A brief analysis of the classification rules of medical dressings

Medical dressing is a common medical device, which plays an important role in the medical and health field and is widely used. It is mainly used to clean and cover the wound surface, absorb exudate from the body, and provide a healing environment for the wound surface. Some medical dressings can also be used to support organs or tissues. At present, common medical dressings on the market include medical absorbent gauze, medical absorbent cotton, and band-aids. In recent years, with the continuous development of technology in the field of medical dressings, medical dressings with new materials and new functions continue to emerge, such as chitosan dressings, biological dressings, foam dressings, etc.

Not managed as a medical device

1. Medical dressings contain chemical components, Chinese medicinal materials, and their extracts, etc., and the components contained only play a pharmacological, immunological or metabolic role, and the main role is played by drugs. It does not clean and cover the wound surface, absorb body exudate, and provide a healing environment for the wound surface.

For example: wound dampness pain relief patch, this product uses medical pressure-sensitive adhesive and natural edible tortoise grass as the main raw materials, and is coated on the medical non-woven substrate, and the surface is covered with polytetraethylene polymer material as a protective film surface. For the sequelae of bone injury, pain caused by osteoarthritis. Because the main function of edible turtle leaf grass in the product is to achieve the purpose of relieving pain, it is not managed as a medical device.

2. Medical dressings not only play the role of pharmacology, immunology or metabolism, but also have the role of medical devices, but the main role is played by drugs.

For example: povidone-iodine wound dressing, the product contains the antibacterial drug povidone-iodine, mainly through the pharmacological action of povidone-iodine to protect the wound from being polluted, so it is not managed as a medical device.

Managed as a medical device

1. Medical dressings not only play the role of pharmacology, immunology or metabolism, but also have the role of medical devices, among which medical devices play the main role.

For example: iodine-containing wound cleaning gel, the product mainly plays the role of absorbing wound exudate, cleaning and protecting the wound, and the iodide contained in the product plays an auxiliary role in reducing the bacteria on the wound surface. Therefore, it is managed according to Class III medical devices.

2. The ingredients contained in medical dressings do not exert pharmacological, immunological or metabolic effects, and meet the definition of medical devices and are managed as medical devices.

a. It is intended to be used for normal skin, to play a role in physical therapy, without other additives, and to have therapeutic or adjuvant medical dressings.

For example: far-infrared plaster, the product contains far-infrared material with non-pharmaceutical ingredients, and is used for the treatment of neck, shoulder, waist, leg and joint pain after absorbing heat through the far-infrared material. In accordance with the management of Class II medical devices.

b. Non-sterile medical dressings intended for use on superficial human body wounds.

For example: Band-Aid (without medicine), the product is made of polyurethane composite film or non-woven fabric coated with adhesives such as medical pressure-sensitive adhesive, is non-sterile, and is used for small superficial wounds and abrasions etc. application. Managed in accordance with Class I medical devices.

c. Sterile medical dressings intended for use on superficial human body wounds, or medical dressings intended for first-degree or superficial-second-degree burn wounds.

Example: Transparent fixed dressing, the product is composed of polyurethane film backing and hypoallergenic acrylic adhesive, which is a sterile single-use product. Used to protect the wound and fix the catheter at the puncture site. In accordance with the management of Class II medical devices.

d. Medical dressings intended to be used in the human body, or for wounds with damaged superficial dermis (excluding superficial II burn wounds), or deep II or III degree burn wounds.

For example: foam dressing, which is composed of sterile polyurethane foam and hydrocolloid adhesive, is used for wounds with more exudation and deep wounds, as well as wounds such as burns and donor sites, to provide a moist environment and promote wound healing. Managed in accordance with Class III medical devices.

e. Medical dressings with an anti-adhesion function, or a function of promoting tissue proliferation and/or a function as a temporary skin substitute, or that can be absorbed in whole or in part by the human body

For example: intrauterine anti-adhesion sponge, the product is composed of chitosan, deionized water, PVF sponge, etc. It has an anti-adhesion function and is used to prevent endometrial adhesion, so it is managed as a Class III medical device.