1、目的


                                                                                                                                                           


通過對事故的及時報告和評估并發(fā)布相關(guān)信息，以降低同類事故的重復(fù)發(fā)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(guī)定警戒系統(tǒng)控制的職責(zé)、工作程序、內(nèi)容和要求。


                                                                                                                                               


本程序適用于帶有CE標(biāo)志的產(chǎn)品和不帶CE標(biāo)志的產(chǎn)品，但事故會導(dǎo)致采取與帶有CE標(biāo)志有關(guān)產(chǎn)品的糾正措施以及歐盟市場出現(xiàn)事故及報告的責(zé)任。



 


本程序同時適用于帶有CE標(biāo)志的產(chǎn)品在歐盟以外國家發(fā)生的事故。


                                                                                                                                                                              


3、職責(zé)


                                                                                                                                          


3.1制造商的職責(zé)：收到事故通知后進行處理，確定責(zé)任部門和歐盟授權(quán)代表及主管當(dāng)局的關(guān)


系。


                                                                                                                                            


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


管當(dāng)局遞交初始報告、調(diào)查結(jié)果及最終報告。


                                                                                                                                            


3.3銷售商的職責(zé)：及時把顧客的抱怨和事故報告?zhèn)鬟f給制造商，并負(fù)責(zé)保存產(chǎn)品的售銷記錄。


                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1管理者代表負(fù)責(zé)對事故報告信息進行分析，技術(shù)部、質(zhì)檢部、生產(chǎn)部會同調(diào)查后，確定需


要報告主管當(dāng)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(dāng)局時，應(yīng)考慮如下方面因素：                                                                                                                                         


a）事故的類型；                                                                                                                                            


b）是否與制造商生產(chǎn)的任何醫(yī)療器械有關(guān)；                                                                                                                                               


c）事故是否有或可能有因器械或提供的有關(guān)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(yīng)向主管當(dāng)局報告。


                                                                                                                                  


4.3.1 導(dǎo)致死亡。


                                                                                                                                                            


4.3.2 導(dǎo)致健康嚴(yán)重受損。


a）嚴(yán)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(yī)療或外科手術(shù)以避免對人體功能或人體組織的永久性損傷。 


                                                                                            


4.3.3 會導(dǎo)致死亡或健康嚴(yán)重惡化，但僥幸沒有發(fā)生的事故（稱為“準(zhǔn)事故”）或發(fā)現(xiàn)器械


方面的缺陷。


                                                                                                                                            


4.4在評估本廠產(chǎn)品和事故的關(guān)系時，應(yīng)考慮：                                                                                                                                                


a）醫(yī)生或?qū)＜业挠^點（基于所得到的證據(jù)）；                                                                                                                                             


b）以前類似事故的證據(jù)；                                                                                                                                              


c）本公司對事故初步評估結(jié)果；                                                                                                                                                     


d）本公司掌握的其它信息證據(jù)。


                                                                                                                                  


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(zhì)。 


                                                                                                                                                  


4.5.2 器械沒有失靈或變質(zhì)，但某一特性可能會導(dǎo)致事故，則應(yīng)做一件“準(zhǔn)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(yīng)在下列的規(guī)定時間內(nèi)通知主管當(dāng)局：