CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

From FDA US Web site FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products. If you wish to find a Class II or Class III recall, you can search the  CDRH Recalls Database .   Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice. Learn more about   medical device recalls here . Click here for> medical devices recalls

Aggiornamento al 28 Dicembre 2015 LINK> AVVISI SITO MINISTERO SALUTE

Il Ministero della Salute  già nel 2007  ha reso disponibile per tutti gli operatori sanitari un glossario per la sicurezza dei pazienti e per la gestione del rischio clinico, elaborato da esperti, che hanno tenuto conto dei documenti fino ad oggi prodotti su tale tematica a livello nazionale ed internazionale. Quello che riproponiamo è l'ultimo glossario che pur essendo del 2013 è ancora oggi poco conosciuto. Clicca qua> per andare al documento (Versione scaricabile non ufficiale) C licca qua> per andare alla versione pubblicata sul sito del Ministero della Salute

(From Ue Web Site http://publications.europa.eu/en/applications) You can now learn how to behave safely in the digital world by playing the Happy Onlife game. This engaging game aims at supporting children aged 8-12 — along with involving their parents and teachers — in initiating active mediation of digital technology. Quiz questions embedded in the game on use of the internet, social networks and online games are designed to prompt discussion between players and empower them to be responsible and safe when using digital media. The game presents key messages about children's use, overuse and misuse of the internet, together with risks such as cyberbullying. It also presents simple and clear strategies of prevention, mediation or remediation of internet issues. Link to Happy Onlife>Click Here

Many products require CE marking before they can be sold in the  EEA  ( EU + Iceland, Lichtenstein and Norway). CE marking proves that your product had been assessed and meets EU safety, health and environmental protection requirements. It is valid for products manufactured both inside and outside the EEA, that are then marketed inside the EEA. To affix the CE marking to your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. Once your product bears the CE marking, you might have to provide your distributors and/or importers with all the supporting documentation concerning CE marking. More information>Click Here