The topic of "reusing high-value disposable medical supplies" reemerges, with the National Health Commission clearly stating: Encouraging the production of reusable supplies.

The topic of "single-use high-value reuse" reemerges, National Health Commission responds

Recently, the National Health Commission issued the "Response to Proposal No. 9780 of the Third Session of the 13th National People's Congress" (hereinafter referred to as the "Response"). Regarding the proposal by representatives on "adjusting some high-value non-implant ophthalmic surgical instruments out of the single-use device catalog," the National Health Commission stated that the single-use of high-value medical consumables may cause resource waste, environmental pollution, and increased medical costs. In practice, some medical consumables can indeed be reused.

Next, the National Health Commission will follow the principles of safety, effectiveness, and economy, actively cooperate with the National Medical Products Administration to adjust the single-use medical device catalog, balancing the safety and economy of reusing single-use medical devices. The following work will also be carried out:

First, it is recommended that the drug regulatory department require or encourage enterprises to develop and produce reusable medical consumables during medical device market approval. For those that cannot be reused, corresponding alternative products or materials should be selected as much as possible to avoid setting unreasonable technical barriers.

Second, cooperate with the drug regulatory department to strengthen research and demonstration. Devices that can be safely and effectively reused during diagnosis and treatment should not be included in the single-use medical device catalog, supporting standardized clinical reuse.

All along, the reuse of single-use medical devices has been explicitly prohibited by national laws and regulations such as the "Law of the People's Republic of China on the Prevention and Control of Infectious Diseases," "Regulations on the Supervision and Administration of Medical Devices," "Disinfection Management Measures," "Hospital Infection Management Measures," and "Supervision and Administration Measures for Single-use Sterile Medical Devices."

The release of this "Response" document has once again drawn industry attention to the topic of reusing single-use consumables.

An inexhaustible market demand supports a trillion-yuan market

Before the 1970s, most medical devices were considered "reusable" because they were mostly made of glass, rubber, and metal materials, such as probes and surgical instruments, which could be reused after wiping and soaking in disinfectant solutions. With the development of medical technology and the use of plastics and other materials in medical products, "single-use medical consumables" gradually became known.

Whether medical consumables are single-use is determined during registration approval or filing, and clearly specified in their instructions for use. According to Article 6 of the "Regulations on the Supervision and Administration of Medical Devices" (2017 revision), the catalog of single-use medical devices is formulated, adjusted, and published by the State Food and Drug Administration in conjunction with the State Health and Family Planning Commission.

Currently, there are hundreds of types of single-use medical consumables on the market, with medical metal needles, medical catheters, medical latex gloves, and disposable syringes accounting for a large proportion.

Additionally, orthopedic implants are one of the largest sub-sectors in the single-use medical device industry, mainly including bone fixation implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, and artificial joints.

With the improvement of living standards, increased health awareness, and enhanced protection awareness of medical staff and patients in hospitals, the demand for single-use medical consumables is increasing. This is also reflected in the data on single-use medical consumables as a proportion of total patient expenses: statistics show that single-use medical consumables account for 22%-30% of total inpatient expenses and about 50% of surgical patient medical expenses.

Furthermore, data from the China Pharmaceutical Materials Association shows that in 2019, the market size of China's single-use medical devices reached 210.2 billion yuan. With a strong and inexhaustible market demand, the demand for single-use medical consumables is expected to further expand, with the market size projected to reach 546.8 billion yuan by 2025, with a compound annual growth rate of 17.3% during this period.

What are the difficulties in "reusing single-use consumables"?

A trillion-yuan market scale, with the further increase in consumption of single-use medical consumables in the future, will cause huge resource waste.

For patients and medical institutions, the reuse of single-use medical consumables is one of the cost-saving measures and can also reduce the amount of medical waste.

Moreover, after developed European countries such as Germany and Denmark implemented the safe reuse of high-value single-use medical consumables, manufacturers were forced to further reduce product prices, saving expenses for the country and patients.

Although there are huge economic benefits, reuse involves many uncontrollable factors:

1. Disinfection safety: The regulatory department for medical device manufacturers is the drug supervision department. When manufacturers apply for registration, they choose "single-use," and the drug supervision department approves registration as "single-use." Therefore, manufacturers do not provide cleaning, disinfection, and sterilization methods for reusing single-use medical devices.

Currently, hospital sterilization supply centers and independent sterilization supply centers are in the process of gradually maturing their technology, with limited sterilization supply levels, which easily causes cross-infection or secondary infection, directly affecting patient safety.

2. Product structure: Many current single-use medical devices are destroyed after use and cannot be reused. The existing structure needs to be improved to enable reuse.

Based on these factors, the National Health Commission reiterated in the "Response" document that according to Articles 35 and 68 of the "Regulations on the Supervision and Administration of Medical Devices" (2017 revision), single-use medical devices must not be reused. Medical institutions, as users, that reuse single-use medical devices will bear legal responsibilities such as warnings, fines, and suspension of production or business imposed by relevant departments.

Additionally, in the "Response" document, the Health Commission mentioned the requirement or encouragement for enterprises to develop and produce reusable medical consumables, but promoting the production of reusable medical consumables still faces certain difficulties.

1. From the manufacturer's perspective, the approval process for single-use medical consumables is simple and quick to market. For manufacturers, compared to reusable medical consumables, single-use products can recover R&D costs faster. Therefore, manufacturers tend to prefer "single-use." For example, Johnson & Johnson's ultrasonic scalpel can be quickly marketed as single-use, while approval for reusable ultrasonic scalpels may take two years.

2. From the hospital's perspective, with the development of minimally invasive surgery and increased patient health awareness, doctors are relatively more willing to choose single-use medical consumables. Moreover, single-use medical consumables are relatively inexpensive to purchase, so hospitals also prefer single-use consumables in procurement, further promoting the development of single-use medical consumables. The market for reusable consumables correspondingly shrinks, and manufacturers are more willing to invest more funds in R&D for single-use medical consumables.

In recent years, the reuse of single-use medical consumables has been frequently mentioned, especially the huge waste caused by high-value single-use medical consumables has attracted industry attention. However, reuse involves many issues such as disinfection safety and product structure. At present, whether single-use medical consumables will be reused in the future still awaits research and promotion by relevant departments.