regulated medical waste

Last updated on January 21, 2021

Medical waste is generated by healthcare facilities (human and animal), research institutions, and even at home. Each time you have blood drawn, surgery, get a filling at the dentist, or visit a pharmacy for a flu shot, you create medical waste. Improper waste disposal has serious health and environmental consequences. Health professionals and consumers need to understand how to protect themselves and their communities.

What Is Regulated Medical Waste?
In general, regulated medical waste (RMW) is healthcare-related waste with the potential to spread disease through blood or other types of contamination if not handled properly. Serious diseases like Ebola, TB, and Hepatitis are examples of contagions that could be spread through the improper handling of RMW. Alternate terms for RMW include biohazardous medical waste and biomedical waste.

It’s critical to understand the difference between general, medical waste and regulated medical waste – for both financial and safety reasons! According to the World Health Organization, “up to 85% of waste generated by health care-related activities is general, non-[bio]hazardous waste” that doesn’t pose a threat to human health or safety. Because of the danger to health and safety, regulated medical waste disposal costs are a lot higher than regular trash collection. It costs up to 10 times as much to dispose of regulated medical waste as it does regular trash. Thus, it’s important to properly segregate regulated medical waste, which has special handling considerations, from non-biohazardous medical waste. Regulated medical waste mixed in with regular trash can spread dangerous pathogens and injure employees and the public.

What Are the Categories of Regulated Medical Waste?

Individual states often designate specific categories of regulated medical waste. They define what waste belongs in each category as well as how each category of waste must be treated. You should always refer to your state’s regulations to see how they define regulated medical waste and how it is categorized. These are the most commonly-used categories of regulated medical waste:

  • Biological waste: Any item that has been contaminated with human blood or bodily fluids (excluding urine, sweat, and feces), or with animal bodily fluids contaminated or suspected to be contaminated by a zoonotic disease.
  • Sharps waste: Sharps are anything that can pierce or cut the skin. This includes needles, syringes with needles, lancets, scalpels, wires, staples, broken glass, etc.
  • Infectious waste: Discarded materials and biological waste products that are infectious but not highly communicable. Waste creators must follow CDC isolation precautions, but often, this waste can be mixed with other, non-regulated medical wastes.
  • Pathological waste: Any recognizable human body part, organs and tissue, or any animal body part, organ or tissue contaminated or suspected to be contaminated by a zoonotic disease.
  • Isolation waste: This includes discarded materials and biological waste products from people or animals infected with dangerous, highly communicable diseases (as defined by the CDC) like Ebola and Marburg. It must be treated as regulated medical waste
  • Trace chemotherapy waste: Residual chemotherapy medications (less than 3% of the original amount), syringes, and items utilized in the preparation of chemotherapy infusions are all required to be disposed of as regulated medical waste. Note that some chemotherapy drugs are classified as hazardous waste. Learn more about disposal of hazardous chemotherapy waste.

What Is Biohazardous Medical Waste?

Generally speaking, this is a catch-all term for regulated medical waste, which is contaminated with blood or other potentially infectious substances and poses the potential danger of transmitting diseases. There is no material difference between the terms regulated medical waste and biohazardous medical waste – they’re different terms for the same substances. However, some states use the term biohazardous medical waste to refer to all of their regulated medical waste.

What Goes in a Sharps Container?

OSHA defines a sharp as any object that can pierce the skin. Those items include:

Only sharps go into sharps containers. Other types of medical waste, such as pharmaceuticals, blood-soaked items, and pathological specimens require a different type of containment.

How Often Should Sharps Containers Be Emptied?

Containers shouldn’t be filled more than 3/4 full. Never overfill a sharps container. Make sure there are no sharps protruding from the container and that the lid fits tightly before packing it for pickup or mail back.

Who Regulates Medical Waste?

Many different governmental agencies oversee the handling of regulated medical waste. For example, the FDA regulates the manufacturing of sharps containers. OSHA regulates the handling of medical waste by employees to assure their safety. USPS regulates how regulated medical waste is shipped through the mail. DOT regulates how regulated medical waste is shipped over the road. Finally, states regulate the disposal of regulated medical waste. Learn more about how state medical waste regulations differ. Always check with your state and local government about specific requirements.

For example, state regulatory differences include:

  • Documentation requirements
  • Tracking form retention
  • Storage time limitations for sharps and red bag RMW
  • Staff training requirements
  • Medical waste management plan development

How Is Medical Waste Transported?

Transportation options vary depending upon the type and amount of waste.

Small and mid-size generators often use affordable mail-back containers. The containers must comply with USPS or DOT regulations depending upon the carrier. Larger quantity generators usually find it more economical to have their waste transported using a registered regulated medical waste hauler.

Also, we also offer high-temperature incineration for treatment of pathological, trace chemotherapy, and pharmaceutical wastes.

Make sure your staff understands the regulations – particularly paperwork and tracking requirements for regulated medical waste. Improperly segregated waste and paperwork errors can lead to large fines.

What Happens to Regulated Medical Waste?

Regulated medical waste requires special handling because it’s potentially dangerous. Red biohazard bags and sturdy containers clearly identify sharps and biohazardous medical waste, so there’s no confusion about the contents.

Once the waste is collected, the containers are moved to a disposal facility. Transportation methods depend on the type of waste and the amount requiring disposal.

  • Mail-back systems. Used to mail back your full containers of properly packaged regulated medical waste, utilizing USPS, which meet USPS regulations or UPS/Fed Ex, which meet DOT requirements.
  • Pickup services that meet DOT requirements. Sharps Compliance directly services 15 states with our route-based services. We also have a robust network of third party haulers we contract, which expands our route-based coverage nationwide. Contact us to learn more about our medical waste pickup service.

At Sharps, we treat regulated medical waste either with our on-site autoclave or incinerator, both of which render it harmless. As part of our goal to be a zero-landfill company, we convert all of our autoclave-treated regulated medical waste into a usable energy source, thereby reducing our carbon footprint and keeping material out of landfills.


Dana has a bachelor’s degree in nursing and a master’s degree in geography and has worked in both the clinical and regulatory compliance settings. Her nursing experience includes working in ER, neuro ICU, hospice, and case management. Her regulatory experience includes conducting environmental compliance reviews for federal grant projects and working as an Environmental Investigator with the TCEQ. Dana joined Sharps Compliance in 2018.

published in Medical Waste