Regulations on the Administration of Medical Wastes (2011Revision)

Regulations on the Administration of Medical Wastes (2011Revision) Regulations on the Administration of Medical Wastes (Issued by the Order No. 380 of the State Council of the People's Republic of China June 16, 2003; amended in accordance with the Decision of the State Council on Abolishing and Amending Some Administrative Regulations by the Order No. 588 of the State Council of the People's Republic of China on January 8, 2011) Chapter 1 General Provisions Article 1 In order to strengthen the safety administration of medical wastes, to prevent the spreading of diseases, to protect the environment and to guarantee the people's health, the present Regulations are enacted in accordance with the Law of the People's Republic of China on Prevention and Treatment of Infectious Diseases and the Law of the People's Republic of China on Prevention and Treatment of the Environmental Pollution by Solid Wastes . Article 2 In the present Regulations, “medical wastes” refer to the directly or indirectly infectious, or poisonous, or otherwise harmful wastes generated by medical institutions in medical treatment, prevention, health care, and other relevant activities. The classified catalogue of medical wastes shall be formulated and promulgated jointly by the administrative departments of public health and environmental protection under the State Council. Article 3 The present Regulations shall apply to the activities of collection, carrying, storage, and disposal of medical wastes, and the supervision and administration thereof, etc. The living garbage generated by the infectious patients or suspect infectious patients treated by medical institutions shall be administered and disposed of as medical wastes. Administration of the anesthetic, psychoactive, radioactive, and poisonous drugs, etc. and the relevant wastes discarded by medical institutions shall be carried out in accordance with the relevant laws and administrative regulations, and the relevant standards and criteria of the state. Article 4 The state promotes the concentrated no-harm disposal of medical wastes, and encourages the research and development of the technology relating to safe disposal of medical wastes. The people's governments at the county level and above shall be responsible for organizing the construction of concentrated disposal facilities of medical waste. The state will give relevant support to the remote and poor areas in the construction of concentrated disposal facilities of medical waste. Article 5 The administrative departments of public health of the people's governments at the county level and above shall carry out unified supervision and administration of the prevention and treatment of diseases in the activities of collection, transport, storage, and disposal of medical wastes; the administrative departments of environmental protection shall carry out unified supervision and administration of the prevention and treatment of environmental pollution in the activities of collection, transport, storage, and disposal of medical wastes. Other relevant departments of the people's governments at the county level and above shall, within the scope of their respective duties, be responsible for the relevant supervision and administration relating to the disposal of medical wastes. Article 6 Every entity and individual shall have the right to disclose, complain, report, and charge against the illegal acts of the medical institutions, of the entities of concentrated disposal of medical wastes, of the supervision and administration departments and the functionary thereof. Chapter 2 General Provisions on the Administration of Medical Wastes Article 7 Medical institutions and entities of concentrated disposal of medical wastes shall establish and perfect the system of responsibility for medical waste administration, with their legal representatives as the primary responsible person, and shall earnestly perform their duties to prevent the spreading of infectious diseases and occurrence of environmental pollution accidents caused by medical wastes. Article 8 Medical institutions and entities of concentrated disposal of medical wastes shall formulate the systems and rules relating to safe disposal of medical wastes and the emergent schemes for accidents; shall set up monitoring departments or equip full-time (part-time) personnel to inspect, supervise and urge, and implement the administration of medical wastes, and to prevent any violation of the present Regulations. Article 9 Medical institutions and entities of concentrated disposal of medical wastes shall give training on the relevant knowledge of law, professional technology, safety protection, and emergent treatment, etc., to their personnel engaging in collection, transport, storage, and disposal, etc., of medical wastes, and to their managerial personnel. Article 10 Medical institutions and entities of concentrated disposal of medical wastes shall take effective measures for vocational hygiene and protection, equip necessary protection articles and make regular health inspections for their personnel engaging in collection, transport, storage, and disposal, etc. of medical wastes, and for their managerial personnel; and shall give immunity vaccination to the relevant personnel to protect them from harms to their health. Article 11 Medical institutions and entities of concentrated disposal of medical wastes shall carry out the set-bill administration in transfer of dangerous wastes in accordance with the Law of the People's Republic of China on Prevention and Treatment of the Environmental Pollution by Solid Wastes . Article 12 Medical institutions and entities of concentrated disposal of medical wastes shall make registration of the medical wastes, the registered contents shall include the source, type, weight or quantity, time of handover, disposal method, and eventual whereabouts of the medical wastes, and the signature of the handling person, etc. The registration materials shall be kept for at least 3 years. Article 13 Medical institutions and entities of concentrated disposal of medical wastes shall take effective measures to prevent the medical wastes from losing, leaking or spreading. In the case of losing, leaking or spreading of medical wastes, medical institutions and entities of concentrated disposal of medical wastes shall take emergent treatment measures to mitigate the harm, and provide medical rescue and on-spot aid to the personnel caused ill; shall at the same time report to the administrative departments of public health and environmental protection of the local people's government at the county level, and notify the entities and residents that might be harmed. Article 14 Any entity or individual is prohibited from transferring or trading medical wastes. It is prohibited to discard any medical wastes on the way of transport, to dump or pile medical wastes at places not for storage, or to mix the medical wastes with other wastes and living garbage. Article 15 It is prohibited to mail any medical wastes. It is prohibited to transport medical wastes by railway or air. Where there is a land route, transport of medical wastes by waterway is prohibited; where it is necessary to transport the medical wastes by waterway in absence of any land route, approval must be obtained from the administrative department of environmental protection of the people's government at the level of city divided into districts, and only after strict environmental protection measures have been applied, may the wastes be transported by waterway. It is prohibited to carry medical wastes and passengers on the same conveyance. It is prohibited to transport medical wastes on the waters of the protection zones of drinking water source. Chapter 3 Administration of Medical Wastes by Medical Institutions Article 16 A medical institution shall collect the medical wastes it generates in a timely manner, and shall put those wastes, according to their types, in the anti-leaking and anti-penetrating special packages or sealed containers. There shall be obvious warning signs and instructions on the special packages and containers of medical wastes. The standards of the special packages and containers and the provisions on the warning signs of medical wastes shall be set forth jointly by the administrative departments of public health and environmental protection under the State Council. Article 17 A medical institution shall set up facilities and equipment for temporary storage of medical wastes, and may not keep medical wastes in the open air; and the temporary storage of medical wastes may not exceed 2 days. The facilities and equipment for temporary storage of medical wastes shall be far from the medical treatment area, food processing area, personnel activity area, and the storage places of living garbage, and shall have obvious warning signs and safety measures against leaking, rats, mosquito and flies, cockroaches, theft, and contact by children, etc. The facilities and equipment for temporary storage of medical wastes shall be disinfected and cleaned regularly. Article 18 A medical institution shall use anti-leaking and anti-spilling special conveyances to collect and transport the medical wastes to the place of temporary storage according to the time and route of the transport of medical wastes within the institution. The conveyances shall be promptly disinfected and cleaned at the designated place within the medical institution. Article 19 A medical institution shall, according to the principle of near and concentrated disposal, hand over the medical wastes to the entity of concentrated disposal of medical wastes in good time. The highly dangerous wastes, such as the culture medium and samples of pathogen, and the storing liquid of bacterium and poisonous seedling shall be disinfected on the spot before being handed over to the entity of concentrated disposal of medical wastes for disposal. Article 20 The sewage generated by medical institutions and the excretion of the infectious patients or suspect infectious patients shall be strictly disinfected pursuant to the provisions of the......