The implementation of UDI for high-value consumables and low-value consumables often depends on the characteristics of the two themselves, and the most obvious difference is that in the application of UDI one thing one code and one batch of one code, consumables products account for more than 95% of medical devices, which is the main force of UDI implementation. Among them, it is specifically divided into two categories: high-value consumables and low-value consumables. In this issue, we analyze the key points and differences between the implementation of UDI for high-value consumables and low-value consumables through case analysis.
High-value consumables, also known as high-value medical consumables, are medical consumables that directly act on the human body, have strict requirements for safety, have a large amount of clinical use, relatively high prices, and bear a heavy burden on the masses. These consumables can be divided into 10 categories according to the scope of application, such as intraocular lenses, blood vessels, springs, and pacemakers.
Low-value consumables, also known as low-value medical consumables, refer to low-value disposable medical materials commonly used by 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.
The implementation of UDI for high-value consumables and low-value consumables often depends on the characteristics of the two themselves, and the most obvious difference is in the application of UDI one thing one code and one batch one code.
Due to the characteristics of high-value consumables such as fast update, high technical requirements, high risk and high price, in recent years, the rational use of high-value consumables has been the focus of control, and the earliest types of medical devices that require the implementation of UDI are almost all high-value consumables, which are more stringent, and generally require the realization of "one thing, one code".
Cases of high-value consumables
Company A is a medical device manufacturer mainly engaged in the production of high-value consumables, and its representative products are orthopedic consumables bone nails. Before the implementation, the UDI public platform learned that because the value of a single product of the enterprise is relatively high, once it is lost, the loss will be great; In addition, the product needs to be implanted into the human body, which is relatively dangerous and risky, and requires more refined management; This, coupled with the requirements of the current UDI policy, means that the company is more suitable for the implementation of UDI in one thing, one code. At the same time, the platform recommends that enterprises use ontology identification for coding, although the cost of coding has been relatively improved, but the security and stability of UDI code, damage resistance and service life have also been greatly guaranteed.
Through the implementation of one thing, one code UDI, it can help enterprise products truly realize the management of the whole life cycle of medical devices, not only traced back to the production and circulation links, but also can be connected to the use link, including hospital management, accurate traceability to surgery, doctors, nurses, patients, and realize the whole process control.
Therefore, the focus of high-value consumables enterprises in the implementation of UDI is often focused on product compliance and traceability applications, and the budget for implementation costs is high.
Cases of low-value consumables
Company B is an enterprise mainly engaged in the production of low-value consumables, and its representative products are disposable masks. Because the value of 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 will also be greatly increased, in this case, the platform to help enterprises adopt a batch of one code of UDI coding scheme for implementation, at the same time for the enterprise to carry out the transformation of production line, the addition of automatic coding equipment and testing equipment, to achieve a box of one code, The efficient production of products is ensured without increasing labor costs.
"One batch of one code" UDI implementation plan can help high-yield enterprises to greatly improve the traceability accuracy, although it can not be as accurate as the implementation of one thing and one code of high-value consumables to locate each product, but for low-value consumables with low risk, positioning to a batch of one code traceability is currently the most cost-effective.
Therefore, for low-value consumables enterprises, the focus of UDI implementation is often focused on product compliance and coding applications, and the implementation cost is strictly controlled.
Source: Health Circles