Experience in using standardization of disposable medical devices

Summary:

Establish a sterile equipment procurement and acceptance system, strictly implement it and keep records. The purchase acceptance record should at least include

Release Date:

Oct 19,2021

1 Establish a sterile equipment procurement and acceptance system, strictly implement it and keep records. The purchase acceptance record should at least include: the name of the company purchasing the product, product name, model specification, product quantity, production batch number, sterilization batch number, product expiration date, etc. According to the records, the source of purchase of each batch of sterile instruments should be traced.

2 Purchasing sterile instruments from production or operation enterprises, the necessary documents (production license, product registration certificate, operation license) and the legal identity of the sales personnel should be verified.

3 Establish a system for destroying sterile instruments after use. The used sterile instruments must be destroyed in accordance with regulations, and the parts and components that no longer have the function of use have been disinfected and harmlessly treated, and records should be kept.

4 If a sterile instrument with a damaged small package and unclear label is found, immediately stop using it, seal it up, and contact the manufacturer in time to replace it.

5 If unqualified sterile instruments are found, they should immediately stop using them, seal them up, and contact the manufacturer in time to replace them.

6 When a suspicious adverse event occurs when using a sterile device, it should be reported to the Provincial Medical Device Adverse Event Monitoring Center in a timely manner as required.

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