Identifying risk characteristics using failure mode and effect analysis for risk management in online magnetic resonance-guided adaptive radiation therapy

Shie Nishioka; Hiroyuki Okamoto; Takahito Chiba; Tatsuya Sakasai; Kae Okuma; Junichi Kuwahara; Daisuke Fujiyama; Satoshi Nakamura; Kotaro Iijima; Hiroki Nakayama; Mihiro Takemori; Yuuki Tsunoda; Keita Kaga; Hiroshi Igaki

doi:10.1016/j.phro.2022.06.002

Identifying risk characteristics using failure mode and effect analysis for risk management in online magnetic resonance-guided adaptive radiation therapy

Phys Imaging Radiat Oncol. 2022 Jun 6:23:1-7. doi: 10.1016/j.phro.2022.06.002. eCollection 2022 Jul.

Authors

Shie Nishioka^{1

2}, Hiroyuki Okamoto¹, Takahito Chiba¹, Tatsuya Sakasai³, Kae Okuma⁴, Junichi Kuwahara³, Daisuke Fujiyama³, Satoshi Nakamura¹, Kotaro Iijima¹, Hiroki Nakayama^{1

5}, Mihiro Takemori^{1

5}, Yuuki Tsunoda³, Keita Kaga³, Hiroshi Igaki⁴

Affiliations

¹ Radiation Safety and Quality Assurance Division, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan.
² Department of Radiation Oncology, Kyoto Second Red Cross Hospital, 355-5, Haruobi-cho, Marutamachi-Agaru, kamanza-dori, Kamigyo-ku, Kyoto-shi, Kyoto 602-8026, Japan.
³ Radiological Technology Division, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan.
⁴ Radiation Oncology Division, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan.
⁵ Department of Radiological Science, Graduate School of Human Health Sciences, Metropolitan University, Higashi-ogu 7-2-10, Arakawa-ku, Tokyo 116-8551, Japan.

Abstract

Background and purpose: Online magnetic resonance-guided adaptive radiotherapy (MRgART) is a new technology of radiotherapy and requires a new quality control program in many aspects. This study aimed to gain a deeper understanding of risks in online MRgART through the application of failure mode and effect analysis (FMEA) for more enhanced and effective quality assurance (QA) programs.

Materials and methods: We present an FMEA conducted by a multidisciplinary team with more than two years of experience. A process map describing the whole process of online MRgART was developed and potential failure modes were identified. High-risk failure modes and their potential causes and corrective measures were also identified. Failure modes were classified into three categories, MRgRT, online ART, and conventional RT, to investigate their features. A comparison with previous studies was also conducted to gain a general perspective.

Results: In total, 153 failure modes and 49 high risks were identified. Among all failure modes, 51, 63, and 66 were related to MRgRT, online ART, and conventional RT, respectively. The hazardous processes were structure segmentation, treatment planning, and treatment beam delivery. Lists of failure modes identified in this study and previous studies were presented. Based on the results, characteristics and general aspects of the risks were discussed.

Conclusion: Exploring the results of the FMEA enhanced our understanding of risk characteristics to improve QA program of online MRgART.

Keywords: Failure mode and effect analysis; Hazardous features; MR-guided radiation therapy; Online adaptive radiation therapy; Process map; Risk analysis.