Regulated Medical Waste

What is Medical Waste

“Medical waste” means any biohazardous, pathology, pharmaceutical, or trace chemotherapy waste not regulated by the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended; sharps and trace chemotherapy wastes generated in a health care setting in the diagnosis, treatment, immunization, or care of humans or animals; waste generated in autopsy or necropsy; waste generated during preparation of a body for final disposition such as cremation or interment; waste generated in research pertaining to the production or testing of microbiologicals; waste generated in research using human or animal pathogens; sharps and laboratory waste that poses a potential risk of infection to humans generated in the inoculation of animals in commercial farming operations; waste generated from the consolidation of home-generated sharps; and waste generated in the cleanup of trauma scenes. Biohazardous, pathology, pharmaceutical, sharps, and trace chemotherapy wastes that meet the conditions of this section are not subject to any of the hazardous waste requirements found in Chapter 6.5 (commencing with Section 25100) of Division 20.

See next page for items included in Biohazard waste (listed above)

Biohazard waste (included in regulated medical waste)

“Biohazardous waste” includes all of the following:

(A)
- Regulated medical waste, clinical waste, or biomedical waste that is a waste or reusable material derived from the medical treatment of a human or from an animal that is suspected by the attending veterinarian of being infected with a pathogen that is also infectious to humans, which includes diagnosis and immunization; or from biomedical research, which includes the production and testing of biological products.
- Regulated medical waste or clinical waste or biomedical waste suspected of containing a highly communicable disease
(B) Laboratory waste such as human specimen cultures or animal specimen cultures that are infected with pathogens that are also infectious to humans; cultures and stocks of infectious agents from research; wastes from the production of bacteria, viruses, spores, discarded live and attenuated vaccines used in human health care or research, discarded animal vaccines, including Brucellosis and Contagious Ecthyma, as defined by the department; culture dishes, devices used to transfer, inoculate, and mix cultures; and wastes identified by Section 173.134 of Title 49 of the Code of Federal Regulations as Category B “once wasted” for laboratory wastes.
(C) Waste that, at the point of transport from the generator’s site or at the point of disposal contains recognizable fluid human blood, fluid human blood products, containers, or equipment containing human blood that is fluid, or blood from animals suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans.
(D) Waste containing discarded materials contaminated with excretion, exudate, or secretions from humans or animals that are required to be isolated by the infection control staff, the attending physician and surgeon, the attending veterinarian, or the local health officer, to protect others from highly communicable diseases or diseases of animals that are communicable to humans.

See next page for Items classified as Infectious waste that are included in medical waste.

Infectious Agents (Included in regulated medical waste)

“Infectious agent” means a type of microorganism, bacteria, mold, parasite, or virus, including, but not limited to, organisms managed as Biosafety Level II, III, or IV by the federal Centers for Disease Control and Prevention, that normally causes, or significantly contributes to the cause of, increased morbidity or mortality of human beings.

On-site Treatment of Regulated Medical Waste

On-site steam sterilizing of regulated medical waste is permissible by departments if the following requirements are met:

Standard written operating procedures shall be established (and posted) for each steam sterilizer; including time, temperature, pressure, type of waste, type of container, closure on container, pattern of loading, water content, and maximum load quantity.
Recording or indicating thermometers shall be checked during each complete cycle to ensure the attainment of 121° Centigrade (250° Fahrenheit) for at least one-half hour, depending on the quantity and density of the load, to achieve sterilization of the entire load. Thermometers, thermocouples, or other monitoring devices identified in the facility operating plan shall be checked for calibration annually. Records of the calibration checks shall be maintained as part of the facility’s files and records for a period of two years or for the period specified in the regulations. (A copy of the calibration certificate must be forwarded to the OEHS Coordinator)
Heat-sensitive tape, or another method acceptable to the enforcement agency, shall be used on each biohazard bag or sharps container that is processed onsite to indicate that the waste went through heat treatment. If the biohazard bags or sharps containers are placed in a large liner bag within the autoclave for treatment, heat-sensitive tape or another method acceptable to the enforcement agency only needs to be placed on the liner bag and not on every hazardous waste bag or sharps container being treated.
The biological indicator Geobacillus stearothermophilus, or other indicator of adequate sterilization as approved by the department, shall be placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions. (see form below)
Records of the procedures specified above shall be maintained for a period of not less than two years.

Monthly Autoclave Spore Test Form

The weight of each load of regulated medical waste processed through each autoclave must be recorded. An annual total must be submitted to the OEHS coordinator at mfay@sdccd.edu.