Definition and types of High Quality Medical Consumables

　　Definition of High Quality Medical Consumables: refers to the consumable Medical devices approved by the drug regulatory department for limited use, including disposable and reusable High Quality Medical Consumables.

　　Types of High Quality Medical Consumables

　　There are many types of High Quality Medical Consumables required for medical activities, and the classification standards are not the same. Most hospitals classify them according to their own actual work conditions. Common classification methods include the following:

　　1. Classification by value

　　High Quality Medical Consumables are complex in specifications and vary widely in price. In daily management, in order to achieve targeted management and better management effect, High Quality Medical Consumables are generally divided into low value consumables and high value consumables according to the value of consumables and combined with clinical practical application.

　　1) Low-value consumables refer to sanitary materials (such as infusion sets, syringes and dressings) with relatively low unit price and without implantation or intervention in the human body. Low-value consumables are commonly used in hospital departments. Although the unit price is relatively low, such consumables are in great demand and widely used in departments. They are basic consumables needed to carry out routine diagnosis and treatment activities in hospitals, and occupy a large amount of warehouse space and inventory cost in hospitals (the cost of low-value consumables in third-level general hospitals accounts for about 1/3 of the total cost of consumables).

　　2) High-value Medical Consumables refer to High Quality Medical Consumables that directly affect the human body, have strict requirements on safety, have large clinical usage, have relatively high price, and have heavy cost burden on patients, including vascular intervention, orthopedic implantation, neurosurgery, electrophysiology, pacemaker, etc. This kind of consumables are mostly specialized materials, relatively low value consumables, less use, but the price is expensive, occupy the hospital master working capital and inventory costs.

　　2, according to the use of classification

　　According to the different use of High Quality Medical Consumables in clinical medical activities, high quality medical consumables can be divided into seven categories, including injection and puncture and polymer materials, medical hygiene materials and dressings, some common medical instruments in operating rooms, medical X-ray accessory equipment and components, dialyzer and dialysis pipeline, and intraocular lens. And special consumables such as catheter, guide wire and stent for clinical departments.

　　3, according to the degree of risk classification

　　The Regulations on the Supervision and Administration of Medical Devices issued by The State Council in 2021 classifies medical devices according to the degree of risk. High Quality Medical Consumables, as part of medical devices, can be categorized by reference.

　　The first category is medical devices with low risk, which can be guaranteed safe and effective by routine management.

　　The second category is the medical devices with moderate risks, which need strict control and management to ensure their safety and effectiveness.

　　The third category is the medical devices with high risk, which need to take special measures for strict control and management to ensure their safety and effectiveness.

　　In evaluating the risk degree of medical devices, factors such as the expected purpose, structural features and use methods of medical devices should be taken into account.

　　4. Classify by characteristics

　　In the daily management of High Quality Medical Consumables, they can be classified according to their characteristics.

　　1) Consumables are divided into implantable consumables and non-implantable consumables according to whether they can be implanted in human body;

　　2) Consumables can be divided into domestic consumables and imported consumables according to the production area;

　　3) Consumables can be divided into inventory management consumables and customized consumables according to whether specifications can be determined before surgery (such as bone plates, bone nails and other consumables can only be determined during surgery);

　　4) It can be divided into disposable consumables and repeatable consumables according to whether they can be reused.

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