Thông tư liên tịch 58/2015/TTLT-BYT-BTNMT

Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31st, 2015, stipulating regulations on biomedical waste management

Nội dung toàn văn joint Circular 58/2015/TTLT-BYT-BTNMT regulations on biomedical waste management 2016


MINISTRY OF HEALTH - MINISTRY OF NATURAL RESOURCES AND ENVIRONMENT
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 58/2015/TTLT-BYT-BTNMT

Hanoi, December 31, 2015

 

JOINT CIRCULAR

STIPULATING REGULATIONS ON BIOMEDICAL WASTE MANAGEMENT

Pursuant to the Law on environmental protection in 2014;

Pursuant to the Government’s Decree No. 38/2015/ND-CP dated April 24, 2015 providing for the management of waste and discarded materials;

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining functions, tasks, authority and organizational structure of Minister of Health;

Pursuant to the Government’s Decree No. 21/2013/ND-CP dated March 04, 2013 defining functions, tasks, authority and organizational structure of the Ministry of Natural Resources and Environment;

The Minister of Health and the Minister of Natural Resources and Environment promulgates the Joint Circular stipulating regulations on biomedical waste management,

Chapter I

GENERAL PROVISIONS

Article 1. Scope of application

1. This Circular promulgates detailed regulations on Clause 6 and Clause 7 Article 49 of the Government’s Decree No. 38/2015/ND-CP dated April 24, 2015 providing for the management of waste and discarded materials.

2. The management of waste generated from the burial and cremation, and radioactive waste generated from medical activities shall be not governed by this Circular. The management of waste generated from the burial and cremation shall comply with regulations on hygiene in burial and cremation fields. The management of radioactive waste generated from medical activities shall comply with regulations on the management of radioactive waste and used radioactive sources and the assurance of radiation safety in medical field.

Article 2. Regulated entities

This Circular is applicable to domestic and overseas agencies, organizations and individuals with activities involved in biomedical waste in the territory of Vietnam.

Article 3. Interpretation of terms

In this Circular, these terms are construed as follows:

1. Biomedical waste means the waste generated from the operation of medical establishments, including hazardous biomedical waste, non-hazardous biomedical waste and medical wastewater.

2. Hazardous biomedical waste refers to the medical waste containing infectious elements or other hazardous characters exceeding the hazardous waste level, including infectious waste and non-infectious hazardous waste.

3. Biomedical waste management refers to the process of minimizing, delimiting, classifying, collecting, storing, transporting, recycling and treating biomedical waste, and supervising the implementation of these actions.

4. Biomedical waste minimization refers to activities of reducing the emission of biomedical waste to the minimum.

5. Biomedical waste collection refers to the process of gathering biomedical waste from where it is generated and transporting it to the biomedical waste storage and treatment area within the medical establishment precincts.

6. Biomedical waste transportation refers to the process of transporting biomedical waste from waste storage areas in medical establishments to the waste storage and treatment areas of the biomedical waste treatment facilities for clusters of medical establishments, concentrated hazardous biomedical waste treatment facilities or the concentrated hazardous waste treatment facilities with biomedical waste treatment items.

7. Medical establishments include medical examination and treatment establishments (except for family-doctor clinics; traditional medicine clinics; pulse, temperature and blood pressure services providers; home healthcare service providers; patient transport services providers (transporting locally and overseas); optical glasses establishments; denture service establishments; infirmaries; health facilities of agencies, units and organizations); preventive medicine establishments; training and research establishments with performance of medical tests.

Chapter II

BIOMEDICAL WASTE MANAGEMENT

Section 1: DELIMITATION, CLASSIFICATION, COLLECTION, STORAGE, MINIMIZATION AND RECYCLING OF HAZARDHOUS AND NON-HAZARDOUS BIOMEDICAL WASTE

Article 4. Biomedical waste delimitation

1. Infectious waste includes:

a) Sharp infectious waste refers to the infectious waste that may cause cuts or punctures, including: injection needles; fixed-needle syringes; sharp ends of transfusion tubes; puncture needles; acupuncture needles; scalpels; surgical nails and saws, and other sharp things;

b) Non-sharp infectious waste includes bloodstained waste or waste stained with body fluids and waste generated from isolation wards;

c) Highly infectious waste includes specimens, containers stained with specimens and waste stained with specimens, generated from level-III or higher bio-safety laboratories as regulated in the Government’s Decree No. 92/2010/ND-CP dated August 30, 2010 detailing the implementation of the Law on infectious disease prevention and control, regarding biosafety in laboratories;

d) Surgical waste includes removed human body tissues and parts, and tested animal carcasses.

2. Non-infectious hazardous waste includes:

a) Discarded chemicals that include or contain hazardous elements;

b) Discarded pharmaceuticals which are classified into cytotoxic group or issued with warning of hazard by manufacturers;

c) Broken, spoiled or used medical equipment which contains mercury and other heavy metals;

d) Discarded dental amalgams;

dd) Other hazardous waste as regulated in the Circular No. 36/2015/TT-BTNMT dated June 30, 2015 of the Minister of Natural Resources and Environment on the management of hazardous waste (referred to as the Circular No. 36/2015/TT- BTNMT).

3. Non-hazardous biomedical waste includes:

a) Daily-life solid waste which are generated from daily life activities and external environment waste in medical establishments;

b) Conventional solid waste generated from medical establishments that does not belong to the List of hazardous biomedical waste or belongs to the List of hazardous biomedical waste as regulated in Point a Clause 4 of this Article but hazardous elements of which are below the hazardous waste level;

c) Non-hazardous liquid waste.

4. The list and codes of hazardous biomedical waste include:

a) The list and codes of hazardous waste regulated in Annex 1 of the Circular No. 36/2015/TT-BTNMT which are provided for the biomedical waste stated in Annex No. 01 (A) enclosed to this Circular;

b) The list of non-hazardous biomedical waste gathered for recycling as regulated in Annex No. 01 (B) enclosed to this Circular.

Article 5. Biomedical waste storage packing, devices and equipment

1. Packing (bags), devices (bins, boxes, cans) and equipment storing biomedical waste shall be performed in accordance with regulations in Clause 2, Clause 3, Clause 4, Clause 5, Clause 6 and Clause 7 of this Article. Waste storage packing, devices and equipment must contain symbols as regulated in Annex No. 02 enclosed with this Circular. Medical establishments must not comply with regulations on storage packing, devices and equipment as regulated in Clause 2 Article 7 of the Circular No. 36/2015/TT-BTNMT.

2. Waste storage packing, devices and equipment must have leak-proof property and sizes in conformity with stored waste amount, ensuring that waste is safely stored.

3. The color of biomedical waste storage packing, devices and equipment is regulated as follows:

a) The color of packing, devices and equipment storing infectious waste is yellow;

b) The color of packing, devices and equipment storing non-infectious hazardous waste is black;

c) The color of packing, devices and equipment storing non-hazardous biomedical waste is green;

d) The color of packing, devices and equipment storing recyclable waste is white.

4. Packing and devices storing biomedical waste with employing incineration method shall not be made out of PVC resin.

5. Waste bins and boxes must have lids which are easy to open and close when using.

6. Other than provisions in Clause 1, Clause 2, Clause 3, Clause 4 and Clause 5 of this Article, bins and boxes storing sharp waste must have hard walls and bottoms which cannot be punctured.

7. Waste storage bins and boxes may be re-used in accordance with storage purpose after they have been cleaned and kept dry.

Article 6. Biomedical waste classification

1. Principle of biomedical waste classification:

a) Both hazardous and non-hazardous biomedical waste must be classified at source and time of generation for management;

b) Each type of biomedical waste must be separately classified into waste storage packing, devices and equipment as regulated in Article 5 of this Circular. In case non-hazardous biomedical wastes are unable to react or interact with each other and treated by the same method, they can be classified into the same storage package, device or equipment;

c) If infectious waste is accidentally stored with other waste or vice versa, such waste mixtures must be collected, stored and treated like infectious waste.

2. Locations of waste classification packing and devices:

a) Each ward, department and section must set places for biomedical waste classification packing and devices;

b) Locations of biomedical waste classification packing and devices must have waste classification and collection instruments.

3. Biomedical waste classification:

a) Sharp infectious waste is stored in yellow bin or box;

b) Non-sharp infectious waste is stored in yellow bag or bin with bin liner;

c) Highly infectious waste is stored in yellow bag or bin with bin liner;

d) Surgical waste is stored in 2 yellow overlapping bags or yellow bin with bin liner;

dd) Solid non-infectious hazardous waste is stored in black bag or bin with bin liner;

e) Liquid non-infectious hazardous waste is stored in devices with lids;

g) Non-hazardous biomedical waste which shall not be recycled is stored in green bag or bin with bin liner;

h) Non-hazardous biomedical waste which shall be recycled is stored in white bag or bin with bin liner.

Article 7. Biomedical waste collection

1. Infectious waste collection:

a) Infectious waste must be separately collected at source and moved to the waste storage area in the medical establishment precincts;

b) Waste storage bags must be closely tied up and waste storage bins must be covered with lids, ensuring that waste shall not be dropped or leaked out during the waste collection;

c) The medical establishment shall provide for suitable routes and time of collecting infectious waste for avoiding causing influence on patients’ areas and other areas in the medical establishment;

d) Highly infectious waste must be preliminarily treated before it is collected and transported to the waste storage and treatment area in the medical establishment precincts;

dd) The infectious waste shall be collected at source and transported to the waste storage area in the medical establishment precincts at least 01 (one) per day;

e) For medical establishments where the amount of generated infectious waste is under 05 kg/day, sharp infectious waste shall be collected at source and transported to the storage area in the medical establishment precincts or moved out for treatment or destruction at least 01 (one) time per month.

2. Non-infectious hazardous waste collection:

a) Non-infectious hazardous waste must be separately collected and stored at the waste storage area in the medical establishment precincts;

b) The collection of discarded dental amalgams and broken, spoiled or used medical equipment that contains mercury: Mercury-containing waste shall be separately collected and stored in plastic boxes or boxes made out of other suitable materials, ensuring that mercury vapor cannot be leaked or emitted to surrounding environment.

3. Non-hazardous biomedical waste collection: The non-hazardous biomedical waste for recycling shall be collected separately from the non-hazardous biomedical waste that is not used for recycling.

Article 8. Biomedical waste storage

1. The medical establishment shall arrange the biomedical waste storage location in its precincts in accordance with the following requirements:

a) The medical establishment in charge of performing the treatment of hazardous biomedical waste for a cluster of medical establishments and hospitals must have a hazardous biomedical waste storage area which meets technical requirements as prescribed in Annex No. 03 (A) enclosed to this Circular;

b) The medical establishment that is not a subject governed by Point a of this Clause must have a hazardous biomedical waste storage area which meets technical requirements as prescribed in Annex No. 03 (B) enclosed to this Circular.

2. Devices and equipment storing hazardous biomedical waste at the waste storage area in the medical establishment must be uniformly performed as regulated in this Circular and satisfy the following requirements:

a) Storage devices and equipment must have strong and unbroken walls, ensuring that the waste cannot be leaked out in the course of waste storage;

b) They must contain symbols of types of stored waste as regulated in the Annex No. 02 enclosed with this Circular;

c) They must be closely covered with lids and able to prevent the intrusion of animals;

d) Chemical storage devices and equipment must be made of materials that do not react with stored waste and contain anti-corrosion property if they are used to store corrosive waste. Devices and equipment storing liquid chemical waste must be closely covered with lids for avoiding the evaporation and overflow of waste.

3. Hazardous and non-hazardous biomedical waste must be separated stored in the waste storage area in the medical establishment precincts.

4. The infectious waste must be stored separately from the non-infectious hazardous waste, except for cases where these types of waste apply the same treatment method.

5. The non-hazardous biomedical waste for recycling shall be stored separately from the non-hazardous biomedical waste that is not used for recycling.

6. Infectious waste storage period:

a) With regard to the infectious waste generated in medical establishments, period for storing infectious waste in medical establishments shall not exceed 02 days in normal conditions. If the infectious waste is stored in cold storage equipment with temperature of below 8°C, the storage period may reach 07 days. As for medical establishments where the amount of infectious waste generated is less than 05 kg/day, the storage period shall not exceed 03 days in normal conditions and waste storage packing must be closely tied up or waste storage equipment must be covered with lids;

b) The infectious waste which is transported from other medical establishments for treatment under the model of medical establishments cluster or concentrated model must be treated in day. If such waste cannot be immediately treated in day, it must be stored in temperature of below 20°C and the storage period shall not exceed 02 days.

7. Medical establishments shall comply with regulations on hazardous biomedical waste storage and storage area as regulated in this Circular and must not comply with regulations stated in Clause 2 Article 7 of the Circular No. 36/2015/TT-BTNMT.

Article 9. Biomedical waste minimization

Medical establishments must carry out plans for minimizing the generation of biomedical waste according to the following order of priority:

1. Install and use suitable equipment, devices, drugs, chemicals and materials, ensuring the biomedical waste generation is limited.

2. Adopt new equipment and technological process in medical activities for reducing the generation of biomedical waste.

3. Manage and use materials suitably and effectively.

Article 10. Management of non-hazardous biomedical waste for recycling

1. Only non-hazardous biomedical waste and types of waste regulated in Clause 3 of this Article are recycled.

2. It is not allowed to use materials that are made of recycled biomedical waste for producing devices or bags used in the food sector.

3. Treated infectious waste that meets national technical regulations on environment shall be managed like non-hazardous biomedical waste.

4. Apart from provisions defined in Clause 1 and Clause 2 of this Article, when transferring the waste regulated in Clause 3 of this Article for recycling, medical equipments must comply with the following regulations:

a) Waste storage packing must be closely tied up and contain the recyclable waste symbol as regulated in Annex No. 02 enclosed with this Circular;

b) The waste-related information must be sufficiently recorded in the recyclable waste handover book by using the form stated in Annex No. 04 enclosed to this Circular.

Section 2: BIOMEDICAL WASTE TRANSPORTATION AND TREATMENT

Article 11: Transportation of hazardous biomedical waste for treatment under the model of medical establishment cluster

1. The transportation of hazardous biomedical waste from medical establishments in a cluster of medical establishments to the cluster's treatment facility must be performed according to the following forms:

a) The medical establishment in the cluster of medical establishments shall hire an external unit that has obtained the license for hazardous waste treatment or the license for hazardous waste management to transport waste generated in medical establishments to the cluster's waste treatment facility. If the owner of hazardous waste treatment facility or the owner of hazardous waste management facility wishes to participate in the transportation of biomedical waste in the cluster but such operation is beyond the scope of the license issued by the state competent authorities, a report must be submitted to the licensing authority before performing such operation as regulated in Clause 5 Article 23 of the Circular No. 36/2015/TT-BTNMT;

b) The medical establishment that itself transports or hires an unit other than entities regulated in Point a of this Clause to transport hazardous biomedical waste from such medical establishment to the cluster’s waste treatment facility must satisfy all requirements in Clause 2, Clause 3 and Clause 4 of this Article, and such transportation must be approved by the people’s committee of province or central-affiliated city (referred to as the provincial people’s committee) via the provincial plan for biomedical waste collection, transportation and treatment.

2. Means of transportation: Medical establishments and units contracted to transport hazardous biomedical waste may use dry van or refrigerator truck or other means of transportation for transporting hazardous biomedical waste from medical equipments to the cluster’s waste treatment facility provided that all requirements stated in Clause 3 and Clause 4 of this Article must be satisfied.

3. Hazardous biomedical waste storage devices and equipment used in means of transportation must meet the following requirements:

a) Have tight walls, bottoms and lids, strong and ruggedized structure, and are unable to be torn or broken by the weight of waste, ensuring that waste is stored safely during the transportation;

b) Contain symbols of types of stored waste as regulated in the Annex No. 02 enclosed with this Circular. Such symbols attached to waste storage equipment must have suitable sizes, distinct and clear color, and be clearly and readably printed.

c) Are fixed or removable from means of transportation provided that waste shall be not dropped or spilled during the transportation.

4. Before being transported, the infectious waste must be carefully packaged in bottles, boxes or bags, ensuring that they shall not be cracked or broken, and stored waste shall not be leaked out during the transportation.

5. During the transportation of biomedical waste from medical establishments to the cluster’s biomedical waste treatment facility, if the transported biomedical waste is overflowed, burned or exploded, or any other incidents occur, measures against environmental incidents must apply immediately as regulated by the law.

Article 12: Transportation of biomedical waste for treatment under the concentrated treatment model

1. Transportation of non-infectious hazardous waste: comply with regulations in Article 8 of the Circular No. 36/2015/TT-BTNMT.

2. Transportation of infectious waste: comply with regulations in Clause 1 of this Article and the following requirements must be satisfied:

a) Before being transported, the infectious waste must be carefully packaged in bags or storage devices, ensuring that they shall not be cracked or broken, and stored waste shall not be leaked out during the transportation;

b) Special trucks used for transporting infectious waste must have dry van or refrigerator bodies;

c) For areas where special trucks for transporting hazardous biomedical waste cannot be used, other means of transportation may be employed provided that all requirements stated in Clause 3 and Clause 4 Article 11 of this Circular must be satisfied and such means of transportation must be included in the license for hazardous waste treatment issued by the competent authorities as prescribed in the Circular No. 36/2015/TT-BTNMT.

3. The transportation of non-hazardous biomedical waste shall comply with laws on non-hazardous waste management.

Article 13: Hazardous biomedical waste treatment

1. Hazardous biomedical waste must be treated in conformity with national technical regulations on environment.

2. Non-incineration and eco-friendly technologies are prioritized, and the treatment of waste must meet national technical regulations on environment promulgated by the Minister of Natural Resources and Environment.

3. Hazardous biomedical waste treatment is performed according to the following order of priority:

a) The treatment is performed at concentrated hazardous biomedical waste treatment facilities or concentrated hazardous waste treatment facilities with biomedical waste treatment items;

b) Hazardous biomedical waste is treated under the model of medical establishment cluster (biomedical waste of a cluster of medical establishment shall be collected and treated together in the treatment system and equipment of a facility in the cluster);

c) Hazardous biomedical waste is treated in the treatment facility in the medical establishment precincts.

4. If hazardous biomedical waste is treated under the model of medical establishment cluster, such treatment model must be approved by the provincial people's committee via the provincial plan for hazardous biomedical waste collection, transportation and treatment in conformity with actual conditions of such province and in accordance with the law on environmental protection.

Article 14. Medical wastewater management

1. Medical wastewater must be managed and treated according to contents of the report on environmental impact assessment, the environmental protection plan, the detailed environmental protection project or the simplified environmental protection project which has been approved or certified by the state competent authorities.

2. Liquid waste products which are discarded together with wastewater are also referred to as the medical wastewater.

Article 15: Management and operation of biomedical waste treatment equipment

1. Biomedical waste treatment equipment must be frequently operated.

2. Biomedical waste treatment equipment must be maintained on the periodical basis as instructed by manufacturers and relevant information must be sufficiently recorded in the log of operation of biomedical waste treatment equipment and systems by using the form stated in Annex No. 05 enclosed to this Circular.

Chapter III

BIOMEDICAL WASTE MANAGEMENT DOCUMENTS AND REPORTING

Article 16. Reporting

1. Reporting frequency: Reports on biomedical waste management results shall be made once per year, commencing from January 01st to December 31st, inclusively.

2. Reporting form: Reports on biomedical waste management results shall be sent to report receiving bodies via paper documents or electronic documents or reporting software.

3. Reporting contents and order:

a) Medical establishments shall prepare reports on biomedical waste management results by using the form stated in Annex No. 06 (A) of this Circular, and send them to departments of health and departments of natural resources and environment of provinces by January 31st of the following year. Medical establishments must not prepare reports on hazardous waste management results as regulated in Point a Clause 6 Article 7 of the Circular No. 36/2015/TT-BTNMT;

b) Departments of Health shall summarize and submit reports on biomedical waste management results by using the form stated in Annex No. 06 (B) of this Circular, and send them to the Health Environment Management Agency, affiliated to the Ministry of Health, by March 31st of the following year;

c) Departments of Natural Resources and Environment shall summarize and report on hazardous waste management results (including biomedical waste) as regulated in Clause 4 Article 11 of the Circular No. 36/2015/TT-BTNMT.

Article 17. Biomedical waste management documents

1. Documents related to environmental procedures shall include one or some of the following documents:

a) Decision on approving report on environmental impact assessment, enclosed with the report on environmental impact assessment;

b) Certificate of environmental protection plan issued by competent authorities, enclosed with the environmental protection plan;

c) Certificate of the completion of environmental protection works, enclosed with report on the completion of environmental protection works;

d) Certificate of commitment on environmental protection, enclosed with written commitment on environmental protection;

dd) Certificate of registration form for meeting environmental standards, enclosed with the registration form for meeting environmental standards;

e) Decision on approving detailed environmental protection project, enclosed with the detailed environmental protection project;

g) Certificate of simplified environmental protection project, enclosed with the simplified environmental protection project;

h) Report on discharge of wastewater into a water resource or project on discharge of wastewater into a water resource, enclosed with approval decision made by state competent authorities;

i) Other environment-related documents as regulated by the law on environment.

2. Documents related to the biomedical waste management include:

a) Register of hazardous waste generators;

b) The logbook of delivery of hazardous biomedical waste or documents of hazardous biomedical waste (applicable to cases that are not defined in Clause 4 Article 23 of the Circular No. 36/2015/TT-BTNMT);

c) Biomedical waste logbook; logbook and handover book of treated infectious biomedical waste that meets national technical regulations on environment and is used for recycling; periodical and/or extraordinary reports on biomedical waste management results;

d) The log of operation of biomedical waste treatment equipment and systems (applicable to the medical establishment that itself perform the biomedical waste treatment and the medical establishment in charge of performing the treatment of hazardous biomedical waste for a cluster of medical establishments).

3. Periodical reports on environmental quality monitoring and supervision.

4. The logbook of delivery of hazardous biomedical waste, documents of hazardous biomedical waste, inspection records and reports on biomedical waste management results made on the periodical or extraordinary basis as requested by competent authorities, and the log of operation and maintenance of biomedical waste treatment equipment and systems shall be retained within 05 (five) years.

Chapter IV

RESPONSIBILITIES OF RELEVANT AGENCIES AND UNITS

Section 1: RESPONSIBILITIES OF STATE COMPETENT AUTHORITIES

Article 18. Responsibilities of the Ministry of Health

1. Provide guidance to departments of health and medical establishments within its authority on the implementation of provisions in this Circular.

2. Approve continuous training programs and documents in biomedical waste management for using nationwide.

3. Direct medical training facilities to add biomedical waste management contents to their full-time training programs.

4. Educate and disseminate laws on biomedical waste management to departments of health and medical establishments within its authority.

5. Inspect the implementation of provisions in this Circular.

Article 19. Responsibilities of the Ministry of Natural Resources and Environment

1. Provide guidance to departments of natural resources and environment on the implementation of provisions in this Circular.

2. Coordinate with the Ministry of Health to organize the dissemination of laws on environmental protection in medical activities.

Article 20. Responsibilities of people’s committees at all levels

1. Responsibilities of the provincial people’s committee:

a) Consider and approve plans for collecting, transporting and treating hazardous biomedical waste in the territory of province in conformity with actual conditions of such province and in accordance with the law on environmental protection;

b) Grant funding for investment and operation of biomedical waste treatment works in the province as regulated by the law;

c) Take prime responsibility and coordinate with the Ministry of Health and the Ministry of Natural Resources and Environment to inspect the implementation of provisions in this Circular by medical establishments in the province.

2. Responsibilities of the people’s committee of district, provincial-affiliated city or town:

a) Coordinate with department of health and department of natural resources and environment to perform plans for collecting, transporting and treating hazardous biomedical waste intra vires;

b) Propagandize and disseminate laws on biomedical waste management to medical establishments and relevant objects intra vires;

c) Coordinate with relevant agencies to inspect the implementation of provisions in this Circular by medical establishments intra vires.

3. Responsibilities of people’s committee of commune/ward/townlet:

People’s committee of commune/ward/townlet shall, within its authority, inspect the implementation of this Circular and laws on environmental protection by medical establishments as regulated by the law.

Article 21. Responsibilities of departments of health

1. Provide guidance to medical establishments in the province on the implementation of provisions in this Circular.

2. Take prime responsibility and coordinate with the department of natural resources and environment to inspect the implementation of provisions in this Circular by medical establishments in the province.

3. Coordinate with the department of natural resources and environment to establish and perform plans for collecting, transporting and treating hazardous biomedical waste in the province.

4. Be in charge of training, propagandizing and disseminating laws on biomedical waste management to medical establishments in the province.

5. Submit reports on biomedical waste management results in the province as regulated in Article 16 of this Circular.

Article 22. Responsibilities of departments of natural resources and environment

1. Take prime responsibility and coordinate with the department of health to establish plans for collecting, transporting and treating hazardous biomedical waste in the province, and submit such plans to the provincial people’s committee for approval. Contents of the plan for collecting, transporting and treating hazardous biomedical waste in the province shall comply with regulations in Clause 3 Article 23 of the Circular No. 36/2015/TT-BTNMT which is detailed in Annex No. 07 enclosed to this Circular.

2. Summarize and submit reports on hazardous waste management results as regulated in Clause 4 Article 11 of the Circular No. 36/2015/TT-BTNMT.

3. Take prime responsibility and coordinate with the department of health to inspect the implementation of provisions in this Circular by medical establishments and hazardous biomedical waste treatment facilities in the province.

4. Cooperate with department of health to train, propagandize and disseminate laws on biomedical waste management to medical establishments in the province.

Section 2: RESPONSIBILITIES OF MEDICAL ESTABLISHMENTS

Article 23. Responsibilities of the head of medical establishment

1. Perform the biomedical waste management as regulated in this Circular and other relevant legislative documents.

2. Assign 01 executive officer to undertake the biomedical waste management and 01 ward/department or officer to be in charge of the biomedical waste management of the medical establishment.

3. Prepare and sufficiently record information in hazardous biomedical waste handover book by using the form stated in Annex No. 08 enclosed to this Circular (except for cases where the medical establishment itself perform the biomedical waste treatment).

4. When performing the transfer of hazardous biomedical waste, the medical establishment must not use documents of hazardous biomedical waste at each transfer of hazardous biomedical waste as regulated in Clause 4 Article 7 of the Circular No. 36/2015/TT-BTNMT provided that the following responsibilities must be fulfilled:

a) If the medical establishment hires a unit that has obtained the license for hazardous waste treatment or the license for hazardous waste management to treat the waste generated by such medical establishment, it shall monthly make a set of documents of hazardous waste for the amount of hazardous biomedical waste transferred during the month as regulated in Annex 3 of the Circular No. 36/2015/TT-BTNMT;

b) If the medical establishment employs the model of biomedical waste treatment for a cluster of medical establishments, the logbook of delivery of hazardous biomedical waste shall replace for documents of hazardous biomedical waste.

5. Grant funding, arrange staff or entering into contract with an external unit to perform the biomedical waste collection, transportation and treatment.

6. Propagandize and disseminate laws on biomedical waste management to all officials, contract employees and relevant individuals in the medical establishment.

7. Organize annual training courses in biomedical waste management for officials, contract employees and relevant individuals in the medical establishment.

8. Submit reports on biomedical waste management results as regulated in Article 16 of this Circular.

Article 24. Responsibilities of the head of the medical establishment in charge of performing the hazardous biomedical waste treatment for the cluster of medical establishments

Apart from regulations in Article 23 of this Circular, the head of the medical establishment in charge of performing the hazardous biomedical waste treatment for the cluster of medical establishments must comply with the following provisions:

1. Perform the hazardous biomedical waste collection, transportation and treatment according to contents of the plan for hazardous biomedical waste collection, transportation and treatment approved by the provincial people’s committee.

2. Ensure technical requirements on means of transportation and waste storage equipment in such means of transportation as regulated in Article 11 of this Circular when collecting and transporting biomedical waste from medical establishments in the cluster.

Chapter V

IMPLEMENTATION

Article 25. Implementation organization

1. The Ministry of Health (Health Environment Management Agency), the Ministry of Natural Resources and Environment (Vietnam Environment Administration) shall guide, inspect, monitor and expedite the implementation of this Circular.

2. Chairpersons of people’s committees of provinces, directors of departments of health, directors of departments of natural resources and environment; heads of medical establishments and other relevant organizations and individuals shall implement this Circular.

Article 26. Terms of reference

If referred documents of this Circular are superseded or amended, superseded or amended documents shall apply.

Article 27. Effect

1. This Circular shall take effect as of April 01, 2016.

2. Decision No. 43/2007/QD-BYT dated November 30, 2007 by the Ministry of Health promulgating regulations on biomedical waste management shall be no longer valid as of the effective date of this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (Health Environment Management Agency) and the Ministry of Natural Resources and Environment (Vietnam Environment Administration) for consideration./.

 

MINISTER
OF NATURAL RESOURCES AND ENVIRONMENT




Nguyen Minh Quang

MINISTER OF HEALTH





Nguyen Thi Kim Tien

 

ANNEX NO. 01

LIST AND CODES OF BIOMEDICAL WASTE
(Enclosed to the Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Minister of Health and the Minister of Natural Resources and Environment)

A. List and codes of hazardous biomedical waste

1. List and codes of infectious waste

Infectious waste refers to the waste that contains or is suspected to contain pathogens (germs, virus, parasites, fungi) with density or amount enough for causing human diseases. List and codes of infectious waste are regulated in the following table:

Codes of hazardous waste

Name of waste

Main hazards

Normal existing state (form)

Hazardous waste level

13 01 01

Infectious waste, including:

 

Solid

 

Sharp infectious waste

SN, LN

Solid

**

Non-sharp infectious waste

LN

Solid/liquid

**

Highly infectious waste

LN

Solid, liquid

**

Surgical waste

LN

Solid

**

2. List and codes of non-infectious hazardous waste

Codes of hazardous waste

Name of waste

Main hazards

Normal existing state (form)

Hazardous waste level

13 01 02

Discarded chemicals that include or contain hazardous elements

D, DS

Solid/liquid

*

13 01 03

Discarded pharmaceuticals which are classified into cytotoxic group or issued with warning of hazard by manufacturers

D

Solid/liquid

**

13 01 04

Discarded dental amalgams

D

Solid

**

13 03 02

Broken, spoiled or used medical equipment which contains mercury and other heavy metals

D, DS

Solid

**

 

Other hazardous waste, including:

 

 

 

16 01 06

Discarded fluorescent lamps

D, DS

Solid

**

16 01 08

Discarded greases

D, DS, C

Solid/liquid

**

16 01 12

Discarded cells and batteries

D, DS, AM

Solid

**

16 01 13

Discarded electronic equipment and components or discarded electrical equipment (other than types defined in codes of 16 01 06, 16 01 12) that contain electronic components (except for electronic modules that do not contain elements exceeding hazardous waste level)

D, DS

Solid

**

18 01 01

Discarded soft packing and clouts (generated from the repair and maintenance of equipment contaminated with greases; containing hazardous chemicals).

D, DS

Solid

*

18 01 04

Covers of drug bottles, vials and devices stained with drugs that belong to the cytotoxic group or are issued with warning of hazard by manufacturers

D, DS

Solid

*

18 02 01

Absorbent and materials discarded from the treatment of exhaust fumes

D, DS

Solid

*

12 01 05

Ashes generated from incinerators of solid biomedical waste

D

Solid

*

10 02 03

Sewage sludge generated from medical wastewater treatment system

D, DS

Solid

*

Notes: D: Hazardous

DS: Biotoxic

C: Combustible

 AM: Corrosive

LN: Infectious

Level “**”: hazardous biomedical waste in any cases; Suspicion level refers to hazardous biomedical waste, and if such waste does not contain hazardous elements as regulated by QCVN 07:2009/BTNMT, it shall not be analyzed and is managed as non-hazardous waste.

B. List of non-hazardous biomedical waste collected for recycling

No.

Type of waste

Requirements

I

Waste of paper materials

 

1

Paper, newspapers, boards, cartons, covers of drug bottles and paper materials

Do not contain infectious elements or other hazardous characters exceeding hazardous waste level

II

Waste of plastic materials

 

1

- Plastic bottles storing drugs or chemicals which are not classified into cytotoxic group or issued with warning of hazard by manufacturers.

Do not contain infectious elements

 

- Plastic soft drink cans and bottles and other plastic things used in daily-life activities

Are not discarded from isolation wards

2

Plastic bottles, transfusion tubes and syringes (excluding sharp edges)

Do not contain infectious elements

III

Waste of metal materials

 

1

Metal soft drink cans and bottles and other metal materials

Are not discarded from isolation wards

IV

Waste of glass materials

 

 

Discarded glass bottles and vials that are used to store drugs or chemicals

Store drugs or chemicals which are not classified into cytotoxic group or issued with warning of hazard by manufacturers

 

ANNEX NO. 02

SYMBOLS DISPLAYED ON BIOMEDICAL WASTE STORAGE PACKINGS, DEVICES AND EQUIPMENT
(Enclosed to the Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Minister of Health and the Minister of Natural Resources and Environment)

WARNING OF WASTE CONTAINING CYTOTOXIC SUBSTANCE

WARNING OF WASTE CONTAINING DISEASE-CAUSING SUBSTANCE

GENERAL WARNING OF THE DANGER OF HAZARDOUS WASTE

SYMBOL OF RECYCLABLE WASTE

WARNING OF WASTE CONTAINING HAZARDOUS SUBSTANCE

WARNING OF WASTE CONTAINING CORROSIVE SUBSTANCE

 

WARNING OF WASTE CONTAINING COMBUSTIBLE SUBSTANCE

 

Notes: Appearance, design and color of symbols of hazardous waste shall apply regulations in TCVN 5053:1990.

 

ANNEX NO. 03

TECHNICAL REQUIREMENTS ON BIOMEDICAL WASTE STORAGE AREAS IN MEDICAL ESTABLISHMENTS
(Enclosed to the Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Minister of Health and the Minister of Natural Resources and Environment)

A. Medical establishments that perform the biomedical waste treatment under the model of clusters of medical establishments and hospitals:

1. The waste storage area must have roof; its foundation is not flooded, and is designed to prevent the rain-water runoff from the outside and ensure that the liquid waste shall not flow out in the event of leaking or overflow.

2. The waste storage area must be divided into cells or have separate storage devices and equipment for each type of waste or group of waste which has same characters; each cell, device or equipment storing hazardous biomedical waste in the waste storage area must have the warning sign with sensible and suitable size and the content in conformity with the type of stored hazardous biomedical waste as regulated in Annex No. 02 of this Circular;

3. The waste storage area must have absorbent materials (such as dry sand or sawdust) and shovels to use in the event of leaking or overflow of liquid hazardous biomedical waste.

4. The waste storage area must be equipped with fire fighting and prevention equipment as regulated by competent fire authorities.

5. Waste storage devices and equipment must be frequently cleaned.

B. Other medical establishments

1. The waste storage area must have roof; its foundation is not flooded, and is designed to prevent the rain-water runoff from the outside and ensure that the liquid waste shall not flow out in the event of leaking or overflow.

2. Biomedical waste storage devices and equipment must be placed in suitable locations.

3. Waste storage devices and equipment must be suitable to each type of waste and the amount of waste generated in the medical establishment. Various types of waste may be stored in one storage device or equipment if they shall be treated by the same treatment method.

4. Waste storage devices and equipment must be closely covered with lids, and marked with symbols of stored waste as regulated in Annex No. 02 enclosed with this Circular.

5. Waste storage devices and equipment must be frequently cleaned.

 

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Loại văn bảnThông tư liên tịch
Số hiệu58/2015/TTLT-BYT-BTNMT
Cơ quan ban hành
Người ký
Ngày ban hành31/12/2015
Ngày hiệu lực01/04/2016
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          joint Circular 58/2015/TTLT-BYT-BTNMT regulations on biomedical waste management 2016
          Loại văn bảnThông tư liên tịch
          Số hiệu58/2015/TTLT-BYT-BTNMT
          Cơ quan ban hànhBộ Y tế, Bộ Tài nguyên và Môi trường
          Người kýNguyễn Minh Quang, Nguyễn Thị Kim Tiến
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