Standard for the use of disposable medical devices
- Jul 28, 2017 -

The use of disposable medical devices requires strict compliance with the following six systems:


1. The establishment of sterile equipment procurement, acceptance system, strict implementation and record. Purchase inspection records should include at least: the purchase of the product name, product name, model specifications, product quantity, production batch number, sterilization lot number, product validity period. According to the record should be able to trace the purchase of each batch of sterile equipment source.


2. From the production or operation of enterprises to purchase sterile equipment, should verify the production or business necessary documents (production license, product registration card, business license), the legal status of sales staff.


3. Establish a system for the destruction of sterile equipment. Used sterile equipment must be destroyed as required, the parts no longer have the use of the function due to disinfection harmless treatment, and make a record.


4. If you find a small package has been damaged, unidentified aseptic equipment, should immediately stop using, storage, and timely contact with the manufacturer, to be replaced.


5. If you find unqualified sterile equipment, should immediately stop using, storage, and timely contact with the manufacturer, to be replaced.


6. The use of sterile equipment, suspicious adverse events, should be required in a timely manner to report the provincial medical device adverse event monitoring center.


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