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Failure Modes and Effects Analysis of Total Skin Electron Irradiation Technique

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B Ibanez-Rosello

B Ibanez-Rosello1*, J Bautista1 , J Bonaque1 , J Perez-Calatayud1,2 , A Gonzalez-Sanchis3 , J Lopez-Torrecilla3 , L Brualla Gonzalez3 , M Garcia-Hernandez3 , A Vicedo-Gozalez3 , D Granero3 , A Serrano3 , B Borderia3 , C Solera3 , J Rosello Ferrando3,4, (1) La Fe University and Polytechnic Hospital, Valencia, Valencia, (2) Unidad Mixta de Investigacion en Radiofisica e Instrumentacion Nuclear en Medicina (IRIMED), Valencia, Valencia,(3) General University Hospital, ERESA, Valencia, Valencia, (4) Universitat de Valencia, Valencia, Valencia,


SU-I-GPD-P-8 (Sunday, July 30, 2017) 3:00 PM - 6:00 PM Room: Exhibit Hall

Purpose: A failure mode and effect analysis (FMEA) of Total Skin Electron Irradiation (TSEI) technique was performed, with the purpose of increasing the quality of the treatment.

Methods: This study has been made in a TSEI reference center, in which 80 patients have been treated following the Stanford method. A multidisciplinary team developed the process map and evaluated the potential failure modes (FMs) of each process step, according to their occurrence (O), detectability (D) and severity (S), following the methodology proposed by the TG-100 of the AAPM. The product of these factors is defined as its risk priority number (RPN), which permits ranked the FMs.

Results: 361 FMs were identified, 103 of which had RPN ≥ 80 and 41 had S ≥ 8. After, considering the current quality management tools, only 30 FMs had RPN ≥ 80. The detailed analysis of them revealed that most of the riskiest FMs were associated to the patient's position during treatment. To cover this item, the position of the screen and the patient was marked on the floor, some templates representing the position of the feet were drawn and the axes must traverse the lasers and the field size within which should position the extremities were marked on the sheet. These are the main quality management tools which have been incorporated in our facility. However, the implementation of this risk analysis revealed its limitations: the subjectivity of the method was demonstrated in the factor evaluation, which has been already been questioned in similar works. Another limitation is the determination of the control’s frequency.

Conclusion: The current quality management tools have been analyzed and new tools were proposed. However, periodic FMEA evaluation should be carried out.

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