2016 Sao Paulo SP Brazil

Transcription

1 ENVIRONMENTAL COMPANY OF SAO PAULO STATE CETESB REGIONAL CENTRE OF STOCKHOLM CONVENTION ON POPs FOR LATIN AMERICA AND THE CARIBBEAN REGION V INTERNATIONAL TRAINING PROGRAM ON ENVIRONMENTAL SOUND MANAGEMENT ON CHEMICALS AND WASTES, ESPECIALLY ON PERSISTENT ORGANIC POLLUTANTS (POPs) AND MERCURY (Hg) Management of Medical Waste Chem. Patricia de Souza Medeiros Barbosa 2016 Sao Paulo SP Brazil

2 MEDICAL WASTE Source:

3 DEFINITION OF HCW National Policy on Solid Waste - NPSW (Law no. 12,305/2010) Waste generated in healthcare services, as defined in regulation or in standards established by the agencies of the National Environment System - SISNAMA, and the National Health Surveillance System - SNVS (Art. 13, section I, item g) 3

4 ANVISA RDC Resolution 306/2004 and CONAMA Resolution 385/2005 All waste resulting from activities executed in services related to human or animal health, including: home care services and field projects analytical laboratories for health products morgues, funeral homes and services and where embalming activities are carried out (thanatopraxy and corpse preservation) teaching and research establishments in the healthcare area drug stores and pharmacies including handlers legal medicine services zoonoses control centers distributors of pharmaceutical products importers, distributors and producers of materials and controls for diagnosis in vitro mobile healthcare units acupuncture services, tattooing services, among others

5 HCW MANAGEMENT BIOLOGICAL CHEMICAL RADIOLOGICAL PHYSICAL SPECIFIC MANAGEMENT METHODS

6 HCW MANAGEMENT The complexity of the HCW requires a joint action by the federal, state and municipal environmental agencies for the environment, healthcare and urban cleansing, with the aim of regulating its management Inadequate management of HCW also imposes occupational risks to work environments, as well as to the population in general

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9 KEY LEGAL AND NORMATIVE ASPECTS In order to minimize these risks, AND preserve public health and the quality of the environment, there is a set of laws, resolutions and standards, issued by official agencies, particularly healthcare and environment agencies, both in the federal sphere and in the state and municipal sphere, which regulate the management of HCW CONAMA Resolution no.06 The incineration or any other burning treatment of solid waste originating from healthcare establishments and transport terminals is waived, and power has been invested in state environmental agencies to establish standards and procedures for the environmental licensing of the collection, transport and conditioning system and final disposal of waste, in states and municipalities that have opted for non-incineration.

10 KEY LEGAL AND NORMATIVE ASPECTS CONAMA* ANVISA** Process of harmonizing federal regulations in relation to HCW management ANVISA RDC Resolution no. 306/2004 and CONAMA Resolution no. 385/2005 * National Environment Council, ** National Health Surveillance Agency

11 KEY LEGAL AND NORMATIVE ASPECTS ANVISA RDC Resolution no. 306/2004 Provides Technical Regulation for HCW management Applied to all generators Disciplines all stages of HCW management in its intra and extra generator establishment aspects, that is: segregation, conditioning, identification, internal and external collection/transportation, internal and external storage and final treatment/disposal

12 KEY LEGAL AND NORMATIVE ASPECTS CONAMA Resolution no. 385/2005 Covers treatment and final disposal of HCW and supplies other provisions Depending on the characteristics of the waste, determines the respective treatment and/or final disposal methods, including in relation to the dispensation of previous treatment for specific HCW groups As with sanitary legislation, it presents the classification of HCW in different groups, determined from the characteristics of the waste and the potential risk posed to public health and the environment, which will require specific forms of treatment and/or final disposal

13 ABNT NBR 12,807 - Healthcare Waste - Terminology (under review) ABNT NBR 12,808 - Healthcare Waste - Classification (under review) ABNT NBR 12,809 - Healthcare Waste Handling - Procedure (under review) ABNT NBR 12,810 - Healthcare Waste Collection - Procedure (under review) CETESB Technical Standard E15.010/ Heat treatment systems without combustion of biologically-contaminated healthcare waste: Procedure Technical Standard E15.011/2007 System for incineration of healthcare waste - Procedure CONAMA Resolution no. 316/ Provides procedures and criteria for the operation of waste heat treatment services (amended by CONAMA Resolution no. 386/2006) CETESB Technical Standard P4.262/ 2007 Management of chemical waste originating from healthcare establishments: procedure CVS (Health Surveillance Center) Ordinance no. 21/2008 Approves the Technical Standard on Management of Hazardous Medicine Waste in Healthcare Services

14 KEY LEGAL AND NORMATIVE ASPECTS National Policy on Solid Waste - NPSW (Law no. 12,305/2010) HCW is waste generated in healthcare services, as defined in regulation or in standards established by the agencies of SISNAMA and SNVS (art.13, section I, item g) and establishes that the HCW generators are subject to the development of a solid waste management plan (Art. 20, section I) Prior to NPSW approval, environmental and sanitary legislation in force in relation to HCW management already established the requirement for generators, in operation or to be implanted, to develop and implant the SWMP

15 KEY LEGAL AND NORMATIVE ASPECTS CONAMA Resolution no. 385/2005 Art. 2, section XI Medical Waste Management Plan - HCWMP: integral document of the environmental licensing process, based on the principles of non-generation of waste and minimization of waste generation, which outlines and describes actions relative to its handling, within the scope of the services in mentioned in art. 1 of this Resolution, considering aspects in relation to the generation, segregation, conditioning, collection, storage, transportation, recycling, treatment and final disposal, as well as the protection of public health and the environment. Art. 3 Generators of medical waste and the legally responsible agent, referred to in art. 1 of this Resolution, are liable for the management of waste from its generation to its final disposal, in order to comply with environmental and public and occupational health requirements, notwithstanding the several liability of all those natural persons and legal entities that, directly or indirectly, cause or may cause environmental degradation, particularly transporters and operators of treatment and final disposal facilities, under the terms of Law no. 6,938 of August 31, 1981.

16 ANVISA RDC Resolution no. 306/2004 and CONAMA Resolution no. 385/2005 HCW Classification Group A Group B Group C Group D Group E Group A1 Group A2 Group A3 Group A4 Group A5

17 Group A Waste with the potential presence of BIOLOGICAL AGENTS that, given its characteristics of increased virulence or concentration, may pose an infection risk. Examples: micro-organism cultures and stocks culture media and instruments used for the transfer, inoculation or mixture of cultures animal carcasses anatomical parts (limbs) of human beings transfusion bags containing blood laboratory sample scraps containing blood and bodily fluids

18 Group A Waste with the potential presence of BIOLOGICAL AGENTS that, given its characteristics of increased virulence or concentration, may present an infection risk. Examples: micro-organism cultures and stocks culture media and instruments used for the transfer, inoculation or mixture of cultures animal carcasses anatomical parts (limbs) of human beings transfusion bags containing blood laboratory sample scraps containing blood and bodily fluids Sub-groups A1, A2, A3, A4 and A5 Treatment/Final disposal

19 Group B Waste containing CHEMICAL SUBSTANCES that may pose a risk to public health or the environment, depending on its flammability, corrosiveness, reactivity and toxicity characteristics. Examples: controlled medicines sanitizer and disinfectant waste laboratory reagents (including packaging) Group C any materials resulting from human activity that contain RADIONUCLIDES in quantities greater than the elimination limits specified in the standards of the National Nuclear Energy Commission - CNEN. Examples: nuclear medicine services radiotherapy WARNING: Radioactive Material

20 Group D Waste that DOES NOT POSE A BIOLOGICAL, CHEMICAL OR RADIOLOGICAL RISK to health or the environment, which may be treated as household waste. Examples: food and food preparation scraps administrative area waste sweeping, flower, pruning and gardening waste Group E PUNCTURING-CUTTING Materials or cutting tools (biological, chemical or radiological contamination). Examples: razor blades, needles, glass ampoules, diamond points, scalpel blades, knives and other similar items.

21 HCW MANAGEMENT STAGES SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL

22 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL Environmental legislation establishes that the segregation of waste at source and at the time of generation is obligatory, in order to reduce the amount of waste that requires treatment prior to final disposal

23 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL Bags or bins that prevent leakage and resist puncturing and rupturing action. The capacity of the conditioning bins must be compatible with the daily generation of each type of waste.

24 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL WARNING: Radioactive Material

25 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL

26 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL

27 Temporary storage (Waste Room) Temporary storage site of the bins containing conditioned waste, at a site close to the generation points, in order to facilitate collection within the establishment and optimize the movement between generating points and the external collection point. It may be waived in cases where the distance between the generation point and the external storage does not justify it.

28 External storage (Waste shelter) Location where waste bins are temporarily stored until external collection, in an exclusive environment with facilitated access for collecting vehicles.

29 External storage (Waste shelter) Dimensions in accordance with the volume of waste generated, with a storage capacity compatible with the collection frequency. ANVISA RDC Resolution no.306/2004 specific requirements for the construction of the shelter for Group and Group E waste with biological risk and the shelter for Group B waste. Easily-putrefacted waste that is collected for a period greater than 24 hours of its storage may be conserved in refrigeration andwhenthisisnotpossible,besubmitted to another conservation method.

30 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL

31 SEGREGATION CONDITIONING IDENTIFICATION INTERNAL TRANSPORTATION STORAGE COLLECTION AND EXTERNAL TRANSPORTATION TREATMENT FINAL DISPOSAL

32 HCW TREATMENT Environmental legislation prohibits the recycling, re-use or use, including for animal feed, of Group A waste INCINERATION and heat treatment without combustion in AUTOCLAVES and in MICROWAVE equipment are processes usually used in the treatment of biologicallycontaminated HCW The HCW treatment systems must be licensed by the competent environmental agency for the purpose of operation, and subject to monitoring in accordance with parameters and frequency defined in the environmental license

33 INCINERATION Oxidation of waste at high temperatures, under controlled conditions, which results in the transformation of chemical substances, in the significant reduction of the volume of waste (90% to 95%) and in the destruction of the biological load contained in waste + GROUP B

34 Final disposal in industrial landfill Classification - ABNT NBR 10004:2004 TEST BURN Set of measures taken at the unit operating with waste supply, to assess the compatibility of the operational conditions of the heat treatment system, in order to comply with the emission limits set out in specific regulations and with the technical requirements established by the competent environmental agency CONAMA Resolution no. 316/ Provides procedures and criteria for the operation of waste heat treatment services (amended by CONAMA Resolution no. 386/2006) Technical Standard E15.011/2007 System for incineration of healthcare waste - Procedure

35 CREMATORIUM

36 HEAT TREATMENT SYSTEMS WITHOUT COMBUSTION Alternative to incineration following CONAMA Resolution no. 06/1991 Promote the reduction of the microbial load contained in waste Final disposal at sanitary landfill ADVANTAGE LOWER COST DISADVANTAGE RESTRICTIONS FOR HCW GROUPS THAT MAY BE TREATED

37 CETESB Technical Standard E15.010/2011 Heat treatment systems without combustion of biologically-contaminated healthcare waste: procedure Equipment for the treatment of HCW Groups A1, A2 and A4 and Group E contaminated biologically, whose operation is based on the time of residence in the process and heating, promoting at least level III microbial inactivation Inactivation of vegetative bacteria, fungi, lipophilic and hydrophilic viruses, parasites and mycobacteria with a reduction equal to or greater than 6Log10, and inactivation of spores of Stearothermophilus bacillus and spores of Subtilis bacillus, with a reduction equal to or greater than 4Log10

38 AUTOCLAVE Sterilization by vapor saturated under pressure, destroying micro-organisms contained in waste by the combined action of temperature, pressure and humidity Sterilization temperature of up to 150 C Treatment cycle of 40 to 50 mins, including loading and unloading of waste

39 AUTOCLAVE

40 AUTOCLAVE Crushing RESTRICTIONS chemical waste and animal carcasses in equipment not provided with pre-coupled crusher Final disposal at sanitary landfill

41 HORIZONTAL AUTOCLAVE

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43 VERTICAL AUTOCLAVE Receipt and Storage of biologically-contaminated HCW

44 Pre-integrated crushing equipment

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46 MICROWAVE Decontamination of HCW with emission of high or low-frequency waves, at a temperature between 95ºC and 105ºC for approximately 30 minutes, which must undergo a crushing and humidifying process previously Closed and automated systems, and there is no generation of liquid effluents RESTRICTIONS chemical residue and large-scale animal carcasses, which must undergo prior fractioning, authorized by the competent healthcare body, as established in effective environmental legislation

47 MICROWAVE

48 ELECTRO-THERMAL DEACTIVATION

49 EFFICENCY TEST CETESB Technical Standard E15.010/2011 Heat treatment systems without combustion of biologically-contaminated healthcare waste: procedure The efficiency of the equipment must be assessed using commercial preparations (tapes) containing minimum populations of 10 4 spores of biological indicators: Bacillus atrophaeus ATCC 9372, for dry heat processes (microwave equipment) or Geobacillus stearothermophilus ATCC 7953, for moist heat processes (autoclaves) EFFICIENCY TEST PLAN

50 CETESB Technical Standard E15.010/2011 Heat treatment systems without combustion of biologically-contaminated healthcare waste: procedure EFFICIENCY TEST PLAN a) type of biological indicator to be used, considering the type of heat treatment without combustion (dry heat or moist heat) b) amount of indicators defined for the test, considering the nominal capacity of the treatment system and its configuration, and c) based on the type of equipment to be assessed, indicate the distribution points of the indicators in the waste load, or the insertion point of the indicators in the equipment, and its insertion frequency throughout the test.

51 CETESB Technical Standard E15.010/2011 Heat treatment systems without combustion of biologically-contaminated healthcare waste: procedure The test must be performed for the nominal capacity of the equipment, before its entry into operation, and whenever a change to the operational conditions for which the equipment was licensed is desired, or when requested by CETESB Autoclave Microwave

52 Autoclave Microwave OUTPUT INPUT Incubation of the material processed in laboratory Growth or non-growth of Bacillus atrophaeus or Geobacillus stearothermophilus

53 Absence of growth of Bacillus atrophaeus or Geobacillus stearothermophilus For operational conditions assessed, the equipment (autoclave or microwave) promotes the reduction of the microbial load compatible with level III inactivation, required by CETESB Technical Standard E15.010/2011 and by CONAMA Resolution no. 358/2005 EFFICIENCY

54 CONAMA Resolution no. 385/2005 Group A1 A2 A3 A4 A5 B C D E Treatment and/or final disposal Process that promotes reduction of microbial load compatible with level III of microbial inactivation and disposal in landfill Process that promotes reduction of microbial load compatible with level III of microbial inactivation and disposal in landfill or burial in animal cemetery Burial in cemetery or heat treatment by incineration or cremation May be forwarded to landfill without prior treatment Incineration Re-use, recovery or recycling/incineration or disposal in hazardous or non-hazardous waste landfills Decay of the radioactive element and disposal according to its biological, chemical or common waste categories Re-use, recovery or recycling/sanitary landfill Direction in accordance with biological, chemical or radiological contamination

55 PANORAMA OF HCW IN BRAZIL Research conducted in 2012 by ABRELPE (Brazilian Association of Public Cleaning and Special Waste Companies) Panorama of Solid Waste in Brazil document Of the 5,565 Brazilian municipalities, 4,282 provided in 2012, totally or partially, services related to the handling of HCW, resulting in a mean index of 1.5 kg per inhabitant/year. In this research, the survey of the information on HCW collected by the municipalities considered a universe of 401 municipalities interviewed by ABRELPE, with 60% of them being used for the projection of HCW amounts collected in the regions and for Brazil. The municipalities consulted and used for projection represent 40% of the total urban population of Brazil, indicated by IBGE (Brazilian Institute of Geography and Statistics) in 2012 Amount of HCW collected by municipalities - regions and Brazil (ABRELPE, 2012) Growth of 3% in total collected Source:

56 PANORAMA OF HCW IN BRAZIL Research conducted in 2012 by ABRELPE (Brazilian Association of Public Cleaning and Special Waste Companies) Panorama of Solid Waste in Brazil document ABRELPE stresses that the data presented for the regions and for Brazil should be interpreted and discussed with caution, since the HCW collection carried out by most municipalities is partial, which contributes significantly to the lack of knowledge about the total amount of HCW generated in Brazil. ABRELPE considers that the majority of Brazilian municipalities only collect and direct HCW generated in public health units, due to the liability assigned to the HCW generators, for the management of such waste from generation to its final disposal, in effective environmental legislation, CONAMA Resolution no. 358/2005 Source:

57 THANK YOU! Chem. Patricia de Souza Medeiros Barbosa CETESB - Environment Agency Of Sao Paulo State Contact pbarbosa@sp.gov.br Phone: 55 xx