Laws of the People's Republic of China

Ministry of Public Health

Order of the Ministry of Public Health of the People's Republic of China

No.36

The Measures for Medical Wastes Management of Medical and Health Institutions, deliberated and adopted at the ministerial meeting of the Ministry of Public Health on August 14, 2003, are hereby promulgated and shall be implemented as of the day of promulgation.

Wu Yi, the Minister of the Ministry of Public Health

October 15, 2003

Measures for Medical Wastes Management of Medical and Health Institutions

Chapter 1 General Provisions

Article 1

With a view to regulating the medical wastes management of medical and health institutions and to effectively preventing and controlling medical wastes from endangering human health and the environment, the present Measures are hereby formulated in accordance with the Regulation on Medical Wastes Management.

Article 2

The medical and health institutions at various levels and of various kinds shall manage medical wastes pursuant to the provisions of the Regulation on Medical Wastes Management.

Article 3

The medical wastes management of medical and health institutions of the whole country shall be supervised by the Ministry of Public Health.

The medical wastes management of medical and health institutions shall be supervised by the administrative departments of public health of the local people's governments at the county level and above within their respective jurisdictions.

Chapter 2 Medical Waste Management Duties of Medical and Health Institutions

Article 4

The medical and health institution shall establish and perfect the responsibility system of medical wastes management, with its legal representative or major principal being the primary responsible person, seriously perform its duties and ensure the safe management of medical wastes.

Article 5

The medical and health institution shall, pursuant to the relevant laws, administrative regulations, departmental rules and normative documents, formulate and implement rules and systems for the management of medical wastes, the work flow and requirements, the duties of the relevant personnel, and the emergent scheme for flowing, leakage, spreading and accidents of medical wastes within the institution. The contents shall include:

1)

Methods of classified collection of medical wastes and the work requirements of the places generating medical wastes within the medical and health institution;

2)

Work rules of the places generating medical wastes and the places of temporary storage of medical wastes within the medical and health institution, and the work requirements for carrying the wastes from the generating places to the temporary storage places;

3)

Provisions on the relevant handover and registration in the carriage of medical wastes within the medical and health institution and in delivering wastes to the disposal entities.

4)

Special operational procedures in the management of medical wastes and emergent measures for the flowing, leakage, expansion and accidents of medical wastes;

5)

Occupational health safety protection of the relevant working staffs engaged in the classified collection, carriage, and temporary storage of medical wastes.

Article 6

The medical and health institution shall establish a monitoring body or allocate full-time (part-time) personnel to be responsible for medical wastes management and perform the following duties:

1)

Directing and inspecting the implementation of the work in the process of classified collection, carriage, temporary storage, and internal disposal of medical wastes;

2)

Directing and inspecting the occupational health safety protection work in the process of classified collection, carriage, temporary storage, and internal disposal of medical wastes;

3)

Organizing emergent treatment in the event of flowing leakage, spreading and accidents of medical wastes;

4)

Organizing the training relating to medical wastes management;

5)

Managing the relevant registration and archives of medical wastes;

6)

Analyzing and dealing with other problems arising in the management of medical wastes in good time.

Article 7

The medical and health institution shall, in the event of flowing, leakage, and spreading of medical wastes, report to the administrative departments of public health and of environmental protection of the people's government at the county level of the place where it is located within 48 hours, and after the investigation and handling, the medical and health institution shall report the investigation and handling results to the said departments.

The administrative department of public health of the people's government at the county level shall pass on such report level by level to the administrative department of public health of the local people's government at the provincial level each month.

The administrative department of public health of the people's government at the provincial level shall gather those reports and submit them to the Ministry of Public Health on the semi-annual basis.

Article 8

When a medical and health institution has caused death to 1 or more persons or health detriment to 3 or more persons as a result of improper management of medical wastes and needs to provide medical aid and on-the-spot rescue to the injured persons, it shall report to the administrative departments of public health and of environmental protection of the people's government at the county level in its locality within 24 hours, and shall take corresponding emergent measures pursuant to the Regulation on Medical Wastes Management.

The administrative department of public health of the people's government at the county level shall, after receiving the report, report level by level to the administrative department of public health of the people's government at the provincial level within 12 hours.

The administrative department of public health of the people's government at the provincial level shall, after receiving the report, report to the Ministry of Public Health within 12 hours.

Where medical wastes have, as found out, caused the spreading of infectious diseases or where there is evidence showing that an accident of spreading of infectious diseases is likely to happen, the medical and health institution shall make a report pursuant to the Law on Infectious Diseases Control and other relevant provisions and take corresponding measures.

Article 9

The medical and health institution shall formulate and organize the implementation of the training plans of the relevant personnel in respect of the professional skills, occupational health safety protection and emerge treatment knowledge, etc., that are needed in the process of classified collection, carriage, temporary storage, and internal disposal of medical wastes.

Chapter 3 Classified Collections, Carriage and Temporary Storage

Article 10

The medical and health institution shall apply classified management of medical wastes pursuant to the Catalogue of Classifications of Medical Wastes

Article 11

The medical and health institution shall collect medical wastes on a classified basis and in good time pursuant to the following requirements:

1)

Placing the medical wastes separately in packages or containers that are in conformity with the Provisions on the Standards and Warning Marks of Special Packages and Containers of Medical Wastes according to the types of the medical wastes;

2)

Before placing the medical wastes, carefully checking the packages or containers of medical wastes to ensure that they are not damaged, leaky or otherwise defective;

3)

Refraining from mixing the infectious, pathological, damaging, drug, and chemical wastes in the process of collection. Small quantities of drug wastes may be mixed with infectious wastes, but indications shall be made on the label;

4)

Executing the relevant laws and administrative regulations and the relevant provisions of the state in management of the abandoned narcotic, psychotropic, radioactive, and poisonous drugs, etc., and the relevant wastes;

5)

Handing over the batch-use waste chemical reagents and waste disinfectors in chemical wastes to the specialized agencies for disposal;

6)

Handing over the batch-use medical utensils, such as thermometers containing mercuric and blood-pressure meters, etc., to the specialized agencies for disposal;

7)

With respect to the highly dangerous wastes among medical wastes, such as the culture medium, samples and preservation liquid of bacteria and toxins of virus, etc., sterilizing with high pressure or steam or conducting chemical disinfection at the places of generation before collecting and disposing of them as infectious wastes;

8)

Strictly disinfecting the infectious rejections generated by segregated infectious patients or suspect infectious patients pursuant to the provisions of the state, and discharging the rejections into the sewage disposal system only after the discharging standards prescribed by the state are reached;

9)

Using double-layer packaging for the infectious rejections generated by segregated infectious patients or suspect infectious patients and promptly sealing the packages;

10)

Refraining from taking out any infectious, pathological, or damaging wastes that have already been put into the packages or containers.

Article 12

Illustrations or written instructions of the classified collection methods of medical wastes shall be displayed at the places generating medical wastes within a medical and health institution.

Article 13

Where the volume of medical wastes reach three fourths of that of the packages or containers in which they are contained, effective sealing methods shall be taken to make tight and close the mouth of the package or container.

Article 14

Where the external of the packages or containers are polluted by infectious wastes, the polluted place shall be disinfected or a new layer of packaging shall be added onto that place.

Article 15

There should be a warning mark on the external of each packaging or container containing medical wastes, and there should be a label in Chinese attached to each package or container, the contents of which shall include: the entity generating the medical wastes, date of generation, class of wastes, and necessary special instructions, etc.

Article 16

The carriage personnel shall carry the medical wastes that are packed on a classified basis from the generating places to the designated internal temporary storage places pursuant to the prescribed time and routes every day.

Article 17

Before carrying the medical wastes, the carriage personnel shall check whether the marks, labels and seals of the packaging or containers are in conformity to the requirements, and may not carry any medical wastes not in conformity with the requirements to the temporary storage places.

Article 18

When carrying the medical wastes, the carriage personnel shall avoid any damage to the packages or containers, shall avoid the flowing, leakage or spreading of medical wastes, and shall prevent direct body contact with the medical wastes.

Article 19

Special conveyances that can prevent leakage and dispersion, that have no sharp edges, and that are easy for loading and cleaning shall be used for the carriage of medical wastes.

The conveyance shall be cleaned and disinfected in good time every day after the carriage work is finished.

Article 20

The medical and health institution shall set up temporary storage facilities and equipment of medical wastes and may not leave the medical wastes in the open; the temporary storage of medical wastes may not exceed 2 days.

Article 21

The temporary storage facilities and equipment of medical wastes set up by a medical and health institution shall meet the following requirements:

1)

Staying afar from medical treatment areas, food processing areas, personnel movement areas, and storage places of house refuse, and being it convenient for the entry and exit of the personnel and conveyance carrying medical wastes;

2)

Being tightly sealed and being managed by full-time (part-time) personnel to prevent non-working staff from contacting the medical wastes;

3)

Having safety measures against rats, flies and mosquito, and cockroaches;

4)

Being leakage proof and refraining from rain-washing;

5)

Being easy for cleaning and disinfection;

6)

Avoiding direct sunshine;

7)

Having conspicuous warning marks of medical wastes and warning marks of "no smoke and food".

Article 22

Low temperature or anti-erosion conditions are required for temporary storage of pathological wastes.

Article 23

The medical and health institution shall hand over the medical wastes to the entity of concentrated disposal of medical wastes approved by the administrative department of public health of the people's government at the county level or above, and shall fill in and keep the handover forms pursuant to the system of handover forms of dangerous wastes.

Article 24

The medical and health institution shall register the medical wastes, and the registered contents shall include the medical wastes' sources, types, weight or quantities, handover time, final whereabouts, and signatures of the handling persons, etc. The registration materials shall be kept for at least 3 years.

Article 25

The temporary storage places and facilities shall be cleaned and disinfected, after the medical wastes have been moved out.

Article 26

The medical and health institution and its working staff are prohibited from transferring to others or trading medical wastes.

It is prohibited to dump or pile up medical wastes at any non-collection or non-temporary storage places, and it is prohibited to mix the medical wastes with other wastes or house refuse.

Article 27

The medical and health institution shall, in the rural areas without the conditions for concentrated disposal of medical wastes, dispose of the medical wastes it generates by itself within the institution according to the requirements of the local administrative departments of public health and of environmental protection. Self- disposition of medical wastes shall meet the following basic requirements:

1)

Used one-off medical equipment and the medical wastes liable to injure persons shall be disinfected and their dangerous shapes shall be changed;

2)

Those medical wastes that can be burned shall be burned in good time;

3)

Those medical wastes that cannot be burned shall be buried after disinfection in a concentrated way.

Article 28

In the event of flowing, leakage, spreading or accident of medical wastes, a medical and health institution shall take emergent measures in good time pursuant to the requirements as follows:

1)

Determining the types and quantities of the medical wastes flowing, leaking and spreading, and the time of occurrence, scope of impact, and seriousness;

2)

Organizing the relevant personnel to conduct on-the-spot treatment of the leaking and spreading of the medical wastes as soon as possible according to the emergent scheme;

3)

When treating the areas polluted by the medical wastes, trying to minimize the affection to the patients, medical personnel, other personnel on the spot, and to the environment.

4)

Taking appropriate safety disposal measures to disinfect or otherwise make harmless the leaking wastes and the polluted areas and materials, and blocking the polluted areas if necessary to prevent the spread of pollution;

5)

When disinfecting the areas polluted by infectious wastes, carrying out the disinfection work from the areas most slightly polluted to those most seriously polluted, and disinfecting any used tools that might have been polluted;

6)

The working staff shall ensure that they have taken sufficient health safety protection measures before carrying out the work.

After the treatment work is finished, the medical and health institution shall investigate into the cause of the event and take effective prevention measures against the occurrence of similar events.

Chapter 4 Personnel Training and Occupational Safety Protection

Article 29

The medical and health institution shall train its working staff and enhance the knowledge of all the staff members in medical wastes management. The working staff and managerial personnel engaging in classified collection, carriage, temporary storage, and disposal of medical wastes shall receive training on the relevant laws, professional skills, and knowledge of safety protection and emergent treatment, etc.

Article 30

The relevant working staff and managerial personnel of medical wastes shall meet the following requirements:

1)

Understanding the provisions of the relevant laws, regulations, rules and normative documents of the state, acquainting themselves with the rules and systems, work procedures and requirements of medical wastes management formulated by the medical and health institution;

2)

Mastering the correct methods and operational procedures of the classified collection, carriage, and temporary storage of medical wastes;

3)

Grasping the safety knowledge, professional skills, and knowledge of occupational health safety protection in classification of medical wastes;

4)

Grasping the methods to prevent being stabbed or scratched by the medical wastes in the process of the classified collection, carriage, temporary storage, internal disposal of the medical wastes, and the treatment methods after the occurrence of such events;

5)

Grasping the emergent treatment measures in the event of flowing, leakage, spreading and occurrence of medical waste accidents.

Article 31

The medical and health institution shall, pursuant to the types of and different degrees of risks of the medical wastes contacted, equip the working staff and managerial personnel engaged in the classified collection, carriage, temporary storage, and disposal of the medical wastes in the institution with necessary protection materials, make regular health inspections to them, and if necessary, give immunization injection to the relevant personnel to prevent their health from impairment.

Article 32

When any working staff of a medical and health institution is stabbed or scratched by the medical wastes during work, he/she shall take corresponding treatment measures and report to the relevant offices in the institution in good time.

Chapter 5 Supervision and Administration

Article 33

The administrative departments of public health of the local people's governments at the county level and above shall, in accordance with the provisions of the Regulation on Medical Wastes Management and the present Measures, make regular supervisory inspection and irregular selective inspection over the medical and health institutions within their respective jurisdictions.

Article 34

The main contents of the supervisory and selective inspections over medical and health institutions are:

1)

The rules and systems concerning medical wastes management and the implementation thereof;

2)

The classified collection, carriage, temporary storage, and internal disposal of medical wastes;

3)

Registration materials and records related to medical wastes management;

4)

Safety protection of the relevant personnel in medical wastes management;

5)

Report, investigation and handling of the events of flowing, leakage, spreading and accidents of medical wastes;

6)

On-spot hygiene monitoring.

Article 35

The administrative departments of public health shall, if finding any hidden risks in the medical and health institutions through supervisory or selective inspections, order the institutions to eliminate such risks immediately.

Article 36

The administrative departments of public health at the county level and above shall investigate into and punish the acts of the medical and health institutions that violate the Regulation on Medical Wastes Management and the present Measures.

Article 37

When improper management of medical wastes causes the spread of infectious diseases, or there is evidence proving the possibility of such spread, the administrative departments of public health shall take corresponding measures in good time in accordance with Article 40 of the Regulation on Medical Wastes Management.

Article 38

The medical and health institutions shall cooperate with the administrative departments of public health in the inspection, monitoring, investigation, and obtaining of evidence, and may not refuse or hinder such process, or provide falsified materials.

Chapter 6 Rules of Punishment

Article 39

If a medical and health institution, violating the Regulation on Medical Wastes Management and the present Measures, is in any of the situations as follows, the administrative department of public health of the local people's government at the county level or above shall order it to correct within a prescribed time limit and give it a warning; if the institution fails to correct within the aforesaid time limit, it shall be imposed on a fine ranging from 2,000 Yuan to 5,000 Yuan:

1)

Failing to establish or perfect the system of medical wastes management, or failing to set up the monitoring body or to allocate full-time (part-time) personnel;

2)

Failing to give the relevant personnel training on the relevant laws, professional skills, safety protection and emergent treatment knowledge, etc;

3)

Failing to register the medical wastes or to keep the registered materials;

4)

Failing to take occupational health safety protection measures for the working staff and managerial personnel engaged in the classified collection, carriage, temporary storage, and disposal of medical wastes within the institution;

5)

Failing to clean and disinfect in good time the used conveyance of medical wastes;

6)

In the case of a medical and health institution which has set up disposal facilities of medical wastes, failing to test and evaluate the hygiene effects of such facilities regularly, or failing to put on record or report the testing and evaluation effects.

Article 40

If a medical and health institution, violating the Regulation on Medical Wastes Management and the present Measures, is in any of the situations as follows, the administrative department of public health of the local people's government at the county level or above shall order it to correct within a prescribed time limit, give it a warning, and may impose on it a fine of less than 5,000 Yuan concurrently; if the institution fails to correct within the said time limit, it shall be imposed on a fine ranging from 5,000 Yuan to 30,000 Yuan:

1)

The places, facilities or equipment of temporary storage of medical wastes are not in conformity with hygienic requirements;

2)

The medical wastes are not placed in special packages or containers according to their types;

3)

The conveyance of medical wastes is not in conformity with the requirements.

Article 41

If a medical and health institution, violating the Regulation on Medical Wastes Management and the present Measures, is in any of the situations as follows, the administrative department of public health of the local people's government at the county level or above shall order it to correct within a prescribed time limit, give it a warning, and impose on it a fine ranging from 5,000 Yuan to 10,000 Yuan; if the institution fails to correct within the aforesaid time limit, it shall be imposed on a fine ranging from 10,000 Yuan to 30,000 Yuan; if spreading of infectious diseases is caused, the original license issuing department shall suspend or revoke the practice license of the medical and health institution; and if any crime has been constituted, the offenders shall be subject to criminal liabilities:

1)

Casting medical wastes within the medical and health institution and dumping and piling up medical wastes at any non-storage places, or mixing the medical wastes with other wastes and house refuse;

2)

Giving the medical wastes to any entities or individuals that have not obtained the operation license;

3)

Failing to make strict disinfection of the sewage and the rejections of infectious patients or suspect infectious patients in accordance with the Regulation and the present Measures, or discharging them into the sewage disposal system where the discharging standards prescribed by the state are not reached;

4)

Failing to manage and dispose of as medical wastes the house refuse of the accepted infectious patients and suspect infectious patients.

Article 42

The medical and health institution that transfer to others or trade medical wastes shall be punished pursuant to Article 53 of the Regulation on Medical Wastes Management.

Article 43

If a medical and health institution, in the event of flowing, leakage or spreading of medical wastes, fails to take emergent measures or fails to report to the administrative department of public health in good time, the administrative department of public health of the local people's governments at the county level or above shall order it to correct, give it a warning, and impose on it a fine ranging from 10,000 Yuan to 30,000 Yuan concurrently; if spreading of infectious diseases is caused, the original license issuing department shall suspend or revoke the practice license of the medical and health institution; and if any crime has been constituted, the offenders shall be subject to criminal liabilities.

Article 44

Where a medical and health institution, without justified reasons, hinders any of the law enforcement personnel of the administrative department of public health in their execution of duties, refuses them to enter the scene, or refuses to cooperate with the law enforcement department in inspection, monitoring, investigation and obtaining of evidence, the administrative department of public health of the local people's government at the county level or above shall order it to correct and give it a warning; if it refuses to correct, the original license issuing department shall suspend or revoke the practice license of the medical and health institution; if the Public Security Administration Regulation of the People's Republic of China is violated and an act violating pubic security administration is committed, the public security organ shall punish the medical and health institution; and if any crime has been constituted, the offenders shall be subject to criminal liabilities.

Article 45

In the rural areas without the conditions for concentrated disposal of medical wastes, if a medical and health institution fails to dispose of the medical wastes pursuant to the Regulation on Medical Wastes Management and the present Measures, the administrative department of public health of the local people's government at the county level or above shall order it to correct within a prescribed time limit and give it a warning; if it fails to correct within the said time limit, it shall be imposed on a fine ranging from 1,000 Yuan to 5,000 Yuan; if spreading of infectious disease is caused, the original license issuing department shall suspend or revoke the practice license of the medical and health institution; and if any crime has been constituted, the offenders shall be subject to criminal liabilities.

Article 46

If a medical and health institution, violating the Regulation on Medical Wastes Management and the present Measures, causes the spread of any infectious disease and causes damages to others, it shall be liable for civil damages.

Chapter 7 Supplementary Provisions

Article 47

The phrase "medical and health institutions" as mentioned in the present Measures refers to the institutions that have obtained the Practice License of Medical Institutions pursuant in according to the Regulation on the Administration of Medical Institutions, as well as the disease prevention and control institutions and blood collection and supply institutions.

Article 48

The present Measures shall be implemented as of the date of promulgation.