Whether disposable medical consumables, especially high-value medical consumables, can be reused has always been a matter of concern and controversy in the industry. Previously, the National Health Commission did issue a document many times, saying: it is clearly forbidden to reuse disposable medical consumables. But recently, the National Health Commission has a different attitude!

In February, the National Health Commission pointed out in its reply to "suggestions on adjusting some non implantable high-value surgical instruments out of the list of disposable medical devices" 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 reusing disposable medical devices, and reasonably control the rise of medical expenses.

The National Health Commission said in the reply that the disposable use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs. In practice, some medical consumables can be reused. Whether medical consumables are disposable or not is decided in the process of registration, examination and approval or filing, and there are clear provisions in the instruction manual.

Data map. Photo by Cao Zihao

Reuse of disposable medical consumables is banned

"In the issue of whether disposable medical consumables can be repeated, the state has banned it." Chen Hongyan, director of the Institute of medical devices, China Medical Materials Association, told reporters that according to articles 35 and 68 of the regulations on the supervision and administration of medical devices (revised in 2017), disposable medical devices shall not be reused, and medical institutions, as users, who reuse disposable medical devices, will be warned, fined and punished by relevant departments Legal liabilities such as suspension of production and business. According to Article 6 of the regulations, the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory department of the State Council in conjunction with the health and family planning department of the State Council.

"Disposable medical devices shall not be reused, and those used shall be destroyed and recorded in accordance with the relevant provisions of the state. Medical devices that can be reused according to regulations shall be cleaned, disinfected or sterilized in strict accordance with regulations, and the effect shall be monitored. " Chen Hongyan said.

Medical High-value consumables are mainly relative to low-value consumables, which mainly belong to medical specialty treatment materials, such as cardiac intervention, peripheral vascular intervention, artificial joint, other organ intervention and other medical materials.

"Disposable high-value medical consumables, especially those implanted in human body, must not be reused." Chen Hongyan suggested to actively promote the research and development of low-cost domestic medical devices (consumables) products, effectively control various costs of products in the market circulation link, and reduce the purchase price of medical devices (consumables). Clinical use of reusable medical devices, reduce the use of disposable medical devices (consumables).

Chen Hongyan said that at present, the recycling of disposable medical consumables involves laws and regulations such as the law of the people's Republic of China on the prevention and control of infectious diseases, the regulations on the supervision and administration of medical devices, technical support such as the safety and effectiveness of reused products, economic feasibility of reuse, social ethics and doctor-patient relationship, which need to be studied and promoted by multiple departments.

"The National Health Commission encourages the production of reusable medical device consumables, which can appropriately reduce medical expenses, save medical insurance payment, and reduce the expenditure of patients' medical consumables at their own expense." Chen Hongyan said.

Reusable medical consumables should be adjusted from the list of disposable medical devices.

"The biggest advantage of disposable medical consumables is that it can effectively block the spread of various infectious diseases among patients. We call it nosocomial infection control." Chen Hongyan explained that in the past, the patient may have been hospitalized with appendicitis, but during the operation, due to the insufficient disinfection and sterilization of medical consumables, the patient may have been infected with hepatitis or pneumonia and other diseases because of a disease in the hospital. The use of disposable medical consumables is mainly to control nosocomial infection and protect patients.

"With the development of the times, the widespread use of disposable medical consumables, hospital infection has been effectively controlled, but all kinds of disposable medical consumables also emerge in endlessly, excessive use leads to waste of resources, environmental pollution and rising medical costs and other problems." Chen Hongyan pointed out that because disposable medical consumables can control nosocomial infection, they are gradually accepted and used by doctors and patients, but this also allows some manufacturers to develop disposable medical consumables. If this part of reusable medical consumables are also included in the list of disposable medical devices, it is a waste of resources. Whether there are such products in the list of disposable medical devices that have been approved before, if so, it can be adjusted under the principles of safety, effectiveness and economy.

In its reply, the National Health Commission said that in the next step, it will follow the principles of safety, effectiveness and economy, actively cooperate with the State Food and drug administration to adjust the list of disposable medical devices, balance the safety and economy of reusing disposable medical devices, and formulate a clear action plan.

During the registration and approval of medical devices, enterprises are required or encouraged to develop and produce reusable medical consumables. For those that cannot be reused, corresponding alternative products or materials should be selected as far as possible to avoid unreasonable technical barriers; It can be reused in the process of diagnosis and treatment, and can ensure safety and effectiveness. It can not be included in the list of disposable medical devices, and support clinical standard reuse.

"Don't confuse the concept. The state has banned the duplication of disposable medical consumables. Reusable medical consumables should be adjusted from the list of disposable medical devices and strictly control disinfection and sterilization in hospitals. " Chen Hongyan explained that for reusable medical consumables, hospitals should clean, disinfect or sterilize them in strict accordance with regulations, and monitor the effect. At the same time, the health care Commission, the medical insurance bureau and the relevant departments of the food and drug administration formed an expert group to re evaluate the list of disposable medical devices, sort out the reusable medical consumables under the principles of safety, effectiveness and economy, no longer produce disposable products, and return to the original reusable state.