Disposable medical devices can be reused and have been approved!


On February 23, according to the Red Star News report, Liang Yijian, a representative of the National People's Congress, calculated an account to the reporter in an interview: "Ultrasonic osteotome cutter head 6000 yuan a, we orthopedics, I did 600 operations last year, that is, 600 blades, a total of 3.6 million yuan. In addition, general surgery and other departments will also use such high-value consumables. So, how many such hospitals, such departments?"

As early as the National Two Sessions in 2018 and 2019, Liang Yijian put forward suggestions and proposals that some disposable medical consumables can be reused. Liang Yijian told reporters that this proposal was passed in January last year.

"Our orthopedics department did 600 operations last year." In an office in the orthopedic ward, Liang Yijian told the Red Star News reporter. In his long-term clinical work, he often pays attention to the fact that the 6000 yuan ultrasonic osteotome head can only be used once, which has caused an economic burden to many patients and also caused a waste of medical consumables.

"Now the hospital sense control technology has been very mature, ultrasonic bone knife head is metal, can be repeatedly disinfected use. But because it is required to be a one-time use, even if you only use 1 second on the operating table, you must throw it away. The cost of an operation is not 6000 yuan, but an ultrasonic bone knife head is 6000 yuan, so it is very wasteful." Liang Yijian said, "there are many materials of this kind, most of which can be disinfected repeatedly."

Therefore, Liang Yijian proposed to the three competent departments for three consecutive years: It is recommended that some disposable medical consumables can be reused. First it was the health department, then the health insurance department, and finally the drug administration department. However, they are unable to completely solve the problem. At the National Two Sessions in 2018 and 2019, he also put forward suggestions and proposals that some disposable medical consumables can be reused.

"Three departments, I wrote a proposal once a year, passed in January last year. The relevant departments of the state decided that part of the one-time use." Liang Yijian introduced.

In fact, in addition to the one-time use of high-value consumables such as ultrasonic osteosome heads, some non-implanted high-value ophthalmic surgical instruments are also the focus of controversy.

In February 2021, in response to the representative's proposal to adjust some ophthalmic non-implanted high-value surgical instruments out of the list of disposable instruments, the National Health and Care Commission also made it clear that in practice, some medical consumables can be reused.

However, whether medical consumables are for one-time use is determined during the registration approval or filing process. Therefore, the National Health Commission said that it will actively cooperate with the State Food and Drug Administration to adjust the catalogue of disposable medical devices, balance the safety and economy of reusable disposable medical devices, and reduce the waste of resources.

Next, the National Health Commission will work in several areas. First, it is suggested that the drug regulatory department requires or encourages enterprises to develop and produce reusable medical consumables when approving the listing of medical devices. For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting unreasonable technical barriers. The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and those that can be reused in the diagnosis and treatment process and can ensure safety and effectiveness are not included in the one-time use medical device catalog, and support clinical standard reuse.

It can be seen that the National Health Commission has a positive attitude towards this problem, but at this stage, there are still many bottlenecks in the reuse of disposable high-value medical consumables. This is not a problem that the National Health Commission can solve with a "encouragement.

First, there is the issue of security. China's hospital sense control technology is still not very perfect, one-time use of medical equipment reuse is difficult, not only to ensure the quality of cleaning, the determination of key performance risk is greater, directly related to patient safety.

At present, there are still many cases of cross infection caused by the repeated use of disposable medical consumables in domestic hospitals, which eventually leads to medical accidents. It is also due to the imperfection of hospital disinfection management system in China. Therefore, it is also an important limiting reason for the reuse of disposable non-implantable high-value medical consumables.

In addition, there is the issue of cost-effectiveness. As stated in the reply of the National Health Commission, whether medical consumables are for one-time use is determined during the registration approval or filing process, which means that this is determined by medical device companies.

As we all know, the approval of disposable medical devices is much simpler than that of reusable medical devices. Not only is the product on the market faster, but the cost recovery speed is also faster, especially for some high-value medical consumables with long research and development time and large capital investment. One-time high price is undoubtedly the best solution for manufacturers to pursue benefits.

Therefore, it is obvious that unless the state funds enterprises to develop and give a large number of rewards, it is difficult for enterprises to actively develop reusable high-value medical consumables!

In addition, in response to this problem, Shen Chenyang, deputy director of the Vascular Surgery Center of Fuwai Hospital, Chinese Academy of Medical Sciences, once said: Economic problems are still solved by economic methods. It is better to encourage domestic device manufacturers to develop lower-cost products and solve price contradictions.

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