Maryland

Regulated
Medical Waste

Background Information
Definition of Special Medical Waste
Managing Regulated Medical Waste
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.

• Special medical waste is a solid waste that is composed of:
• Anatomical material, which is human or animal body parts, including tissues and organs;
• Blood (human or animal);
• Blood-soiled articles, which means any article that contains blood in any form as a result of contact with blood;
• Contaminated material which means:
  • Microbiological laboratory waste;
  • The feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces;
  • An article soiled with the feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces; or
  • An article that has come into contact with a known infectious agent.
• Microbiological laboratory waste, which means waste from a microbiological laboratory that contains an infectious agent and includes cultures and stocks of infectious agents and associated biologicals; or
• Sharps, which means a syringe, needle, surgical instrument, or other article that is capable of cutting or puncturing human skin.

• Household waste;
• Wastes generated in the handling of an animal unless the generator knows or has reason to know that the animal has a disease that is capable of being transmitted to humans;
• The ash or by-product from an incinerator authorized by a state to burn special medical waste; and
• Wastes not generated in the ordinary course of business.

• Determining whether or not the generator has special medical waste;
• Obtaining an identification number
• Record keeping;
• Additional reporting; and
• Applicable requirements of the U.S. Department of Transportation Hazardous Materials Regulations.

• A generator who has not received a Maryland identification number may obtain one by applying to the Secretary. Upon receiving the request the Secretary will assign an identification number to the generator.
• A generator may not offer his special medical waste to transporters that have not received a Maryland identification number.

• Packaging: Before transporting or offering for transport, the generator shall:
  • Place blood or blood-soiled article in a container that will prevent blood from spilling or otherwise leaving the container;
  • Place anatomical materials in a leak proof bag or bags with a combined thickness of at least 3 mils or equivalent strength, and place the bag or bags in a clearly labeled rigid container to protect the bag or bags from puncture;
  • Place a sharp in a container which is impervious to puncture; and
  • Comply with any regulation by the Secretary of Health and Mental Hygiene, and other applicable regulations that are intended to ensure safety in handling infectious agents.
• Labeling: Before transporting or offering special medical waste for transportation off-site, a generator shall:
  • Label each package with the generator identification number and the words, "Special Medical Waste"; and
  • Ensure that the label is clearly visible.
• Treating: If a generator treats special medical waste before transporting or offering for transport, then the generator may treat the special medical waste only as provided in the regulations.
• Disposal of Sharps: A generator may not dispose of sharps in a solid waste landfill unless the generator incinerates the sharps or first sterilizes and then mechanically destroys the sharps.

• Autoclaving;
• Chemical disinfection;
• Cremation;
• Disinfection;
• Mechanical destruction after decontamination; or
• An alternative method that meets the criteria of the regulations.

• Encapsulation;
• Incineration;
• Mechanical destruction after decontamination; or
• An alternative method that meets the criteria of the regulations.

• Burying;
• Depositing in a facility approved by local ordinance to accept the type of solid waste being disposed; or
• Incineration.

• Generators shall keep a copy of each annual report and exception report for a period of at least 3 years from the date of the report.
• Generators shall keep records of any test results, waste analyses, or other determinations made in accordance with the regulations for at least 3 years from the date that the waste was last sent to on-site or off-site treatment, storage, or disposal.
• The periods of retention are extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary.
• Additional Reporting. The Secretary, as the Secretary deems necessary, may require generators to furnish additional reports concerning the quantities and disposition of special medical wastes.

• A transporter may not transport special medical wastes without having received a State identification number from the Secretary.
• A person may not transport special medical waste to a facility within the State or from a source within the State unless the person obtains a certificate from the Department. A special medical waste hauler certificate is required of persons engaged in transporting special medical wastes.
• Transporters using vehicles or articulated transports to transport special medical waste to a facility within the State or from a source within the State shall:
  • Display prominently the vehicle certificate; or
  • Affix the vehicle certificate to the outside of the left door of the cab of the special medical waste vehicle.

• The facility designated by the generator;
• An alternate facility designated by the generator, if the special medical waste cannot be delivered to the designated facility because an emergency prevents delivery;
• Next designated transporter; or
• Place outside the United States designated by the generator.