Official: this kind of consumables should be strictly controlled!

These precautions are for the use and reuse of disposable consumables Recently, the Shanghai Health and Health Commission issued a notice on printing and distributing the benchmark of administrative penalty for medical device management in Shanghai It is pointed out in the document that if the medical device using unit reuses the disposable medical device or fails to destroy the used disposable medical device in accordance with the provisions, it will be punished according to the following provisions On March 15, the national health and Health Commission issued the management measures for clinical use of medical devices (Draft for comments), which reiterated the provisions on the management of disposable medical devices It is required that medical institutions should strictly implement the measures for the administration of hospital infection and other relevant regulations, and use disinfection devices and disposable medical devices that meet the national regulations The disposable medical devices shall not be reused; the reusable medical devices shall be cleaned, disinfected or sterilized in strict accordance with the requirements, and the effect shall be monitored If a medical institution violates this provision, it shall be given a warning first; if it refuses to make corrections, it shall be fined not less than 5000 yuan but not more than 20000 yuan; if the circumstances are serious, it shall be ordered to stop practicing The persons directly in charge and other persons directly responsible of public medical institutions shall be punished according to law For the use of disposable consumables, according to the information on the official website of the state health insurance bureau, it is shown in the reply to the medical guarantee [2019] No 80 proposed by the second session of the 13th National People's Congress According to the state health insurance bureau, there is no precedent in the world for the establishment of a catalogue of disposable medical devices In the early stage, the State Food and drug administration has entrusted relevant units to carry out research on the development of catalogue of disposable medical devices The research group visited a number of medical device manufacturers and medical institutions, and carried out questionnaire surveys to medical device regulatory departments, health departments, medical device production and operation enterprises, hospitals and clinicians, patients and the general public According to the survey, at this stage, there are still big differences among stakeholders on the formulation of the catalogue of disposable medical devices In 2017, the State Food and Drug Administration issued the newly revised catalogue of medical devices, which clearly marked the disposable medical devices and played a guiding role in the research, development, production and use of disposable medical devices This means that the catalogue of disposable medical devices will not be published in the near future Liang Yijian, who has been on the front line of surgery for many years, paid special attention to the huge waste of disposable consumables used in surgery, the people's Daily reported Through research, he found that a large number of disposable consumables, including ultrasonic scalpels, can be reused after strict disinfection, which can not only reduce the economic burden of patients, but also save a lot of medical insurance funds But Liang Yijian also said that I found that disposable consumables are well supervised, but the risk prevention and control of reuse after strict disinfection is complex The recovery and reuse of disposable medical consumables are related to 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 management of medical devices, technical guarantee of safety and effectiveness of reused products, economic feasibility of reuse, social ethics and doctor-patient relationship This requires joint research and promotion by multiple departments It is reported that in the next step, the State Food and Drug Administration will cooperate with relevant departments to carry out the reuse of high-value medical consumables, and provide support in the functional verification, safety and effectiveness guarantee and other technical aspects of reused products Experts from Fuwai Hospital of the Chinese Academy of Medical Sciences once told the media that for the reuse of disposable high-value medical consumables, it is imperative that the devices implanted into the human body should not be reused "Economic problems are still solved by economic methods It is better to encourage domestic equipment manufacturers to develop products with lower cost and solve the price contradiction Moreover, if more reusable medical devices are selected, less disposable ones are selected " The state health insurance bureau pointed out that in the future, the charging policy for disposable medical consumables will be controlled through the following three points: First, medical service charges can enable medical institutions to recover reasonable and compliant service costs and ensure the normal development of valuable medical services in clinical practice.