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⚠️ Regulated Medical Waste in the US Explained

Learn what is regulated medical waste, how OSHA & DOT define sharps and biohazard waste, and how to manage both safely and compliantly.

Updated over 3 months ago

The definition and scope of Regulated Medical Waste (RMW) vary slightly by state, but at the federal level, OSHA and DOT provide broad classifications, and states adopt more specific lists.

RMW is also sometimes referred to as "infectious waste" or "biohazardous waste."


ℹ️ Federal Definition (Key Sources):

  • OSHA (29 CFR 1910.1030 – Bloodborne Pathogens Standard) defines regulated waste to include:

    • 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) refers to these materials as Category B Infectious Substances (UN 3291) when transported and requires special packaging and labeling.


🔢 Types of Regulated Medical Waste

🔹 Sharps Waste

Sharps are any object capable of puncturing or cutting the skin, and when contaminated, are a form of regulated medical waste, which includes:

  • Used needles

  • Syringes with needles attached

  • Lancets

  • Scalpel blades

  • Broken glass vials contaminated with blood or bodily fluids

  • Suture needles and other surgical sharps

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, which includes:

  • 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.

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

Category

Sharps Waste

Biohazardous Waste

Definition

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

Contaminated non-sharp items with blood or OPIM

Examples

Needles, syringes, scalpels, broken and contaminated glass

Blood-soaked dressings, gloves, suction canisters

Container Type

Rigid, puncture-proof sharps containers

Leak-proof red biohazard bags

Transport Class

UN3291 – Infectious Substance, Category B

UN3291 – same classification

Disposal Method

Incineration or autoclaving

Incineration, autoclaving, or other state-approved treatment


✅ Compliance Support via PureWay

PureWay offers:

  • 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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