Medical and Biological Waste

Table of Contents

Introduction & Learning Objectives

Background (Science & Health)

Administration & Authority

  • Regulations & Laws
  • Inspection Tools & Equipment
  • Enforcement Strategies
  • Summary of Standards

Resources

Post-test

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Medical and Biological Waste

Primary Authors

Contributing Authors

Special Acknowledgements

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DISCLAIMER:

This training module is brought to you by the Local Public Health Institute of Massachusetts (the Institute) and by the New England Alliance for Public Health Workforce Development (Alliance). The Institute is a Massachusetts Department of Public Health funded entity created to strengthen local public health through training and education. It is managed by the Boston University School of Public Health's Office of Public Health Practice and is supported in part by the Center for Disease Control and Prevention (CDC)'s Grant/Cooperative Agreement Number 5U90TP116997-10, Public Health Preparedness and Response for Bioterrorism and the Alliance, funded by the Health Resources and Services Administration (HRSA) from 2000 - 2014. The contents of this module are solely the responsibility of the authors and do not necessarily represent the official views of the CDC or the HRSA. The authors of this module have no financial interests or relationships to disclose.

 

 

Introduction

Medical and biological waste has characteristics that may cause it to be infectious or physically dangerous to human health or the environment. Examples of medical or biological waste include sharps (needles, syringes, and lancets), blood and blood products, cultures and stocks of infectious agents, pathological waste, and contaminated animal carcasses and bedding. Due to the potential hazards associated with this type of waste, its treatment, storage, transportation, and disposal is regulated by federal, state and local agencies. This module will focus primarily on the local board of health (LBOH) responsibilities related to the management of home-generated sharps.

Learning Objectives

After completing this module, you will be able to:

Background

In the late 1980s, there was an increase in medical debris washing up on the beaches along the East Coast and the Great Lakes, including items such as needles, syringes, blood bags, bandages, and vials. As a result, there were beach closures, negative economic impacts on shore communities, and increased public concerns about potential health and environmental hazards from this type of debris. Additional reports of careless management and improper or illegal disposal of medical waste, possibly contaminated with HIV and Hepatitis B viruses, heightened the worry.

As a result, the federal government enacted the Medical Waste Tracking Act of 1988. The Act defined medical waste as "any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals." This definition includes, but is not limited to the following, which may or may not meet the definition of medical waste within Massachusetts regulations:

The Act also designated which medical wastes would be subject to regulations, established a cradle-to-grave tracking system, required management standards for segregating, packaging, labeling, marking, and storing the medical waste, and established record keeping requirements and penalties that could be imposed for mismanagement. The US Environmental Protection Agency (EPA) promulgated the Act and classified medical waste as an industrial, non-hazardous waste.

The Act was limited in scope and only created a two-year demonstration program that ultimately applied to four states and Puerto Rico. While the Act expired in 1991, it is significant because it is used as a prototype for many state regulations. The EPA continues to have some oversight over medical waste through the Resource Conservation and Recovery Act and its cradle-to-grave concept.

  

Massachusetts has taken proactive measures to prevent health or environmental problems from medical or biological waste. MDPH promulgated regulations that stipulate minimum requirements for the management of medical or biological waste.

Due to the complexity of this public health issue, this module will discuss the laws and regulations in Massachusetts with a focus on 105 CMR 480.000: Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII). Medical or biological waste is classified as a special (not hazardous) waste in Massachusetts and is regulated by multiple state and local agencies. It can be generated from health, research, and medical facilities, laboratories, funeral homes, veterinary practices, private homes, home health care providers, dentists, tattoo parlors, and other residential settings (i.e., nursing homes, assisted living facilities).

Potential hazards from medical or biological waste include:

  

View the Massachusetts Department of Environmental Protection (MassDEP) flyer, which addresses safe disposal of prescription and over-the-counter drugs.

Improperly managed medical or biological waste has the potential to create conditions that can adversely affect the public's health and the environment by causing disease outbreaks and injuries or by contaminating drinking water supplies or recreational waters. According to the Agency for Toxic Substances and Disease Registry, the following chain of events must occur to result in infection.

  

 In order to prevent infections, injuries, or environmental contamination, medical or biological waste must be properly managed. View the Quiz Me to determine key elements to properly manage medical or biological waste.

 Toggle open/close quiz question 

It is important to be knowledgeable of bloodborne pathogens, proper protection and spill response. Some options for awareness level online training can be accessed at

See Occupation Safety and Health Administration (OSHA) 1910.1030 for more information on bloodborne pathogens.

Regulations and Laws

Massachusetts General Laws

Chapter 172 of the Acts of 2006 (effective September 18, 2006) amended MGL Ch 94C s27 and s32I by decriminalizing the distribution and possession of hypodermic syringes and needles and authorizing pharmacists to sell syringes and needles without a prescription to any person who has attained the age of 18. As a result of this change in legislation, any person showing identification that confirms they are age 18 or older may purchase needles and syringes from a pharmacy without a prescription and without fear of criminal prosecution.

View the April 2, 2009 letter from MDPH to Massachusetts pharmacists and pharmacy managers that clarifies the amended law.

 MGL Ch 94C s27A specifically states, "notwithstanding any general or special law to the contrary, the department of environmental protection and the department of public health, in conjunction with other relevant state and local agencies and government departments, shall design, establish and implement, or cause to be implemented a program for the collection and disposal of spent non-commercially generated hypodermic needles and lancets. The program shall be designed to protect the public health and the environment by providing for the safe, secure and accessible collection and disposal of hypodermic needles and lancets. The departments may collaborate with private companies as well as not-for-profit agencies when designing, establishing and implementing this program."

MGL Ch 111 s127A provides penalties for improper disposal of infectious or physically dangerous medical or biological waste and MGL Ch 111 s31.allows LBOH to make reasonable health regulations (i.e., establishing permit requirements for medical or biological waste haulers).

  

MDPH

MDPH developed regulations stipulating minimum requirements for the management of medical or biological waste (State Sanitary Code [SSC] Chapter VIII 105 CMR 480.000). These regulations were originally adopted in 1989, and most recently amended in 2010. The 2010 revisions included a statewide ban on disposal of sharps in household trash, effective July 1, 2012.

View a May 14, 2012 letter from MDPH to LBOH explaining the significance of the July 1, 2012 statewide ban on the disposal of sharps in household trash.

MassDEP

MassDEP oversees Solid Waste Regulations 310 CMR 19.000, which govern solid waste transfer and disposal facilities. 310 CMR 19.000 includes requirements for waste treatment at medical facilities in order for infectious waste to be disposed of at a sanitary landfill or municipal waste combustor (as regular solid waste):

 

Inspection Tools and Equipment

LBOH are required to conduct an initial inspection of a sharps collection center or kiosk, as specified in 105 CMR 480.135.

A general list of tools and equipment necessary for inspection activities would include:

 

Enforcement Strategies

sharps kiosk.jpg

Inspection of Sharps Collection Centers

LBOH are required to inspect all sharps collection centers, including kiosks, once prior to initial operation to ensure compliance with the requirements of 105 CMR 480.000. Upon the completion of the inspection, the LBOH must notify MDPH within 30 days with the location and address of the sharps collection center. MDPH will maintain a list. Operators must complete a Sharps Collection Center Notification Form and submit it to MassDEP. View the form.

 

   

 

Community Plans for Sharps Collection

In addition to enforcement of 105 CMR 480.000, LBOH should develop community plans, as specified in MGL Ch 94C s27A, and 105 CMR 480.125 (B) for programs that will collect and dispose of spent non-commercially generated hypodermic needles and lancets (sharps). These programs must be designed to protect the public health and the environment by providing for safe, secure and accessible collection and disposal of sharps.

LBOH alone or in partnership, should:

  1. Provide home sharps users with access to sharps collection containers or kiosks and the names of sharps disposal companies
  2. Establish sharps collection centers at private (i.e., medical facilities or pharmacies) or municipal facilities (i.e., fire or police stations, public health offices)
  3. Establish community collection days
  4. Establish or promote medical waste mail-back programs approved by the US Postal Service
  5. Participate in needle exchange programs (there are four state-funded needle exchange sites in MA - Boston, Cambridge, Northampton, and Provincetown - Boston.com provides a map of needle exchange sites in MA)

  

The EPA provides a brochure that summarizes community options for safe needle disposal. Please note that the use of needle destruction devices have not been approved in MA because any manipulation of sharps can increase the probability of sticks. LBOH should contact MDPH with any questions at 617-624-5757.

 

Summary of Standards

105 CMR 480.000: Minimum Requirements for the Management of Medical or Biological Waste (SSC Chapter VIII)

Medical or biological waste is defined as waste that because of its characteristics may cause, or significantly contribute to, an increase in mortality or an increase in serious irreversible or incapacitating reversible illness; or pose a substantial present potential hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.

The following types of waste are identified and defined as medical or biological waste, and shall be subject to these requirements:

  1. blood and blood products
  2. pathological waste
  3. cultures and stocks of infectious agents and their associated biologicals from facilities such as laboratories
  4. certain contaminated animal waste
  5. sharps, which are discarded medical articles that may cause puncture or cuts, including, but not limited to, all needles, syringes, lancets, pen needles, Pasteur pipettes, broken medical glassware/plasticware, scalpel blades, suture needles, dental wires, and disposable razors used in connection with a medical procedure
  6. biotechnology by-product effluents (reflects continuity with MA Plumbing Code and references CDC/National Institutes of Health Biosafety Lab and Risk Group levels and rDNA)

What's excluded?

  1. Teeth, sputum, vomit, urine or fecal matter IF uncontaminated with visible blood
  2. Animal waste if not designated in the regulation or not known to be contaminated
  3. Used feminine hygiene products

 

Treatment

On-site: This is not commonly utilized. A backup plan must be designed and included in case the on-site treatment system fails.

Off-site: This is most commonly utilized. A third party company takes the waste elsewhere for treatment.

 

  

 The table below summarizes the standards in the regulation. Further descriptions can be found in the regulations.

Section of

105 CMR 480

Standard

Brief description

.100

Storage

Containers: type (boxes or bags), color (red, fluorescent orange, or orange-red), marking, and security

Note: Must include biohazard symbol and word

Storage areas: floor construction, maintenance, signage, security, size and frequency of removal

All medical or biological waste (except sharps from home users) must be either treated on-site or transported off-site at least once each calendar.

.125

Home sharps

As of July 1, 2012, home sharps including unopened packages of hypodermic needles and lancets can't be disposed of in solid municipal waste, which includes household waste.

Note that prior to July 1, 2012, it had been acceptable for home sharps to be stored in sturdy containers such as empty, hard plastic laundry bottles and disposed of as household trash. Residents may not be aware of the new regulations that require the use of an approved sharps container.

.135

Sharps collection centers

Collection, security and other management standards.

Arrangements for transport and disposal including rules for accepting home sharps and having written agreements with medical waste transporters for regularly scheduled pick-ups.

Kiosks involve less handling of sharps and have fewer provisions. Kiosks with engineering controls and a 3rd party contract have even fewer provisions.

LBOH must conduct initial inspection and provide notification to MDPH.

.150

Approved disinfection methods to render waste non-infectious

  • Steam/disinfection autoclaving;
  • Chemical disinfection;
  • Incineration at an approved incineration facility; or
  • Any other method approved in writing by the Department. As of February 2013, there are none.

The section also includes monitoring and testing standards for the on-site treatment of medical or biological waste.

.200

Disposal

Specifications for disposal by type of waste.

Sharps example: Containers of sharps shall either be disposed of by incineration at an approved incineration facility or rendered noninfectious (as set forth in 105 CMR 480.150) and processed by grinding or other effective method to eliminate the physical hazard of the sharps.

They can then be disposed of in a sanitary landfill approved by the MassDEP, or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval within that jurisdiction.

.300

Packaging, labeling, shipping

Waste still considered infectious must be securely packaged in a primary container (red bag or sharps box) colored and labeled to indicate that it contains infectious or physically dangerous medical or biological waste.

These must be placed in secondary containers that are secondary containers which are colored and labeled and:

  • Rigid;
  • Leak resistant;
  • Impervious to moisture;
  • Of sufficient strength to prevent tearing or bursting under normal conditions of use and handling; and
  • Sealed to prevent leakage during handling and transport.

.400

Shipping papers for waste generators (including small scale generators that transport their own waste and sharps collection centers)

May transport up to 50 lbs. every 30 days to an affiliated entity.

For waste being transported off site that hasn't been rendered noninfectious, shipping papers must contain:

  • A contact name and emergency contact number;
  • A description of the waste to be shipped;
  • The total quantity of waste to be shipped;
  • The type of container or containers in which waste is to be transported; and
  • The destination of the delivery.

In addition to signed and dated shipping papers and corresponding tracking forms to confirm receipt, a record keeping log must be kept (both for at least 375 days). These must be made available to LBOH or MDPH upon request.

All shipping must comply with other transportation requirements as applicable (US DOT 49 CFR, Parts 171-180, MGL Ch111 s31A, and USPS 39 CFR Part 111.

.425

Tracking

Confirmation and documentation as waste is transported and received for treatment.

An electronic system can be used if it is secure and if a hard copy is filed.

.500

Procedures and Records for waste generators, small-scale generators, and sharps collection centers

Includes written procedures for:

  • Training and emergency contact information;
  • Maintaining record keeping logs or forms for treatment, parametric monitoring, challenge testing, applicable registrations, and material safety and data sheets;
  • Contingency plan for spills and accidents and the tools and materials sufficient to implement these procedures in case of a spill or accident; and
  • Also denotes retention periods for records.

.550

Alternate methods

 Will be considered for the treatment, storage, or disposal of medical or biological waste under certain conditions

.600

Administration and Enforcement

  • Inspection authority;
  • Notice of violation (to generators and/or registered professionals);
  • Penalties;
  • Injunctions;
  • Variances;
  • Removal of nuisances.

    

Resources

CDC Biologic and Infectious Waste

EPA Industrial Waste

MassDEP Household Hazardous Waste

MDPH Medical Waste

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You have completed the Medical and Bioligcal Waste module.

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Certificate of Completion

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