ENVIRONMENTAL COMPANY OF SAO PAULO STATE – CETESB

REGIONAL CENTRE OF STOCKHOLM CONVENTION ON POPs FORLATIN 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 WasteChem. Patricia de Souza Medeiros Barbosa

2016

Sao Paulo – SP – Brazil

MEDICAL WASTE

Source: http://descarte-de.blogspot.com.br/

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

DEFINITION OF HCW

ANVISA RDC Resolution 306/2004 and CONAMA Resolution 385/2005

morgues, funeral homes and services and where embalming activities are

carried out (thanatopraxy and corpse preservation)

drug stores and pharmacies

including handlers

zoonoses control centers

home care services and field projects analytical laboratories

for health products

legal medicine servicesteaching and research establishments in the

healthcare area

importers, distributors and producers of materials and controls

for diagnosis in vitro

acupuncture services, tattooing services, among others

mobile healthcare units

distributors of pharmaceutical products

All waste resulting from activities executed in services related to human oranimal health, including:

SPECIFIC MANAGEMENT METHODS

BIOLOGICAL

CHEMICAL

RADIOLOGICAL

PHYSICAL

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

HCW MANAGEMENT

1991 - CONAMA Resolution no.06

The incineration or any other burning treatment of solid waste originatingfrom healthcare establishments and transport terminals is waived, and powerhas been invested in state environmental agencies to establish standards andprocedures for the environmental licensing of the collection, transport andconditioning system and final disposal of waste, in states and municipalitiesthat have opted for non-incineration.

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.

KEY LEGAL AND NORMATIVE ASPECTS

Process of harmonizing federal regulations in relation to HCW management

ANVISA RDC Resolution no. 306/2004 and CONAMA Resolution no. 385/2005

CONAMA* ANVISA**

KEY LEGAL AND NORMATIVE ASPECTS

* National Environment Council, ** National Health Surveillance Agency

ANVISA RDC Resolution no. 306/2004

Provides Technical Regulation for HCW management

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

Applied to all generators

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

KEY LEGAL AND NORMATIVE ASPECTS

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 E15.010/2011 - Heat treatment systems without combustion of biologically-contaminated healthcare waste: ProcedureTechnical Standard E15.011/2007 – System for incineration of healthcare waste - Procedure

CONAMA Resolution no. 316/2002 - 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: procedureCVS (Health Surveillance Center) Ordinance no. 21/2008 – Approves the Technical Standard on Management of Hazardous Medicine Waste in Healthcare Services

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

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.

KEY LEGAL AND NORMATIVE ASPECTS

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

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 stocksculture media and instruments used for the transfer, inoculation or mixture of culturesanimal carcassesanatomical parts (limbs) of human beingstransfusion bags containing bloodlaboratory sample scraps containing blood and bodily fluids

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 stocksculture media and instruments used for the transfer, inoculation or mixture of culturesanimal carcassesanatomical parts (limbs) of human beingstransfusion bags containing bloodlaboratory sample scraps containing blood and bodily fluids

Sub-groups → A1, A2, A3, A4 and A5

Treatment/Final disposal

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 medicinessanitizer and disinfectant wastelaboratory 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

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 scrapsadministrative area wastesweeping, 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.

• SEGREGATION

• CONDITIONING

• IDENTIFICATION

• INTERNAL TRANSPORTATION

• STORAGE

• COLLECTION AND EXTERNAL TRANSPORTATION

• TREATMENT

• FINAL DISPOSAL

HCW MANAGEMENT STAGES

• 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

• 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.

• SEGREGATION

• CONDITIONING

• IDENTIFICATION

• INTERNAL TRANSPORTATION

• STORAGE

• COLLECTION AND EXTERNAL

TRANSPORTATION

• TREATMENT

• FINAL DISPOSAL

WARNING: Radioactive Material

• SEGREGATION

• CONDITIONING

• IDENTIFICATION

• INTERNAL TRANSPORTATION

• STORAGE

• COLLECTION AND EXTERNAL

TRANSPORTATION

• TREATMENT

• FINAL DISPOSAL

• SEGREGATION

• CONDITIONING

• IDENTIFICATION

• INTERNAL TRANSPORTATION

• STORAGE

• COLLECTION AND EXTERNAL

TRANSPORTATION

• TREATMENT

• FINAL DISPOSAL

Temporary storage (Waste Room)

Temporary storage site of the binscontaining conditioned waste, at a site close tothe generation points, in order to facilitatecollection within the establishment andoptimize the movement between generatingpoints and the external collection point.

It may be waived in cases where thedistance between the generation point and theexternal storage does not justify it.

Location where waste bins are temporarily stored until external collection, inan exclusive environment with facilitated access for collecting vehicles.

External storage (Waste shelter)

External storage (Waste shelter)

Dimensions in accordance with the volume of waste generated, with a storagecapacity compatible with the collection frequency.

ANVISA RDC Resolution no.306/2004 – specific requirements for theconstruction of the shelter for Group and Group E waste with biological risk andthe shelter for Group B waste.

Easily-putrefacted waste that is collectedfor a period greater than 24 hours of itsstorage may be conserved in refrigerationand when this is not possible, be submittedto another conservation method.

• SEGREGATION

• CONDITIONING

• IDENTIFICATION

• INTERNAL TRANSPORTATION

• STORAGE

• COLLECTION AND EXTERNAL

TRANSPORTATION

• TREATMENT

• FINAL DISPOSAL

• SEGREGATION

• CONDITIONING

• IDENTIFICATION

• INTERNAL TRANSPORTATION

• STORAGE

• COLLECTION AND EXTERNAL

TRANSPORTATION

• TREATMENT

• FINAL DISPOSAL

INCINERATION and heat treatment without combustion in AUTOCLAVES and in MICROWAVE equipment are

processes usually used in the treatment of biologically-contaminated HCW

Environmental legislation prohibits the recycling, re-use or use, including for animal feed, of Group

A waste

HCW TREATMENT

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

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

INCINERATION

Final disposal in industrial landfill

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

Classification - ABNT NBR 10004:2004

CONAMA Resolution no. 316/2002 - Provides procedures and criteria for the operation of waste heattreatment services (amended by CONAMA Resolution no. 386/2006)Technical Standard E15.011/2007 – System for incineration of healthcare waste - Procedure

CREMATORIUM

HEAT TREATMENT SYSTEMS WITHOUT COMBUSTION

Promote the reduction of the microbial load contained in waste

Alternative to incineration following CONAMA Resolution no. 06/1991

Final disposal at sanitary landfill

ADVANTAGE LOWER COST

DISADVANTAGE RESTRICTIONS FOR HCW GROUPS THAT MAY BE TREATED

CETESB Technical Standard E15.010/2011Heat 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

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

AUTOCLAVE

AUTOCLAVE

Crushing

Final disposal at sanitary landfill

RESTRICTIONS chemical waste and animal carcasses in equipment not provided with

pre-coupled crusher

AUTOCLAVE

HORIZONTAL AUTOCLAVE

Receipt and Storage of biologically-contaminated

HCW

VERTICAL AUTOCLAVE

Pre-integrated crushing equipment

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

MICROWAVE

ELECTRO-THERMAL DEACTIVATION

The efficiency of the equipment must be assessed using commercial preparations (tapes) containing minimum populations of 104 spores of biological

indicators: Bacillus atrophaeus ATCC 9372, for dry heat processes (microwave equipment) or Geobacillus

stearothermophilus ATCC 7953, for moist heat processes (autoclaves)

EFFICENCY TEST

CETESB Technical Standard E15.010/2011Heat 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.

EFFICIENCY TEST PLAN

CETESB Technical Standard E15.010/2011Heat treatment systems without combustion of biologically-contaminated

healthcare waste: procedure

CETESB Technical Standard E15.010/2011Heat 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

Incubation of the material processed in laboratory

INPU

TO

UTP

UT

Growth or non-growth of Bacillus atrophaeus or Geobacillus stearothermophilus

Autoclave Microwave

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

Group Treatment and/or final disposal

A1Process that promotes reduction of microbial load compatible with level III ofmicrobial inactivation and disposal in landfill

A2Process that promotes reduction of microbial load compatible with level III ofmicrobial inactivation and disposal in landfill or burial in animal cemetery

A3 Burial in cemetery or heat treatment by incineration or cremation

A4 May be forwarded to landfill without prior treatment

A5 Incineration

BRe-use, recovery or recycling/Incineration or disposal in hazardous ornon-hazardous waste landfills

CDecay of the radioactive element and disposal according to its biological, chemicalor common waste categories

D Re-use, recovery or recycling/Sanitary landfill

E Direction in accordance with biological, chemical or radiological contamination

CONAMA Resolution no. 385/2005

PANORAMA OF HCW IN BRAZIL

Amount of HCW collected by municipalities - regions and Brazil (ABRELPE, 2012)

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

Growth of 3% in total collected

Source: http://www.abrelpe.org.br/Panorama/panorama2012.pdf

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.

Source: http://www.abrelpe.org.br/Panorama/panorama2012.pdf

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

THANK YOU!

Chem. Patricia de Souza Medeiros Barbosa

CETESB - Environment Agency Of Sao Paulo State

www.cetesb.sp.gov.br

Contact

Email: pbarbosa@sp.gov.br

Phone: 55 xx 11 3133 3125