Italy

The Italian Ministry of Health published a report presenting the expenditure on medical devices for the national healthcare system at 2016. On a total healthcare expenditure for goods and services of 17.6 billion of Euros, 5.8 billion (33%) are related to medical devices.

Regional guidelines on the use of leadless pacemakers within the region have been released by the technical committee for medical devices in Veneto.

Assobiomedica published a report presenting the status of the ventilation and monitoring equipment installed across the public and private hospitals at 2016. The scenario pictured by the analysis appears to be critical considering the high number of units older than 10 years.

Emilia Romagna Region announced the launch of two new series of documents, according to the new regional assessment framework for medical devices developed during 2017: rapid assessment reports and preliminary information reports.

Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.

Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

The analyses were performed on the 2015 data from 16 Regions, on the basis of 35 indicators. According to the score assigned, Regions were classified as “compliant” (i.e., score ≥ 160 or between 140 and 160 with no critical values in any of the indicators) or “non-compliant” (i.e., score < 140 or between 140 and 160 with at least one critical value in one of the indicators). Overall results showed that the Country is split into two sections: Regions in the north were all compliant while those in the south, with the only exception of Basilicata, showed suboptimal performances.

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.

A list of scientific societies and technical and scientific medical associations appointed to release national guidelines will be defined in the next months by the Ministry of Health, following its decree issued on 2nd August 2017.

The previous regional guidelines on brain stimulation therapy for advanced Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy, published in 2014, have been updated by the Regional Technical Commission for Medical Devices considering the new evidence on the specific groups of patients and some modifications in the indications for use of some devices. Check out indications for different neurostimulator technologies. These recommendations will form the foundation for reimbursement of devices in the region.