Failure modes and effects analysis of pediatric I‐131 MIBG therapy: Program design and potential pitfalls

Abstract

Background: There is growing interest among pediatric institutions for implementing iodine-131 (I-131) meta-iodobenzylguanidine (MIBG) therapy for treating children with high-risk neuroblastoma. Due to regulations on the medical use of radioactive material (RAM), and the complexity and safety risks associated with the procedure, a multidisciplinary team involving radiation therapy/safety experts is required. Here, we describe methods for implementing pediatric I-131 MIBG therapy and evaluate our program's robustness via failure modes and effects analysis (FMEA). Methods:We formed a multidisciplinary team, involving pediatric oncology, radiation oncology, and radiation safety staff. To evaluate the robustness of the therapy workflow and quantitatively assess potential safety risks, an FMEA was performed. Failure modes were scored (1-10) for their risk of occurrence (O), severity (S), and being undetected (D). Risk priority number (RPN) was calculated from a product of these scores and used to identify high-risk failure modes. Results: A total of 176 failure modes were identified and scored. The majority (94%) of failure modes scored low (RPN <100). The highest risk failure modes were related to training and to drug-infusion procedures, with the highest S scores being (a) caregivers did not understand radiation safety training (O = 5.5, S = 7, D = 5.5, RPN = 212); (b) infusion training of staff was inadequate (O = 5, S = 8, D = 5, RPN = 200); and (c) air in intravenous lines/not monitoring for air in lines (O = 4.5, S = 8, D = 5, RPN = 180). Conclusion: Through use of FMEA methodology, we successfully identified multiple potential points of failure that have allowed us to proactively mitigate risks when implementing a pediatric MIBG program.

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry

“…Failure mode and effects analysis (FMEA) is a fundamental methodology for identifying possible failure modes and implementing preventive measures. Despite its extensive use in various specialties for risk assessment, only a few studies have applied FMEA to RPT ( 39 , 62 , 63 ). A multi-institutional research incorporating fault tree analysis will identify potential failure modes so that the severity and likelihood can be evaluated and measures to mitigate risks can be undertaken, as described in AAPM’s TG-100 recommendations ( 64 ).…”

Application of Failure Mode and Effects Analysis to Improve the Quality of the Front Page of Electronic Medical Records in China: Cross-Sectional Data Mapping Analysis

“…In recent years, FMEA has been widely used in various fields, including the medical field. Studies on medical services [21], medicine distribution [22], infection control [23], and medical equipment operation and maintenance [24] have used FMEA to date.…”

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

“…13 Maintaining the therapy may also include modifying the SOP in response to potential problems or actual events, such as near-misses or failures, by implementing process improvement approaches, for example, failure modes and effects analysis (FMEA) or root-cause analysis (RCA), as demonstrated previously for other radiopharmaceutical therapies. 23,30 8 KEY RECOMMENDATIONS FOR IMPLEMENTING A LU-177-PSMA-617 THERAPY PROGRAM…”

“…Once therapy is initiated, it is important to maintain the therapy by providing on‐going support, updating the procedures and forms, and storing treatment records, for example, the written directive (§35.40) and records of administered activity (§35.2063), radiation survey results (§35.2070), and patient release (§35.2075) 13 . Maintaining the therapy may also include modifying the SOP in response to potential problems or actual events, such as near‐misses or failures, by implementing process improvement approaches, for example, failure modes and effects analysis (FMEA) or root‐cause analysis (RCA), as demonstrated previously for other radiopharmaceutical therapies 23,30 …”