The Single photon emission tomography associated with Computed Tomography, known as SPECT-CT, is a hybrid diagnostic imaging method that combines the functional information obtained from SPECT with the anatomical map provided by CT. This technology is used in many fields because it allows to study tumors accurately, brain degenerative and infectious pathologies. As for all services in Nuclear Medicine, a radiopharmaceutical, that is weakly radioactive, is injected intravenously and tends to concentrate specifically in the sites where there is a pathological increase in cellular metabolism by emitting gamma photons. The device records the radiations emitted and transforms them into images that describe the functional processes within the patient's body. The objective of this paper is to illustrate the steps necessary for the purchase and installation of a latest generation of SPECT-CT, produced by Siemens, which I was able to assist during the internship carried out at the s.c. Clinical Engineering of the IRCCS Istituto Nazionale dei Tumori. The funds necessary for the acquisition of the equipment and ancillary services have been found through a financing assigned by the Lombardy Region and aimed at replacing large biomedical equipment that has reached the end of its life or whose replacement is expected. It was possible to purchase the new technology through a public procurement procedure entirely managed by ARIA (Regional Agency for Innovation and Purchases), which designated Siemens Healthcare srl as the competing winner. The purchase procedure took place through the use of the "Sintel" computerized trading system and the adjudication happened through an open procedure in favor of the economically most advantageous offer. For the attribution of the scores of the two competitors' offers, were taken into consideration technical, qualitative and economic elements. To set up the 2 rooms (diagnostic room and control room), the installation of the new SPECT-CT required construction works, mechanical plant engineering and electrical plant engineering. During the activities all the necessary measures have been implemented in order to avoid interference with the hospital activities in progress and guarantee the safety of the users of the health service and of the employees. After the delivery of the equipment, there was the mechanical and electrical installation in order to verify its functional performance. There have been tests by radioprotection to verify compliance with the dose limits defined by Legislative Decree n. 257 of 9 May 2001. Following the positive outcome of all the checks, the acceptance form was signed by the s.c. Projects and Technical Services, of the s.c. Nuclear Medicine, of the s.c. ICT and Company Information Systems, and finally by the s.c. Clinical Engineering. After an adequate period of training, the SPECT-CT tomograph was put into service and and the suitability for clinical use was announced by the Director of the s. Nuclear Medicine.
La Tomografia ad Emissione di singolo fotone associata alla Tomografia Computerizzata, nota come SPECT-CT, è una metodica ibrida di diagnostica per immagini che combina le informazioni funzionali ottenute dalla SPECT con la mappa anatomica fornita dalla TC. Questa tecnologia è utilizzata in numerosi campi perché permette di studiare in modo accurato tumori, patologie degenerative cerebrali e patologie infettive. Come per tutte le prestazioni in Medicina Nucleare, viene iniettato per via endovenosa un radiofarmaco, debolmente radioattivo, che tende a concentrarsi in modo specifico nella sede dove vi è un patologico incremento del metabolismo cellulare emettendo fotoni gamma. L’apparecchiatura registra le radiazioni emesse e le trasforma in immagini che descrivono i processi funzionali all’interno del corpo del paziente. L’obiettivo del presente elaborato consiste nell’illustrazione delle fasi necessarie all’acquisto ed all’installazione di una SPECT-CT di ultima generazione, prodotta da Siemens, alle quali ho avuto modo di assistere e partecipare durante il tirocinio svolto presso la struttura complessa di Ingegneria Clinica della Fondazione IRCCS Istituto Nazionale dei Tumori. I fondi necessari all’acquisizione dell’apparecchiatura e dei servizi accessori sono stati reperiti attraverso un finanziamento assegnato dalla Regione Lombardia e finalizzato alla sostituzione di grandi apparecchiature biomediche giunte a fine vita o di cui si prevede l’esigenza di sostituzione. É stato possibile acquistare la nuova tecnologia tramite una gara d’appalto interamente gestita da ARIA (Agenzia Regionale per l’Innovazione e gli Acquisti), che ha designato come concorrente vincitore Siemens Healthcare srl. La procedura di acquisto è avvenuta mediante l’utilizzo del sistema informatico di negoziazione “Sintel” e l’aggiudicazione è avvenuta mediante procedura aperta a favore dell’offerta economicamente più vantaggiosa, considerando, per l’attribuzione dei punteggi delle offerte dei due concorrenti, elementi tecnico/qualitativi ed economici. Per predisporre i 2 locali (sala diagnostica e sala comandi) all’installazione della nuova SPECT-CT sono state necessarie opere edili, di impiantistica meccanica e di impiantistica elettrica. Durante le attività sono state attuate tutte le misure necessarie per evitare interferenze con le attività ospedaliere in corso e garantire l’incolumità dei fruitori del servizio sanitario e del personale dipendente. Alla consegna dell’apparecchiatura sono seguiti installazione meccanica ed elettrica di tutte le sue parti e specifici controlli di qualità, al fine di verificarne le prestazioni funzionali. Ci sono state le prove da parte della radioprotezione per verificare il rispetto dei limiti di dose definiti dal Decreto Legislativo n. 257 del 9 maggio 2001. A seguito dell’esito positivo di tutti i controlli è stato firmato il modulo di accettazione da parte della s.c. Progetti e Servizi Tecnici, della s.c. Medicina Nucleare, della s.c. ICT e Sistemi Informativi Aziendali, ed infine dalla s.c. Ingegneria Clinica. Dopo un adeguato periodo di formazione, è stata dichiarata la messa in servizio del tomografo SPECT-CT e l’idoneità all’uso clinico da parte del Direttore della s.c. Medicina Nucleare.
Installazione di una SPECT-CT presso la Fondazione IRCCS Istituto Nazionale dei Tumori : dall'acquisto al primo utilizzo
VILELLA, SARA
2018/2019
Abstract
The Single photon emission tomography associated with Computed Tomography, known as SPECT-CT, is a hybrid diagnostic imaging method that combines the functional information obtained from SPECT with the anatomical map provided by CT. This technology is used in many fields because it allows to study tumors accurately, brain degenerative and infectious pathologies. As for all services in Nuclear Medicine, a radiopharmaceutical, that is weakly radioactive, is injected intravenously and tends to concentrate specifically in the sites where there is a pathological increase in cellular metabolism by emitting gamma photons. The device records the radiations emitted and transforms them into images that describe the functional processes within the patient's body. The objective of this paper is to illustrate the steps necessary for the purchase and installation of a latest generation of SPECT-CT, produced by Siemens, which I was able to assist during the internship carried out at the s.c. Clinical Engineering of the IRCCS Istituto Nazionale dei Tumori. The funds necessary for the acquisition of the equipment and ancillary services have been found through a financing assigned by the Lombardy Region and aimed at replacing large biomedical equipment that has reached the end of its life or whose replacement is expected. It was possible to purchase the new technology through a public procurement procedure entirely managed by ARIA (Regional Agency for Innovation and Purchases), which designated Siemens Healthcare srl as the competing winner. The purchase procedure took place through the use of the "Sintel" computerized trading system and the adjudication happened through an open procedure in favor of the economically most advantageous offer. For the attribution of the scores of the two competitors' offers, were taken into consideration technical, qualitative and economic elements. To set up the 2 rooms (diagnostic room and control room), the installation of the new SPECT-CT required construction works, mechanical plant engineering and electrical plant engineering. During the activities all the necessary measures have been implemented in order to avoid interference with the hospital activities in progress and guarantee the safety of the users of the health service and of the employees. After the delivery of the equipment, there was the mechanical and electrical installation in order to verify its functional performance. There have been tests by radioprotection to verify compliance with the dose limits defined by Legislative Decree n. 257 of 9 May 2001. Following the positive outcome of all the checks, the acceptance form was signed by the s.c. Projects and Technical Services, of the s.c. Nuclear Medicine, of the s.c. ICT and Company Information Systems, and finally by the s.c. Clinical Engineering. After an adequate period of training, the SPECT-CT tomograph was put into service and and the suitability for clinical use was announced by the Director of the s. Nuclear Medicine.| File | Dimensione | Formato | |
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https://hdl.handle.net/10589/151075