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本帖最后由 石桥wshh1975 于 2019-7-5 09:29 编辑
1. What is a multi-dose vial?
A multi-dose vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that contains more than one dose of medication. Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
多剂量药物（vials:西林瓶或安瓿）是指用于胃肠外用药（注射或infusion）的液体药物小瓶，包含超过一次剂量的药物。多剂量药物（vials:西林瓶或安瓿）有制造商标注，典型的含有抗菌保存药物以阻止微生物生长。但保存剂对于病毒没有效果，也不能用于防护因医务人员安全注射落实不到位导致的污染。
2. Can multi-dose vials be used for more than one patient? How?
Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area (e.g., nurses station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use only.
多人份药物（vials:西林瓶或安瓿）应尽可能专人专用。如果多人份药物不得不多人共用，药物只能保存在专门的药物配制区域（如护士站），不得进入诊疗操作区（immediate patient treatment areas）。以避免直接或间接接触物表、设备的潜在污染，而导致继发的感染。如果多人份药物进入了诊疗操作区（immediate patient treatment areas），则必须专人专用。
3. What are examples of the “immediate patient treatment area”?
Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays.
如手术间、操作间、麻醉间、操作车、病室或隔间都属于诊疗操作区（immediate patient treatment areas）
4. Our hospital uses bar code technology that requires scanning of medication vials and drawing up medication in the patient room. If multi-dose vials (e.g., insulin) are dedicated for single-patient-use only, can they be accessed in the patient room?
Ideally, from an infection control perspective, all medication preparation should occur in a dedicated clean medication preparation area (e.g., nurses station), away from immediate patient treatment areas. However, if there is a need to access multi-dose vials in the patient room (e.g., for the purposes of bar-coded medication administration) the vial must be dedicated for single-patient-use only, the patient should be housed in a single-patient room, and all medication preparation should be performed in a designated clean area that is not adjacent to potential contamination sources (e.g., sink, used equipment). Following medication preparation, the vials should be stored, in accordance with manufacturer’s instructions, in a manner to prevent inadvertent use for more than one patient and/or cross-contamination.
我们医院使用条码技术，需要到病室（患者的房间）加药，如果多剂量药物（如胰岛素）专人专用，可否带至病室？
理想情况下，从感控角度看，所有药物的配制均应在专门的清洁配药区（如护士站），而不应在诊疗操作区。但是，如果需要将多剂量药物带到病室（如条码配药管理），药物必须且只能专人专用，患者必须住单人间，所有药物的配制必须在划定的清洁区，不得靠近潜在污染源(如水池、使用中的设备）。药物配制后，药瓶应根据制造商的要求储存，且应采取有效措施避免该药物用于其他患者和/或交叉污染
5. When should multi-dose vials be discarded?
Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. In addition, the United States Pharmacopeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:
If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date.
The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer’s original expiration date.
5.多剂量药物何时废弃？
药物的无菌状态被破坏或不能确定时应废弃药品，另外，美国药典（USP）总则797建议遵守以下要求：
如果多剂量药物打开或取用（如针刺抽吸），该药物应标明开启日期，有效期28天，除非制造商特别说明
如果多剂量药物未开启或取用（如针刺抽吸），根据制造商的失效期丢弃
制造商的失效期指的是多剂量药物未开启状态下不能使用的日期。最大使用期限（beyond-use-date）是指药物开启后的使用时间，最大使用期限（beyond-use-date）不得超出失效期
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