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Regulated and Medical Waste in United States

Updated this week

Learn what Regulated Medical Waste (RMW) is, how sharps and biohazard waste are defined by OSHA and the DOT, and how to handle them safely and in compliance with regulations.

While the exact definition of RMW can vary by state, federal agencies like OSHA and the DOT provide broad classifications, which states often refine with more specific lists. RMW is also commonly called infectious waste or biohazardous waste.


Federal Definition Key Sources

At the federal level, OSHA and DOT outline what qualifies as regulated medical waste, setting standards for safe handling, packaging, and transport. These definitions form the foundation for compliance across states and facilities.

  • OSHA 29 CFR 1910.1030 – Bloodborne Pathogens Standard
    This rule explains how employers must protect workers from exposure to blood and infectious materials, including proper handling and disposal of regulated medical waste. Regulated waste includes:

    • Liquid or semi-liquid blood or other potentially infectious materials (OPIM)

    • Contaminated items that would release blood or OPIM in a liquid or semi-liquid state if compressed

    • Items caked with dried blood or OPIM that could release these materials during handling

    • Contaminated sharps

    • Pathological and microbiological wastes containing blood or OPIM

  • DOT 49 CFR Parts 171–173
    These materials are classified as Category B Infectious Substances (UN 3291) when transported and require special packaging and labeling.


Types of Regulated Medical Waste

Regulated medical waste is primarily divided into two categories, sharps waste and biohazardous waste. Both pose unique risks and must be handled, stored, and disposed of according to strict OSHA, DOT, and state regulations to ensure safety and compliance.

  • Sharps Waste

    Sharps are objects capable of puncturing or cutting the skin, and when contaminated, they are classified as regulated medical waste and include the following examples.

    • Used needles

    • Syringes with needles attached

    • Lancets

    • Scalpel blades

    • Broken glass vials contaminated with blood or bodily fluids

    • Suture needles and other surgical sharps

    Stated below are the key compliance considerations for sharps waste disposal.

    • Sharps must be disposed of in rigid, puncture-resistant, leak-proof sharps containers.

    • Containers with sharps must be labeled with the biohazard symbol or marked according to DOT and OSHA requirements.

    • Disposal of sharps via mail-back systems (e.g., PureWay) or pickup services must comply with USPS Publication 52 (if mailed) and DOT regulations.

  • Biohazardous Waste Non-sharps RMW
    Biohazardous waste is any non-sharp material contaminated with potentially infectious agents, and includes the following.

    • Blood-soaked bandages

    • Surgical gloves and gowns contaminated with blood or OPIM

    • Cultures and stocks from laboratories

    • Pathological waste (e.g., human tissues, organs)

    • Body fluids are visibly contaminated with blood.

    Stated below are the key compliance considerations for biohazardous waste disposal

    • Biohazardous waste must be disposed of in leak-proof, labeled red bags and then secondary containment (e.g., boxes or tubs) for transport.

    • Biohazardous waste must follow OSHA, DOT, and state-specific handling, storage, and transportation regulations.


Differences Between Sharps and Biohazardous Waste

Proper handling of regulated medical waste (RMW) is important to keep people safe and follow regulations. Sharps, such as needles, and biohazardous waste, like blood-soaked gloves, are both types of RMW, but they differ in several ways:

  • Appearance and Type

    • Sharps
      Needles, syringes, lancets, and other items that can puncture or cut.

    • Biohazardous Waste
      Items contaminated with blood or other potentially infectious materials (OPIM), such as gloves, gowns, dressings, or cultures.

  • Storage

    • Sharps

      Must be stored in puncture resistant, leak proof containers.

    • Biohazardous Waste

      Stored in leak resistant, color-coded bags (usually red) or containers.

  • Transport

    • Sharps

      Requires special containers that meet DOT standards (UN 3291).

    • Biohazardous Waste

      Requires sealed, labeled bags or containers, often managed via contract pickup or mail-back programs.

  • Disposal

    • Sharps

      Incinerated or treated through approved sharps disposal programs.

    • Biohazardous Waste

      Treated by autoclaving, chemical disinfection, or incineration, depending on type and local regulations.


Sharps Waste

Sharps waste includes items that can puncture or cut the skin. Because of their high risk for injury and contamination, sharps require specialized handling and disposal.

  • Definition

    Items that can puncture skin and are contaminated with blood or OPIM.

  • Examples

    • Needles

    • Syringes

    • Scalpels

    • Broken and contaminated glass

  • Container Type

    • Rigid, puncture-proof sharps containers

  • Transport Class

    • UN3291 – Infectious Substance, Category B

  • Disposal Method

    • Incineration

    • Autoclaving


Biohazardous Waste

Biohazardous waste includes non-sharp items contaminated with blood or other potentially infectious materials (OPIM). These materials must be handled carefully to prevent contamination and exposure.

  • Definition

    Contaminated non-sharp items with blood or OPIM.

  • Examples

    • Blood-soaked dressings

    • Gloves

    • Suction canisters

  • Container Type

    • Leak-proof red biohazard bags

  • Transport Class

    • UN3291 – Infectious Substance, Category B

  • Disposal Method

    • Incineration

    • Autoclaving

    • State -approved treatment


Compliance Support via PureWay

PureWay provides comprehensive solutions to help facilities manage regulated medical waste safely and in compliance with federal and state requirements. The following offers are available.

  • Mail-back sharps and RMW systems are fully compliant with USPS UN3291 and DOT.

  • Pickup services for larger generators.

  • Sharps containers, red bags, secondary containment, and labeling materials.

  • Training programs to help facilities comply with OSHA’s Bloodborne Pathogens Standard.

Access to state-specific waste definitions and regulations in the PureWay State Compliance Map.

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