Regulated Medical Waste

Connecticut

Biomedical Waste

Background Information
Definition of Biomedical Waste (BMW)
Managing BMW
Disposal of BMW
Incinerating BMW
Licensed Transporters
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
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 Biomedical Waste (BMW)

BMW is any infectious, pathological, and chemotherapy waste generated during the administration of human medical care or the performance of medical research involving humans or animals. BMW includes:

Infectious waste (including sharps).
Pathological waste.
Chemotherapy waste.
Mixed with a BMW.
Disposable non-decontaminated reusable containers.

Managing Biomedical Medical Waste (BMW)

A generator of BMW is any person who owns or operates a facility that produces BMW in any quantity. This includes, but is not limited to, the following: hospitals, skilled nursing facilities, laboratories, physicians’ offices, veterinarians, dental offices, and funeral homes. Where more than one generator of BMW is located in the same building, each individual business entity is considered a separate generator.

Generators must prepare a written management plan for each facility that generates BMW. The BMW plan must set forth policies and procedures for segregating the waste and to ensure the below conditions are met:

BMW that is mixed with hazardous waste or radioactive material will be managed as hazardous waste or radioactive material.
Any solid waste this is mixed with BMW will be managed as BMW.

Follow these prescribed practices for managing BMW:

Segregate sharps, body fluids and other BMW.
Implement a written BMW Management Plan.
Package in appropriate containers.
Label containers with water-resistant labels.
Mark primary and secondary containers with water-resistant identification tags.

Identification and Segregation

Generators must segregate BMW from other solid waste before placing the BMW into primary containers. BMW must be segregated into the following groupings:

Sharps.
Bodily fluids in a quantity greater than 20 cubic centimeters (cm³).
Other biomedical waste.

Packaging Requirements

Before transporting BMW, generators are required to package the BMW as follows:

Place BMW in containers that are rigid, leak-resistant, impervious to moisture, sufficiently strong to prevent tearing or bursting under normal conditions, and sealed to prevent leakage.
Place sharps in containers that are puncture-resistant.
Body fluids in quantities greater than 20 cm³ must be placed in containers that are break-resistant and tightly lidded or stoppered.
Employees packaging BMW must wear personal protective equipment.
The outside of each container must be marked with a water-resistant label displaying the universal biohazard symbol or the words "medical waste" or "infectious waste."

Storage Requirements

BMW must be stored in such a way that it avoids mixing with other materials, and access to it must be limited to personnel authorized by the generator, transporter, or solid waste facility operator to handle it. Outdoor storage areas, such as dumpsters, sheds, or trailers, must be locked. Furthermore, the areas used for storage must be constructed of finished materials that are impermeable and capable of being easily maintained in a sanitary condition.

The waste itself should be stored in a manner and location that protects it from water, precipitation, wind, animals, and does not provide a breeding place or food source for insects or rodents. To maintain a non-putrescent state, BMW may be refrigerated during storage. Finally, a sign displaying the universal biohazard symbol and/or the words “BIOHAZARD” must be posted wherever BMW is stored.

Labeling and Marking Biomedical Waste (BMW) for Off-Site Transport

Before transporting BMW, the generator must:

Place the waste in a red bag to render it universally recognizable as biomedical.
Package it in rigid, leak-resistant containers that are resistant to moisture.
Use a container that is strong enough to avert tearing or bursting under normal circumstances and seal it to prevent leakage.
Make sure each container displays the universal biohazard symbol or the words “BIOHAZARD” in large, easy-to-read lettering.
Never reuse a container that housed BMW for any purpose unless its surfaces were protected from contamination through the use of a liner or bag that was removed with the waste, or it has been thoroughly washed and disinfected, with all visible traces of prior contamination removed.

Disposal of Biomedical Waste (BMW)

BMW which has been treated in accordance with BMW regulations and which has been rendered unrecognizable may be disposed of as municipal solid waste. Solid waste facilities shall not accept BMW which is not packaged, labeled and marked as required by regulations, or which is not accompanied by a tracking form that complies with all applicable law. The methods of disposal are as follows:

Chemotherapy waste by incineration.
Pathological waste (i.e. human tissue, organs, body parts) by incineration or internment.
Infectious waste (i.e. body fluids or items dripping with body fluids, discarded sharps, biological waste generated from research) either by incineration, discharge to a sanitary sewer, or treatment by steam sterilization or other approved alternative treatment technology (ATT). The waste may be discharged to a sewer given it is liquid or semi-liquid in form, and that secondary treatment is provided at a private or public treatment works. In all cases, once the waste has been treated in accordance with the provisions of the regulations, the end result must be rendered unrecognizable as biomedical waste. It may then be disposed of as municipal solid waste. Note: this category includes ALL infectious waste EXCEPT that which falls under the categories of “chemotherapy” and “pathological.”
Needles which are specifically used to administer antineoplastic agents shall be handled in accordance with this section or under regulations adopted for the handling of chemotherapy waste; and
Syringes designed to deliver drugs into the human body in a manner other than injection shall be exempted from the disposal requirements of this section.

On-Site Treatment or Disposal of Biomedical Waste (BMW)

If BMW is treated or disposed of at the site where it was generated, the generator shall develop written procedures for each treatment or disposal method in use at such site which methods shall be consistent with the provisions of this section and shall ensure compliance with such procedures.

Such procedures shall be incorporated into the BMW management plan required by law and shall (1) assure the effectiveness of any treatment method in use and reflect acceptable standards of practice, (2) provide for and conduct an ongoing program of staff training on the implementation of such procedures and the requirements of this section, and (3) provide for a quality assurance program to assure compliance with the biomedical management plan prepared as required by law.

Incinerating Biomedical Waste (BMW)

Biomedical waste incinerator residue shall be managed as a special waste in accordance with the regulations. A steam sterilizer used to decontaminate biomedical waste shall be operated in accordance with the following requirements:

In a gravity flow sterilizer, biomedical waste shall be subjected to a temperature of not less than two hundred fifty degrees Fahrenheit at fifteen pounds per square inch of gauge pressure for no less than sixty minutes.
In a vacuum type sterilizer, biomedical waste shall be subjected to a temperature of not less than two hundred seventy degrees Fahrenheit at twenty-seven pounds per square inch gauge pressure for no less than forty-five minutes.
Notwithstanding subdivisions (1) and (2) of this subsection, a different combination of operational time, temperature and pressure may be utilized for steam sterilization of biomedical waste if such combination is first described in writing to the commissioner and approved in writing by the commissioner. The commissioner shall not grant approval unless such combination is proven on the basis of thorough tests, including tests of its capacity to kill bacillus stearothermophilus and to completely and reliably kill all microorganisms in waste at design capacity.
Biomedical waste shall be steam sterilized in its primary container. The primary container shall be placed in the sterilization chamber so that sufficient space is provided between the chamber walls and the container to allow the steam to penetrate the container. The primary container shall then be unsealed to allow the steam to penetrate the contents of the container.
Unless the steam sterilizer is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, the operator of such sterilizer shall affix to the primary container temperature-sensitive tape which indicates when the desired temperature is reached. Biomedical waste shall not be considered decontaminated unless the temperature-sensitive tape indicates that a temperature of at least two hundred fifty degrees Fahrenheit was reached during the sterilization process. A steam sterilizer which is used for the first time after July 1, 1994, shall automatically and continuously monitor and record temperatures throughout the entire length of each steam sterilization cycle.
At least once during every forty hours of operation, tests shall be conducted to evaluate the effectiveness of the sterilization process, including tests of the capacity of such process to kill bacillus stearothermophilus. A log shall be maintained recording the dates and results of such test.
At least once during every forty hours of operation, a sterilization unit shall be evaluated to determine whether it is operating properly with respect to temperature and pressure. A log shall be maintained recording the dates and results of such evaluations and the dates of calibration.
For each sterilization unit a log shall be maintained recording, for each use, the date, time, operator, type and approximate amount of biomedical waste treated, the sterilization pressure reading and the poststerilization reading on the temperature-sensitive tape.

Sharps shall be physically altered so as to render them unrecognizable in accordance with the regulations.

Prohibitions

No person shall:

Deliver biomedical waste or cause biomedical waste to be delivered to any incinerator, whether located inside or outside of this state, unless such incinerator complies with all applicable law; or
Operate an incinerator in which biomedical waste is burned unless such incinerator complies with all applicable law.

Licensed Transporters

Generators must use transporters permitted by DEP. Connecticut requires separate permits for transporting hazardous and biomedical waste. Under Connecticut law, ANY person who transports BMW, regardless of the quantity, needs a permit issued by the Commissioner. To receive the most current list of licensed BMW transporters, contact the Waste Engineering and Enforcement Division’s Solid Waste Section at 860-424-3366.

One exception to this permit requirement is if you are a BMW Small Quantity Generator (SQG) and you generate or transport less than 50 lbs in a month or in any single shipment. SQG’s may self-transport without a permit, ship certain BMW using the US Postal Service and are exempt from certain tracking and record keeping requirements. SQG’s may ship to a solid waste facility or another facility owned by the generator. Generators may ship from the original generation point to a central collection point if:

The waste is segregated, packaged, labeled and marked.
Written authorization is provided for employees.
The waste is transported by employer/employees.
Shipping logs are maintained at each site.

*Although qualified SQG’s can self-transport certain BMW, it is recommended that you use a permitted BMW transporter to ship BMW, to ensure that the waste is being transported in accordance with applicable law.

Each generator of biomedical waste shall submit to the Commissioner of Environmental Protection, in writing, the name of the person said generator has contracted with to dispose of its biomedical waste, the amount of such waste and the site of disposal.

Tracking Forms, Reporting and Recordkeeping

Generators must use the DEP-provided form to track BMW from cradle to grave. The generator must prepare one copy for its facility, one copy for the transporter, and two copies for the solid waste facility where the BMW is being transported.

If applicable, maintain the following records on-site for three years:

Signed Medical Waste Tracking forms.
Original US Postal Service receipts and return mail receipts.
Operating logs and annual reports.
Shipping logs.
Exception reports.

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. Connecticut is one of 24 states operating an approved occupational safety and health program. However, the Connecticut program only covers the workplace safety and health of public sector employees only.

Private sector employees in Connecticut are covered by Federal OSHA. OSHA state and federal 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.

Other Resources

Biomedical waste information.