Analisi dei dispositivi medici nelle sperimentazioni cliniche all’Istituto Ortopedico Rizzoli di Bologna
Giulia Roatti, Massimiliano Luppi, Laura Fantini, Serena Cioni, Maria Antonietta Melfi, Laura Trombetta, Paola Iovino,
Introduction: The clinical assessment is a mandatory activity for any risk class of Medical Device (MD) before marketing a new device but it is also important later as post-marketing surveillance, in order to guarantee patients access to safe technologies and reliable over time. The purpose of the analysis was to monitor the progress of experimental MD, analyzing the National Classification of Medical Devices (CND) and quantify the economic value of the experimental treatments.
Materials and Methods: As part of a search for greater quality in the field of MD, the Istituto Ortopedico Rizzoli’s (IOR’s) Hospital Pharmacy has set up a registry to monitor the movements of experimental MD. The analysis included the data of the experimental MD provided during the period 01/01/2013-31/12/2014 by the IOR’s Hospital Pharmacy. At each MD CE marked was awarded the list price or the hammer price, while every MD without CE mark was awarded the cost of the MD considered the gold standard in use.
Results: From 01/01/2013 to 31/12/2014 were administered 259 experimental MD, 90 in 2013 and 169 in 2014 for a total estimated value of € 43.389,6 (€ 19.818,3 in 2013; € 23.571,3 in 2014). The experimental MD used in the period under review were grouped into five categories, according to the CND. The “Absorbable products for filling and reconstruction” (CND P900402) represented the types of medical devices further investigated (73% of the total or 189 samples used), followed by “Equipment for medication vacuum” (CND Z12040205) representing 22% of the total.
Conclusions: The clinical trial allows the use of highly innovative MD without burdening the national health system, entailing a clinical and economic advantage. Since these MD are not used in clinical practice, it is necessary to perform a careful monitoring, in order to frame properly future fields of application and assess the cost / benefit.
Key words: medical device, clinical trial, cost evaluation