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Disposable Medical Device

- May 04, 2018 -

The use of disposable medical devices requires strict adherence to the following six systems:

1. Establish a system for the procurement and acceptance of sterile instruments, strictly enforce and record. The purchase acceptance record shall include at least the name of the company that purchased the product, product name, model specification, product quantity, production lot number, sterilization batch number, and product expiration date. According to the records should be able to trace the source of the purchase of each batch of sterile equipment.

2. Procurement of sterilized equipment from a production or business enterprise shall verify the necessary documents (production license, product registration certificate, business license) of the production or enterprise, and the legal status of the salesperson.

3. Establish a post-use destruction system for sterile devices. Used sterilized instruments must be destroyed according to regulations. Parts that are no longer functional are sterilized and harmless.

4. If it is found that the small package has been damaged, the identification of unclear sterile equipment, should immediately stop using, sealed, and timely contact with the manufacturer to be replaced.

5. If unqualified sterilized instruments are found, they shall be immediately stopped from use, sealed, and promptly contacted by the manufacturer to be replaced.

6. When using a sterile device to produce suspicious adverse events, the provincial Medical Device Adverse Event Monitoring Center shall be promptly reported as required.



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