9. Proposte e conclusioni
9.5 Conclusioni
Le tecnologie biomediche costituiscono una risorsa fondamentale ai fini del miglioramento delle attività di tutela e cura della salute della popolazione e tuttavia troppo spesso il loro utilizzo o viene promosso con eccessiva facilità senza averne valutato adeguatamente le implicazioni o viene limitato dai timori derivanti dall’incertezza circa gli esiti e le conseguenze del loro impiego.
Il superamento di tali limiti presuppone uno sforzo teso al rafforzamento delle basi metodologiche dell’Health Technology Assessment (HTA) nelle varie fasi di sviluppo del prodotto e degli strumenti di valutazione e di analisi delle dimensioni di rischio e di incertezza connesse all’utilizzo delle tecnologie sanitarie. Se può ritenersi ormai sufficientemente consolidato l’utilizzo dell’HTA per le tecnologie mature, non altrettanto può dirsi per le tecnologie innovative che non presentano ancora evidenze empiriche relative agli effetti del loro utilizzo su cui fondare le scelte e le decisioni circa la commercializzazione, da parte dei produttori, e il finanziamento, da parte dei sistemi sanitari pubblici e/o privati.
L’iter previsto dalla normativa di riferimento per l’ottenimento del marchio CE richiede una accurata valutazione del rischio della tecnologia, ma viene trascurato il fatto che numerosi fattori di rischio non dipendono dalla tecnologia in sé stessa, quanto dalla sua interazione con gli altri elementi della struttura organizzativa e, in primo luogo, dalla formazione e dall’esperienza del medico che la utilizza.
La presente tesi ha proposto un quadro di riferimento metodologico e alcuni casi di studio esemplificativi che evidenziano come il processo di valutazione e gestione del rischio deve essere un processo continuo - non limitato al solo momento della commercializzazione - e circolare, volto a identificare nuovi elementi di rischio e nuove modalità di gestione degli stessi.
Le figure tecniche di riferimento per le tecnologie sanitarie, quali l’ingegnere clinico e l’ingegnere biomedico, devono compiere uno sforzo di ampliamento del loro background formativo e focalizzare maggiore attenzione sugli aspetti di valutazione dei rischi, dei costi e dei benefici delle nuove tecnologie sanitarie.
I medici, i produttori di tecnologie, i progettisti, i ricercatori in ambito biomedico, gli economisti, gli assicuratori, i giuristi, devono congiuntamente agire in via preventiva - e precauzionale - al verificarsi dell’evento dannoso come effetto indesiderato o non previsto della tecnologia sanitaria, investendo risorse, umane ed economiche, nello studio e nella valutazione di ogni aspetto e di ogni possibile effetto della tecnologia e della interazione di essa con gli altri componenti dei sistemi sanitari. In questo modo si è certamente in grado di contenere e di gestire il rischio, ma anche di mitigare, per quanto possibile, l’incertezza.
Pubblicazioni della candidata
Turchetti, G., Labella B., “Il risk management”, in Comandè, G., Turchetti, G. (a cura di), La responsabilità sanitaria. Valutazione del rischio e assicurazione, Cedam, Padova, 2004
Turchetti, G., Labella B., “Il risk management sanitario”, in Comandè, G., Turchetti, G. (a cura di), La responsabilità sanitaria. Valutazione del rischio e assicurazione, Cedam, Padova, 2004
Turchetti, G., Labella B., “Applicazioni innovative di programmi di risk
management: casi significativi e proposte operative”, in Comandè, G., Turchetti
G. (a cura di), La responsabilità sanitaria. Valutazione del rischio e assicurazione, Cedam, Padova, 2004
Pietrabissa A., Turchetti G., Labella B., Cinquini L., Miolo P., Dario P., Mosca F., “Multidisciplinary Approach to research and development of healthcare technology: the EndoCAS Project” presentato alla Conferenza Internazionale “HTAi Annual Meeting: Bringing HTA into Practice”, Roma, Giugno 2005
Turchetti, G., Labella, B., Pietrabissa, A., Megali, G., Tonet, O., Cinquini, L., Miolo, P., Dario, P., Mosca, F., “The multidisciplinary approach as the way to innovation in healthcare technology: the EndoCAS Project” presentato alla 4th International Conference on the Management of Healthcare & Medical Technology, Aalborg, Danimarca Agosto 2005
Turchetti, G., Labella, B., Valdastri, P., Menciassi, A., Dario, P., The importance of
giving an alternative: the case of fetal surgery, accettato per la pubblicazione dal
l’International Journal of Healthcare Technology and Management
Wickramasinghe,N., Turchetti,G., Labella,B., Moglia,A., Menciassi,A., Dario,P., Geisler,E., Wickramasinghe,S., “Embracing technologies to effect MIS and MIT: the
benefits of minimal invasive surgery and techniques (MIS and MIT) in Hirschsprung’s patients” presentato alla 5th International Conference on the
Management of Healthcare & Medical Technology, Chicago, Illinois, Agosto 2006
Turchetti, G., Labella, B. “L’innovazione nelle tecnologie biomediche tra rischio,
incertezza, precauzione e gestione” in Comandè, G. (a cura di) Gli strumenti della
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APPENDICE I: Cenni sulla regolamentazione europea delle tecnologie mediche