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Are pet and human vaccination adjuvants the same?

As with humans, most common adjuvants in pet and other veterinary vaccines are alum (crystalline aluminium salts such as aluminum oxyhydroxide or aluminium hydroxyphosphate) and oil-water emulsions (either water-in-oil or oil-in-water) stabilized by surfactants (detergent). Chemical structure of oils used in such adjuvant emulsions influence both the efficacy and safety of the vaccine. Older veterinary vaccines used to contain mineral oil-based adjuvants. Mineral oils are powerful immune stimulators but also induce injection site reactions that could be severe (1). Metabolizable oils (e.g. squalene, a precursor of cholesterol) are less immunostimulatory compared to mineral oils, which means the formulated vaccine is safer (2).Pets and Other Veterinary Vaccine AdjuvantsSafety regulations and registration costs are lower for veterinary vaccines. Thus, their regulatory and liability burden is lower. In turn, a greater variety of adjuvants are used in veterinary vaccines. Many of the adjuvants used in commercial veterinary vaccines are proprietary, i.e. their composition is not public knowledge. However, a few examples of pet and livestock adjuvants components are publicly available. The following examples are not meant to be comprehensive. Rather to illustrate two points, one, the range of adjuvants used in veterinary vaccines, and two, inclusion of adjuvants that wouldn't be approved in humans, such as Quil-A and IFA (Incomplete Freund's Adjuvant).DogsLeishmune, anti-Leishmania donovani vaccine, is licensed for use in Brazil. Leishmaniasis is a vector-borne (transmitted by the bite of an infected sand fly) protozoan parasite disease. It's endemic in Brazil so they need to vaccinate dogs against it. This vaccine is adjuvanted with Quil-A, a plant-derived Saponin, a sugar with glycosidic bonds.Here are the principal features of Quil-A.As is clear, Quil-A not approved for human use due to excess toxicity. This suggests either that adjuvant toxicity is species-specific or that the bar for regulatory approval is lower for non-humans.Pirodog and Nobivac Piro are vaccines licensed in Europe to protect against tick-borne parasitic diseases caused by Babesia canis and Babesia rossi. Like Leishmune, they are also adjuvanted with plant-derived saponin.The Cat Adjuvants Controversy: Feline-Injection-Site Sarcomas (FISS)In 1992, Dr. Mattie Hendrick, a veterinary pathologist at the University of Pennsylvania, published a study linking adjuvants to sarcomas in cats (3). This coincided with two things. One, a recent enactment of a Pennsylvania state law requiring rabies vaccination of cats. Two, the first Feline Leukemia vaccine (FeLV) adjuvanted with alum came out in 1985, and around the same time the rabies vaccine switched from modified live to alum-adjuvanted killed.Occurring at the vaccination site, these sarcomas sometimes contained residual alum and appeared to be inflammatory in appearance (4).However, these sarcomas were also found associated with injection of nonvaccine products (5, 6, 7, 8).A 1993 study (6) suggested causal association between alum-adjuvanted vaccines (FeLV and rabies) and sarcomas. It and another study (9) also estimated sarcoma risk at around 2 per 10000 doses of vaccine administered.Several other studies also implicated vaccine adjuvant-induced inflammation at the injection site (10, 11, 12).In the US, the Vaccine-Associated Feline Sarcoma Task Force was formed in 1996 to address this issue and to support research on this topic (13).A later multicenter case-control study did not find higher sarcoma risk among cats vaccinated with adjuvanted vaccines compared to nonadjuvanted ones (14). The caveat to this study was that nonadjuvanted vaccines such as recombinant ones were used in small numbers of cats.Later, other studies as well found no relationship between vaccine brand, type, and inactivated versus modified-live vaccines, and the risk of sarcoma formation (15, 16, 17).Later and larger epidemiologic studies estimated risk at 1 per 10000 doses of vaccine, i.e. much lower (18, 19).It's not clear if a newer canarypox-vectored rabies vaccine reduces sarcoma risk since studies support both possibilities (15, 16). FISS was an important impetus for development of this vaccine.A silver lining to this story is that in January 2002, the US Department of Agriculture (USDA) proposed a new rule that made it mandatory for manufacturers to keep a record of adverse effects and report them to the USDA (20).Based on detailed review of the literature, the Vaccination Guidelines Group (VGG) of the World Small Animal Veterinary Association (WSAVA) published the following guidelines for the vaccination of dogs and cats (21):“Sites of Vaccination for CatsOver the past 20 years it has become evident that one trigger for the feline injection site sarcoma (FISS) may be the administration of adjuvanted FeLV and rabies vaccines. Most subcutaneous injections (including of vaccines) have traditionally been given into the interscapular region of the cat and this is a common site for formation of a FISS. The infiltrative nature of these tumours has meant that often radical surgical resection was necessary to attempt removal of these lesions. In North America the response to this issue was the recommendation of a protocol whereby the two perceived high-risk adjuvanted vaccines would be administered into distinct anatomical sites that would be more amenable to surgical removal of any FISS that might develop. Accordingly the recommendation ‘left leg leukaemia, right leg rabies’ suggested that FeLV vaccine should be given as far distal as possible into the left hind limb, whilst rabies vaccine should be given as far distal as possible into the right hind limb. A recent study has evaluated the effect of this practice by comparing the anatomical distribution of FISS in cats before the recommendation was made (1990–1996) and after the practice was adopted (1997–2006). These data show a significant decrease in the prevalence of interscapular FISS and an increase in prevalence of tumours in the right (but not left) hind limb. More notably, there was also an increase in the number of tumours reported arising in the right and left lateral abdomen, and this was attributed to the difficultly of injecting into the distal hindlimb and these abdominal sites being accidentally injected (Shaw et al., 2009).This practice has not been adopted outside of North America. Given these recent data, the VGG recommends the following approach to reducing the risk of FISS:•Non-adjuvanted vaccines should be administered to cats wherever possible.•Vaccines (particularly adjuvanted products) should not be administered into the interscapular region.•Vaccines (particularly adjuvanted products) should be administered into other subcutaneous (and not intramuscular) sites.The most accessible sites, with acceptable safety for the vaccinator (i.e. to avoid accidental self-injection during difficult restraint of the animal), would appear to be the skin of the lateral thorax or abdomen. The skin of the lateral abdomen represents the best choice as FISS that might arise at this site may be more readily excised than those occurring in the interscapular or intercostal regions where more extensive surgical resection is required.•Vaccines should be administered into a different site on each occasion. This site should be recorded in the patient’s record or on the vaccination card by use of a diagram indicating which products were administered on any one occasion. The sites should be ‘rotated’ on each occasion. Alternatively, a practice might develop a group policy that all feline vaccinations are administered to a specific site during one calendar year and this site is then rotated during the following year.•The VGG encourages all cases of suspected FISS to be notified via the appropriate national reporting route for suspected adverse reactions.”Other useful references for FISS (22, 23, 24).PigsI'm including pig vaccine adjuvants whose composition is publicly available, again to illustrate the inclusion of adjuvants that wouldn't be approved in humans, such as IFA (Incomplete Freund's Adjuvant).Porcine Circovirus Type 2 (PCV2) causes a wasting syndrome in piglets, a considerable economic cost in livestock agriculture. There are at least 4 commercial PCV2 vaccines, each formulated with a different adjuvant.The mineral (paraffin) oil called IFA (Incomplete Freund's Adjuvant) was long ago shown to have site injection site reactivity in humans. Circovac approved for use in Canada and Europe, Circumvent in Canada and USA, and Porcilis PCV2 in Europe and Korea, all include it.Acrylic acid polymer listed as aqueous polymer in the table above is one of the oldest and safest adjuvants used in pigs and other livestock (25).Its half-life is unknown (26).Also called Carbopol, it cross-links to create a network, a shape that easily entraps a variety of antigenic structures, enabling optimal controlled release of small antigenic moieties (27).Squalene, a cholesterol precursor, is an adjuvant with a historic lineage stretching back to the original discovery of adjuvants in the 1890s by Lydia Rabinowitsch-Kempner. Context? Butter, yes, butter!In turn, squalene brings us full circle to some of the modern adjuvants we now use in human vaccines.Human Vaccine Adjuvants: Recent Innovations and additionsFor several decades, the only adjuvant approved for human use was alum.Problem with alum is that it mainly promotes antibody production but not other types of immune responses.This truncates its usefulness.For example, activated cytotoxic T cells are crucial in control and elimination of viruses but alum is not efficient at activating them.An attempt to circumvent such limitations of alum is to add Pattern recognition receptor (PRR) agonists to it.GlaxoSmithKline's Hepatitis B vaccine, Engerix-B, has alum (aluminium hydroxide) plus a TLR4 (Toll-like Receptor) agonist (MPL®, Monophosphoryl lipid A, a proprietary derivative of gram-negative bacteria cell wall) named AS04.The same adjuvant AS04 is also present in the Cervarix® vaccine, approved by the US Food and Drug Administration (FDA) in 2009.Virosomes are liposomal adjuvants, a combination of natural or synthetic phospholipids with viral envelope phospholipids, glycoproteins or other viral proteins. Their key attribute? Ability to fuse (fusogenic). Two virosome-based vaccine products are licensed in Europe. The Crucell company, Berna Biotech AG developed and patented the virosome-adjuvanted flu vaccine Inflexal®, and Hepatitis A vaccine, Epaxal®.MF59, a new Oil-in-Water Emulsion approved for use in humans in EuropeDeveloped and licensed by Chiron-Novartis Vaccines.Contains biodegradable squalene oil (4.3%) and non-ionic surfactants, Tween 80 and Span 85, in a citrate buffer.Squalene is a natural precursor to cholesterol.MF59 adjuvant activity was serendipitously discovered when it was being developed as a delivery system for another experimental adjuvant.Used in the flu vaccine Fluad in Europe.MF59-adjuvanted flu vaccine induces similar response against H5N1 compared to the alum-adjuvanted one.A major advantage of MF59 is that it is very dose-sparing, i.e. induces similar immune response using much less dose of antigen so very cost-saving and much more optimal for pandemic flu vaccine production.Unlike the alum-adjuvanted vaccine, the MF59-adjuvanted one induces both cellular immunity and antibody production.BibliographyOda K., Tsukahara F., Kubota S., Kida K., Kitajima T., Hashimoto S.: Emulsifier content and side effect of oil based adjuvant vaccine in swine. Research in Veterinary Science 81, 2006 51-57.Aucouturier J., Deville S., Perret C., Vallée I., Boireau P. Assessment of efficacy and safety of various adjuvant formulations with a total soluble extract of Trichinella spiralis. Parasite. 2001 Jun;8 (2 Suppl):S126-32.Hendrick MJ, Goldschmidt MH, Shofer F, et al: Postvaccinal sarcomas in the cat: Epidemiology and electron probe microanalytical identification of aluminum. Cancer Res 52:5391-5394, 1992.Hendrick MJ. Historical review and current knowledge of the risk factors involved in feline vaccine-associated sarcomas. J Am Vet Med Assoc 1998;213:1422–1423.Morrison WB, Start RM. Vaccine-Associated Feline Sarcoma Task Force. J Am Vet Med Assoc 2001;218:697–702.Kass PH, Barres WG Jr, Spangler WL, et al. Epidemiologic evidence for a causal relation between vaccination and fibrosarcoma tumorigenesis in cats. J Am Vet Med Assoc 1993;203:396–405.Macy DW. Vaccine adjuvants. Semin Vet Med Surg (Small Anim) 1997;12:206–211; Hendrick MJ. Historical review and current knowledge of the risk factors involved in feline vaccine-associated sarcomas. J Am Vet Med Assoc 1998;213:1422–1423.Couto CG, Macy DW. Review of treatment options for vaccineassociated feline sarcoma. J Am Vet Med Assoc 1998;213;1426–1427.Esplin DG, McGill LD, Meininger AC, et al. Postvaccination sarcomas in cats. J Am Vet Med Assoc 1993;202:1245–1247.Macy DW, Hendrick MJ. The potential role of inflammation in the development of postvaccinal sarcomas in cats. Vet Clin North Am Small Anim Pract 1996;26:103–109.Hendrick MJ. Feline vaccine-associated sarcomas: current studies on pathogenesis. J Am Vet Med Assoc 1998;213:1425–1426.Jelinek FE. Postinflammatory sarcoma in cats. Exp Toxicol Pathol 2003;55:167–172.Richards JR. Feline Sarcoma Task-Force meets. J Am Vet Med Assoc 1997;210:310–311.Kass PH, Spangler WL, Hendrick MJ, et al. Multicenter case-control study of risk factors associated with development of vaccine-associated sarcomas in cats. J Am Vet Med Assoc 2003; 223:1283–1292.Wilcock B, Wilcock A and Bottoms K. Feline postvaccinal sarcoma: 20 years later. Can Vet J 2012; 53: 430–434.Srivastav A, Kass PH, McGill LD, Farver TB and Kent MS. Comparative vaccine-specific and other injectable-specific risks of injection-site sarcomas in cats. J Am Vet Med Assoc 2012; 241: 595–602.Scherk, Margie A., et al. "2013 AAFP Feline Vaccination Advisory Panel Report." Journal of feline medicine and surgery 15.9 (2013): 785-808. Page on felineasthma.orgMoore GE, DeSantis-Kerr AC, Guptill LF, Glickman NW, Lewis HB and Glickman LT. Adverse events after vaccine administration in cats: 2560 cases (2002–2005). J Am Vet Med Assoc 2007; 231: 94–100.Gobar G and Kass P. World Wide Web-based survey of vaccination practices, postvaccinal reactions, and vaccine site-associated sarcomas in cats. J Am Vet Med Assoc 2002; 220: 1477–1482.Animal and Plant Health Inspection Service, USDA. 9 CFR Parts 101 and 116 [Docket No. 00-071-1]. Viruses, Serums, Toxins, and Analogous Products; Records and Reports. Fed Regist 2002;67: 1910–1913.Day, M. J., M. C. Horzinek, and R. D. Schultz. "WSAVA guidelines for the vaccination of dogs and cats." Journal of Small Animal Practice 51.6 (2010): e1-e32. Page on wiley.comSpickler, Anna R., and James A. Roth. "Adjuvants in veterinary vaccines: modes of action and adverse effects." Journal of Veterinary Internal Medicine 17.3 (2003): 273-281. Adjuvants in Veterinary Vaccines: Modes of Action and Adverse EffectsRichards, James R., et al. "The 2006 American association of feline practitioners feline vaccine advisory panel report." Journal of the American Veterinary Medical Association 229.9 (2006): 1405-1441.Heegaard, Peter MH, et al. "Adjuvants and delivery systems in veterinary vaccinology: current state and future developments." Archives of virology 156.2 (2011): 183-202. Page on researchgate.netDiamantstein, T., Wagner, B., Beyse, I., Odenwald, M.V., Schulz, G., 1971. Stimulation of humoral antibody formation by polyanions. I. The effect of polyacrylic acid on the primary immune response in mice immunized with sheep red blood cells. Eur. J. Immunol. 1, 335–340.Mair, K. H., et al. "Carbopol improves the early cellular immune responses induced by the modified-life vaccine Ingelvac PRRS® MLV." Veterinary microbiology 176.3 (2015): 352-357. Carbopol improves the early cellular immune responses induced by the modified-life vaccine Ingelvac PRRS® MLVSingla, A.K., Chawla, M., Singh, A., 2000. Potential applications of carbomer in oral mucoadhesive controlled drug delivery system: a review. Drug Dev. Ind. Pharm. 26, 913–924.

How can I do a good EVS project?

Ramnarain Ruia Jr. College, Matunga05/09/2015Environmental studies ProjectHospital Waste Management in Kurla Area:ü1.Selection of Topic (10 marks)ü2.Objectives(4 marks)ü3.Review of literature(4 marks)ü4.Relevance(4 marks)ü5.Proposed methodology(8 marks)6..Description of the method followed(8 marks)ü7.Observation(2 marks)ü8.Analysis(4 marks)ü9.conclusion(2 marks)10.Report writing(4 marks)11.viva-voice(10 marks)“Hospital (Medicinal) Waste”An Environmental Hazard and Its ManagementSelection of topic:The proper management of biomedical waste has become a worldwide humanitarian topic today. Although hazards of poor management of biomedical waste have aroused the concern world over, especially in the light of its far-reaching effects on human, health and the environment.2Now it is a well-established fact that there are many adverse and harmful effects to the environment including human beings which are caused by the “Hospital waste” generated during the patient care. Hospital waste is a potential health hazard to the health care workers, public and flora and fauna of the area. The problems of the waste disposal in the hospitals and other health-care institutions have become issues of increasing concern.Hospital is a place of almighty, a place to serve the patient. Since beginning, the hospitals are known for the treatment of sick persons but we are unaware about the adverse effects of the garbage and filth generated by them on human body and environment. Now it is a well-established fact that there are many adverse and harmful effects to the environment including human beings which are caused by the "Hospital waste" generated during the patient care. Hospital waste is a potential health hazard to the health care workers, public and flora and fauna of the area. Hospital acquired infection, transfusion transmitted diseases, rising incidence of Hepatitis B, and HIV, increasing land and water pollution lead to increasing possibility of catching many diseases. Air pollution due to emission of hazardous gases by incinerator such as Furan, Dioxin, Hydrochloric acid etc. have compelled the authorities to think seriously about hospital waste and the diseases transmitted through improper disposal of hospital waste. This problem has now become a serious threat for the public health and, ultimately, the Central Government along with state government had to intervene for enforcing proper handling and disposal of hospital waste and an act was passed in July 1996 and a bio-medical waste (handling and management) rule was introduced in 1998.A modern hospital is a complex, multidisciplinary system which consumes thousands of items for delivery of medical care and is a part of physical environment. All these products consumed in the hospital leave some unusable leftovers i.e. hospital waste. The last century witnessed the rapid mushrooming of hospital in the public and private sector, dictated by the needs of expanding population. The advent and acceptance of "disposable" has made the generation of hospital waste a significant factor in current scenario.As I live in Kurla I am very much familiar with the present day conditions regarding the above topic. The area is much crowdy as compared to other areas of the city. It is the main site where one can find slum areas, so the chances of effects due to improper hospital waste management are more in this area. Also the people are not aware of the fact that there is something called hospital waste management. Most of the people categorize all the waste under same column and that’s the worst part of it.Therefore in order to catch people’s attention towards this problem I choose this topic under environmental studies.I am sure that it may contribute a little fraction in creating awareness among the citizens.Objectives:Need of biomedical waste management in hospitals:While selecting this topic, the question aroused in my mind was “why do we need to separate this waste from household waste?” I gone through various articles and the reports served by municipality officials and came to know that how dangerous it would be if we are not separating this waste. Still separating wasn’t enough. It has to be decomposed or manage properly in order make it safeHospital 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 many resources in terms of money, man power, material and machine for management of hospital waste?The reasons due to which there is great need of management of hospital waste such as:1.Injuries from sharps leading to infection to all categories of hospital personnel and waste handler.2.Nosocomial 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 ash3.To make people aware of the fact, what is hospital waste?Hospital waste refers to all waste generated, discarded and not intended for further use in the hospital.According to Biomedical Waste (Management and Handling) Rules, 1998 of India “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.Review of literature:As this topic is very much familiar with metro cities like Mumbai I got a lot of information regarding above topic from following sources:ØRecent reports given by local municipality and state government officials.ØGuidelines given by WHO regarding hospital waste management and their disposal.ØInterviews of respected hospital officials (waste managers).ØEfforts carried out by various NGO’s in respective areas.ØAt the State level, many States are developing new standards to control medical waste disposal.ØBecause of the information need to support the implementation of the regulations, both the Federal Government and the States have conducted various studies. This paper represents a discussion of what has been learned as a result of these studies.ØEvaluation of medical waste treatment technologies conducted by private industries;ØCase study: hospital waste management (Kurla area)Relevance:Scientific Relevance:·In order to understand how this topic is related scientifically following points must be understood. The following information provides how this waste is classified:-(1) General waste: Largely composed of domestic or house hold type waste. It is non-hazardous to human beings, e.g. kitchen waste, packaging material, paper, wrappers, plastics.(2) Pathological waste: Consists of tissue, organ, body part, human foetuses, blood and body fluid. It is hazardous waste.(3) Infectious waste: The wastes which contain pathogens in sufficient concentration or quantity that could cause diseases. It is hazardous e.g. culture and stocks of infectious agents from laboratories, waste from surgery, waste originating from infectious patients.(4) Sharps: Waste materials which could cause the person handling it, a cut or puncture of skin e.g. needles, broken glass, saws, nail, blades, and scalpels.(5) Pharmaceutical waste: This includes pharmaceutical products, drugs, and chemicals that have been returned from wards, have been spilled, are outdated, or contaminated.(6) Chemical waste: This comprises discarded solid, liquid and gaseous chemicals e.g. cleaning, house keeping, and disinfecting product.(7) Radioactive waste: It includes solid, liquid, and gaseous waste that is contaminated with radionucleides generated from in-vitro analysis of body tissues and fluid, in-vivo body organ imaging and tumour localization and therapeutic procedures.·How this waste is disposed?Based on Bio-medical Waste (Management and Handling) Rules 1998, notified under the Environment Protection Act by the Ministry of Environment and Forest (Government of India).1. Segregation of wasteSegregation is the essence of waste management and should be done at the source of generation of Bio-medical waste e.g. all patient care activity areas, diagnostic services areas, operation theaters, labour rooms, treatment rooms etc. The responsibility of segregation should be with the generator of biomedical waste i.e. doctors, nurses, technicians etc. (medical and paramedical personnel). The biomedical waste should be segregated as per categories mentioned in the rules.2. Collection of bio-medical wasteCollection of bio-medical waste should be done as per Bio-medical waste (Management and Handling) Rules. At ordinary room temperature the collected waste should not be stored for more than 24 hours.Types of container and colour code for collection of bio-medical waste.CategoryWaste classType of containerColour1.Human anatomical wastePlasticYellow2.Animal waste-do--do-3.Microbiology and Biotechnology waste-do-Yellow/Red4.Waste sharpPlastic bag puncture proof containersBlue/White Translucent5.Discarded medicines and Cytotoxic wastePlastic bagsBlack6.Solid (biomedical waste)-do-Yellow7.Solid (plastic)Plastic bag puncture proof containersBlue/White Translucent8.Incineration wastePlastic bagBlack9.Chemical waste (solid)-do--do-3. TransportationWithin hospital, waste routes must be designated to avoid the passage of waste through patient care areas. Separate time should be earmarked for transportation of bio-medical waste to reduce chances of it's mixing with general waste. Desiccated wheeled containers, trolleys or carts should be used to transport the waste/plastic bags to the site of storage/ treatment.Trolleys or carts should be thoroughly cleaned and disinfected in the event of any spillage. The wheeled containers should be so designed that the waste can be easily loaded, remains secured during transportation, does not have any sharp edges and is easy to clean and disinfect. Hazardous biomedical waste needing transport to a long distance should be kept in containers and should have proper labels. The transport is done through desiccated vehicles specially constructed for the purpose having fully enclosed body, lined internally with stainless steel or aluminium to provide smooth and impervious surface which can be cleaned. The drivers compartment should be separated from the load compartment with a bulkhead. The load compartment should be provided with roof vents for ventilation.4. Treatment of hospital wasteTreatment of waste is required:· to disinfect the waste so that it is no longer the source of infection.· to reduce the volume of the waste.· make waste unrecognizable for aesthetic reasons.· make recycled items unusable.4.1 General wasteThe 85% of the waste generated in the hospital belongs to this category. The, safe disposal of this waste is the responsibility of the local authority.4.2 bio-medical waste: 15% of hospital waste· 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.· Autoclave and microwave treatment Standards for the autoclaving and microwaving are also mentioned in the Biomedical waste (Management and Handling) Rules 1998. All equipment installed/shared should meet these specifications. The waste under category 3,4,6,7 can be treated by these techniques. Standards for the autoclaving are also laid down.· 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.· Secured landfill:: The incinerator ash, discarded medicines, cytotoxic substances and solid chemical waste should be treated by this option.· Incineration: The incinerator should be installed and made operational as per specification under the BMW rules 1998 and a certificate may be taken from CPCB/State Pollution Control Board and emission levels etc should be defined. In case of small hospitals, facilities can be shared. The waste under category 1,2,3,5,6 can be incinerated depending upon the local policies of the hospital and feasibility. The polythene bags made of chlorinated plastics should not be incinerated.· It may be noted that there are options available for disposal of certain category of waste. The individual hospital can choose the best option depending upon the facilities available and its financial resources. However, it may be noted that depending upon the option chosen, correct colour of the bag needs to be used.5. Safety measures5.1 All the generators of bio--medical waste should adopt universal precautions and appropriate safety measures while doing therapeutic and diagnostic activities and also while handling the bio-medical waste.5.2 It should be ensured that:· drivers, collectors and other handlers are aware of the nature and risk of the waste.· written instructions, provided regarding the procedures to be adopted in the event of spillage/ accidents.· protective gears provided and instructions regarding their use are given.· workers are protected by vaccination against tetanus and hepatitis B.6. Training· each and every hospital must have well planned awareness and training programme for all category of personnel including administrators (medical, paramedical and administrative).· all the medical professionals must be made aware of Bio-medical Waste (Management and Handling) Rules 1998.· to institute awards for safe hospital waste management and universal precaution practices.· training should be conducted to all categories of staff in appropriate language/medium and in an acceptable manner.7. Management and administrationHeads of each hospital will have to take authorization for generation of waste from appropriate authorities as notified by the concerned State/U.T. Government, well in time and to get it renewed as per time schedule laid down in the rules. Each hospital should constitute a hospital waste management committee, chaired by the head of the Institute and having wide representation from all major departments. This committee should be responsible for making Hospital specific action plan for hospital waste management and its supervision, monitoring and implementation. The annual reports, accident reports, as required under BMW rules should be submitted to the concerned authorities as per BMW rules format.8. Measures for waste minimizationAs far as possible, purchase of reusable items made of glass and metal should be encouraged. Select non PVC plastic items. Adopt procedures and policies for proper management of waste generated, the mainstay of which is segregation to reduce the quantity of waste to be treated. Establish effective and sound recycling policy for plastic recycling and get in touch with authorised manufactures.Social relevance:This project completely focuses on why do we need to separate this waste and why do we need to dispose them effectively.§It has a great impact on health of local citizens. So it is completely socially relevant.§A major issue related to current Bio-Medical waste management in many hospitals is that the implementation of Bio-Waste regulation is unsatisfactory as some hospitals are disposing of waste in a haphazard, improper and indiscriminate manner. Lack of segregation practices, results in mixing of hospital wastes with general waste making the whole waste stream hazardous. Inappropriate segregation ultimately results in an incorrect method of waste disposal.§Inadequate Bio-Medical waste management thus will cause environmental pollution, unpleasant smell, growth and multiplication of vectors like insects, rodents and worms and may lead to the transmission of diseases like typhoid, cholera, hepatitis and AIDS through injuries from syringes and needles contaminated with human.6§Various communicable diseases, which spread through water, sweat, blood, body fluids and contaminated organs, are important to be prevented. The Bio Medical Waste scattered in and around the hospitals invites flies, insects, rodents, cats and dogs that are responsible for the spread of communication disease like plague and rabies. Rag pickers in the hospital, sorting out the garbage are at a risk of getting tetanus and HIV infections. The recycling of disposable syringes, needles, IV sets and other article like glass bottles without proper sterilization are responsible for Hepatitis, HIV, and other viral diseases. It becomes primary responsibility of Health administrators to manage hospital waste in most safe and eco-friendly manner6.The problem of bio-medical waste disposal in the hospitals and other healthcare establishments has become an issue of increasing concern, prompting hospital administration to seek new ways of scientific, safe and cost effective management of the waste.· Municipal authority : As quite a large percentage of waste (in India upto 85%), generated in Indian hospitals, belong to general category (non-toxic and non-hazardous), hospital should have constant interaction with municipal authorities so that this category of waste is regularly taken out of the hospital premises for land fill or other treatment.· Co-ordination with Pollution Control Boards: Search for better methods technology, provision of facilities for testing, approval of certain models for hospital use in conformity with standards 'aid down.· Development of non-PVC plastics as a substitute for plastic which is used in the manufacture of disposable items• Establishment of training programs for workers to improve the quality and quantity of work.• Protection of workers against occupational risks.·Economic Relevance:Medical waste requires more amount of money as compared to household waste or any other waste as it has to be decomposed very efficiently and carefully. Regardless of how much money is being spent we need to check for whether the money spent is being used properly or not for that we need to search for cost effective and environmental friendly technology for treatment of bio-medical and hazardous waste. Also, to search for suitable materials to be used as containers for bio-medical waste requiring incineration/autoclaving/ microwaving. This project mainly focuses on reducing expenditure regarding waste management.Cost reductions can be achieved by taking particular measures at different stages in the management of wastes: On-site management• Comprehensive management of chemicals and pharmaceuticals stores.• Substitution of disposable medical care items by recyclable items.• Adequate segregation of waste to avoid costly or inadequate treatment of waste that does not require it.• Improved waste identification to simplify segregation, treatment, and recycling. Comprehensive planning• Planning collection and transport in such a way that all operations are safe and cost-efficient. • Possible cooperative use of regional incineration facilities, including private sector facilities where appropriate.• Selection of a treatment and disposal option that is appropriate for waste type and local circumstances.• Use of treatment equipment of appropriate type and capacity. Measures at personnel levelPROPOSED METHODOLOGY:In order to collect all the information and to have a descriptive look on the topic stated above, the best way was to take interviews of the respective people in the field of waste management. As most of the people in this area are not that much familiar with the things like how waste in managed and how all things take place, there was no use of taking interviews of local people. So most important task in front of me was to collect all information and put this in front of local citizens so that they would understand what this thing is.Interviewee:Hospital waste managers.Workers or handlers.Transporters.BMC officials in respective areas.Local people facing problems regarding the same.Medical students in the area stated above.Active NGO’s in above area.Citizens in damping areas.Requirements:As I have to conduct interviews I have to be prepared with all the questions.A camera is must for recording all statements given by respective people.List of prestigious hospitals in the area.List of hospital waste managers in respective hospitals.Sufficient information regarding the questions which I need to ask.Permission of hospital authorities to conduct interviews.A guide.How to proceed?As stated earlier, my motto was to conduct interviews of officials and put them in front of local citizens:Questions to officials:1.What are Biomedical wastes?2.What are biodegradable and non-biodegradable wastes?Questions to workers:3.What is the quantum of waste that is generated by a hospital?4.What are disinfection and sterilization?5.What are the colour codes and type of containers used for disposal of biomedical waste?6.What materials can be recycled?7.How long can bio medical waste be stored?Questions to BMC officials:8.What are the hazards associated with poor health care waste management?9.Who are the persons at risk of the hazards of medical procedures?10.What are the rules and regulations governing the disposal of these wastes?Questions to medical students:11.What are the responsibilities of health care institutions regarding biomedical waste management?Questions to NGO’s:12.What are the different hospital waste categories?13.What is Biosafety?14.What are the disinfectants commonly used for disinfection of materials contaminated with blood and body fluids?15.How is disinfection of the various items commonly used in the hospital carried out?Thus, this is how I need to proceed in order to complete my project work. Along with that I may require methods like mouth publicity, pamphlets regarding the same. And most important in order to complete it effectively I need to be guided by my EVS teacher.DESCRIPTION OF THE METHOD FOLLOWED:Answers to the questions asked:1.Biomedical wastes are defined as waste that is generated during the diagnosis, treatment or immunization of human beings or animals, or in research activities pertaining thereto, or in the production of biological.2.Biodegradable waste means any waste that is capable of undergoing anaerobic or aerobic decomposition, such as food and garden waste, and paper and paperboard. It also includes waste from households, which because of its nature and composition is similar to biodegradable waste from households.Non-biodegradable wastes are the wastes that cannot be decomposed by bacteria eg.plastics, bottles and tins.3.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. e.g. a 100 bedded hospital will generate 100 – 200 kgs of hospital waste/day. It is estimated that only 5 – 10% of this comprises of hazardous/infectious waste (5 – 10kgs/day)4.Proper disposal of biomedical waste is of paramount importance because of its infectious and hazardous characteristics. Improper disposal can result in the following:· Organic portion ferments and attracts fly breeding· Injuries from sharps to all categories of health care personnel and waste handlers· Increase risk of infections to medical, nursing and other hospital staff· Injuries from sharps to health workers and waste handlers· Poor infection control can lead to nosocomial infections in patients particularly HIV, Hepatitis B & C· Increase in risk associated with hazardous chemicals and drugs being handled by persons handling wastes· Poor waste management encourages unscrupulous persons to recycle disposables and disposed drugs for repacking and reselling· Development of resistant strains of microorganisms5.ProcedurePerson at riskMode of TransmissionCollection of blood samplesPatient Health workerContaminated needle, gloves, Skin puncture by needle or container,Contamination of hands by bloodTransfer of specimens (within laboratory)Laboratory personnelContamination of exterior of specimen container, Broken container,Splash of specimenHIV serology and virologyLaboratory personnelSkin puncture, splash of specimen,6.The Government of India has promulgated the Biomedical Waste (Management and Handling) Rules 1998. They are applicable to all persons who generate, collect, receive, store, transport, treat, dispose or handle biomedical wastes. This includes hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories and blood banks.7.It is mandatory for such institutions to:Set up biomedical waste treatment facilities like incinerators, autoclave and microwave systems for treatment of the wastesMake an application to the concerned authorities for grant of authorizationSubmit a report regarding information about the categories and quantities of biomedical wastes handled during the preceding year by 31 Jan every yearMaintain records about the generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling bio medical wasteReport immediately any accident to the prescribed authority8.Biosafety is essentially a preventive concept and consists of wide variety of safety precautions that are to be undertaken, either singly or in combination, depending on the type of hazard by all medical, nursing and paramedical workers as well as by patients, attendants, ancillary staff and administrators in a hospital.9.Disinfection and sterilization are important procedures in biosafety. Disinfection refers to procedures which reduce the number of microorganisms on an object or surface but not the complete destruction of all microorganism or spores. Sterilisation on the other hand, refers to procedures, which would remove all microorganisms, including spores, from an object. Sterilisation is undertaken either by dry heat (for 2 hours at 1700C in an electric oven – method of choice for glass ware and sharps) or by various forms of moist heat (i.e. boiling in water for an effective contact time of 20 min or steam sterilization in an autoclave at 15 lb/sq inch at 1210C for 20 min)Name of DisinfectantAvailable chlorineRequired chlorineRequired chlorine Contact periodAmount of disinfectant to be dissolved in 1 ltr of waterSodium hypochlorite5%0.5%30 min100 mlCalcium hypochlorite70%0.5%30 min7.0 gmNa OCl powder-0.5%30 min8.5 gm10.OBSERVATION:Amount and composition of hospital waste generated(a) AmountAreaQuantity (kg/bed/day)SionDadarAndheriKurla2.54.52.53.0b) (Hazardous/non-hazardous)Hazardous15%a) Hazardous but non-infective5%b) Hazardous and infective10%Non-hazardous85%c) Composition(By weight):Plastic14%CombustibleDry cellublostic solid45%Wet cellublostic solid18%Non-combustible20%ANALYSIS:Following observations were made during my visit to respective clinics and hospitals in Kurla area.Major Sources§Govt. hospitals/private hospitals/nursing homes/ dispensaries.§Primary health centers.§Medical colleges and research centers/ paramedic services.§Veterinary colleges and animal research centers.§Blood banks/mortuaries/autopsy centers.§Biotechnology institutions.§Production units.Minor Sources§Physicians/ dentists’ clinics§Animal houses/slaughter houses.§Problems relating to biomedical waste§advances in this area. The need of proper hospital waste management system is of prime importance and is an essential component of quality assurance in hospitals§Blood donation camps.§Vaccination centers.§Acupuncturists/psychiatric clinics/cosmetic piercing.§Funeral services.§Institutions for disabled personsCONCLUSION:Medical wastes should be classified according to their source, typology and risk factors associated with their handling, storage and ultimate disposal. The segregation of waste at source is the key step and reduction, reuse and recycling should be considered in proper perspectives. We need to consider innovative and radical measures to clean up the distressing picture of lack of civic concern on the part of hospitals and slackness in government implementation of bare minimum of rules, as waste generation particularly biomedical waste imposes increasing direct and indirect costs on society. The challenge before us, therefore, is to scientifically manage growing quantities of biomedical waste that go beyond past practices. If we want to protect our environment and health of community we must sensitize our selves to this important issue not only in the interest of health managers but also in the interest of community.

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