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Waste Management | Infection Prevention for Support Services and the Care Environment | Table of Contents | APIC 12/30/20, 3:55 PM

Waste Management
Author(s): William J. Pate, BS, MPH, DPH
Safety Manager, Environment of Care

University Health System


San Antonio, TX

Published: October 3, 2014

Declarations of William Pate was elected board member for the


Conflicts of South Texas Chapter of the Health Physics Society
Interest: through April 2014. He is also employed by The
University of Texas Medical Branch as an
Environmental Health and Safety Consultant.

Abstract
The infection preventionist has varying levels of involvement with
healthcare waste management and is often focused on regulated
medical waste. An effective waste management program is complex
due to numerous regulations and guidelines, evolving technologies,
expanding healthcare delivery settings, emerging infectious diseases,
and the potential for bioterrorism. Although responsibility for the
management of healthcare waste is typically outside the area of
responsibility for most infection preventionists, they may still be
included in a wide range of areas related to management of
healthcare wastes beyond the traditional role. This chapter provides
information and resources to assist the infection preventionist with
successful participation in the safe management of healthcare wastes.

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Key Concepts
Definitions of medical waste can be confusing.
Medical waste regulations and guidance should be based on
scientific analysis.
Waste management plans should include input from the infection
prevention and control program.
The infection preventionist should be aware of new technology and
emerging issues related to healthcare wastes.
Performance improvement may be used to measure effectiveness of
waste management.
International positions for managing healthcare wastes vary
considerably based on country-specific regulatory requirements and
definitions.

Background
In the late 1980s and early 1990s, medical waste caught the public's
attention because of its potential for environmental contamination and
disease transmission. Media sensationalism focusing on beach wash-
ups and dwindling landfill space combined with fears regarding
human immunodeficiency virus (HIV) transmission resulted in
emotional reaction and confusion that was not based on scientific
analysis.1,2,3,4

When asked to define the risks that healthcare wastes pose to the
public and to the community, experts at the Centers for Disease
Control and Prevention (CDC) stated: "There is no epidemiologic
evidence to suggest that most hospital waste is any more infectious
than residential waste. Moreover, there is no epidemiologic evidence
that hospital waste disposal practices have caused disease in the
community; therefore, identifying wastes for which special precautions
are indicated is largely a matter of judgment about the relative risks
of disease transmission."5Although this statement was originally

prepared in 1985, it was restated for inclusion in the CDC's 2003


Guidelines for Environmental Infection Control in Health-Care Facilities.
6Although there is no documented evidence of transmission of

disease to the public through healthcare waste streams, data


limitations prevent firm conclusions on risk from being developed.4

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Unfortunately, some confusion remains, compounded by inconsistent,


specific, and occasionally conflicting definitions of "medical waste" or
"infectious waste." This is promoted by input from individuals with
little knowledge of infectious disease transmission or related
microbiology. Documents have been drafted at local, state, and
federal levels that lack scientific risk/benefit analysis.1,3,6

Hospitals and other healthcare settings have recognized the potential


occupational risk of disease transmission and therefore use caution
when handling and disposing of wastes.7Healthcare "infectious"
wastes may include microbiological laboratory waste, hazardous
waste, blood/body fluids, sharps, pathology wastes, pharmaceutical
wastes, and certain wastes from patients who are placed in isolation.4

Careful handling, sorting, and transportation, as well as appropriate


packaging and disposal of waste from these settings may help to
explain the absence of transmission in the community.

This chapter discusses healthcare waste from a practical and


scientific perspective, with the majority of the chapter focusing on
traditional "infectious" waste. However, the infection preventionist (IP)
may be involved in other aspects related to waste management in a
variety of healthcare settings. These selected issues include
purchasing, design of waste disposal areas, reuse and recycling
(including increasing popularity of reusable sharps disposal
containers), handling and disposal of special types of waste (bacillus
Calmette-Guérin [BCG], gene therapy, probiotics, piped systems
waste, mixed wastes, chemotherapeutics, radioactive materials, and
emerging infectious and bioterrorism agents), waste disinfection and
sterilization technologies, ecological considerations, and assessment
of a waste management plan using performance improvement.
Accordingly, brief and pragmatic overviews of varied waste topics are
included to assist the IP, and resources are provided for further
consideration. Individual healthcare facilities and services must
consider applicable codes, regulations, and guidelines prior to
implementing or updating an effective waste management program.

Basic Principles
Waste-related Regulation and Guidance
On the federal level in the United States, several agencies have
published regulations pertaining to "infectious," "medical," or

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"regulated" waste. The U.S. Environmental Protection Agency (EPA),


the U.S. Occupational Safety and Health Administration (OSHA), and
the U.S. Department of Transportation (DOT) have such regulations.8,9

,10,11,12In addition, both the CDC and EPA have issued guidance
documents pertaining to medical waste management.5,6,12,13At the

request of the U.S. Congress, the Agency for Toxic Substances and
Disease Registry prepared and published a comprehensive review of
the public health implications of medical waste.14

The Joint Commission includes medical waste as hazardous within its


Environment of Care standards through several elements of
performance (EP) within EC.02.01.01 and in EP 6 under Infection
Prevention and Control in standard IC.02.01.01.9The U.S. Postal

Service has laws related to sending hazardous and biological


substances through the mail.14The Nuclear Regulatory Commission

has jurisdiction over waste that contains both biological and


radiological hazards ("mixed waste").15The U.S. Food and Drug

Administration's Center for Devices and Radiological Health has


regulatory authority over selected aspects of waste management,
including the designation of sharps disposal boxes as class II medical
devices.16

Other agencies have regulations and guidelines related to wastes from


healthcare settings; selected entities are identified where indicated in
the chapter. (Also refer to 4. Accrediting and Regulatory Agencies.)
In the United States, various state and local governments have a
range of regulations related to these materials. Therefore, it is
important that IPs recognize which regulations are applicable based
on the authority having jurisdiction for their healthcare setting(s). IPs
should remain current with applicable state and federal regulatory
activity within the United States or with the authority having
jurisdiction for regulatory oversight in the international community.

Waste Terminology
The primary constituent of healthcare waste that is traditionally of
interest to IPs is waste capable of transmitting infectious agents.
Articles on this topic offer inconsistent findings due to lack of a
standardized definition of what constitutes waste capable of
transmitting an infectious disease.13Terms such as "biomedical

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waste," "regulated waste," "red bag waste," "medical waste," and


"infectious waste" have been used interchangeably. The same term
may have a different definition depending on the resource. For
example, in a background paper, the Office of Technology Assessment
defined "medical waste" as "all the types of wastes produced by
hospitals, clinics, doctors' offices, and other medical and research
facilities. These wastes include infectious or 'red bag' hospital wastes,
hazardous (including radioactive) wastes and any other general
wastes."17In the Medical Waste Tracking Act of 1988, "medical waste"

was defined as "any solid waste which is generated in the diagnosis,


treatment or immunization of human beings or animals, in research
pertaining thereto, or in the production or testing of biologicals."18

Categories of waste that are included in these definitions vary from


state to state and even from federal agency to federal agency.3,6,8,10,

11,13,19To reduce confusion, the term "infectious waste" is used here


to refer to "waste that is capable of producing an infectious disease."

A common misconception is to assume that the presence of a


pathogen will result in infection from wastes. Pathogenic organisms
are found in many different day-to-day settings. Household garbage,
bed linens, soiled diapers, and unwashed hands are all examples of
environments in which pathogens can routinely be found both within
and outside the healthcare setting.3,6,13A number of studies have

shown that although hospital wastes can have a greater variety of


organisms than residential wastes, those from households are more
heavily contaminated.6,13Even when generated from healthcare
activities, most garbage, soiled bed linens, and diapers do not have
any special handling requirements in most instances.6For a waste to

be capable of causing infection, the following specific factors are


necessary: (1) dose, (2) host susceptibility, (3) presence of a
pathogen, (4) virulence of a pathogen, and (5) portal of entry.
Concisely, all five of these factors must be present for infection to
occur from waste.3

Infectious Waste Categories


Many categories of infectious waste have been proposed by a variety
of associations, individuals, and agencies in the past.3,6,13,17,19

However, if the preceding definition is strictly adhered to, developing


categories of infectious waste is fairly simple and should include the

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following.

CONTAMINATED SHARPS
All discarded sharps (e.g., needles, scalpels) that have come into
contact with potentially infectious materials should be considered
infectious waste. This category of infectious waste poses the greatest
risk for injuries.3,6,8,13,20The risk of infection is related to

contamination with a sufficient dose of pathogenic organisms (such as


Hepatitis B virus [HBV], Hepatitis C virus [HCV], or HIV) and the
provision of a portal of entry into a susceptible host via a puncture or
cut. These devices represent a significant occupational hazard to
those handling and disposing of them. However, once contaminated
sharps are properly placed into appropriate rigid, puncture-resistant
containers, the environmental risk they pose is negligible.1,2,3,6,8,13,21,

22,23,24(Also see 107. Minimizing Exposure to Blood and Body


Fluids.)

MICROBIOLOGIC CULTURES AND STOCKS OF INFECTIOUS AGENTS


Of all of the possible categories of infectious waste, untreated
cultures, stocks, and amplified microbial populations pose the
greatest potential for infectious disease transmission because they
contain high concentrations of potentially pathogenic organisms.6,21,22

Laboratory personnel should handle discarded cultures and stocks


accordingly.22,23Cultures and stocks may be stored in glass

containers (e.g., tubes) that, if broken, become contaminated sharps


and therefore should be handled carefully. Microbiologic waste may
be treated on-site prior to discarding (e.g., by autoclaving) and
subsequently disposed as nonhazardous solid waste in accordance
with related solid-waste disposal regulations.6,21,22

ANIMAL WASTES
Discarded material originating from animals inoculated with infectious
agents during research, production of biologicals, or pharmaceutical
testing should be considered infectious waste.21These materials are

similar to microbiologic cultures and stocks because they may contain


high concentrations of pathogenic organisms. Therefore, animal
wastes that fit into this category are handled in the same manner.
Certain tissues and bodies from animal research areas may have
special considerations for handling and disposal dependent on

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potential for zoonotic microbes; each should be addressed based on


knowledge of the specific organism.6,21

BLOOD AND BLOOD PRODUCTS


Blood and blood products, as defined in the OSHA Bloodborne
Pathogens standard (e.g., serum, plasma, and other components
known or suspected to be contaminated with a transmissible agent)
must be handled carefully. Small amounts of these materials dried on
dressings or other disposable items represent an insignificant hazard
once they are properly contained because of the absence of a portal
of entry and a means of transmission.8Bulk blood, blood-tinged
suctioned fluids, excretions, and secretions are considered infectious
waste because they may be splashed onto mucous membranes or
because the container may break and become a contaminated sharp.
These fluids may be carefully poured down a drain connected to a
sanitary sewer that is designed for the disposal of human waste.6

Before disposing of these fluids in the sanitary sewer, it is important


to verify that local regulations allow this practice, as there may be
local prohibitions on the disposal of whole blood in the sanitary
sewer. Personnel must follow Universal/Standard Precautions,
including the use of personal protective equipment (PPE), due to
splash and aerosolization potential.6,8Alternative treatment methods
for inactivation or handling prior to disposal are available.

SELECTED ISOLATION WASTES


Discarded waste materials contaminated with excretions, exudates,
and secretions from patients with highly communicable diseases
(classification 4 by the CDC in Classification of Etiologic Agents on
the Basis of Hazard, e.g., Ebola) treated in isolation should be
classified as infectious waste.21Blood and sharps originating from
these patients are already included in the preceding categories.

PATHOLOGY WASTES
Pathology wastes include human tissues and body parts that are
collected at autopsy or during surgery. Pathology wastes do not
usually fit the definition of infectious waste outlined previously. There
is an absence of a portal of entry and most of these materials have
been soaked in alcohol or formaldehyde and thus seldom contain
pathogens. Incineration or grinding and discharging into a sanitary

, ,
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sewer are the common acceptable methods of treating this waste.6,8,

22

Nonincluded Wastes
Other categories of infectious waste have been suggested even
though there is no scientific justification for their inclusion.13,17

Personnel who are responsible for developing safe handling and


disposal practices for these materials must keep in mind that the
waste discharged from healthcare institutions differs little from that in
normal households.6,13,17Most persons with infectious diseases are
not hospitalized. Thus, characterizing all waste as infectious increases
healthcare costs and creates undue confusion and concern.3,5,6,13,20

Waste Management Plan


Plan Basics
The efficient waste management plan addresses every step from
acquiring materials that become waste to generation of waste,
discarding, collection and containment, handling, accumulation and
storage, transportation, treatment, and ultimate disposal.6,13The key
to success is a collaborative effort, including the IP's involvement.

Infectious Waste
Once a facility has a working definition of "infectious waste," the next
step is to develop or update a plan for managing these materials. A
management plan is addressed to some extent by regulatory,
advisory, and licensing agencies such as OSHA and the CDC, various
state agencies such as the Department of Natural Resources or
Department of Health, as well as other bodies, such as The Joint
Commission.5,6,8,9This written plan should include provisions for the

assignment of responsibility and authority for overseeing the program


to an individual, such as the IP or the facility safety officer, who is
knowledgeable regarding infectious disease transmission and who is
familiar with applicable federal, state, and local regulations. This will
ensure that these materials are handled as required and in a scientific
manner. Objectives for the plan include (1) rendering infectious waste
safe for disposal; (2) ensuring that there is minimal risk to patients,
personnel, visitors, and the community from exposure to pathogenic

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organisms associated with waste generated in the healthcare facility;


(3) meeting or exceeding all federal, state, and local regulations; and
(4) educating the healthcare personnel regarding the management
plan and the real versus the perceived risk associated with "infectious
waste." For example, the effective application of a facility-wide
medical waste assessment and management plan resulted in a 58
percent reduction in volume of waste designated as medical at one
facility.25

The other components of an "infectious waste" management plan


include (1) designation, (2) segregation, (3) packaging, (4) storage, (5)
transport, (6) treatment or disposal, (7) contingency planning, and (8)
staff training.8,10,26Each component is discussed further in the
following sections.

DESIGNATION
Once a facility has developed definitions for infectious and
noninfectious wastes, sorting the discarded materials into the proper
waste stream should align with regulatory, safety, and cost-reduction
facets.10,26It is recommended that a list of infectious wastes
generated in the facility be developed and that the generating areas
be identified in the management plan. For example, blood/blood
products known or suspected to be infected with transmissible agents
are generated on patient floors and in surgery, the autopsy suite,
clinics, emergency rooms, and ancillary departments.

SEGREGATION
Individuals who are knowledgeable about the waste's origin and its
hazard potential must segregate infectious waste at the point of
origin.13,17,19,26,27The waste should then be placed into appropriate

designated leakproof containers. Needles must never be recapped,


bent, or broken by hand before being discarded. Infectious waste with
multiple hazards (e.g., used sharps from patient receiving
chemotherapy) must be segregated as necessary for the management
and treatment of the waste characteristic with the most stringent
handling requirements. For example, proper segregation of waste
generated in the surgical suite can limit the volume to that which
meets definitions of infectious waste if perioperative personnel can be
engaged in separation at this point of use. Examples of successful
segregation in this setting have been described that also offer benefits

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of environmental sustainability and facilitate recycling of the large


quantity of materials and packaging generated during perioperative
care.28

PACKAGING
Infectious waste must be packaged properly to protect patients, staff,
visitors, and the public from potential exposure to infectious materials
and to facilitate the proper handling, storage, treatment, or disposal
of the waste.5,6,8,10,13,29,30Selection of the packaging must be
appropriate for the type of waste being contained to maintain the
integrity of the packaging during collection, transport, storage, and
disposal. States generally specify packaging requirements in their
infectious waste regulations. In addition, OSHA and the CDC specify
that sharps be placed in rigid puncture-proof containers.5,6,8

Infectious waste must be properly identified as a biohazard. Infectious


waste containers should be labeled with a biohazard label or color-
coded red to identify the contents. OSHA requires either red color-
coding or use of the universal biohazard symbol and term
"biohazard."8,22State regulations may require additional information on
the packaging, such as the name of the generating facility, date,
bilingual terminology, and so forth. Packaging used for shipment will
often contain additional markings and be labeled to comply with
applicable shipping regulations (e.g., orientation arrows on sharps
containers).

Sharps containers must be impervious, rigid, puncture resistant,


leakproof on the sides and bottom, and closable.6,24,31Plastic bags
are appropriate for bulk solid or semisolid infectious wastes or for
disposables containing residual liquids. Plastic bags should be
impervious and tear resistant. Potentially infectious liquid wastes can
be carefully poured down a designated sanitary sewer using
appropriate engineering controls and PPE.6,8When this is not
desirable or possible, liquid wastes should be placed in leakproof
containers, such as a flask or bottle, that can be tightly capped or
stoppered. Absorbent material sufficient to absorb the entire contents
of the containers must be added to the outer container. Free-flowing
liquids should not be poured directly into a waste container. Suction
canisters must be tightly closed and placed in plastic bags. Bags may
need to then be placed in a secondary container, such as a

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cardboard box, to preserve the integrity of the packaging during


transport and storage. Semirigid or rigid secondary containers usually
are required for off-site transport of infectious waste.8,29

STORAGE
Infectious waste should be treated and disposed of as soon as
possible after generation.5,6,17,19,26,29,30Although there is no published
national standard for how long infectious waste may be stored, some
states may have limits on storage time at the generating facility. The
proper packaging outlined here will ensure containment and exclusion
of rodents and vermin. Storage areas should have limited access, and
a biohazard symbol should be posted so it is readily visible to anyone
with access to the area. Many states have specifications for the type
of enclosure required for storage of infectious waste, and they often
specify the duration of storage that is permissible. Some states have
very elaborate requirements for storage areas that require the room to
have floors that slope to a drain that is connected to a sanitary
sewer. This provides for a safe method of cleaning up liquid spills. In
any case, a system for immediate spill containment and cleanup
should be available in the storage area (e.g., hose connected to
steam line).

TRANSPORT
The internal and external systems used for the transportation of
infectious waste must maintain the integrity of the packaging and
protect handlers.5,6,7,10,17,18,19,29,30Mechanical waste collection
devices and gravity or pneumatic-chute transport of infectious waste
are discouraged due to potential damage to packaging. Leakproof
carts that are readily cleanable or that can be lined with plastic are
generally used for transportation of infectious waste from the
generating areas to the storage area where it will be picked up for
treatment. Commercial or private vehicles that are employed in the
transport of infectious waste should be leakproof and identified in
accordance with municipal, state, and federal regulations. IPs should
be aware of regulatory requirements and provide input into relevant
key operational services. For example, a facility's clinical laboratory
couriers, who often pick up not only specimens but also infectious
waste from affiliated physician practices and other ambulatory care
facilities, commonly provide transport of infectious waste. In general,
states require the registration of vehicles utilized in the transportation
of infectious waste. Although some facilities will transport and treat

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their own infectious waste, appropriately licensed commercial


companies may be contracted to transport and treat healthcare
wastes.

A waste manifest documenting the shipment information must


accompany transported waste. A waste manifest serves as a
document that tracks the waste from the generating facility until its
final disposition, and it acts as a record of the waste's movement.
The waste manifest also acts as a legal document whereby the
generator certifies that the waste has been correctly classified,
packed, marked, and labeled according to applicable shipping
regulations. Because of this, it is important that the waste manifest be
reviewed and signed by a trained individual before the waste is
transported off-site. The DOT considers the individual signing the
waste manifest to be a hazardous materials employee, and thus the
employer as required in 49 CFR must train them. Having the waste
manifest signed by untrained employees can result in significant
penalties. Copies of waste manifests must be retained for a minimum
of 3 years under DOT regulations, although states can require longer
retention time.

TREATMENT
Many options are available for the proper treatment of infectious
waste.2,6,10,13,14,17,21,30,31,32,33,34,35The method selected will be
determined by the amount of infectious waste generated, the
capabilities of the facility, and the cost effectiveness of on-site
treatment versus contracting the service to a licensed commercial
vendor. The type of treatment selected will depend on municipal,
state, and federal regulations. Incineration was traditionally selected
by hospitals as the primary method for treating infectious waste but
has decreased in application due to EPA regulations related to the
Clean Air Act and control of emissions (also refer to Supplemental
Resources). Depending on the type of infectious waste, acceptable
methods for rendering these materials innocuous include steam
sterilization, chemical disinfection, gas/vapor sterilization, and
irradiation decontamination. Modern alternative technologies have
broadened the scope of available treatment options. Microwave,
infrared, hyperchlorination, and laser technologies are only a few of
the new technologies being utilized to render infectious waste
innocuous. The treatment selected should be based on the type of
waste generated and the suitability of available options. States
generally require that the efficacy of the treatment methods selected

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be monitored. The monitoring system selected will depend on the


treatment method utilized. For example, steam sterilization treatment
would be monitored utilizing a biological indicator that includes
Bacillus stearothermophilusspores.

DISPOSAL
The direct disposal of infectious waste at a properly sited landfill does
not present a threat to public health and safety, according to many
experts, and is still acceptable in many areas.6,8,13However, perceived
risk concerns and the nationwide movement away from land disposal
have resulted in widespread landfill prohibitions on the disposal of
untreated infectious waste in landfills. After treatment, medical wastes
are usually disposed of in a sanitary landfill. Untreated liquid medical
waste, such as bulk blood or the contents of suction containers, can
be disposed of by carefully pouring them into the sanitary sewer
when allowed by local regulations. When designing an infectious
waste management plan, it may be helpful to communicate with the
waste hauler contractor and local landfill representatives during the
planning process. This will help ensure that the healthcare facility is in
compliance with regulatory codes, and most importantly, it will help
ensure education and training for those who handle and haul these
materials.

CONTINGENCY PLANNING
Systems should be in place to address unforeseen events that may
disrupt the normal treatment, transportation, and disposal of
infectious waste materials.10Both on-site and off-site contingencies
should be available. Alternate strategies should be available in case
on-site treatment systems fail or if there is an unanticipated power
shortage. A backup disposal contractor should be designated in case
there is a disruption of the ability of the primary outside contractor to
serve the facility. Emergency spill procedures should also be in place
for on-site and off-site emergencies.

TRAINING
Training of all personnel involved in the generation, handling,
transporting, treatment, or disposal of infectious waste is imperative
for the infectious waste management plan to be effective.6,8,17,29,36,37
Training should include the definition of infectious waste, handling
procedures, appropriate PPE, hand hygiene, labeling or coding that

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designates an item as infectious waste, and postexposure


management. There is also specific training required by regulatory
agencies such as OSHA and the DOT. For example, individuals
involved in the infectious waste shipping process (which includes
signing of waste manifests), must meet DOT training requirements
that includes at a minimum general awareness training, function-
specific training, safety training, and security awareness training. As
part of this training, the employee must be tested and the employer
must certify in writing that the employee has met the training
requirements. Training must be completed within 90 days of hire, with
refresher training completed every 3 years. The employer must
maintain records associated with worker training.

Infection Prevention Implications


The IP may be involved in developing and coordinating the infectious
waste management plan. The plan should be based on sound
scientific information and consistent with local, state, and federal
regulations and guidelines. An article by Rutala et al. contained
noteworthy information related to medical waste that may be
considered when developing or revising a healthcare waste
management plan.7

Hospitalized patients generate approximately 15 pounds of hospital


waste per day, which averages to approximately 6,700 tons of daily
waste by hospitals.
About 15 percent of the total hospital waste by weight is
considered "infectious waste" (1,000 tons/day).
The cost of disposing of infectious waste is 5 to 20 times greater
than that for disposal of noninfectious hospital wastes.
With the exception of "sharps" such as needles, which have
caused disease only in an occupational setting, there is no
scientific evidence that medical waste has caused disease in the
hospital or in the community.
Household waste contains, on average, 100 times as many human
pathogens as medical waste.
The beach wash-ups of syringe-related materials that created
nationwide concern were found to come from illegal drug use and
home healthcare; hospitals were not implicated as the cause of this
problem.

Other Waste Management Concerns

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PURCHASING
Products brought into healthcare settings and development of policies
and procedures related to their use should be part of an effective
infection prevention and control program.28Product selection should
consider published recommendations and guidelines and comply with
regulatory agency standards (e.g., sharps, disposal containers, or
chemotherapy waste boxes).5,6,8,9,10,11,12,13,15,16,36Workers involved
with handling of waste, such as used needles, should be included in
an evaluation process.8(Also see 107. Minimizing Exposure to Blood

and Body Fluids.) Waste minimization efforts, as part of a waste


management plan, can be achieved by purchasing products that
generate less waste or are substituted for existing items.

WASTE DISPOSAL AREAS


Healthcare wastes of all types should be sorted at the point of
creation. For example, used sharps should be immediately discarded
into sharps disposal containers.6,8,24The design and construction of
renovated or new healthcare facilities should include the IP in the
process from conception through commissioning.6,38,39Waste handling

and areas for storage and disposal should be designed and located
as appropriate for the types of wastes generated by the facility.39(Also
see 118. Construction and Renovation and 109. Environmental
Services)

WASTE REDUCTION, INCLUDING REUSE AND RECYCLING


The IP may be asked to help evaluate reusable items to replace
single-use, disposable items in an effort to reduce waste volume.
(Also see 32. Reprocessing Single-Use Devices.) Reusable
containers for regulated medical waste and sharps disposal boxes are
one such effort that has gained popularity with the increased
emphasis on environmental stewardship. Some have raised concerns
over safety of reusable sharps disposal containers in terms of
adequate removal of potential contaminants after they are emptied,
cleaned/disinfected, and returned to a facility.12Neely et al. compared
recovery of surface contaminants from a disposable cardboard
container with a plastic liner (note: this is not in compliance with
OSHA-issued requirements for sharps containers) to a reusable plastic
container.40The proportion and diversity of microbial contaminants on

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the reusable containers was higher; however, quantitative details (e.g.


colony forming units) were not provided, and the majority of these
contaminants were common skin commensals. Neely et al. compared
the overall rate of healthcare-associated infection (HAI) before and
after implementing a new policy of disinfecting the top of the reusable
container and observed a statistically significant decrease; however,
this study design could not account for a variety of other
interventions that might account for this change. Runner cultured
surfaces of reusable containers for bacteria and certain viruses
delivered to a community hospital.41Quantitative levels of microbes

recovered were not provided in the study and, as in the study by


Neely et al., most of the bacteria were common skin commensals.
Polymerase chain reaction (PCR) testing did identify a proportion
positive for certain bloodborne viruses; however, PCR testing is very
sensitive and does not always correlate with presence of viable
infectious virus. The IP needs to keep the findings of both studies in
perspective relative to principles of disease transmission outlined in
the Waste Terminology section of this chapter. Visible soil on or inside
reusable containers should prompt notification of the manufacturer
and not even be placed into use. Surface contaminants, even with
bloodborne infectious agents, do not represent an appreciable risk to
healthcare personnel given routine hygiene for hands and the
environment typical of the hospital setting. Extensive studies of risk of
occupational exposure to bloodborne infectious agents have indicated
that the risk strata is highest for hollow-bore devices introduced
through the skin, much lower for percutaneous introduction of
blood/other potentially infectious material, and likely negligible for
intact skin that is in contact with a contaminated surface. By contrast
there is evidence that reusable sharps containers can dramatically
lower the incidence of sharps injuries to healthcare personnel during
disposal of contaminated sharps.42As described, the IP must be

involved in the evaluation, selection, and implementation of a sharps


disposal system, regardless of the container design that is chosen. A
careful risk assessment should be completed to ensure that
reprocessing of containers is effective and in compliance with
regulations for the safety of patients and staff.12

SELECTED SPECIAL TYPES OF WASTE

BLADDER CANCER THERAPY WITH BACILLUS CALMETTE-GUÉRIN


Intravesical infusion of BCG to treat superficial bladder cancer was

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first reported in 1976 as an alternative to chemotherapy.43This


immunotherapy was subsequently approved in 1990 by the FDA for
use in the United States for carcinoma in situ, which is found in 20 to
30 percent of bladder cancer cases.44Intravesical administration of

BCG appears to be associated with fewer adverse reactions, with


influenza-like symptoms (including fever, chills and nausea) and
discomfort as the most commonly reported.44,45However, there have
been a few cases of localized and disseminated Mycobacterium
bovisinfections following infusion.45Treatments for bladder cancer that
may be used with or without BCG include mitomycin C, thiotepa,
doxorubicin, oral bropirimine, interferon alpha, keyhole limpet
hemocyanin, and valrubicin.46,47

Little information is provided on infection prevention and the safe


handling and subsequent disposal of items potentially contaminated
with BCG. Although the Mycobacteriumused for BCG is an attenuated
strain, the amount of organism used for intravesical treatment is that
of approximately 2,000 vaccinations.48Care must be taken to prevent
introduction of BCG onto environmental surfaces or other items. A
case of iatrogenic meningitis was reported in two
immunocompromised children, presumably from contamination in the
pharmacy cabinet where both chemotherapy and BCG to treat
patients were prepared.48Control measures during BCG preparation
include a combined transfer/mixing device that eliminates aerosols;
the use of an applicator that connects to the catheter for infusion
also prevents exposure. The entire setup should be discarded as
potentially infectious waste.49Cleaning of potentially contaminated
surfaces should be with a tuberculocidal-rated disinfectant (e.g.,
phenolic-based) per manufacturer's instructions. Recommendations in
the United Kingdom by the Control of Substances Hazardous to
Health (COSHH) regulations for worker protection include PPE (plastic
apron, gloves, and face visor), disposal of materials and PPE as
"clinical waste," and use of a phenolic-based disinfectant on
potentially contaminated surfaces. COSHH also recommends that
voided urine containing BCG be treated with a phenol-based liquid
mixed in the toilet for at least 10 minutes before flushing.49An

alternative instruction to the patient after BCG bladder instillation is to


"sit down to urinate for 6 hours after treatment to avoid splashing of
the urine."50Directions state that after each urination "during this 6-

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hour period, pour household bleach (about the same amount of


bleach as the amount of urine) into the toilet, then wait 15 minutes
before flushing" and to wash hands afterward.50

GENE THERAPY
As of May 2000 there were 425 gene therapy protocols worldwide,
with approximately 70 percent of these in the United States.51
Although human gene transfer and treatment had originally focused
on genetic deficiency diseases, more than 60 percent of trials and
activities since gene therapy products approved have been aimed at
cancer.52The vectors used in gene therapy pose a potential infectious
risk; for more than 3,100 patients treated, varied protocols were used
for 177 retroviruses, 65 adenoviruses, 25 poxviruses, and 3 adeno-
associated viruses. The remaining 109 treatments used lipofection and
other noninfectious methods. Other vectors that have been proposed
or used include Epstein-Barr, baculovirus, canarypox, fowlpox, herpes
simplex, vesicular stomatitis, and HIV viruses.52

Information related to the safety of gene therapy in healthcare


settings was introduced to most IPs in a 1999 article by Evans and
Lesnaw.53The numerous recommendations included protection of
healthcare personnel, other patients, and appropriate Transmission-
based Precautions. These included suggestions that waste resulting
from gene therapy be handled as biohazardous material and that
disposal treatment should follow medical regulated waste protocols
(i.e. incineration).52In some localities, regulations may require
inactivation on-site prior to disposal.53

The U.S. Food and Drug Administrations' (FDA's) Center for Biologics
Evaluation and Research regulates gene therapy research and trials
with the objective to ensure safety.54,55The National Institutes of
Health Recombinant DNA Advisory Committee provides protocol
development oversight.53,56Federal supervision at the local level is by
the Institutional Review Board and the Institutional Biosafety
Committee, with optional input from the Infection Control Committee.
55The CDC has not yet developed infection preventionguidelines for

gene therapy.54The major goal for IPs is to prevent transmission of


the vector or any recombinant vector between persons, including

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those handling and preparing the vectors (i.e., pharmacy). Therefore,


the existing system recommended by the National Institutes of Health
and CDC for biosafety levels and disinfectants should be referenced.
Another concern is vector shedding that may occur inside and
outside an isolation room from the treated patient, those caring for
the patient, and others entering the patient's area, including
housekeeping personnel. Protocols for safe transport of the vector
product and items for disposal should be established and include
training based on the vector and current knowledge of the vector.53,54
Coordination with the waste disposal company may be required. If a
healthcare facility is involved in gene therapy, the IP should be
consulted and involved in policy and procedure development as well
as education and training. Gene therapy and vectors are evolving, and
the IP should follow current guidelines as appropriate to minimize
potential risks related to handling and disposal. A biological safety
officer position is suggested by some as a key member of any gene
therapy trial team; the role includes ensuring appropriate handling of
waste materials.56

PROBIOTICS
Probiotics are beneficial and endogenous microflora that include live
microbial supplements; they have been studied primarily for protection
of the gut (e.g., Lactobacillus).57,58The use of probiotics continues to
be explored in clinical settings. Probiotics may present side effects or
risks for susceptible individuals, including infection, deleterious
metabolic activity, excessive immune stimulation, and gene transfer;
the latter three theoretic risks have not been reported in humans. The
risk of infection is low, but cases have been observed, including
fungemia with Saccharomyces boulardiiand Lactobacillus rhamnosus.59
Regulation and guidelines for probiotics are limited, with concern
related to inclusion as dietary/food or pharmaceutical applications.60,
61Forms used in clinical settings may be a closed capsule or a sachet
that is opened and combined with enteral nutrition or drink for
ingestion.59Probiotic microbial supplements may be given alone or in

combination with prebiotics, selected additives that may enhance


survival of the probiotic strain while stimulating the body's
endogenous flora.58Safe handling, management, and disposal of the
probiotic are necessary to minimize the risk of infection. Selecting a
safe place for preparation, dispensing or mixing, and disposal of

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associated waste materials is crucial to minimize infectious risks,


especially for areas with immunocompromised patients.59

PIPED SYSTEMS WASTE


Vacuum and suction systems are part of the medical gas systems and
should not be overlooked in a waste management program. The
installers, inspectors, and verifiers should be certified based on codes
and regulations.62Piped suction/vacuum systems and disposal of
associated liquids are considered biohazardous. Such systems may
be used for suction of body fluids in surgical and procedure areas,
dentistry, laboratories, and research settings.62,63,64The waste holding

tank, part of the piped vacuum system, should be installed per


recommendations, with the waste tank contents discarded through a
drain into the sanitary sewer system.62

Laser plume and surgical smoke may be evacuated into the wall
suction system in some locations. Analysis of surgical smoke and
aerosols has shown that viable organisms can be present, including
bacteria and viruses, in addition to numerous potentially hazardous
chemicals.63,64,65A case of patient-to-patient transmission of human

papillomavirus has been reported during a laser procedure.64Use of


wall suction, even with in-line filtration, is only suitable for minimal
amounts of plume; a smoke evacuator system with appropriate
filtration system is preferred. In both situations, the in-line filters from
wall suction and plume capture equipment should be treated and
discarded as potentially infectious waste.63,64

Plumbing systems, specifically sanitary sewers, are approved for


disposal of small amounts of blood and body fluids, as mentioned,
provided procedures are in place to protect the worker.6,8A concern
over pharmaceutical wastes, specifically antibiotics entering the sewer
system, has been raised.57,66Stewardship and potential contribution to
antibiotic resistance and environmental impact warrant further study.

MIXED OR MULTIHAZARDOUS WASTES


The most stringent regulation should be used for handling and
disposal when healthcare wastes are mixed; these may include
infectious wastes that also contain hazardous chemicals or

, , , , ,
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radionuclides.1,13,19,22,30,67

CHEMOTHERAPEUTICS
Handling and disposal of antineoplastic and cytotoxic drugs used for
chemotherapy present potential risks for patients and workers. The
drugs and related supplies should be addressed in the waste
management plan.7,57Per the National Institute for Occupational
Safety and Health, workers at risk of exposure to these hazardous
drugs include "shipping and receiving personnel; pharmacists and
pharmacy technicians; nursing personnel; physicians; operating room
personnel; environmental services personnel; and personnel involved
in veterinary practices where hazardous drugs are used."68Because
these drugs are filtered and may be concentrated by the kidneys,
urine from treated patients should be handled and discarded with
care.57,68

RADIOACTIVE MATERIALS
Facilities using radiopharmaceutical therapy must have specific
procedures in place for the handling and disposal of radioactive
wastes that may also contain bloodborne pathogens (i.e., those mixed
with blood, body fluids, or tissues).67Although radioactive patient
excreta released into the sanitary sewer is typically exempted from
most regulatory requirements, the collection of the same radioactive
excreta into a diaper requires that this previously not-included and
unregulated waste must now be managed as radioactive waste. It is
important to remain cognizant of other instances when potentially
infectious materials contaminated with radioactive materials can
become a waste management concern for the organization. Examples
include the following:

A patient with recent dosing experienced gastrointestinal bleeding


and required emergency surgery with follow-up care in the intensive
care unit. Staff may be exposed to blood and tissue that is
radioactive (e.g., I-sodium iodide dose for thyroid ablation) and
contains potential bloodborne pathogens.69,70Subsequent pathology
and postmortem care may also require special handling of tissues
and wastes.69

Brachytherapy for the treatment of prostate cancer includes


implantation of radioactive seeds into the prostate. Infection

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prevention and waste handling for the procedure area and


subsequent follow-up with the patient in the clinic or at home must
be considered if this treatment is provided.71

Technetium 99-m labeling is used to identify sentinel nodes for


surgical excision in cancer, such as for patients with melanoma or
breast cancer. Specific procedures must be developed for this
radioactive material in the surgical area and laboratory where
excised tissue may be processed and discarded.72

Most hospitals have a radiation safety officer (RSO) or health physicist


that is responsible for ensuring the safe use of radioactive materials.
The RSO is an invaluable resource for the IP faced with a radioactive
waste management concern and can provide guidance on effective
means to manage potentially infectious waste contaminated with
radioactive materials.

EMERGING INFECTIOUS AGENTS AND POTENTIAL BIOTERRORISM AGENTS


Selected agents, including microbes and biologicals, have been
identified based on their risk to national security or public health, and
each facility must have the capacity to destroy discarded cultures and
stocks on-site.6,21The emergence of new infectious agents may
present new challenges in waste disposal, especially when knowledge
about a causative agent is limited and information about transmission
or infectious nature is incomplete, such as was seen with severe
acute respiratory syndrome coronavirus in the early 2000s. In these
cases, stringent recommendations for waste handling and disposal
are often implemented.6,73Tissues and certain wastes from prion
diseases such as Creutzfeldt-Jakob disease and the variant strain
causing bovine spongiform encephalopathy, commonly called mad
cow disease, require special handling and disposal.6(Also see 98.
Viral Hemorrhagic Fevers, and 75. Creutzfeldt-Jakob Disease and
Other Prion Diseases) Incineration with a minimum secondary
temperature of 1,000°C or alkaline hydrolysis using pressurized 1
N NaOH or KOH at 150°C are two possible disposal methods for
animal carcasses and other tissues suspected of containing prions.21

Potential bioterrorism agents, such as smallpox, have prompted


guidance that includes waste handling and disposal.74,75For example,
in smallpox vaccination plans, the handling and disposal of bifurcated
needles, vaccination site dressings, and discarded unused vaccine

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must be addressed for safe waste management.74(Also see 122.


Infectious Disease Disasters: Bioterrorism, Emerging Infections,
and Pandemics.)

New Technologies for Waste Treatment


Many technologies are available or under development to treat or
decontaminate regulated medical wastes. Methods reduce microbial
load, and the final waste product does not need to be sterile prior to
disposal.6,13,20Processes include autoclaving, incineration, internment
(anatomic wastes), chemical disinfection,
grinding/shredding/disinfection methods, energy-based technology
(microwave or radio waves), disinfection/encapsulation, and disposal
into a sanitary sewer.6,35Incineration is an effective method for treating

most medical wastes and is appropriate for antineoplastics; however,


it should not be used for radionuclides.13,15,64,65Regulation at federal
and state levels, due to environmental impact, has limited the
availability of incinerators, so alternative methodologies—both on-site
and off-site—are being utilized.13,30,33,35,76,77Criteria for choosing
treatment include suitability for types of waste, risks related to
handling, effectiveness of treatment, uniformity or quality of process,
costs (capital, operating, startup, labor, materials), success of process
(experience of others using same method), occupational and
environmental risks, reduction in waste volume and weight,
community acceptance, and applicable regulatory compliance.13

Performance Improvement
To help assess the effectiveness of the waste management plan,
performance improvement measurements can be used. For instance,
The Joint Commission standards may be referenced when identifying
and documenting a performance improvement activity.9Examples of
performance improvement related to waste include (1) monitoring
exposures to body fluids and sharps injuries related to disposals of
contaminated needles; (2) monitoring of the "fullness" of needle boxes
to indicate if the boxes are changed at proper intervals; and (3)
evaluation of sorting waste appropriately with a visual audit or
evaluation of contents in waste containers (appropriate precautions
are required if the latter approach is used). Periodic audits of waste
generation areas and accumulation points, including questioning of
staff on appropriate waste management procedures, can help an
organization identify opportunities for training and process

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improvements. Regardless of the performance improvement monitors


selected, the data should be used to ensure the program is working.
Data analysis and reports of performance improvement measures
provide objective measures to verify the effectiveness of any
corrective actions taken and identify opportunities for improvement.
Cost-reduction strategies may follow the same strategy as outlined in
a report by Garcia describing interventions and related improvement
measurements to reduce the volume of waste.78

Conclusions
This chapter provides a brief historical overview and the practical
information necessary for the appropriate management of wastes
generated in healthcare settings that may present an infectious risk.
"The most practical approach to medical waste management is to
identify waste that represent[s] a sufficient potential risk of causing
infection during handling and disposal and for which some
precautions likely are prudent."5Additional information related to waste

management is provided to assist the IP with other types of waste


that may be found in today's varied healthcare settings.

Future Trends
Costs for packaging, segregation, treatment, and disposal of
infectious waste will likely increase in the future. Incineration will likely
continue to decline as other treatment technologies develop and
regulations on incinerators become more stringent. Scientific-based
studies to characterize the risks associated with healthcare wastes
will assist lawmakers in updating regulations. Recycling of some items
currently categorized as infectious waste is under consideration, with
estimates that between 30 to 50 percent of medical waste can be
recycled. As stated by Daschner, "There are no infectious risks
associated with recycling hospital waste."79Environmental stewardship
will also prompt continued interest in interventions to minimize waste
volume, such as reusable disposal containers. As resources become
more limited and environmental concerns intensify, innovative
approaches to managing healthcare wastes will continue to evolve.

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International Perspective
A review of the permutations and combinations of waste management
systems in use throughout the international community is beyond the
scope of this chapter. However, the literature suggests that waste
management systems vary drastically from none at all to highly
regulated functioning systems.25,79,80,81,82,83,84Many countries have
considered the regulations and guidelines promulgated in the United
States to help establish their own standards. Some countries have
encountered "growing pains" similar to those the U.S. healthcare
community went through in the 1980s and 1990s.

For example, in Great Britain, according to one author, digging a hole,


burying medical waste, and then covering successive layers with lime
is a common practice when items cannot be incinerated.80Problems

associated with infectious waste disposal practices are compounded


in undeveloped countries where trash may be dumped anywhere.
Trash "pickers" commonly rummage through discarded trash to find
usable or salable items.81Children are often involved, and this practice
represents another source of infectious disease exposure beyond
those caused by poor sanitation, lack of safe food and water, and
poor medical care. Unfortunately, in some instances, the
mismanagement of healthcare waste has caused some institutions in
developing countries to give up single-use syringes in favor of
reusable glass syringes. While this eliminates the waste management
issues, it is causing the return of infections due to the use of
unsterilized syringes.4The following are a few examples of general

infectious waste issues that have been cited in the international


literature:

Absence of professional training in how to handle these wastes81

So many other medical concerns that waste management, in


general, is ignored81

Licensing standards are unclear, conflicting, or confusing31,82

Inadequate incineration/sterilization82

No plans in place for collection and storage82

Some have laws/regulations, but they are not enforced82

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Needles and syringes are commonly thrown in the regular trash83

Lack of finances/resources prohibits implementation84

No availability of technologies84

Those in the international community looking to implement a practical,


scientific, infectious waste management program can refer to the
body of this chapter in addition to references cited and the
supplemental resources provided.

Supplemental Resources
American Society of Gene & Cell Therapy. Available at:
http://www.asgt.org.

American Urological Association. Available at: http://www.auanet.org.

Agency for Toxic Substances and Disease Registry (ATSDR). Available


at:http://www.atsdr.cdc.gov.

Association for Professionals in Infection Control and Epidemiology


(APIC). Available at: http://www.apic.org.

Canadian Standards Association . Z317.10-09 Standard: Handling of


Waste Materials in Health Care Facilities and Veterinary Health Care
Facilities; 2009. Available at: http://www.csagroup.org.

Centers for Disease Control and Prevention (CDC). Workbook for


Designing, Implementing, and Evaluating a Sharps Injury Prevention
Program. Available at: http://www.cdc.gov/sharpssafety/index.html.

Centers for Disease Control and Prevention (CDC). Primary


Containment of Biohazards. Selection, Installation and Use of
Biological Safety Cabinets. Appendix A in BMBL 5th Edition. 2009.
Available at: http://www.cdc.gov/od/ohs/.

Clinical and Laboratory Standards Institute (formerly National


Committee for Clinical Laboratory Standards, NCCLS). Available
at:http://www.clsi.org.

European Association of Urology. Guidelines on Bladder


Cancer.Available at: http://www.uroweb.org/guidelines/online-
guidelines/.

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Friedman C, Petersen KH. Infection Control in Ambulatory Care.


Sudbury, MA: Jones and Bartlett Publishers, 2004.

Healthcare Environmental Resource Center (HERC). Available


at:http://www.hercenter.org.

International POPS Elimination Network. IPEN is a global network of


public interest nongovernmental organizations united in support of a
common Persistent Organic Pollutants Elimination Platform. Available
at: http://www.ipen.org.

National Institutes of Health (NIH). Available at:http://www.nih.gov.

National Institutes of Health (NIH). Guide to waste disposal website.


Available
at:http://orf.od.nih.gov/EnvironmentalProtection/WasteDisposal/Pages/default.aspx.

Physicians for Social Responsibility (PSR) is a leading public policy


organization representing the medical and public health professions
and concerned citizens, working together for a healthful environment
and other concerns. Available at:http://www.psr.org.

U.S. Department of Transportation (DOT). Available at:


http://www.dot.gov.

U.S. Environmental Protection Agency (EPA). Available at:


http://www.epa.gov.

U.S. Occupational Safety and Health Administration (OSHA). Available


at: http://www.osha.gov.

U.S. Postal Service. Domestic Mail Manual (DMM) Issue 58 plus


Postal Bulletin changes through PB 22125 (4–1–04) and C024—Other
Restricted or Non-Mailable Matter are Available at:
http://pe.usps.gov.

World Health Organization (WHO). Laboratory Biosafety Manual, 3rd


ed. Revised. 2004. Available at: http://www.who.int/en.

World Health Organization (WHO). Waste From Health-Care Activities.


Fact sheet no. 253. WHO; 2007. Available at: http://www.who.int/en.

World Health Organization (WHO). Health-care waste management.


Fact sheet no. 281. WHO; 2011. Available at: http://www.who.int/en.

World Health Organization (WHO). Policy Paper: Safe Health-care

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Waste Management. 2004. Available at:


http://www.who.int/water_sanitation_health/medicalwaste/hcwmpolicy/en/.

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[1] Hedrick E. Editorial: infectious waste management—will science prevail?
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[2] Keene JH. Medical waste: a minimal hazard. Infect Control Hosp
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[3] Rutala WA, Mayhall CG, The Society for Hospital Epidemiology of
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[4] Salkin IF. Review of Health Impacts from Microbiological Hazards in


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[5] Centers for Disease Control and Prevention (CDC), Department of Health
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[6] Sehulster L, Chinn RY, CDC, et al. Guidelines for environmental infection
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[7] Rutala WA, Odette RI, Samsa GP. Management of infectious waste by
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[8] Occupational Safety and Health Administration. 29 CFR Part 1910.1030.


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[9] The Joint Commission. Comprehensive Accreditation Manual for


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