UNIT I INTRODUCTION TO

HOSPITAL ADMINISTRATION

Lecture 6:Biomedical Waste Management

Dr. R. S ubashini
SSN Co lleg e o f Eng ineering
BIOMEDICAL WASTE
MANAGEMENT
Contents

• Need for BWM

• Magnitude of the problem
• WHO statistics
• BMW Management rules
• Schedules(1-6)
• Forms(1-6)
Definition
Biomedical Waste Means any waste, which is generated
during the diagnosis, treatment
or
Immunization 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
4
Biomedical Waste

5
Need for BWM
• Biomedical wastes, potential source of
diseases, like
 AIDS
 Tuberculosis
 Hepatitis and
 other bacterial diseases.
 Poor infection control practices & poor
waste management patient-Nosocomial
infections
 Magnitude of the problem

Developed countries generate 1 to 5 kg/bed/day

BMW

INDIA:- No national level study

Local/regional level study shows-
hospitals generate roughly 1-2 kg/bed/day

According to WHO total BMW consist of-

: 85% non infectious/non hazardous
waste
: 10% infective waste
: 5% non-infectious but hazardous.
Sources
BWM rules
• On 20th July 1998 Ministry of Environment and Forests
(MoEF), Govt. of India, Framed a rule known as ‘Bio-
medical Waste (Management and Handling) Rules,
• 1st Amendment Dated 06/03/2000
• 2nd Amendment Dated 17/09/2003
• The MoEF has notified the new Draft “Bio-Medical Waste
(Management & Handling) Rules 2011” on 24TH August,
2011 under the Environment Protection Act, 1986 to
replace the earlier Rules. Provide uniform guidelines and
code of practice for management and handling of
biomedical wastes generated from Hospitals, clinics &
other institutions generating Biomedical Waste.
 1998 2011
1 Occupiers with more than 1000 beds Every occupier generating BWM, requires
required to obtain authorisation to obtain authorisation

2 Operator duties absent Duties of the operator listed

3 Biomedical waste divided in ten Biomedical waste divided in 8 categories

categories

4 Rules restricted to HCEs with more than Treatment and disposal of BMW made
1000 beds mandatory for all the HCEs

5 No format for annual report A format for annual report appended with the
rules

6 Form VI is absent Form VI i.e. the report of the operator on

HCEs not handing over the BWM added to
the Rules

8/24/2012 11
Bio-medical Waste Management
And Handling Rules 2011

RULES- 1 to 17

SCHEDULES- I to VI

FORMS- I to VI
 1. SHORT TITLE AND
COMMENCEMENT:

 (1) These rules may be called the Bio-Medical Waste

(Management and Handling) Rules, 2011.

 (2) They shall come into force on the date of their

publication in the official Gazette.
 2. APPLICATION:

 These rules apply to all persons who generate, collect, receive,

store, transport, treat, dispose, or handle bio medical waste
in any form & shall not apply to-

a) Radioactive waste as covered under the “Atomic energy Act

1962”
b) Hazardous chemicals covered under the “Manufacture, storage
& import of hazardous chemicals Rules 1989”
c) Wastes covered under the Municipal solid wastes Rules 2000
d) The lead acid batteries covered under the “Batteries Rules
2001”
e) Hazardous wastes covered under the “Hazardous waste
Rules
2008”
 3. DEFINITIONS:

(1)"Act" means the Environment (Protection) Act,

1986 (29 of 1986);
(2)"Animal House" means a place where animals are
reared/kept for experiments or testing purposes;
(3)"Authorisation" means permission granted by the
prescribed authority for the generation, collection,
reception, storage, transportation, treatment, disposal
of bio-medical waste.
(4)"Authorised person" means an occupier or operator
authorised by the prescribed authority to generate,
collect, receive, store, transport, treat, dispose and/or
handle bio-medical.
(5)"Bio-medical waste" means any waste, which is generated during the
diagnosis, treatment or immunisation of human beings or animals or in
research activities & including categories mentioned in Schedule I of these
rules;
(6)"Biologicals" means any preparation made from organisms or micro-
organisms or product of metabolism and biochemical reactions intended for
use in the diagnosis, immunisation or the treatment of human beings or
animals or in research activities;
(7)"Bio-medical waste treatment and disposal facility" means any facility
wherein treatment, disposal of bio-medical waste is carried out;
(8)"Occupier" means a person having administrative control over the
institution and the premises generating biomedical waste;
(9)"Operator of a bio-medical waste treatment facility" means a person who
controls or operates a facility handling the bio-medical waste;
(10) "Schedule" means schedule appended to these rules;
(11) “Form” means form appended to these rules;
 4. DUTIES OF THE OCCUPIER:

It shall be the duty of every occupier-

1. To take all steps to ensure that BMW is handled without
any adverse effect to human health & environment.
2. To provide training for all its health care workers.
3. To immunize all its health care workers.
4. To ensure segregation of BMW at the point of
generation.
5. To ensure occupational safety of all its heath care workers
by providing personal protective equipments.
6. To conduct health care check-up annually for all its
workers & maintain the records for the same.
7. To install necessary equipments & regular supply of
materials required for handling BMW.
 4. DUTIES OF THE OCCUPIER:
CONT..

8.To maintain & update everyday BMW management

register according to quantity, categories & final mode of
disposal as specified in SCHEDULE-1.
9.To develop a system of reporting of unintended accidents
like sharp injuries, mercury spills, fire hazards which are
likely to occur during BMW handling. Such records shall be
maintained and reported in Form III along with annual
report and should indicate even the nil report.
10.To inform the prescribed authority immediately in case
the operator of a facility does not collect the BMW within the
intended time.
11.To establish a BMW management cell or unit if the facility
has more than 30 beds. Such unit or cell shall meet once in
six months & the records of minutes of such meetings shall be
submitted along with the annual report to the prescribed
authority.
 5. DUTIES OF THE OPERATOR:
• 1. To take all necessary steps to ensure that the BMW collected from the
occupier is transported, handled, stored, treated & disposed of without any
adverse effect to human health & environment.
• 2. To ensure timely collection of BMW from the health care facilities.
• 3. To inform the prescribed authority immediately regarding the health
care establishments/facilities, which are not handling over the segregated
BMW.
• 4. To provide training of all its workers.
• 5. To undertake appropriate pre-placement & periodic medical
examination and immunize all its workers and records for the same.
• 6. To ensure occupational safety by providing protective equipments.
• 7. To develop system of reporting of unintended accidents in Form III
with annual report even the nil reporting.
• 8. To maintain a log book of treatment equipment according to weight of
batch; categories of waste treated; time; date; duration of treatment cycle &
total hours of operation.
 6.RESPOSIBILITIES OF AUTHORITIES:

 The authority specified in

column 2 of the Schedule-
VI shall perform the
duties as specified in
column 3 of the said
Schedule as per the
provisions of these Rules.
 7. TREATMENT AND DISPOSAL:

 (1) Bio-medical waste shall be treated and disposed of in

accordance with Schedule I, and in compliance with the
standards prescribed in Schedule V.
 (2) Any person including an occupier/operator of a
BMW treatment facility intends to promote new
technologies for treatment of BMW shall approach the
Central Government/Central Pollution Control board for
prior approval.
 (3) Every occupier shall either set up his own BMW
treatment equipment, prior to commencement of its
operation or ensure treatment of BMW through an
authorised common BMW treatment facility.
 (4) Every operator of a common BMW treatment facility
shall set up BMW treatment equipments, prior to
commencement of its operation.
 7. TREATMENT AND DISPOSAL: cont.

 (5) Use of chlorinated plastic bags for handling of BMW

shall be prohibited & the occupier/operator of a common
BMW facility shall not dispose of such plastics by
incineration.

 (6) The occupier/operator of a BMW treatment facility shall

dispose of the recyclable BMW such as plastics & glass etc.
through authorised recyclers. The occupier shall maintain a
record of such recyclable wastes auctioned or sold.

 (7) In the event of breakage of mercury containing medical

instruments, necessary precautions shall be taken by the
occupier to segregate such waste as per guideline.
 8. SEGREGATION, PACKAGING,
TRANSPORTATION AND STORAGE:
(1) Untreated BMW shall not be mixed with other wastes.
(2)Bio-medical waste shall be segregated into containers/bags at the point of
generation in accordance with Schedule II.
(3) The containers shall be labelled according to Schedule III.
(4)The transporter shall transport the BMW from the premises of an occupier to
any off-site BMW treatment facility only with label as prescribed in schedule III
along with the necessary information prescribed in Schedule IV.
(5)Untreated BMW shall be transported only in specific vehicle authorised by the
competent authority.
(6)No untreated BMW of categories 1,2,3&6 shall be kept stored beyond a period
of 48 hours. If for any reason it becomes necessary to store the waste beyond such
period, the authorised person must take permission of the prescribed authority .
(7)The municipal body of the area shall continue to pickup & transport
segregated non BM solid waste as well as dully treated BMW for disposal at
municipal dump site.
 9. PRESCRIBED AUTHORITY:

1) The prescribed authority shall be the State Pollution

Control Boards in respect of State & Pollution control
Committees in respect of Union Territories.
2) The prescribed authority in respect of all health care
establishments of the Armed Forces shall be the
Director General, Armed Forces Medical Services.
3) The prescribed authority shall function under the
supervision & control of the respective Government of
the state.
4) The prescribed authorities shall comply with the
responsibilities as stipulated in Schedule VI of the
Rules.
 10. PROCEDURE FOR AUTHORISATION:

1) Every occupier/operator of BMW treatment facility shall make an application

in Form-1 to the prescribed authority for grant of authorization.
2) The prescribed authority shall on receipt of Form-1 make such enquiry as it
deems fit & if it is satisfied may grant /renew an authorization.
3) A provisional authorization in Form-IV shall be granted for trial run for a
period of one year. On satisfactory performance during trial period , the
authorization shall be renewed for a further period of five year.
4) The prescribed authority, after giving reasonable opportunity to the applicant,
may refuse to grant/renew authorization & to be recorded in writing.
5) Every application for authorization shall be disposed of by the prescribed
authority within ninety days.
6) The prescribed authority may cancelled/suspend an authorization.
7) Every occupier/operator shall intimate the prescribed authority about any
change/variation in the activity relating to BMW management & shall submit a
fresh application in Form-I.
 11. ADVISORY COMMITTEE:

1) The government of every state shall constitute an Advisory

Committee under the chairmanship of State Health
secretary. The committee shall include representatives from
state department of health, environment, urban
development, animal husbandry & veterinary sciences, State
Pollution Control Board, local bodies/urban/municipal
corporation, representative from Indian Medical
Association, common BMW treatment facility & non
government organization. The advisory committee shall
meet once in six months & review all the matters related to
implementation of Rules.
2) Ministry of defence shall constitute an advisory committee
under chairmanship of Additional Director General of
Armed Forces Medical Services.
3) The Government of every State shall constitute District
Level Monitoring Committee in the districts under the
chairmanship of District Medical Officer.
 12. ANNUAL REPORT:

1) Every occupier/operator shall submit an annual report to

the prescribed authority in Form-II by 31st January
every year, to include information about the categories
and quantities of BMW handled during the preceding
year.
2) The prescribed authority shall send this information in a
compiled form to the Central Pollution Control Board
by 31 March of every year.
3) The Central Pollution Control Board shall send this
information in a compiled Form to the Ministry of
Environment and Forest by 30th June of every year
 13. MAINTENANCE OF RECORDS:

1) Every authorised person shall maintain records

related to the generation, collection, reception,
storage, transportation, treatment, disposal and/or
any form of handling of bio-medical waste.

2) All records shall be subject to inspection and

verification by the prescribed authority at any time.
 14. ACCIDENT REPORTING:
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 authorised
person shall report the
accident in Form-III to the
prescribed authority
forthwith.
 15. APPEAL:

1) Any person aggrieved by an order made by the

prescribed authority under these rules, may prefer
appeal within 30 days in Form-V to the Secretary
(Environment) of State Government.

2) Any person aggrieved by an order of the Director

General Armed Forces Medical Services under
these rules, may prefer an appeal within 30 days in
Form-V to the Ministry of Environment and Forest.
 16. COMMON DISPOSAL
/INCINERATION SITES:

The Municipal Corporation, Municipal Boards, Urban

or Local Bodies, shall be responsible for providing
suitable common disposal/incineration sites for the
biomedical wastes generated in the area under their
jurisdiction.
 17. LIABILITY OF THE OCCUPIER,
OPERATOR OF A
1) The occupier/operator of a BMW treatment facility shall be
FACILITY
liable for all the damage caused to the environment or the
public due to improper handling of BMW.

2) The occupier/operator of BMW treatment facility shall be liable

for action under section 5 and 15 of Environment Protection
Act 1986. This is punishable with imprisonment for a term
which may extend to five years or with fine which may extend
to one lakh rupees, or with both, and in case the 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.
 Schedules

CATEGORIES OF BIO-MEDICAL
Schedule I WASTE

COLOUR CODING & TYPE OF

Schedule II CONTAINER FOR DISPOSAL OF
BIO-MEDICAL WASTES

LABEL FOR BIO-MEDICAL WASTE

Schedule III CONTAINERS/BAGS
 CONT..

LABEL FOR TRANSPORT OF

Schedule IV BIO-MEDICAL WASTE
CONTAINERS/BAGS

STANDARDS FOR TREATMENT

Schedule V AND DISPOSAL OF
BIO-MEDICAL WASTES

LIST OF AUTHORITIES AND

Schedule VI THECORRESPONDING DUTIES
 SCHEDULE I
CATEGORIES OF BIO-MEDICAL WASTE

Treatment & disposal

Category Waste category (type)
option

Category No. 1 Human Anatomical Waste Incineration

Category No. 2 Animal waste Incineration

Solid Waste ( item

Category No. 6 contaminated with blood Incineration
& body fluids)
Incineration
CONT..

Disinfection by
chemical
treatment/autoclaving
/microwaving or
destruction by needle
tip cutter followed by
Category No. 4 Waste Sharps mutilation/shredding
& final disposal
through authorised
CBWTF or in secured
landfill or designated
concrete waste sharp
pit.
 CONT..
Discarded Medicine & Disposal in secured land
Category No. 5
Cytotoxic drugs fill/Incineration

Disinfection by chemical
Category No. 6 Soiled Waste treatment/autoclaving/
microwaving followed by
mutilation/shredding
Infectious solid waste then disposal through
(such as catheters, hand authorised recyclers
Category No. 7
gloves, tubings, saline
bottles etc.)
Chemical treatment &
Chemical Waste discharge into drains
Category No. 8 (disinfection, insecticides meeting the norms &
etc.) solid disposal in secured
landfill
Autoclaving
 SCHEDULE-II
COLOUR CODING & TYPE OF CONTAINER FOR DISPOSAL OF
BIO-MEDICAL WASTES

15/07/2016 41
8/24/2012 42
Red bag
Yellow bag
Blue bag
• All types of glass bottle and broken
glass articles
• Outdated and discarded medicine
Black bag
 SCHEDULE-III
LABEL FOR BIO-MEDICAL WASTE CONTAINERS/BAGS

BIOHAZARD SYMBOL CYTOTOXIC HAZARD

SYMBOL

BIOHAZARD
CYTOTOXIC
 SCHEDULE-IV
LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS

• Phone No………
• Day………………. • Phone No………………
Month…………….day • Telex No………..
• Telex No………………..
• Fax No…………..
• Year………………
• Fax No……………………
• Contact Person……….
• Date of • Contact Person……..
generation…………………… • In case of emergency please
• Waste Category No……………… contact

• Waste quantity……………………. • Name and Address:

• Phone No.
• Sender’s Name and Address
• Receiver’s Name and Address
BMW transportation
 SCHEDULE-V
STANDARDS FOR TREATMENT AND DISPOSAL OF
BIO-MEDICAL WASTES

• STANDARDS FOR INCINERATORS

• STANDARDS FOR WASTE AUTOCLAVING
• STANDARDS FOR LIQUID WASTE
• STANDARDS FOR MICROWAVING
• STANDARDS FOR DEEP BURIAL
SCHEDULE-VI

LIST OF AUTHORITIES AND THE

CORRESPONDING DUTIES
1)Ministry of Environment & forests
2)Central/State Ministry of Health Family Welfare,
Veterinary and Animal Husbandry
3)Ministry of Defence
4)Central Pollution Control Board
5)State Gov./Union Territory Gov./Administration
6)State Pollution Control Boards/Committees
7)Local bodies such as Gram Panchayat,
Municipalities
 FORMS

APPLICATION FOR
FORM I
AUTHORISATION

ANNUAL REPORT
FORM II (To be submitted to the
prescribed authority by 31
January every year)

FORM III
ACCIDENT REPORTING
 CONT..
Authorization for operating
facility for collection,
FORM IV reception, treatment, storage,
transport and disposal of
BMW

Application for filing appeal

FORM V
against order passed by the
prescribed authority

Report of the Operator of the

Common BMW treatment &
FORM VI
disposal facility / Establishment
not handing over BMW
 Bio-Medical Waste (Management and Handling) Rules, 2011
FORM I
APPLICATION FOR AUTHORISATION
To (To be submitted in duplicate.)
The Prescribed Authority
(Name of the State Govt/UT Administration) Address.
1. Particulars of Applicant
(i) Name of the Applicant (ii) Name of the Institution:
(In block letters & in Address:
full) Tele No., Fax No. Telex No.
2. Activity for which authorisation is sought:
(i) Generation (ii) Collection (iii) Reception (iv) Storage (v) Transportation (vi) Treatment (vii) Disposal (viii) Any
other form of handling
3. Please state whether applying for fresh authorisation or for renewal:
(In case of renewal previous authorisation-number and date)
4. (i) Address of the institution handling bio-medical wastes:
(ii) Address of the place of the treatment facility:
(iii) Address of the place of disposal of the waste:
5. (i) Mode of transportation (in any) of bio-medical waste:
(ii) Mode(s) of treatment:
6. Brief description of method of treatment and disposal (attach details):
7. (i) Category (see Schedule 1) of waste to be handled
(ii) Quantity of waste (category-wise) to be handled per month
8. Declaration; I do hereby declare that the statements made and information given above are true to the best of
my knowledge and belief and that I have not concealed any information. I do also hereby undertake to provide any
further information sought by the prescribed authority in relation to these rules and to fulfil any conditions
stipulated by the prescribed authority.
Date : Signature of
the Applicant
Place : Designation of
the Applicant
 Bio-Medical Waste (Management and Handling) Rules, 2011
FORM II
ANNUALREPORT
(To be submitted to the prescribed authority by 31 January every
year)

1 . Particulars of the Occupier:

(i) Name of the authorised person (occupier/operator):
(ii) Name of the institution:
Address
Tel. No
2. Type of health care facility:
3. Categories of Bio-medical waste generated:
4. Category-wise quantity of waste treated:
5. Additional details:
6. Any other relevant information:
7. Certified that the above report is for the period from………
Date ............................... Name and Signature
Place.............................. of the Head of the Institution
 Bio-Medical Waste (Management and Handling) Rules, 2011
FORM III
ACCIDENT REPORTING

1. Date and time of accident:

2. Sequence of events leading to accident:
3. The waste involved in accident :
4.Assessment of the effects of the accidents on human health and the
environment:
5. Emergency measures taken:
6. Steps taken to alleviate the effects of accidents:
7. Steps taken to prevent the recurrence of such an accident:

Date ............................... Signature .........................

Place.............................. Designation......................
 OTHER
FORMS

FORM-IV: Authorization for operating a facility for

collection, reception, treatment,
storage, transport and disposal of BMW
FORM-V: Application for filing appeal against order
passed by the prescribed authority
FORM-VI: Report of the Operator of the Common
BMW treatment & disposal facility/
Establishment not handing over BMW