Recently, the National Health Commission issued the "Answer to Recommendation No. 9780 of the Third Session of the 13th National People's Congress" (hereinafter referred to as "Answer"), showing that some representatives proposed to adjust some non-implantable high-value surgical instruments in ophthalmology to one-time use Recommendations for the device catalog.
In this regard, the National Health Commission stated that the one-time 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 for single use is determined during the process of registration, approval or filing, and it is clearly stipulated 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 also stated that the next step will be in several areas.
First, it is recommended that the drug regulatory department require or encourage 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 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 norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
Cannot be reused
On February 4, the National 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 the regulations should be cleaned, disinfected or sterilized in strict accordance with the regulations, and their effects Monitoring; single-use medical devices must not be reused, and used ones should be destroyed and recorded in accordance with relevant national regulations.
Prior to this, in August 2019, the National Medical Insurance Administration also mentioned this issue in the "National Medical Insurance Administration's Reply to Recommendation No. 6395 of the Second Session of the Thirteenth National People's Congress".
The National Medical Insurance Bureau stated that the recycling and reuse of disposable medical consumables involves relevant laws and regulations, technical guarantees such as the safety and effectiveness of reused products, the economic feasibility of reuse, social ethics, and doctor-patient relationships, which require joint research by multiple departments. Advance.
