THE MINISTER OF HEALTH

DECIDES:

Article 1.- To promulgate together with this Decision the Regulation on Medical Waste Management.

Article 2-. The Regulation on Medical Waste Management shall apply to all State-run, private and foreign-invested medical establishments. In the course of implementation, the medical establishments should select methods prescribed in this Regulation for implementation, which are suitable to their respective conditions.

Article 3.- This Decision shall take effect 60 days after its signing.

Article 4.- The directors of the Ministry�s Office, Department of Therapy, Legal Department, Department for Medical Equipment-Projects and Department of Prophylactic Medicine; chief inspector, Department heads of agencies attached to the Ministry of Health, directors of the Health Services of the provinces and centrally-run cities; directors of institutes and hospitals under the Ministry of Health; headmasters of medical workers� training schools, heads of the medical sections of branches, managers of foreign-invested medical establishments and private medical establishments shall have to implement this Decision.

The Minister of Health

Chapter I

GENERAL PROVISIONS

Article 1.- In this Regulation, the terms below shall be construed as follows:

1. Wastes are understood as those prescribed in Clause 2, Article 2 of the 1993 Law on Environmental Protection.

2. Medical wastes are those arising from the activities of medical examination and treatment, healthcare, testings, disease prevention, research and training at the medical establishments. Medical wastes may be in the solid, liquid or gaseous form.

3. Hazardous wastes are those containing substances or compounds which bear one of the characters of causing direct hazards (inflammability, explosibility, erodibility, contagiosity and other hazardous characters), or, when interacted with other substances, causing hazards to environment and human health.

4. Hazardous medical waste means the waste that contains one of such elements as blood, body fluid, excrement; parts or organs of human or animal bodies; injection syringes or needles and pointed and sharp objects; pharmaceuticals; chemicals and radioactive substances used in health service. If these wastes are not destroyed, they will cause hazards to environment and human health.

5. The management of hazardous medical wastes means the activities of controlling wastes throughout a process from the time they are discharged till they are preliminarily treated, gathered, transported, stored and destroyed.

6. Collection means the separation, classification, gathering, packing and temporary keeping of wastes at wasters gathering places of medical establishments.

7. Transportation means the process of carrying wastes from their places of origin to where they are preliminary treated, kept and destroyed.

8. Preliminary treatment means the process of disinfection or bactericide of highly contagious wastes near the places of their origin before they are carried to places of storing or destruction.

9. Destruction is the process of applying technologies to isolate (including burial) hazardous wastes, depriving them of the capability to cause hazards to environment and human health.

1. This Regulation shall apply to hospitals, research institutes, district health centers, polyclinics, specialized clinics, maternity homes, medical stations, private medical services establishments, prophylactic medicine centers, medical workers� training establishments (referred collectively to as medical establishments).

2. The medical establishments, besides having to abide by this Regulation, shall have to comply with the State�s current stipulations on management of hazardous wastes.

1. Directors or managers of all medical establishments shall be responsible for the management of hazardous medical wastes from the time they are generated to the final process of destruction.

2. Persons directly involved in the process of management of medical wastes must be trained and comply with the regulations already issued.

Article 4.- The medical establishments shall have to minimize and classify wastes as prescribed right at their discharge sources and not to let hazardous medical waste mix with daily-life wastes. The hazardous medical wastes must be safely treated before they are discharged into the environment.

Article 5.- The medical establishments shall have to draw up plans to upgrade, build, operate and maintain waste treatment establishments and at the same time coordinate with environmental bodies as well as local waste treatment establishments in managing and treating medical wastes as prescribed.

Article 6.- The funds for investment in infrastructure construction and hazardous medical waste management shall be taken from the following sources:

a) The State budget.

b) Financial support from international organizations.

c) Assistance from various Governments and non-governmental organizations.

d) Capital from various economic sectors.

Chapter II

CLASSIFICATION AND DETERMINATION OF WASTES

Article 7.- The wastes in the medical establishments are classified into 5 categories as follows:

1. The clinical waste.

2. The radioactive waste.

3. The chemical waste.

4. The pressure gas cylinders

5. Daily- life waste.

Article 8.- Determination of waste categories

1. The clinical waste includes 5 groups:

a) Group A covers contaminated waste, including materials absorbed with blood, fluid and/or excrement of diseased persons such as bandages, gauzes, hand-gloves, starch used in bone setting, fabrics, artificial anal bags, blood transfusion tubes, puncture tubes, strings and fluid bags....

b) Group B embraces pointed or sharp objects, including injection syringes and needles surgey knife blades and handles, surgery nails, saws, injection ampoules, broken glass pieces and all materials which may cause cuts or punctures, regardless of whether they are contaminated or not.

c) Group C covers highly contagious wastes discharged from laboratories, including hand-gloves, glass, testing tubes, disease samples after puncture/testing/culture, blood bags....

d) Group D covers pharmaceutical wastes, including:

i) Expired pharmaceutical products, contaminated pharmaceutical products, dropped pharmaceutical products, pharmaceutical products without any demand for use.

ii) Drugs making cells toxicated.

e) Group E covers human and animal tissues and organs, including all tissues of the body (whether or not contaminated); organs, legs, arms, placenta, fetuses, animal corpses.

2. Radioactive wastes

Radioactive wastes are wastes having activity degrees like radioactive substances. At the medical establishments, radioactive wastes originate from diagonosis, chemo-therapy and research (Appendix 1: Radioactive nucleus used at medical establishments). The radioactive wastes shall include solid, liquid and gaseous wastes.

a) The solid radioactive wastes include materials used in tests, diagnoses, hospitalization such as syringes, injection needles, protection glasses, absorbing papers, sterile gauzes, test tubes, bottles and pots for containing radioactive substances....

b) The liquid radioactive wastes include solutions containing radioactive nucleus, which originate in the process of diagnosis and hospitalization such as patients� urine, excrements, water left after the cleaning of instruments contaminated with radioactive substances....

c) The gaseous radioactive wastes include gases used in clinical process such as 133 Xe, gases leaking from radioactive substance depots....

3. Chemical wastes

The chemical wastes include solid, liquid and gaseous wastes. The chemical wastes in the medical establishments are classified into two:

- The non-hazardous chemical wastes such as sugar, fatty acid, several kinds of organic and inorganic salt.

- The hazardous chemical wastes which include:

a) Formaldehyde: used in pathological surgery, blood filter, dead body embalment and the preservation of test samples in a number of other departments.

b) Optical activity chemicals: found in solutions used for fixation and film development.

c) Solvents: Solvents used in medical establishments shall include halogen compounds such as methylene chlorofom, freons, trichlloro ethylene; evaporating anaesthesia such as halothane; non-halogen compounds such as xylene, acetone, isopropanol, toluen, ethyl acetate and acetonitrile.

d) Ethylene oxide: Ethylene oxide is used to sterilize medical equipment, operating rooms, which is, therefore, held in cylinders and connected to sterilization equipment. Such kind of gas may cause toxic factors and cancer in human body.

e) Chemical compounds include cleansing and sterilizing solutions such as phenol, oil and grease and cleaning solvents....

4. Pressure gas cylinders

Medical establishments often store pressure gas cylinders such as oxygen cylinders, CO2 cylinders, gas cylinders, simple gas cylinders, gas cylinders for only one use. These cylinders are easy to cause fire and explosion when burned, which must, therefore, be separately collected.

5. Daily-life wastes, including

a) Wastes not contaminated with hazardous elements, which originate from patients� rooms, working offices, corridors, supplying sections, warehouses, laundry, dining halls..., including papers, documents, packing materials, cardboard boxes, plastic bags, film bags, materials for packing foodstuffs, left-over food of patients, flowers, garbage swept from house floors.

b) External-environment wastes include tree leaves and garbage from external environment areas....

Chapter III

PROCESS OF COLLECTING AND STORING SOLID WASTES AT MEDICAL ESTABLISHMENTS

Article 9.- The waste collecting principles

1. Wastes must be classified right at the time they are generated and must be kept in bags or bins according to the regulations.

2. Hazardous medical wastes must not be kept mixedly with daily-life wastes. If the hazardous medical wastes are accidentally put together with the daily-life wastes, such waste mixture must be treated and destroyed like the hazardous medical wastes.

Article 10.- Standards of waste bags, boxes and bins

1. Waste bags, boxes and bins specified according to colors

a) Yellow bags, boxes and bins: for storing clinical wastes, with outside symbols indicating the biological hazards.

b) Green: for storing the daily-life wastes.

c) Black: for storing chemical wastes, radioactive wastes, cell-toxicated drugs.

d) Bags, boxes and bins in the above-mentioned colors are only used for storing wastes and not for other purposes.

2. Waste bag standards:

a) Bags for storing to-be-burned wastes must be the PE or PP plastic bags; PVC plastic bags are not used as many pollutants shall be created when they are burned.

Article 11.- Locations for placing waste bags and bins

1. Locations to place hazardous medical waste and daily-life waste bins must be clearly determined in each department/section. Each department should have a place to keep waste bags and bins according to each type.

2. Waste bags and bins must be placed near the sources of waste generation such as operating rooms, bandage changing rooms, injection rooms, child delivery rooms, patients� rooms, testing rooms, corridors. On injection and operation trolleys, there must be boxes to keep pointed and sharp objects in order to facilitate the classification.

3. The waste bags must comply with the provisions on color system, not replacing yellow and black bags holding hazardous wastes with green bags.

Article 12.- Gathering wastes at the place of their generation

1. The orderlies shall have to daily gather hazardous medical wastes and daily-life wastes from the places of their generation to the department�s waste-gathering location.

2. The clinical wastes, when being taken out of departments/sections, must be put into yellow plastic bags; the chemical wastes and radioactive wastes be put in black plastic bags marked with the inscription stating the places of waste generation.

3. Yellow boxes containing pointed and sharp objects, and preliminarily treated wastes must be put into yellow plastic bags which shall be tied up close.

4. Wastes generated from departments must be transported to the waste-gathering place of the medical establishment at least once a day and when necessary.

5. Plastic bags shall be tied up close when they are filled with wastes up to the prescribed volume (2/3 of the bag). The bags must not be sealed close with staples.

Article 13.- Transportation of wastes within medical establishments

1. Medical establishments must stipulate ways and time for the transportation of wastes, and avoid transportation of wastes through patients-tending areas and other clean areas.

2. Each medical establishment must has its own means to transport wastes from the gathering places of departments/sections to the gathering place of the whole establishment. Such means are only used for the transportation of wastes, and must be cleaned and disinfected after being used. The waste-carrying means must be designed in a way that wastes are easily put in and taken out and that they shall be easily cleaned, disinfected and dried.

Article 14.- Keeping wastes in medical establishments

1. Waste-storing places at medical establishments must satisfy the following conditions:

i) Being far from food-preparing places, warehouses and paths.

ii) Having ways for waste carriers to come from the outside.

iii) The hazardous medical wastes must be kept separately from the daily-life wastes.

iv) Having roofs, protection fences, doors and locks. To prevent animals, rodents and insects from penetrating therein.

v) The land areas are suitable to the waste volumes generated from the medical establishments.

vi) Being equipped with facilities for hand-washing, means for protection of personnel, cleaning tools and chemicals.

vii) Being built with water drainage systems, dry and airy floors.

2. The time for storing hazardous medical wastes at medical establishments

a) For hospitals: In principle, wastes must be carried daily for destruction. The maximum time for keeping hazardous medical wastes in hospital is 48 hours.

b) For small medical establishments such as prophylactic medicine centers, polyclinics, maternity homes, health stations with small volumes of hazardous medical wastes, such wastes must be put into appropriate plastic bags which shall be tied close. Wastes of Groups A, B, C and D must not be kept at medical establishments for more than a week. Particularly Group E wastes must be immediately buried or destroyed.

Chapter IV

TRANSPORTATION OF SOLID HAZARDOUS MEDICAL WASTES OUT OF MEDICAL ESTABLISHMENTS

Article 15.- Transportation

1. The medical establishments shall sign contracts with hazardous medical waste- transporting and destroying establishments licensed to operate by the competent environmental bodies. Where the latter is not available in a locality, the concerned medical establishment shall have to transport them.

2. The hazardous medical waste transport means must not be used for other purposes.

3. The hazardous medical waste transport means must be cleaned after each transportation.

4. Hazardous medical wastes, if being transported to far destruction places, must be packed in bins or cardboard boxes in order to avoid cracks or breaks en route.

5. Group E wastes must be put in yellow plastic bags, then packed in bins/ boxes which shall be glued close and labeled before being transported for destruction.

Article 16.- Dossiers on waste transport

1. Each medical establishment must have a system of books to monitor the volume of generated wastes and cards to monitor the volume of wastes transported daily for destruction.

2. The card for monitoring the transportation and destruction of hazardous medical wastes shall contain the following details: the name of the medical establishment; the volume of generated wastes, the volume of wastes transported for destruction; the names and signatures of the waste deliverer, receiver and destroyer.

Chapter V

MODEL-TECHNOLOGY-METHOD OF TREATING AND DESTROYING SOLID WASTES

Article 17.- Models of solid hazardous medical waste destruction

1. For medical establishments in cities, one of the following models shall apply:

a) Building and operating a regional hazardous medical wastes incinerator for the whole city.

b) Building and operating hazardous medical waste incinerators according to hospital groups. Such an incinerator can be placed in a hospital where exists a land area for installation and operation of an incinerator and roads convenient for nearby medical establishments to transport their hazardous medical wastes thereto for incineration.

c) Using industrial hazardous waste incinerating establishments in localities, if any.

2. For medical establishments in provincial towns, one of the following models shall apply:

a) Building and operating hazardous medical waste incinerators according to hospital groups.

b) Building and operating a hazardous medical waste incinerator in each medical establishment. This model shall apply only to medical establishments without incinerators built for regions or hospital groups, or hospitals where large volume of hazardous medical wastes of high contagiosity such as TB hospitals, tropical disease clinical medicine hospital....

The incinerator in the hospital premise must not be placed near the population quarters. Its chimney must be higher than adjacent tall building and the incinerator location must be at the end of the direction of the monsoon in the year.

3. For district medical centers: If no hazardous medical waste incinerator is available for regions or hospital groups, simple and manual incinerators may apply. Ashes and other left-overs after the burning shall be buried or destroyed together with daily-life wastes.

4. For polyclinics, maternity homes and commune health stations: either of the two following modes shall apply:

a) Open-air incineration.

b) Burning by manual incinerators.

Article 18.- Solid hazardous medical waste incinerating technologies.

Medical establishments should base themselves on the incineration models mentioned above and their economic capabilities, including funds for installation, operation as well as maintenance, to opt for the following technologies suitable to each locality:

Article 19.- Hygienic burial.

1. It is only applied to medical establishments lacking conditions for incineration of hazardous medical wastes.

2. Not to bury hazardous medical wastes with daily-life wastes.

3. Hazardous medical wastes shall be allowed to be buried only at prescribed areas.

4. The hazardous medical wastes burial sites must satisfy the environmental criteria and technical requirements guided and evaluated by the environmental bodies.

Article 20.- Preliminary treatment methods.

1. General provisions: Highly contaminated clinical wastes must be safety treated near the places of their origin before they are put into yellow plastic bags for transportation to incineration places.

2. The clinical wastes which need to be preliminarily treated include Group C wastes, materials and devices after being used for examination and/or treatment of HIV/AIDS or syphilis patients; sputum of TB sufferers....

3. Preliminary treatment method: Depending on their own conditions and available facilities, medical establishments shall apply the following methods:

a) Boiling.

b) Killing germs with chemicals.

c) Sterilization by hot air or steam.

Article 21.- Destruction of clinical wastes

1. Group A wastes

a) Preliminary treatment: A number of Group A wastes of high contagiosity such as wastes stained with blood and/or fluid of HIV/AIDS or syphilis patients, sputum of TB sufferers..., which must be disinfected immediately after such wastes are generated and before they are transported for destruction.

b) Destruction methods: One of the following methods may apply:

i) Incineration by the best method.

ii) Burying them in a hygienic manner.

2. Group B wastes

a) Injection syringes and needles for one use, before being transported to destruction, must be put into boxes containing pointed and sharp objects. It is best not to take needles from syringes nor to re-inset the needles with a view to avoiding the possibility of getting hurt.

b) Destruction methods: Like for Group A wastes.

3. Group C wastes

a) Preliminary treatment: Wastes of this Group are highly contagious; hence, they must be preliminarily treated before being transported from the testing departments to places of their storage or destruction.

In case of the lack of conditions for pre-destruction treatment, they must be packed in yellow plastic bags and transported directly to incinerators.

b) Destruction methods: Like for Group A wastes.

4. Group D wastes

a) For pharmaceutical wastes, one of the following methods may apply:

i) Incineration: together with contaminated wastes, if incinerators are available.

ii) Burial: Before being carried for burial, wastes must be inertized. The inertization techniques shall be effected as follows: mixing wastes with cement and a number of other materials in order to deactivate hawardous substances in the wastes. The mixture percentages shall be as follows: 65% being the pharmaceutical wastes, 15% powdered lime, 15% cenment, 5% water. After being created into unique blocs in form of clods, they shall be carried away for burial.

iii) Discharge into sewages: Wastes in small volumes in forms of pills, tables (under 500 tables) or liquid or semi-liquid wastes shall be weakened with water and discharged into the sewage systems of the medical establishments (if the establishments have waste water treatment systems).

Pharmaceutical wastes must not be discharged into natural water sources such as rivers, lakes, swamps....

b) For wastes being cell-intoxicated drugs, one of the following destruction methods may apply:

i) Returning them to their places of original supply.

ii) Incinerating them at high temperature. Cell-intoxicated wastes must be burned in high-temperature incinerators because when they are burned at low temperature, poison gases shall be generated. (Appendix 3: Minimum temperatures for destruction of cell-intoxicated wastes).

5. Group E wastes: Group E wastes shall be destroyed by either of the two following methods:

i) Incinerating them together with contaminated wastes if incinerators are available.

ii) Burning them in graveyards or prescribed places. In a number of localities, according to the cultural practices, relatives of diseased persons may carry placentas, embryos, limbs and cut-out parts of the bodies for burial, provided that the medical establishments must ensure that such wastes must be carefully wrapped and packed in yellow plastic bags before they are assigned to the patients� next of skin.

Article 22.- Destruction of radioactive wastes

Shall comply with the provisions of the Ordinance on radioactive safety and control of June 25, 1996; the Government�s Decree No.50/CP of July 16, 1998 detailing the implementation of the Ordinance on Radioactive Safety and Control, and the State�s current regulations.

Article 23.- Destruction of chemical wastes

1. Destruction of non-hazardous chemical wastes: one of the following methods shall apply:

a) Reuse.

b) Destruction like the daily-life wastes.

2. Destruction of hazardous chemical wastes

a) Principles:

i) Hazardous chemical wastes with different characteristics cannot be mixed together for destruction.

ii) Halogen-containing wastes must not be burned as such will pollute the air.

iii) Hazardous chemical wastes must not be discharged into waste water system.

iv) Chemical wastes in large volumes must not be buried as such may pollute underground water streams.

b) Destruction methods: One of the following methods may apply:

i) The best way is to send them back to their place of original supply.

ii) Incineration

iii) Burial: Before being carried away for burial, chemical wastes must be inertized (deactivated ?).

Article 24.- Destruction of pressure gas cylinders

Pressure gas cylinders must not be placed mixedly with clinical wastes for incineration as it may cause explosion. One of the following destruction methods may apply:

1. Sending them back to their place of production.

2. Reusing them

3. Destroying them like daily-life waste, for small cylinders.

Article 25.- Destruction of daily-life wastes

Being not included in groups of hazardous wastes, the daily-life wastes must not be incinerated. The daily-life wastes must be put into green plastic bags, gathered, transported and stored separately from the hazardous medical wastes, and destroyed like wastes discharged from household families. Where hazardous medical wastes are accidentally placed together with daily-life wastes, such bags of wastes must be treated like bags of hazardous medical wastes.

Chapter VI

TREATMENT OF WASTE WATER AND GASEOUS WASTES

Article 26.- Waste water treatment

1. General provisions

Each hospital must have a synchroneous waste water gathering and treating system. Hospital waste water, when being discharged into areas outside the hospitals� premises, must reach the current standards of Vietnam.

2. Models

Hospitals built previously without waste water treating system must be newly constructed.

Hospitals with waste water treating systems built previously, but now damaged or out or order must have such systems renovated and upgraded for efficient operation.

New hospitals, when built, must be designed and constructed with waste water treating systems.

3. Technologies

Selected waste water treatment technologies must satisfy the criteria on environmental hygiene and suit the terrain conditions, investment fund, operation and maintenance costs. One of such methods can be selected as biological method, chemical method, mechanical method or the combination of such methods. Equipment and technologies to be used must be synchroneous and approved by the competent State bodies in charge of environmental technologies.

Article 27.- Gaseous waste treatment

1. General provisions

Laboratories, chemicals or pharmaceuticals depots must be up to the current standards of Vietnam.

2. Models

Laboratories, chemicals or pharmaceuticals depots must be furnished with air ventilating systems and poison gas treatment boxes.

Chapter VII

IMPLEMENTATION ORGANIZATION

Article 28.- Setting up the Steering Committee

1. At the Ministry of Health: The Ministry�s Steering Committee for hospital waste treatment shall be set up with a member of the Ministry�s leadership as its head.

2. At the provincial/municipal Health Services. A Health Service�s Steering Committee shall be set up with a member of the Service�s leadership as its head, leaders of provincial hospitals, prophylactic medicine centers and functional sections of the Service as its members. This Committee is tasked to advise the director of the provincial/municipal Health Service on the management of medical wastes in the localities and projects for investment in infrastructure facilities for treatment and destruction of hazardous medical wastes.

Article 29.- Training

1. The medical establishments shall disseminate the "Regulation on management of medical wastes" to their cadres, officials and employees.

2. The Ministry of Health shall elaborate programs and compile materials for training cadres in charge of the management of wastes of medical establishments.

3. Medical establishments shall organize training for persons directly involved in the process of waste management and treatment.

Article 30.- Investment in infrastructure

1. Basing themselves on the Regulation on management of medical wastes, the medical establishments shall draw up plans for management of their own wastes and at the same time map out projects for investment in infrastructure for treatment and destruction of hazardous medical wastes.

2. Directors of the Health Services of provinces and centrally-run cities shall have to sum up projects of their attached medical establishments. After getting consents of concerned bodies in the localities, the provincial/ municipal Health Service directors shall submit their projects to the presidents of the People�s Committees of provinces and centrally-run cities for approval.

3. The Department of Therapy of the Health Ministry shall have to sum up projects of hospitals and institutes with hospital beds under the Health Ministry. After getting the consents of concerned Department, the Department of Therapy shall submit projects to the Minister of Health for approval.

4. Directors of the medical establishments of the ministries and branches shall submit their projects to the managing ministers for consideration and approval.

Article 31.- Organization of examination and inspection

1. Directors of the Health Services of the provinces and centrally-run cities shall have to coordinate with concerned sections and branches in organizing the examination and inspection of the observance of the Regulation on management of medical wastes in the medical establishments of the localities and medical establishments located therein.

2. Director of the Department of Therapy, the Ministry of Health, shall coordinate with concerned Departments in organizing in the inspection of the observance of the Regulation on management of medical wastes of hospitals and other medical establishments throughout the country.

3. Director of the Prophylactic Medicine Department shall have to inspect and assess the quality of the waste treatment systems which must comply with the regulations on environmental hygiene.

4. The Health Ministry�s inspectorate shall have to inspect and handle the violations of the Regulation on management of medical wastes in strict accordance with the provisions of law.

The Minister of Health

Appendix 1

RADIOACTIVE NUCLEUS USED IN MEDICAL ESTABLISHMENTS

Appendix 3

MINIMUM TEMPERATURE TO DESTROY CELL-INTOXICATED DRUGS