Clinical Waste in Developing Countries

An analysis with a case study of India, and A critique of the Basel - TWG guidelines

The Basel Action Network (BAN) is a global alliance of toxic activists working to halt the globalisation of the toxics crisis. For more information on BAN visit our website at: www.ban.org or contact us at:

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Health Care Without Harm (HCWH) is an international coalition of organisations and individuals committed to find remedies for pollution from health care practices. It has over 100 member organisations currently. For information on HCWH visit our website at: www.noharm.org or contact us at:

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Authors:

Glenn McRae, Vice President
CGH Environmental Strategies
Burlington, Vermont USA

Ravi Agarwal, Chief Co-ordinator
Srishti
1001, Antariksha Bhawan, 22
K.G. Marg, New Delhi - 110003 India

Phone: 3328006, 3725325
Email: ravig@unv.ernet.in

With key inputs from Ms. Jharna, Jawahar Lal Nehru University, New Delhi

Contents

Section I -- Introduction
An Overview Of Clinical Waste (in the context of developing countries)

Section II -- The Case Study of India
Recommendations for Developing Countries

Section III -- Critique
of the Basel Convention's TWG Draft Technical
Guidelines on the Environmentally Sound
management of Bioclinical and Healthcare Waste

References

Introduction

Health care waste, if not managed scientifically has the potential of posing a serious threat to health and environment. The grave health hazard posed by the inefficient handling of clinical waste to the most proximate i.e. the hospital staff, ragpickers, municipal workers and the community at large , have been well, documented. In developing countries, incorporation of a holistic and scientific clinical waste policy within in overall hospital management is still an exception and not a rule.

Despite the inherent hazardous nature of the clinical wastes , its treatment and disposal remains a negligent and unattended area within the overall urban municipal waste, too, in these countries. The problem is further accentuated by the indiscriminate onslaught of the obsolete and redundant incinerator industry for on site clinical waste disposal into the South Asian and African countries.

The evolution of a separate category of clinical waste within the municipal waste stream dates back to the late 1970s, when clinical wastes including syringes and bandages were washed up on US east coast beaches. The public outcry which followed led to the formulation of the US Clinical Waste Tracking Act (MWTA) which finally came into force on November 1, 1988. The first solutions adopted to solve this problem was reflected in the installation of the installation of 6,500 on-site, small and unregulated clinical waste incinerators in health care facilities. It was soon realised that these small burners are not only more polluting than the clinical waste itself, but they also provided a license to create more and more waste, much of it disposable plastic, since it could all be `easily burned .

When dioxins sted to be recognised as a serious concern, scientific studies about this class of super toxins and its connection to incineration led to USEPA's first dioxin reassessment, which was released as a draft report in 1994. It stated that over 60% of the total TEQ load of dioxins in the US was from clinical waste incinerators. When this finding was reflected in the US clinical waste incinerators standards, released on September 15th 1997, the EPA document predicted that 93 to 100 percent of `small' incinerators, burning about 200 lb of clinical waste per hour, would shut down, since it would be too expensive to retrofit them. This capacity is equivalent to the largest incinerators currently being used in countries like India. Also recognising this the Indian Government banned the combustion of PVC in clinical waste incinerators.

This should have been the final nail in the coffin for clinical waste incinerators, which over the years had seen a rapid decrease in market shares, as hospitals opted for alternative technologies and approaches. Many large clinical waste incinerator companies started switching over to cleaner technologies.

However, though in developed countries the small, on-site incinerator industry became redundant, it started to find markets in developing countries, where regulation was more relaxed. It is very evident in India where new laws make it mandatory for the health care sector to clean up before December 1999. International companies started pushing hard to sell outdated incinerators instead of allowing local cost effective solutions to evolve. There are innumerable examples of incinerator technologies, rendered outdated by regulations in the western world, being peddled in India, Pakistan and Bangladesh, with a clear policy of dual standards of environment and human health. In fact in one instance there was also a move to shift a closed second hand incinerator from the US to India.

International agencies such as the World Bank, ADB, the WHO as yet do not have clearly stated and comprehensive developing country policies which promote either the evolution of local solutions, or lay enough emphasis on managing waste, training and capacity building, waste minimisation. In fact the approach has been to opt for easier and dangerous options like small on-site incineration. In India, for example, massive NGO and citizen's pressure has forced the World Bank to review its clinical waste disposal policy in its Health Sector capacity building programs, to a point where they are now stated to have stopped promoting on-site incineration of clinical waste. The emphasis needs to be on building awareness, and the availability of cleaner technology options such as autoclaving, simple chemical disinfection etc. In India at least, owing to a high degree of information dissemination by NGOs and doctors, the WHO is also drafting a more appropriate clinical waste policy along with the Government. However this is not necessarily true in other South Asian countries.

It is important to realise that most developing countries do not have the facility to either monitor or regulate dioxins and furans, especially in the narrow regulatory limits as have been set in the west. Such facilities are also extremely expensive, and a big strain on regulatory agencies which can barely cope with more conventional pollutants such as NOx, SOx etc. Hence setting a strict standard for such toxins becomes a theoretical exercise, and can only be avoided through the adoption of cleaner technologies, processes and practices as well as waste minimisation.

Besides, fund availability in health care sectors in such countries is very limited. Solutions must be able to address key problems, such as the management of `sharps' and basic segregation which require low cost approaches rather than expensive technology centric ones. They must reflect the lessons learnt by the developed countries, not repeat their mistakes, and be those which are good for the next decade or two since invesments, once made here are not easy to replace in a cash strapped scenario.

An Overview Of Clinical Waste

Defining Clinical Waste

Very broadly clinical waste is defined as `any solid or liquid waste that is generated in the diagnosis, treatment or immunisation of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals.

Definitions of clinical waste have evolved with a view to aid in regulating it. Given the fact that the clinical waste stream is an extremely complex one, and which includes chemicals which could be hazardous , as also normal kitchen or office waste which are akin to municipal solid waste, the definition of regulated clinical waste becomes important. Broadly clinical wastes include all types of wastes produced by hospitals, clinics, doctors' offices and other clinical and research facilities, these wastes include infectious, hazardous, radioactive and other general wastes.

While a term like `hospital waste' would encompass all wastes which emanate from a health care facility, `clinical waste' can be generated in small clinics or outfits without kitchens or offices. The definition used must also keep in mind that only a small portion of the total hospital waste is infection, which could range from 10 to 25%. No matter which definition is used, it should enable an identification of infectious or potentially infectious waste in any health related waste stream. Over time various narrower descriptions have been used in various regulations around the world.

Quantity of Clinical Waste

Hospital waste is a small fraction of urban municipal waste. Estimates of it can be made from the number of beds in any city and an average amount of waste created per bed. The range varies widely depending the per bed waste generation and the method of estimation used. In India, normally 1 to 2 kg of waste per bed have been measured. There have been various estimates for developing countries, including India. However estimates range from 1.00 to 4.5 kg per bed per day.

Nature of Clinical Waste

There seems to be a greater consensus on how much of the waste generated is actually infectious or hazardous. WHO states that "…85% (of hospital wastes) are actually non-hazardous, around 10% are infectious wastes, and around 5% are non-infectious but hazardous wastes. In the US for example, about 15% of hospital waste is regulated as infectious waste. In India this could range from 15 to 35% depending on the total amount of waste generated.

Risks associated with infectious clinical wastes

Infected hospital waste can transmit diseases, especially if it finds portals of entry. "There is strong epidemiological evidence from Canada, Japan and the USA, that the main concern of infectious hospital waste is the transmission of HIV/AIDS virus and, more often of Hepatitis B or C virus (HBV) through injuries caused by syringes contaminated by human blood."

To the Community:

The risk to the general public is secondary and occurs in three ways: (1) accidental exposure from contact with wastes at municipal disposal bins; (2) exposure to chemical or biological contaminants in water; (3) exposure to chemical pollutants (e.g., mercury ,dioxin) from incineration of the wastes.

To the Workers:

Environmental workers, including ward boys, janitors, municipal workers and ragpickers, along with nurses are the group most at risk from infected clinical waste. However, there is a lack of priority on basic worker safety when dealing with wastes within health care facilities, and installing end-of-pipe disposal technologies does little to minimise their risk. Sharps, which include syringes and needles, have the highest disease transmission potential amongst all categories of clinical waste. Almost 85% of sharp injuries are caused between their usage and subsequent disposal. More than 20% of those who handle them encounter `stick' injuries, as studies show. It is of less importance if the shap is later incinerated or autoclaved, if it has already transmitted disease.

A three year study carried out in Jordan found that of the 1000 odd persons involved in patient related activities, 248 health care workers had needle stick injuries, of which 34.6% were staff nurses, 19% environmental workers, 15.7% interns, 11.7% residents, 8.5 % practical nurses and 6% technicians. The study concluded that needlestick and sharp injuries occur frequently in developing countries, and that safer disposal facilities and routine hepatitis B vaccine should be adopted.

Hazardous clinical waste risks

Largely ignored, this class of hospital waste, which consists mainly of chemicals and discarded cytotoxic drugs, poses risk scenarios to hospital workers. Some common hazardous chemicals, some of which are probable carcinogens or pose other health risks include:

· Chemotherapy and Antineoplastioc chemicals , which are the largest volume of
hazardous chemicals.

· Formaldehyde, which is normally used in pathology, autopsy, embalming etc.

· Photographic chemicals such as fixer, developer which has 45% glutaraldehyde etc.

· Solvents such as methyl chloride, chloroform, freons, trichloroethylene etc.

· Mercury

· Ethylene Oxide used as sterilizers.

Incineration of Clinical Waste

Most clinical administrations have focused on installing disposal technologies such as incinerators and not on implementing a ‘practice' of waste management within the hospital. Chronic problems in incinerators, both relating to very high toxic levels as well as difficulties in operating a sophisticated engineering technology in a clinical setting have given rise to a debate which attempts to define a clean technology for clinical waste disposal. Some of the problems associated with the functioning of incinerators are:

Operational Problems: Clinical waste incinerators, particularly in developing and poorer countries, often operate under sub-optimal conditions. ‘Batch processing' where waste is fed on an ‘as arrives basis', low operational temperatures, give rise to poor performance, and high emissions.

This seems to be generally more true in developing countries. Most hospitals in the Delhi were found to be operating incinerators at 400 to 500 deg. C whereas they were rated at about 1200 deg. C. The percentage of incinerators that were functioning poorly or not operational in some other developing countries are as below:

Absence of Pollution Control Devices: Adequate Pollution Control Devices are not fitted to all incinerators, nor are these devices always regulated by adequate standards.

Difficulty of repair and maintenance: Incineration technology is expensive. Often and particularly in developing countries, the technology is old, and their are costs and efficiency sacrificed with maintenance problems.

Over-sizing of incinerator, per volume of waste: Experiences in Latin America show the tendency to install ‘oversized incinerators'. These are either not efficiently utilised or ineffective since they have to be filled with either too little waste leading to `batch processing', or burning of waste which was never meant to be incinerated in the first place.

Unresolved disposal of incinerator ash: Incinerator ash, consists of both fly ash and bottom ash. The ash is highly toxic concentration of heavy metals, dioxins and furans. Ironically, as the air pollution equipment becomes more effective in removing particulate matter, the toxicity of the fly ash increases. One of the largest hospitals in Delhi was found to have lead in its incinerator ash at levels which would classify the ash as hazardous.

Ash is regularly dumped into a landfill where it is rarely or insufficiently covered with inert material, and ground water pollution through leaching is common. Besides the presence of heavy metals, etc., released especially by the burning of plastics, there is also the problem of sharps remaining in it. landfilling the ash then poses special injury problems to ragpickers etc.

Dioxins and furans are found in incinerator ash at levels of the order of picograms per gram of ash. Even internationally, while the law often stipulates stringent requirements on handling of the ash, there is usually no clear guidance on its disposal. Some ash is treated as hazardous waste, but much of it finds its way into ordinary domestic landfill sites.

Environmental and Health risks associated with clinical waste incineration

Incineration has specific health concern since it not only destroys the pathogen but also the material on which the pathogen resides. In the process they transform solid and liquid toxic wastes into gaseous emissions. The pollutants of Clinical waste incinerators, include:

· Pathogens (entities with infection potential),

· Metals (e.g. cadmium, a neurotoxic chemical and thought to be a probable human
carcinogen),

· Acid gases (e.g. hydrogen chloride, nitrogen oxides and sulphur dioxides), which can
cause acute effects such as eye and respiratory irritation, can contribute to acid rain,
and may enhance the toxic effects of heavy metals)

· Particulate emissions (which can absorb heavy metals and organic and lodge in
human lungs, and serve as irritants possible responsible for chronic health effects).

· Increased chlorine made material e.g. PVC, which creates dioxin, a known animal
carcinogen, and considered human carcinogen.

Alternative Technologies to Incineration for Clinical Waste

There is a concerted move towards non-incineration technology, particularly for clinical waste. Nearly 80% of the hospitals in California use alternatives to on-site incineration.Some of the factors which have contributed to such a shift include:

· Increased awareness of the environmental and health impacts of incinerators.

· Increased cost of incineration given increased equipment needs defined by new
emission standards.

· Difficulty in finding new sites for incinerators.
· An increasing availability of non-incineration technologies.

Section II

A Case Study of India

India can serve as a case study for developing countries, since the context of developing countries is very different from that of more industrialised societies. India has witnessed accelerated activity in clinical waste disposal. Not only does it have a large health care sector which ranges from elite services to primary health care, but it also has a large presence of other stakeholders such as multilateral funding agencies, highly informed NGOs and clinical professionals, a legal framework, health agencies like WHO, within the overall constraints which a developing country faces. The solutions which evolve here can serve as a guide for all other developing countries.

In India , like in many other developing countries, the disposal of clinical wastes has been handled very casually and thus with time it has assumed the proportions of a crisis management problem . Municipal bins overflow with municipal as well as clinical waste; and there is a general fear of epidemic tormenting city administration. Despite recommendations both here as well as abroad, to rectify waste management systems within an overall framework, hospital administrations have ignored larger systemic practices and instead picked up only end -of -pipe solutions such as incineration . Even the first draft rules of the Indian Ministry of environment and Forests of June 1995 recommended installation of on-site incinerators in all 50 bedded hospitals and above.

Further, acting on these, in a Public Interest Litigation ,the Supreme Court of India, in March 1996, ordered that this be implemented for the city of Delhi. The active and timely intevention by Indian NGOs such as Srishti, led to a review of Supreme Court order. Consequently, the Court in its reviewed order called for the inclusion of alternative and safer technologies in the draft rules and authorised the Central Pollution Control Board to set standards for the same. Finally, after an extended procrastination the government of India, issued the amended Bio - Clinical Waste (Management and Handling ) Rules , on July 20, 1998.

One of the critical features of these were the recognition for the need of alternative technologies, and an attempt to avoid dioxin production through a ban on the burning of plastics, especially PVC. Avoid the problem rather than regulate it was the `mantra', though effectively regulating it is going to be highly problematic. Both these were a direct outcome of information dissemination and advocacy by NGOs.

Despite this it must be cautioned that overall the problem persists. Incorporation of scientific treatment and disposal of clinical ashes in the overall hospital management is a long cherished dream , yet to be achieved. Even the most elementary technology i.e. incineration is installed only in the tertiary care hospitals and even there in most cases incinerators operate at sub-optimal conditions ."Batch processing" where waste is fed on an as-arrives basis, and low operational temperatures, give rise to poor performance and high emissions. The secondary and primary health care centres do not practice any scientific disposal practices and clinical waste is often up with the municipal wastes. Hospital wastes are thrown in open garbage dumps or in open nearby municipal bins.

The overall scenario on segregation of wastes too is undisputedly dismal. Srishti studies have constantly shown that in the majority of the hospitals there is no segregation of wastes and even in hospitals where it is there, waste is handled so casually that infectious wastes and sharps are dumped `alongwith the rest. Colour coded bags are not used either due to their unavailability or the doctors and nurses are not aware of the need to segregate the wastes. In other cases, where wastes are segregated by the hospital staff, it is done for the purpose of retrieving useful items. Even in several hospitals with or without incinerators, contractors are engaged to dispose of clinical wastes. This gives way to malpractices as waste recycling by ragpickers, and possible reuse of used syringes has become an accepted way of life. Further, majority of the facilities give no primary treatment to the liquid wastes before discharging them into the sewers. Even some large hospitals use municipal crematoria for organs, tissues etc.

Hospitals are currently burning wastes or dumping bins which are transported to unsecured dumps. The wastes contain mercury and other heavy metals, chemical solvents and preservatives (e.g.,formaldehyde) which are known carcinogens and plastics (e.g. ,PVC) which when combusted produce dioxins and other pollutants which pose serious human health risks not only to workers but to the general public through food supplies .

The workers in the health care facilities do not take care of the hazards associated with clinical wastes. Workers are not provided protective gears like gloves ,face masks and boots in most of the health care facilities. In the instances where they are provided, workers do not use the protective equipment as it impedes their work and they find it uncomfortable.

The lack of awareness about the importance and benefits of waste management programmes in health care facilities is due to several reasons- includes the staff's unexplained unwillingness to participate, lack of motivation, lack of proper training and education besides the permanent cash crunch which hampers providing protective gear to hospital staff for segregating wastes. and above all , the harsh fact -treating wastes is not profitable.

Thus, much groundwork needs to be done . Capacity building in the health care sector, traning and awareness, involvement of all agencies such as the Ministry of health and the state health departments,the WHO and better enforcement of regulation with greater polluter acceptability have to be addressed. This is important, keeping in consideration the resource crunch crisis and poor quality health care services prevailing in the health care sector in India.

Further, many external forces are forcing unviable approaches on a funds starved health care sector in India e.g. World Bank had recommended, though this is now changing, the setting up of on -site incinerators in its State Health Systems Development Project II for Karnataka , Punjab and West Bengal.

There is however a ray of hope since there are changes in the right direction too, albeit small ones. Some hospitals are opting for autoclaves in place of incinerators, and the Government of Delhi has ordered seven large autoclaves. The first centralised microwave technology was granted approval by the CPCB in Sept ‘96 and is awaiting installation. There is a move for training and capacity and agencies UNDP are also getting involved.

The World Bank and the WHO are coming up with more sustainable and cleaner policies. NGOs and the media are playing a watchdog as well as a constructive role in helping set up model hospital systems. Though the industrial sector has still to catch up with viable alternatives, though there is a recognition that a sizeable market exists, and entrepreneurs are appearing on the scene.

The need is for constant action and a continuing focus on finding cost effective and effective solutions.

11 Recommendations For Improving Clinical Waste Management in Developing Countries:

1) Definitions and Goals Set: Before any clear improvement can be made in clinical waste management, consistent and scientifically based definitions must be established as to what is meant by clinical waste and its components and what the goals are for how it is managed. Importantly, in the clinical wastes, "potentially infectious waste" as a category must first be addressed for the proper management treatment and disposal .

2) Waste Segregation: It is critical that wastes are segregated (preferably at the point of generation) prior to treatment and disposal. Proper segregation should be achieved through training, clear standards and tough enforcement.

3) Proper Sharps Management: A proper sharps management should be instituted in all health care facilities. In this way, most of the risk of disease transmission from clinical waste would be prevented.

4) Waste Reduction: Emphasis needs to be put on waste reduction of hazardous materials e.g. hospital waste management would benefit from a policy of a phase out of mercury-based products and technologies .

5) Training and Education: Proper training and education must be offered to all workers from doctors to ward boys, to labourers and rag pickers to ensure an understanding of the risks that wastes pose, how to protect themselves and how to manage wastes (especially how to properly segregate).

6) Proper Collection System: If the benefits of segregation are to be realised then there must be secure internal and external collection and transportation systems for waste. In addition the very real concern of hospital administrators and municipal officials to prevent the reuse of clinical devices, containers and equipment after disposal should be taken into account in any management scheme.

7) Cohsesive Waste Management Plan: To ensure continuity and clarity in these management practices, health care institutions should develop clear plans and policies for the proper management and disposal of wastes. They need to be integrated into routine employee training, continuing education and hospital management evaluation processes for systems and personnel.

8) Reprocessing: There should be continued emphasis on the science of reprocessing of equipment and materials in clinical facilities. A reprocessing industry must be supported with investment in proper equipment and training so that it is carried on in a safe and efficient manner.

9) Avoid Incineration: The rush to incinerate clinical waste as an ultimate solution to a problem without definition, is an injustice to developing countries, public health and the environment . Lesser risks are associated with the treatment of unsegregated wastes through other treatment technologies such as autoclaving, hydroclaving ,microwaving and chemical disinfection ,which affect workers more than general public and contaminate water sources rather than air if improperly operated . Choices of treatment technologies should be made in line with a clear knowledge of the waste stream to be managed and the goal to be achieved through treatment.

Technology should fit the situation and work in the management system to achieve the final goal as part of the overall system, not as a replacement for the system.

10) Non-Combustion Chemical Disposal: The development of an non-combustion disposal industry which is capable of managing chemical hazardous waste is essential.

11) Development of Sanitary Landfills, Sewage Treatment: The Development of sanitary landfills, sewage treatment plants and other waste management facilities is necessary to securing public health in the country and providing for the ultimate safe disposal of those wastes which cannot be otherwise recycled ,composted or reused.

Section III

A Critique of the Technical Working Group of the Basel Convention Draft Technical Guideline on the Environmentally Sound management of bioclinical and healthcare waste (Y1; Y2; Y3) 2nd Draft

Overview

While the effort to provide waste guidelines is laudable, there are four overarching basic flaws in the current draft.

1. There is a reliance on, and faith in, incineration as part of an overall management strategy for clinical waste which does not follow either science or best practices.

2. The definitions of waste are convoluted and confusing from a health care facility management perspective, and in their presentation often confuse the handling of waste with the need for the use of universal precautions by all workers in health care facilities.

3. Any attempt to set international generic standards for the management of clinical waste is problematic given the wide variety of practices and resources available at any place on the globe. What guidelines and standards are set should be well co-ordinated with the major agencies who are also in the process of setting standards such as the WHO.

4. The text constantly steps outside of its intent as a guideline and tries to assume to guise of a manual dictating methodology.

While the guidelines recognise that proper waste management starts with education, training, good systems and infrastructure, and real science for effective and safe implementation it continually falls back on and embeds throughout the discussion the need for and default too incineration as a technology which will somehow take care of the problem. As we have seen in our direct experience in North American, South Asia, and the South Pacific, and as others (including the WHO) have documented, throughout the world, the default to incineration in most cases precludes good management of wastes at point of generation, and results in mixed hazardous waste streams, unsafe conditions for workers, and increased pollution of the community by inadequately managed incinerators. While the draft guidelines note that only a very small portion of a properly segregated waste stream is in need of special treatment for disinfection (biological) or neutralisation (chemical), the fall back to incineration throughout the document provides little incentive for good management practices to be established. In addition, incineration of wastes, except for a small portion (e.g. anatomical, some pharmaceuticals, and chemotherapy) incineration is a costly, unreliable and unsafe technology, the role of which is being rapidly reduced in the United States for all those reasons. In addition the draft document incorrectly assesses technologies such as autoclaving and microwaving, as well as chemical disinfection as "pre-treatments" rather than as fully certified treatments for clinical waste. In the document chart (7.37), incinerators are listed as the only treatment. Finally in 7.6.2, on disposal methods, incineration is listed as a "disposal method" which is incorrect. Incineration is a waste treatment technology. While it reduces the volume of solid waste, it produces a secondary solid waste (ash and other residuals) which must be disposed of (often as a hazardous material), and transfers the risk by creating new hazards in air and water from the operation and residuals of incineration. Any new guidelines should speak only to best and practices, and not re-establish antiquated technologies which are known to be hazardous.

The second general issue with the guidelines is the increasingly convoluted and unhelpful (from a facility management perspective) definitions of waste types. Throughout the definition sections (3, 4 & 5) there is information categorising waste, risk, hazards, disease transmission pathways, and sources. All of this information would suit better as an appendix, if included at all. The information could be summarised in a few paragraphs providing a rationale of why wastes from health care pose significantly different types of risks than other wastes, and what the source of those wastes are. These sections will create more confusion than clarity. Section 6, where definitions are actually taken up, suffers from the confusion created earlier. In addition, there is confusion between what concerns need to be addressed for waste management (the subject of these guidelines) and what concerns are more general to the issues of "universal precautions" that should be practised by all employees in a health care facility whether they have anything to do with waste or not. These issues need to be separated and dealt with individually.

The final general issue concerns the need for co-ordination of any guidelines with the other international agencies which are in the process of working on standards, such as the World Health Organisation (WHO), and with existing national standards, particularly some of those recently promulgated by countries such as India. As much as possible the Basel guidelines should compliment and expand on these, rather than possibly contradict them. Additional time will be needed to do such an analysis, and the working group should be in close contact at least with WHO.

Guidelines should provide guidance, and act as the basis for implementation manuals and protocols to be developed. These guidelines, especially in sections 7-10 repeatedly and inadequately cross the line into implementation. There are a number of good guides for health care waste management available. They should be referenced and promoted by these guidelines, not replaced by them. The guidelines try and accomplish too much in this and as a result lose their power and effectiveness as a guide.

A Section by Section Critique

Introduction

From our experience in establishing programs to manage wastes generated in health care settings in facilities throughout the United States, and assessing waste systems and establishing guidelines in India, the Caribbean and New Zealand, we find that the basic premises as laid out in the introduction are a sound, if incomplete basis within which to pursue this discussion. In particular we would emphasise numbers 2, 7 and 8 in that these wastes, when properly managed pose no greater risks than that of "properly processed domestic or industrial wastes." The desired approach is proper management and management systems -- "human health should at all time take precedence over waste management requirements."

Where the introduction and premises could be strengthened is first in numbers 6 and 8 where workers and occupational safety are left out. Number 6 should read: "The safe management of bioclinical and healthcare waste is essential for worker, community and environmental health." In number 8 the rewrite should be: "The primary objective of such measures is to reduce or minimise the risks to patients, helth care professionals and hospital labourers, the public, disposal personnel (both formal and informal) and the environment."

Without such inclusions we are not acknowledging that the people most at risk from both biological and chemical risks in hospitals are the staff and workers. The potential risk or infection or exposure is highest in the time period that these workers are in contact with the material. In addition, as wastes leave the facility for treatment or disposal, we must also acknowledge that in addition to the formal waste disposal and transport workers employed by municipal and private entities, in most countries there is a vast number of informal workers (often called scavengers or ragpickers) who engage in practices in managing wastes that bring them into potential contact with hazards and possibly infectious materials as well.

Next, if we accept the premise that "human health should at all times take precedence" in waste management decisions and practices, then the repeated reference to and recommendation for the incineration of wastes throughout the rest of the document lies in direct contradiction to this basic guiding tenet. Incineration has indeed been identified as the best practice for destroying pathological wastes (primarily for aesthetic reasons), and is necessary for the proper destruction of chemotherapy wastes, and pharmaceuticals that are outdated or no longer of use because of the special properties of these materials. In emergency situations it is the desired treatment for wastes associated with outbreaks of Level IV (Centre for Disease Control guidelines) diseases. However, all other wastes generated in health care settings which are potentially contaminated with infectious agents can be adequately and safely treated with other readily available and cheaper treatment technologies (e.g. autoclaves, microwaves). The experience of the United States, which is seeing a rapid decline in the number of operating incinerators accepting clinical wastes, is that the incineration of that portion of the waste stream deemed potentially infectious, is simply a "risk transference" strategy which actually increases risk. Incineration simply takes the risk from one medium, "potentially" infectious, and transfers it to another medium, "known hazardous," and instead of having to manage a possible biological risk, actually spreads a very real chemical risk into the community through incinerator emissions. The U.S. EPA has identified clinical waste incinerators as one of the top contributors of dioxin and mercury to the environment because of the nature of the wastes from health care. Wastes from healthcare can be in mixed categories, being contaminated with both chemical and biological material, thus needing special treatment, or are produced from a material (e.g. PVC - as in IV bags) which if treated improperly (i.e. incineration) can create a chemical hazard where none existed before. The American Hospital Association, recognising this problem, has recently entered into an MOU with the EPA to work on reducing these risks. The guidelines as currently constructed contradict this extensive experience and body of scientific data, and do not establish "best practices" in this regard.

Finally, the guidelines have to make more allowances for differences in settings (rural vs. urban), resource availability, and diversity of cultural practices to allow for the best solutions to be achieved in each setting where they will be applied. In many cases the specificity of the guidelines curtails the ability of local conditions to be accommodated.

2. Purpose and Scope of Guidelines

There is a definite problem in approaching this issue with so many definitions of Bioclinical and Healthcare Wastes, Clinical and Related Wastes, Infectious Wastes, etc. which are not used consistently in the guidelines, and which are not consistent with the definitions or efforts of other international agencies also seeking to establish guidelines. In the frst two sentences of subpoint #9 the terms differ: "Bioclinical or healthcare waste"; and then "Bioclinical and Healthcare Waste." The use of the conjunction "and/or" is confusing and unnecessary. The entire reworking of the definition in #3 General Definition is confusing and does not lend itself to application in health care settings. The idea of using the term "Risk" to describe a type of waste, as in "Healthcare Risk Waste," obscures the fact that the management of any type of waste has risks, and dilutes the value of the term "risk."

The WHO, CDC and other agencies have guidelines that differ. Guidelines differ from country to country, and within the United States the definitions and regulations are different in 42 of the 50 states. Management of these wastes is also influenced by various federal authorities including OSHA, EPA, and DOT, none of which regulate all wastes or the process of waste management but influence some portion of the process leading to increased confusion. The confusion over definitions was highlighted in the first draft working group paper by the interchangeability of the terms hazardous, biohazardous and infectious. The replacement with the awkward term and resulting definition of Bioclinical and Healthcare waste, and then the sub categories of "bioclinical and high risk healthcare waste" lend more confusion to the issue than clarity, and will result in extremely difficult situations in translating this guidelines into understandable terms in various settings and cultures, as well as languages around the world.

We strongly recommend that the Working Group assist in initiating a joint working group with WHO, CDC and key national regulatory bodies from OECD and non-OECD member countries to provide some uniformity of definition. These guidelines should be drafted with a clear understanding that then need to be implementable within facilities, that management staff will need to refer to them as they build programs that comply.

This effort should then be directed toward those bodies providing funding for health care system infrastructure improvements (e.g. World Bank State Health System Program) and provide guidance for those projects where they address waste management, and with other programs (e.g. World Bank, IMF, national economic development programs) which fund industry and facility and technology development so that such efforts in health care facilities and products, as well as treatment facilities do not act in contradiction to one another.

3. General Definition of bioclinical and healthcare waste

In the definition of wastes in the draft document clear distinction should be made between the various waste streams that are created when wastes generated in health care settings are properly segregated. For purposes of this document, wastes should be defined in such a way that the handling, treatment and disposal practices associated with them logically follow the defined waste grouping.

There is a great deal of confusion in how point 3.12 breaks out the waste categories. It is also incomplete. The breakout of the WHO risk groups in this definition is not useful, and begins to confuse (as many guidelines do) the issues of "universal precautions" which are practices of healthcare workers to protect themselves and patients from exposure to biological agents, and the management of wastes. Universal precautions should be observed by all health care workers, but this is a different issue than the basis on which we make waste management decisions. Table 1 under heading 4.3, is not necessary, leads to confusion, and if it is to be included needs to be in a different section. In number 4.1 and then more fully in 4.6 a new "risk," genotoxic, is defined and cited as if it were a class of waste, but it is not broken out in section 3, and the term used to cover this is cytotoxic or more generally chemical. This again leads to confusion. For the purposes of good management all wastes should be considered "risks." Thereis no such thing as "risk waste" and "risk-free" waste. If these categories reflect previously defined categories within the Basel Convention, then it would be best to start by modifying those previously established categories, rather than build new guidelines on inadequate assumptions and infrastructure.

In addition, while a number of waste categories are broken out not all are defined (i.e., chemical and radioactive).

The definition of "Healthcare" in 3.12 is fine. "Bioclinical and healthcare waste" should be changed simply to "Healthcare Waste" and this should be broken into a series of subcategories. These include:

1) General Wastes which should encompass approximately 85% of the wastes generated in these settings, and which can be covered as non-hazardous, non-infectious solid wastes to be managed in accordance with general solid waste recycling and disposal guidelines. This includes all the wastes generated from offices, construction, food service, and non-clinical areas, as well as all non-contaminated waste from patient rooms, treatment and diagnostic services areas (which makes up the majority of wastes in those areas as well if properly segregated).

2) Clinical and Related Wastes which must be broken down into their component parts to have proper handling and treatment defined (e.g. infectious wastes and cytotoxic wastes require separate handling and safety procedures). Different procedures must also be followed for liquid wastes and solid wastes. These wastes are wastes generated in the process of providing direct care to patients, or in associated laboratory or other functions designed to deliver or support direct care.

2a) Bio-Hazardous / Infectious wastes

Guidelines for determining which wastes should be thus classified are provided in documents published by the American Hospital Association and the Association of Operating Room Nurses which are referenced at the end of this paper. Generally they are materials that could harbor potentially infectious agents and may pose a threat to human health if a person was to come into direct contact with them.

2a.1) Human tissue / pathological waste (not including cadavers or foetuses which have special considerations)

2a.2) Anatomical wastes (including P.O.C. - products of conceptions / foetuses)

2a.3) Laboratory cultures and specimens

2a.4) Liquid blood and blood products and body fluids

2a.5) Blood or body fluid soaked gauze, bandages, sponges and other materials

2a.6) Blood bags and other containers used to hold blood

2a.7) Wastes from isolation rooms of patients with known highly contagious diseases

2a.8) Experimental animal carcasses and body parts

2a.9) Experimental animal bedding and other animal room wastes

2b) Sharps

3) Pharmaceutical waste

4) Cytotoxic waste

5) Chemical wastes (e.g. formalin, xylene, mercury, silver)

6) Radioactive wastes

In addition special consideration must be given to wastes which combine hazard attributes such as dental waste which includes tissue, teeth and mercury fillings, or a broken thermometer which may be considered a "sharp" as broken glass and contaminated by mercury. In both these instances a different pathway for treatment and disposal must be created that is not included in the normal treatment pathway in the categories above.

This type of a waste classification system is based on the need to manage separated waste streams, not on where the waste comes from or what "super" category of waste it originates in.

Beyond the definition issues are the difficulties for establishing guidelines and implementing programs which will manage wastes generated at a wide variety of facilities, often widely dispersed in any logical management territory. Such an effort requires the active participation of authorities from private and public sectors, and cross training of personnel handling general municipal wastes in the handling of wastes.

The issues affecting the treatment and disposal of CR wastes shold only be taken up when the efforts in reduction, source separation, and adequate management (including training of staff) are addressed. The need for treatment and disposal facilities will be determined by the quantity and type of wastes generated after these initial steps are successful accomplished. The ability of all countries to address the problem proactively is problematic given the varying administrative, management and training capacity available, but encouragement should be given to developing these capacities as an alternative to widespread adoption of inappropriate technological solutions to the problem which do not address worker safety or public health issues (e.g. waste to energy plants, cement kilns, etc.) which are promoted in the document.

Additional comments follow and note specific issues referencing specific points in the draft document: Without clear definitions in the first three sections however, the value of the remaining document is questionable. For further information (see appended bibliobgraphy).

4. Hazards of bioclinical and healthcare waste

For this section to be usable, it should be consolidated, with simple statement of the various hazards associated with wastes, and Table 1, if retained at all should be relegated to an appendix, and Table 2 should be deleted as it is arbitrary and generic and more appropriate to a discussion of universal precautions rather than waste management risk. It also does not cover the risks associated with the informal sector ragpickers and scavengers) who comprise the vast majority of waste workers in the world.

A brief overview of universal precautions and worker safety issues would be much more useful. Section 4.6 concerning genotoxic wastes (which is new terminology not previously used - risk categories should align themselves with waste categories) concerns the use of these drugs, and the hazards associated with use, and not in association with their waste by-products. This creates confusing language.

In all sections where waste water is discussed, and the possibility of disposal (and treatment) being the draining of liquids to the sanitary sewer, need to take note of the fact that in most of the world there is no "sanitary sewer" or even primary treatment of liquid wastes. The building of such an infrastructure is still a largely undone public health task. The pouring of non-disinfected biological agents or non-neutralised chemical agents down the drain should be considered very carefully, as the waste water from most facilities in the "non-developed" world, drains directly in public thoroughfares, open street gutters, or into water supplies which are also used by the public for washing, cleaning and drinking. In these cases dilution is not necessarily a good practice. It should also be observed that some substances whose regular treatment may be disposal down the drain (e.g. glutaraldehyde) are regulated as a pesticide in the US, and require a deactivation agent before disposal. Other wastes such as liquids from photo developing often contain high levels of metals like silver if there is no silver recovery system in place. Chemical and pharmaceutical residues may (as noted) cause problems with the proper working of a biological sewage treatment plant, and some of these residues can survive the treatment process and are being identified in water supplies of industrial nations.

5. Field of application / source identification

The attempt to identify healthcare establishments is a good exercise, but the classification by size of source (Large, Medium and Small) is subjective and of little use. Focus should be on the wastes generated from whatever source. While "home-based healthcare" is listed as a small institution, it is virtually unrecognised and un-regulated in all countries even though it is one of the fastest growing segments of the healthcare delivery system. In the United States alone it is estimated that diabetics administering their own care dispose of more than on billion syringes each year from their homes. This is entirely unregulated. If the focus is on point of generation, rather than on the type of waste generated it will be more difficult to identify, track and eventually regulate. In addition, identifying large sources versus small sources lends a false sense of how to prioritise. In some cases it might be much more important to attend to small generators first, both because you can often fix a problem more simply, and because their current practices might actually pose a greater risk to the public health because of the decentralised nature of their waste disposal.

6. Waste identification and classification.

The classification of wastes was addressed earlier in this paper. An additional concern with these groupings is with A and [A]. If one looks at the overall composition of a mixed waste stream from a health care facility, much of it will be similar to general household and municipal waste, in fact more than 85%, but this is too loose a definition, especially with much direct healthcare shifting to the home. In addition, in western "developed" nations many of the "patients" who we might consider most ill, and who are at least publicly perceived of as "infectious" are receiving care at home, including dialysis, transfusions, IV administered medications, injections, wound care, etc. People who are HIV positive, diabetic, infected with hepatitis, are often cared for at home. All of this renders the expression under "A" not very useful.

As to category [A], "blood and body fluid waste (materials contaminated with blood or other body fluids)" is a rather general classification, and mixes the risk potentially associated with liquid blood and body fluids (at minimum dripping wet) and materials stained with or containing dried fluids, which pose little or no risk and can be included in the general waste category as previously constructed in this paper.

Under "C," Infectious waste is awkwadly defined as "waste from defined diseases." First waste does not come from a disease. Waste is generated when some material becomes potentially contaminated with an agent known to be potentially infectious. While, as noted, a sharp could be infectious, it is not relevant from a waste management perspective, as all sharps should be handled as if they were potentially infectious since, by their nature, they pose the greatest (and only documented) risk to the transmittal of disease from healthcare waste.

The fact sheets, if re-worked, may be of value as an appendix, but should be removed from the text of the guidelines. Some of the major issues with the fact sheets include:

A1: Blood and body fluid wastes

More description is necessary. Is the contamination such that the blood or fluid is "flowable" or merely staining the material. This will lead to different management choices. Waste management guidance calls for incineration in a household waste incineration plant as "proper management." If the concern of these guidelines is truly about safeguarding public health then the constant references to waste incineration should be deleted. Mass incineration of household wastes, just as with clinical waste, is problematic at best and creates a number of human and environmental health problems that are clearly and fully documented in the literature.

B1: Human anatomical waste

Waste management guidance should identify the use of crematoria and burial as being the best options and site guidelines for proper operation or management of these options. Care should be made to honour site specific cultural and religious practices and beliefs.

B2: Waste posing the risk of injury (sharps)

Better description is needed again. It should be noted that all wastes pose the risk of injury. The exemptions and special provisions need to accommodate mixed wastes. Many times sharps are contaminated by chemicals. How should sharps wastes from chemotherapy or the pharmacy be treated? In addition, if all broken glassware is to be treated as sharps, how will the wastes from a broken mercury thermometer or blood pressure cuff be treated, as a sharp or as a hazardous waste. There is a need for being able to isolate and manage these separate but related waste streams.

7. Applicable state of the art management and treatment and disposal technologies

If paragraph 34 is to be taken as a guiding principle then much of this section needs to be changed to reflect how one achieves the use of the "best mechanism for improvement in environmental performance" and "environmentally sound ... treatment and disposal."

35. The promotion of ISO 14000 standards is a positive step, but two considerations need to be addressed. The first is "who keeps score?" and the second is how this will affect the operation of small facilities both in urban and rural settings.

36. The promotion of waste audits of tools in the management process is essential not just in characterising the waste but in setting a baseline for quantities and management practices, so that progress can be somehow measured and monitored. In defining waste audits and what they can do it is essential that a matrix be established to base the measurement on, incorporating such variables as pounds per day, census, and number and types of procedures. Waste audits are outlined in McRae and Shaner (Guidebook, 1996, AHA). Audits should be an internalised management process. Waste management companies seldom have the expertise or incentive to perform audits at clinical facilities.

37. The box in this section purports to not exhibit any "preference" but it classification of technologies by "pre-treatment" and "treatment" categories does present a preference or evaluation, assuming that treatment is needed after "pre-treatment." Currently classified as "pre-treatment," microwave, autoclave, chemical disinfection, and thermal destruction are all certified treatment echnologies. The incineration technologies (the only "treatment" technologies listed) are all problematic, despite the past extensive use of these technologies. If selection of the safest, most environmental technologies which represent the "best practices" in the field is the goal of these guidelines, then many of the methods indicated under "treatment" in this table would be deleted.

This section is greatly overburdened and as a result disorganised mixing the broach category of management with the specific topics and issues related to treatment and disposal. Issues with treatment and disposal should be consolidated under Section 8.

Waste management guidelines should be based on a strict segregation protocol. Establishing that protocol should be the key and first issue covered in this section. Issues of "avoidance/prevention" should be addressed under each type of waste, not generically. An additional section should be added to address issues that deal with manufacturer responsibility and the role of purchasing decisions in waste reduction and pollution prevention.

7.1 Avoidance / Prevention

This is a key provision of the Basel Convention, and should be the overall guiding principle of this set of guidelines. While there are numerous options for healthcare purchasing to reduce the impact of operations, they should not be mixed.

A rich set of resources is available from:

The Sustainable Hospital Project at the University of Massachusetts/Lowell in the United States. Website: http://www.uml.edu/centers/LCSP/hospitals/

The United States Environmental Protection Agency - Region V, Website: http://www.epa.gov/grtlakes/seahome/mercury/src/title.htm

University of Missouri / Lincoln University, United States Pollution Solutions - Health Care Facilities, Website: http://www.orion.org/~owm/health.htm

There should also be a level of prioritisation for steps that facilities should take. Properly managing solvents, eliminating mercury containing technology and installing a silver recovery system in radiology should take precedence over recycling newspapers and replacing disposable cutlery. Recommendations and options should be organised around what category of waste they address, and what priority they should be organised in. In many cases the best results in facility cost savings will follow the most important steps in pollution prevention.

In the case of suggestions such as replacing disposable items, care should be taken in evaluating the best and most environmentally friendly alternative, as reusable items require washing and disinfection or sterilisation. While in most cases the balance can be tipped to favour reusable and durable items, there is a cost and it needs to be made apparent.

44. Packaging

Reducing packaging waste through purchasing practices and addressing these issues with manufacturers is an important aspect of a total approach to clinical waste management. However, for these guidelines this discussion should be relegated to the appendix. The one area relevant to this discussion that should be up front is the problem associated with materials that are hazardous (e.g. solvents, mercury) or become hazardous in some treatments (e.g. PVC plastics in incineration; waste bags and containers with heavy metals in the colouring - cadmium). These issues can be addressed when speaking to segregation, and are urgent issues to prioritise, unlike some volume reduction initiatives.

7.1.2. Kitchen and canteen waste

Composting is a viable and proven method for diverting waste from food services in urban and rural hospitals as well as large and small. Given the high quantity of organic wastes in many countries, tying into a municipal composting infrastructure is a viable option that should be promoted.

7.1.3. Laboratory waste and chemical residues

Solvents and fixatives used in labs can often be captured and refined so that they are completely viable to use again through readily available technology. There are also product substitutes availablefor substances such as xylene which should be explored. Formalin can be filtered and reused. While these processes require an initial investment and trained staff, with the high cost of these chemicals and the dangers related to disposal, the initial investment can quickly be recouped.

A new section should be added for radiology discussing the management of the developing solutions for longer life, and neutralisation of the solutions prior to disposal. Emphasis should also be placed on installing silver recovery equipment in the developing process, and the possibility of recycling of x-ray film.

7.2 In-house collection, segregation (including labelling, handling)

50. Colour coded bags - while uniform colour coding is desirable, the WHO system as detailed in Table 3 will face many obstacles as there are well established colour coding schemes in other countries which will be hard to change. In the U.S. "Red bag" waste is general infectious waste including pathological and anatomical wastes. Yellow bags are used to designate cytotoxic wastes. All other waste is in black or clear bags. However in many parts of the world, general infectious waste is in yellow bags. If a specific proposal for colour coding is proposed, then a transition plan to bring countries into alignment should also be proposed. Otherwise the WHO system should be presented as a model for countries without systems, and information should be collected on the different national systems in place.

51. Containers - should be selectively and strategically placed. Too many containers create confusion. If receptacles for collection of general infectious waste are in every room and too convenient they will fill up with all waste. This has been proven in a number of settings. Key containers should be in position any place certain wastes are generated. These include sharps containers, containers for cytotoxic waste, and other wastes produced in labs which are hazardous in nature. Containers for general infectious waste however should be strategically located in central locations with a lid and clearly marked so that unnecessary wastes will not be deposited in them. Containers for different wastes should not be in proximity to one another, as it increased the likelihood of mistakes and mixing of wastes.

53. If any material, including waste containers and bags, is potentially going to be incinerated then they should definitely not be made out of halogenated plastics. In addition, attention should be paid to the make up of the dyes that colour containers as cadmium is frequently used in red sharps containers and red bags.

Table 3. WHO Recommendation colour coding for bioclinical and healthcare waste: Footnote 2 indicates that "Sharps containers may be yellow if they will be burnt together with other infectious waste." Such statements continue to litter these guidelines assuming incineration as a treatment technology appropriate for most wastes. These statements should be removed.

7.5 Transport (including labelling, handling, emergency/contingency plans)

A section should be added discussing the need for protection of transport workers and handlers, including immunisations and personal protective gear.

7.5.2 Labelling

All labelling should be multi-lingual (as determined by the staff responsible for packaging and moving the waste), and sufficient attention should be paid to the possible lack of literacy among these staff, and adequate and easily identifiable additional symbols and signs should be on the packaging to ensure understanding of the hazardous nature of the contents.

7.6 Disposal

This should be a whole section in and of itself.

Table 4. This table is not useful. The indication that incineration is recommended for solid waste is not responsible, especially solid wastes in a health care waste stream, due to the all too often "mixed" nature of the wastes which can and often do contain halogenated plastics, and substances such as mercury even in the best segregated systems.

7.6.1 Treatment methods

It does not make sense for treatment to be a subset of disposal. This should be a separate section and come before disposal. Disposal methods are determined by treatment choices.

Table 5. Pyrolytic incineration: It should be additionally noted that there is a high cost of maintenance, and there are numerous problems associated with air pollution and contaminated ash.

Single Chamber incinerators: It is highly irresponsible to even consider suggesting that single chamber incinerators or a drum or brick incinerator be listed in a table that is entitled treatment options.

Wet-thermal treatment: Shredding is not a necessity in this technology and is quite problematic and should not be advanced as part of a set of viable options or best practices. The advantages of this technology is that it is more than 100 years old, most hospitals in all countries have at least one unit in a lab with technicians trained in how to use it.

7.6.1.1. Steam Sterilisation.

Autoclaving is a disinfection technology not a "sterilisation" technology. At some point in these guidelines the distinction between disinfection and sterilisation should be made. Wastes need to be disinfected or neutralised not sterilised before disposal.

Aerosols (chemical and bio) are generated during compaction, shredding and grinding operations. Such alteration of the waste should be highly discouraged prior to treatment especially because of the dangers of bio-aerosols, and only allowed as part of a treatment or predisposal method for wastes under highly controlled circumstances. Any additional movement or mechanical treatment of bioclinical wastes increases the risk associated with management of those wastes for the workers involved.

Proper autoclave operation should include monitoring of fugitive emissions and condensate.

7.6.2 Disposal methods

Incineration is a treatment method, not a disposal method. The ash residues must still be disposed of. The potentially hazardous nature of these residues makes them more difficult to deal with than the solid waste which was many times as great in volume.

7.6.2.1. Incineration

Incineration may NOT be used as a method for the treatment (and certainly not for disposal) of bioclinical and healthcare waste. Its usefulness as a treatment technology should be confined to anatomical and pathological wastes, cytotoxic wastes and some pharmaceuticals. The rest of the waste stream has adequate and safer options for treatment prior to disposal.

A WHO study of incinerators operating in different countries found that all of them were operating at substandard conditions, without adequately trained workers, and by inference were creating major health hazards by their operation. In comparison with other treatment technologies, incinerators are expensive, difficult to run, subject to breakdowns, and create major pollution problems affecting public health over a wide region.

7.6.2.2. Landfilling

The proper operation of a sanitary landfill should be discussed in the appendix. The referencing of concern about specific issues with land filling infectious wastes with no pre-treatment is so far without basis - as noted no studies have been undertaken to determine actual harm from this method if the waste material is confined to that portion which is considered infectious. This is one of the many instances where it is critical to separate out the components of the waste stream for informed discussion. The State of North Carolina (USA), Division of Waste management allows for direct land filling of untreated clinical wastes in their regulations. In fact studies have shown that general household waste can contain many more infectious agents than mixed general waste coming from hospitals.

The "best practice" discussion is not complete, and for many areas in the world, direct burial may be the best option to be considered. Criteria for this option should be pursued. Best management for health care wastes will parallel the developent of best management practices for other general wastes. Treatment options require additional handling of wastes which increases the chances for environmental pollution and worker exposure. A thorough examination of the landfill option in warranted and may be the most appropriate solution in more rural areas. We should not simply accept as in 117, that burial is not "Best Practice." In a properly engineered and secured site, it could serve a very necessary function.

Table 6. Again, single chamber burners should be eliminated.

7.7.1.1 Duties of the head of the hospital, and 7.7.1.2. Duties of the Waste Management Officer

These two sections are far too specific and prescriptive to be useful in all but a narrow range of circumstances given the variable nature of the institutions that are being discussed. These sections should a in the appendices as suggestions.

7.7.2.2. Dealing with spills

This section is too generic, and should be relegated to the appendices if retained at all. Spills are greatly varied in nature. What about a mercury spill? What about a situation where the spill is both blood and chemical? These guidelines should reference resources, not try and be a manual for management of all wastes and all situations.

8. Treatment / disposal of specific bioclinical and healthcare waste

It is unclear what this section is planning to cover. Again, these are guidelines not a manual.

9. Waste management auditing

There are some excellent resources on waste management auditing specific to health care facilities and these should be referred to rather than a separate and incomplete protocol being put forward as a guideline.

10.1 Education and Training of personnel of healthcare establishments

It is important not to get too specific (e.g. 10.1.3. "The ideal number of participants for a training course is 20-30). Training is very much a culturally determined event. It is not generic. At one hospital in Bombay, street theatre was effectively used to educate the cleaners and waste handlers in large groups. There is no ideal group or training style. There should be recommendations on a number of styles and approaches and reference to literature. Training is key to any program. There are a variety of training needs for each category of workers in a facility. Often waste training can be integrated in other training that needs to go on within a facility.

An additional section should be added on the risks associated with the ergonomics of handling, packaging and treatment of wastes. The hazards associated with the management of ash from incinerators should also be added here.

Training for any personnel responsible for operating any treatment technology should be outlined, not just landfills and incinerators. No technology will work without a well trained staff. Training should be periodic, not just one time.

"The most important contributor to safety is staff training both in the health care facility and for those operators responsible for collection, transport and handling of wastes."

BIBLIOGRAPHY for Section III

For further guidelines specific reference should be made to the following documents:

"Guidebook for Hospital Waste Reduction Planning and Program Implementation," by Glenn McRae and Hollie Shaner, R.N. (American Hospital Association, 1996)

"An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities," by Connie Leach Bisson, Glenn McRae, and Hollie Shaner, R.N. (American Hospital Association, 1993).

"AORN Position Paper on Clinical Waste: Regulated Clinical Waste Definition and Treatment: A Collaborative Document," AORN Journal, July 1993, Vol.b 58, No. 1, pp. 110-114.

"Clinical Waste Position Paper," by Rutala, Dr. William and C. Glen Mayhall, MD.,, Society for Hospital Epidemiology of America, 875 Kindgs Highway, West Deptford, NJ, 08096.

"Management of infectious waste by US hospitals," by Rutala, Dr. William, et al. JAMA. 1989: 262: 1635 - 1640.

"Becoming a Mercury Free Facility: A Priority to be Achieved by the year 2000," by Shaner, Hollie, RN.. Professional Management Publication, ASHES, American Hospital Association, 1997.

"The Case Against Mercury: Rx for Pollution Prevention," The Terrene Institute. In co-operation with the U.S. EPA, Region 5, Chicago IL. (312-886-7783).

"Managing Hospital Waste: A Guide for Health Care Facilities," Shristi, 1998, New Delhi, India. C/o 1001 Antariksh Bhawan, 22 K.G. Marg, New Delhi - 110001 email: ravig@unv.ernet.in.

"The Health Care Industry's Impact on the Environment: Strategies for Global Change," University of Vermont Teleconference, Jan. 12, 1998. Video. With Eric Chivian, MD, Jean Richardson, PhD, Ted Schettler, MD, MPH, Jan Schultz, RN, Hollie Shaner, RN, Susan Wilburn, RN, MPH. The University of Vermont, Dept. of Continuing Education, Burlington, VT 05401, USA. Http://uvmce.uvm.edu:443/profprog.htm.

Two web resources also link to important and current information on issues relevant to the evaluation of this document:

The Nightingale Institute for Health and the Environment: http://www.nihe.org

Health Care without Harm: http://www.sustain.org/hcwh

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