Regulated Medical Waste

Delaware

Infectious Waste

Background Information
Definition of Regulated Medical Waste
Managing Regulated Medical Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Infectious Waste

Infectious wastes are special solid wastes that may cause human disease and may reasonably be suspected of harboring human pathogenic organisms, or may pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, disposed of or otherwise managed. Types of solid wastes designated as infectious include but are not necessarily limited to the following:

Biological wastes;
Sharps;
Discarded Biologicals;
Isolation Wastes; and
Other infectious wastes

Managing Infectious Waste

Registration

All generators of infectious waste shall obtain an “Infectious Waste Identification Number” for each site or location that generates infectious waste. Registration shall be submitted on a form provided by the Department.

Permit Requirements

Any person required to have a permit for activities that will occur in the management of infectious waste shall apply for a permit in accordance with the regulations. No activity shall occur prior to receipt of all permits required by the Department.

A new or revised operation plan for treatment, storage and/or disposal of infectious waste shall be submitted to the Department whenever there is an increase of more than 15 percent over a three calendar month average in the maximum quantity of infectious waste receiving treatment, storage or disposal per month by the facility or when changes are otherwise made in an existing operation plan.

Prohibitions

Infectious waste may not be disposed at a sanitary landfill unless the waste has been rendered noninfectious and non-recognizable. (In the case of extracted teeth, sterilization followed by landfilling would be acceptable).
Compactors, grinders or similar devices may not be used by a generator to reduce the volume of infectious waste until after the waste has been rendered noninfectious, or unless the device is part of an approved treatment process which renders the waste non-infectious.
Infectious wastes shall not be sent to a recycling facility.
Waste consisting of human anatomical remains, including human fetal remains, may not be disposed of at sanitary landfills. The remains must be incinerated, cremated or interred in accordance with applicable regulations.
Trans-chutes shall not be used to transfer infectious waste between locations where it is contained.

Packaging Requirements

The generator of infectious waste shall not submit for transport, storage, treatment or disposal any waste that is not packaged in accordance with the regulations.

As a bag or other container becomes full, it must be immediately sealed, packaged, labeled and managed Contractors or other agents may provide services to the generator, including packaging and labeling of infectious waste; however, no contract or other relationship shall relieve the generator of the responsibility for packaging and labeling the infectious waste as required by these regulations.

Sharps are to be packaged as follows:

Sharps shall be contained in leak proof, rigid, puncture-resistant containers that are tightly lidded. As soon as the first sharp is placed in an empty container, the container shall be labeled with the word "SHARPS", and the Biological Hazard Symbol.

All infectious waste other than sharps shall be packaged as follows:

Waste shall be contained in two (one bag inside the other) RED BAGS. The bags shall be individually tied or sealed. As a bag or other container becomes full, it must be immediately sealed, packaged, labeled and managed as described in this part;
All bags containing infectious waste shall be red in color. Waste contained in red bags shall be considered infectious waste and managed as infectious waste;
Bags shall be sealed by lapping the gathered open end and binding with tape or closing device such that no liquid can leak; and
In addition to the plastic bag containers described in this section, all infectious wastes must be enclosed in a double-walled corrugated fiberboard box or equivalent rigid container before it is transported beyond the site of generation.

All infectious waste shall be labeled immediately after packaging. A label shall be securely attached to the outer layer of packaging and be clearly legible. The label may be a tag securely affixed to the package. Indelible ink shall be used to complete the information on the labels, and the labels shall be at least three inches by five inches in size.

All infectious substances that are transported must be packaged as described in 49 CFR 173.196, October 1, 1996, Edition, even when that transport is wholly within the boundaries of the State.

Storage Requirements

Infectious waste shall be contained in a manner that:

Affords protection from vectors, rain and wind;
Prevents the spread of infectious agents;
Does not provide a breeding place or food source for insects or rodents; and
Prevents the leakage of waste from the storage bag or container.

Infectious waste shall be placed in separate containers from other waste at the point of origin in the producing facility.

Infectious waste may not be stored at the waste producing facility for more than the following periods of time:

Up to fourteen days at room temperature (18 to 28 degrees Celsius, 65 to 82 degrees Fahrenheit) or up to 45 days in a refrigerator (2 to 7 degrees Celsius, 36 to 44 degrees Fahrenheit) for all types of infectious waste, so long as it does not produce conditions that are offensive or harmful to facility personnel or the public welfare.
Ninety days in a freezer (-20 to -18 degrees Celsius, -4 to -1 degrees Fahrenheit) not used for food or patient related items.
Exemption. Sharps which are disposed in a container specifically designed for sharps and which is sealed so as to prevent leaks when it is full, are exempt from the time limit on storage.

A container used for the storage of infectious waste may not be reused unless one of the following applies:

It has been decontaminated utilizing a Department-approved decontamination procedure; or
The surface of the container has been protected from direct contact with infectious waste.

Reusable containers for infectious waste shall be thoroughly washed and decontaminated by an approved method each time they are emptied, unless the surfaces of the containers have been completely protected from contamination by disposable liners, bags or other devices removed with the waste. Approved methods of decontamination include, but are not limited to, agitation to remove visible soil combined with one of the following procedures:

All parts of the container shall come in contact with hot water of at least 82 degrees C (180 degrees F) for a minimum of 15 seconds.
All parts of the container shall come in contact with chemical sanitizer by rinsing with or immersion in one of the following for a minimum of 3 minutes:
- Hypochlorite solution (500 ppm available chlorine),
- Phenolic solution (500 ppm active agent),
- Iodophor solution (100 ppm available iodine), or
- Quaternary ammonium solution (400 ppm active agent).

Reusable pails, drums, dumpsters or bins used for containment of infectious waste shall not be used for containment of waste to be disposed of as noninfectious waste or for other purposes except after being decontaminated by procedures as described in this paragraph.

Areas used for the containment of infectious waste shall be secured so as to deny access to unauthorized persons and shall be marked with prominent warning signs and the biohazard symbol on, or adjacent to, the exterior of entry doors, gates or lids. Wording of warning signs shall be in English, "CAUTION -- INFECTIOUS WASTE STORAGE AREA -- UNAUTHORIZED PERSONS KEEP OUT" . Warning signs shall be readily legible during daylight from a distance of at least 25 feet.

Spill Management

All infectious waste management facilities are required to keep a small containment and cleanup kit within 100 feet of any area where infectious wastes are managed. The facility shall maintain and implement a plan that provides the means of decontamination of any person having had bodily contact with infectious waste while transporting the waste to the treatment or disposal site or while handling or disposing of the waste at the site.

Transport of Infectious Medical Waste

All transporters of infectious waste must be in compliance with all applicable federal and state regulations and codes. No person shall transport infectious waste without first having obtained a permit from the Department

Transporters must deliver infectious waste to an off-site processing or disposal facility within 15 days from collection from the generation facility. Infectious waste shall be transported in a manner which protects it from vectors, rain and wind; prevents the spread of infectious agents; does not provide a breeding place or food source for vectors, and prevents leakage of waste from the storage bags or other containers.

Transporters must meet specific requirements in regard to:

Type of transport vehicles;
Cleaning/decontamination of vehicles;
Vehicle transport warning signs and labeling requirements
Spill management; and
Loading an unloading infectious waste.

Manifest Requirements

A generator of infectious waste shall complete a multi-copy manifest before shipping, or causing the shipment of, infectious waste off site. The generator, transporter and the operator of the infectious waste facility must sign and date the manifest and keep copies of it. Copies of the manifest shall be retained by all parties for at least three years.

Treatment and Disposal of Infectious Waste

All treatment of infectious waste must utilize a method that will render the waste non-infectious.

All pathological waste must be incinerated, cremated or interred. Other disposal methods are not acceptable for this type of waste. This requirement does not prohibit the disposal of certain specified wastes in a permitted wastewater treatment system

Treatment of infectious waste must be conducted in a manner that eliminates the infectious potential of the waste. A treatment process eliminates the infectious potential of infectious waste if the owner or operator of a treatment unit demonstrates that an Initial Efficacy Test and Periodic Verification Test(s) have been completed successfully.

Recordkeeping and Reporting Requirements

Each generator of infectious waste shall submit an annual report on a form provided by the Department, summarizing the information from all manifests completed during the preceding calendar year. This report shall be submitted to the Department within ninety days after the end of the calendar year.

Each transporter of infectious waste shall submit an annual report on a form provided by the Department, summarizing the information from all manifests completed during the preceding calendar year. This report shall be submitted to the Department by April 1 of the year following the year covered by the report.

All waste management or treatment facilities that manage infectious waste shall maintain required, detailed records for a period of three years.

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste. Delaware is one of 26 states covered entirely by the federal OSHA program. This program is operated by the Occupational Safety and Health Administration. OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.