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1. The use of disposable medical devices will be reduced

Recently, the National Health Commission issued the "Reply to Recommendation No. 9780 of the Third Session of the Thirteenth National People's Congress" (hereinafter referred to as the "Reply").

According to the reply, the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical expenses. Whether medical consumables are for one-time use is determined during the registration approval or filing process, and there are clear regulations in the instructions for use.

According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the Food and Drug Administration of the State Council in conjunction with the health and family planning department of the State Council.

**The National Health Commission will follow the principles of **, effectiveness, and economy, and actively cooperate with ** Food and Drug Administration to adjust the catalog of single-use medical devices to balance the security and economy of reuse of single-use medical devices, and reduce Resource waste, reduce environmental pollution, reasonably control medical expenses, and increase the economic burden of patients.

**The Health Commission also stated that the next step will be in several areas.

First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices. For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers;

The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical standards for those that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective.

On February 4, the **Health Commission issued the "Administrative Measures for the Clinical Use of Medical Devices", which also put forward requirements for the reuse of consumables: medical devices that can be reused according to regulations should be cleaned, disinfected or sterilized in strict accordance with regulations, and carried out Effect monitoring; disposable medical devices shall not be reused, and used ones shall be destroyed and recorded in accordance with the relevant regulations of **.

Prior to this, in August 2019, the ** Medical Insurance Bureau also mentioned this issue in the "** Medical Security Bureau's Reply to Recommendation No. 6395 of the Second Session of the Thirteenth National People's Congress."

**The Medical Insurance Bureau stated that the recycling and reuse of disposable medical consumables involves various issues such as relevant laws and regulations, the effectiveness of reused products **, technical guarantees, the economic feasibility of reuse, social ethics, and doctor-patient relationships, requiring multiple departments Joint research and advancement.

In the next step, the ** Food and Drug Administration will cooperate with relevant departments to carry out the reuse of high-value medical consumables, and provide support in the technical aspects of the functional verification of reused products and the guarantee of ** effectiveness.

2. The New Deal may affect the huge disposable medical equipment industry

According to "World Preview 2018, Outlook to 2024", the global medical device market sales in 2017 was US$405 billion, an increase of 4.6% year-on-year; sales are expected to reach US$594.5 billion in 2024, with a compound growth rate of 5.6% from 2017 to 2024 .

Orthopedic implants

Orthopedic implantation is one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, Artificial joints, etc.

Thanks to my country’s huge population base, accelerated social aging process and rising medical demand, my country’s orthopedic implant market has grown from 13.9 billion yuan in 2014 to 22.5 billion yuan in 2017. Influenced by factors such as "replacement", the growth of the orthopedic implant market has gradually slowed down in recent years. According to data from the "China Medical Device Blue Book 2019 Edition", the market size of orthopedic implanted medical devices in my country in 2019 was 30.6 billion yuan.

The growing popularity of indwelling needles

The indwelling needle has the advantages of simple operation, alleviating patients' pain, ensuring rational medication, convenient infusion, and reducing nursing workload. It is mainly used for intermittent, continuous or daily intravenous infusion therapy. In 2019, the market size of indwelling needles in China reached 2.71 billion yuan. The market size is expected to reach 4.24 billion yuan in 2025. During 2019-2025, the compound annual growth rate will be 7.7%.

Carrying out the reuse of high-value medical consumables may affect the domestic disposable medical device market. At present, the disposable medical device market is showing a growth trend, but considering policy factors, the future growth rate may slow down, and the product output will shrink to a certain extent.

3. Stones from other mountains: Europe and the United States are also compressing and regulating the industry

Disposable medical devices are widely used, and their convenience and accuracy in clinical practice have greatly promoted the improvement of medical standards. There are no laws and regulations in my country that clearly define the scope, standards and requirements for the reuse of disposable medical devices. The United States and Germany have relatively complete management of the reuse of disposable medical devices.

America

In 1987, the US FDA's law enforcement policy guidelines stipulated that personnel who reuse disposable medical devices need to prove that they can be adequately cleaned and disinfected, and that repeated use will not affect the security and effectiveness of disposable medical devices.

After many discussions and research, the US FDA put forward scientific guidelines for regulating the reuse of disposable medical devices in 2000, and gradually formed a set of laws and regulations for the reuse of disposable medical devices.

In October 2002, the "FDA Device User Fees and Modernization Act" regulated the reuse of disposable medical devices: FDA is responsible for formulating a list of reusable disposable medical devices; reusable medical products and new products must be implemented In the listing procedure, reusable medical products must be labeled with "reusable disposable medical devices" and the name of the recycler; according to quality system regulations, the FDA equates hospitals that recycle single-use medical devices with manufacturers, but most hospitals pass Entrust a third-party recycling company to re-use disposable medical devices. Medical products used in a hospital can be circulated to another hospital for continued use after being processed by the recycling company; in terms of supervision, the adverse reaction reporting system is when collecting adverse reaction reports , The type of disposable medical device to be recycled should be added and the recycler should be indicated.

Germany

In 2002, Germany promulgated a new version of the "Medicine Supplies Amendment Act", which included the reuse of disposable medical devices in the ** regulations, clarifying that the reuse of disposable medical devices is positive and necessary. Among them, Volume 3 stipulates: the reuse of disposable medical devices refers to those with low pathogenic source or sterile disposable medical devices, and their repeated use must go through strict screening, cleaning, disinfection, testing and other procedures to ensure that they are reused** In addition, the disinfection process of disposable medical devices must be completed under the supervision of relevant management personnel, and enterprises handling disposable medical devices must also be included in the supervision scope of relevant regulatory authorities.

In Germany, reusable disposable medical devices must be returned to the hospital where the product** is used in accordance with regulations. Reused medical products can only flow between a hospital and a reuser, and reprocessed disposable medical devices can only be used For patients who use the disposable medical device for the first time; only certified units can re-use disposable medical devices, and the re-user must track the entire process of reusing the device.