1、目的


                                                                                                                                                           


通過對事故的及時報告和評估并發布相關信息，以降低同類事故的重復發生，使病人或使用者的安全及健康得以保護。    


                                                                                                                              


2、范圍


                                                                                                                                          


本程序規定警戒系統控制的職責、工作程序、內容和要求。


                                                                                                                                               


本程序適用于帶有CE標志的產品和不帶CE標志的產品，但事故會導致采取與帶有CE標志有關產品的糾正措施以及歐盟市場出現事故及報告的責任。



 


本程序同時適用于帶有CE標志的產品在歐盟以外國家發生的事故。


                                                                                                                                                                              


3、職責


                                                                                                                                          


3.1制造商的職責：收到事故通知后進行處理，確定責任部門和歐盟授權代表及主管當局的關


系。


                                                                                                                                            


3.2歐盟授權代表的職責：收到事故信息及時通知制造商并協助其處理，同時向歐盟所在國主


管當局遞交初始報告、調查結果及最終報告。


                                                                                                                                            


3.3銷售商的職責：及時把顧客的抱怨和事故報告傳遞給制造商，并負責保存產品的售銷記錄。


                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1管理者代表負責對事故報告信息進行分析，技術部、質檢部、生產部會同調查后，確定需


要報告主管當局的事項。


                                                                                                                                            


4.2制造商在決定某項事故是否需要報告主管當局時，應考慮如下方面因素：                                                                                                                                         


a）事故的類型；                                                                                                                                            


b）是否與制造商生產的任何醫療器械有關；                                                                                                                                               


c）事故是否有或可能有因器械或提供的有關器械的信息的缺陷引起的。



 


4.3管理者代表針對事故符合以下特征之一或組合時，應向主管當局報告。


                                                                                                                                  


4.3.1 導致死亡。


                                                                                                                                                            


4.3.2 導致健康嚴重受損。


a）嚴重威脅生命的疾病或損傷。                                                                                                                                                     


                                                                          



 
  b）身體功能的永久性損傷或身體組織的永久性損傷。


  c）需要醫療或外科手術以避免對人體功能或人體組織的永久性損傷。 


                                                                                            


4.3.3 會導致死亡或健康嚴重惡化，但僥幸沒有發生的事故（稱為“準事故”）或發現器械


方面的缺陷。


                                                                                                                                            


4.4在評估本廠產品和事故的關系時，應考慮：                                                                                                                                                


a）醫生或專家的觀點（基于所得到的證據）；                                                                                                                                             


b）以前類似事故的證據；                                                                                                                                              


c）本公司對事故初步評估結果；                                                                                                                                                     


d）本公司掌握的其它信息證據。


                                                                                                                                  


4.5事故報告中的信息，可能包括以下方面：


                                                                                                                                                            


4.5.1 器械性能和/或特性的失靈或變質。 


                                                                                                                                                  


4.5.2 器械沒有失靈或變質，但某一特性可能會導致事故，則應做一件“準事故”報告。



 


4.5.3 器械的說明書不夠確切，或有遺漏或不足。


                                                                                                                                                            


4.6事故報告的時間限制                                                                                                                                                             


制造商在收到事故通知后，由管理者代表組織，在完成了初步評估報告后，應在下列的規定時間內通知主管當局：