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Program Information

Microsphere Brachytherapy Failure Mode and Effects Analysis in a Dual-Vendor Environment

K Younge

K C Younge*, C I Lee , M Feng , P Novelli , J M Moran , J I Prisciandaro , Univ Michigan Medical Center, Ann Arbor, MI


WE-G-BRA-9 (Wednesday, July 15, 2015) 4:30 PM - 6:00 PM Room: Ballroom A

Purpose: To improve the safety and quality of a dual-vendor microsphere brachytherapy program with failure mode and effects analysis (FMEA).

Methods: A multidisciplinary team including physicists, dosimetrists, a radiation oncologist, an interventional radiologist, and radiation safety personnel performed an FMEA for our dual-vendor microsphere brachytherapy program employing SIR-Spheres (Sirtex Medical Limited, Australia) and Theraspheres (BTG, England). We developed a program process tree and step-by-step instructions which were used to generate a comprehensive list of failure modes. These modes were then ranked according to severity, occurrence rate, and detectability. Risk priority numbers (RPNs) were calculated by multiplying these three scores together. Three different severity scales were created: one each for harmful effects to the patient, staff, or the institution. Each failure mode was ranked on one or more of these scales.

Results: The group identified 164 failure modes for the microsphere program. 113 of these were ranked using the patient severity scale, 52 using the staff severity scale, and 50 using the institution severity scale. The highest ranked items on the patient severity scale were an error in the automated dosimetry worksheet (RPN = 297.5), and the incorrect target specified on the planning study (RPN = 135). Some failure modes ranked differently between vendors, especially those corresponding to dose vial preparation because of the different methods used. Based on our findings, we made several improvements to our QA program, including documentation to easily identify which product is being used, an additional hand calculation during planning, and reorganization of QA steps before treatment delivery. We will continue to periodically review and revise the FMEA.

Conclusion: We have applied FMEA to our dual-vendor microsphere brachytherapy program to identify potential key weaknesses in the treatment chain. Our FMEA results were used to improve the effectiveness of our overall microsphere program.

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