Gestione dei campioni gratuiti di Dispositivi Medici marcati CE al di fuori di un contesto sperimentale: l’esperienza dell’Azienda USL di Bologna
Valentina Valastro, Nicoletta Sarchione, Giusy Di Sanza, Chiara Falesiedi, Patrizia Falcone, Giovanni Brigati, Fortunata Cotti, Marco Faccioli, Federico Manfredi, Luisa Moratello, Elisa Ortolani, Paola Zuccheri, Morena Borsari
Background Medical devices are often characterized by a high degree of innovation and high costs, which makes their management crucial for Regional Health Systems in Italy. Actually, in November 2012 Directorate-General for Health of Emilia Romagna issued a note about this topic, aimed to ensure clinical effectiveness and safety: healthcare organizations have to implement clinical government actions, focusing on the enhancement of the device vigilance.
Local Health Unit of Bologna (AUSLBO) has established in 2013 a governance project, led by a Working Group of Pharmacists, aimed at withstanding, educating and informing healthcare professionals involved in the management of medical devices samples.
After six years from the start, the procedure had to be revised to encourage users’ commitment on the governance project. Such a review followed the periodical analysis of the request forms and its critical issues, clearly simplifying their management.
Materials and methods Once a medical device request is sent from the user to the Pharmacy, the Commission of Medical Devices assesses and endorses it eventually. After testing, users send an outline resume of use to the Pharmacy in terms of evaluating their experience.
The Commission of Medical Devices shall forward an accountability record of devices request submitted, half-yearly, to the Medical Direction.
The revision, accomplished by AUSLBO Commission of Medical Devices, concerned a redefinition of tasks is set between Pharmacy and Clinical Engineering Service, and the streamlining of the following forms: “medical device request” and “outline resume of use” (the second one is a form in which the healthcare professional expresses an opinion about his experience using the device).
Results The above mentioned revision has actually improved the procedure, increasing the number of requests by 45%. 144 requests of medical devices were submitted in 2019; the Pharmacy received 99 requests in the same gap of time in 2018. A request may include more than one device: considering their single number, 272 samples has been requested in 2019. There is an increase of 52% of requests concerning class III medical devices (the high-risk ones) in 2019. The average time needed to evaluate the requests has shrunk by 34% compared to 2018, which results in a quicker endorsement of the Pharmacy. The management of medical devices samples generated a saving of € 88,000, related to the 80% of devices (for which it was possible to determine the price).
Conclusions The increase of requests demonstrates a good outcome towards the procedure revision. Redefinition of tasks optimized the Hospital Pharmacist role on the procedure, saving time in managing demands, and giving space and focus on documents evaluation and device-vigilance.
Key words: Medical device, free samples management, authorization procedures, flow chart, economic impact