35th COMPETENT AUTHORITY MEDICAL DEVICE

Ministero della Salute
Ministero della Salute
35th COMPETENT
AUTHORITY MEDICAL
DEVICE MEETING
The Medical Device Vigilance System in Italy
Rosaria Boldrini
Head of Unit V
General Directorate of medical devices and pharmaceutical service
Ministry of Health
Rome, 16th October 2014
Medical Devices integrated sector
Medical devices sector is extremely complex. It is characterized by an high level of
dynamism, heterogeneity of products, high number of actors and organic legislation
Manufacturers
Vigilance System
Clinical Investigations
Medical Device
Market Surveillance
NHS Expenditure on MD
EC Certificates
Post-market
Pre-market
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Ministero della Salute
The focus of this section
In this section we will focus on the Medical Device Vigilance System in Italy
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Ministero della Salute
Principal purpose
The principal purpose of the Medical Device Vigilance System is to improve the
protection of health and safety of patients, users and others by means of:
The rapid identification of each new problem in order to identify corrective
actions
The sharing of information between Competent Authorities
manufacturers to obtain a timely application of corrective actions
and
The monitoring of an effective and correct implementation of corrective
actions
The prevention of the reiteration of similar incidents thanks to the
implementation of appropriate corrective measures and the
publication of warnings
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The actors involved
There are several actors from different institutional levels involved in the Medical
Device Vigilance System
National
Competent
Authorities in
UE Member
States
Italian
Ministry of
Health
Healthcare
professionals
Regions
Healthcare
Local
Authority
Italian and
foreign
manufacturers
MEDICAL DEVICE VIGILANCE SYSTEM
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Ministero della Salute
Dispovigilance - Main features
“Dispovigilance” is the IT System to support the Medical Device Vigilance System.
It is designed to manage data on incidents related to medical devices, FSCA (Field
Safety Corrective Actions), NCAR (National Competent Authority Reports) and the
transmission of data to the European database Eudamed. The system also allows
the management of FSNs (Field Safety Notice) and gives the possibility to publish
them on the Italian Ministry of Health website, for online consultation by the
operators and citizens.
Incident
Management
Corrective actions
Alert Management
Medical Device
Vigilance System
Data transmission
to Eudamed DB
NCAR
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Recent update of the Medical Device Vigilance System
During 2014, we have implemented additional features in Dispovigilance in order to
meet the requests of the Italian Regions for a centralized system able to improve the
information’s circulation. This is the first step to create a national network.
The main updates are:
Online Incident Report forms for healthcare professionals and Manufacturers
NCAR uploads
New access credentials for Italian Regions and Local Health Authorities
XML file and a csv file generation for data acquisition for different regional DB
Reports for data consultation
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New online incident report form – Healthcare professional
a)
Assisted search of healthcare facilities and medical devices in national
databases. Pre-filled sections of the form
b)
Mandatory fields and data consistency validation to ensure the quality and
the integrity of data entries
The new online report allows the user to send event highlights to the Ministry of
Health. The process is divided into 4 steps:
Data entry of
the
information
regarding
the place of
the event
Data entry of
the
information
regarding
the medical
device
Data entry of
the
information
regarding
the event
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Data entry of
the
information
regarding
the compiler
Ministero della Salute
New online incident report form – Healthcare professional (1/4)
The online reports are sent by
each health facility:
-Hospitals
-Community care facilities
-Pharmacies, GP , Clinics (LHA)
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New online incident report form – Healthcare professional (2/4)
The identification of medical
device is guaranteed by the
"Identifying registration number"
used in the Italian Databank of
Medical Device
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New online incident report form – Healthcare professional (3/4)
The main information about the
event are requested
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New online incident report form – Healthcare professional (4/4)
The main information about the
compiler are requested
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How to send the report
Creation of the
Sending the report
report in .pdf
clicking the
Ministry of Health
"Invia
webpage Compilation of
Rapporto"
online report
button
Information at:
http://www.salute.gov.it/portale/temi/p2_5.jsp?lingua=italiano&area=dispositivi-medici&menu=vigilanza
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Online Incident Report form for Manufacturers
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EUDAMED NCAR upload
It’s now possible to upload NCAR reports downloaded from Eudamed
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Functionality of consultation data
The new profiles can browse the incident related data. In addition, it will be possible
to consult the outcome of the investigation once the report has been completed by
the Ministry of Health.
Outcome of the report
Research on the reports
Results
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Italian Regions data download
The Italian Regions can download data on their incidents in .xml or .csv files
Monitoring function of the
researches
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The expected benefits
Optimization of the
investments
Centralized
National MD
Vigilance
System
European MD
Vigilance
Operatore
System
The centralized system
allows the optimization of
investments
since
any
adjustments for compliance
with the European system
would be provided by the
Central Administration.
Information sharing
Integration with the Medical
Devices Consumption
National DB
Italian
Ministry of
Health
Healthcare
professionals
Segnalazione
Centralized
Regions
National MD
Vigilance
System
Local Health
Authoritiy
The new profiles “Regions” and
“Local Health Authorities” allow
better sharing of information
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Centralized
National MD
Vigilance
System
Medical Devices
Operatore
Consumption
National BD
The Medical Device Vigilance
System is linked with both the
National Repertory of Medical
Devices and the Medical
Devices Consumption National
DB. These links allow to analyze
the risks of medical devices
taking into account the
frequency of use and the
potential users involved.
Ministero della Salute
Italian data on Vigilance System
Incident's
Year
2012
2013
2014
ND
Total
Manufacturer
Report
Healtcare
Manufacturer & Healthcare All Incident
professional Report
professional Report
Reports
920
1339
1369
386
4014
828
519
679
122
2148
19
249
295
243
23
810
1997
2153
2291
531
6972
Ministero della Salute
Italian data on Vigilance System
Incident Reports by first level of CND (National Classification of Medical Devices)
Multi-level hierarchical classification
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Ministero della Salute
Thank you for your attention!
Rosaria Boldrini
Head of Unit V
General Directorate of medical devices and pharmaceutical service
Ministry of Health
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Ministero della Salute

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