Implementation of the failure modes and effects analysis in a Hospital Radiopharmacy Unit.

AIM: The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures. MATERIALS AND METHODS: By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated. RESULTS: A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented. CONCLUSIONS: The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk.

Relevance of quantification in brain PET studies with 18F-FDG. / Relevancia de la cuantificación en los estudios PET cerebrales con 18F-FDG.

The inclusion of 18F-FDG PET as a biomarker in the diagnostic criteria of neurodegenerative diseases and its indication in the presurgical assessment for drug-resistant epilepsies allow to improve specificity of these diagnosis. The traditional interpretation of neurological PET studies has been performed qualitatively, although in the last decade, several quantitative evaluation methods have emerged. This technical development has become relevant in clinical practice, improving specificity, reproducibility and reducing the interrater reliability derived from visual analysis. In this article we update/review the main imaging processing techniques currently used. This may allow the Nuclear Medicine physician to know their advantages and disadvantages when including these procedures in daily clinical practice.

Detection of epileptogenic focus with two new methods of processing of SPECT and PET cerebral images: PET-Analysis and PISCOM. / Detección del foco epileptógeno mediante dos nuevos métodos de procesamiento de imágenes SPECT y PET cerebral: PET-Analysis y PISCOM.

Functional neuroimaging with positron emission tomography with 18F-fluorodeoxyglucose (PET-18F-FDG) and perfusion single photon emission computerized tomography (SPECT) are increasingly more essential for presurgically locating the epileptogenic focus. We present the case of an 18-year-old male with epileptic seizures refractory to antiepileptic treatment. Magnetic resonance (MR) showed dysplasia in the posterior right insular cortex. Subtraction of ictal SPECT co-registered to MR (SICOM) detected a focal increase of uptake in the left fronto-parietal cingulate and PET-FDG showed normal distribution of the radiotracer. The posterior right insula was resected with histopathological results of grade I ganglioglioma according to the World Health Organization classification. The patient made favourable post-surgical progress, and remains seizure-free after 5 years (Engel I). Retrospective analysis of this case with two new image processing methods (PET analysis and PET interictal subtracted ictal SPECT coregistered with MR [PISCOM]) correctly localized the epileptogenic focus in the posterior right insular cortex.

Validation of semi-quantitative methods for DAT SPECT: influence of anatomical variability and partial volume effect.

The aim of this work was to evaluate the influence of anatomical variability between subjects and of the partial volume effect (PVE) on the standardized Specific Uptake Ratio (SUR) in [(123)I]FP-bib SPECT studies. To this end, magnetic resonance (MR) images of 23 subjects with differences in the striatal volume of up to 44% were segmented and used to generate a database of 138 Monte Carlo simulated SPECT studies. Data included normal uptakes and pathological cases. Studies were reconstructed by filtered back projection (FBP) and the ordered-subset expectation-maximization algorithm. Quantification was carried out by applying a reference method based on regions of interest (ROIs) derived from the MR images and ROIs derived from the Automated Anatomical Labelling map. Our results showed that, regardless of anatomical variability, the relationship between calculated and true SUR values for caudate and putamen could be described by a multiple linear model which took into account the spill-over phenomenon caused by PVE (R² ≥ 0.963 for caudate and ≥0.980 for putamen) and also by a simple linear model (R(2) ≥ 0.952 for caudate and ≥0.973 for putamen). Calculated values were standardized by inverting both linear systems. Differences between standardized and true values showed that, although the multiple linear model was the best approach in terms of variability (X² ≥ 11.79 for caudate and ≤7.36 for putamen), standardization based on a simple linear model was also suitable (X² ≥ 12.44 for caudate and ≤12.57 for putamen).

Implementación del análisis modal de fallos y efectos en una Unidad de Radiofarmacia Hospitalaria / Implementation of the failure modes and effects analysis in a Hospital Radiopharmacy Unit

Objetivo El objetivo de este estudio es la implementación en una Unidad de Radiofarmacia Hospitalaria de una metodología de análisis de riesgos para poder identificar de forma proactiva los posibles modos de fallo y priorizar medidas correctivas. Material y métodos Mediante el análisis modal de fallos y efectos (AMFE) se identificaron los posibles modos de fallo de cada una de las etapas de los procesos de prescripción, preparación y administración de los radiofármacos de diagnóstico y de terapia. A partir de las variables de severidad, probabilidad y detectabilidad se cuantificó el riesgo mediante el número de prioridad de riesgo (NPR) para cada modo de fallo, subproceso y tipo de radiofármaco. Se establecieron medidas de mejora y se calculó la reducción en el NPR. Resultados Se identificaron 96 modos de fallos (58 para los radiofármacos de diagnóstico y 38 para los de terapia). La identificación biunívoca del paciente con el radiofármaco es el modo de fallo con mayor NPR (60) y el subproceso de marcaje celular el que presenta mayor riesgo (NPR 286). Como resultado de las medidas de mejora se disminuyó el NPR global en un 22% para los radiofármacos de diagnóstico y 20% para los de terapia. Esta reducción sería del 46 y el 31%, respectivamente, si se implantara un software de radiofarmacia y tecnología de código de barras en la administración. Conclusiones La aplicación de la metodología AMFE como herramienta de análisis de riesgos permite identificar los puntos críticos de los procesos relacionados con los radiofármacos y priorizar medidas para disminuir el riesgo (AU)

Aim The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures. Materials and methods By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated. Result A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented. Conclusions The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk (AU)

Relevancia de la cuantificación en los estudios PET cerebrales con 18F-FDG / Relevance of quantification in brain PET studies with 18F-FDG

La inclusión de la PET 18F-FDG como biomarcador en los criterios de diagnóstico clínico de enfermedades neurodegenerativas y su indicación en el estudio precirugía en la epilepsia resistente a los fármacos permiten mejorar la especificidad del diagnóstico. La interpretación clásica de los estudios PET neurológicos se ha abordado de forma cualitativa, aunque en la última década hemos sido testigos del auge en los sistemas de evaluación cuantitativa. Este desarrollo técnico es de vital importancia en la práctica clínica, ya que mejora la especificidad y la reproducibilidad y reduce el efecto dependiente del observador derivado del análisis visual. Consideramos que es conveniente exponer la complejidad de las técnicas de procesamiento de imagen empleadas, lo que permitirá al especialista en Medicina Nuclear conocer sus ventajas e inconvenientes a la hora de incluirlas en la práctica clínica diaria

The inclusion of 18F-FDG PET as a biomarker in the diagnostic criteria of neurodegenerative diseases and its indication in the presurgical assessment for drug-resistant epilepsies allow to improve specificity of these diagnosis. The traditional interpretation of neurological PET studies has been performed qualitatively, although in the last decade, several quantitative evaluation methods have emerged. This technical development has become relevant in clinical practice, improving specificity, reproducibility and reducing the interrater reliability derived from visual analysis. In this article we update/review the main imaging processing techniques currently used. This may allow the Nuclear Medicine physician to know their advantages and disadvantages when including these procedures in daily clinical practice

Detección del foco epileptógeno mediante dos nuevos métodos de procesamiento de imágenes SPECT y PET cerebral: PET-Analysis y PISCOM / Detection of epileptogenic focus with two new methods of processing of SPECT and PET cerebral images: PET-Analysis and PISCOM

La neuroimagen funcional de la PET con 18F-FDG y la SPECT de perfusión son exploraciones cada vez más imprescindibles para la localización prequirúrgica del foco epileptógeno. Presentamos el caso de un paciente varón de 18 años con crisis epilépticas refractarias a tratamiento antiepiléptico. La RM mostró displasia en córtex insular posterior derecho. El SISCOM detectó un aumento focal de captación en cíngulo frontoparietal izquierdo y en la PET-FDG se visualizaba una distribución normal del radiotrazador. Se realizó resección insular posterior derecha, cuyo resultado anatomopatológico fue ganglioglioma grado I de la clasificación de la OMS. El paciente mostró una evolución posquirúrgica favorable, encontrándose libre de crisis desde hace 5 años (Engel I). Un análisis retrospectivo de este caso con 2 nuevos métodos de procesamiento de imágenes: PET-Analysis y PISCOM, permitió localizar correctamente el foco epileptógeno en córtex insular posterior derecho

Functional neuroimaging with positron emission tomography with 18F-fluorodeoxyglucose (PET-18F-FDG) and perfusion single photon emission computerized tomography (SPECT) are increasingly more essential for presurgically locating the epileptogenic focus. We present the case of an 18-year-old male with epileptic seizures refractory to antiepileptic treatment. Magnetic resonance (MR) showed dysplasia in the posterior right insular cortex. Subtraction of ictal SPECT co-registered to MR (SICOM) detected a focal increase of uptake in the left fronto-parietal cingulate and PET-FDG showed normal distribution of the radiotracer. The posterior right insula was resected with histopathological results of grade I ganglioglioma according to the World Health Organization classification. The patient made favourable post-surgical progress, and remains seizure-free after 5 years (Engel I). Retrospective analysis of this case with two new image processing methods (PET analysis and PET interictal subtracted ictal SPECT coregistered with MR [PISCOM]) correctly localized the epileptogenic focus in the posterior right insular cortex