Prof. (Dr.) Prashant MehtaM.Sc, Ph.D. (Chemistry), MBA, Ph.D. (Management)

National Law University, Jodhpur

Healthcare Waste An Environmental Concern of Escalating Magnitude

• Residential

• Commercial

• Institutional

• Construction Waste

• Municipal services

• Treatment plant sites

• Industrial

• Agricultural

• Healthcare Waste

Municipal Solid Waste (MSW)

Industrial Solid Waste

Bio-Medical / Hospital Waste

Agricultural Waste

Classification Bio-Medical Waste

Hospital Wastes

Non Hazardous Wastes

Hazardous Wastes

Radioactive and Cytotoxic

Wastes

Infectious Wastes

Sharps Non Sharps

Solids

IncinerableNon Incinerable

(Autoclave, Microwave)

Liquids

Non Infectious Wastes

Bio-DegradableNon

Biodegradable

Regulatory Framework: India

Environmental Protection Rules, 1986 - This regulations were drawn up by the government under the powersconferred on it in terms of the Environment Protection Act, 1986.

1. The Municipal Solid Wastes (Management and Handling) Rules 1999

2. The Hazardous Waste (Management and Handling) Rules, 1989

3. The Plastics (Manufacture, Usage and Waste Management Rules), 2009

4. The E-Waste (Management and Handling Rules), 2010

5. National Rural Health Mission (NRHM) under Ministry of Health and Family Welfare, in 2007 developed andadopted an Infection Management Environment Plan (IMEP) which outlines a comprehensive framework forimplementation of infection control measures and effective healthcare waste management generated byhealthcare facilities.

6. The issue of Bio-Medical Waste Management (BMWM) in India has attracted the attention of the highest judicialbody at the level of Supreme Court of India.

7. It has issued instructions regarding management of Bio-Medical Waste and Government of India was one of thefirst countries to frame and implement Bio-Medical Waste Management and Handling Rules, 1998 (lateramended in 2000 and 2003) in the exercise of power conferred by Sections 6, 8, and 25 of the Environment(Protection) Act, 1986.

Bio-Medical Waste Management and Handling Rules

• Definition of biomedical waste - Any waste that is generated during the diagnosis, treatment, or immunization of human beings or animals, or in research activitiespertaining to or in the production or testing of biologicals.

• Application of the Biomedical Waste Rules - The rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle BMW’s in any form.

• Duty of occupier (operator) - of a healthcare facility (hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood banketc) to ensure that BMWs are handled without any adverse effect to human health and the environment, and according to the prescribed treatment and disposalrequirements as per the Biomedical Waste Rules.

• Prescribed authority - State Pollution Control Boards (SPCBs) in States and Pollution Control Committees in territories are responsible for permitting and enforcing therequirements of the Biomedical Waste Rules.

• Permit - Each occupier (operator) handling BMW’s and providing services to 1,000 or more patients per month is required to obtain a permit from the prescribedauthority.

• Recordkeeping - Each occupier (operator) is required to maintain records on the generation, collection, reception, storage, transportation, treatment, and disposal ofBMWs. All records are subject to inspection and verification by the prescribed authority at any time.

• Accident reporting - Each occupier (operator) is required to report any accident related to the management of BMW’s.

• Annual reporting - Each occupier is required to submit an annual report to the prescribed authority to provide information about categories and amounts of wastesgenerated and treated, and modes of treatment used.

• Common disposal/ Incineration sites - Local public entities are required to provide common disposal / incineration sites, and the occupiers (operators) of such sites arerequired to comply with the Biomedical Waste Rules.

• Segregation, Packaging, Transportation, and Storage - BMWs are not to be mixed with other waste. According to the Rules, BMWs are to be segregated into labelledbags/containers. Transportation of BMWs is to be conducted in authorized vehicles. No untreated waste is to be stored more than 48 hours, unless special permission isobtained from the regulatory authorities.

• Standards - Technology and discharge standards for incineration, autoclaving, microwaving, liquid waste discharges, and deep burial are prescribed in the BiomedicalWaste Rules.

Categories and Segregation of Bio-Medical Waste

S. No. Bio-Medical Waste Categories Container Colour Treatment and Disposal

1. Human anatomical waste Yellow Incineration / Deep Burial

2. Animal Waste Yellow Incineration / Deep Burial

3. Microbiology and biotechnology waste (infectious

wastes from laboratory)

Yellow / Red Incineration / Autoclaving / Microwaving

4. Waste sharps (for example, needles, syringe,

scalpels)

Blue / White /

Translucent

Disinfection / Mutilation / Autoclaving / Microwaving

5. Discarded medicines and cytotoxic drugs Black Incineration/Destruction and Secure Landfilling

6. Soiled waste (items contaminated with blood or

body fluids such as cotton dressings, beddings)

Yellow / Red Incineration / Autoclaving / Microwaving

7. Solid waste (for example, tubing, catheters,

intravenous sets)

Blue / White /

Translucent / Red

Disinfection by chemical treatment / Autoclaving / Microwaving

8. Liquid waste (from laboratory, washing, cleaning,

housekeeping, disinfecting)

- Disinfection by chemical treatment and discharge into drains

9. Incineration ash Black Municipal Landfilling

10. Chemical wastes Black Chemical treatment and discharge into drains for liquids, and

secured landfills for solids.

BMW Categories Draft - 2011 Amendments

BMWM RULES - 2011 BMWM RULES - 1998Every 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 are clearly listed Duties of Operator were absent

Categories of Biomedical Waste reduced to Eight. Category No. 8

(containing liquid waste generated from laboratory, cleaning, washing,

and disinfection activities) and Category No. 9 (containing incineration

ash) have been discarded.

Biomedical waste was divided in ten categories

Treatment and disposal of BMW made mandatory for all the Healthcare

Establishments.

Treatment and disposal of BMW made mandatory for all the Healthcare

Establishments with more than 1000 beds.

A format for annual report is appended with the Rules. Accident reporting

has been made mandatory.

There was 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. It empowers the operator of CBMWTF to report

against the HCEs who are not carrying out proper segregation of their

wastes.

Form VI absent

Healthcare Waste and Examples

Types of Healthcare Wastes Examples

Communal or General healthcare waste (solidwastes that are not infectious, chemical, orradioactive)

Infectious waste (wastes suspected of

containing pathogens)

Anatomical waste

Sharps

Pharmaceutical waste

Genotoxic waste

Chemical waste

Heavy metal waste

Pressurized containers

Radioactive waste

Cardboard boxes, paper, food waste, plastic and glass bottles

Cultures, tissues, dressings, swabs, and other blood-soaked items; waste from isolation wards

Recognizable body parts, amputated organs, placenta, aborted foetuses

Needles, scalpels, knives, blades, broken glass

Expired or no longer needed medicines or pharmaceuticals

Wastes containing genotoxic drugs and chemicals (used in cancer therapy)

Laboratory reagents, film developer, solvents, expired or no longer needed disinfectants, and

organic chemical wastes (for example, formaldehyde, phenol-based cleaning solutions)

Batteries, broken thermometers, blood pressure gauges

Aerosol cans, gas cylinders (that is, anaesthetic gases such as nitrous oxide, halothane, enflurane,

and ethylene oxide; oxygen, compressed air)

Unused liquids from radiotherapy; waste materials from patients treated or tested with unsealed

radionuclides

Problems With Healthcare Wastes

• According to the Ministry of Environment and Forests (MoEF) gross generation of bio-medical wastes in India is4,05,702 kg/day of which only 2,91983 kg/day is disposed, which means that almost 28 percent of the bio-medical and hospital waste is left untreated and not disposed off.

• Extrapolating from past figures of number of beds and average quantity of waste generation at the rate of 1 to1.5 kg per bed per day, it is estimated that about 0.33 million tonnes of hospital waste is being generated peryear which is far less than waste generated by other developed countries.

• Almost 53.25 percent of healthcare establishments are in operations without the adequate authorization fromState Pollution Control Board (SPCB), and the waste generated from such facilities goes unaccounted / untreatedand is dumped without any treatment illegally.

• The waste generated by healthcare establishments by the process of rendering healthcare services, can behazardous, toxic, and even lethal due to the presence of pathogens in sufficient concentration or quantity thatcould result in rapid proliferation, transmission, and spreading of infectious, dangerous and fatal communicablediseases such as Hepatitis, HIV/AIDS, Cancer, and other blood borne diseases.

• During incineration, in most cases there is no proper filtering of emitted flue gases which pollutes the air causingillnesses to the nearby populations. Therefore institutionalizing effective healthcare waste management systemsin all healthcare facilities is a key prerequisite to improving efficiency and effectiveness of healthcare of people.

Genotoxic Wastes

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 (see below), vomit, urine, or faeces from patients treatedwith cytostatic drugs, chemicals, and radioactive material.

Cytotoxic (or antineoplastic) drugs, the principal substances in this category, have the ability to kill or stop thegrowth of certain living cells and are used in chemotherapy of cancer. They play an important role in the therapyof various neo-plastic conditions but are also finding wider application as immunosuppressive agents in organtransplantation and in treating various diseases with an immunological basis.

Cytotoxic drugs are most often used in specialized departments such as oncology and radiotherapy units, whosemain role is cancer treatment; however, their use in other hospital departments is increasing and they may alsobe used outside the hospital setting.

Most Common Genotoxic Wastes

Classified as carcinogenic

Chemicals: benzene

Cytotoxic and other drugs: azathioprine, chlorambucil, chlornaphazine, ciclosporin, cyclophosphamide, melphalan,semustine, tamoxifen, thiotepa, treosulfan

Radioactive substances: (radioactive substances are treated as a separate category in this handbook)

Classified as possibly or probably carcinogenic

Cytotoxic and other drugs: azacitidine, bleomycin, carmustine, chloramphenicol, chlorozotocin, cisplatin, dacarbazine,daunorubicin, dihydroxymethylfuratrizine (e.g. Panfuran S—no longer in use), doxorubicin, lomustine, methylthiouracil,metronidazole, mitomycin, nafenopin, niridazole, oxazepam, phenacetin, phenobarbital, phenytoin, procarbazinehydrochloride, progesterone, sarcolysin, streptozocin, trichlormethine a

Classified by working groups of the International Agency for Research on Cancer (IARC).

Categories of Harmful Cytotoxic Drugs

• 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. Cytotoxic wastes are generated from several sources and can include the

following:

• Contaminated materials from drug preparation and administration, such as 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 1 week after drug administration. In specialized oncological hospitals, genotoxic waste (containing cytostatic or

radioactive substances) may constitute as much as 1% of the total healthcare wastes.

Chemical Wastes

• Formaldehyde 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 usuallycontains 5–10% hydroquinone, 1–5% potassium hydroxide, and less than 1% silver. The developer containsapproximately 45% 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 andhistology laboratories, and engineering departments. Solvents used in hospitals include halogenated compounds, suchas methylene chloride, chloroform, trichloroethylene, and refrigerants, and non-halogenated compounds such asxylene, methanol, acetone, isopropanol, toluene, ethyl acetate, and acetonitrile.

• Organic chemicals Waste generated in health-care facilities include: • disinfecting and cleaning solutions such asphenol-based chemicals used for scrubbing floors, perchlorethylene used in workshops and laundries; • oils such asvacuum-pump oils, used engine oil from vehicles (particularly if there is a vehicle service station on the hospitalpremises); • insecticides, rodenticides.

• Inorganic chemicals Waste inorganic chemicals consist mainly of acids and alkalis (e.g. sulfuric, hydrochloric, nitric, andchromic acids, sodium hydroxide and ammonia solutions). They also include oxidants, such as potassium permanganate(KMnO4) and potassium dichromate (K2Cr2O7), and reducing agents, such as sodium bisulfite (NaHSO3) and sodiumsulfite (Na2SO3).

Wastes with High Content of Heavy Metals

• Wastes with a high heavy-metal content represent a subcategory of hazardous chemical waste, and are usuallyhighly toxic.

• Mercury wastes are typically generated by spillage from broken clinical equipment but their volume isdecreasing with the substitution of solid-state electronic sensing instruments (thermometers, blood-pressuregauges, etc.).

• Whenever possible, spilled drops of mercury should be recovered. Residues from dentistry have a high mercurycontent.

• Cadmium waste comes mainly from discarded batteries. Certain “reinforced wood panels” containing lead arestill used in radiation proofing of X-ray and diagnostic departments.

• A number of drugs contain arsenic, but these are treated here as pharmaceutical waste.

Pressurized Containers

• Anaesthetic Gases: nitrous oxide, volatile halogenated hydrocarbons (such as halothane, isoflurane, andenflurane), which have largely replaced ether and chloroform. Applications in hospital operating theatres, duringchildbirth in maternity hospitals, in ambulances, in general hospital wards during painful procedures, indentistry, for sedation, etc.

• Ethylene oxide: Applications for sterilization of surgical equipment and medical devices, in central supply areas,and, at times, in operating rooms.

• Oxygen stored in bulk tank or cylinders, in gaseous or liquid form, or supplied by central piping. Applicationinhalation supply for patients.

• Compressed Air: Applications in laboratory work, inhalation therapy equipment, maintenance equipment, andenvironmental control systems.

Radioactive Wastes

• Radioactive waste includes solid, liquid, and gaseous materials contaminated with radionuclides. It is producedas a result of procedures such as in-vitro analysis of body tissue and fluid, in-vivo organ imaging and tumourlocalization, and various investigative and therapeutic practices.

• Radionuclides used in healthcare have unsealed sources that are usually liquids that are applied directly and notencapsulated during use; sealed sources are radioactive substances contained in parts of equipment orapparatus or encapsulated in unbreakable or impervious objects such as “seeds” or needles.

• The waste produced by health-care and research activities involving radionuclides, and related activities such asequipment maintenance, storage, etc., can be classified as follows: • sealed sources; • spent radionuclidegenerators; • low-level solid waste, e.g. absorbent paper, swabs, glassware, syringes, vials; • residues fromshipments of radioactive material and unwanted solutions of radionuclides intended for diagnostic ortherapeutic use; • liquid immiscible with water, such as liquid scintillation-counting residues used inradioimmunoassay, and contaminated pump oil; • waste from spills and from decontamination of radioactivespills; • excreta from patients treated or tested with unsealed radionuclides; • low-level liquid waste, e.g. fromwashing apparatus; • gases and exhausts from stores and fume cupboards.

Major Challenges

• Indian healthcare establishments have pitiable operational strategies, absence of documentedwaste management and disposal policy, very poor budgetary support in the government runhospitals, private hospitals ignore the rules for monetary consideration, untrained ward attendants,and other supporting staff.

• There are no waste management committees at present in Indian hospitals which should essentiallybe consist of the head of the establishment, all the departmental heads, hospital superintendents,nursing superintendents, hospital engineers with a waste management officer along with anenvironmental control advisor and an infection control advisor.

• Insufficient support and guidance from regulatory agencies further complicates the problem ofwaste management. Regulations in the form of waste reduction and recycling targets, carbon creditearnings, development of minimum energy efficiency standards for equipments are necessary forprevention of pollution and reduction of environmental load on sustained basis.

• Adequate and requisite number of sanitary landfills is lacking in India.

• Resistance to change is often a barrier to implementation of new waste management programmes.

Waste Exposure Risk

• Until recent times, healthcare waste in India was not segregated before disposal to the dump site or incinerator.

• Infectious wastes containing potentially harmful micro-organisms can also infect hospital patients, healthcare

employees, and visitors to patients and rag pickers mostly women and children from the lowest socio-economic

strata, awareness of health risks in general is poor. .

• As a result many of them contract diseases from used needles, syringes, and other sharps present risks of injury

and infection (for example, hepatitis B and C, and HIV), other infected bio-medical waste.

• WHO predicts that India is on the verge of having an HIV epidemic. Tuberculosis (TB) and HIV combined together

is taking great toll on the human health and life. Hepatitis B and C infections are on the rise. Mortality due to

Hepatitis C has gone up significantly.

• Management of healthcare waste is very important for controlling diseases.

Conclusions: Waste Related

• Waste hierarchy as well as rules are not framed for all kinds categories of waste and Waste management effortsin India are not directed by a clear-cut policy.

• Medical wastes should be classified according to their source, typology, and risk factors associated with itshandling, storage, and ultimate disposal.

• The segregation of waste at source is the key step. Reduction, reuse, and recycling should be considered inproper perspectives.

• MoEF / Pollution Control Boards / States do not have a complete data about all the various kinds of waste beinggenerated in India, risks associated to health /environment, and instances of the polluter being held responsiblefor unsafe disposal were very few.

• Absence of adequate funds and trained manpower for waste management and handling activities, weakcompliance to laws, ineffective monitoring, and absence of a single body taking ownership of waste issues inIndia is burgeoning challenge.

• The challenge before us is to scientifically manage growing quantities of bio-medical waste that is untreated, ifwe really want to protect our environment and provide better health for community.

Summary

The toxicity of anticancer chemotherapy has been well known since its initial clinical use. Indeed, it has often

been these drugs' toxic side effects that have limited their therapeutic value. The risk-benefit equation for a

cancer patient often determines these drugs' appropriate use despite acknowledged side effects. Although

these drugs present the same potential toxicities to exposed healthcare workers, that risk-benefit ratio is

altered.

A balance must be achieved to continue the use of these beneficial drugs in patients, while assuring the health

of personnel administering them.

A body of guidance now exists on how to achieve this goal. Much of the new guidance revisits the long standing

elements of a comprehensive safe handling program and reminds us that the risk remains and our vigilance is

required, but that a harmonized safe handling approach has been adopted that assures minimal risk to workers

who provide lifesaving therapies to their patients.