The Italian Ministry of Health published in August 2020 its first report on the surveillance activity it carries out on medical devices to ensure only safe and effective devices are circulating on the national territory.
The monitoring and vigilance of medical devices is one of the duties the Ministry fulfills as a national Competent Authority (CA).
This duty is carried out in collaboration with all the involved stakeholders, especially manufacturers, distributors, and health workers who play an active role in reporting the incidents to the Ministry. This allows the CA to carefully analyze each episode and, when necessary, implement measures to prevent similar incidents from happening again and ensure the health and safety of the final users.
The 2018 Report
The Report analyzes data from 2018, as recorded by the system of national surveillance on medical devices (in-vitro diagnostic medical devices excluded), following notices from healthcare professionals and manufacturers.
According to the Italian Ministry of Health, 6.068 incidents with medical devices were recorded in 2018, a stable number if compared to the one recorded in 2017 (6.107 cases, -0,6%), but still growing when compared to 2016 (5.086 cases, +20%), a trend that the Ministry attributes to the growing awareness of manufactures and health workers towards the importance of the surveillance system.
The data is organized according to the national classification of medical devices (CDN), a system that groups devices into homogenous classes according to their diagnostic and/or therapeutic purpose. Whenever the incident report lacked certain information on the device involved (such as the device’s commercial name, batch code, etc.), the device has been ascribed to the “Undefined Category”.
The table below shows the data on the incidents reported in 2018 per Medical Device category:
|
Device |
Incidents |
|
Devices for |
478 |
|
Hematology and hemotransfusion devices |
21 |
|
Cardiocirculatory devices |
437 |
|
Disinfectants, |
1 |
|
Dyalisis devices |
58 |
|
Gastrointestinal devices |
47 |
|
Sutures |
127 |
|
Active-implantable |
1640 |
|
Endotherapy and electrosurgical devices |
60 |
|
Reusable surgical instruments |
22 |
|
Devices for generic |
48 |
|
Devices for nervous and medullar systems |
9 |
|
Implantable |
1297 |
|
Dental, ophthalmologic |
20 |
|
Respiratory and anaesthesia devices |
51 |
|
Sterilization devices |
1 |
|
Protection devices |
52 |
|
Medical devices, urogenital apparatus |
52 |
|
Medical devices – varius |
31 |
|
Supports or technical |
16 |
|
Medical equipment and |
802 |
|
Category undefined |
798 |
|
Tot. |
6068 |
Source:Rapporto sulle attività di vigilanza sui dispositivi medici (2018).
Overall, the categories that reported the highest number of incidents were:
· Active Implantable devices (27%);
· Implantable prosthetic and osteosynthesis devices (21%);
· Medical equipment and related accessories and materials (13,2%);
· Devices for collecting, administering, and picking (7,9).
With the exclusion of the “unrefined category”, the abovementioned four categories amounted to 77% of all incidents reported.
The below graphs show the composition of the two most involved categories according to the Report:
Source: Adaptation of data from Rapporto sulle attività di vigilanza sui dispositivi medici (2018).
Source: Adaptation of data from Rapporto sulle attività di vigilanza sui dispositivi medici (2018).
Out of 6.068 incidents reported, only 4,3% led to consequences for human health.More specifically, 1,7% resulted in death of the patient; all the other resulted in an unforeseen worsening of the health condition of the patient or a serious public health risk.
Notably, the majority of the most serious incidents involved implantable prosthetic and osteosynthesis devices, amounting to 34% of the total death cases, followed by active implantable devices (21%) and cardiocirculatory devices (18%).
Regional discrepancies
It must also be noted that the Report underlines that more than half of the incidents (54%) were reported by just 4 Italian Regions (Lombardy, Emilia-Romagna, Veneto, and Tuscany). There is therefore a territorial lack of homogeneity, which leads the Ministry to presume a strong phenomenon of under-reporting across the Italian territory.
Laura Menozzi
Regulatory Affairs Department
26/10/2020
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References:
Ministero della salute (2018). Rapporto sulle attività di vigilanza sui dispositivi medici. Sintesi dei dati rilevati dal ministero della salute con la banca dati dispovigilance. Retrieved on 26/10/20 from http://www.salute.gov.it/imgs/C_17_pubblicazioni_2940_allegato.pdf