Insights on trends in the management of metrological analysis of devices in blood and transfusion medicine services: Verification based on their fitness for purpose and suitability for their respective applications.
Transfus Apher Sci
; 63(1): 103874, 2024 Feb.
Article
en En
| MEDLINE
| ID: mdl-38233312
ABSTRACT
In the field of blood and transfusion medicine, European Directorate for the Quality of Medicines & HealthCare recommends practices for metrological devices. Monitoring and measurement resources, as well as their permitted metrological limits, must be considered in this regard. We must understand variables such as metrological domains, the International System of Units, metrological traceability, and metrological requirements and controls in the field of transfusions in order to understand these metrological devices. An approach to metrological analysis and subsequent actions was constructed using flowcharts. As part of this methodology, a metrological device was selected, along with regulatory and normative requirements. A calibration and a test were conducted to demonstrate the application of the figure based on current recommendations. Current recommendations are consistent with the suggested ROC approach. The metrological devices must be verified based on their suitability for their respective applications (fitness-for-purpose).
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Medicina Transfusional
Tipo de estudio:
Guideline
Límite:
Humans
Idioma:
En
Revista:
Transfus Apher Sci
Asunto de la revista:
HEMATOLOGIA
Año:
2024
Tipo del documento:
Article