DECISION

PROMULGATING THE REGULATION ON MANAGEMENT OF MEDICAL WASTES

THE MINISTER OF HEALTH

Pursuant to the Government’s Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tusks and organizational structure of the Health Ministry;
Pursuant to the November 29, 2005 Law on Environmental Protection;
At the proposal of the Director of the Therapy Department, the Director of Vietnam Preventive Medicine Department and the Director of the Legal Department of the Health Ministry,

DECIDES:

Article 1. To promulgate together with this Decision the Regulation on Management of Medical Wastes.

Article 2. This Decision takes effect 15 days after its publication in “CONG BAO.”

To annul Decision No. 2575/1999/QD-BYT of August 27, 1999, of the Minister of Health, promulgating the Regulation on Management of Medical Wastes.

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THE MINISTER OF HEALTH




Nguyen Quoc Trieu

REGULATION

 ON MANAGEMENT OF MEDICAL WASTES
(Promulgated together with Decision No. 43/2007/QD-BYT of November 30, 2007, of the Minister of Health)

Chapter I

GENERAL PROVISIONS

Article 1. Governing scope

1. This Regulation provides for the management of medical wastes, the rights and responsibilities of organizations and individuals in the management of medical wastes.

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Article 2. Subjects of application

This Regulation applies to medical examination and treatment establishments, maternity homes, health stations, establishments engaged in medical and pharmaceutical research, preventive medicine, training of heath workers, production of and trading in pharmaceutical products, vaccines, medical biologicals (collectively referred to as medical establishments) and organizations as well as individuals involved in the transportation, treatment or destruction of medical wastes.

Article 3. Interpretation of terms

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

1. Medical wastes means materials in solid, liquid or gaseous form, discharged from medical establishments, including hazardous medical wastes and ordinary medical wastes.

2. Hazardous medical wastes means medical wastes containing elements hazardous to human health and environment such as contagiousness, intoxication, radiation, flammability, explosiveness, corrosiveness or other hazardous characters if these wastes are not safely destroyed.

3. Management of medical wastes means activities of managing the classification, preliminary treatment, collection, transportation, storage, minimization, re-­use, recycle, treatment and destruction of medical wastes, and inspecting as well as overseeing the implementation.

4. Minimization of medical wastes means activities of restricting to the utmost the discharge of medical wastes, including reduction of medical waste volumes at their sources, use of recyclable or re-usable products, good management and strict control of the process of accurate classification of wastes.

5. Re-use means the use of a product for many times until the end of its lifetime or the use of products for a new function or a new purpose.

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7. Collection of wastes at their sources means the process of classifying, gathering, packing and temporarily storing wastes at places where wastes are generated in medical establishments.

8. Transportation of wastes means the process of transporting wastes from their sources to places of preliminary treatment, storage or destruction.

9. Preliminary treatment means the process of disinfecting or sterilizing highly contagious wastes at their sources before the transportation thereof to places of storage or destruction.

10. Waste treatment and destruction means the process of using technologies to deprive the wastes of their hazard to human health and environment.

Article 4. Prohibited acts

1. Discharging hazardous medical wastes, which are not yet treated or destroyed up to prescribed standards, into the environment.

2. Treating and destroying hazardous medical wastes not according to the prescribed technical process and not at the prescribed place.

3. Delivering medical wastes to organizations or individuals having no legal person status for operation in the domain of waste management.

4. Trading in hazardous wastes.

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Chapter II

IDENTIFICATION OF MEDICAL WASTES

Article 5. Groups of medical wastes

Based on their physical, chemical and biological properties and hazards, wastes in medical establishments are classified into the following 5 groups:

1. Contagious wastes

2. Hazardous chemical wastes

3. Radioactive wastes

4. Pressure containers

5. General wastes.

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1. Contagious wastes:

a/ Sharp and pointed wastes (Type A) are those which can cause cuts or punctures and may be infected, including injection needles, sharp and pointed ends of transfusion tubes, scalpels, nails and saws, injection ampoules, broken glass pieces and other sharp and pointed instruments used in medical activities.

b/ Non sharp and non-pointed contagious wastes (Type B) are those stained with blood or body biological fluids and wastes from isolation wards.

c/ Highly contagious wastes (Type C) are those generated at laboratories such as swabs and containers stained with swabs.

d/ Surgery wastes (Type D), which include human tissues, organs, body parts; placentas, fetuses and tested animal carcasses.

2. Hazardous chemical wastes:

a/ Expired or poor-quality pharmaceuticals which are no longer usable.

b/ Hazardous chemicals used in medical activities (Appendix 1 to this Regulation).

c/ Tissue intoxicants, including drug bottles and pots, instruments stained with tissue intoxicants or substances secreted from patients treated with chemicals (Appendix 2 to this Regulation).

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3. Radioactive wastes:

Radioactive wastes include solid, liquid and gaseous ones, which are generated from diagnostic, therapeutic, research and production activities.

The list or radioactive drugs and marked compounds used in diagnosis and therapy was promulgated together with Decision No. 33/2006/QD-BYT of October 24, 2006, of the Minister of Health.

4. Pressure containers, which include oxygen, CO2 or gas cylinders, prone to cause fires and explosion when put on the fire.

5. General wastes are those which do not contain contagious elements, hazardous chemicals, radioactive substances, inflammable or explosive elements, including:

a/ Garbage from patients’ rooms (excluding isolation wards).

b/ Wastes generated from medical activities such as glass bottles and pots, serum bottles, plastic materials, assorted plasters for broken bone cast, which are not stained with blood, biological fluids and hazardous chemicals.

c/ Wastes generated from administrative activities: papers, newspapers, documents, packing materials, cardboard boxes, plastic bags and film bags.

d/ External wastes: leaves and garbage from external areas.

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STANDARDS OF INSTRUMENTS AND BAGS FOR CONTAINING AND TRANSPORTING SOLID WASTES IN MEDICAL ESTABLISHMENTS

Article 7. Color coding

1. Yellow for contagious wastes.

2. Black for hazardous chemical and radioactive wastes.

3. Green for ordinary wastes and small pressure cylinders.

4. White for recycled wastes.

Article 8. Waste bags

1. Yellow and black bags must be made of PE or PP, not PVC plastic.

2. Medical waste bags must be at least 0.1 mm thick and have sizes suitable to waste volume and the maximum volume of 0.1 m3

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4. Waste bags must comply with the color system specified in Article 7 of this Regulation and be used for proper purposes.

Article 9. Sharp and pointed waste containers

1. Sharp and pointed waste containers must suit the final destruction methods.

2. Sharp and pointed waste containers must satisfy the following standards:

a/ Their walls and bottoms are hard enough so as not to be punctured.

b/ They can resist infiltration.

c/ They have proper sizes.

d/ They have lids which are easy to open and close.

dd/ Their mouths are big enough for putting sharp and pointed objects without push.

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g/ They are in yellow.

h/ They have handles or are attached with a fixed system.

i/ The contained sharp and pointed objects do not fall outside upon transportation.

3. For medical establishments using injection needle-destroying machines or injection syringe- and needle-cutters, sharp and pointed waste containers must be made of metal or hard plastic, which can be usable and must constitute a part of the injection needle- and syringe-destroying machines or cutters.

4. For re-usable sharp and pointed waste plastic containers, before their re-use, they must be cleansed and disinfected under the medical instrument-disinfecting process. The disinfected plastic containers for re-use must retain all their original properties.

Article 10. Waste bins

a/ To be made of high-density plastic with thick and hard bottoms or made of metal with pedal lids. Collection bins of 50 liters or larger should be wheeled.

b/ Yellow bins are used for gathering yellow waste bags and boxes.

c/ Black bins are used for gathering black waste bags. For radioactive wastes, bins must be made of metal.

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dd/ White bins are used for gathering white waste bags.

e/ Bin capacity depends on generated waste volumes, ranging from 10 liters to 250 liters.

g/ The bin’s outside must be printed with a signal line at the 3/4 height and with the phrase “KHONG DUOC DUNG QUA VACH NAY” (NOT CONTAINED ABOVE THIS LINE).

Article 11. Waste type symbols

The outside of bags and bins storing assorted hazardous wastes and to-be-recycled wastes must bear symbols indicating proper waste types (Appendix 3 to this Regulation, not printed herein):

a/ Yellow bags and bins storing contagious wastes display the symbol of biological hazard.

b/ Black bags and bins storing tissue-intoxicating wastes display the symbol of tissue intoxicants and the phrase “CHAT GAY DOC TE BAO” (TISSUE INTOXIOANTS).

c/ Black bags and bins storing radioactive wastes display and the phrase “CHAT THAI PHONG XA” (RADIOACTIVE WASTES).

d/ White bags and bins storing to-be-recycled wastes display the symbol of recyclable wastes.

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Vehicles carrying wastes must meet the standards of having walls, lids and tight bottoms, being convenient for loading and unloading wastes, for cleaning, cleansing and drying.

Chapter IV

CLASSIFICATION, COLLECTION, TRANSPORTATION AND STORAGE OF SOLID WASTES AT MEDICAL ESTABLISHMENTS

Article 13. Classification of solid wastes

1. Waste generators must classify wastes right at their sources.

2. Wastes must be stored in bags and bins with prescribed color codes and symbols.

Article 14. Collection of solid wastes in medical establishments

1. Waste bin locations

a/ Departments and sections must clearly identify places for bins to store each type of medical waste; waste sources must have corresponding collection bins.

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c/ Waste bins must be up to prescribed standards and cleaned daily.

d/ Clean bags for waste collection must be always available at places where wastes are generated for replacement of bags of the same kinds, already transported to temporary waste storage places of medical establishments.

2. Each type of waste must be gathered into collection tools according to the prescribed color code and affixed with labels or inscriptions on the outside of waste bags.

3. Hazardous medical wastes must not be stored together with general wastes. If hazardous medical wastes are accidentally stored together with general wastes, such waste mixtures must be treated and destroyed like hazardous medical wastes.

4. The waste volume in each bag is only 3/4 full, then the bags must be tied up.

5. Collection frequency: Nurses or assigned employees shall collect hazardous medical wastes and general wastes from their sources to the concentrated waste places of departments at least once a day and when necessary.

6. Highly contagious wastes, before being collected to the concentrated waste places of medical establishments, must be preliminarily treated at their sources.

Article 15. Transportation of solid wastes in medical establishments

1. Hazardous wastes and general wastes generated at departments/sections must be separately transported to the waste storage places of medical establishments at least once a day and when necessary.

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3. Waste bags must be closely tied up and transported by special vehicles; wastes and waste liquid must not be dropped en route and their strong smells must not be dispersed in the course of transportation.

Article 16. Solid waste storage in medical establishments

1. Hazardous medical wastes and general wastes must be stored in separate chambers.

2. Re-usable and recyclable wastes must be stored separately.

3. Waste storage places in medical establishments must satisfy the following conditions:

a/ Being at least 10 meters away from dining halls, patients’ rooms, public passages, crowded places.

b/ Being accessible to waste-carrying vehicles from the outside.

c/ Waste storage houses must have roofs, protection fences, doors and locks and must not be intruded freely by animals, rodents or unconcerned persons.

d/ Their areas suit the volume of wastes generated at medical establishments.

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e/ Having culvert systems, walls and anti-seepage floors, being well ventilated.

g/ Medical establishments are encouraged to store wastes in cold houses.

4. Duration for hazardous medical waste storage in medical establishments

a/ The duration for storage of hazardous wastes in medical establishments must not exceed 48 hours.

b/ The duration for waste storage in cold houses or boxes may reach 72 hours.

c/ Surgery wastes must be transported for daily burial or destruction.

d/ For medical establishments with a volume of less than 5 kg of medical waste a day, the collection frequency must be at least twice a week.

Chapter V

TRANSPORTATION OF SOLID MEDICAL WASTES FROM MEDICAL ESTABLISHMENTS

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1. Medical establishments shall sign contracts with establishments having the legal person status for transportation and destruction of wastes. Where there are no establishments with the legal person status for transportation and destruction of medical wastes in localities, medical establishments shall report such to local administrations for solution.

2. Hazardous medical wastes must be transported by special vehicles meeting the requirements stated in Circular No. 12/2006/TT-BTNMT of December 26, 2006, of the Ministry of Natural Resources and Environment, guiding conditions for professional practice and procedures for making dossiers, registration, grant of practice licenses and hazardous waste management codes.

3. Hazardous medical wastes, before being transported to destruction places, must be packed in bins to avoid cracks or breaks en route.

4. Surgery wastes must be stored in two yellow hags, packed separately in bins or boxes closely tied up and displaying the phrase “CHAT THAI GIAl PHAU (SURGERY WASTES) before being transported for destruction.

Article 18. Dossiers on waste monitoring and transportation

Each medical establishment must establish a system of books to monitor the daily waste volume; keep records of hazardous medical wastes and general wastes carried for destruction, made according to a set form in Circular No. 12/2006/TT-BTNMT of December 26, 2006, of the Ministry of Natural Resources and Environment, guiding conditions for professional practice and procedures for making dossiers, registration, grant of practice licenses, hazardous waste management codes.

Chapter VI

SOLID MEDICAL WASTE TREATMENT AND DESTRUCTION MODELS AND TECHNOLOGIES

Article 19. Hazardous solid medical waste treatment and destruction models and the application thereof

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a/ Model 1: Concentrated hazardous medical waste treatment and destruction centers.

b/ Model 2: Hazardous medical waste treatment and destruction facilities for clusters of medical establishments.

c/ Model 3: On-spot treatment and destruction of hazardous solid medical wastes.

2. Medical establishments shall base themselves on plannings, geological elements, economic and
environmental conditions to apply one of the medical waste treatment and destruction models specified in Clause I of this Article.

Article 20. Hazardous medical waste treatment and destruction technologies

1. The selection of hazardous medical waste treatment technologies must ensure environmental standards and satisfy the requirements of treaties to which Vietnam is a contracting party.

2. Hazardous medical waste treatment technologies include incineration in furnaces reaching environmental standards; hot-steam disinfection; microwave and other treatment technologies. The application of environment-friendly technologies is encouraged.

Article 21. Methods of preliminary treatment of highly contagious wastes

1. Highly contagious wastes must be safely treated near their sources.

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a/ Chemical disinfection: Highly contagious wastes are soaked in 1-2% cloramin B or 1-2% javel water for at least 30 minutes or other disinfectant chemicals under the use instructions of producers and regulations of the Health Ministry.

b/ Hot-steam disinfection: Highly contagious wastes are put into disinfection steamers which are operated under producers’ instructions.

c/ Non-stop boiling for at least 15 minutes.

3. Highly contagious wastes, after being preliminarily treated, can be buried or wrapped in yellow plastic bags for mixture with contagious wastes. If these wastes are preliminarily treated by autoclave or microwave methods or other modern technologies up to prescribed standards, they can be later treated like general wastes and be recycled.

Article 22. Contagious waste treatment and destruction methods

1. Contagious wastes can be treated and destroyed by one of the following methods:

a/ Autoclave disinfection

b/ Microwave disinfection

c/ Incineration

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dd/ Where contagious wastes are treated by autoclave, microwave method or other modern technologies up to the prescribed standards, they can be later treated, recycled or destroyed like general wastes.

2. Sharp and pointed wastes:

One of the following destruction methods can be applied:

a/ Incineration in special furnaces together with other contagious wastes.

b/ Direct burial in cement holes exclusively used for burial of sharp and pointed objects: The holes are built with concrete bottoms, walls and lids.

3. Surgery wastes:

One of the following methods can apply:

a/ The contagious waste treatment and destruction methods mentioned in Clause 1 of Article 22.

b/ They are wrapped in two yellow bags, packed in cases and buried in cemeteries.

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Article 23. Chemical waste treatment and destruction methods

1. General methods for treatment and destruction of hazardous chemical wastes:

a/ Returning them to suppliers under contracts.

b/ Incinerating them in high blast furnaces

c/ Destroying them by method of alkali neutralization or hydrolysis.

d/ Pre-burial inertization: Mixing wastes with cement and a number of other materials in order to fasten hazardous substances in wastes. The mixture ratios will be as follows: 65% pharmaceutical, chemical wastes, 15% lime, 15% cement, 5% water. After an unique block is created, it is transported for burial.

2. One of the following methods can be applied to the treatment and destruction of pharmaceutical wastes:

a/ Incinerating them in furnaces, if any, together with contagious wastes.

b/ Burying them at hazardous waste burial sites.

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d/ Liquid pharmaceutical wastes are diluted and discharged into waste water treatment systems of medical establishments.

3. One of the following methods can apply to the treatment and destruction of tissue-intoxicating wastes:

a/ Returning them to suppliers under contracts.

b/ Incinerating them in high-temperature furnaces (Appendix 2: A number of tissue-intoxicating drugs frequently used in medical activities and the minimum temperature for destruction of tissue intoxicants).

c/ Using a number of oxides such as KMnO2, H2SO4, etc., degrading tissue intoxicants into non-hazardous compounds.

d/ Inertization then burial at concentrated waste burial sites.

4. Treatment and destruction of wastes containing heavy metals:

a/ Returning them to producers for recovery of heavy metals.

b/ Destroying them at places for safe destruction of industrial wastes.

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Article 24. Radioactive waste treatment and destruction

Medical establishments using radioactive substances and radioactive substance- related instruments or equipment must comply with current legal provisions on radiation safety.

Article 25. Pressure cylinder treatment and destruction

One of the following methods can apply:

a/ Returning them to producers,

b/ Re using them.

c/ Burying them like pressure cylinders of small capacity.

Article 26. General solid waste treatment and destruction

1. Recycling, re-use

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b/ To be- recycled general wastes must not contain contagious elements and hazardous chemicals affecting human health.

c/ Wastes allowed for recycling and reuse are only supplied to organizations or individuals licensed for such operation and having the function of recycling wastes.

d/ Medical establishments assign one unit to organize, inspect and strictly supervise the treatment of general wastes according to regulations for recycling and re-use.

2. Treatment and destruction: Burial at local waste burial sites.

Chapter IX

TREATMENT OF WASTE WATER AND GASEOUS WASTE

Article 27. General provisions on treatment of waste water

1. Each hospital must have a synchronous waste water collection and treatment system.

2. Those hospitals, which do not have waste water treatment systems, must build complete waste water treatment systems.

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4. Newly built hospitals must include waste water treatment systems into construction items approved by competent agencies.

5. Hospital waste water treatment technologies must satisfy environmental standards and conform to topographical conditions, investment, transportation and maintenance costs.

6. Waste water treatment must be qualitatively examined periodically and waste water treatment dossiers must be kept.

Article 28. Waste water collection

1. Hospitals must have separate systems for collecting surface water and waste water from various departments, rooms. Waste water culvert systems must run underground or be covered with lids.

2. Waste water treatment systems must have mud-gathering tanks.

Article 29. Requirements on hospital waste water treatment systems

1. They are structured with an appropriate technological process for treatment of waste water up to environmental standards;

2. Their capacities suit the volume of hospitals’ waste water;

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4. Mud discharged from waste water treatment systems must be managed like solid medical wastes.

5. Waste water treatment must be qualitatively inspected periodically. There must be books on management of operation and results of relevant quality inspection.

Article 30. Treatment of gaseous wastes

1. Laboratories, chemicals or pharmaceuticals storehouses must be constructed with air ventilation systems and toxic gas-gathering cabinets up to the prescribed standards.

2. Equipment using toxic chemical gas must have systems for treating gas up to prescribed standards before it is discharged into environment.

3. Gas discharged from solid medical waste incinerators must be treated up to Vietnam’s environmental standards.

Chapter X

ORGANIZATION OF IMPLEMENTATION

Article 31. Responsibilities for management of medical wastes

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a/ To manage medical wastes from the time they are generated to the time they are finally destroyed.

b/ To possibly contract the transportation, treatment and destruction of medical wastes to organizations or individuals having the legal person status.

c/ To formulate plans on management of medical wastes and work out schemes for investment in and upgrading of infrastructure for management of their units’ medical wastes and submit them to competent authorities for approval. Investment projects on construction of infrastructure for medical waste treatment and destruction must comply with current regulations on management of capital construction investment.

d/ To purchase and supply adequate special means up to standards for the classification, collection, transportation and treatment of wastes; to coordinate with local environment bodies and waste treatment establishments in treating and destroying medical wastes according to regulations.

e/ To apply measures to reduce the volume of to be- destroyed medical wastes through minimization, collection, recycling and re-use activities after they are treated according to regulations.

2. Directors of provincial/municipal Health Services shall manage and formulate plans on treatment of medical wastes in their respective localities and submit them to provincial/municipal People’s Committee presidents for consideration, approval and implementation organization.

3. Heads of medical establishments under the Health Ministry and heads of branches’ health sections shall manage, draw up plans on disposal of medical wastes of their establishments and attached units, and submit them to the minister of the managing ministry for consideration, approval and implementation organization.

4. Bureaus, departments and the Inspectorate of the Health Ministry shall manage medical wastes according to their respective functions and tasks prescribed by the Minister of Health.

Article 32. Training and research

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2. Medical establishments shall guide the implementation of the Regulation on management of medical wastes to their staff members and concerned subjects, guide patients and their families in classification of medical wastes according to regulations.

Article 33. Registration of owners of waste sources and waste treatment

Medical establishments shall register to be owners of waste sources and waste treatment under the guidance in Circular No. 12/2006/TT-BTNMT of December 26, 2006, of the Ministry of Natural Resources and Environment, guiding conditions for professional practice and procedures for making dossiers, registration, grant of practice licenses and hazardous waste management codes.

Article 34. Fund

1. Medical establishments shall arrange funds for medical waste management.

2. Funds invested in the construction of infrastructure, operation and management of medical wastes come from the following sources:

a/ State budget:

- Health non-business budget.

- Environmental protection non-business budget.

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c/ Other lawful capital sources.

MINISTER OF HEALTH





Nguyen Quoc Trieu

APPENDIX 1

HAZARDOUS CHEMICALS FREQUENTLY USED IN MEDICAL ACTIVITIES
(Attached to Decision No. 43/2007/QD-BYT of November 30, 2007, of the Minister of Health)

Formaldehyde

Photochemical substances:

- Hydroquinone;

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- Silver;

- Glutaraldehyde

Dissolvents:

- Halogen compounds: Methelene chloride, chloroform, freons, teichloro ethylene and 1.1.1-trichloromethane.

- Evaporating anaesthetics: Halothane (fluothane), enflurane (ethrane), isoflurane (forane).

- Sans-halogen compounds: cylene, acetone, isopropanol, toluen, ethylo acetate, acetonitrile, benzene.

Ethylencoxide

Chemical compounds:

- Phenol

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- Cleansing dissolvents

- Ethanol alcohol; methanol

- Acide.

APPENDIX 2

SOME TISSUE INTOXICANTS FREQUENTLY USED IN MEDICAL ACTIVITIES AND MINIMUM TEMPERATURES FOR DESTRUCTION THEREOF
(Attached to Decision No. 43/2007/QD-BYT of November 30, 2007, of the Minister of Health)

Drugs

Destruction temperature (0C)

Asparaginase

Bleomycin

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Camustine

Cisplatin

Cyclophosphamide

Cytarabine

Decarbazine

Dactinomycin

Daunorubicin

Doxorubicin

Epirubicin

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Fluorouracil

Idarubicin

Melphalan

Metroptrexate

Mithramycin

Mitomycin C

Mitozantrone

Mustine

Thiotepa

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Vincristine

Vindesine

800

1,000

1,000

800

800

900

1,000

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700

700

1,000

700

700

500

1,000

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800

800

800

1,000

1,000

1,000

APPENDIX 3

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The symbol of biological hazard

The symbol of tissue intoxicants

The symbol of radioactive substance

The symbol of recyclable wastes

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APPENDIX 4

LIST OF WASTES TO BE GATHERED FOR RECYCLING
(Attached to Decision No. 43/2007/QD-BYT of November 30, 2007, of the Minister of Health)

General waste materials neither stained with nor containing hazardous elements (contagious elements, hazardous chemicals, radioactive substances, tissue intoxicants), which are allowed to be collected for recycling, including:

a/ Plastic:

- Plastic bottles containing solutions without hazardous chemicals, such as NaCl 0.9% solulion, Bicarbonatenatri, ringer lactat, molecular paste solution, kidney filtering fluid and plastic bottles containing other non-hazardous solutions.

- Other plastic materials not stained with hazardous elements.

b/ Glass

- Glass bottles containing solutions without hazardous elements.

- Glass ampoules containing injection drugs not containing hazardous elements.

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d/ Metal: Metal materials not stained with hazardous elements.