Note metodologiche sull’acquisizione e sull’uso dei sistemi chiusi sottovuoto per il prelievo, il trattamento e la conservazione dei campioni ematici venosi destinati alla diagnostica di laboratorio

AUTORI

ABSTRACT

Methodological notes on acquisition and use of close evacuated systems for collection, handling and storage of venous blood samples for laboratory diagnostics

Evacuated systems for collection of venous blood are integrated systems of medical and in vitro diagnostic medical devices regulated under European Directives and Italian Legislative Decrees. Both Directives and Decrees endorse the requirement that the whole combination of devices, representing an integrated apparatus, must be safe and not impair the specific performance of each single device. According to mandatory requirements, manufacturers must ensure full compatibility between each component of the system, while the users are responsible for verifying the compatibility of different devices in order to avoid potential quality and safety problems. The acquisition of various devices from different manufacturers may lead to combinations that are not validated by manufacturers themselves and are thus expected to be validated and verified by the users to demonstrate that the system remains safe and will not impair the performance of the individual elements. Therefore, the possibility of purchasing different devices separately should be carefully weighted in terms of risk-benefit, taking into consideration the additional costs of the validation/verification process that should be carried out by the potential user. Since preanalytical problems are the major source of errors in the total testing process, the selection and acquisition of close evacuated systems for blood collection should be considered a critical issue for assuring quality, safety and efficiency of the preanalytical phase of laboratory diagnostics and, therefore, of the total testing process.

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