Massachusetts

Infectious Waste

Background Information
Definition of Infectious Medical Waste
Managing Infectious Medical Waste
Disposal of Infectious 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.

Definition of Infectious Medical Waste

In Massachusetts, infectious medical waste is considered a special solid waste. Infectious or Physically Dangerous Medical or Biological Waste is waste, which because of its characteristics may: cause, or significantly contribute to an increase in mortality or an increase in serious irreversible or incapacitating reversible illness; or pose a substantial present potential hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.

The following types of waste are identified and defined as infectious or physically dangerous medical or biological waste:

• Blood and Blood Products: Discarded bulk human blood and blood products in free draining, liquid state; body fluids contaminated with visible blood; and materials saturated/dripping with blood;
• Pathological Waste: Human anatomical parts, organs, tissues and body fluids removed and discarded during surgery or autopsy, or other medical procedures and specimens of body fluids and their containers;
• Cultures and Stocks of Infectious Agents and Associated Biologicals: All discarded cultures and stocks of infectious agents and associated biologicals, biotechnological by-product effluents, cultures of specimens from medical and pathological laboratories, cultures and stocks of infectious agents from research laboratories, wastes from the production of biologicals, and discarded live and attenuated vaccines intended for human use;
• Contaminated Animal Carcasses, Body Parts and Bedding: The contaminated carcasses and body parts and bedding of all research animals known to be exposed to pathogens;
• Sharps: Discarded medical articles that may cause puncture or cuts, including but not limited to all used and discarded hypodermic needles and syringes, pasteur pipettes, broken medical glassware, scalpel blades, disposable razors, and suture needles; and
• Biotechnological By-Product Effluents: Any discarded preparations made from genetically altered living organisms and their products.

• All medical or biological waste, except sharps, shall be contained in a primary container which is a red, fluorescent orange or orange-red plastic bag that is impervious to moisture and has sufficient strength to resist ripping, tearing, or bursting under normal conditions of use and handling, and which meets the American Society for Testing Materials (ASTM) standard D1922-06a and ASTM D1709-04. Each primary container shall:
  • Be marked prominently with the universal biohazard warning symbol and the word “Biohazard” in a contrasting color; and
  • Be secured so as to prevent leakage and to preclude loss of contents during handling, storage, and/or transport.
• All areas for on-site storage of containers of medical or biological waste, excluding kiosks dedicated for the sole purpose of collecting home sharps pursuant to M.G.L. c. 94C, § 27A, shall be in an uncarpeted room or area with impervious, cleanable, non-absorbent flooring, used exclusively for waste storage.
• All on-site storage areas shall:
  • Have prominent signage indicating the space is used for the storage of regulated medical or biological waste;
  • Be designed or equipped to prevent unauthorized access;
  • Be designed or located to protect the waste from the elements and prevent access by vermin;
  • Provide sufficient space to allow for clear separation of regulated medical or biological waste from any other waste, when applicable;
  • Be adequate to accommodate the volume of regulated medical or biological waste generated prior to removal of waste for either waste transport off-site or on-site treatment, and
  • Be maintained such that there is no putrescence of off-site odors, using refrigeration when necessary.
• Sharps shall be segregated from other wastes and aggregated immediately after use in red, fluorescent orange or orange-red leakproof, rigid, puncture-resistant, shatterproof containers that resist breaking under normal conditions of use and handling, meet ASTM standard F2132-0I, and that are marked prominently with the universal biohazard warning symbol and the word "Biohazard" in a contrasting color.
• Free draining blood and blood products and biotechnology by-product effluents shall be stored at all times in leakproof containers that are securely sealed.
• Compactors or grinders shall not be used to process medical or biological waste until it has been rendered noninfectious and safe for disposal in accordance with 105 CMR 480.150.
• All medical or biological waste, except from home sharps users, must be treated on-site or transported off-site for treatment at a minimum once per calendar year.

• Blood and Blood Products
  • If the waste generator is connected to a municipal sewerage system or septic system, free draining blood and blood products except blood saturated materials may be disposed of directly into these systems unless such disposal is otherwise restricted by the authorized approving agency.
  • If the waste generator is prohibited by the authorized approving agency from disposing of blood and blood products into the municipal sewerage system or septic system, blood and blood products, except blood saturated materials, shall be sent to an approved incineration facility for incineration or shall be rendered noninfectious by gas, chemical or steam sterilization prior to disposal and disposed of in a sanitary landfill approved by the Department of Environmental Protection or in case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.
• Sharps. Containers of sharps shall either be:
  • Disposed of by incineration at an approved incineration facility; or
  • Rendered noninfectious as set forth in 105 CMR 480.100(F) and processed by grinding or other effective method to eliminate the physical hazard of the sharps and disposed of in a sanitary landfill approved by the Department of  Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.
• Blood Saturated Materials, Cultures and Stocks of Infectious Agents and Associated Biologicals, Dialysis Waste and Laboratory Waste. These wastes shall either be:
  • Rendered noninfectious on site by steam sterilization, incineration, thermal inactivation, or chemical disinfection and disposed of in a sanitary landfill approved by the Department of Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval; or
  • Disposed of onsite at an approved incineration facility, or placed in a second 3 mil bag for transport to an approved incineration facility off-site.
• Biotechnology By-Product Effluents. These wastes shall not be removed from the site of the waste generator unless the viable organism containing recombinant DNA molecules have been rendered noninfectious by a validated method. The following methods shall be used as appropriate:
  • Steam sterilization;
  • Chemical disinfection;
  • Incineration at an approved incineration facility; or
  • Other methods approved by the Department.
  • The methods, which rely on heat, shall be evaluated mechanically and biologically by using a recording thermometer and indicator microorganism with a defined heat susceptibility pattern.
  • If these wastes are rendered noninfectious by chemical disinfection, the chemical used shall be of demonstrated efficacy against the target or indicator organism.
  • Once rendered noninfectious, biotechnology by-product effluents may be disposed of directly into the waste generator's connection to the municipal sewerage system or septic system unless such disposal is otherwise restricted by the authorized approving agency.
  • If the generator is prohibited by the authorized approving agency from disposing of biotechnology by-product effluents through the municipal sewerage system or septic system, these wastes shall be rendered noninfectious and disposed of in a sanitary landfill approved by the Department of Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.
• Pathological waste and contaminated animal carcasses shall be disposed of at an approved incineration facility or by interment provided however that liquid pathological waste may also be disposed in accordance with the regulations and discarded teeth and tissue may also be disposed of in accordance with the regulations. These wastes shall be placed in a second three-mil bag if they are to be transported off-site for disposal.

• Be distinctively marked with the international biohazard symbol and colored red to indicate that it contains waste; and
• In the case of sharp wastes, be distinctively labeled to indicate that it contains sharp waste capable of inflicting punctures or cuts.

• Rigid;
• Leak resistant;
• Impervious to moisture;
• Of sufficient strength to prevent tearing or bursting under normal conditions of use and handling, and
• Sealed to prevent leakage during transport.
• Bear a label that states the name, address and telephone number of the generator. The label shall be affixed in a manner that ensures that it cannot be easily removed.

• Written policies and procedures for rendering waste noninfectious shall be developed that assure effectiveness and compliance with the requirements.
• The waste generator shall maintain records of temperature and dwell times used in each instance where waste has been rendered noninfectious by gas or steam sterilization and records of each biological spore test culture result. Such records shall be retained for at least three years.
• The waste generator shall maintain records of volume and type of waste rendered noninfectious on-site which shall be available for Department review. Such records shall be retained for at least three years.

• Generators shall prepare manifests before shipping waste, which has not been rendered noninfectious off-site. The manifest is a tracking document designed to record the movement of waste from the generator through its trip with a transporter to an approved disposal facility and final disposal. The generator shall appoint a designee to prepare, sign and maintain such manifests. The manifest must include the following information:
  • Description of waste to be shipped;
  • Total quantity of waste; and
  • Type of container in which waste is transported.
• A generator shall designate on the manifest the address of the site to which the waste is to be delivered and sign it. The transporter of the waste or an agent of the transporter shall sign the manifest to indicate that the transporter has received the waste and will comply with the generator's transportation instructions. When the waste arrives at the approved off-site disposal facility, and has been disposed of, the disposal facility owner or agent of the owner shall sign the manifest and return the original to the generator.
• If the generator does not receive the manifest from the disposal facility within 30 days after shipment of waste by the generator, the generator shall report this fact to the Department of Public Health.
• The generator shall maintain a copy of the manifest both as initially sent out and as returned by the disposal facility for a period of three years.
• In the absence of any restriction concerning individuals who are authorized to transport waste, including but not limited to those imposed by boards of health or the Department of Environmental Protection, generators who transport their own waste shall follow the manifest requirements set forth in the regulations.