外来手术器械管理制度.docxVIP

外来手术器械管理制度

目录

一、总则....................................................3

1.1制定目的.............................................3

1.2适用范围.............................................4

1.3管理原则.............................................4

二、职责分工................................................5

2.1采购部门职责.........................................5

2.2质量管理部门职责.....................................6

2.3使用部门职责.........................................8

2.4消毒供应室职责.......................................8

2.5医疗废物处理部门职责................................10

三、采购管理...............................................11

3.1采购申请............................................12

3.2供应商选择与评估....................................13

3.3采购合同签订........................................14

3.4质量验收............................................15

四、储存与分发管理.........................................16

4.1储存条件............................................17

4.2标识与记录..........................................18

4.3分发流程............................................18

4.4出库管理............................................19

五、消毒与灭菌管理.........................................20

5.1消毒方法............................................21

5.2灭菌方法............................................22

5.3消毒灭菌效果监测....................................23

5.4消毒灭菌记录........................................24

六、使用与维护管理.........................................25

6.1使用规范............................................27

6.2维护保养............................................28

6.3使用记录............................................29

七、报废与回收管理.........................................29

7.1报废标准............................................30

7.2报废流程............................................31

7.3回收处理............................................32

八、质量监控与改进.........................................33

8.1质量监控措施........................................35

8.2不良事件报告................................