Can disposable medical devices be reused?


The website of the People's Government of Fuling District, Chongqing City released a piece of information that a medical institution was investigated for repeated use of disposable medical devices.

Release Date:

Oct 19,2021

The website of the People's Government of Fuling District, Chongqing City released a piece of information that a medical institution was investigated for repeated use of disposable medical devices.

According to the on-site supervision and inspection, the nurses of the clinic used the same kind of medicine to use the same disposable syringe repeatedly when dispensing medicine, and were investigated and dealt with by the Health and Family Planning Supervision and Enforcement Bureau. Can single-use medical devices, so-called disposable devices, be reused? In fact, this has been a controversial topic for more than 20 years.

According to a research report on "Reprocessing and Reuse of Disposable Medical Devices in China: A Pilot Survey", although the law explicitly prohibits the reuse of single-use medical devices, there are still a large number of reused medical devices in hospitals. Condition.

Similar to the above-mentioned cases where disposable medical devices are reused, most of them are caused by the management problems of medical institutions and the improper operation of medical staff. But more because of "profitable", especially some expensive high-value medical consumables.

Previously, the director of an oncology department at Shenzhen Liuhua Hospital was also punished heavily for repeated use of a disposable high-value consumable cryoablation needle.

The cryoablation needle is a disposable high-value medical consumable, and its product packaging and instruction manual clearly indicate that the product is “disposable”“cannot be reused”. However, He and Liu used less than 50 ablation needles 603 times, and the number of cryoablation needles charged to patients was 603, and the total amount was about 5.99 million yuan. Huge profits have caused this gray area to continue to spread.

However, let this reason aside. In the actual use process, in response to the extensive use of disposable high-value medical consumables in clinics to increase the cost of surgery, many clinical departments in hospitals "average cost" and "proportion of consumables" #39;Seriously exceeding the standard” and other phenomena, also plague many medical institutions.

This year, Liu Xiuyun, a deputy to the National People's Congress, once again made suggestions to the National Health Commission in response to this problem.

Deputy to the National People's Congress

Set standards for reuse of disposable medical devices

Liu Xiuyun suggested: The National Health Commission and related technical departments should set up a special working group to conduct a reasonable screening of the catalog of single-use medical devices in use in medical institutions every year, and deal with them separately according to the situation.

For medical devices that are currently in use by medical institutions and that can be reused to ensure safe and effective, as well as some technical improvements that can be reused to ensure safe and effective medical devices, the catalog of disposable medical devices should be adjusted and provided in a timely manner. Approval of production qualifications, sales permits and other document numbers.

For some non-implantable disposable high-value medical consumables, if new medical device products cannot be provided as substitutes, after scientific demonstration, unified "reprocessing" and "resterilization" can be formulated rule. On the premise of ensuring good performance of consumables and no risk of infection, medical institutions or manufacturers can reuse them according to the same standards to reduce costs and avoid waste

For some disposable high-value medical consumables that cannot be improved and transformed into conventional medical devices, the materials are complicated or there are many electronic controls, which are difficult to clean and disinfect thoroughly. Repeated disinfection can easily cause material damage, which can easily bring potential surgery to patients Security risks Liu Xiuyun called for reducing the price of these one-time high-value medical consumables through centralized large-scale procurement and open competition at the national level, thereby reducing the medical costs of patients and bringing real benefits to patients.

The latest statement of the National Health Commission,

Encourage the production of reusable consumables!

For a long time, the country has emphasized that single-use medical devices should not be reused. This is mainly to prevent some medical institutions from simply pursuing benefits, regardless of the risk of infection and material damage, and blindly reusing them, bringing medical care to patients. harm.

However, the direction of the wind seems to have changed. In recent years, the National Health Commission seems to have a new answer in its response to the "Proposal of the People's Congress".

Especially this year, in response to the proposal to adjust some non-implantable high-value ophthalmic surgical instruments from the list of disposable medical devices, the National Health Commission pointed out that it will actively cooperate with the State Food and Drug Administration to adjust the list of disposable medical devices , Balance the safety and economy of the reuse of disposable medical devices, and reasonably control the rise of medical expenses

At the same time, enterprises are encouraged to develop and produce reusable medical consumables. For those that cannot be reused, the corresponding alternative products or materials should be selected as far as possible to avoid setting unreasonable technical barriers.

Isn't this the result that Liu Xiuyun hopes for in the proposal?

Reuse of disposable medical devices?

More difficult!

From the absolute prohibition and encouragement of production, the state's attitude towards the reuse of disposable consumables is no longer simple "one size fits all", but it is not easy to achieve it. There are two reasons for this:

The first is safety. At present, the hospital disinfection supply center and the independent disinfection supply center are in the process of gradual maturity. It is difficult to reuse disposable medical devices. It is not only necessary to ensure the cleaning quality, but also to determine the key performance, which is directly related to the safety of the patient

At present, there are still many cases of cross-infection caused by repeated use of disposable medical consumables in domestic hospitals, which eventually lead to medical accidents. Whether the hospital disinfection management system in our country is imperfect or not also has a lot to do with it. Therefore, this is also an important reason to limit the reuse of disposable non-implantable high-value medical consumables

The second one is cost-effectiveness. Whether the medical device can be reused depends on the manufacturer. Compared with reusable medical devices, disposable medical devices have the advantages of simple approval process, quicker launch, and faster cost recovery. On the contrary, reusable medical devices are often in accordance with "one-time use"

Designed, such as Johnson & Johnson’s ultrasonic knife, one of which is now disposable, it is damaged after use and cannot be reused. Its price has been reduced by nearly half and it is already on the market. Another reason is that the Health Commission encourages the development of new reusable medical consumables

However, for such products, it will be a very long process from research and development to market launch. Without special support from national policies and funds, it will not be easy to achieve

So, in summary, the realization of "reuse" of disposable consumables is promising, but it is difficult! Unless the country leads the research and development, it is difficult to rely on the conscious research and development of the enterprise!

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