undergoing a Low Dose Rate (LDR) Prostate Brachytherapy Treatment. Methods: FMEA was applied to identify all the sub processes involved in the stages of identifying patient, source handling, treatment preparation, treatment delivery, and post treatment. These processes characterize the radiation treatment associated with LDR Prostate Brachytherapy. The potential failure modes together with their causes and effects were identified and ranked in order of their importance. Three indexes were assigned for each failure mode: the occurrence rating (O), the severity rating (S), and the detection rating (D). A ten-point scale was used to score each category, ten being the number indicating most severe, most frequent, and least detectable failure mode, respectively. The risk probability number (RPN) was calculated as a product of the three attributes: RPN = O X S x D. The analysis was carried out by a working group (WG) at UPMC. Results: The total of 56 failure modes were identified including 32 modes before the treatment, 13 modes during the treatment, and 11 modes after the treatment. In addition to the protocols already adopted in the clinical practice, the prioritized risk management will be implanted to the high risk procedures on the basis of RPN score. Conclusion: The effectiveness of the FMEA method was established. The FMEA methodology provides a structured and detailed assessment method for the risk analysis of the LDR Prostate Brachytherapy Procedure and can be applied to other radiation treatment modes.},
doi = {10.1118/1.4957130},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
  • Purpose: To perform a failure mode and effects analysis (FMEA) of the process for treating superficial skin cancers with the Xoft Axxent electronic brachytherapy (eBx) system, given the recent introduction of expanded quality control (QC) initiatives at our institution. Methods: A process map was developed listing all steps in superficial treatments with Xoft eBx, from the initial patient consult to the completion of the treatment course. The process map guided the FMEA to identify the failure modes for each step in the treatment workflow and assign Risk Priority Numbers (RPN), calculated as the product of the failure mode’s probability ofmore » occurrence (O), severity (S) and lack of detectability (D). FMEA was done with and without the inclusion of recent QC initiatives such as increased staffing, physics oversight, standardized source calibration, treatment planning and documentation. The failure modes with the highest RPNs were identified and contrasted before and after introduction of the QC initiatives. Results: Based on the FMEA, the failure modes with the highest RPN were related to source calibration, treatment planning, and patient setup/treatment delivery (Fig. 1). The introduction of additional physics oversight, standardized planning and safety initiatives such as checklists and time-outs reduced the RPNs of these failure modes. High-risk failure modes that could be mitigated with improved hardware and software interlocks were identified. Conclusion: The FMEA analysis identified the steps in the treatment process presenting the highest risk. The introduction of enhanced QC initiatives mitigated the risk of some of these failure modes by decreasing their probability of occurrence and increasing their detectability. This analysis demonstrates the importance of well-designed QC policies, procedures and oversight in a Xoft eBx programme for treatment of superficial skin cancers. Unresolved high risk failure modes highlight the need for non-procedural quality initiatives such as improved planning software and more robust hardware interlock systems.« less
  • Purpose: The effectiveness of using a combination of three sources, {sup 60}Co, {sup 192}Ir and {sup 169}Yb, is analyzed. Different combinations are compared against a single {sup 192}Ir source on prostate cancer cases. A novel inverse planning interior point algorithm is developed in-house to generate the treatment plans. Methods: Thirteen prostate cancer patients are separated into two groups: Group A includes eight patients with the prostate as target volume, while group B consists of four patients with a boost nodule inside the prostate that is assigned 150% of the prescription dose. The mean target volume is 35.7±9.3cc and 30.6±8.5cc formore » groups A and B, respectively. All patients are treated with each source individually, then with paired sources, and finally with all three sources. To compare the results, boost volume V150 and D90, urethra Dmax and D10, and rectum Dmax and V80 are evaluated. For fair comparison, all plans are normalized to a uniform V100=100. Results: Overall, double- and triple-source plans were better than single-source plans. The triple-source plans resulted in an average decrease of 21.7% and 1.5% in urethra Dmax and D10, respectively, and 8.0% and 0.8% in rectum Dmax and V80, respectively, for group A. For group B, boost volume V150 and D90 increased by 4.7% and 3.0%, respectively, while keeping similar dose delivered to the urethra and rectum. {sup 60}Co and {sup 192}Ir produced better plans than their counterparts in the double-source category, whereas {sup 60}Co produced more favorable results than the remaining individual sources. Conclusion: This study demonstrates the potential advantage of using a combination of two or three sources, reflected in dose reduction to organs-at-risk and more conformal dose to the target. three sources, reflected in dose reduction to organs-at-risk and more conformal dose to the target. Our results show that {sup 60}Co, {sup 192}Ir and {sup 169}Yb produce the best plans when used simultaneously and can thus be an alternative to {sup 192}Ir-only in high-dose-rate prostate brachytherapy.« less
  • Purpose: To perform a failure modes and effects analysis (FMEA) study for Gamma Knife (GK) radiosurgery processes at our institution based on our experience with the treatment of more than 13,000 patients. Methods: A team consisting of medical physicists, nurses, radiation oncologists, neurosurgeons at the University of Pittsburgh Medical Center and an external physicist expert was formed for the FMEA study. A process tree and a failure mode table were created for the GK procedures using the Leksell GK Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detectionmore » (D) for failure modes were assigned to each failure mode by each professional on a scale from 1 to 10. The risk priority number (RPN) for each failure mode was then calculated (RPN = OxSxD) as the average scores from all data sets collected. Results: The established process tree for GK radiosurgery consists of 10 sub-processes and 53 steps, including a sub-process for frame placement and 11 steps that are directly related to the frame-based nature of the GK radiosurgery. Out of the 86 failure modes identified, 40 failure modes are GK specific, caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the GK helmets and plugs, and the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, overlooked target areas, inaccurate previous treatment information and excessive patient movement during MRI scan. Conclusion: The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process.« less
  • Purpose: We have been treating localized prostate cancer with high-dose-rate (HDR) brachytherapy combined with hypofractionated external beam radiation therapy (EBRT) at our institution. We recently reported the existence of a correlation between the severity of acute genitourinary (GU) toxicity and the urethral radiation dose in HDR brachytherapy by using different fractionation schema. The purpose of this study was to evaluate the role of the urethral dose in the development of acute GU toxicity more closely than in previous studies. For this purpose, we conducted an analysis of patients who had undergone HDR brachytherapy with a fixed fractionation schema combined withmore » hypofractionated EBRT. Methods and Materials: Among the patients with localized prostate cancer who were treated by 192-iridium HDR brachytherapy combined with hypofractionated EBRT at Gunma University Hospital between August 2000 and November 2004, we analyzed 67 patients who were treated by HDR brachytherapy with the fractionation schema of 9 Gy x two times combined with hypofractionated EBRT. Hypofractionated EBRT was administered at a fraction dose of 3 Gy three times weekly, and a total dose of 51 Gy was delivered to the prostate gland and seminal vesicles using the four-field technique. No elective pelvic irradiation was performed. After the completion of EBRT, all the patients additionally received transrectal ultrasonography-guided HDR brachytherapy. The planning target volume was defined as the prostate gland with a 5-mm margin all around, and the planning was conducted based on computed tomography images. The tumor stage was T1c in 13 patients, T2 in 31 patients, and T3 in 23 patients. The Gleason score was 2-6 in 12 patients, 7 in 34 patients, and 8-10 in 21 patients. Androgen ablation was performed in all the patients. The median follow-up duration was 11 months (range 3-24 months). The toxicities were graded based on the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer toxicity criteria. Results: The main symptoms of acute GU toxicity were dysuria and increase in the urinary frequency or nocturia. The grade distribution of acute GU toxicity in the patients was as follows: Grade 0-1, 42 patients (63%); Grade 2-3, 25 patients (37%). The urethral dose in HDR brachytherapy was determined using the following dose-volume histogram (DVH) parameters: V30 (percentage of the urethral volume receiving 30% of the prescribed radiation dose), V80, V90, V100, V110, V120, V130, and V150. In addition, the D5 (dose covering 5% of the urethral volume), D10, D20, and D50 of the urethra were also estimated. The V30-V150 values in the patients with Grade 2-3 acute GU toxicity were significantly higher than those in patients with Grade 0-1 toxicity. The D10 and D20, but not D5 and D50, values were also significantly higher in the patients with Grade 2-3 acute GU toxicity than in those with Grade 0-1 toxicity. Regarding the influence of the number of needles implanted, there was no correlation between the number of needles implanted and the severity of acute GU toxicity or the V30-V150 values and D5-D50 values. Conclusions: It was concluded that HDR brachytherapy combined with hypofractionated EBRT is feasible for localized prostate cancer, when considered from the viewpoint of acute toxicity. However, because the urethral dose was closely associated with the grade of severity of the acute GU toxicity, the urethral dose in HDR brachytherapy must be kept low to reduce the severity of acute GU toxicity.« less
  • Purpose: To evaluate the severity of genitourinary (GU) toxicity in high-dose-rate (HDR) brachytherapy combined with hypofractionated external beam radiotherapy (EBRT) for prostate cancer and to explore factors that might affect the severity of GU toxicity. Methods and Materials: A total of 100 Japanese men with prostate cancer underwent {sup 192}Ir HDR brachytherapy combined with hypofractionated EBRT. Mean (SD) dose to 90% of the planning target volume was 6.3 (0.7) Gy per fraction of HDR. After 5 fractions of HDR treatment, EBRT with 10 fractions of 3 Gy was administrated. The urethral volume receiving 1-15 Gy per fraction in HDR brachytherapymore » (V1-V15) and the dose to at least 5-100% of urethral volume in HDR brachytherapy (D5-D100) were compared between patients with Grade 3 toxicity and those with Grade 0-2 toxicity. Prostate volume, patient age, and International Prostate Symptom Score were also compared between the two groups. Results: Of the 100 patients, 6 displayed Grade 3 acute GU toxicity, and 12 displayed Grade 3 late GU toxicity. Regarding acute GU toxicity, values of V1, V2, V3, and V4 were significantly higher in patients with Grade 3 toxicity than in those with Grade 0-2 toxicity. Regarding late GU toxicity, values of D70, D80, V12, and V13 were significantly higher in patients with Grade 3 toxicity than in those with Grade 0-2 toxicity. Conclusions: The severity of GU toxicity in HDR brachytherapy combined with hypofractionated EBRT for prostate cancer was relatively high. The volume of prostatic urethra was associated with grade of acute GU toxicity, and urethral dose was associated with grade of late GU toxicity.« less