Regulated Medical Waste

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 Regulated Medical Waste

Regulated medical waste means a special category of solid waste that includes specific types of medical waste subject to handling and tracking requirements. A regulated medical waste is any waste, as defined in these regulations, generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the preparation of human remains for burial or cremation, or in the production or testing of biologicals, or in the development of pharmaceuticals. Regulated medical wastes mixed with nonhazardous solid wastes must be considered regulated medical wastes. The Following categories of medical wastes are regulated medical waste:

Cultures and stocks of infectious agents and associated biologicals.
Pathological wastes including tissues, organs, and body parts that are removed during surgery or autopsy, or other medial procedures.
Human blood, body fluids and blood products.
Sharps.
Animal waste that are known to be contaminated with human pathogens.
Isolation wastes including biological waste and discarded materials contaminated with blood, excretion, 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.
Spill/cleanup material including any material collected during or resulting from the cleanup of a spill of regulated medical waste.
Mixtures including any waste which is a mixture of regulated medical waste and some other type of waste which is neither radioactive nor a hazardous waste of a type other than regulated medical waste.

Managing Regulated Medical Waste

Registration

Healthcare facilities must register with the Rhode Island Department of Environmental Management and obtain a regulated medical waste generator registration number. Details of the registration process can be found in section 16 of DEM-DAH-MW-01-92. Also, see “Generator Application Form” below under Additional Resources.

Identification and Segregation

A person who generates a medical waste within the State of Rhode Island must determine if that waste is a regulated medical waste. Any wastes that contain regulated medical waste mixed with general solid waste must be managed as regulated medical wastes. Any regulated medical wastes which meet the definition of “hazardous waste”, or which are mixed with hazardous wastes must be managed as hazardous waste in accordance with the most current DEM Rules and Regulations for Hazardous Waste Management.

Generators must segregate regulated medical waste from the general waste stream to the maximum extent practicable to ensure the special handling and treatment required by these regulations. Separation from the general waste stream must occur at the point at which the regulated medical waste is generated.

Packaging Requirements

Regulated medical waste must be properly packaged to assure effective containment throughout the handling, storage, transport, and treatment process. In addition to the specific packaging and containment requirements for each category of regulated medical waste, generators must ensure that all regulated medical waste is placed in a container or containers that are rigid, leak-resistant, impervious to moisture, of a strength sufficient to prevent tearing or bursting under normal conditions of use and handling and are sealed to prevent leakage during transport.

Materials for packaging must be strong enough to remain intact during whatever type of handling, storage, and transport the container may undergo. Mechanical compaction of regulated medical waste must not be conducted prior to treatment and/or disposal, unless the mechanical compaction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste.

All sharps and unused sharps, including sharps with residual fluids, must be packaged in containers that are puncture-resistant. Sharps containers with openings large enough to allow entry of any human hand must also be subject to any additional physical and administrative controls necessary to prevent access by the public during normal conditions of use.

In addition to the general packaging and containment requirements for regulated medical wastes, human blood and blood products and body fluids in quantities greater than twenty cubic centimeters must be packaged in containers that are break-resistant and tightly lidded or stoppered. The container must identify the contents as regulated medical waste by displaying the Universal Biohazard Symbol on the outside of the container.

Those regulated medical wastes which are not sharps or fluids in bulk quantities must be packaged in either rigid containers that are designed to be tightly sealable or in plastic bags that meet the following requirements:

The plastic bags must be impervious to moisture and be tear-resistant;
The plastic bags must be a distinctive red or orange color, or clear. If a clear bag is used then the universal biohazard symbol must be appropriately displayed on the bag;
A container used on-site to hold regulated medical waste must have either a red or orange plastic bag plainly visible; or if a clear bag is used then the universal biohazard symbol must be displayed on the container as well as on the bag.

Storage Requirements

The following rules apply to the storage of RMW:

On-Site Transport of Regulated Medical Waste

To ensure the safe transport of regulated medical wastes within the generating facility, generators must comply with the following requirements:

The regulated medical waste must be properly packaged to ensure containment of the waste and all containers and packages containing regulated medical wastes must be sealed to prevent leakage or spillage while in transport.
The handling, transfer, and loading of packages and containers of regulated medical wastes must be performed in a manner that does not destroy the integrity of the packaging.
Regulated medial waste will not be subjected to violent mechanical stress during on-site transport.
Wheeled carts will be used for the transport of packages or containers of regulated medical wastes if these packages or containers will be moved more than a short distance or if these packages or containers cannot be easily handled by one person regardless of the distance to be moved.
Any regulated medical waste which is contained in plastic bags will not be moved or transported in mechanical devices, dumb waiters, or chutes, unless the chutes are designed to prevent accumulation of wastes in corners and edges and are lined with materials which can be easily cleaned.
Carts used for the transport of packages and containers or regulated medical wastes must be sturdy and will be routinely cleaned and disinfected, and immediately cleaned and disinfected after use if the cart has been contaminated by medical waste.
Items other than regulated medical waste must not be placed in the same cart with regulated medical waste at any point during on-site transportation.

Labeling and Marking Regulated Medical Waste for Off-Site Transport

All containers used for the packaging and containment of regulated medical wastes must be labeled with the universal biological hazard symbol or must be clearly labeled as containing regulated medical waste. In addition all packages or containers which will be transported or offered for transport off-site must meet the labeling and marking requirements of the regulations.

Generators must label each package or container of regulated medical waste wit a water-resistant label affixed to or printed on the outside of the container. The label must include the words “Medical Waste”, or display the universal biohazard symbol. Red plastic bags used as inner packaging need not display a label.

Marking Requirements

Generators and intermediate handlers must mark each package or container or regulated medical waste according to the following marking requirements before the waste transported or offered for transport off-site. Refer to the State Department of Environmental Management Regulations (DEM-DAH-MW-01-92) for specifics.

On-Site Treatment and/or Destruction of Regulated Medical Waste

Generators are subject to the requirements of all applicable State solid waste and air emission regulations. Generators must notify in writing all employees involved with on-site treatment and/or destruction of regulated medical wastes.

Generators that accept regulated medical waste from other generators for treatment must apply for a license.

Incineration. Generators must keep an operating log at their incineration facility that includes information pertaining to operation of the incineration facility. Generators must retain the operating log for at least three years from the date of the last entry in the log.

The owner or operator of an on-site incinerator must prepare and submit copies of the on-site incinerator report to the Rhode Island Department of Environmental Management.

The report must be submitted on the form provided in Appendix II of the Rhode Island Regulation DEM-DAH-MW-01-92.

Steam Sterilization. A steam sterilizer used to convert untreated regulated medical waste into treated regulated medical waste must be operated in accordance with the following requirements:

The sterilizers must be dedicated for waste only. They must be operated in accordance with the manufacturer’s specifications for waste in regard to time, temperature, pressure, and capacity, provided that these specifications change the biological character or composition of the regulated medical waste so as to substantially reduce or eliminate its potential for causing disease.
If no manufacturer’s specifications for waste exist, or if another combination of time, temperature, pressure and capacity is used, such combination must be proven, on the basis of thorough tests, to render the regulated medical waste treated.
Regulated medical waste must be steam sterilized in its primary container.
Unless a steam sterilizer is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, the operator of such sterilizer must affix to the primary container temperature-sensitive tape which will indicate when the desired temperature is reached.
At least once during every forty hours of operation, tests must be conducted to evaluate the effectiveness of the sterilization process, including tests of the capacity of such process.
At least once during ever forty hours of operation, a sterilization unit must be evaluated to determine whether it is operating properly with respect to temperature and pressure. A log must be maintained recording the dates and results of such evaluations and the dates of calibration. The log must be kept for at least three years from the date of the last entry in the log.

Alternative On-Site Treatment. Any method or process other that incineration or steam sterilization used by a generator for treatment and/or destruction of regulated medical waste on-site must be approved by the Director in accordance with Section 15.07 of the regulations. Each generator must maintain records concerning quantity, weight, date the waste was treated and/or destroyed, results of required quality assurance. Records must be maintained by the generator for a period of at least three years from the date the waste was treated and destroyed.

Generator Requirements for Off-Site Transportation of Regulated Medical Waste

Licensed Transporters. Generators must use transporters who have been issued a Rhode Island Regulated Medical Waste Transporter Permit number by the Rhode Island Department of Environmental Management, except:

Generators of fifty pounds or more of regulated medical waste per calendar month
Small quantity generators
Shipments between generator’s facilities
Shipments of sharps through the U.S. Postal Service and/or private courier service

Tracking Forms, Reporting and Recordkeeping. Generators must prepare a tracking form for off-site shipment of RMW (see exceptions above). Multi-page tracking forms can be obtained from Rhode Island Department of Environmental Management, Office of Waste Management. The generator must sign the certification statement on the tracking form, obtain the signature of the initial transporter, and retain one of copy of the form. Copies of the tracking forms must be retained for at least three (3) years. See “Tracking Form Instructions” below under Additional Resources.

Generators who are exempt from use of the tracking form (e.g., small quantity generators) must maintain a shipment log that contains shipment dates, quantity shipped, address of the destination and the signature of an employee who is transporting the waste. The log must be kept in the facility’s records for at least three (3) years and semiannual reports must be sent to the Rhode Island Department of Environmental Management, Office of Waste Management. See “Small Quantity Generator Report Form” below under Additional Resources.

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. Rhode Island 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.

Rhode Island