The document summarizes the key points of the Bio-Medical Waste Management Rules 2016 in India. It defines occupiers and operators who are subject to the rules. The rules mandate segregation, storage, transportation and treatment of biomedical waste. Waste is required to be segregated into categories like infectious, sharp and general waste and disposed of according to treatment standards. Occupiers have duties around safe handling, training staff, and reporting. New requirements under the rules include phasing out chlorinated plastic, immunizing healthcare workers, and maintaining online records within defined timelines.
Community medicine let's think beyond diseaseDr.Jatin Chhaya
Introduction - Community Medicine
Concept of Hygeine, Public health, Preventive & Social Medicine and Community diagnosis..
Difference between Clinician and Epidemiologist..
Course - Diploma in Pharmacy
Subject - Hospital and Clinical Pharmacy
Topic: Hospital
For More Educational Resources visit to YouTube Channel: https://www.youtube.com/channel/UCCZaj-OnTx1n8JZKuBlJJcg
Website: https://amarskulkarni.wordpress.com
Health and wellness center by Dr. Jitender, MD PGIMERYogesh Arora
Health and wellness center is one of the two component of Ayushmann Bharat. HWC ensures comprehensive, quality, and affordable care to be achieved by all.
Community medicine let's think beyond diseaseDr.Jatin Chhaya
Introduction - Community Medicine
Concept of Hygeine, Public health, Preventive & Social Medicine and Community diagnosis..
Difference between Clinician and Epidemiologist..
Course - Diploma in Pharmacy
Subject - Hospital and Clinical Pharmacy
Topic: Hospital
For More Educational Resources visit to YouTube Channel: https://www.youtube.com/channel/UCCZaj-OnTx1n8JZKuBlJJcg
Website: https://amarskulkarni.wordpress.com
Health and wellness center by Dr. Jitender, MD PGIMERYogesh Arora
Health and wellness center is one of the two component of Ayushmann Bharat. HWC ensures comprehensive, quality, and affordable care to be achieved by all.
This webinar will tell you what you need to know about clinical trials, their history, and help you prepare for a trial. If you’re currently considering participating in a clinical trial, we hope that this webinar helps to answer many of your questions.
In the presentation you'll learn the difference between different types of clinical trial and the design and purpose of clinical trials, and you'll get an inside look at the approval process.
The webinar was hosted by Dawn Richards, Director of Patient and Public Engagement at Clinical Trials Ontario and featured a panel of patients, James Davidson, Eric Pitters and Kathie LaForge.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
Reporting of ICSR (individual case safety report)ClinosolIndia
An Individual Case Safety Report (ICSR) is a report of an adverse event or suspected adverse reaction to a medicinal product that has occurred in a patient or study subject. Reporting of ICSRs is a critical component of pharmacovigilance, as it helps to identify and assess potential risks associated with the use of a medicinal product.
The process for reporting an ICSR typically involves the following steps:
Identification of an adverse event or suspected adverse reaction: This may occur through a variety of channels, including spontaneous reports from healthcare professionals or patients, reports from clinical trials or other studies, or signals detected through pharmacovigilance activities.
Collection of information: Once an adverse event or suspected adverse reaction has been identified, information about the event must be collected, including the patient's demographic information, medical history, and details about the adverse event or reaction.
Assessment of causality: The information collected about the adverse event or reaction must be assessed to determine whether there is a causal relationship between the medicinal product and the event.
Completion of the ICSR: Once causality has been established, an ICSR must be completed, typically using a standardized form or electronic system. The ICSR should include all relevant information about the patient, the medicinal product, and the adverse event or reaction.
Submission of the ICSR: The completed ICSR must be submitted to the appropriate regulatory authority, typically through a designated reporting system.
It is important to report ICSRs in a timely and accurate manner, as this helps to ensure that potential risks associated with the use of medicinal products are identified and addressed promptly. Failure to report ICSRs can result in serious consequences, including harm to patients, regulatory action against pharmaceutical companies, and damage to public confidence in the healthcare system.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
This webinar will tell you what you need to know about clinical trials, their history, and help you prepare for a trial. If you’re currently considering participating in a clinical trial, we hope that this webinar helps to answer many of your questions.
In the presentation you'll learn the difference between different types of clinical trial and the design and purpose of clinical trials, and you'll get an inside look at the approval process.
The webinar was hosted by Dawn Richards, Director of Patient and Public Engagement at Clinical Trials Ontario and featured a panel of patients, James Davidson, Eric Pitters and Kathie LaForge.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
Reporting of ICSR (individual case safety report)ClinosolIndia
An Individual Case Safety Report (ICSR) is a report of an adverse event or suspected adverse reaction to a medicinal product that has occurred in a patient or study subject. Reporting of ICSRs is a critical component of pharmacovigilance, as it helps to identify and assess potential risks associated with the use of a medicinal product.
The process for reporting an ICSR typically involves the following steps:
Identification of an adverse event or suspected adverse reaction: This may occur through a variety of channels, including spontaneous reports from healthcare professionals or patients, reports from clinical trials or other studies, or signals detected through pharmacovigilance activities.
Collection of information: Once an adverse event or suspected adverse reaction has been identified, information about the event must be collected, including the patient's demographic information, medical history, and details about the adverse event or reaction.
Assessment of causality: The information collected about the adverse event or reaction must be assessed to determine whether there is a causal relationship between the medicinal product and the event.
Completion of the ICSR: Once causality has been established, an ICSR must be completed, typically using a standardized form or electronic system. The ICSR should include all relevant information about the patient, the medicinal product, and the adverse event or reaction.
Submission of the ICSR: The completed ICSR must be submitted to the appropriate regulatory authority, typically through a designated reporting system.
It is important to report ICSRs in a timely and accurate manner, as this helps to ensure that potential risks associated with the use of medicinal products are identified and addressed promptly. Failure to report ICSRs can result in serious consequences, including harm to patients, regulatory action against pharmaceutical companies, and damage to public confidence in the healthcare system.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
Biomedical waste management and biohazards by Dr. Sonam AggarwalDr. Sonam Aggarwal
According to biomedical waste (management and Handling rules 1998 of India) –
"bio-medical 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.
https://www.slideshare.net/SonamAggarwal7/biomedical-waste-management-and-biohazards-by-dr-sonam-aggarwal
A quick refresher of the different waste categories as defined in the Bio-Medical Waste Rules 2016 (short BMW Rules) and its amendment BMW Rules 2018. The presentation also describes standards as per these rules for some of the disposal methods such as incineration, autoclave, deep burial and sharps waste pit.
A small section on COVID-19 PPE waste disposal has been included in this update
PET CT beginners Guide covers some of the underrepresented topics in PET CTMiadAlsulami
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- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
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Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
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The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
2. BIOMEDICAL WASTE RULES APPLY TO:- All who
generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste :-
•Hospitals,
• Nursing homes
•Clinics
•Dispensaries,
•Veterinary institutions
•Animal houses,
•Pathological laboratories(Irrespective of
the size)
•Blood banks,
•Clinical establishments
• Research or educational institution
• Health camps,
• Medical or surgical camps,
• Vaccination camps,
• Blood donation camps,
• First aid rooms of schools,
• Forensic and research labs.
• Ayush hospitals,
2
3. WHY BMW Rules 2016 ?
3
• Hospital or Lab Infectious waste
is not dumped in open ground
….potentially hazardous to the
environment and human beings
4. BMW RULES-2016 COMPRISE OF :-
18 Rules, 4 Schedules, and 5 Forms
Schedule I BMW color coding, collection, treatment and disposal
Schedule II Standards for treatment and disposal
Schedule III Prescribed Authorities and Responsibilities
Schedule IV Labels for BMW containers and Bags
Form I Accident Reporting
Form II and III Application and Authorization document
Form IV Annual Report
Form V Appeal
4
5. DEFINITION COMMONLY USED IN BMW 2016
OCCUPIER means a person having administrative control over the institution and the
premises generating bio-medical waste, which includes a hospital, nursing home, clinic,
dispensary, veterinary institution, animal house, pathological laboratory, blood bank, health care
facility and clinical establishment, irrespective of their system of medicine and by whatever
name they are
OPERATOR of a common bio-medical waste treatment facility" means a person who owns
or controls a Common Bio-medical Waste Treatment Facility (CBMWTF) for the collection,
reception, storage, transport, treatment, disposal or any other form of handling of bio-medical
waste;
5
6. KEY FUNCTIONS – AUTHORISATION
Every occupier or operator handling bio-medical waste, irrespective
of the quantity shall make an application in Form II to the prescribed
authority i.e. State Pollution Control Board and Pollution Control Committee,
for grant of authorisation
Prescribed authority shall grant the authorisation in Form III and the validity
of authorisation synchronised with validity of consent orders for bedded
health care facility(HCF). One time authorisation for non bedded HCF
6
10. 10
How to segregate waste .... in Non
Chlorinated Bags
WASTE
BMW
PLASTIC
NON
PLASTIC
SHARP
PUNCTURE
PROOF
GENERAL
11. 11
What goes in RED BAG
• Disposable contaminated waste
which can be recyclable – will be
disposed by autoclaving treatment
followed by shredding
• Tubing, bottles,
• Intravenous tubes and sets,
catheters, urine bags,
• Syringes (without needles and fixed
needle syringes) and
• Vaccutainers with their needles cut
and gloves.
12. 12
WHAT GOES IN YELLOW BAG
Human anatomical wastes
• Body parts / tissues etc
Cotton dressings, plaster casts
Gauze pieces
Antibiotics and other drugs
Microbiology waste
• Culture devices, stocks or
specimen of microorganisms
Discarded linens, mattresses,
dressings soiled with blood or
body fluids
•
13. WHAT GOES IN BLUE
BAG....CARD BOARD BOX
Glassware – broken ,
Contaminated glass
Medicine Vials, ampoules
If glass slides to be re-used dis-
infect in 1% hypochlorite and then
autoclave at 160deg C for one hour
13
14. 14
WHAT GOES IN WHITE PUNCTURE
PROOF CONTAINER • White (Translucent) – Waste sharps
including metals – packed in puncture
proof containers
Needles, syringes with fixed needles
Scalpels, Blades, lancet
Suture needle, aluminum foil
Any contaminated sharp object
causing puncture/cuts
Handed over to Waste Agency… when
2/3 rd full.
15. CHEMICAL/LIQUID WASTE
• Chemical liquid waste:
• Liquid generated from X-ray films
developing,
• Formalin(neutralised)
• Infected secretions,
• Aspirated body fluids,
• Liquid from laboratory instruments
• Floor washing etc should be pre-treated
onsite using Sodium Hypochlorite or
connected to ETP
15
16. AT SOURCE PRE TREATMENT
16
• AUTOCLAVE pre-requisites : Ideally each autoclave should have
graphic or computer recording devices which will automatically and
continuously monitor and record dates, time of day, load
identification number and operating parameters throughout the
entire length of the autoclave cycle.
• (All records to be kept for 05 years)
17. VALIDATION TEST FOR AUTOCLAVE
17
Use four biological indicator strips, one is used as a
control and left at room temperature, Three will be placed
in the approximate centre of three containers with the waste.
Frequency : Conduct this test three consecutive times to
define the minimum operating conditions The temperature,
pressure and residence time at which all biological
indicator vials or strips for three consecutive tests show
complete inactivation of the spores.
Follow-on action once in three months and maintain
records .
18. 18
STANDARDS FOR AUTOCLAVING OF BIO- MEDICAL
WASTE. (Pre-treatment..at source)
• Chemical indicator strip….is to be used with
each batch of waste and note change in
color as an indication of temperature and
pressure achieved.
Frequency: To use more than one strip with
every batch and record the same.
Spore testing at least once in every week
• Medical waste shall not be considered as
properly treated unless the time, temperature
and pressure indicators indicate that the
required time, temperature and pressure were
reached during the autoclave process or
AUTOCLAVE AGAIN
• PROCEDURE : The autoclave
should be dedicated for the
purposes of disinfecting and
treating bio-medical waste.
• When operating a gravity flow
autoclave, medical waste shall be
subjected to: A temperature of not
less than 121° C and pressure of 15
pounds per square inch (psi) for an
autoclave residence time of not less
than 60 minutes;
19. 19
DUTIES OF OCCUPIER-Healthcare facility
1)Handle waste as per norms
2) Safe storage of waste
3)Onsite pre-treatment of infective waste
4) Replace chlorinated plastic bags,gloves and bood bags with non chlorinated
5) Dispose of solid waste separate from bio medical waste other than bio-medical waste
in accordance
6)To provide training to all its health care workers at the time of induction and thereafter at
least once every year and the details of training programmes conducted, number of
personnel trained and number of personnel not undergone any training shall be provided
in the Annual Report
7)Immunise all its health care workers against Hepatitis B and Tetanus as per protocol
8) Establish a Bar- Code System for bags or containers containing bio-medical waste
9) Ensure segregation of liquid chemical waste at source and ensure pre-treatment
or neutralisation
20. 20
DUTIES OF OCCUPIER-Healthcare facility
10) Provide PPE to healthcare workers
11) Report major accidents
12) Make available the annual report on its web-site
13) Inform the prescribed authority immediately if waste is not picked or
retained for more than 48 hrs
14) Establish a committee to review and meet once in every six months and the
record of the minutes of the meetings of this committee and incorporate
in annual report
15) Maintain all records for a period of 05 yrs
16) Conduct health check up at the time of induction and at least once in a
year for all its health care workers
17) Maintain daily register and upload monthly records on website
22. TIMELINES FOR NEW REQUIREMENTS
22
New Requirements Timeline for implementation Remarks
Pre-treatment of laboratory waste, microbiology
waste, blood samples before giving to disposal
*Immediate effect. Check with your BMW
management Co.
Phase out chlorinated bags, gloves, blood bags Within 2 years from date of
issue of new BM rules i.e. w.e.f
28th March 2018
Check with your BMW
management Co.
Training Health care workers about handling of
Biomedical waste
*Immediate effect Details of training to be
submitted along with
Annual report
Immunization of Health care workers for
Hepatitis B and Tetanus
*Immediate effect Records of vaccination
to be maintained.
23. TIMELINES FOR NEW REQUIREMENTS
23
New Requirements Timeline for implementation Remarks
Barcode system for bags or containers
containing biomedical waste
Within 1 year from date of issue of
BM rules
Check with your BMW
management Co.
Health check up of Health care workers
during induction and annually there after.
*Immediate effect Records to be
maintained
Maintain and update biomedical waste
management register and monthly report
on website
Within 2 years from date of issue of
BMW-2016 rules i.e. within 28th
March 2018
Website required
Major accidents to be reported along with
annual report
Should be documented and reported Nil
Maintain records of autoclaving,
Microwaving etc for a period of five years
*Immediate effect Nil
24. TIMELINES FOR NEW REQUIREMENTS
24
New Requirements Timeline for implementation Remarks
Annual report on website Within 2 years from date of issue of
BMW-2016 rules i.e. within 28th
March 2018
Website required
Setup BMW management
committee, and meetings be
done bi-annually. Minutes
submitted in annual report.
*Immediate effect SRL Labs who submit
annual reports to state
PCB should comply.