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Title: WE-H-BRC-03: Failure Mode and Effects Analysis in the First Clinical Implementation of a Novel Stereotactic Breast Radiotherapy Device: GammaPod™

Abstract

Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of higher than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planningmore » with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.« less

Authors:
; ; ; ; ; ;  [1];  [2];  [1];  [3]
  1. University of Maryland School of Medicine, Baltimore, MD (United States)
  2. Xcision Medical Systems, Rockville, MD (United States)
  3. (United States)
Publication Date:
OSTI Identifier:
22617039
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; ALIGNMENT; FAILURES; HAZARDS; IMAGES; MAMMARY GLANDS; NEOPLASMS; PLANNING; QUALITY ASSURANCE; RADIOTHERAPY; RISK ASSESSMENT; SIMULATION

Citation Formats

Mossahebi, S, Feigenberg, S, Nichols, E, Becker, S, Prado, K, Yi, B, Mutaf, Y, Niu, Y, Yu, C, and Xcision Medical Systems, Rockville, MD. WE-H-BRC-03: Failure Mode and Effects Analysis in the First Clinical Implementation of a Novel Stereotactic Breast Radiotherapy Device: GammaPod™. United States: N. p., 2016. Web. doi:10.1118/1.4957981.
Mossahebi, S, Feigenberg, S, Nichols, E, Becker, S, Prado, K, Yi, B, Mutaf, Y, Niu, Y, Yu, C, & Xcision Medical Systems, Rockville, MD. WE-H-BRC-03: Failure Mode and Effects Analysis in the First Clinical Implementation of a Novel Stereotactic Breast Radiotherapy Device: GammaPod™. United States. doi:10.1118/1.4957981.
Mossahebi, S, Feigenberg, S, Nichols, E, Becker, S, Prado, K, Yi, B, Mutaf, Y, Niu, Y, Yu, C, and Xcision Medical Systems, Rockville, MD. 2016. "WE-H-BRC-03: Failure Mode and Effects Analysis in the First Clinical Implementation of a Novel Stereotactic Breast Radiotherapy Device: GammaPod™". United States. doi:10.1118/1.4957981.
@article{osti_22617039,
title = {WE-H-BRC-03: Failure Mode and Effects Analysis in the First Clinical Implementation of a Novel Stereotactic Breast Radiotherapy Device: GammaPod™},
author = {Mossahebi, S and Feigenberg, S and Nichols, E and Becker, S and Prado, K and Yi, B and Mutaf, Y and Niu, Y and Yu, C and Xcision Medical Systems, Rockville, MD},
abstractNote = {Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of higher than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.},
doi = {10.1118/1.4957981},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
  • Purpose: A dedicated stereotactic gamma irradiation device, the GammaPod Trade-Mark-Sign from Xcision Medical Systems, was developed specifically to treat small breast cancers. This study presents the first evaluation of dosimetric and geometric characteristics from the initial prototype installed at University of Maryland Radiation Oncology Department. Methods: The GammaPod Trade-Mark-Sign stereotactic radiotherapy device is an assembly of a hemi-spherical source carrier containing 36 {sup 60}Co sources, a tungsten collimator, a dynamically controlled patient support table, and the breast immobilization system which also functions as a stereotactic frame. The source carrier contains the sources in six columns spaced longitudinally at 60 Degree-Signmore » intervals and it rotates together with the variable-size collimator to form 36 noncoplanar, concentric arcs focused at the isocenter. The patient support table enables motion in three dimensions to position the patient tumor at the focal point of the irradiation. The table moves continuously in three cardinal dimensions during treatment to provide dynamic shaping of the dose distribution. The breast is immobilized using a breast cup applying a small negative pressure, where the immobilization cup is embedded with fiducials also functioning as the stereotactic frame for the breast. Geometric and dosimetric evaluations of the system as well as a protocol for absorbed dose calibration are provided. Dosimetric verifications of dynamically delivered patient plans are performed for seven patients using radiochromic films in hypothetical preop, postop, and target-in-target treatment scenarios. Results: Loaded with 36 {sup 60}Co sources with cumulative activity of 4320 Ci, the prototype GammaPod Trade-Mark-Sign unit delivers 5.31 Gy/min at the isocenter using the largest 2.5 cm diameter collimator. Due to the noncoplanar beam arrangement and dynamic dose shaping features, the GammaPod Trade-Mark-Sign device is found to deliver uniform doses to targets with good conformity. The spatial accuracy of the device to locate the radiation isocenter is determined to be less than 1 mm. Single shot profiles with 2.5 cm collimator are measured with radiochromic film and found to be in good agreement with respect to the Monte Carlo based calculations (congruence of FWHM less than 1 mm). Dosimetric verifications corresponding to all hypothetical treatment plans corresponding to three target scenarios for each of the seven patients demonstrated good agreement with gamma index pass rates of better than 97% (99.0%{+-} 0.7%). Conclusions: Dosimetric evaluation of the first GammaPod Trade-Mark-Sign stereotactic breast radiotherapy unit was performed and the dosimetric and spatial accuracy of this novel technology is found to be feasible with respect to clinical radiotherapy standards. The observed level of agreement between the treatment planning system calculations and dosimetric measurements has confirmed that the system can deliver highly complex treatment plans with remarkable geometric and dosimetric accuracy.« less
  • Purpose: This paper introduces a new external beam radiotherapy device named GammaPod that is dedicated for stereotactic radiotherapy of breast cancer. Methods: The design goal of the GammaPod as a dedicated system for treating breast cancer is the ability to deliver ablative doses with sharp gradients under stereotactic image guidance. Stereotactic localization of the breast is achieved by a vacuum-assisted breast immobilization cup with built-in stereotactic frame. Highly focused radiation is achieved at the isocenter due to the cross-firing from 36 radiation arcs generated by rotating 36 individual Cobalt-60 beams. The dedicated treatment planning system optimizes an optimal path ofmore » the focal spot using an optimization algorithm borrowed from computational geometry such that the target can be covered by 90%-95% of the prescription dose and the doses to surrounding tissues are minimized. The treatment plan is intended to be delivered with continuous motion of the treatment couch. In this paper the authors described in detail the gamma radiation unit, stereotactic localization of the breast, and the treatment planning system of the GammaPod system. Results: A prototype GammaPod system was installed at University of Maryland Medical Center and has gone through a thorough functional, geometric, and dosimetric testing. The mechanical and functional performances of the system all meet the functional specifications. Conclusions: An image-guided breast stereotactic radiotherapy device, named GammaPod, has been developed to deliver highly focused and localized doses to a target in the breast under stereotactic image guidance. It is envisioned that the GammaPod technology has the potential to significantly shorten radiation treatments and even eliminate surgery by ablating the tumor and sterilizing the tumor bed simultaneously.« less
  • Purpose: The first GammaPod™ unit, a dedicated prone stereotactic treatment device for early stage breast cancer, has been installed and commissioned at University of Maryland School of Medicine. The objective of this study was to investigate potential dosimetric impact of inaccurate breast contour. Methods: In GammaPod treatments, patient’s beast is immobilized by a breast cup device (BCID) throughout the entire same-day imaging and treatment procedure. 28 different BICD sizes are available to accommodate patients with varying breast sizes. A mild suction helps breast tissue to conform to the shape of the cup with selected size. In treatment planning, dose calculationmore » utilizes previously calculated dose distributions for available cup geometry rather than the breast shape from CT image. Patient CT images with breast cups indicate minor geometric discrepancy between the matched shape of the cup and the breast contour, i.e., the contour size is larger or smaller. In order to investigate the dosimetric impact of these discrepancies, we simulated such discrepancies and reassessed the dose to target as well as skin. Results: In vicinity of skin, hot/cold spots were found when matched cup size was smaller/larger than patient’s breast after comparing the corrected dose profiles from Monte Carlo simulation with the planned dose from TPS. The overdosing/underdosing of target could yield point dose differences as large as 5% due to these setup errors (D95 changes within 2.5%). Maximal skin dose was overestimated/underestimated up to 25%/45% when matched cup size was larger/smaller than real breast contour. Conclusion: The dosimetric evaluation suggests substantial underdosing/overdosing with inaccurate cup geometry during planning, which is acceptable for current clinical trial. Further studies are needed to evaluate such impact to treating small volume close to skin.« less
  • Purpose: To improve the safety and efficiency of a new stereotactic radiosurgery program with the application of failure mode and effects analysis (FMEA) performed by a multidisciplinary team of health care professionals. Methods and Materials: Representatives included physicists, therapists, dosimetrists, oncologists, and administrators. A detailed process tree was created from an initial high-level process tree to facilitate the identification of possible failure modes. Group members were asked to determine failure modes that they considered to be the highest risk before scoring failure modes. Risk priority numbers (RPNs) were determined by each group member individually and then averaged. Results: A totalmore » of 99 failure modes were identified. The 5 failure modes with an RPN above 150 were further analyzed to attempt to reduce these RPNs. Only 1 of the initial items that the group presumed to be high-risk (magnetic resonance imaging laterality reversed) was ranked in these top 5 items. New process controls were put in place to reduce the severity, occurrence, and detectability scores for all of the top 5 failure modes. Conclusions: FMEA is a valuable team activity that can assist in the creation or restructuring of a quality assurance program with the aim of improved safety, quality, and efficiency. Performing the FMEA helped group members to see how they fit into the bigger picture of the program, and it served to reduce biases and preconceived notions about which elements of the program were the riskiest.« less
  • Purpose: and Leipzig applicators (VLAs) are single-channel brachytherapy surface applicators used to treat skin lesions up to 2cm diameter. Source dwell times can be calculated and entered manually after clinical set-up or ultrasound. This procedure differs dramatically from CT-based planning; the novelty and unfamiliarity could lead to severe errors. To build layers of safety and ensure quality, a multidisciplinary team created a protocol and applied Failure Modes and Effects Analysis (FMEA) to the clinical procedure for HDR VLA skin treatments. Methods: team including physicists, physicians, nurses, therapists, residents, and administration developed a clinical procedure for VLA treatment. The procedure wasmore » evaluated using FMEA. Failure modes were identified and scored by severity, occurrence, and detection. The clinical procedure was revised to address high-scoring process nodes. Results: Several key components were added to the clinical procedure to minimize risk probability numbers (RPN): -Treatments are reviewed at weekly QA rounds, where physicians discuss diagnosis, prescription, applicator selection, and set-up. Peer review reduces the likelihood of an inappropriate treatment regime. -A template for HDR skin treatments was established in the clinical EMR system to standardize treatment instructions. This reduces the chances of miscommunication between the physician and planning physicist, and increases the detectability of an error during the physics second check. -A screen check was implemented during the second check to increase detectability of an error. -To reduce error probability, the treatment plan worksheet was designed to display plan parameters in a format visually similar to the treatment console display. This facilitates data entry and verification. -VLAs are color-coded and labeled to match the EMR prescriptions, which simplifies in-room selection and verification. Conclusion: Multidisciplinary planning and FMEA increased delectability and reduced error probability during VLA HDR Brachytherapy. This clinical model may be useful to institutions implementing similar procedures.« less