BIO-MEDICAL WASTE MANAGEMENT

RULES, 2016,2018 .WHAT’S NEW?

Dr Shazia Shams
Lecturer ,
PHI, Nagpur
Why manage Hospital Waste?

Dr Shazia Shams
Purpose of Infection Management and Environment Plan
(IMEP)

Inappropriate
disinfection

Unhygienic and unsanitary Poor sterilisation

conditions and inadequate techniques,
water at healthcare facilities.

Poor bio-medical waste

handling, treatment and Inadequate use of
disposal practices protective gears,

Dr Shazia Shams
 Waste generated in the hospital

General waste (80 – 85%) Biomedical waste (15 – 20%)

Non infectious and Non hazardous Infectious waste – 10 - 15%
Municipal disposal Non infectious but hazardous – 0 - 5%

Infectious waste 15%

 Need for Managing Waste
Danger to the patients
Many patients have poor immunological status
Resistance to antibiotics

Vulnerability of Hospital Staff

Danger to the community

Spread of infection through waste
Access of waste to animals
Spread of Infection through recycling trade
Problems caused by Incinerators/ burning
Contamination of Water-table

Dr Shazia Shams
 Untidy Hospital

Used bottles and syringes lying openly

Dr Shazia Shams
 Mixing of Biomedical waste with General Waste

Biomedical waste collected openly in the corridor

Dr Shazia Shams
Unhygienic labour room

Dr Shazia Shams
 Patient Safety

Syringe left after drug

administration

Dr Shazia Shams
 Open Disposal
of Placenta –
Invitation to
Dogs

Dr Shazia Shams
What is Biomedical Waste ?

Dr Shazia Shams
Definition of Biomedical Waste
Biomedical waste has been defined as “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
biologicals” as per Biomedical waste (management &
handling rules) 1998.

Dr Shazia Shams
Definition of Biomedical Waste
Biomedical waste has been defined as “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 or in health camps, including the categories
mentioned in Schedule I appended to these Rules” as per
Biomedical Waste Rules 2016.

Dr Shazia Shams
Dr Shazia Shams
 Biomedical waste rules 2016
Gazetted on 28th March 2016

Replaces Biomedical Waste (Management & handling) Rules 1998

Major Changes –

 Scope – also includes Ayush Health Facilities, Vaccination Camps,

First-Aid Rooms of Schools, Forensic Labs, etc.

 Constitution of a new committee at the state level

 Small facilities less than thirty beds may designate a qualified person to
review and monitor the activities relating to bio-medical waste
management Dr Shazia Shams
 Biomedical waste rules 2016
Bar Code System for bags & containers (after 28th March 2017)

Phase-out Chlorinated bags and Non-chlorinated plastic bags after 28 th March

2018

On-site disinfection of laboratory waste, microbiological waste, blood samples

& blood bags

Treatment & disposal of Liquid waste in accordance with the water (Prevention
& control of Pollution) 1974

‘On-site’ Waste Management can be established if nearest CTF is 75 kms away

Segregated collection – Four Categories

Prior Approval for ‘Deep Burial’

Dr Shazia Shams
 These rules that apply to all persons who:
Generate
Collect
Receive
 Store
Transport
Treat
Dispose
Or handle BMW in any form: hospitals, nursing
home, clinics, dispensary, vet inst, labs,
research/edu . institutes, camps, first aid rooms of
schools, blood banks, Ayush, clinical est.
Dr Shazia Shams
 Colour Coding for Collection System
(BMW Rules 1998)
Colour Coding Type of Container Waste Category Treatment options
Categories 1, 2, 3 & Incineration deep
Yellow Plastic Bag
6. burial
Autoclaving/Micro-
 Red Plastic Bag Categories 3, 6, 7 waving Chemical
Treatment

Autoclaving/Micro-
Plastic Bag waving/ Chemical
Blue/ White /puncture-proof Cat. 4, Cat. 7 Treatment &
Translucent containers Destruction /
shredding

Disposal in secured
Black Plastic Bag Categories 5, 9, 10
landfill.

Dr Shazia Shams
 Categories of Waste: Schedule I
(BMW Rules 2016)
Category Type of Waste Bag/ Container Treatment/ Disposal

1. Yellow a. Human Incineration/ Plasma

Anatomical Pyrolysis/ Deep-burial
b. Animal Incineration/ Plasma
Anatomical Yellow colour Non- Pyrolysis/ Deep-burial
c. Soiled Waste chlorinated Plastic Bag or OR Autoclave/
d. Expired Drugs Containers Microwave/ Hydroclave
Return/ Plasma Pyrolysis
e. Chemical
Incineration/ Plasma
Pyrolysis
f. Chemical liquid Separate Collection System Pre-treatment then
leading to Effluent treatment discharge
system
g. Discarded linen Non-Chlorinated Yellow Incineration/ Plasma
Colour bags or suitable Pyrolysis OR Shredding
packing material & mutilation
h. Microbiology Autoclave Safe bag NACO/ WHO Norms
(On-site)

Dr Shazia Shams
 Categories of Waste: Schedule I (BMW Rules
2016)
Category Type of Waste Bag/ Container Treatment/ Disposal
Red Contaminated Red Coloured non- Autoclave/ Microwave/
Waste (Recyclable) chlorinated plastic Hydroclave followed by
shredding or mutilation
or combination

White SHARPS including Puncture Proof/ Leak Proof/ Autoclave/ Dry Heat
Metals Tamper proof Sterilisation or
shredding or Mutilation
or Encapsulation or
designated concrete
sharp pit

Blue Glassware Cardboard Boxes with Blue Disinfection by Sodium

colour marking Hypochlorite solution or
Autoclaving/
Microwaving/
Hydroclaving
Metallic Body
Implant
Dr Shazia Shams
 Management Of BMW

Segregation Collection

Transport Disposal

Dr Shazia Shams
Segregation
Different types of waste should be
collected separately
Should be done at point of generation
Different coloured bins are to be used
Segregation ensures occupational and
health safety
Segregation also reduces the cost of
treatment and disposal
Dr Shazia Shams

SCHEDULE III
(See rule 8 (4))
LABEL FOR TRANSPORTING BIO-MEDICAL WASTE BAGS OR
CONTAINERS
Day ............Month ..............
Year ...........
Date of generation ................... 
Waste category No ........
Waste quantity………… 
Sender's Name and Address Receiver's Name and Address:
Phone No ........ Phone No ...............
Fax No ............... Fax No .................
Contact Person ........Contact Person ......... 
In case of emergency please contact :  
Name and Address :
Phone No. 
Note : Label shall be non-washable and prominently visible.
  Dr Shazia Shams
 TRANSPORTATION
WITHIN HOSPITAL
of Waste
Storage

No untreated
●
●

biomedical waste shall

be kept stored beyond
48 hrs.
APPROX 1200 CRORES INJECTIONS
ADMINISTERED ANNUALLY
WORLDWIDE.

Dr Shazia Shams
Who is at risk for sharps injuries?
Any worker who may come in
contact with contaminated
sharps is at risk, including
nurses, ANMs, lab workers,
doctors and waste handlers.

The main issue is

contamination from blood or
other potentially infectious
materials.

Dr Shazia Shams
Categories of staff exposed to Needle stick Injuries
Staff prone to needle-stick Relative % of
injuries injuries
Staff nurses 34.6%
Interns 15.7%
Residents 11.7%
Trainee nurses 8.5%
Technical Staff 6%
Workers responsible for waste 19%
management / cleaning
Others 4.5%
Dr Shazia Shams
 ESTIMATED RISK OF INFECTION FOLLOWING A
NEEDLESTICK FROM AN INFECTED SOURCE-PATIENT

35% 30%
30%
25%
20%
15%
10%
5% 3%
0.30%
0%
Hepatitis B Virus Hepatitis C Virus HIV
Source: Needlestick injuries studies among healthcare workers

Dr Shazia Shams
Unsafe Injection Practices
Reuse
Wrong Technique
Unhygienic Practices
Waste Management Mechanism
Outcome
o Short Term – Abscess Formation, Skin Rashes,
Irritation, Pain, Disabilities
o Long Term – HIV, HCV & HBV(33%)
Why Re use
Lack of Awareness
Altruism – Limited number of syringes, many patients
in need
Economic Reasons – Financial Gains
What are some of the incorrect practices that
have resulted in transmission of disease?

Practices that have resulted in transmission of hepatitis C

virus (HCV) and/or hepatitis B virus (HBV) include the
following:

Using the same syringe to administer medication to more

than one patient, even if the needle was changed;
Using the same medication vial for more than one patient,
and accessing the vial with a syringe that has already been
used to administer medication to a patient;
Using a common bag of saline or other IV fluid for more
than one patient, and accessing the bag with a syringe that
has already been used to flush a patient's catheter.
Can some of these incorrect practices also result in
transmission of bacterial infections?

Yes. These incorrect practices put patients at risk for bacterial,

fungal, and viral infections.

Do medication vials have a preservative in them to prevent

contamination?

Most multi-dose medication vials that are intended for several

medication administrations have a preservative in them to prevent
bacterial growth. Single-use vials do not contain a preservative. The
preservative has no effect on viruses. Safe injection practices and
appropriate aseptic technique are necessary to prevent bacterial
and viral contamination of medication vials that can result in
patient infections.
 Point of use Devices
Needle Pullers & Hub Cutter

Needle Puller Hub cutter

HAND HYGIENE
Moments of Hand Washing
Points to be remembered
Points to be remembered
Points to be remembered
Personal Protective Equipments
Sequence* for Donning PPE
• Shoe cap
• Gown first
• Mask or respirator
• Goggles or face shield
• Gloves

*Combination of PPE will affect sequence – be practical

How to Don Sterile Gloves
How to Don Sterile Gloves Cont..
How to Remove Sterile Glove
Processing of Instruments and storage

Objective:

Decontamination

Cleaning

Sterilization or HLD

Storage.

Friday, January 01, 2021 NHSRC 54

Decontamination and cleaning of Instruments

Decontamination of operating table, examination

table, dressing table etc. after every procedure either

by chlorine solution or disinfectant like carbolic acid.
Decontamination of instruments with 0.5% of

chlorine solution for ten minutes.

Thorough cleaning of instruments with soap and

water after decontamination

 Steps of processing instruments and
other items
Decontamination
(Soak in 1% chlorine solution 10 Where
minutes) Autoclave
Not
Cleaning with brush, Available
detergent and water
Preferred Method Acceptable Method
Sterilization HLD

Autoclave Chemical Chemical

15lbs/In2 soak in Soak in
pressure 121ºC, Glutaraldehyde Glutaraldehyde
(250ºF) (2%) for 8 hrs, (2%) for 20 min.
20 min/30 min Rinse with Rinse with
sterile water boiled for 20 min
Cool, dry and Store
Friday, January 01, 2021 56
NHSRC
Disinfection and sterilization of instruments

Autoclaving-at 121degree C,15 pound pressure for 20

minutes(30 minutes if wrapped and for linen)

Use of heat sensitive strips to monitor the efficiency of

sterilization
Autoclaved instruments are kept in clean area

Expiry date should be mentioned on the pack

Once the pack is opened, instruments are not used later

 Sterilization Method
Sterilization
•Wet /Steam Sterilization:
Sterilize the wrapped items for 30
min at 121°C and 15 lbs/In2or 20
min for unwrapped items.
•Dry Sterilization:
Exposure to 160°C for 120 min or
170°C for 60 min
Soaking in Chemicals
•Chemical Sterilization: Used when
instruments or other items are heat sensitive
or when heat sterilization is unavailable.
• Items can be sterilized by soaking in 2%
Gluteraldehyde for at least 8-10hrs followed
by thorough rinsing with sterile water.

•Emergency sterilization (flash

sterilization)
132º C at 30 lbs of pressure for
3min

Friday, January 01, 2021 NHSRC 58

Exposure to Toxic Metals:
Mercury
 Mercury Fact Sheet
A thermometer contains approx.
0.6 gm of mercury
In a study by Toxics Link, it was
found that approx. 70
Thermometers break in a month
in a large hospital
Mercury disposed by one hospital
per year-840 gm only through
breakage of thermometers

Dr Shazia Shams
Symptoms of Mercury poisoning
Impairment of peripheral vision
Disturbance of sensations
Lack of coordination of movements
Impairment of speech or hearing
Skin rashes
Mood swings & mental disturbance
Abnormal brain development

Dr Shazia Shams
MANAGING MERCURY SPILL

Dr Shazia Shams
 Mercury Spill Management
 Remove all jewellery (mercury binds with the metal)
 Put on rubber or latex gloves
 Pickup broken glass and place in a glass container with 5 to10 ml of water
 Use syringe for sucking the mercury droplets. Locate any remaining mercury with
the flash light; the beads will reflect the light making them easier to locate.
 Seal the glass container and label as “mercury waste” and place in a safe corner.
 Place all materials used in the clean-up, including gloves, in a trash bag.
 Seal the trash bag with tape and label as “mercury waste”.
 Wash the area with mercury neutralizing agents like 20% calcium sulphide or
sodium thiosulphate solution (if the chemicals are available).
 Wash your hands, face, and any other areas of your body exposed to the mercury.
 Keep the room well ventilated.
CBMWTSDF
(Common Bio-Medical Waste Treatment, Storage and Disposal Facility)

CBMWTSDF is an integrated facility comprising

of Double Chambered Incineration with scrubber

as an APCD  {air pollution control device},
Autoclave, Shredder, ETP, own vehicles for
collection and transportation of BMW. BMW Transportation

Why Required –
 Every individual occupier cannot provide their

own facility.
 Easier to concentrate on vigilance of Central

facility.
 Ensure adequate treatment and disposal of BMW.

CBMWTSDF
Dr Shazia Shams
Central biomedical waste disposal facility
CWTF Sharp pit

Dr Shazia Shams
Spill Management
 Blood And Body Fluids Spill Management

A biohazard caution board must be displayed at the spill

area

The staff should use appropriate PPE

Cover spill with an absorbent material - Newspaper/ Blotting

paper

Pour freshly prepared 1% sodium hypochlorite solution: 20

minutes contact time

Discard the absorbent into Yellow cover

Wet mop the area with disinfectant

Spill Management
CWTF
Autoclave Shredder

Dr Shazia Shams
CWTF:
Incinerator Effluent Treatment Plant

Dr Shazia Shams
STANDARDS:TREATMENT, DISPOSAL: Sch II
Standards for Incinerators
Standards for waste autoclaving:
Standards for liquid waste:
Standards for plasma pyrolysis
Standards of microwaving
Standards for deep burial
Standards for efficacy of chemical disinfection
Standards for dry heat sterilization

Dr Shazia Shams
FORMS:
FORM – I (See rule 10): APPLICATION FOR AUTHORISATION

OR RENEWAL ( submitted in duplicate.)

Form – II (See rule 13) ANNUAL REPORT:

 Form –III (See rule 13), ANNUAL REPORT:

FORM – IV (See rule 4(i), 5(g) and 15 (2)) ACCIDENT

REPORTING
 FORM –V (See rule 10)

FORM –VI (See rule 16 Application for filing appeal against

order passed by the prescribed authority.

 Form –VII (see rule 5 (c) Report of CBWTF ON HCF
 Procedure for authorization

Authorization: occupier/ operator: Form II, III

Validity: 5ys: Bedded Occupiers CBMWTDF

Grant: 90 days

Authorisation: one time for Non-bedded occupiers: 90 d

Dr Shazia Shams
Annual report

 Occupier/operator: prescibed authority: F IV, 30th June

Maintenance of records:

Authorised person: maintain records: BMW: 5 y

Records: subject to inspection and verification: prescribed

authority and MOEFCC

 Dr Shazia Shams
Accident reporting:
Major accident: intimate immediately: prescribed
authority: within 24 h remedial steps
 

Small accidents and remedial steps taken: Annual

Appeal: 30 days form V: Secretary Env State :

Appeal disposed off in 90 d

Dr Shazia Shams
Conclusions: Highlights BMWM, rules 2016
Ambit of the rules
Hazardous , MO, radioactive: different Acts
Duties: Occupier, CBWTF, Authority
No categorization
Deep burial, CBWTF exempted: remote, defense
Stds: Non chlorinated bags: barcode, GPS Vehicle
Standards of equipments, effluent, pits, parameter
Recycling: authorized recyclers
Sustainable, eco friendly, green technologies, waste to
energy

Dr Shazia Shams
Bio-Medical Waste Management (Amendment)
Rules March 16, 2018
Original provision
 Rule ( 4c) -It shall be the duty of
every occupier to pre-treat the
laboratory waste, microbiological
waste, blood samples and blood
bags through disinfection or
sterilization on-site in the manner
as prescribed by the World Health
Organization (WHO) or National
AIDs Control Organization
(NACO) guidelines and then sent
to the common bio-medical waste
treatment facility for final disposal
Amended provision
 It shall be the duty of every occupier
to pre-treat the laboratory waste,
microbiological waste, blood
samples and blood bags through
disinfection or sterilization on-site in
the manner as prescribed by the
World Health Organization (WHO)
guidelines on Safe management of
wastes from health care activities
and WHO Blue Book, 2014 and
then sent to the Common bio-
medical waste treatment facility
for final disposal.
 Original provision
 Rule 4 (p) -It shall be the duty of
every occupier to make available
the annual report on its web-site and
all the health care facilities shall
make own website within two years
from the date of notification of
these rules.
 Rule 5 (c) -It shall be the duty of
every operator of a common bio-
medical waste treatment and
disposal facility to establish bar
coding and global positioning
system for handling of bio- medical
waste within one year
Amended provision
 It shall be the duty of all the health
care facilities (any number of beds)
shall make available the annual
report on its web-site within a
period of two years from the date
of publication of Bio-Medical
Waste Management (Amendment)
Rules, 2018
 It shall be the duty of every operator
of a common bio-medical waste
treatment and disposal facility to
establish bar coding and global
positioning system for handling of
bio- medical waste in accordance
with the guidelines issued by the
Central Pollution Control Board by
27th March, 2019
Original provision
Rule 7(8) -Every occupier shall
phase out use of non-chlorinated
plastic bags within two years from
the date of publication of these
rules and after two years from such
publication of these rules, the
chlorinated plastic bags shall not be
used for storing and transporting of
bio-medical waste and the occupier
or operator of a common bio-
medical waste treatment facility
shall not dispose of such plastics by
incineration and the bags used for
storing and transporting biomedical
waste shall be in compliance with
the Bureau of Indian Standards. Till
the Standards are published, the
carry bags shall be as per the Plastic
Waste Management Rules, 2011.
Amended provision
Every occupier shall phase out use
of chlorinated plastic bags within
two years from the date of
publication of these rules and after
two years from such publication of
these rules, the chlorinated plastic
bags shall not be used for storing
and transporting of bio-medical
waste and the occupier or operator
of a common bio-medical waste
treatment facility shall not dispose
of such plastics by incineration and
the bags used for storing and
transporting biomedical waste shall
be in compliance with the Bureau
of Indian Standards. Till the
Standards are published, the carry
bags shall be as per the Plastic
Waste Management Rules, 2016.
 Original provision Amended provision

 The prescribed authority shall

 Rule 13(2) -The prescribed authority
shall compile, review and analyze the
information received and send this
information to the Central Pollution
Control Board on or before the 31st July
of every year.
compile, review and analyze the
information received and send this
information to the Central Pollution
Control Board in Form IVA before
the 31st July of every year.

 
Along with the changes in the Rules, amendments have also been made to
Schedule I, II and III and the format for submission of the annual report
information on bio-medical waste management has been inserted as Form
IVA.
 
The Amendment Rules have come into force from March 16, 2018.
[G.S.R. 234 (E)]
URL: http://www.egazette.nic.in/WriteReadData/2018/183847.pdf

.
अिधसूचना 19 फरवरी, 2019
1) These rules may be called the Bio-Medical Waste
Management (Amendment) Rules, 2019.
2. In the Bio-Medical Waste Management Rules,
2016 (herein after referred to as the said rules), in
rule 4,-
(i) For clause (n), the following clause, shall be
substituted, namely:- “(n) ,in case of all bedded health
care units, maintain and update on day to day basis the
bio-medical waste management register and display
the monthly record on its website according to the bio-
medical waste generated in terms of category and
colour coding as specified in Schedule I;”;
(ii) For clause (p), the following clause shall be substituted,
namely:- “(p) ,in case of all bedded health care facilities (any
number of beds), make available the annual report on its
web-site within a period of two years from the date of
publication of the Bio-Medical Waste Management
(Amendment) Rules, 2018

3. In Schedule II to the said rules, against serial number 8, in

item (1), in the Note, for clause 3, the following clause shall
be substituted, namely: -“3. Health Care Facilities having less
than ten beds shall have to comply with the output discharge
standard for liquid waste by 31st December, 2019.”
Things to remember…..
• Chemical treatment using at least 1% hypochlorite
solution or other chemical reagent.
• Ensure that chemical solution has adequate strength to
disinfect
• Mutilation/shredding must be such that so as to prevent
unauthorized reuse.
• There will be no chemical pretreatment before
incineration.
• Chlorinated plastics/bags shall not be incinerated.
• Disposal of bio-medical waste by deep burial shall be
prohibited in Towns and Cities.
• Liquid waste generated from laboratory, washing,
cleaning, house keeping and disinfecting activities shall
be treated along with other effluent generated from
premises.
Required Attitude- “Be an Effective Team Player. Teamwork is the key to
BMW

Dr Shazia Shams
Thank You