One-time non-implanted high-value consumables reuse will have a new action. The National Health and Health Commission proposed that the next step is the National Hospital infection quality Control Center to investigate the current situation of disposable medical devices used in hospitals. Recently, the National Health and Health Commission made public its response to recommendation No. 5011 of the first session of the Thirteenth National people's Congress on strengthening the management and use of disposable non-implanted medical consumables and reducing medical waste. That is, a controversial topic for nearly 20 years: the reuse of disposable non-implantable consumables. In response, the National Health Commission first listed the provisions on the management of disposable use of medical devices. Article 6 of the regulations on Supervision and Administration of Medical Devices, which is directly related to the supervision of medical devices, stipulates: "the catalogue of disposable medical devices shall be formulated by the department of food and drug administration under the State Council in conjunction with the competent department of health and family planning under the State Council," Adjust and publish. Reuse ensures safe and effective medical devices and is not included in the list of disposable medical devices. The list of disposable medical devices shall be adjusted for medical devices which can be safely and effectively used after repeated use due to design, production process, disinfection and sterilization techniques. " Article 35 states that "disposable medical devices shall not be reused and used shall be destroyed and recorded in accordance with relevant state regulations." Noting that "disposable medical devices shall not be reused," Those that have been used shall be destroyed and recorded in accordance with the relevant provisions of the state. "Law of the people's Republic of China on Prevention and Control of Infectious Diseases" regulations on Supervision and Administration of Medical Devices Measures for Supervision and Administration of Bacteriological Medical Devices "all have explicit provisions." In fact, the reuse of disposable non-implantable consumables has many practical problems and is also the bottleneck of reuse.
The State Health and Health Commission raised five questions in the response:
First of all, the decision of whether the medical device can be reused is in the manufacturer, because the examination and approval process of the disposable medical device and the reusable medical device is simple, the market is fast, the recovery cost is also fast, The reusable is the opposite, so the manufacturer is more inclined to design according to the “one-time use”. For example, the ultrasound knife of the Johnson & Johnson company, one that is now used in one time, is destroyed after use, cannot be reused, and the price of the ultrasonic scalpel is nearly half the price and has been listed. The other is the R & D of a new reusable, improved, existing structure that can be cleaned, and this product is to be approved by the FDA and may take two years. II. The issue of enterprise application. The competent department of the manufacturer is the drug regulatory department. When the manufacturer applies for registration, the manufacturer shall select the “one-time use”. The registration of the drug regulatory department shall be approved by the “one-time use”. The manufacturer will not provide the cleaning and disinfection sterilization method of the one-time medical device multiplexing. III. In terms of the structure of consumables, many high-value consumables (surgical instruments) are a complex combination of structures and materials, and the multiplexing process is almost impossible without changing the design structure. The fourth, the choice and management of the hospital, on the one hand, with the development of the medical technology, the use of the surgical minimally invasive surgical instrument for the safety of the operation of the patient can not be replaced, the surgeon is willing to use the disposable surgical instrument, and the development of the disposable surgical instrument is promoted, The use of a reusable surgical instrument market is shrinking. With the ultrasonic knife as an example, the early product of Olympus has a reusable ultrasonic knife, and there is still a hospital in use, its performance is different from the new one-time product, but because the one-time market is large, the manufacturer has not put more funds into the R & D of the reusable ultrasonic knife. On the other hand, the problem of hospital management. The disposable medical device is relatively inexpensive to purchase, and some hospitals are inclined to purchase a single-use medical device. and finally, the problem of sterilization and sterilization of the disposable consumable material is solved. The hospital disinfection and supply center and the independent disinfection and supply center are in the process of gradually mature technology at the present stage, and the reuse of the disposable medical device is difficult, not only the quality of cleaning is ensured, the determination risk of the key performance is greater, and the safety of the patient is directly involved. Therefore, it is not possible to simply evaluate whether the disposable medical device can be multiplexed. The single-use medical device can be reused, and the specific device is specifically analyzed. In fact, it is pointed out in the industry that for some expensive consumables, the non-multiplexing represents a waste, and the cost of the procurement of the consumables is not returned. Although there is no hospital to do this, there are also a number of media reports that the hospital's illegal use of consumable materials has led to medical accidents. A member of the National Health and Health Committee's Committee of Experts on the Control of the Infection of Health, in an interview with the media, said it was risky to multiplex. However, since the reuse cannot be prohibited, the relevant specifications of the third party are to be developed. Discuss how to reuse and how to achieve security. i. e., it is known that multiplexing is a security risk, but the non-multiplexing is not in line with the situation actually encountered. At the end of the response, the State Health and Health Commission said that the next step would be to carry out three aspects of its work. Take the lead of the national hospital infection quality control center, investigate the current situation of the medical device used in the hospital in one time, and select the specific types of the high-value consumables to be solved through the investigation data and make suggestions, and evaluate the safety of the clinical reuse risk and the reuse disposal. Establish the close contact mechanism between the user of the medical device and the manufacturer, such as the establishment of the platform of the user and the manufacturer of the medical device through the expert group of the quality control center, the relevant professional personnel (the hospital equipment management department, the hospital infection, the operation doctor and the operating room, The disinfection and supply center and the technical personnel of the manufacturer) shall strengthen the connection, and push the manufacturer to improve the operation medical device products, or to improve the technology of the multiplexing treatment. To strengthen the management of the disposable medical device used in the hospital, the first choice is reusable, and the market orientation can be promoted. If the disposable medical device is selected after cost accounting, it is necessary to strictly implement the one-time use.