Consumables are the main force in the implementation of UDI. Among them, it is specifically divided into two categories: high-value consumables and low-value consumables. In this article, we will analyze the key points and differences between the implementation of UDI for high-value consumables and low-value consumables.
High-value consumablesAlso known as high-value medical consumables, it is a medical consumables that directly act on the human body, have strict requirements for safety, have a large amount of clinical use, are relatively high, and bear a heavy burden on the masses. These consumables can be divided into 10 categories according to the scope of application, such as industrial crystals, blood vessels, springs, and pacemakers.
Low-value consumablesAlso known as low-value medical consumables, it refers to the low-value disposable medical materials commonly used in hospitals in the process of carrying out medical services, including disposable syringes, infusion sets, blood transfusion sets, blood collection tubes, medical dressings, drainage bags, drainage tubes, indwelling needles, medical gloves, surgical sutures, etc.
Key points for implementing UDI for high-value consumables:
SecuritySince high-value consumables are directly related to the safety and health of patients, their safety and effectiveness are of paramount importance. Implementing UDI can help track and manage high-value consumables, ensuring their quality and safety.
Retrospective: The traceability of high-value consumables is at the heart of their management. The implementation of UDI can realize the full traceability of high-value consumables from production to use, which helps to identify and deal with problems in a timely manner.
Risk control: High-value consumables often involve a higher level of risk, such as implantable medical devices. Implementing UDI can help healthcare facilities and regulatory authorities conduct risk assessment and control of high-value consumables and reduce risk.
High-value consumables have the characteristics of fast update, high technical requirements, high risk, and high cost, and have been the focus of control in recent years and require refined management. The earliest types of medical devices that require the implementation of UDI are almost all high-value consumables, and the requirements for them are more stringent, generally requiring the realization of "one thing, one code".
Key points for the implementation of UDI for low-value consumables:
Low-value consumables such as disposable masks and other products, usuallyThe value of the product itself is not high, and the risk is low, but the production volume and sales volume are largeThe implementation focus is to solve the cost problem, the value of low-value consumables in the product itself is not high, the risk is also low, but the output and sales are very large, if each product is UDI coded, the efficiency of the product and the daily completion rate will be greatly affected, material costs, labor costs and so on will also be greatly improved.
If UDI is assigned to every low-value consumable product, the efficiency and daily completion rate of the product will be greatly affected, and the material cost and labor cost will also be greatly improved. In this case, it is recommended that enterprises adopt a batch of one-code UDI coding schemes for implementation, and at the same time, enterprises need to consider the transformation of production lines, and add automatic coding equipment and testing equipment to ensure the efficient production of products without increasing labor costs.
In short, the difference between the implementation of UDI for high-value consumables and low-value consumables is mainly due to the risk level, traceability requirements, output, cost, etc. Manufacturers should formulate a reasonable UDI implementation plan according to the actual situation to ensure the smooth implementation of high-value consumables and low-value consumables.