Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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ISSN No : 2394 - 3033, V – 1, I – 2, 2014 Journal Club for Management Studies (JCMS) Manuscript No: JCMS/RES/2014/12, Received On: 27/10/2014 , Accepted On : 07/11/2014, Published On: 20/11/2014 RESEARCH ARTICLE © All Rights Reserved by “Journals Club & Co.” 11 Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India Dr. Prashant Mehta 1 * 1 Assistant Professor, Faculty of Science, National Law University, Jodhpur, Rajasthan ABSTRACT Medical care is vital for our life, health and wellbeing. But the waste generated from medical activities can be hazardous, toxic and even lethal because of their high potential for diseases transmission. The hazardous and toxic parts of waste from healthcare establishments comprising infectious, medical, and radioactive material as well as sharps constitute a grave risks to mankind and the environment, if these are not properly treated /disposed or are allowed to be mixed with other municipal waste. In India, practical information on this aspect is slowly developing and research on the public health implications because of poor management of medical wastes (both Hospital and Biomedical) is hardly any and limited in scope. Findings drawn from literature particularly from the developing economies and more so India, highlights range of issues like lack of adequate finance, lack of awareness of the risks involved in handling medical wastes (both Hospital and Biomedical), lack of appropriate legislation or in other words poorly enforced legislation, and lack of specialized staff to handle and dispose medical wastes (both Hospital and Biomedical). The paper recommends how medical wastes (both Hospital and Biomedical) practices can be improved in medical facilities all across the country and how legislation will be helpful in handling this problem of great magnitude. KEYWORDS Biomedical Wastes, Hospital Waste, Waste Management, Infections, Sustainability, Waste Related Legislation INTRODUCTION Healthcare is vital for our life, health, and wellbeing. Healthcare activities are a means of protecting health, curing patients, and saving lives. However the waste generated from medical activities is hazardous, toxic, and even lethal because of their high potential for disease transmission (20 percent of which entails risk either of infection, of trauma, of chemical or radiation exposure). Although the risks associated with hazardous medical waste and the ways and means of managing that waste are relatively well Address for Correspondence: Dr. Prashant Mehta, Assistant Professor, Faculty of Science, National Law University, Jodhpur, Rajasthan Email: [email protected]

Transcript of Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

ISSN No : 2394 - 3033, V – 1, I – 2, 2014 Journal Club for Management Studies (JCMS)

Manuscript No: JCMS/RES/2014/12, Received On: 27/10/2014 , Accepted On : 07/11/2014, Published On: 20/11/2014

RESEARCH ARTICLE

© All Rights Reserved by “Journals Club & Co.” 11

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

Dr. Prashant Mehta 1*

1 Assistant Professor, Faculty of Science, National Law University, Jodhpur, Rajasthan

ABSTRACT Medical care is vital for our life, health and wellbeing. But the waste generated from medical activities can be hazardous, toxic and even lethal because of their high potential for diseases transmission. The hazardous and toxic parts of waste from healthcare establishments comprising infectious, medical, and radioactive material as well as sharps constitute a grave risks to mankind and the environment, if these are not properly treated /disposed or are allowed to be mixed with other municipal waste. In India, practical information on this aspect is slowly developing and research on the public health implications because of poor management of medical wastes (both Hospital and Biomedical) is hardly any and limited in scope. Findings drawn from literature particularly from the developing economies and more so India, highlights range of issues like lack of adequate finance, lack of awareness of the risks involved in handling medical wastes (both Hospital and Biomedical), lack of appropriate legislation or in other words poorly enforced legislation, and lack of specialized staff to handle and dispose medical wastes (both Hospital and Biomedical). The paper recommends how medical wastes (both Hospital and Biomedical) practices can be improved in medical facilities all across the country and how legislation will be helpful in handling this problem of great magnitude.

KEYWORDS

Biomedical Wastes, Hospital Waste, Waste Management, Infections, Sustainability, Waste Related Legislation

INTRODUCTION

Healthcare is vital for our life, health, and

wellbeing. Healthcare activities are a

means of protecting health, curing patients,

and saving lives. However the waste

generated from medical activities is

hazardous, toxic, and even lethal because

of their high potential for disease

transmission (20 percent of which entails

risk either of infection, of trauma, of

chemical or radiation exposure). Although

the risks associated with hazardous

medical waste and the ways and means of

managing that waste are relatively well

Address for Correspondence: Dr. Prashant Mehta, Assistant Professor, Faculty of Science, National Law University, Jodhpur, Rajasthan Email: [email protected]

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 12

known and described in various manuals

and other literature, the effective treatment

(waste handling and management) and

elimination / disposal methods advocated /

described requires an considerable

technical, financial resources, and strong

legal framework, which are often lacking

in most situations. The staff is often

unequipped / untrained for coping with this

task of handling and disposing bio-medical

wastes.

A healthcare activity for instance,

immunizations, diagnostic tests, medical

treatments, surgical procedures, and

laboratory examinations helps protect,

restore health, and save lives but at the

same time the obvious question is what

about the wastes and by-products they

generate. From the total of all wastes

generated by healthcare activities, almost

80 percent is general waste which is nearly

comparable to domestic waste, remaining

20 percent of wastes is considered highly

hazardous that may be infectious, toxic,

and radioactive in nature. Thus such

hazardous waste represents a threat to the

environment and human health if not

handled or disposed of properly.

In addition, the inappropriate treatment or

disposal of that medical (hospital and

biomedical) waste can lead to

environmental contamination or pollution

of air, water, and soil. Surface and ground

water contamination takes place when

waste reach water bodies. Residues from

waste can change the water chemistry,

which can affect all levels of an

ecosystem. The health of animals and

humans are affected when they drink the

contaminated water. A specific

environmental hazard caused by waste is

leachate, which is the liquid that forms, as

water trickles through contaminated areas

leaching out the chemicals. Thus poor

waste management practice can jeopardize

life of medical or paramedical care staff,

hospital employees who handle medical

(hospital and biomedical) waste, patients,

their families, and also impact population

living in vicinity of hospitals. In

unfavorable contexts, the risks associated

with hazardous medical (hospital and

biomedical) waste can be significantly

reduced through simple and appropriate

measures.

DEFINITION OF BIO-MEDICAL

WASTES

‘Bio-medical waste’ means any solid and

or liquid waste including its container and

any intermediate product, which is

generated during the diagnosis, treatment

or immunization of human beings or

animals or in research pertaining thereto or

in the production or testing thereof. All

biomedical waste is hazardous. In hospital

it comprises of 20 percent of total hospital

waste. The physiochemical, biological

nature of these components, their toxicity,

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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and potential hazard are different,

necessitating different methods / options

for their treatment / disposal. In Schedule I

of the Bio-medical Waste (Management

and Handling) Rules, 1998, therefore, the

waste originating from different kinds of

such establishments, has been categorized

into 10 different categories (as mentioned

in the box below) and their treatment and

disposal options have been indicated.

Handling, Segregation, Mutilation,

Disinfection, Storage, Transportation, and

Final disposal are vital steps for safe and

scientific management of biomedical waste

in any establishment1.

Components of Bio-Medical Waste

1. Human Anatomical Waste (tissues, organs, body parts etc.)

2. Animal Waste (as above, generated during research/experimentation, from veterinary hospitals etc.)

3. Microbiology and biotechnology waste, such as, laboratory cultures, micro-organisms, human and animal cell cultures, toxins etc.

4. Waste sharps, such as, hypodermic needles, syringes, scalpels, broken glass etc.

5. Discarded medicines and Cytotoxic drugs

6. Soiled waste, such as dressing, bandages, and plaster casts, material contaminated with blood etc.

7. Solid waste (disposable items like tubes, catheters etc. excluding sharps)

8. Liquid waste generated from any of the infected areas

9. Chemical Wastes and 10. Incineration Ash Waste

Bio-medical waste needs to be properly

managed due to various hazards it poses to

health of people, environment besides

legal, aesthetic reasons, and ethical

reasons. The ethical aspect is more

important as it is related to the social

responsibilities, which the health

professions have, as a result of their status,

knowledge, and skills and an obligation to

alert those who are at risk. This is reflected

by the compulsory notification of

infectious and notifiable diseases as a

measure of public Hospital Management.

The issue of indiscriminate Bio-Medical

Waste disposal and management in India

has attracted the attention of the highest

judicial body at the level of Hon’ble.

Supreme Court of India which has time to

time issued instructions regarding

management of Bio-Medical Waste and its

proper management.

INFECTIOUS WASTE

Infectious waste is suspected to contain

pathogens (bacteria, viruses, parasites, or

fungi) in sufficient concentration or

quantity to cause disease in susceptible

hosts. This category includes:

Cultures and stocks of infectious agents

from laboratory work.

Waste from surgery and autopsies on

patients with infectious diseases (e.g.

tissues, and materials or equipment that

have been in contact with blood or other

body fluids).

Waste from infected patients in isolation

wards (e.g. excreta, dressings from

infected or surgical wounds, clothes

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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heavily soiled with human blood or other

body fluids).

Waste that has been in contact with

infected patients undergoing

haemodialysis (e.g. dialysis equipment

such as tubing and filters, disposable

towels, gowns, aprons, gloves, and

laboratory coats).

Infected animals from laboratories.

Any other instruments or materials that

have been in contact with infected persons

or animals.

Note: Infected "Sharps" are a subcategory

of infectious waste.

All these institutions produce waste, which

is increasing in its amount and type, due to

advances in scientific knowledge and is

creating its impact2. The hazardous and

toxic waste from healthcare establishments

comprising infectious, bio-medical, and

radio-active material as well as sharps

(hypodermic needles, knives, scalpels etc.)

constitute a grave risk to human health

both for patients and personnel who handle

these wastes poses a threat to public health

and environment3, if these are not properly

treated or disposed off and are allowed to

get mixed with other municipal waste. Its

propensity to encourage growth of various

pathogen and vectors besides its ability to

contaminate other nonhazardous / non-

toxic municipal waste jeopardizes the

efforts undertaken for overall municipal

waste management. The rag pickers and

waste workers are often worst affected,

because unknowingly or unwittingly, they

rummage through all kinds of poisonous

material while trying to salvage items

which they can sell for reuse.

At the same time, this kind of illegal and

unethical reuse can be extremely

dangerous and even fatal. Diseases like

cholera, plague, tuberculosis, hepatitis

(especially HBV), AIDS (HIV), diphtheria

etc. in either epidemic or even endemic

form, pose grave public health risks.

Unfortunately, in the absence of reliable

and extensive data, it is difficult to

quantify the dimension of the problem or

even the extent and variety of the risk

involved. With a judicious planning and

management, however, the risk can be

considerably reduced.

Hospital waste is a potential health hazard

to the health care workers, public, flora,

and fauna of the area where it is discarded.

Hospital acquired infection, transfusion

transmitted diseases, rising incidence of

Hepatitis B, and HIV, increasing land and

water pollution lead to increasing

possibility of catching many diseases

which reoccurs. Hospitals are known for

the treatment of sick persons but we are

unaware about the adverse effects of the

garbage and filth generated by them on

human body and environment. Now it is a

well-established fact that there are many

adverse and harmful effects to the

environment including human beings

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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which are caused by the "Hospital waste"

generated during the patient care.

DESCRIPTION OF MEDICAL WASTE

The term "medical waste" covers all

wastes produced in health-care or

diagnostic activities. 75 percent to 80

percent of hospital wastes are similar to

household refuse or municipal waste and

do not entail any particular hazard. Refuse

similar to household waste can be put

through the same collection, recycling and

processing procedure as the community's

municipal waste. The other 20 percent to

25 percent is called hazardous medical

waste or special waste. This type of waste

entails health risks. Emissions from

incinerators or other waste burning devices

and landfills can cause air contamination.

Incinerators routinely emit dioxins

(Dioxins are known to increase the

likelihood of cancer and are considered a

serious threat to public health.

Environmental campaigners describe

dioxins as among the most dangerous

poisons known), furans(Furan is a

colorless, flammable, highly volatile liquid

with a boiling point close to room

temperature. It is toxic and may be

carcinogenic), and polychlorinated bi-

phenyls (Also called PCBs, these were

used as coolants and insulating fluids for

transformers and capacitors, stabilizing

additives in flexible PVC coatings of

electrical wiring and electronic

components etc. PCB production was

banned in the 1970s due to the high

toxicity of most products containing PCBs.

PCBs are classified as persistent organic

pollutants which bio-accumulate in

animals). The wastes and by-products

cover a diverse range of materials, as the

following list illustrates4:

Infectious Wastes - Waste suspected to

contain pathogens e.g. laboratory cultures;

waste from isolation wards; tissues

(swabs), materials, or equipment that have

been in contact with infected patients,

excreta, wastes contaminated with blood

and its derivatives, discarded diagnostic

samples, infected animals from

laboratories, and contaminated materials

(swabs, bandages), and equipment

(disposable medical devices etc.)

Anatomic Wastes / Pathological Wastes -

Human tissues or fluids e.g. body parts;

blood and other body fluids; fetuses.

Recognizable body parts and animal

carcasses. Infectious and anatomic wastes

together represent the majority of the

hazardous waste, up to 15percent of the

total waste from healthcare activities.

Pathological waste consists of tissues,

organs, body parts, human fetuses and

animal carcasses, blood, and body fluids.

Within this category, recognizable human

or animal body parts are also called

anatomical waste. This category should

be considered as a subcategory of

infectious waste, even though it may also

include healthy body parts.

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Sharps - Sharp waste e.g. needles;

infusion sets; scalpels; knives; blades;

broken glass. Sharps are items that could

cause cuts or puncture wounds, including

needles, hypodermic needles, scalpel and

other blades, knives, infusion sets, saws,

broken glass, and nails. Whether or not

they are infected, such items are usually

considered as highly hazardous health-care

waste

Chemical Wastes - Waste containing

chemical substances e.g. laboratory

reagents; film developer; disinfectants that

are expired or no longer needed; solvents.

Chemical waste consists of discarded

solid, liquid, and gaseous chemicals, for

example from diagnostic and experimental

work and from cleaning, housekeeping,

and disinfecting procedures. Chemical

waste from health care may be hazardous

or non-hazardous; in the context of

protecting health, it is considered to be

hazardous if it has at least one of the

following properties viz Toxic, Corrosive

(e.g. Acids of pH < 2 and Bases of pH >

12); Inflammable, Reactive (Explosive,

Water- Reactive, Shock- Sensitive);

Genotoxic (e.g. Cytostatic Drugs). Non-

hazardous chemical waste consists of

chemicals with none of the above

properties, such as sugars, amino acids,

and certain organic, and inorganic salts.

Pharmaceuticals Wastes - Waste

containing pharmaceuticals e.g.

pharmaceuticals that are expired or no

longer needed; items contaminated by or

containing pharmaceuticals (bottles,

boxes). Pharmaceutical waste includes

expired, unused, spilt, and contaminated

pharmaceutical products, drugs, vaccines,

and sera that are no longer required and

need to be disposed of appropriately. The

category also includes discarded items

used in the handling of pharmaceuticals,

such as bottles or boxes with residues,

gloves, masks, connecting tubing, and drug

vials.

Radioactive Matter / Waste - Waste

containing radioactive substances: radio-

nuclides used in laboratories or nuclear

medicine, urine or excreta of patients

treated. Glassware contaminated with

radioactive diagnostic material or radio-

therapeutic materials. Waste containing

radioactive substances e.g. unused liquids

from radiotherapy or laboratory research;

contaminated glassware, packages, or

absorbent paper; urine and excreta from

patients treated or tested with unsealed

radio-nuclides; sealed sources Cultures and

stocks of highly infectious agents, waste

from autopsies, animal bodies, and other

waste items that have been inoculated,

infected, or in contact with such agents are

called highly infectious waste.

Wastes with High Heavy Metal Content

Batteries; broken thermometers; blood-

pressure gauges; etc. heavy metals. Wastes

with a high heavy-metal content represent

a subcategory of hazardous chemical

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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waste, and are usually highly toxic.

Mercury wastes are typically generated by

spillage from broken clinical equipment

but their volume is decreasing with the

substitution of solid-state electronic

sensing instruments (thermometers, blood-

pressure gauges, etc.). Whenever possible,

spilled drops of mercury should be

recovered. Residues from dentistry have

high mercury content. Cadmium waste

comes mainly from discarded batteries.

Certain "reinforced wood panels"

containing lead is still used in radiation

proofing of X-ray and diagnostic

departments. A number of drugs contain

arsenic, but these are treated here as

pharmaceutical waste. Broken mercury

thermometers. Genotoxic waste,

radioactive matter and heavy metal content

represent about 1percent of the total waste

from health-care activities.

Pressurized Containers - Gas cylinders;

gas cartridges; aerosol cans. Many types of

gas are used in health care, and are often

stored in pressurized cylinders, cartridges,

and aerosol cans. Many of these, once

empty or of no further use (although they

may still contain residues), are reusable,

but certain types - notably aerosol cans -

must be disposed of. Whether inert or

potentially harmful, gases in pressurized

containers should always be handled with

care; containers may explode if incinerated

or accidentally punctured.

Genotoxic Wastes - Waste containing

substances with genotoxic properties e.g.

waste containing cytostatic drugs (often

used in cancer therapy); genotoxic

chemicals. Genotoxic waste is highly

hazardous and may have mutagenic,

teratogenic, or carcinogenic properties. It

raises serious safety problems, both inside

hospitals and after disposal, and should be

given special attention. Genotoxic waste

may include certain cytostatic drugs,

vomitus, urine, or faces from patients

treated with cytostatic drugs, chemicals,

and radioactive material. Cytotoxic (or

antineoplastic) drugs, the principal

substances in this category, have the

ability to kill or stop the growth of certain

living cells and are used in chemotherapy

of cancer. They play an important role in

the therapy of various neoplastic

conditions but are also finding wider

application as immunosuppressive agents

in organ transplantation and in treating

various diseases with an immunological

basis. Cytotoxic drugs are most often used

in specialized departments such as

oncology and radiotherapy units, whose

main role is cancer treatment; however,

their use in other hospital departments is

increasing and they may also be used

outside the hospital setting. Cytotoxic

wastes are generated from several sources

and can include the following:

Contaminated Materials from drug

preparation and administration, such as

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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syringes, needles, gauges, vials,

packaging;

Outdated Drugs, excess (leftover)

solutions, drugs returned from the wards;

Urine, faeces, and vomit from patients,

which may contain potentially hazardous

amounts of the administered cytostatic

drugs or of their metabolites and which

should be considered genotoxic for at least

48 hours and sometimes up to one week

after drug administration. In specialized

oncological hospitals, genotoxic waste

(containing cytostatic or radioactive

substances) may constitute as much as

1percent of the total healthcare wastes.

Harmful Cytostatic Drugs can be

categorized as follows:

Alkylating Agents: cause alkylation of

DNA nucleotides, which leads to cross-

linking and miscoding of the genetic stock;

Antimetabolites: inhibit the biosynthesis

of nucleic acids in the cell;

Mitotic Inhibitors: prevent cell

replication.

HAZARDOUS CHEMICALS USED IN

MAINTENANCE OF HOSPITALS

AND HEALTHCARE CENTERS

Formaldehyde - It is a significant source of

chemical waste in hospitals. It is used to

clean and disinfect equipment (e.g.

haemodialysis or surgical equipment), to

preserve specimens, to disinfect liquid

infectious waste, and in pathology,

autopsy, dialysis, embalming, and nursing

units.

Photographic Chemicals - Photographic

fixing and developing solutions are used in

X-ray departments. The fixer usually

contains 5-10 percent hydroquinone, 1-5

percent potassium hydroxide, and less than

1 percent silver. The developer contains

approximately 45 percent glutaraldehyde.

Acetic acid is used in both stop baths and

fixer solutions.

Solvents - Wastes containing solvents are

generated in various departments of a

hospital, including pathology and

histology laboratories and engineering

departments. Solvents used in hospitals

include halogenated compounds, such as

methylene chloride, chloroform,

trichloroethylene, and refrigerants, and

non-halogenated compounds such as

xylene, methanol, acetone, isopropanol,

toluene, ethyl acetate, and acetonitrile.

Organic Chemicals - Waste organic

chemicals generated in Health-Care

Facilities Include disinfecting and

cleaning solutions such as phenol-based

chemicals used for scrubbing floors,

perchlorethylene used in workshops and

laundries; oils such as vacuum-pump oils,

used engine oil from vehicles (particularly

if there is a vehicle service station on the

hospital premises); insecticides,

rodenticides.

Inorganic Chemicals - Waste inorganic

chemicals consist mainly of acids and

alkalis (e.g. sulfuric, hydrochloric, nitric,

and chromic acids, sodium hydroxide and

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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ammonia solutions). They also include

oxidants, such as potassium permanganate

(KMnO4) and potassium dichromate

(K2Cr2O7), and reducing agents, such as

sodium bisulfite (NaHSO3) and sodium

sulfite (Na2SO3). Chemicals and

pharmaceuticals amount to about

03percent of waste from healthcare

activities.

WASTE GENERATED IN INDIA

As per the Tenth Plan document, India

produces 48 million tonnes (MT) of urban

solid waste annually, with solid waste

generation being approximately 0.4 kg per

capita per day. The Director General of

Health Services estimates that 5.4 MT of

bio-medical waste is being generated in the

country every year; based on the

generation figure of 250 grams/capita/day.

The Tenth Plan document also estimates

that around 7.2 MT of hazardous waste is

being generated in the country. However,

no estimates exist for the other kinds of

wastes being generated in the country5.

A. RISKS AND IMPACT ON HEALTH

AND THE ENVIRONMENT

All persons who are in contact with

hazardous medical waste are potentially

exposed to the various risks it entails:

persons inside the establishment

generating the waste, those who handle it,

and persons outside the facility who may

be in contact with hazardous wastes or

their by-products, if there is no medical

waste management or if that management

is inadequate. The following groups of

persons are potentially exposed:

Inside the hospital: care staff (doctors,

nursing staff, auxiliaries), stretcher-

bearers, scientific, technical and logistic

personnel (cleaners, laundry staff, waste

managers, carriers, maintenance personnel,

pharmacists, laboratory technicians,

patients, families and visitors).

Outside the hospital: off-site transport

personnel, personnel employed in

processing or disposal infrastructures, the

general population (including adults or

children who salvage objects found around

the hospital or in open dumps).

B. RISKS ASSOCIATED WITH

HAZARDOUS MEDICAL WASTE

The health risks associated with hazardous

medical waste can be divided into four

categories:

1. RISKS OF TRAUMA AND

INFECTION

Health-care wastes are a source of

potentially dangerous micro-organisms

that can infect hospital patients, personnel

and the general public. There are many

different exposure routes: through injury

(cut, prick), through contact with the skin

or mucous membranes, through inhalation

or through ingestion.

Some accidental exposure to blood (AEB)

or to other body fluids are examples of

accidental exposure to hazardous medical

waste6.

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As regards viral infections such as AIDS

and hepatitis B and C, it is nursing staff

that are most at risk of infection through

contaminated needles. Sharps and

pathogenic cultures are regarded as the

most hazardous medical waste. In 2000,

the World Health Organization (WHO)

estimated that at world level accidents

caused by sharps accounted for 66,000

cases of infection with the hepatitis B

virus, 16,000 cases of infection with

hepatitis C virus and 200 to 5,000 cases of

HIV infection amongst the personnel of

health-care facilities. Some wastes, such as

anatomical wastes, do not necessarily

entail a health risk or risk for the

environment but must be treated as special

wastes for ethical or cultural reasons. A

further potential risk is that of the

propagation of micro-organisms outside

health-care facilities which are present in

those facilities and which can sometimes

be resistant, a phenomenon that has not yet

been sufficiently studied.

2. SURVIVAL OF MICRO-ORGANISMS

IN THE ENVIRONMENT

Pathogenic micro-organisms have a

limited capacity of survival in the

environment. Survival depends on each

microorganism and on environmental

conditions (temperature, humidity, solar

Table 1: Examples of infections that can be caused by hazardous medical waste

Type of infection Infective agent Transmission agent

Gastrointestinal infections Enterobacteria (Salmonella, Vibrio cholerae, Shigella, etc.)

Feces, vomit

Respiratory infections

Mycobacterium tuberculosis, Streptococcus pneumoniae, SARS virus (Severe Acute Respiratory Syndrome),

measles virus

Inhaled secretions, saliva

Eye infections Herpes virus Eye secretions

Skin infections Streptococcus Pus

Anthrax Bacillus anthracis Skin secretions

Meningitis Neisseria meningitidis Cerebro-spinal fluid

AIDS Human Immunodeficiency Virus (HIV) Blood, sexual secretions, other body fluids

Haemorrhagic fever Lassa, Ebola, Marburg, and Junin viruses Blood and secretions

Viral hepatitis A Hepatitis A virus Feces

Viral hepatitis B and C Hepatitis B and C viruses Blood and other biological fluids

Avian influenza H5N1 virus Blood, feces

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Table 2: Summary of what is known about

the survival of various pathogens

Pathogeni

c micro-

organism

Observed survival time

Hepatitis

B virus

Several weeks on a surface

in dry air

1 week on a surface at 25°C

Several weeks in dried

blood

10 hours at60°C

Survives 70percent ethanol.

Infectious

dose of

hepatitis B

and C

viruses

-1 week in a drop of blood

in a hypodermic needle

Hepatitis

C > 7 days in blood at 4°C.

HIV

-3-7 days in ambient air

Inactivated at 56°C =-15

minutes in 70percent

ethanol =-21 days in 2 of

blood at ambient

temperature =-Drying the

virus reduces its

concentration by 90-

99percent within the next

few hours.

radiation, availability of organic substrate,

presence of disinfectants, etc.). Bacteria

are less resistant than viruses.

The concentration of micro-organisms in

medical waste, with the exception of

laboratory cultures of pathogens and the

excreta of infected patients, is generally no

higher than in household refuse. However,

medical waste contains a wider variety of

micro-organisms. On the other hand, the

survival time of the micro-organisms

present in medical waste is short (probably

because the wastes contain disinfectants).

The role played by carriers such as rats and

insects must also be taken into account in

the evaluation of micro-organism survival

time in the environment. They are passive

carriers of pathogens, and measures must

be taken to control their proliferation

3. BIOLOGICAL RISKS

ASSOCIATED WITH EXPOSURE TO

SOLID HOUSEHOLD REFUSE

Since exposure conditions are often the

same for employees dealing with

household refuse and those dealing with

medical waste, the impact on the health of

the former can be used as an indicator for

the latter. Various studies conducted in

high-income countries have shown the

following results: Compared to the general

population, in the case of persons

employed in the processing of household

waste the risk of infection is 6 times

higher; the risk of contracting an allergic

pulmonary disease is 2.6 times higher; the

risk of contracting chronic bronchitis is 2.5

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times higher; and the risk of contracting

hepatitis is 1.2 times higher. Pulmonary

diseases and bronchitis are caused by

exposure to the bio-aerosols contained in

the air at the sites where the refuse is

dumped, stored or processed.

4. CHEMICAL RISKS - Many chemical

and pharmaceutical products are used in

health-care facilities. Most of them entail a

health risk due to their properties (toxic,

carcinogenic, mutagenic, repro-toxic,

irritant, corrosive, sensitizing, explosive,

flammable, etc.). There are various

exposure routes for contact with these

substances: inhalation of gas, vapor or

droplets, contact with the skin or mucous

membranes, or ingestion. Some substances

(such as chlorine and acids) are incom-

patible and can generate toxic gases when

mixed. The identification of potential

hazards caused by certain substances or

chemical preparations can be easily done

through labeling: symbols, warning

statements or hazard statements. More

detailed information is set out in the

material safety data sheet (MSDS).

Cleaning products and, in particular,

disinfectants are examples of dangerous

chemicals which are used in large

quantities in hospitals. Most are irritant or

even corrosive, and some disinfectants

(such as formaldehyde) can be sensitizing

and toxic.

Mercury is a heavy metal in liquid form at

room temperature and pressure and is

highly toxic. It is very dense (1 liters of

mercury weighs 13.5 kg). It evaporates

readily and can remain for up to a year in

the atmosphere. It accumulates in

sediments, where it is converted into

methyl mercury, a more toxic organic

derivative. Mercury is found mainly in

thermometers, manometers, dental alloys,

certain types of battery, electronic

components and fluorescent or compact

fluorescent light tubes. Health-care

facilities are one of the main sources of

mercury in the atmosphere due to the

incineration of medical waste. These

facilities are also responsible for the

mercurial pollution of surface water. There

is no threshold under which it does not

produce any undesirable effect. Mercury

can cause fatal poisoning when inhaled. It

is harmful in the event of transcutaneous

absorption and has dangerous effects on

pregnancy. Silver is another toxic element

that is found in hospitals (photographic

developers). It is bactericidal. Bacteria

which develop resistance to silver are also

thought to be resistant to antibiotics.

C. RISKS ASSOCIATED WITH THE

INAPPROPRIATE PROCESSING

AND DUMPING OF HAZARDOUS

MEDICAL WASTE

A. Incineration Risks - In some cases,

particularly when wastes are incinerated at

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 23

low temperature (less than 800°C) or when

plastics containing polyvinyl chloride

(PVC) are incinerated, hydrochloric acid

(which causes acid rain), dioxins, furans

and various other toxic air-borne pollutants

are formed. They are found in emissions

but also in residual and other air-borne ash

and in the effluent gases released through

incinerator chimneys. Exposure to dioxins,

furans and other coplanar polychlorinated

biphenyls can have effects that are harmful

to public health. These substances are

persistent, that is to say, the molecules do

not break down in the environment and

they accumulate in the food chain. The

bulk of human exposure to dioxins, furans

and coplanar polychlorinated biphenyls

takes place through food intake.

Even in high-temperature incinerators

(over 800°C) there are cooler pockets at

the beginning or the end of the incineration

process where dioxins and furans can

form. Optimization of the process can

reduce the formation of these substances if

it is ensured, for example, that incineration

takes place only at temperatures above

800°C and if the formation of combustion

gas is prevented at temperatures of 200 -

400°C. And lastly, the incineration of

metals or of materials with a high metal

content (especially lead, mercury and

cadmium) can result in metals being

released into the environment.

D. RISKS RELATED TO RANDOM

DISPOSAL OR UNCONTROLLED

DUMPING

In addition to the above-mentioned risks,

burial and random dumping on

uncontrolled sites can have a direct impact

on the environment in terms of soil and

water pollution which impacts nearly

everyone including animals.

E. RISKS RELATED TO THE

DISCHARGE OF RAW SEWAGE

Poor management of wastewater and

sewage sludge can result in the

contamination of water and soil with

pathogens or toxic chemicals. Pouring

chemical and pharmaceutical wastes down

the drain can impair the functioning of

biological sewage treatment plants or

septic tanks. These can end up polluting

the ecosystem and water sources.

Antibiotics and their metabolites are

excreted in the urine and feces of patients

under treatment and end up in sewage.

Hospital sewage contains 2 to 10 times

more antibiotic-resistant bacteria than

domestic wastewater, a phenomenon

which contributes to the emergence and

propagation of pathogens such as MRSA

(methicillin-resistant Staphylococcus

aurous).

LEGISLATIVE AND POLICY

IMPERATIVES

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 24

International agreement has been reached

on a number of underlying principles that

govern either public health or safe

management of hazardous waste. These

principles outlined below should be taken

into consideration when national

legislation or regulations governing

healthcare waste management are

formulated:

The “Basel Convention” signed by

more than 100 countries, concerns

transboundary movements of

hazardous waste; it is also applicable to

health-care waste. Countries that

signed the Convention accepted the

principle that the only legitimate

transboundary shipments of hazardous

waste are exports from countries that

lack the facilities or expertise to

dispose safely of certain wastes to

other countries that have both facilities

and expertise.

The “polluter pays” principle implies

that all producers of waste are legally

and financially responsible for the safe

and environmentally sound disposal of

the waste they produce. This principle

also attempts to assign liability to the

party that causes damage.

The “precautionary” principle is a

key principle governing health and

safety protection. When the magnitude

of a particular risk is uncertain, it

should be assumed that this risk is

significant, and measures to protect

health and safety should be designed

accordingly.

The “duty of care” principle stipulates

that any person handling or managing

hazardous substances or related

equipment is ethically responsible for

using the utmost care in that task.

The “proximity” principle

recommends that treatment and

disposal of hazardous waste take place

at the closest possible location to its

source in order to minimize the risks

involved in its transport. According to

a similar principle, any community

should recycle or dispose of the waste

it produces, inside its own territorial

limits.

LEGAL PROVISIONS

National legislation is the basis for

improving health-care waste practices in

any country. It establishes legal controls

and permits the national agency

responsible for the disposal of healthcare

waste, usually the ministry of health, to

apply pressure for their implementation.

The ministry of environment or national

environmental protection agency may also

be involved; there should be a clear

designation of responsibilities before the

law is enacted.

The law should be complemented by a

policy document, and by technical

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 25

guidelines developed for implementation

of the law. This legal “package” should

specify regulations on treatment for

different waste categories, segregation,

collection, storage, handling, disposal, and

transport of waste, responsibilities, and

training requirements; it should take into

account the resources and facilities

available in the country concerned and any

cultural aspects of waste-handling. A

national law on healthcare waste

management may stand alone or may be

part of more comprehensive legislation

such as the following:

Law on management of hazardous

wastes: application to health-care

waste should be explicitly stated;

Law on hospital hygiene and infection

control.

The law should include the following:

A clear definition of hazardous health-

care waste and of its various

categories;

A precise indication of the legal

obligations of the health-care waste

producer regarding safe handling and

disposal;

Specifications for record-keeping and

reporting;

Specifications for an inspection system

to ensure enforcement of the law, and

for penalties to be imposed for

contravention;

Designation of courts responsible for

handling disputes arising from

enforcement of or noncompliance with

the law.

DISPOSAL GUIDELINES AND

LEGISLATIONS

Environmental health policies formulated

by nation states are intended to eliminate

the effects of exposure to environmental

hazards. While hospitals and other related

institutions providing healthcare are

engaged in safeguarding and promoting

human health, these very institutions

generate a lot of waste, the disposal of

which has serious environmental

implications. Therefore scientific methods

and effective safeguards for handling and

disposal of biomedical and hospital waste

had to be codified.

Indiscriminate disposal of infected and

hazardous waste from hospitals, nursing

homes, and pathological laboratories has

led to significant degradation of the

environment, leading to spread of diseases

and putting the people to great risk from

certain highly contagious and transmission

prone disease vectors. This has given rise

to considerable environmental concern.

The first standard on the subject to be

brought out in India was by the Bureau of

Indian Standards (BIS), IS 12625:1989,

entitled ‘Solid Wastes Hospitals

Guidelines for Management’ (Annexure

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 26

7.1) but it was unable to bring any

improvement in the situation. In this

scenario, the notification of the

‘Biomedical BIO-MEDICAL WASTE

(MANAGEMENT & HANDLING)

RULES 1998 assumes great significance.

Accordingly all the hospitals in the public

and private sector are now bound to follow

these rules to evade legal action7. The

Biomedical Waste Management &

Handling) Rules, 1998 came into force on

1998. In exercise of the powers conferred

by section 6, 8, and 25 of Environment

Protection Act, 1986, the Central

Government notified these rules for the

Management and Handling of biomedical

wastes generated from Hospitals, clinics,

other institutions for scientific importance.

The Biomedical waste means any waste,

which is generated during the diagnosis,

treatment or immunization of human

beings or animals or in research activities

pertaining thereto or in the production or

testing of biological and including

categories mentioned in schedule I of the

Rules.

It shall be the duty of every occupier of

an institution generating bio-medical

waste which includes a hospital, nursing

home, clinic, dispensary, veterinary

institution, animal house, pathological

laboratory, blood bank by whatever

name called to take all steps to ensure

that such waste is handled without any

adverse effect to human health and the

environment. The Segregation,

Packaging, Transportation and Storage

shall be done as under:-

1. Bio-medical waste shall not be mixed with other wastes.

2. Bio-medical wast e shall be segregated into containers / bags at the points of generation in accordance with Schedule II prior to its storage transportation, treatment and disposal. The containers shall be labeled according to Schedule III.

Every occupier of an institution

generating, collecting, receiving, storing,

transporting, treating and /or handling

Biomedical Waste shall apply on Form 1

for Authorization to the Board. The Board

grants authorizations after satisfying

itself. Every occupier / operator shall

submit an annual report to the prescribed

authority in Form II by 31 January every

year, to include information about the

categories and quantities of bio-medical

wastes handled during the preceding year.

The prescribed authority shall send this

information in a complied form to the

Central Pollution Control board by 31

March every year.

When any accident occurs at any

institution or facility or any other site

where bio-medical waste is handled or

during transportation of such waste, the

authorized person shall report the

accident in Form III to the prescribed

authority forthwith. Any person aggrieved

by an order made by the prescribed

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 27

authority under these rules, may within

thirty days from the date on which the

order is communicated to him, prefer an

appeal to such authority as the

government of State / Union Territory

may think fit to constitute. Provided that

the authority may entertain the appeal

after the expiry of the period of thirty

days if it is satisfied that the appellant

was prevented by sufficient cause from

filing the appeal in time. For violating the

provisions of these Rules, the Board can

file a complaint under section 15 of

Environment Protection Act which

provide for imprisonment which may

extend upto 5 years with fine. The Board

can also have directions for closure of

any defaulting hospital / clinic /

institution under section 5 of Environment

Protection Act as per powers delegated by

the Central Government. The Central

Government has notified these rules on

20th July, 1998 in exercise of section 6, 8,

and 25 of the Environment (Protection)

Act, 1986. Prior to that, the draft rules

were gazetted on 16th October, 1997 and

Public suggestion / comments were

invited within 60 days. These suggestions

were considered before finalising the

rules.

SCOPE AND APPLICATION OF THE

RULES

These rules apply to all those who

generate, collect, receive, store, transport,

treat, dispose or handle bio-medical waste

in any form. According to these rules, it

shall be the duty of every occupier of an

institution generating bio-medical waste,

which includes hospitals, nursing homes,

clinics, dispensaries, veterinary institution,

animal houses, pathology laboratories,

blood banks etc., to take all steps to ensure

that such wastes are handled without any

adverse effect to human health and the

environment.

They have to either set up their own

facility within the time frame (Schedule

VI) or ensure requisite treatment at a

common waste treatment facility or any

other waste treatment facility. Every

occupier of an institution, which is

generating, collecting, receiving, storing,

transporting, treating, disposing and/or

handling bio-medical waste in any other

manner, except such occupier of clinics,

dispensaries, pathological laboratories,

blood banks etc., which provide Treatment

/ service to less than 1000 (one thousand)

patients per month shall make an

application in prescribed form to the

prescribed authority for grant of

authorisation to carry on the work.

The State Pollution Control Board /

Committees have been asked to take action

against the defaulting hospitals or nursing

homes under section 15(1) of the

Environment (Protection) Act, 1996 which

reads as “ Whoever fails to comply with or

contravenes any of this act, or the rules

made or orders or directions issued

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 28

hereunder in respect of each such failure or

contravention, be punishable with the

imprisonment for a term which may extend

to 5 years or with fine which may extend

to one lakh rupees, or with both, and in

case of failure or contravention continues,

with additional fine which may extend to

five thousand rupees for every day during

which such failure or contravention

continues after the conviction for the first

such failure or contravention”8.

CONCERN FOR ENVIRONMENT

The following are the main environmental

concerns with respect to improper disposal

of bio-medical waste:

a. Spread of infection and disease

through vectors (fly, mosquito, insects

etc.) which affect the in-house as well

as surrounding population.

b. Spread of infection through contact /

injury among medical/non-medical

personnel and sweepers / rag pickers,

especially from the sharps (needles,

blades etc).

c. Spread of infection through

unauthorised recycling of disposable

items such as hypodermic needles,

tubes, blades, bottles etc.

d. Reaction due to use of discarded

medicines.

e. Toxic emissions from defective /

inefficient incinerators.

f. Indiscriminate disposal of incinerator

ash / residues.

BIO MEDICAL WASTES

(MANAGEMENT AND HANDLING)

RULES 2011

Ministry of Environment and Forests has

revised the Bio Medical

Waste (Management and Handling) Rules

promulgated under the Environment

Protection Act of 1986. The Rules now

called the Bio Medical Wastes

(Management and Handling) Rules 2011

are made more stringent and has been

notified for information of the masses and

feedback received from all fronts would be

considered by the Central Government.

BIO-MEDICAL WASTE RULES 2011:

KEY PROVISIONS

The new Rules on BMW are elaborate,

stringent and several new provisions have

been added in it. The Rules are not

applicable for the radioactive waste,

hazardous waste, municipal solid waste

and battery waste which would be dealt

under the respective rules. One of the

features of the new rules is that now every

occupier, operator regardless of the

number of patients being serviced has to

seek prior authorization from the

prescribed authority which is the State

Pollution Control Board for States and

Pollution Control Committee for Union

Territories. Earlier hospitals serving

thousand or more patients only required to

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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Table 3: BMW Rules 2011 vs. 1998

2011 1998

Every occupier

generating BMW,

irrespective of the

quantum of wastes

comes under the

BMW Rules and

requires to obtain

authorization

Occupiers with

more than 1000

beds required to

obtain authorization

Duties of the

operator listed

Operator duties

absent

Categories of

Biomedical Waste

reduced to Eight

Biomedical waste

divided in ten

categories

Treatment and

disposal of BMW

made mandatory

for all the HCEs

Rules restricted to

HCEs with more

than 1000 beds

A format for

annual report

appended with the

Rules

No format for

Annual Report

Form VI i.e. the

report of the

operator on HCEs

not handing over

the BMW added to

the Rules

Form VI absent

obtain authorization from the concerned

authorities. The present Rules also

specifies that irrespective of the quantum

of wastes generated, every occupier such

as from the hospitals, nursing homes,

clinics, dispensaries, veterinary

institutions, animal houses, pathological

laboratories and blood banks generating,

collecting, receiving, storing, transporting,

disposing or handling bio medical wastes

needs to obtain authorization from the

prescribed authority. “Such a change has

been proposed because earlier hospitals

did not give a clear picture of the number

of patients being served and thus evaded

authorization and were exempted from

treating their wastes.

The Bio Medical Waste (Management and

Handling) Rules 1998 contained ten

categories of wastes which have been

reduced in the present rules to eight. The

2011 Rules have discarded Category No. 8

(containing liquid waste generated from

laboratory, cleaning, washing, and

disinfection activities) and Category No. 9

(containing incineration ash). However,

laboratory wastes listed in Category 8 has

been included in the present Category 3.

The current rules have also cleared the

confusion over the color coding of the

containers used for disposal of BMW. The

Schedule II of the 1998 Rules creates a

confusion regarding the disposal of

Category 3 and Category 6 wastes which

could either be disposed in yellow or red

colored bags. Similarly, Category 7 wastes

could also be disposed in red or blue bags.

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 30

The present Rules have thus clarified the

ambiguity and allotted one color code to

each category of waste.

Table 4: Color Coding and Type of

Container for Disposal of BMW

Color

Coding

Type of

Container to

be Used

Waste

Category

Number

Yellow

Non

Chlorinated

plastic bags

Category

1,2,5,6

Red

Non

Chlorinated

plastic

bags/puncture

proof container

for sharps

Category

3,4,7

Blue

Non

Chlorinated

plastic bags

container

Category 8

Black

Non

Chlorinated

plastic bags

Municipal

Waste

Apart from the various categories of

wastes, Schedule II of the Rules has also

incorporated the storage and disposal of

municipal solid waste (MSW) generated

from the hospitals. The Rules expounds

that the MSW such as paper waste, food

waste and other noninfectious wastes

generated from the hospitals should be

stored in black colored bags/containers and

disposed as per the Municipal Solid Waste

(Management and Handling) Rules 2000.

NEW / EMERGING TECHNOLOGY

FOR WASTE TREATMENT /

MANAGEMENT OF WASTE

Different methods have been developed

for rendering bio-medical waste

environmentally innocuous and

aesthetically acceptable but all of them are

not suitable for our condition. The ‘Bio-

Medical Waste (Management & Handling)

Rules, 1998’ has elaborately mentioned the

recommended treatment and disposal

options according to the 10 different

categories of waste generated in health

care establishments. Standards for the

treatment technologies are given in

Schedule V of the Rules, which must be

complied with.

A comparison of the advantages and

limitations of the different technologies for

treatment of bio-medical waste is given at

Annexure A review of the above schedule

would show that there is no single

technology, which can take care of all

categories of bio-medical waste. A

judicious package has to be evolved for

this purpose. For example, small and

medium hospitals can opt for local (in

house) disinfection, mutilation / shredding

and dedicated autoclaving plus off-site

incineration at a common treatment /

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 31

disposal facility followed by disposal in

sanitary and secured landfills.

1. Incineration - This is a high

temperature thermal process employing

combustion of the waste under controlled

condition for converting them into inert

material and gases. Incinerators can be oil

fired or electrically powered or a

combination thereof. Broadly, three types

of incinerators are used for hospital waste:

multiple hearth type, rotary kiln and

controlled air types. All the types can have

primary and secondary combustion

chambers to ensure optimal combustion.

These are refractory lined. In the multiple

hearth incinerators, solid phase

combustion takes place in the primary

chamber whereas the secondary chamber

is for gas phase combustion. These are

referred to as excess air incinerators

because excess air is present in both the

chambers. The rotary kiln is a cylindrical

refractory lined shell that is mounted at a

slight tilt to facilitate mixing and

movement of the waste inside. It has

provision of air circulation. The kiln acts

as the primary solid phase chamber, which

is followed by the secondary chamber for

the gaseous combustion. In the third type,

the first chamber is operated at low air

levels followed by an excess air chamber.

Due to low oxygen levels in the primary

chamber, there is better control of

particulate matter in the flue gas. In a

nutshell, the primary chamber has

pyrolytic conditions with a temperature

range of about 800 ± 50◦C. The secondary

chamber operates under excess air

conditions at about 1050 ± 50◦C. The

volatiles are liberated in the first chamber

whereas they are destroyed in the second

one. Some models are fitted with educator

mechanism, which maintains the system

under negative pressure and helps control

the flue gases more effectively. The

chimney height should be minimum 30

meters above ground level. Installation of

incinerators in congested area is not

desirable. In the Bio-medical Waste

(Management and Handling) Rules,

Incineration has been recommended for

human anatomical waste, animal waste,

cytotoxic drugs, discarded medicines and

soiled waste.

2. Autoclave Treatment - This is a

process of steam sterilisation under

pressure. It is a low heat process in which

steam is brought into direct contact with

the waste material for duration sufficient to

disinfect the material. These are also of

three types: Gravity type, Pre-vacuum type

and Retort type. In the first type (Gravity

type), air is evacuated with the help of

gravity alone. The system operates with

temperature of 121◦C and steam pressure

of 15 psi. for 60-90 minutes. Vacuum

pumps are used to evacuate air from the

pre-vacuum autoclave system so that the

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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time cycle is reduced to 30-60 minutes. It

operates at about 132◦C. Retort type

autoclaves are designed to handle much

larger volumes and operate at much higher

steam temperature and pressure. Autoclave

treatment has been recommended for

microbiology and biotechnology waste,

waste sharps, soiled and solid wastes .This

technology renders certain categories of

bio-medical waste innocuous and

unrecognizable so that the treated residue

can be land-filled.

3. Hydroclave Treatment – It is

innovative equipment for steam

sterilization process (like autoclave). It is a

double walled container, in which the

steam is injected into the outer jacket to

heat the inner chamber containing the

waste. Moisture contained in the waste

evaporates as steam and builds up the

requisite steam pressure (35-36 psi).

Sturdy paddles slowly rotated by a strong

shaft inside the chamber tumble the waste

continuously against the hot wall thus

mixing as well as fragmenting the same. In

the absence of enough moisture, additional

steam is injected. The system operates at

132◦C and 36 psi steam pressure for

sterilization time of 20 minutes. The total

time for a cycle is about 50 minutes, which

includes start-up, heat-up, sterilization,

venting, and depressurization and

dehydration. The treated material can

further be shredded before disposal. The

expected volume and weight reductions

are upto 85 percent and 70 percent

respectively. The hydroclave can treat the

same waste as the autoclave plus the waste

sharps. The sharps are also fragmented.

This technology has certain benefits, such

as, absence of harmful air emissions,

absence of liquid discharges, non-

requirement of chemicals, reduced volume

and weight of waste etc. Tata Memorial

Hospital in Mumbai has installed the first

hydroclave in India in September 1999.

4. Microwave Treatment - This again

is a wet thermal disinfection technology

but unlike other thermal treatment systems,

which heat the waste externally,

microwave heats the targeted material

from inside out, providing a high level of

disinfection. The input material is first put

through a shredder. The shredded material

is pushed to a treatment chamber where it

is moistened with high temperature steam.

The material is then carried by a screw

conveyor beneath a series (normally 4-6

nos.) of conventional microwave

generators, which heat the material to 95-

100◦C and uniformly disinfect the material

during a minimum residence time of 30

minutes and total cycle is of 50 minutes. A

second shredder fragments the material

further into unrecognizable particles before

it is automatically discharged into a

conventional / general waste container.

This treated material can be land-filled

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 33

provided adequate care is taken to

complete the microwave treatment. In the

modern versions, the process control is

computerized for smooth and effective

control. Microwave technology has certain

benefits, such as, absence of harmful air

emissions (when adequate provision of

containment and filters is made), absence

of liquid discharges, non-requirement of

chemicals, reduced volume of waste (due

to shredding and moisture loss) and

operator safety (due to automatic hoisting

arrangement for the waste bins into the

hopper so that manual contact with the

waste bags is not necessary). However, the

investment cost is high at present.

According to the rules, category Nos, 03

(microbiology and biotechnology waste),

04 (waste sharps), 06 (soiled waste), and

07 (solid waste) are permitted to be

microwaved.

5. Chemical Disinfecting - This

treatment is recommended for waste

sharps, solid and liquid wastes as well as

chemical wastes. Chemical treatment

involves use of at least 01percent

hypochlorite solution with a minimum

contact period of 30 minutes or other

equivalent chemical reagents such as

phenolic compounds, iodine,

hexachlorophene, iodine-alcohol or

formaldehyde-alcohol combination etc.

Preceding of the waste is desirable for

better contact with the waste material. In

the USA, chemical treatment facility is

also available in mobile vans. In one

version, the waste is shredded, passed

through 10percent hypochlorite solution

(dixichlor) followed by a finer shredding

and drying. The treated material is land

filled.

6. Sanitary and Secured Land filling -

Sanitary and secured land filling is

necessary under the following

circumstances:

• Deep burial of human anatomical

waste when the facility of proper

incineration is not available (for towns

having less than 5 lakh population and

rural areas).

• Animal waste (under similar conditions

as mentioned above) - Secured landfill.

• Disposal of autoclaved / hydroclave /

microwaved waste (unrecognizable) -

Sanitary landfill.

• Disposal of incineration ash - Sanitary

land-fill.

• Disposal of bio-medical waste till such

time when proper treatment and

disposal facility is in place - Secured

land-fill.

• Disposal of sharps - Secured land-fill.

This can also be done within a hospital

premises as mentioned below.

• In case disposal facility for sharps is

not readily available in a town, health

care establishments, especially

hospitals having suitable land, can

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

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construct a concrete lined pit of about

1m length, breadth and depth and

cover the same with a heavy concrete

slab having a 1-1.5m high steel pipe of

about 50mm diameter. Disinfected

sharps can be put through this pipe.

When the pit is full, the pipe should be

sawed off and the hole sealed with

cement concrete. This site should not

be water logged or near a bore well.

CONCLUSION

Hospital Management must understand the

gravity of the issue and they must be able

to differentiate between hospital waste and

general waste. They must ensure proper

identification, segregation at the source of

generation, collection in prescribed

colored containers, safe transportation,

appropriate treatment and environmentally

sound disposal of Bio-Medical Waste.

They should also provide health education

and training9 of everyone involved in the

management and handling of Bio-Medical

Waste.

While there a large number of technologies

available for the safe disposal of hospital

waste, a large number of health care

institutes are deterred from setting up a

sound waste disposal system owing to

misconceptions over the cost of such a

system. In India, hospital waste

management continues to be a largely

ignored area because of the lack of

awareness among the public and the health

care institutes. This lack of awareness can

be attributed to the lackadaisical attitude of

the administration to enforce the punitive

regime that has been provided for by the

regulations of the Central Government, in

cases of violation of these regulations.

While these regulations are adequate to

deal with the problem of waste

management, the continued lethargy on

part of the administration is the root cause

for the rampant mismanagement of

hospital waste.

It is agreed by the researcher that it is not

feasible for small clinics to set up their

own waste treatment plants, but their small

setup should not prevent them from

following the prescribed procedure for

segregation and packaging hospital waste

as per the color coding. The more viable

option for these small scale health care

institutes is that there should be a common

treatment plant for the waste that is

collected from these institutions.

In fact there are already initiatives in this

direction, for instance in the district of

Erode, 200 small clinics have jointly

acquired 20 acres of land for the purpose

of disposal and burial of hospital waste. If

the government is serious at implementing

its own regulations then initiatives like the

above ones should be furthered by

affording favorable treatment to such

institutions in the form of relaxed tax

norms and other such benefits.

Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India

© All Rights Reserved by “Journals Club & Co.” 35

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HOW TO CITE THIS ARTICLE Dr. Prashant Mehta. (2014). Legal Provisions and Management Perspectives of

Biomedical and Hospital Waste in India. Journal Club for Management Studies (JCMS), 1(II), 11-36.