In the United States, the Department of Transportation (DOT) assigns the responsibility of packaging regulated medical waste for shipment to the shipper (e.g., hospital). Healthcare organizations that generate medical or other hazardous waste are always expected to package it appropriately for disposal to ensure staff, patient, and environmental safety, coupled with maintaining compliance with federal, state, and local regulations.

It also falls on them to ensure that each employee involved with the packaging is adequately trained. A good number of healthcare organizations sometimes struggle to correctly segregate, package, and dispose of regulated medical waste (RMW).

The best practices involve putting together clear packaging procedures and making sure staff are aware of and consistently follow them. Improper handling of medical waste can pose a serious threat to employees, public health, and the environment, which is why several federal agencies have regulations and guidelines for medical waste disposal.

The term regulated medical waste is defined differently by many state and federal agencies. Under DOT rules, regulated medical waste (RMW) refers to waste or reusable materials suspected or verified to feature an infectious substance and is generated in the diagnosis, treatment, immunization, or biomedical research of humans or animals.

An infectious substance is referred to in DOT regulations as a Division 6.2 material and is defined as a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agents, such as a proteinaceous infectious particle (prion) known to grow or cause disease in humans or animals.

These pathogens are ever-present in medical wastes and healthcare facilities are tasked with correctly segregating, packaging, and shipping these hazardous materials, including chemicals, compressed gases, etc. However, packaging and transportation regulations vary, depending on the type of material.

The first step in creating RMW packaging procedures is to understand what is noted as regulated medical waste. Regrettably, there is no generally accepted definition for RMW in the United States, and federal and state agencies tend to have some variance on what falls within the category.

A good working definition is any waste that has the potential to cause infection and has regulations around its collection, transportation, treatment, and disposal.

Some examples may include contaminated disposable gowns, used gauze, and procedural drapes. Additionally, owing to the COVID-19 pandemic of recent years, a good number of healthcare organizations are beginning to consider personal protective equipment (PPE) used when treating COVID patients as RMW.

Once an organization notes the RMW it generates, guidelines will have to be developed for segregating that waste. This ensures that each type of waste is well disposed of and does not pose a threat to health or environmental safety.

Factors to Consider When Packaging Regulated Medical Waste for Shipment

There are several regulatory bodies concerned with RMW, and depending on the agency, their focus varies. However, it still falls on the generators to understand the state and federal regulations that drive those services. Here are factors to consider when packaging regulated medical waste for shipment; 

  1. United States Postal Service (USPS)

In the United States, the USPS is known to regulate what can and can’t be sent through the mail and sets the packaging specifications. For instance, USPS won’t give room for some types of regulated medical waste – body parts, liquid wastes, or Category A infectious wastes.

Therefore, if your RMW falls into one of these categories, or if it isn’t packaged, marked, labeled, and documented according to USPS regulations, it can’t be shipped or sent via mail. Healthcare facilities that generate medical waste and are looking to leverage mail-back systems for transport and disposal will first have to comply with USPS regulations as well as those established by their state.

  1. Individual States Regulations

While USPS and DOT are federal regulatory agencies that dictate processes across state lines, state-specific regulations meant to govern RMW transportation are known to differ from one state to another. For instance:

  • A state may limit what is transported via USPS.
  • Some states limit the amount of regulated waste shipped through the mail, limiting mail-back use to small quantity generators.
  • Some also limit the time a generator can store regulated wastes before they can be transported. Note that in states with tight storage time-frames, healthcare facilities are expected to assess the volumes they generate in those specified frequencies to determine whether mail-back or pickup is preferable.
  1. Department of Transportation (DOT)

Have it in mind that the DOT is tasked with regulating the transport of regulated medical wastes via highways, waterways, and air travel. As a healthcare facility, if you intend to use a pickup service for your waste disposal, you are expected to follow DOT and state regulations for waste classification and packaging.

Also, note that the DOT mandates specific training for all employees involved in packaging regulated wastes for transport and those tasked with filling out the required shipping papers.

  1. Type and Volume of Waste Generated

This is also another factor that will influence how a medical waste generator chooses to package medical waste for disposal or shipment. If your facility generates a large volume of RMW or a waste type that can’t be mailed (like pathological wastes or large volumes of liquid waste); you may have to opt for a pickup service.

But, if your facility generates smaller volumes of RMW – like pharmaceuticals or universal wastes, the mail-back system may be your most ideal choice. However, note that no regulations mandate you to leverage a single transport option for all waste streams!

Therefore, when taking into consideration the type and amount of waste generated and the associated cost of transportation and disposal, you may find that a blended program of both pickup service and mail-back systems aligns well with your needs.

How to Properly Package Regulated Medical Waste for Shipment

After extensively researching and gathering information about the what and why of RMW disposal, healthcare facilities are expected to address the how. Below are the steps involved in the packaging process;

  1. Select a Suitable Regulated Medical Waste Container

Medical waste generators can either leverage corrugated boxes or specially designed reusable containers to store or hold RMW. Corrugated boxes will have to be appropriately sealed on the bottom with two-inch-wide, clear, packing tape.

Printed text and arrows will be needed to differentiate the receptacle’s top and bottom. While reusable containers may not require a special setup, ensure you use appropriate marking and color-coding for both disposable and reusable containers.

  1. Line the Medical Waste Container with a Red Biohazard Bag

You must use a red bag specifically made for this purpose. Aside from the fact that they are meant to effectively contain the waste, they also help to indicate by their color and labeling that the waste is hazardous. The bag will have to line the inside of the receptacle, overlapping its four outer sides. Don’t forget that different states may have varying requirements for bag thickness and weight limitations.

  1. Place the Appropriate Medical Waste in The Lined Container

Coupled with properly outlining what should go in the RMW container, it’s also necessary to indicate what should not. Things like medications, loose needles, syringes, general trash, and recycling should not be thrown away in a red bag.

Sharps will have to be disposed of in a closed, puncture-resistant container, and pharmaceutical wastes are expected to be placed in their own designated, color-coded receptacle. Also note that trace chemotherapy waste and pathological waste, although forms of RMW, will have to be further segregated and also properly marked for incineration.

  1. Tie the Bag

You must ensure there is room at the top of the bag before tying it. Staff will need to put on gloves when securing the bag, gathering its edges, and twisting the top to seal the contents. They will also have to make a strong, hand-tied single or gooseneck knot to avoid any leakage. They can also leverage a zip tie or tape to secure the knot, although various facilities may have varying rules when it comes to this.

  1. Prepare the Waste for Pickup

After the bag is properly secured, it should be placed in a transport container, and this also will have to be sealed. When making use of a reusable transport container, staff are advised to utilize the auto-locking flaps or secure the lid depending on the receptacle design.

When it comes to corrugated transport containers, they should seal the top of the box with two-inch-wide, clear packing tape. Note that the red bags should not be visible once the outer container is closed and sealed.

  1. Check the Markings

Know that the outer box will need to be appropriately labeled to meet federal, state, and local requirements. It will also have to include any bar codes or other information the waste hauler requires.


As you can see, there are many factors to consider when packaging regulated medical wastes for shipping or disposal. While good processes are pertinent for proper RMW disposal, a reliable waste management partner is also vital. Also, note that staff members that work in areas where RMW is generated will need to receive training on how to properly handle contaminated materials.