20 Biomedical Waste Management Rules, 2016

Dr. Geetika Walia

INTRODUCTION

Medical care is vital for our life and health, but the waste generated from medical activities represents a real problem of living nature and human world. Improper management of waste generated in health care facilities causes a direct health impact on the community, the health care workers and on the environment. Every day, relatively large amount of potentially infectious and hazardous waste are generated in the health care hospitals and facilities around the world.1

When patient care activities are carried out in a healthcare setting, certain waste is produced which has the potential to cause harm to human beings and environment. Such waste includes soiled cotton, bandages, hypodermic needles, syringes, tubing’s such as intravenous sets, and urinary catheters etc. Such waste is commonly called as bio-medical waste (BMW) in India, though it is also known by various other names such as clinical waste, medical waste and health-care waste in different parts of world.2

The growth of hospitals are a good sign of the advancement and increase in the health care facilities to the masses but there is a rising concern with respect to the disposal of bio- medical waste. The quantum of waste that is generated in India is estimated to be 1-2 kg per bed per day in a hospital and 600 gm per day per bed in a general practioner’s clinic.3In order to tackle the problem of bio medical waste the Government of India in exercise of the powers conferred by section 64, 85and 256 of the Environment (Protection) Act, 1986 (29 of 1986), published the Bio-Medical Waste (Management and Handling)

Rules, 1998 which was further amended in 2016. According to Union Minister of State for Environment, Forests and Climate Change, while releasing the rules emphasized on the point that these rules will “make a big difference to the Clean India Mission”.

There was an immediate need felt by the Government of India to draft rules with regards to biomedical waste because of the following reasons:

1. Hospitals were disposing of waste in a haphazard, improper and indiscriminate manner.
2. Lack of segregation practices, results in mixing of hospital wastes with general waste making the whole waste stream hazardous.
3. Inappropriate segregation ultimately results in an incorrect method of waste disposal.

The objective of this paper is as follows:

1. To understand what exactly is the meaning of biomedical waste
2. The risks involved with biomedical wastes
3. To elucidate why it is important to deal with biomedical waste management
4. And lastly how the biomedical waste is been dealt with after the coming into force of the Biomedical Waste Management Rules, 2016

RATIONALE OF HOSPITAL WASTE MANAGEMENT

Hospital waste management is a part of hospital hygiene and maintenance activities. In fact only 15% of hospital waste i.e. “Biomedical waste” is hazardous, not the complete. But when hazardous waste is not segregated at the source of generation and mixed with nonhazardous waste, then 100% waste becomes hazardous. The question then arises that what is the need or rationale for spending so much resource in terms of money, man power, material and machine for management of hospital waste? The reasons are7:

1. injuries from sharps leading to infection to all categories of hospital personnel and waste handler.
2. infections in patients from poor infection control practices and poor waste management.
3. risk of infection outside hospital for waste handlers and scavengers and at time general public living in the vicinity of hospitals.
4. risk associated with hazardous chemicals, drugs to persons handling wastes at all levels.
5. ‘disposable’ being repacked and sold by unscrupulous elements without even being washed.
6. drugs which have been disposed of, being repacked and sold off to unsuspecting buyers.
7. risk of air, water and soil pollution directly due to waste, or due to defective incineration emissions and ash.

BIO- MEDICAL WASTE

Bio-medical waste means any waste generated during diagnosis, treatment or immunization of human beings or animals. Management of healthcare waste is an integral part of infection control and hygiene programs in healthcare settings. These settings are a major contributor to community-acquired infection, as they produce large amounts of biomedical waste.8 Biomedical waste may have serious public health consequences and a significant impact on the environment. Sound management of Biomedical waste is thus a crucial component of environmental and health protection.

The biomedical waste management rules define biomedical waste as “biomedical waste” means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or research activities pertaining thereto or in the production or testing of biological or in health camps, including the categories mentioned in Schedule I appended to these rules.9 The schedule I mention four categories of bio- medical wastes which includes:

(a). human anatomical waste (body parts, organs, human tissues etc.),

(b). animal waste (Experimental animal carcasses, body parts, organs, tissues, including the waste generated from animals used in experiments or testing in veterinary hospitals or colleges or animal houses),

(c). soiled waste (Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residual or discarded blood and blood components.

(d). Expired or Discarded Medicines: Pharmaceutical waste like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along with glass or plastic ampoules, vials etc.

(e). Chemical Waste: Chemicals used in production of biological and used or discarded disinfectants.

(f). Chemical Liquid Waste : Liquid waste generated due to use of chemicals in production of biological and used or discarded disinfectants, Silver X- ray film developing liquid, discarded Formalin, infected secretions, aspirated body fluids, liquid from laboratories and floor washings, cleaning, house- keeping and disinfecting activities etc.

(g). Discarded linen, mattresses, beddings contaminated with blood or body fluid

(h). Microbiology, Biotechnology and other clinical laboratory waste: Blood bags, Laboratory cultures, stocks or specimens of micro- organisms, live or attenuated vaccines, human and animal cell cultures used in research, industrial laboratories, production of biological, residual toxins, dishes and devices used for cultures.

2. Contaminated Waste (Recyclable)Wastes generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vaccutainers with their needles cut) and gloves.
3. Waste sharps including Metals: Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts. This includes used, discarded and contaminated metal sharps.
4. (a) Glassware: Broken or discarded and contaminated glass including medicine vials and ampoules except those contaminated with cytotoxic wastes.

(b) Metallic Body Implants

Rule 2 of the Rules talks about the fact that these rules shall apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, ayush hospitals, clinical establishments, research or educational institutions, health camps, medical or surgical camps, vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories and research labs. Further Rule 2 also talks about the establishments to which these rules would not be applied and they are:

• (a) radioactive wastes as covered under the provisions of the Atomic Energy Act, 1962(33 of 1962) and the rules made there under;
• (b) hazardous chemicals covered under the Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 made under the Act;
• (c) solid wastes covered under the Municipal Solid Waste (Management and Handling) Rules, 2000 made under the Act;
• (d) the lead acid batteries covered under the Batteries (Management and Handling) Rules, 2001 made under the Act;
• (e) hazardous wastes covered under the Hazardous Wastes (Management, Handling and Transboundary Movement) Rules, 2008 made under the Act;
• (f) waste covered under the e-Waste (Management and Handling) Rules, 2011 made under the Act; and

• (g) hazardous micro organisms, genetically engineered micro organisms and cells covered under the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Micro organisms or Cells Rules, 1989 made under the Act.

HOSPITAL WASTE MANAGEMENT

The process of bio- medical waste management consists of:

1. Waste collection
2. Segregation into appropriate coloured bins
3. Storage of bio- medical waste
4. Transport to final disposal site
5. Final disposal

The general rules governing the management of this bio- medical waste can be summarized as under:

1. Segregation of waste: It is important to understand here that the Health care facilities (HCFs) which are generating this bio- medical waste must segregate biomedical waste (the wastes involved in diagnosis, treatment and immunization such as human and animal anatomical waste, treatment apparatus such as needles and syringes and cytotoxic drugs) at the time of generation itself. Further a duty is cast upon the occupier to make a provision within the premises for a safe, ventilated and secured location for storage of segregated biomedical waste in colored bags or containers to ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage by animals and the bio-medical waste from such place or premises shall be directly transported in the manner as prescribed in these rules to the common bio-medical waste treatment facility or for the appropriate treatment and disposal. Further a healthcare facility means place where diagnosis, treatment or immunization of human beings or animals is provided irrespective of type and size of health treatment system, and research activity pertaining thereto. These HCF’s can store this waste for up to 48 hours after which they either treat it in- situ or a worker from a common biomedical waste treatment facility (CBMWF) comes to collect it. The treatment of this bio- medical waste is done by bio- medical waste treatment and disposal facility which is any facility wherein treatment, disposal of bio- medical waste or processes incidental to such treatment and disposal is carried out, and includes common bio-medical waste treatment facilities.10
2. Collection of bio-medical waste: It is important duty which is cast upon the occupier to take allnecessary steps to ensure that bio- medical waste is handled11 without any adverse effect to human health and the environment and in accordance with these rules and further make a provision within the premises for a safe, ventilated and secured location for storage of segregated biomedical waste in colored bags or containers.12 Further it is the duty of the common bio-medical waste treatment and disposal facility13 take all necessary steps to ensure that the bio- medical waste collected from the occupier is transported, handled, stored, treated and disposed of, without any adverse effect to the human health and the environment, in accordance with these rules and guidelines issued by the Central Government or, as the case may be, the central pollution control board from time to time. Further it is also the duty to ensure timely collection of bio- medical waste from the occupier. The colour coding is as follows:

   3.Transportation: the transportation of the bio- medical waste from the premises of an occupier to any off- site bio- medical waste treatment facility only in the vehicles authorized to carry such material with a label of biohazard.14

4. Treatment: Occupier shall hand over segregated waste to common bio- medical waste treatment facility for treatment, processing and final disposal. No occupier shall establish on- site treatment and disposal facility, if a service of common bio- medical waste treatment facility is available at a distance of seventy- five kilometer. The treatment of bio- medical waste is done in the following ways:

• Deep burial: The waste under category 1 and 2 only can be accorded deep burial and only in cities having less than 5 lakh population.
• Shredding: The plastic (IV bottles, IV sets, syringes, catheters etc.), sharps (needles, blades, glass etc) should be shredded but only after chemical treatment/microwaving/autoclaving. Needle destroyers can be used for disposal of needles directly without chemical treatment.Shredding is a process by which waste are reshaped or cut into smaller pieces so as to make the wastes unrecognizable. It helps in prevention of reuse of bio-medical waste and also acts as identifier that the wastes have been disinfected and are safe to dispose off.
• Autoclave and microwave treatment: Autoclaving is a low-heat thermal process where steam is brought into direct contact with waste in a controlled manner and for sufficient duration to disinfect the wastes. For ease and safety in operation, the system should be horizontal type and exclusively designed for the treatment of bio-medical waste. For optimum results, pre-vacuum based system is preferred against the gravity type system.
• Incineration: It is a controlled combustion process where waste is completely oxidized and harmful microorganisms present in it are destroyed/ denatured under high temperature. Usually used for the waste that can not be reused, recycled or disposed of in landfill site.

CONCLUSION

Proper management of Bio medical waste is a concern that has been recognized by both government agencies and the Non governmental organizations. Several hazards and toxic materials containing should be disposed off with proper take and care. Inadequate and inefficient segregation and transportation system may cause severe problem to the society hence implementing of protective measures, written policies all of these factors contribute to increased risk of exposure of staff, patients and the community to biomedical hazards. In order to accelerate the rate at which proper processing and management methods are designed, timely regulatory and legislative policies and procedures are needed. To properly separate, process and isolation of wastes, they must be well-characterized, which is challenging. Safe and effective management of bio medical waste is not only a legal necessity but also a social responsibility. Lack of concern in persons working in that area, less motivation, awareness and cost factor are some of the problems faced in the proper hospital waste management. Proper surveys of waste management procedures in various practices are needed. Clearly there is a need for education as to the hazards associated with improper waste disposal. An effective communication strategy is imperative keeping in view the low awareness level among different category of staff in the health care establishments regarding biomedical waste management.