Alabama
Medical/Infectious
Waste
Background Information
Definition of Medical/Infectious Waste
OSHA Regulations
Contacts
Statutes, Regulations
and Guidelines
Contact
More Information
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
The term medical/infectious waste is defined as:
- Cultures and stocks of infectious agents and
associated biologicals.
- Human pathological waste.
- Human blood and blood products including:
- Liquid waste human blood;
- Products of blood;
- Items saturated and/or dripping with human
blood; or
- Items that were saturated and/or dripping
with human blood that are now caked with dried human blood.
- Sharps that have been used in animal or human
patient care or treatment or in medical, research, or industrial
laboratories, including hypodermic needles, syringes (with or without
the attached needle), Pasteur pipettes, scalpel blades, blood vials,
needles with attached tubing, and culture dishes (regardless of
presence of infectious agents). Also included are other types of
broken or unbroken glassware that were in contact with infectious
agents, such as used slides and cover slips.
- Animal waste including contaminated animal carcasses,
body parts, and bedding of animals that were known to have been
exposed to infectious agents during research (including research
in veterinary hospitals), production of biologicals or testing
of pharmaceuticals.
- Isolation wastes including biological waste
and discarded materials contaminated with blood, excretions, exudates,
or secretions from humans who are isolated to protect others from
certain highly communicable diseases, or isolated animals known
to be infected with highly communicable diseases.
- Unused sharps including the following unused,
discarded sharps: hypodermic needles, suture needles, syringes,
and scalpel blades.
The definition of medical/infectious waste does
not include hazardous waste; household waste; ash from incineration
of medical/infectious waste, once the incineration process has been
completed; human corpses, remains, and anatomical parts that are
intended for interment or cremation; and domestic sewage materials.
Notification and Medical Waste Plan Preparation
Prior to initiating any waste generation, treatment,
transportation or disposal activity a healthcare facility that will
generate medical waste must notify the Department and prepare a written
plan to ensure proper management of medical waste. This plan must
be maintained and updated as necessary and made available to the
Alabama Department of Environmental Management upon request. This
plan must address the following, if applicable to the generators:
- The type of medical waste generated;
- Proper segregation, packaging and labeling procedures
of untreated medical waste intended for off-site transportation;
- Treatment method to be utilized on-site;
- Transporter of any untreated medical waste transported
off-site;
- Storage facilities utilized both on-site and
off-site;
- All treatment/processing facilities utilized;
- All disposal facilities utilized;
- Frequency medical waste is removed off-site
from medical waste generator’s facility; and
- Training of employees.
On-site Medical Waste Management
Packaging and Labeling. Medical waste intended
for transport to off-site disposal must be packaged and maintained
in the following manner:
- The outermost layer of packaging for medical
waste must be packaged in containers which have either a red background
color or utilize red lettering with contrasting background color
and conspicuously labeled with either the words “Infectious” or “Medical
Waste” or “Biohazardous” and/or contain the International Biological
Hazard Symbol.
- The wording must be either printed on the
container or securely attached by label on two or more sides. The
wording must utilize letters two inches or larger in size, and
the International Biological Hazard Symbol, must be six inches
or larger in diameter. The wording and symbol, if utilized,
must be in a contrasting color to the background color.
- The ink utilized must be indelible and considered
permanent when exposed to the environment under normal weather
conditions.
- Containers must be impermeable to moisture and
must have a strength which prevents ripping, tearing, or bursting
under normal conditions of use.
- Sharps must be placed directly into leak proof,
rigid, puncture-resistant containers and sealed to prevent loss
of contents under normal handling procedures. These containers
must be clearly labeled as described in (1) above unless placed
in rigid shipping containers that meet this requirement.
- Small containers may used to collect untreated
medical waste placed inside larger containers to better facilitate
storage, transportation, or disposal provided that they meet certain
requirements.
- The outermost layer of packaging must be properly
identified with the following information. This information must
be securely attached or permanently printed and must be clearly
legible. Indelible ink must be used to print the information on
the label or container.
- The name and address;
- The date the waste was packaged in its outermost
container;
- One of the following words or phrases used
in conjunction with the International Biological Hazard Symbol: “Medical
Waste” or “Biohazardous” or “Infectious.”
- Containers of medical waste must remain intact
without signs of leakage until treatment.
- Containers of medical waste must be handled
in a manner that does not affect the integrity of the packaging.
- Disposable single use containers used for the
storage and transportation of untreated medical waste must be rigid,
leak resistant, puncture resistant, burst resistant, and tear resistant
under normal conditions of handling and use. Reusable containers
must meet these same requirements in addition to being constructed
of smooth, easily cleanable, impermeable materials and resistant
to corrosion.
- Containers utilized for collection, storage
and transportation must be constructed of materials that are compatible
with the treatment method to be utilized.
- The collection of treated medical waste
intended for transport off-site must comply with the following
requirements:
- The containers must not be red in color,
or display the International Biological Hazard Symbol or display
one of the following phrases: “Medical Waste”; “Infectious” or “Infectious
Waste”; or “Bio Hazardous”.
- Any other identification normally used to
indicate medical waste as being untreated.
Storage of Untreated Waste. The following
rules apply to the storage of untreated medical waste. Note that
storage begins after a shipping container is prepared for shipment
to a storage or treatment facility.
- Storage facilities must be fully enclosed.
- Designated storage facilities must not be utilized
for other purposes.
- Surfaces of storage facilities which may come
into contact with medical waste must be constructed of smooth,
easily cleanable materials that are impervious to liquids.
- Storage facilities must be conspicuously identified
with signs which contain either the phrase “Medical Waste,” “Infectious
Waste,” “Biohazardous,” or display the International Biological
Hazard Symbol.
- Storage facilities must be adequately secured
to prevent entry of unauthorized persons.
- Storage facilities must be operated in such
a manner to minimize entry by rodents and vectors.
- The operation of storage facilities must minimize
or prevent objectionable odors as determined by the Department
from migrating off-site.
- Persons manually handling untreated medical
waste at the storage facility must wear impermeable gloves and
protective clothing to minimize exposure.
- Storage of medical waste by the generator must
not exceed seven calendar days from the date initial storage begins
unless waste is refrigerated at a temperature less than 45 degrees
Fahrenheit. This requirement does not apply to generators who
generate less than 220 pounds per month of medical waste.
Storage of Treated Waste. The following
rules apply to the storage of treated medical waste.
- Containerized treated medical waste may be mixed
with other solid waste for storage prior to transportation to an
approved disposal facility.
- When written certification is required on a
per load basis, storage facilities must provide transporters the
certification, provided by the person who treated the waste, to
be delivered to the permittee or his designee of the disposal facility
utilized.
Treatment of Medical Waste
Medical waste intended for transport to a solid
waste disposal facility must be treated on-site or at some alternative
location prior to disposal. When written certification is required
by the Department or the permittee of the disposal facility to be
utilized on a per load basis, the person treating the medical waste
must provide the transporter the certification. The certification
must state that all regulated medical waste has been treated prior
to placing the waste in a designated location for transport to an
approved disposal facility. When written certification is required
on a less frequent basis as noted above, the responsible person for
the treatment facility must provide the certification to the permittee
or his designee of the disposal facility to be utilized. The following
rules apply to specific types of treatment.
- Incinerators. Persons owning or operating
an incinerator (combustion unit) must comply with the requirements
of the Department’s regulations regarding air pollution control.
- Steam Sterilizers. Medical waste may
be treated by steam sterilizers (autoclaves) provided the following
requirements are met:
- Medical waste containing hazardous chemicals,
or radioactive waste must not be approved for this method of
treatment.
- Certain medical waste, including sharps and
recognizable human tissue, organs, body parts, and infected animals,
must be further processed after the steam sterilization process.
- Steam sterilizers should be equipped to continuously
monitor and record temperature and pressure during the entire
length of each cycle. Sterilizers not so equipped must affix
a temperature sensitive tape to each bag or container or obtain
approval from the Department of an equivalent test.
- Each bag or container must be exposed to a
minimum temperature of 250 degrees Fahrenheit and at least 15
pounds of pressure for 30 minutes. Processing requirements may
be altered if proper decontamination is assured by appropriate
testing, and approval is received from the Department.
- Each sterilizer must be evaluated for effectiveness
under full loading by an approved method at least once for each
40 hours of combined operation. Biological indicators such as
spores of “Bacillus stearothemophilus” may be utilized with Departmental
approval.
- A written log or other means of documentation
as approved by the Department must be maintained for each steam
sterilization unit.
- Sterilizers utilized for waste treatment must
not be utilized for sterilization of equipment, food, or other
related items.
- Other Treatment Methods. Other treatment
methods may be approved by the Department which are consistent
with the intent of this Division. A person must make a request
in writing for approval of an alternative treatment method.
- Disposal by Sanitary Sewer. Medical
waste, such as liquids which are amenable to disposal by sanitary
sewer, may be discharged subject to the following conditions:
- Sanitary sewer system must provide secondary
treatment;
- Solid and liquid waste removed from systems
which do not provide secondary treatment (e.g., holding tanks)
must be further processed in a sanitary sewer system that
provides secondary treatment. Prior approval for sewer systems
not regulated by the Water Division of the Department must
be obtained from the Local Health Officer.
- Sanitary sewer system must be operated
in such a manner that medical waste will not bypass the treatment
facility during normal operating conditions.
Disposal of Untreated Waste
Medical waste must be treated on-site at the point
of generation or off-site at an approved treatment facility prior
to delivery to a solid waste disposal facility.
Disposal of Treated Waste
All treated medical waste intended for disposal
in a sanitary landfill must be disposed of in an approved facility. Requirements
for disposal in an approved solid waste disposal facility is as follows:
- Medical waste containing liquids must be further
processed to eliminate free liquids and further reduce the liquid
consistency to the point where the waste would be considered bladeable
by disposal facility personnel.
- Written certification to the effect that medical
waste has been properly treated must be provided to the permittee
or his designee. The minimum frequency for providing this certification
must be annually. The treater must be responsible for providing
this certification. The permittee or the Department may require
more frequent certification.
OSHA
Regulations
In addition to the state medical waste environmental
regulations there are some Occupational Safety and Health Administration
(OSHA) rules that apply to medical/infectious waste. Alabama is
one of 26 states covered entirely by the federal OSHA program. This
program is operated by the Occupational Safety and Health Administration. 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.
Statutes,
Regulations and Guidelines
Alabama Department
of Environmental Management Land Division - Solid Waste Program Regulations, Chapter
335-13-7, Medical Waste
Contacts
Alabama Department
of Environmental Management Land Division
More
Information
Alabama Medical Waste Program |