Advanced Medical Devices for Preparation and Administration of Chemotherapeutic Agents: Results from a Multi-Dimensional Evaluation

Lucrezia Ferrario,1 Fabrizio Schettini,1 Elisabetta Garagiola,1 Adriana Cecchi,2 Lucia Lugoboni,3 Paolo Serra,4 Emanuele Porazzi,1 Emanuela Foglia1 1Carlo Cattaneo – LIUC University and LIUC Business School, Castellanza, Italy; 2ARCS – Azienda Regionale di Coordinamento per la Salute, Udine, Italy; 3Bee Care, Lugano, Switzerland; 4Brotzu Hospital, Cagliari, ItalyCorrespondence: Lucrezia FerrarioCarlo Cattaneo – LIUC University and LIUC Business School, Corso Matteotti 22, Castellanza, VA 21053, ItalyTel +39 033 1572504Fax +39 033 1572513Email lferrario@liuc.itPurpose: To evaluate the incremental benefits concerning the implementation of closed-system medical devices for the preparation and administration of chemotherapy agents (integrated or not with traceable workflow), within an Italian clinical practice, in which the use of such technologies is not standardized.Methodology: Four Scenarios, implying different levels of technologies introduction, were analyzed, based on the presence and/or absence of closed systems and traceable workflow, in the preparation and in the administration phase. A literature review was conducted, in order to retrieve efficacy and safety measures. Economic and organizational benefits, assuming a hospitals perspective, were assessed by means of health-economics tools, considering 27,660 (± 695.86) drugs on average prepared, on an annual basis, by 12 hospitals involved. The typology of medical devices and other devices/equipment used, the human resources involved, and the time spent for the preparation and administration phases were collected.Results: Literature stated that the introduction of advanced technologies (CSTDs in the preparation phase, closed-system in the administration phase, both integrated by a traceable workflow) could: i) decrease surface contamination (12.24% vs 26.39%, P< 0.001) and ii) improve the capability to identify dosage errors (7% vs 0.096%, P< 0.05). The above technologies presented the best trade-off between cost sustained and efficacy gained. Despite marginal investments (ranging from +1% to +6%) being required for their acquisition, an organizational saving equal to more than 1,000 working hours emerged, which could be spent on other hospital activities.Conclusion: The implementation of closed systems, integrated with a traceable workflow grounding on gravimetric control, may be considered a valid technological alternative within the investigated setting. The marginal incremental costs could be absorbed already in the first year after their introduction, in particular, because of the potential time saving in using closed systems in both the preparation and administration phases, demonstrating the sustainability and feasibility of such advanced technologies.Keywords: closed-system medical device, chemotherapy agents, safety, economic evaluation, HTA, organisational benefits