Background Information
Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).
Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.
Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.
In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.
OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.
Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.
Definition of Medical/Infectious
Waste
Potentially
infectious medical waste is the term used most extensively throughout
the state health regulations. Potentially infectious medical
waste includes:
- Cultures and
stocks of infectious agents and associated biologicals, including
cultures from medical and pathological laboratories, from research
and industrial laboratories.
- Human pathological
wastes including tissue, organs, body parts and fluids that
are removed during surgery or autopsy.
- Human blood,
human blood products, blood collection bags, tubes and vials.
- Sharps used or
generated in health care or laboratory settings.
- Bandages, diapers, "blue
pads," and other disposable materials if they have covered
infected wounds or have been contaminated by patients isolated
to protect others from the spread of infectious diseases.
- Any other refuse
which has been mingled with potentially infectious biomedical
waste.
Eating
utensils, animal carcasses and bedding, and "very small
quantities" (less than 250 grams or 1/2 pound) of human
or animal tissue, clean dressings, and clean surgical wastes
from persons or animals not known to be infected, are excluded
from the definition of potentially infectious biomedical waste.
The last two categories of material must be disposed in tightly
closed plastic bags or other impervious containers.
Animal
carcasses and tissues and wastes from large animals must be disposed
either as potentially infectious biomedical waste, or according
to regulations of the Livestock Sanitary Board. Carcasses, tissue,
and wastes of pets may be buried, rendered [cooked at a minimum
temperature of 250 degrees Fahrenheit for at least thirty (30)
minutes], incinerated, or disposed either in accordance with
these regulations or on the order of a licensed veterinarian.
Regulation of Medical Waste
In Louisiana, there are three
(3) sources of regulations for medical wastes:
- Louisiana Department of
Environmental Quality, (DEP)
- Louisiana Department of
Health and Hospitals (DHH), and
- Occupation Safety and Health
Agency (OSHA)
The DEP is authorized to promulgate
rules and regulations for the transportation, incineration, and
disposal of medical waste. At this time, DEP rules only regulations
only cover disposal aspects of infectious waste.
The DHH rules and regulations
for medical waste are far reaching; they cover packaging and
labeling, storage, transport, and treatment.
OSHA rules (Occupational Exposure
to Bloodborne Pathogens Standards) impact various aspects of
medical/infectious waste, including management of sharps, requirements
for containers that hold or store medical/infectious waste, labeling
of medical/infectious waste bags/containers, and employee training.
Managing
Regulated Medical Waste
The following is a summary
of Louisiana Department of Health and Hospitals Regulations pertaining
to medical waste. This agency has regulations governing the
packaging, labeling, storage, transportation, and treatment of
medical waste, contained in the Louisiana Sanitary Code, Chapter
XXVII.
Packaging
and Labeling - Potentially infectious biomedical waste
(i.e., medical waste) must be packaged in a manner that prevents
exposure to the material. Liquids must be in a sturdy, leak-resistant
container. Sharps must be in a closed, rigid, break-resistant,
puncture-resistant container. Plastic bags and other containers
must be clearly labeled, impervious to moisture, strong enough
to prevent tearing or bursting under normal conditions, and
closed prior to transport. A second level of containment is
necessary if the material is to be stored prior to transport.
All
containers of potentially infectious biomedical waste must be
labeled "Potentially Infectious Biomedical Waste," "Medical
Waste," or "Infectious Waste." Untreated waste
must bear the name and address of the generator or transporter
when it leaves the generator's premises. Treated waste that is
still recognizable must carry a supplemental label to specify
the treatment method used, the date of treatment, and the name
or initials of the person responsible for treatment. All labels
must be clearly visible and legible, and must be water resistant.
Note: There are no requirements in the DHH Regulations that state
that the bags, boxes, containers, etc., be a certain color.
Storage
and Transport - Potentially infectious medical wastes
must be stored in a secure manner. Compactors shall not be
used for storage. Except for small quantities (defined as a
single package containing less than 11 pounds of waste other
than sharps or less than 2.2 pounds of sharps), wastes can
be transported off the site where they were generated only
by transporters permitted by the State Health Officer.
Small
quantity generators, including doctors', dentists', and veterinarians'
offices and private households, may transport small quantities
of properly packaged and labeled wastes to approved large quantity
generators, permitted storage facilities, or permitted treatment
facilities without meeting the requirements for transport and
treatment that large quantity generators must meet.
Transportation
of potentially infectious waste (except by small quantity generators,
as described above) is governed by Section 27:023 of the regulations.
This section contains provisions for transporter permits; written
contracts between generators and transporters; vehicles used
in transportation; transporter operation plans (including worker
safety and decontamination provisions), and delivery of potentially
infectious biomedical waste only to properly permitted facilities.
Treatment and Disposal Healthcare
facilities may store and treat their own potentially infectious
biomedical wastes, if they obtain a proper permit and comply
with substantive provisions of the regulations as to packaging,
labeling, storage, transportation, and treatment.
Acceptable treatment methods
for potentially infectious biomedical waste include:
- incineration,
- steam sterilization [generally,
autoclaving at least 248 degrees Fahrenheit (120 degrees C.)
and a minimum pressure of 15 psi for a minimum of 30 minutes,
or longer if necessary,
- disposal of liquids into
a sanitary sewer system that meets the requirements of the
sanitary code,
- thermal inactivation [dry
heat of at least 320 degrees F. (160 C.) at atmospheric pressure
for at least 2 hours, excluding lag time,
- chemical disinfection (use
of chemical agents that have been approved by the State Health
Officer), and
- irradiation (only with
the written approval of the State Health Officer).
Sharps must be incinerated,
encased in plaster or other approved substances in a tightly
closed container, or treated in some other manner that renders
them unrecognizable as medical sharps and practically precludes
the release of recognizable needles and syringes if compacted.
Once treated, potentially
infectious biomedical waste may be disposed in a permitted sanitary
landfill in accordance with the Solid Waste Regulations of the
Department of Environmental Quality. As noted above, treated
and still recognizable medical waste must carry a supplemental
label specifying the treatment method and date, and the name
or initials of the person responsible for treatment.
