Managing Regulated Medical Waste

Guidelines for Implementation of Public Health Law 1389 AA-GG and Environmental Health Regulations of 10 NYCRR, Part 70

Original 12/95

(Revised 9/05)

Table of Contents

Forward

General Overview of Roles and Responsibility for Department of Health Management of Regulated Medical Waste

In 2003, the Department of Health assigned the overall responsibility for implementation of regulations pertaining to regulated medical waste (10NYCRR, Part 70) with the Office of Health Systems Management, Division of Health Care Standards and Surveillance, Bureau of Hospital and Primary Care Services. These regulations affect all Article 28 providers (e.g., hospitals, residential health care facilities, diagnostic and treatment facilities and clinical laboratories). The lead role for part 70 was previously with the Center for Environmental Health with certain elements of Part 70 managed by the Bureau of Hospital and Primary Care Services (Sharps) and Wadsworth Center – Division of Clinical Labs for: alternative RMW technology systems/biologicals…).

The current roles and responsibilities for RMW is as follows:

  • OHSM - Division of Health Care Standards and Surveillance - Bureau of Hospital and Primary Care Services - Overall - Part 70 - RMW
  • Wadsworth Center - Division of Clinical Labs - issues involving Alternative RMW technology systems/biologicals
  • CEH - Issues involving radiological, water contamination….
  • Department of Environmental Conservation - 6 NYCRR, Part 350--all non-Article 28 entities-pharmaceuticals, research facilities, permits for incinerators, issues involving storage/transport/disposal of RMW….

Introduction

These guidelines are intended to help medical facilities comply with the revised 10 NYCRR, Part 70 regulations which governs the management of regulated medical waste. In 1995 the Department issued a set of "Interpretive Guidelines" to implement PHL 1389 aa-gg. These new regulations set in motion a process to ensure regulated parties continue to upgrade their RMW practices. The criteria discussed in this document will provide a basis for determining what waste generated by health care providers meets the definitions of regulated medical waste and could pose a risk of disease transmission if not managed properly. Implementation waste management procedures based upon the definitions found in Public Health Law, plus these guidelines should reduce the overall amount of regulated medical waste. While 10 NYCRR, Part 70 does not govern how physician private practice, dental and veterinarian offices, as well as university settings manage their RMW streams, these entities may find these guidelines useful in developing their individual waste management protocols. Some materials that have been associated with the delivery of health care and managed as regulated medical waste will no longer be considered as such. One notable example is I.V. bags and associated tubing. Their inclusion into the broad definitions of regulated medical waste found in the federal Medical Waste Tracking Act of 1988 was based solely upon the fact that they looked "medical". Not only does this reasoning run contrary to the basic tenets of disease transmission, it also reinforces misconceptions about the waste stream generated in health care facilities. These guidelines point out that I.V. bags and associated tubing are no longer considered as regulated medical waste under the Public Health Law . These new guidelines follow the adoption of the "Revised Part 70" Environmental Health Regulations which consist of five (5) Subparts and are summarized here as follows:

Existing Part 70 is rescinded and replaced with a new Part 70 containing five Subparts: 70-1 Applications and Definitions; 70-2 Management of Regulated Medical Waste (RMW); 70-3 Requirements for Autoclaves to Treat Regulated Medical Waste; 70-4 Approval of Alternative Regulated Medical Waste Treatment Systems; and 70-5 Approval Process for Alternative Technologies. This amendment clarifies terminology; adds flexibility to existing regulatory requirements; and codifies advisories for RMW management previously promulgated in guidance documents, following 1993 statutory amendments. This proposal revises regulatory definitions for RMW, infectious agents and treatment in conformance with the Law; amends container-labeling requirements; and incorporates applicable requirements for transport and disposal of RMW, allowing for increased flexibility in financial management and planning.

Section 70-1.1 - This section specifies that the requirements apply to hospitals, residential health care facilities, and diagnostic and treatment centers and clinical laboratories.

Section 70-1.2 - This section includes new and revised definitions for terms used throughout the Subpart, including "alternative regulated medical waste treatment system", "autoclave", "biologicals", "certificate of treatment", "challenge testing", "clinical laboratory", "culture and stocks", "culture dishes and devices for transferring, inoculating and mixing cultures", "cycle", "decontamination", "destroyed waste", "efficacy testing", "hazardous waste", "household medical waste", "incinerator", "infectious agent", "monitoring", "operating parameters", "operation plan", "parametric control", "primary container", "residence time", "secondary container", "sharp", "solid waste", "sterilize", "universal warning sign", and "validation testing".

Section 70-2.1 - This section stipulates the minimum requirements of a written plan for the management of RMW.

Section 70-2.2 - This section contains requirements and standards for containment and storage of RMW; clarifies requirements for disposal and establishes time frames for storage of primary containers used to discard sharps; clarifies time frame for storage of RMW in patient care areas and clinical laboratories; sets requirements for rooms or areas used to store RMW; sets labeling requirements for secondary containers used to transport untreated RMW off-site for treatment; clarifies decontamination procedures and guidelines for reusing secondary containers; specifies disposal requirements for secondary containers intended for single use; clarifies on-site processing procedures for reusable sharps containers; and describes requirements for transport of RMW within a facility.

Section 70-2.3 - This section specifies treatment methods for RMW; provides disposal requirements for hazardous, chemotherapeutic and radioactive waste; provides requirements for treatment of human tissue(s), or organs and animal body parts; stipulates transport, packaging and treatment requirements for cultures and stocks containing infectious agents; provides provision for sharps destruction and treatment; stipulates requirement for a response plan for handling untreated waste found commingled with solid waste; requires a radiation detection system for a facility to screen incoming waste for the presence of radioactive materials; requires a contingency plan for handling radioactive material found commingled with RMW delivered for treatment at a treatment facility; and clarifies treated RMW disposal options.

Section 70-2.4 - This section describes requirements for transfer of untreated waste for off-site treatment; clarifies that generators of RMW must transfer custody of untreated waste only to an appropriately permitted (by DEC) hauler; provides exemption if monthly waste generation is under 50 pounds; establishes requirement for use of medical waste tracking forms; clarifies applicability of Federal Department of Transportation requirements to certain cultures and stocks; specifies treatment requirements for solid waste transported with untreated RMW.

Section 70-2.5 - This section contains record-keeping requirements and retention times for the quantity, types, on-site treatment and disposal of RMW.

Section 70-3.1 - This section contains validation testing requirements for autoclaves used to treat RMW; and specifies required elements of protocols for validation testing.

Section 70-3.2 - This section contains requirements for, and minimum elements of, an operational plan for facilities using autoclaves; specifies procedures that must be followed upon autoclave failure to meet operating parameters; contains requirements for monitoring autoclave performance; specifies standards for autoclave performance and for containment of RMW for treatment by autoclaving; and clarifies treatment of autoclaved sharps prior to disposal.

Section 70-3.3 - This section clarifies the minimum operating parameters for treatment of RMW in a gravity-feed autoclave and in a vacuum-displacement autoclave; specifies approval requirements for use of an autoclave at alternative operating parameters.

Autoclave parameter for RMW treatment processes shall conform to the following:

  1. Gravity Autoclaves
    • Not less than 250° F (121° C) temperature @ 31 psig pressure use at residence time not less than 60 minutes.
    • Not less than 275° F (135° C) temperature @ 31 psig with a residence time not less than 45 minutes.
    • Not less than 300° F (147° C) temperature @ 52 psig with residence time not less than 30 minutes.
  2. Vacuum Autoclaves
    • Not less than 250° F (121° C) temperature @ 15 psig with residence time not less than 30 minutes

Section 70-3.4 - This section contains record keeping requirements and time frames for efficacy and validation testing, autoclave training, and documentation of corrective actions, modification of approved operating plans, residence time, pressure and temperature of treated loads.

Section 70-4.1 - This section clarifies criteria for department approval of alternative treatment methods for RMW; and provides approval guidelines and time frames.

Section 70-4.2 - This section establishes requirement for an operational plan approved by the department for each facility using an alternative RMW treatment system; stipulates required elements of the operation plan, including segregation of waste, safety and training plans for personnel handling RMW, emergency procedures, performance monitoring and routine maintenance; describes requirements for modification of the approved operation plan; stipulates the need for an approved plan prior to operation; describes procedures for system failure during operation; specifies monitoring requirements during operation; and stipulates operating personnel training requirements.

Section 70-4.3 - This section clarifies the requirement for a protocol for validation testing; stipulates validation testing requirements to be met prior to placing system in operation.

Section 70-4.4 - This section stipulates the additional record-keeping requirements and retention times for efficacy and validation testing; for personnel records; for corrective actions; and for plan modifications.

Section 70-5 - This section summarizes the approval process for Alternative Treatment Technologies in New York State.

Statute, Regulation, and Guidelines

Similarly, the Environmental Conservation Law was amended by Chapter 438 so that the definitions of regulated medical waste found in ECL 27 - 1501 is consistent with the Public Health Law. This ensures that the universe of regulated medical waste generators operate under the same definitions.

Even though Chapter 438 of the Laws of 1993 transferred the responsibility of maintaining the definitions of regulated medical waste to the Department of Health, it is important to note that the Department of Environmental Conservation, pursuant to ECL, Article 27, Title 15 continues to have an important regulatory oversight role in the storage, transportation and disposal of regulated medical waste, including oversight of non-article facilities such as private medical practices, research and university facilities.

Education

Educating the public to the actual issues and risks associated with regulated medical waste, while not addressed in Public Health Law or the enabling legislation, still is an important consideration. Often obscured in the public discussion and debate is the fact that truly infectious waste (as defined by being the source of transmissible diseases) is a minuscule component of the state's overall solid waste stream and that this type of waste is routinely handled every day inside and outside of health facilities all over the world without causing disease.

Treated Regulated Medical Waste and its Disposal as Solid Waste

One provision of Chapter 438 of the Laws of 1993 which provides opportunity for cost savings is the ability to dispose of properly treated regulated medical waste as solid waste. However, to fully realize this management option, solid waste handlers and disposers must be provided with specific details on how the waste has been treated. This has been provided for by a Certificate of Treatment which must accompany each load of treated waste to its ultimate destination. This form may not necessarily address all the concerns of the waste handler, particularly in light of the misconceptions they may share regarding the medical waste stream in general and the mechanisms of pathogen transmission in particular. However, the use of the form does provide the transporter and landfill operator greater assurance that the waste has been appropriately treated prior to shipment for disposal. It is also appropriate to initiate discussions with your local solid waste management authorities so that they are made aware of what additional materials may now be found in the solid waste stream as a result of the revision in the definitions. In addition it would be prudent to discuss what, if any, reservations they may have regarding the disposal of treated regulated medical waste, e.g., co-mingling of treated medical waste with other forms of solid waste. This highlights the importance of education which must be considered as a cornerstone in fully realizing the intent of Chapter Law 438 and the revised Part 70 regulations.

Universal Precautions and Managing Regulated Medical Waste

According to the Centers for Disease Control and Prevention (CDC) and occupational Safety and Health Administration (OSHA), "universal precautions" refers to an infection control system which assumes that any direct contact with a patient, particularly their body fluids, has the potential for transmitting disease. This system resulted from the heightened awareness and concern over the potential risk of transmitting Human Immunodeficiency Virus (HIV) and Hepatitis B (HBV) to health care providers. Therefore, universal precautions is a qualitative system designed to ensure the safety of the individual health care provider.

Contact with any body fluid, regardless of the quantity, is considered to be a potential source of infectious agents. Conversely, the revisions of Public Health Law as it relates to the definitions of regulated medical waste described in the following categories and the methods used to treat and process medical waste provide a quantitative system for the overall handling of regulated medical waste.

The revisions discussed in these guidelines are intended to ensure the public's health and safety, as well as those, within and outside health care facilities, who must manage medical waste. The quantity, as well as quality of the waste must be considered in determining if it should be designated as regulated medical waste.

At this point it is appropriate to clarify the application of universal precautions as it relates to the handling and disposal of tubing used in patient care. The critical factor for determining if the tubing used in patient care should be considered as regulated medical waste are: (1) direct contact with any of the fluids identified by OSHA as being possible sources of transmission of infectious agents, and (2) the quantities of these fluids. OSHA1 has described semen, vaginal secretions, pleural fluid, cerebrospinal fluid, synovial fluid, pericardial fluid, amniotic fluid, saliva in dental procedures, and any other fluid visibly contaminated with blood. Conversely, feces, urine and vomitus are not included unless they contain visible blood. For tubing to be designated as regulated medical waste, it would have to have been in contact with those fluids listed by OSHA. For example, tubing used in gastrointestinal procedures which is visibly coated with body fluids should be discarded as regulated medical waste.

Guidelines

Each section of the Public Health Law that was amended by Chapter 438 of the Laws of 1993 discussed both the Legislative intent and the Department's perspective.

Public Health Law 1389 - aa: Definitions

Chapter 180 of the Laws of 1989 broadened the state's regulated medical waste definitions to be consistent with the Federal Medical Waste Tracking Act. In doing so it increased the number of subcategories of medical waste and included many items which did not pose a risk of disease transmission but simply looked "medical". The revised definitions resulting from Chapter 438 of the Laws of 1993 reduced the number of subcategories and in some instances, provided for further qualification of items in the subcategory. However, it is important to note that the revised general definitions of medical waste includes wastes resulting from diagnosis and treatment of animals, as well as that produced from health care research and development.

The general definitions states,

"Regulated medical waste
shall mean any of the following waste which is generated in the diagnosis, treatment or immunization of human beings or animals, in research pertaining thereto, or in production and testing of biologicals, provided however, that regulated medical waste shall not include hazardous waste identified or listed pursuant to Section 27-0903 of the Environmental Conservation Law, or any household waste promulgated under this section."

Six subcategories exist within the general definitions of regulated medical waste. The last subcategory provides for the Commissioner of Health to designate specific items which previously have not been considered as regulated medical waste. As no items have yet to be added to this subcategory, the remaining five are considered to be part of the current working definitions of regulated medical waste.

Subcategory 1 - Cultures and Stocks

"This waste shall include cultures and stocks of agents infectious to humans, and associated biologicals, cultures from medical or pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live or attenuated vaccines, or culture dishes and devices used to transfer, inoculate or mix cultures."

The key to this subcategory is understanding what is meant by agents infectious to humans. The department has identified that such agents are currently described in Section 2.1 of the State Sanitary Code as those causing communicable diseases (Attachment 1). These guidelines also recommend the inclusion within this subcategory of those agents designated as requiring biosafety level II - IV in the CDC/NIH Manual for Biosafety in Microbiological and Biomedical Laboratories (3rd edition, May, 1993).

In context of this subcategory, cultures and stocks refer to systems used to grow and maintain infectious agents in vitro, including, but not limited to:

  • nutrient agars, gels, broths (including those utilizing human blood or blood products);
  • human and primate cell lines; and
  • impure animal cell lines.

The term biologicals is intended to mean preparations made from living organisms and their products which are used in diagnosing, immunizing, or treating human beings or animals, including, but not limited to:

  • serums;
  • vaccines;
  • antigens; and
  • antitoxins.

Last, the phrase "culture dishes and devices used to transfer, inoculate or mix cultures" refers to the use of items that have come in contact with high concentrations of infectious agents as in the recovery of such agents in culture from clinical specimens and includes:

  • plastic or glass plates, flasks, vials, beakers, bottles, jars, and tubes;
  • inoculation loops and wires;
  • manual and mechanical stirring devices;
  • rubber, plastic, and cotton stoppers and plugs;
  • filtering devices made of natural and artificial substances; and
  • materials used to clean and disinfect items indicated above after routine use or accident.

Subcategory 2 - Human Pathological Wastes

"This waste shall include tissue, organs, and body parts (except teeth and the contiguous structures of bone and gum), body fluids that are removed during surgery, autopsy, or other medical procedures, or specimens of body fluids and their containers, and discarded material saturated with such body fluids other than urine, provided that the Commissioner, by duly promulgated regulation, may exclude such discarded material saturated with body fluids from this definitions if the Commissioner finds that it does not pose a significant risk to public health. This waste shall not include urine or fecal materials submitted for other than diagnosis of infectious diseases."

It should be quite clear that organs, tissues and associated fluids removed as result of surgical or autopsy procedures are regulated medical waste. Some confusion however could exist regarding the phrase "discarded materials saturated with such body fluids other than urine". The determining factor for these materials to be regulated medical waste is if they are saturated to the point of dripping. This is consistent with OSHA's blood borne pathogen standard which defines saturated as referring to material that when squeezed produce free flowing fluid. The Department does not encourage individuals to squeeze any item to determine if it is saturated. Rather, the department expects that health care professionals will use their experience and training to make this determination. Examples of body fluids include, but are not limited to blood, cerebrospinal fluid and amniotic fluid and any body fluids which are visibly contaminated with blood.

One exception of particular interest in the definitions of this subcategory requires additional clarification. Urine is not considered regulated medical waste unless it is submitted as a clinical specimen for laboratory tests. However, if a patient is found to have a disease which may be transmitted through urine, then the material containing this fluid (including diapers) must be considered regulated medical waste. Similarly, incontinence materials are not regulated medical waste provided that the patient does not have an infectious disease transmissible by urine. Conversely, since feces always contain microorganisms and, since these microorganisms even if potentially pathogenic, cannot be transmitted from trash containers or disposal sites. Fecal contaminated materials are not considered to be regulated medical waste.

Questions have also arisen regarding the appropriate disposal of organs and tissues which have been fixed for cytological and/or histological examination. Since the fixatives are considered to be hazardous materials, organs and tissues discarded with these chemicals must be processed as hazardous waste, except for blocks of tissue in paraffin or similar embedding materials. The latter prevent the fixatives from leaching into the environment and the chemical fixatives destroy any potential pathogens in the tissue block. Therefore, tissue blocks can be discarded as solid waste. Conversely, if organs and tissues are disposed of separately from the fixatives, then they should be handled in accordance with Section 4215 of Article 42 of the Public Health Law. Specifically, tissues, organs, recognizable body parts and cadavers which have been chemically preserved and can no longer be sources of transmissible disease should be disposed of by cremation or interment. Section 4215 (1) allows the individual in possession of body parts removed by dissection from cadavers to retain the parts for scientific purposes. Similarly, organs or recognizable body parts which have been removed during surgery can be retained by the patient for religious purposes provided that the organs or body parts cannot serve as sources of disease transmission.

Subcategory 3 - Human Blood and Blood Products

"This waste shall include: (I) discarded waste human blood, discarded blood components (e.g. serum and plasma), containers with free flowing blood or blood components or discarded saturated material containing free flowing blood or blood components; and (II) materials saturated with blood or blood products provided that the commissioner, by duly promulgated regulation, may exclude such material saturated with blood or blood products from this definitions if the commissioner finds that it does not pose a significant risk to public health."

Blood and its components, including stocks from transfusion or materials saturated with free flowing blood, are viewed as regulated medical waste.

Questions have been raised regarding the appropriate disposal of menses pads. OSHA has ruled that feminine hygiene products used to absorb menstrual flow are not regulated medical waste. Waste containers into which these are discarded should protect individuals from physical contact with these items.

Subcategory 4 - Sharps

"This waste shall include but not be limited to discarded unused sharps and sharps used in animal or human patient care, medical research, or clinical or pharmaceutical laboratories, hypodermic, intravenous, or other medical needles, hypodermic or intravenous syringes to which a needle or other sharp is still attached, Pasteur pipettes, scalpel blades, or blood vials. This waste shall include, but not be limited to, other types of broken or unbroken glass (including slides and cover slips) in contact with infectious agents. This waste shall not include those parts of syringes from which sharps are specifically designed to be easily removed and from which sharps have actually been removed, and which are intended for recycling or other disposal, so long as such syringes have not come in contact with infectious agents."

The single most important aspect of sharps which gives rise to fear and apprehension is their inherent ability to cause puncture wounds and/or lacerations which may create a portal of entry for infectious agents. Although syringes with attached needles are the classic examples of sharps, other items used in the delivery of health care or in research and which have come in contact with infectious agents, e.g., glass or rigid plastic culture tubes, flasks, beakers, etc., must also be considered as sharps and be disposed of accordingly. Therefore, even though many of the items identified in this subcategory do not exemplify the "classic sharp", they still can give rise to puncture or laceration wounds.

One point needs to be clarified. No attempt should be taken to remove the needle from the barrel of the syringe. To do so would only increase the opportunity for needle stick injury. The total unit should be placed in a sharps container and disposed of as regulated medical waste. In those instances, however, where only the barrel of the unit is utilized, as found for example in infusion pump setups, then the barrel can be disposed of as solid waste provided it did not come into contact with infectious agents.

All syringes (barrel and needle) and those other sharps which have come into contact with infectious agents must be contained in a rigid, puncture resistant container, secured to preclude loss of contents, and either, red in color or conspicuously labeled with either the universal biohazard symbol or the word biohazard. In addition, all sharps after treatment must be destroyed to remove the risk of puncture wounds, before being disposed of as solid waste. Glass and plastic materials (other than syringes) which have not come in contact with infectious materials need not be treated and destroyed but should be disposed of carefully as solid waste, preferably in rigid containers. These containers are not required to be red in color or labeled with the universal biohazard symbol nor the word biohazard.

Even though they are not considered to be regulated medical waste certain types of medical equipment have found their way into sharps containers. The most common type of equipment to be disposed of in this manner is endoscopes, perhaps due to the pincers found at the end of the tubing. Medical equipment should not be disposed of in this manner as it is costly and an alternative decontamination (i.e. cold sterilization) would be more appropriate.

Subcategory 5 - Animal Waste

"This waste shall mean discarded materials including carcasses, body parts, body fluids, blood, or bedding originating from animals known to be contaminated with infectious agents (i.e. zoonotic organisms) or from animals inoculated during research, production of biologicals, or pharmaceutical testing with infectious agents."

Again, it is important to understand that exposure to a known infectious agent is necessary before the waste should be considered as regulated medical waste. In certain instances, most notably rabies, the ability to determine whether an animal has been exposed must await a specific laboratory analysis. Given the nature of the suspected infectious agent in this case, it would be prudent to manage the waste generated in handling and preparing the carcass as regulated medical waste. Preserved animals used for educational purposes are not regulated medical waste and can be disposed of as solid waste if they are not considered hazardous waste due to the fixative used to preserve the body.

Other Definition Revisions

Beyond the revisions in the definitions of regulated medical waste, two other terms were amended. These include:

  • Treatment
    shall mean any method, technique or process designed to change the character or composition of any regulated medical waste so as to either neutralize such waste or to render such waste not infectious as approved by the commissioner pursuant to section thirteen hundred eighty-nine-dd of this title
    .

The intent of the revision to this definition was to remove any illusion that effective treatment of regulated medical waste could be accomplished by any process other than one which directly reduces concentration of potential pathogens. It should be noted that by regulation, three treatment processes are approved; incineration, autoclaving and in the case of liquids, discharge to a sewerage system which is connected to a municipal secondary wastewater treatment facility.

  • Infectious Agents
    shall mean any organisms that cause disease or an adverse health impact to humans, except that the commissioner may prescribe by regulation additional infectious agents as may be necessary to protect health and the environment
    .

It is also important to point out one pathogen which will not be identified in the list found in Section 2.1 of the State Sanitary Code. Although HIV is not listed, it is prudent to recognize this pathogen as an infectious agent for the purposes of managing the regulated medical waste stream.

Managing the Regulated Medical Waste Stream

Beyond the revisions to several of the definitions found in the Public Health Law, Chapter 438 of the Laws of 1993 also revised two other sections that have an effect on the management of regulated medical waste. One revision effects the labeling of red bags used to contain regulated medical waste and the other concerns disposal of treated regulated medical waste.

Public Health Law 1389 - cc: Storage and containment of regulated medical waste. [Eff. July 1, 1995, as amended by L. 1993, c. 438]

Containment of regulated medical waste shall be separate from other wastes. Containers used for the containment of regulated medical waste shall be marked prominently on the containers with the universal warning sign or the word biohazard.

Prior to this provision's effective date of July 1, 1995, containers (bags and sharps containers) were required to be labeled prominently with either the word "infectious" or the words "regulated medical waste". Clearly, supplies of the outdated labeled bags and sharps containers held by health related facilities were not uniformly depleted on July 1, 1995. The department will allow facilities to use up their current stocks but when they reorder, they must acquire bags and containers which meet the labeling requirements of the new statute.

Public Health Law 1389 - dd: Treatment and disposal of regulated medical waste.

1. Treatment or disposal of regulated medical waste shall be by one of the following methods: (c) By decontamination by autoclaving, or by other technique approved by the department, so as to render the waste noninfectious. Regulated medical waste so treated shall be disposed of as solid waste provided it does not otherwise meet the definitions of hazardous waste as defined in the regulations promulgated under section 27-0903 of the environmental conservation law or the regulations promulgated thereunder, and is accompanied by a certificate, in a form prescribed by the commissioner, which evidences such treatment. 2. Regulated medical waste shall not be disposed of by burial at a landfill disposal facility, unless treated in accordance with subdivision one of this section. All sharps must be rendered unrecognizable prior to disposal.

This provision of the statute for the disposal of treated regulated medical waste as solid waste should result in decreased expenditure by health care facilities which elect to treat on-site. There are numerous alternative technologies which are currently available from over forty manufactures within the United States and Europe. They vary in capacity from those designed for use in physician/dentist offices, capable of treating twenty-five to one hundred pounds per cycle, to systems to be used in major medical centers or regional treatment facilities, which are able to treat one ton or more of waste per cycle (generally a cycle is one to one and one/half hours in length). In many instances these alternative technologies simultaneously treat, destroy, and reduce the volume of regulated medical waste through the use of pre- or post-treatment grinders/shredders or by use of extremely high temperatures (upwards of 15,000 o) to reduce the waste to ash. They vary in cost from less than $2,000 per unit to approximately $750,000 per system. The larger the capacity, the greater the waste reduction and the more automated the technology, the higher the initial cost of the unit.

However, regardless of the capacity, the extent of the automation, or overall volume reduction, all alternative systems treat regulated medical waste using one of three methods; (a) heating the waste to a minimum of 210o F by means of microwaves, radio waves, hot oil, hot water, steam or superheated gases; (b) exposing the waste to chemicals such as sodium hypochlorite (household bleach) or chlorine dioxide; or (c) by subjecting the waste to heated chemicals. As indicated in the above section, all alternative technologies must be reviewed and approved by the Department's Wadsworth Center (Regulated Medical Waste Program - RMWP) prior to being offered for sale in New York State. Each manufacturer seeking approval of an alternative treatment system for use in the State must comply with 10 NYCRR Part 70, Section 70-4&5. A list of such approved treatment technologies and information on the application procedures to obtain approval for alternative systems, as well as questions related to efficacy testing methods and results can be obtained by calling the RMWP at (518) 408-1146.

It is important to understand that a form which evidences treatment by an approved technology must accompany the treated waste to the solid waste facility. The department has developed a form for this purpose which must be used by those facilities that treat on-site by incineration or autoclaving. The department does not require the use of this specific form with waste treated by some alternative treatment technologies. For specific information contact the RMWP. There is one critical factor which must be pointed out. Sharps as defined in subcategory 4 must be treated and destroyed (rendered unrecognizable) before they can be disposed of in a landfill. Sharps which are only treated are still considered regulated medical waste and, therefore, can not be disposed of in a landfill.

On-site Treatment and Disposal Strategies

As a result of the revisions in definitions of regulated medical waste and the ability to dispose treated regulated medical waste as solid waste, on-site treatment programs should be equally or more cost effective than many commercial options. With regards to utilizing on-site treatment of RMW, two questions are frequently asked. One - why should the facility have an operational plan approved and on file with DOH? While it is required pursuant to 10NYCRR, Part 70-3.2, it is important to note that having such a plan in place will assist the facility in disposing of such waste as solid waste. Hospital and clinical laboratory RMW operational plans using autoclave treatment methodology must be submitted for review and approval to the Clinical Laboratory Evaluation Program, Wadsworth Center, New York State Department of Health, P.O. Box 509, Empire State Plaza, Albany, New York 12201-0509. All other Article 28 facilities must submit their operational plans developed to address the on-site treatment of regulated medical waste by autoclaves to the Bureau of Hospital and Primary Care Services, Hedley Park Place 433 River Street, Troy, New York 12180-2299.The second question relating to autoclaving regulated medical waste is the type of bag to be used to collect and store the waste prior to treatment by autoclaving. The typical red bag currently employed in the collection of regulated medical waste is not designed to withstand the high temperature and pressure conditions created in an autoclave. However, there are specially designed bags which are available to be used in autoclaving regulated medical waste. These bags not only remain intact, but also enhance the sterilization process by allowing easier passage of steam into the waste. The department encourages those facilities which utilize autoclaves to treat regulated medical waste to use autoclavable bags as they do come in the color red with the appropriate language imprinted on them.

Sharps Collection from Private Residences

In an effort to address the safe disposal of sharps generated in the private residence, Chapter 438 of the Laws of 1993 requires hospitals and nursing homes to establish procedures whereby such household generated waste can be dropped off for proper disposal. The overall intent of the 1993 legislation was to provide consumers with convenient and accessible means of disposing of household sharps, and to ensure that they do not cause injuries to sanitation and resource recovery workers, or end up in places where they may might pose a danger, including streets, playgrounds, recycling bins, beaches, etc. To be effective, hospitals and nursing home programs must be: convenient, accessible and easy to use, promoted in the community, understood and supported by staff, safe and secure, and they must be monitored and improved.

Household sharps collection programs have grown in visibility and importance as a result of several factors including:

  • increase in the number of sharps generated from outpatient and home care treatment
  • increase in the number of persons with diabetes, cancer, and the administration of fertility treatments and allergy medications
  • increased awareness of the risks to sanitation workers resulting from the comingling of sharps and general household trash

In New York State we have an advantage as a result of existing laws, and our established Sharp Collection and Disposal Programs at hospitals and nursing homes. In addition, the Expanded Syringe Demonstration Program (ESAP) of 2001 reinvigorated and promoted safe sharps collection and disposal which included a resource directory of disposal locations and hours of operation. The development of new and convenient collection and disposal options to supplement facility-based programs have all contributed to the success of the program. This waste covered is specific to that generated as a result of self maintenance programs involving the delivery of injectable medication and includes sharps only. Sharps as described for purposes of this program include needles, syringes and lancets, only.

A common concern identified in the Public Health Law is the nature of the container used by the private resident to store used sharps. Containers which do not provide protection against needle stick injuries cannot be considered adequate for the purposes of this program. Individuals who are responsible within the health care facility for managing this program cannot be exposed to the risk of needle stick injury which may result from improperly packaging of sharps. Therefore, it is imperative that an individual who wishes to participate in this program be educated to make informed choices in disposing of their household generated sharps. At a minimum, the container adopted and / or accepted by the facility must be shatter proof, leak proof and puncture resistant. If this cannot be assured by the generator, the health facility does not have to accept the sharps. Each hospital or nursing home in the consumer health service area should be contacted to obtain literature on the facility sharps program. A directory of hospitals/nursing homes can be obtained from the Department. The primary elements which should be included in the household sharps disposal plan/procedure are:

  • Establishment of the location for delivery
  • Operational hours - Could range from daily to once a week, depending upon the locality.
  • Drop-off points - Sharps must have controlled access. Residential sharps will not be considered as regulated medical waste until the health facility has accepted them according to their established procedure.
  • Identification of responsible staff - Individuals involved with managing the household sharps program will need to be trained on the proper handling of sharps and precautions necessary in handling sharps not disposed of in the appropriate containers, or in the event spillage. Plans which detail the responsibilities of these individuals should also provide specific information on how staff will respond to spills.
  • Use of secondary containers - The facility's site for drop-off of household sharps must have secondary containers available so that sharps containers brought in can be placed directly into the secured container. This will reduce the likelihood of direct contact by hospital personnel with household sharps
  • Public Information - The public will need information regarding the procedure in order to participate in the program. This can take the form of brochures, press releases or television or radio spots.

Questions and Comments

If staff of any facility, consumer or interested party have questions concerning the information contained in these guidelines, contact the following:

  • Article 28 Facilities (hospitals, nursing homes, etc) issues.
    • The Bureau of Hospital & Primary Care Services (518) 402-1003
  • Clinical Laboratories - Alternative Technologies issues.
    • The Wadsworth Center, Regulated Medical Waste Program (RMWP) (518) 408-1146
  • Non-Article 28 Facilities (research facilities, universities, and private physician offices, permited haulers, or storage, transport and disposal RMW) issues.
    • The Department of Environmental Conservation (518) 402-8706

Informational Sources

Federal References

  1. 29 CFR, Part 1910 - RMW Transport - Labeling…
    • Container, bag or box shall bear facility name, address, 24 hour telephone number and contact person
    • Container shall reflect appropriate symbol and signage and should be appropriate size, at least 19" x 14" on outer surface of container and reflect words such as:
      • "Bio-Medical Waste"
      • "Biohazardous Waste"
      • "Biohazardous"
      • "Infection Waste"
      • "Infection Substances"
      • "Radioactive Substances"
      • Bags - RMW bags shall be red in color
      • Sharps containers should be packaged and sealed at the point of origin and comply with DOT requirements.
    • If a bag or Sharps container is to be inserted into a secondary container, the larger container shall have the same appropriate labeling as described above.
  2. 49 CFR, Part 173 - Non-Bulk Packaging of RMW
    • Meet DOT requirements
    • Be containers in inner packaging
    • Inner packaging of liquids must be rigid, contain absorbent material of sufficient quantity and appropriate location to absorb the entire amount of liquid in the event of a spill
    • If transporting SHARPS, container must be puncture resistant and capable of retaining liquid
    • Use of carts for transporting waste in facilities must have smooth, non-porous interior surfaces, free of cracks, crevices, and other defects that could damage plastic film inner packaging or impede disinfection operations
    • After each carts use, the cart must be disinfected by any means effective for neutralizing the infectious substances (e.g., use of bleach…)
    • Untreated cultures and stocks of class four(4)risk group must not be transported by cart or bulk outer packaging means (BOP)
    • Radioactive waste must not be transported by cart of BOP
    • Chemotherapeutic waste; untreated stocks and cultures or infectious substances containing risk group 2 or 3 pathogenic organisms; unabsorbed liquids; and SHARPS containers may be transported in a cart or BOP, if packaged in a rigid non-bulk package container
    • Carts must be constructed of metal, rigid plastic or fiberglass; fitted with a lid to prevent leakage during transport.

RMW Risk Group Table

(Source: 49 CFR, Part 171)(2)

Risk Group Pathogen Risk to Individuals Risk to the Community
4 A pathogen that usually causes serious or human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatments and preventive measures are not usually available. High High
3 A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another, and for which effective treatments and preventive measures are available. High Low
2 A pathogen that can cause human or animal disease but is unlikely to be a serious infection on exposure, for which there are effective treatments and preventive measures available and the risk of spread of infection is limited. Moderate Low
1 A micro-organism that is unlikely to cause human or animal disease. None or very low None or very low