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Reflections on the inclusion of surgical gowns, surgical orders, etc. in the management of Class II medical devices
2023-07-10

As a necessary protective clothing during the operation, the surgical gown is used to reduce the risk of medical personnel contacting pathogenic microorganisms, and also to reduce the risk of the mutual transmission of pathogenic microorganisms between medical personnel and patients. It is a Safety barrier in the sterile area during the operation.
The National Health Commission has issued a notice on the issuance of basic standards and management norms for three types of medical institutions, including medical disinfection supply centers (for trial implementation), requiring disinfection supply institutions that provide services to medical institutions to obtain a "Medical Institution Practicing License" and to provide wearable, breathable, and waterproof surgical gowns, surgical orders, etc A foldable infection control instrument with bidirectional protection function that conforms to the classification catalog of surgical instruments is defined as a "soft instrument".
As a necessary protective device during the surgical process, soft instruments are used to reduce the risk of contact between medical personnel and patients with pathogenic microorganisms, reduce the infection rate of the surgical site, improve medical quality, and shorten patient hospitalization time.
When using soft devices managed according to the second category of medical devices, the principle of "four no one strict" should be followed:
Surgical gowns or sheets with damage, holes, or tears should not be used;
Unsterilized surgical gowns and sheets should not be used;
Do not use surgical gowns or sheets that have obvious fading or aging;
Surgical gowns and sheets should not be used beyond their expiration date (frequency);
Strictly follow the product's cleaning, disinfection, and sterilization procedures for reprocessing.

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