Circular 20/2021/TT-BYT management of medical waste within medical establishments’ premises

CIRCULAR

Providing regulations on management of medical waste within medical establishments’ premises

Pursuant to Law on Environmental Protection No. 72/2020/QH14 dated November 17, 2020;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Health Environment Management Agency;

The Minister of the Ministry of Health hereby promulgates the Circular providing regulations on management of medical waste within medical establishments’ premises.

Chapter 1

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular prescribes in detail the classification, collection, storage and management of medical waste within medical establishments’ premises.

2. This Circular does not regulate the management of medical radioactive waste.  The management of medical radioactive waste shall comply with regulations of the Ministry of Science and Technology on management of radioactive waste and used radioactive sources.

Article 2. Subjects of application

This Circular applies to medical establishments, including medical examination and treatment establishments with operation licenses as prescribed by the law on medical examination and treatment, preventive medical establishments, health sector training establishments, medical and pharmaceutical research and testing laboratories that generate medical waste; domestic and foreign agencies, organizations and individuals concerned to the management of medical waste on the territory of Vietnam.

Article 3. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. Medical waste means the waste generated from activities of medical establishments, including: hazardous medical waste, ordinary solid waste, non-hazardous emissions and liquid waste and medical wastewater.

2. Infectious waste means the waste contaminated with the human blood or pathogenic microorganisms.

3. Medical waste collection means the process of gathering medical waste from the place where they are generated to temporary storage areas or to the disposal sites within the medical establishments’ premises.

Chapter 2

IDENTIFICATION, CLASSIFICATION, COLLECTION, STORAGE, REDUCTION, RECYCLING, TRANSFER OF MEDICAL WASTE

Article 4. Medical waste identification

1. Hazardous medical waste includes infectious waste and non-infectious hazardous waste.

2. Infectious waste includes:

a) Sharps and infectious waste, including needles, syringes, sharp ends of infusion lines, puncture needles, acupuncture needles, scalpel blades, nails, saws used in surgery, syringes, and pieces of glass. Broken glass and other discarded sharps objects that are sticky, contain body blood or contain disease-causing microorganisms;

b) Non-sharps infectious waste, including cotton, bandages, gauze, gloves, and other non-sharps waste that is absorbent, sticky, contains blood from the body, and contains disease-causing microorganisms; vaccine vials of inactivated or attenuated vaccines that are discarded; liquid infectious waste (including drainage fluid after surgery, medical procedures, waste fluid containing human blood or disease-causing microorganisms);

c) Waste with high risk of infection, including specimens, containers, contaminated with specimens, waste contaminated with specimens discarded from laboratories equivalent to biosafety level II or higher; waste generated from isolated patient rooms, isolated treatment areas, and testing sample collection areas for patients with dangerous group A and group B infectious diseases;

d) Surgery waste, including tissues, discarded human parts, and experimental animal carcasses;

3. Non-infectious hazardous waste includes:

a) Discarded chemicals containing hazardous ingredients and properties that exceed the hazardous waste threshold or having hazard warnings on the packaging from the manufacturer;

b) Discarded pharmaceutical products falling under the cytotoxicity category or having hazard warnings on the packaging from the manufacturer;

c) Bottles, vials containing drugs or chemicals, tools contaminated with drugs or chemicals belonging to the cytotoxic category or having hazard warnings on the packaging from the manufacturer;

d) Broken, damaged, or discarded used medical equipment containing mercury and cadmium (Cd); discarded batteries and accumulators; lead-coated materials used in radiation shielding;

dd) X-ray film cleaning solution, wastewater from testing and analysis equipment and waste solutions with hazardous elements exceeding the hazardous waste threshold;  

e) Other medical waste containing ingredients and properties exceeding the hazardous waste threshold or having hazard warnings on the packaging from the manufacturer.

4. Ordinary solid waste includes:

a) Domestic solid waste arises from daily activities of healthcare staff, patients, patients' families, students, visitors and external waste in medical establishments (except domestic waste arising from quarantine and treatment areas for people with dangerous infectious diseases);

b) Discarded chemicals without ingredients and properties exceeding the hazardous waste threshold;

c) Bottles, vials containing drugs or chemicals, and equipment contaminated with drugs or chemicals that are not cytotoxic or do not have hazard warnings on the packaging from the manufacturer;

d) Discarded vaccine vials other than inactivated vaccines or attenuated vaccines;

dd) Sharps non-infectious waste without ingredients and properties exceeding the hazardous waste threshold;

e) Treated infectious waste that meets the national technical regulation on environment;

g) Sludge from the wastewater treatment system without hazardous ingredients or properties that exceed the hazardous waste threshold; ash and slag from solid medical waste incinerators without hazardous ingredients or properties that exceed the hazardous waste threshold;

h) Other ordinary solid waste;

i) The list of ordinary solid waste allowed to be collected for recycle purpose as specified in Appendix 1 to this Circular.

5. Emissions, including emissions arising from laboratories that cause dangerous infectious diseases, transmitted through the air; emissions from biosafety level III laboratories or higher.

6. Non-hazardous liquid waste, including discarded liquid medicines and chemicals not falling under the cytotoxicity category, without hazard warnings from manufacturers, containing neither hazardous elements exceeding hazardous waste threshold nor pathogenic microorganisms.

7. Medical wastewater, including wastewater from professional activities in medical establishments. In case the medical wastewater is discharged into the medical wastewater collecting system, it shall be managed as same as the medical wastewater.

Article 5. Packaging, tools, equipment storing medical waste

1. Packaging (bags), tools (bins, boxes, cans), and equipment used for medical waste storage must ensure safe storage of waste, be waterproof, leak-proof and have dimensions appropriate to the amount of waste stored. On such packaging, tools and equipment, there must be the name of the type of waste stored and the symbol as specified in Appendix No. 02 to this Circular.

2. Colors of the packaging, tools, and equipment used for medical waste storage shall comply with provisions of Clauses 3, 4, 5, and 6 Article 6 of this Circular.

3. Tools and equipment used for waste storage must have a lid that is convenient to open and close during the use, and may be recycled after being cleaned and disinfected.

4. Tools storing sharps waste must have hard walls and bottom that are puncture-proof, while their mouth must be well-designed to avoid spilling.

5. Tools and equipment storing infectious waste must have a tight lid to prevent animal invasion.

6. Tools and equipment storing waste chemicals must be made from materials that are non-reactive with the stored chemicals and corrosion-resistant if the chemicals are corrosive.

7. Tools storing liquid hazardous waste must have a lid to prevent evaporation and spill.

8. Packaging and equipment storing burnt medical waste must not be made from PVC plastic.

Article 6. Medical waste classification

1. Principles for classification of medical waste:

a) Medical waste must be classified at the place and time of generation;

b) Each type of medical waste must be separately classified into the packaging, tools, and equipment under Article 5 of this Circular. In case the hazardous medical waste does not react with each other and is treated with the same method, it may be classified into one containing packaging, tool, equipment (excluding infectious sharps waste);

c) In case the infectious waste is stored at the same place as other waste, such mixed waste must be collected, stored, and treated as infectious waste and managed according to the nature of the waste after treatment.

2. Placing of tools and packaging used for waste classification:

a) At faculties, departments, divisions: arrange the appropriate and safe place for the storage tools, packaging, and equipment;

b) At the place where the storage tools, packaging, and equipment are placed, there must be an instruction for classification and collection of waste.

3. Classification of infectious waste:

a) Sharps and infectious waste shall be put in the yellow puncture-proof trash can or container;

b) Non-sharps infectious waste shall be put in the yellow lined trash can;

c) Highly infectious waste shall be put in the yellow lined trash can;

d) Surgery waste shall be double-bagged or put in the yellow lined trash can;

dd) Liquid infectious waste shall be put in a sealed bag or in a storage tool with a sealed lid.

4. Classification of non-infectious hazardous waste:

a) Non-infectious hazardous waste must be classified by hazardous waste code for storage in appropriate packaging, tools, and equipment.  Hazardous waste with the same properties that does not react with each other and may be treated with the same method may use the same packaging, tool, equipment;

b) Non-infectious hazardous solid waste shall be put in black bags, trash cans, or lined trash cans;

c) Non-infectious hazardous liquid waste shall be put in storage tools with a sealed lid which bearing a code and name of the stored waste.

5. Classification of ordinary solid waste:

a) Ordinary solid waste that is no recycled shall be put in blue bags, trash cans, or lined trash cans. Sharps waste shall be put in puncture-proof trash cans;      

b) Ordinary solid waste that is recycled shall be put in white bags, trash cans, or lined trash cans.

6. Non-hazardous liquid waste shall be put in storage tools with a sealed lid, labeled with the waste name.

Article 7. Collection of medical waste

1. Collection of infectious waste:

a) A medical establishment shall regulate the flow and time for collection of infectious waste to limit affection to the patient care area and other areas within the establishment.

b) Waste collection equipment must be sealed without leaking any waste during the collection process; 

c) Infectious waste must be separately collected from the place where it is generated to the temporary waste storage area in the medical establishment. Before collection, waste bags must be tightly sealed and waste containers must have tight lids;

d) Waste with a high risk of infection must be pre-treated near the place of waste generation to remove pathogens with disinfection equipment. For medical establishments that do not have waste sterilization equipment, before collecting waste bags with high risk of infection, they must tie the bag tightly and continue to put it in a second infectious waste bag and tie the mouth of the bag tightly, and put it in the infectious waste collection bin. The outside of the bin shall be labeled “HIGHLY INFECTIOUS WASTE”, and collected and stored separately in the infectious waste storage area for treatment or transfer to units with handling functions according to regulations;

dd) Infectious liquid waste shall be discharged into the medical wastewater collection system of the medical establishment, and managed in accordance with regulations on wastewater management;

e) Infectious waste shall be collected from the place of waste generation to the storage area within the medical establishments’ premises at least once a day. For those that generate less than 5 kg of infectious waste within a day, infectious waste shall be collected at least once a day and infectious and sharps waste shall be collected at least once a month.

2. Collection of non-infectious hazardous waste:

a) Non-infectious hazardous waste shall be collected and stored separately at the waste storage area within the medical establishment’s premise;

b) Broken, damaged, and discarded medical equipment containing mercury shall be collected and stored separately in plastic boxes or suitable materials, ensuring no leakage or dispersion of mercury vapor to the environment.

3. Collection of ordinary solid waste: ordinary solid waste that is recycled and ordinary solid waste that is non-recyclable shall be collected separately.

4. Collection of non-hazardous liquid waste: non-hazardous liquid waste shall be discharged into the wastewater collection system of the medical establishment, and managed in accordance with the regulations on wastewater management.

5. Emissions shall be treated to remove pathogenic microorganisms before being released to the surrounding environment.

6. Collection of wastewater:

a) The wastewater collection system must be a closed system to ensure the collection of all wastewater generated in the medical establishment;

b) Medical wastewater shall be collected and treated in accordance with applicable laws on wastewater management.

Article 8. Storage of medical waste

1. The medical establishment shall arrange a waste storage area within its premise which satisfies the following requirements:

a) Hospitals and medical establishments treating medical waste according to the cluster model must have their waste storage areas satisfied the technical requirements specified in Section A Appendix 3 to this Circular;

b) Medical establishments other than those specified at Point a of this Clause shall store their medical waste in accordance with technical requirements specified in Section B Appendix 3 to this Circular.

2. Each type of waste shall be stored separately at the temporary waste storage area within the medical establishment’s premise, except for the cases where such waste has same properties, does not react with each other, and may be treated with the same method.

3. Duration for storage of infectious waste:

a) For infectious waste generated at a medical establishment, the storage duration must not exceed 2 days under normal conditions. In case the infectious waste is stored in cold storage equipment at temperatures below 8°C, the storage duration must not exceed 7 days;

b) For infectious waste transferred from other medical establishments for treatment according to the cluster model or centralized treatment, it shall be treated within the day. If the infectious waste is not treated within the day, it must be stored at temperatures below 20°C for a maximum duration of 2 days.

c) For medical establishments generate less than 5 kg of infectious waste a day, the storage duration must not exceed 3 days under normal conditions; and the infectious waste must be stored in sealed packages or storage equipment covered tightly.

4. Storage duration of non-infectious hazardous waste: the storage duration must not exceed 1 year from the date of waste generation. In case the waste transport and treatment plan is unavailable or the appropriate hazardous waste treatment establishments have not yet been identified causing the storage duration of more than 1 year, the medical establishment shall report that in a separate writing or in combination with the annual report on medical waste management to competent agencies in accordance with Article 13 of this Circular, and to other competent agencies in accordance with the law.

5. For medical establishments in difficult, remote, mountainous and island areas where there are no appropriate treatment measures, sharps infectious waste shall be stored safely in concrete tanks within the medical establishment’s premises after sterilization, with warning signs in the waste storage area.

Article 9. Medical waste minimization

Medical establishments shall take the following measures to minimize medical waste:

1. Procurement, installation, and use of supplies, equipment, tools, drugs, chemicals, and other raw materials suitable for use needs.

2. Upgrading of equipment, professional procedures and other measures to minimize medical waste.

3. Application of measures, roadmap and minimization of the use of disposable plastic products, non-biodegradable plastic bags to reduce the generation of plastic waste.

4. Classification of plastic waste for recycling or treatment in accordance with the law.

Article 10. Management of recyclable ordinary solid waste

1. Based on the list of recyclable ordinary solid waste specified in Appendix 1 to this Circular, medical establishments shall promulgate the list of ordinary solid waste collected for recycling according to the waste generation.

2. Treated infectious waste that meet the national technical regulation on environment shall be managed as recyclable ordinary solid waste. When transferring waste, medical establishments must ensure that the packaging is sealed and labeled with a recycling symbol specified in Appendix 2 to this Circular, and record sufficient information into the book of transfer of disinfected waste that meets the national technical regulation on environment for recycling specified in Appendix 4 to this Circular.

3. Plastic waste must be classified and collected for recycling and treatment in accordance with the law.

Article 11. Management and operation of medical waste treatment facilities, equipment, and system

1. Medical establishments that treat medical waste themselves or according to the cluster model must regularly operate the medical waste treatment facilities, equipment, and system in accordance with the manufacturer’s instruction, ensuring that the waste treatment meets the national technical regulation on environment and comply with the law on environmental supervision and monitoring.

2. Medical waste treatment facilities, equipment, and system must be maintained according to the manufacturer’s instruction on periodic manner. Sufficient information shall be recorded into the construction, equipment, and medical waste treatment system operation log books as prescribed in Appendix 05 to this Circular.

Article 12. Medical waste transfer

1. Medical establishments that do not process medical waste themselves must transfer medical waste according to the following regulations:

a) Hazardous medical waste shall be transferred to appropriate licensed units as prescribed by the law; and the quantity of waste after each transfer must be fully recorded in the waste delivery book, made using the form specified in Appendix 6 to this Circular; hazardous waste documents shall be used according to regulations;

b) Ordinary solid waste shall be transferred to appropriate functional units for transportation and treatment in accordance with the applicable law.

3. Units receiving the medical waste shall transport the waste according to regulations, without leakage. Medical waste shall be treated in a manner that meets the national technical regulation on environment.

4. Medical establishments shall treat hazardous medical waste according to the cluster model approved by the provincial-level People’s Committees. The handover of medical waste for treatment under the cluster model must be recorded into the hazardous medical waste delivery book, made using the form specified in Appendix 6 to this Circular.

Chapter 3

MEDICAL WASTE REPORTING REGIME AND MANAGEMENT DOSSIERS

Article 13. Reporting regime

1. Reporting frequency: The report on result of medical waste management shall be made annually, from December 15 of the year preceding the reporting period to December 14 of the reporting year.

2. Form of report: The report on result of medical waste management shall be sent in writing or via email, or reporting software.

3. Reporting content and order:

a) Medical establishments shall send the reports on their medical waste management, using the form specified in Section A, Appendix 7 to this Circular, to the Departments of Health of provinces or centrally-run cities (hereinafter referred to as the provincial-level Department of Health) in the localities; or to the Ministry of Health (the Health Environment Management Agency) for medical establishments affiliated to the Ministry of Health before December 16 of the reporting period;

b) The provincial-level Department of Health shall send the report on the medical waste management in the locality to the Ministry of Health (the Health Environment Management Agency), using the form specified in Section B, Appendix 7 to this Circular before December 20 of the reporting period.

Article 14. Medical waste management dossiers

Medical establishments shall keep and preserve the following dossiers:

1. Environmental license and other documents, dossiers related to the environment according to regulations (for medical establishments requiring environmental licenses).

2. Medical waste delivery book; hazardous medical waste documents (if any).

3. Construction, equipment, and medical waste treatment system operation log books (for medical establishments that treat waste themselves)

4. Relevant minutes of inspection or examination (if any).

5. Annual report on the medical waste management; report on the result of environmental supervision and monitoring (if any).

6. Other relevant documents.

Chapter 4

IMPLEMENTATION PROVISIONS

Article 15. Implementation responsibilities

1. The Health Environment Management Agency shall

a) Direct, guide, and inspect the implementation of this Circular;

b) Promulgate technical guidelines on medical waste management within the medical establishment’s premise;

c) Provide training and propagate regulations on medical waste management for the provincial-level Departments of Health and medical establishments under the management.

2. Provincial-level Departments of Health shall

a) Direct, guide, and inspect the implementation of this Circular in the area under the management;

b) Provide training and propagate regulations on medical waste management specified in this Circular for medical establishments under the management;

c) Direct affiliated medical establishments to make medical waste management plans;

d) Coordinate with the provincial-level Departments of Finance to allocate funding to invest and upgrade the medical waste treatment facilities, equipment, and system for medical establishments under the management;

dd) Report medical waste management in accordance with Article 13 of this Circular.

3. Medical establishments shall

a) Manage medical waste in accordance with this Circular and other related legal documents;

b) Assign heads of medical establishments to undertake the medical waste management; arrange staff in charge of medical waste management; assign tasks to the Department of Infection Control or faculties, departments, divisions in charge of medical waste management; arrange personnel or coordinate with external units to operate medical waste treatment equipment, system, facilities according to requirements of the task (for medical establishments treating waste themselves);

c) Make medical waste management plans or combine such plans with the annual operation plans of the medical establishments; allocate funding for the management of medical waste;

d) Classify types of waste generated from activities of the medical establishment in order to take appropriate management measures in accordance with this Circular;

dd) Comply with requirements of plans, measures, and equipment to prevent and respond to environmental incidents caused by the waste as prescribed by law (including treatment plans in case the hazardous medical waste increases abnormally due to epidemic diseases or force majeure events);

e) Provide training and propagate regulations on medical waste management for public employees, workers, and concerned subjects;

g) Report the medical waste management in accordance with Article 13 of this Circular.

Article 16. Implementation provisions

1. Effect

a) This Circular takes effect from January 10, 2022;

b) Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015, of the Ministry of Health and the Ministry of Natural Resources and Environment, on medical waste management, ceases to be effective from the effective date of this Circular.

2. Implementation organization

a) The Director of the Health Environment Management Agency, Chief of the Ministry Office of the Ministry of Health, Chief Inspector of Ministry of the Ministry of Health, Directors of Departments, Administrations and General Departments under the Ministry of Health, and other related agencies, organizations, individuals shall implement this Circular;

b) Any difficulties arising in the course of implementation of this Circular should be reported to the Ministry of Health (the Health Environment Management Agency) for consideration and settlement./.

Appendix 1

List of ordinary solid waste allowed to be collected for recycling
(Attached to the Minister of the Minister of Health’s Circular No. 20/2021/TT-BYT dated November 26, 2021)

* Other Appendices are not translated herein.