What is the situation of medical excipients based on the management of medical devices?

Release time:

2023-12-14

Medical excipients include natural gauze, synthetic fiber, polymer film, foam polymer, hydrocolloid, alginate excipients, etc.

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Medical excipients are consumables packaged to cover wounds, wounds, or other damaged medical materials. With the in-depth study of the pathophysiology of wound healing process, the understanding of wound healing process has also deepened, leading to the continuous improvement and development of medical wound hyperthermia. Today, compared to the early days, new wound treatment dressings have undergone revolutionary changes, with various performance medical dressings available for clinical nursing staff to choose from. At present, alginate is an international medical excipient.

What is the situation of medical excipients based on the management of medical devices?

(1) Medical excipients not only have pharmacological, immunological, and metabolic effects, but also have the function of medical devices, among which medical devices play a major role.

For example, iodine wound cleaning gel is mainly used to absorb wound penetration and clean and protect wound. Iodide contained in the product can reduce bacteria on wound surface. Therefore, according to the level of medical device management.

(2) Medical excipients include pharmacology, immunology, and non metabolizing components, which are managed according to the definition of medical devices.

Medical dressings intended for normal skin, with physical therapeutic effects, without other additives, and with therapeutic or adjuvant therapeutic effects.

For example, far-infrared patches are far-infrared materials containing leap components that absorb heat through far-infrared materials and are used to treat the neck, shoulders, waist, and legs. According to the management of medical devices.

Expected to be used for surface wound materials in the human body, it is a medical dressing rather than a sterile one.

For example, band aids (excluding drugs) are products made of polyurethane composite films or non-woven fabrics coated with medical pressure-sensitive adhesives and other adhesives. They are not sterile and are used for shallow wounds or abrasions. According to the management of medical devices.

Expected to be used for surface material wounds in the human body, it is a sterile medical dressing or a medical dressing for 1 degree or shallow 2 degree wounds.

For example, transparent fixed dressings are composed of polyurethane film lining and low sensitivity adhesive acrylic adhesive, using disposable sterile products. To protect the wound, fix the catheter at the puncture site. According to the management of medical devices.

4. Wounds that are damaged inside or on the surface of the human body (excluding superficial wounds), or medical dressings intended for use in wounds of varying depths or degrees.

For example, foam dressings are composed of sterile polyurethane foam and colloidal adhesive, which can penetrate more wounds, deep wounds, bedding and other wounds to provide a moist environment and promote wound healing. According to the category of medical device management.

For example, medical dressings that have anti adhesion function, or promote tissue proliferation and/or temporary skin replacement function, or can be fully or partially absorbed by the human body. For example, the uterine cavity adhesive sponge is composed of chitosan, deionized water, PVF sponge, etc. It has the anti adhesion function of preventing endometrial adhesion in the uterine cavity and is managed by grade medical devices.

 

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