1. INTRODUCTION

Issues surrounding the poor management of Health-Care Waste in terms of the "Cradle" to "Grave" Principal reaches the front pages of newspapers and make headlines on the radio and television every now and then.

This simply indicates the sensitivity surrounding this waste stream and the need for the players in the industry to shape up.

It also indicates a need for the industry to be closely examined and to be tailored to meet the demands of the generators always taking into account the effect on the public and the impact on the environment.

2. DEFINITION

In order to avoid confusion and to have a common understanding of the waste stream under discussion, the following descriptions could be used.

The term Medical Waste is commonly used to identify waste which is generated through the activities of medical care and which has been in contact with blood or human body fluids, human tissue, used in the treatment of infectious and or contagious disease, sharps, pathological waste, infected animal carcasses etc.

The SABS Code 0248:1993 deals with the handling and disposal of waste materials within health-care facilities. It identifies medical waste as hazardous waste, which refers to any material or substance that, if handled improperly, has the potential to harm people, property or the environment. All human anatomical waste, blood and body fluids are potentially hazardous.

The Minimum Requirements for the Classification, Handling and Disposal of Hazardous Waste, uses the classification scheme of the International Maritime Dangerous Goods Code as published in SABS Code 0228. (p 72 WHO man)

Infectious waste is a subcategory of Class 6 (Class 6.2)

Radioactive substances is a Class 7 waste

Compressed gases e.g. aerosols are a Class 2 waste

Other wastes that are produced in the Health-care Sector are flammable substances, formulated substances, pharmaceutical substances and cytotoxic substances.

The above Minimum Requirements define hazardous waste as

Health-care waste is defined as the total waste stream from health-care establishments, research facilities and laboratories. In addition, health-care activities in minor or scattered sources, including health-care provided at home may also generate health-care waste.

75-90% of the waste of health-care providers is general waste, which is comparable to domestic waste.

The remaining 10% to 25 % are hazardous health-care wastes, which may create a variety of health risks.

The W H O has identified categories of healthcare waste and prescribes the correct disposal method for each of the categories.

The type of waste we need to focus on in terms of the latter, is the following hazardous healthcare wastes, for the reason that the unsafe disposal thereof could have detrimental effects for people who might come in contact with the waste as well as for the environment:

• Infectious waste
• Pathological waste
• Sharps
• Pharmaceutical waste
• Chemical waste
• Heavy metals
• Radioactive waste
• Genotoxic waste
• Pressurised containers

Infectious waste is that waste that contains or is suspected to contain pathogens, bacteria, viruses parasites or fungi in sufficient concentrations or quantity to cause disease in susceptible hosts.

It includes any waste that is generated during diagnosis, treatment or immunisation of humans or animals; in research pertaining to this; in the manufacturing and testing of biological agents – including blood, blood products and contaminated blood products, cultures, pathological wastes, sharps, human and anatomical wastes and isolation wastes.

Pathological or anatomical waste is waste that consists of tissues, organs, body parts, foetuses and animal carcasses.

Blood and body fluids, teeth, hair and nail clippings are excluded from this category.

Sharps are items that could by their nature cause cuts and puncture wounds.

Included in this category are needles, hypodermic needles, scalpels and other bladed, broken glass and ampoules.

Pharmaceutical waste includes expired, unused, spilt, and contaminated pharmaceutical products, drugs, vaccines and sera that are no longer needed

Although this waste type may contain live vaccines, which must be treated as infectious, almost all pharmaceuticals must be treated as a hazardous chemical waste.

Chemical hazardous waste includes any waste that has one or more of the following characteristics:

• Corrosivity, pH <6 and pH >12
• Reactivity, (explosive, reacts with water, air or other wastes)
• Flammability, Flash Point <61^oC
• Toxicity (Poisonous)

Heavy metals include s mercury from broken thermometers, blood pressure guages and used batteries.

Any substance which consists of or contains any radioactive nuclide whether natural or artificial and whose specific activity exceeds 74Bq/g (0.002uCi/g) of chemical elements and which has a total activity greater than (0.1uCi)

Genotoxic waste has mutagenic, teratogenic or carcinogenic properties.

Pressurised containers include gas cylinders, gas cartridges and aerosols

1. PRINCIPLES AND THE LAW

The doctrine of duty of care involves two components viz. a duty to take care and a breach of that duty.

These two issues are usually referred to as the "Duty issue" and the

The defendant must have had a duty to conform to a reasonable standard of care in order to found liability.

A defendant owes a duty of care to persons to whom harm may reasonably be foreseen.

The test for ascertaining the existence of a duty of care is the foresight of a reasonable man.

The foreseeability formula for the determination of a duty comprises two separate but related inquiries.

• Would a reasonable man in the same circumstances have foreseen harm, and
• Would a reasonable man have taken measures to guard against the occurrence of such foreseeable harm?
• If the answer to the second question is also in the affirmative, then the duty to take care is established.

The doctrine of the duty of care is particularly applicable to the controversial field of liability for omissions. (J.C. van der Walt, Delict, Principles and Cases, 29.)

The criterion for the determination of the existence of a duty to act positively was generally formulated in terms of reasonableness and equity. (Coetzee vs Fick) A duty arises only if the apprehended damage could be prevented by reasonably practical measures.

What relevance has this got for the generator of medical waste and the contractor who is supposed to safely handle and dispose of such waste?

A duty arises where a defendant has by prior positive conduct created a potential risk of harm to others. If a person omits to take reasonable steps to prevent the risk materialising, the duty is breached.

Where a person is in control of a potentially dangerous thing, he is under a duty to take care to prevent the risk materialising.

In terms of the "Cradle to Grave" concept, the generator of waste is responsible for the safe disposal of such waste. The onus is not discharged until he has satisfied himself of the fact that the waste had been safely disposed of.

What then should the generator do to ensure that his liability for the waste that he had disposed of ends?

The answer is simply to ensure that waste is disposed of at a facility that is intended for, and permitted by the respective authorities for the safe disposal of health-care waste.

For this reason a Closed Loop Waste Manifest System must be in place. This system tracks the waste from "Cradle to Grave". As waste changes hands from person to person it is signed over.

Once the waste is safely disposed of, the document is finally signed off and returned to the generator as proof of safe disposal. By returning the signed copy to the generator, the loop is closed and the liability of the generator is discharged. Unless a waste contractor can offer a Health-care Waste generator this service, the generator can never be sure of safe disposal and its liability is not discharged. It is therefore imperative that a health-care waste generator uses a reputable contractor who has all the systems and safeguards in place.

In terms of the "Polluter Pays" principle which goes hand in hand with the "Cradle to Grave" principal, the polluter is responsible for reparation of damages caused through the illegal disposal of his waste. As generator of waste, he is also in terms of the "Cradle to Grave" concept responsible for the actions of the contractor who handles his waste. The onus is on the generator to satisfy itself of the good intentions of a contractor and to ensure that it is issued with a manifest upon final safe disposal.

The W H O suggests the use of the "Precautionary Principal"

In terms of the "Precautionary Principal one should follow the following steps when determining a handling and disposal method where the risk is unknown:

• Assume that the risk is significant
• Plan protection measures accordingly

In terms of section 24 of the Constitution of the Republic of South Africa 108 0f 1996, everyone has the right

• To an environment that is not harmful to their health or wellbeing and
• To have the environment protected for the benefit of present and future generations through reasonable legislative and other methods that:

1. Prevent pollution and other ecological degradation,
2. Promote conservation and
3. Secure ecologically sustainable development and use of natural resources while promoting justifiable economic and social development.

Entrenches the following principles, some of which have already been discussed:

• Sustainable development involving waste avoidance or at least minimisation
• Reuse and responsible disposal,
• The application of the "Best Practicable Environmental Option,
• The principle of "Cradle to Grave"
• The "Polluter Pays" principle.

In terms of this Act no person may discard of waste or dispose of it in any manner except at a permitted disposal site or in a manner or by means of a facility or method and subject to any conditions imposed by the Minister of Water Affairs and Forestry. The Minister of Environmental Affairs and Tourism administers all other aspects of waste in terms of this Act.

In terms of regulations promulgated under Section 21 of the act certain activities were identified which may have a substantial detrimental effect on the environment. One of the activities identified is the disposal of waste in terms of section 20 of the Act.

This act deals with Group 1 hazardous substances and prescribes the method by which containers containing Group 1 hazardous substances, must be disposed of

This act prescribes various regulatory requirements for the disposal of amongst other things, hazardous chemical substances.

The act lists incineration processes as a scheduled process and consequently any person undertaking such activity is required to follow the procedures set out in terms of the Act to obtain a certificate from the Chief Air Pollution Control Officer in the Department of Environmental Affairs and Tourism.

In addition to the National laws, various provinces have introduced their own laws while local authorities have also regulated waste through the introduction of bylaws e.g. Johannesburg’s Refuse (Solid Waste) Bylaws AN1037 of 18 June 1975.

As is evident from the above, a variety of Departments and authorities through various acts, regulations, ordinances and bylaws all regulate some or other aspect of waste.

In order to overcome this problem of fragmentation in the approach to waste management as a whole, a Draft White Paper on Integrated Pollution and Waste Management was published in 1998.

The paper has as its vision the assistance of government in developing, implementing and maintaining an integrated pollution and waste management system which contributes to effective prevention, minimisation and control of pollution and waste.

It sets certain policy aims, which include:

• Promoting the management and minimisation of the impact of unavoidable waste from its generation to its final disposal.
• Ensuring the remediation of any pollution of the environment by holding the responsible parties accountable.

The draft Policy also underlines the launch and development of the National Waste Management Strategy Program as being imperative.

The strategy was completed in October 1999 and consists of 8 action plan documents.

Key issues addressed include:

• The Strategy follows the hierarchy approach internationally accepted, namely:

1. Cleaner production through waste prevention and minimisation
2. Recycling through reuse, recovery and composting
3. Treatment through physical, chemical and destruction
4. Disposal through landfilling

• Strategic objectives include:

1. Facilitating enforcement
2. Integrating the regulatory approach
3. Making use of the "Polluter Pays" principle
4. Total cost accounting

• Categorising waste into general and hazardous:

1. Hazardous waste will be classified according to the nine classes and four hazard ratings set out in the Department of Water Affairs and Forestry’s minimum requirements document.

• The principles upon which the Strategy is based:

1. accountability
2. affordability
3. cradle to grave
4. equity
5. integration
6. open information
7. polluter pays
8. waste avoidance and minimisation
9. co-operative governance
10. sustainable development
11. environmental protection and justice
12. Subsidiarity.

The proposed Integrated Pollution and Waste Management Act.

• The proposed purpose of this Act is to achieve the broad goal and objectives of the National Waste Management Strategy.

Approaching the system from "Cradle" (Generation) to "Grave" (Final Disposal) follows the logical sequence of events and allows for options to be evaluated and choices to be made chronologically in order to optimise the system from a safety, health, environmental and financial point of view.

Healthcare workers should take all necessary steps to avoid the production of waste.

This can be achieved through:

• Reduction of waste at source
• Implementing proper management and control measures
• Managing stock on a FIFO system thereby avoiding expiry of older stock

• Where ever possible, products which are recyclable should be purchased
• Reusable medical and other equipment should be sterilised using proven technology and procedures.

This is a very important aspect not only from a risk point of view but also from a cost point of view.

It is essential that the Hazardous Health-care waste be separated from the Non Hazardous Health-care waste for the following reasons:

• It is dangerous to have hazardous waste managed in the general waste stream
• High PVC content of general waste plastics is not suitable for incineration
• The cost of hazardous waste management is much higher than general waste
• The various types of hazardous wastes have very specific packaging, handling, storage and disposal instructions. Incorrect packaging could lead to injuries e.g. needle stick injuries.
• Incineration of pressurised containers could lead to explosions, which could damage the refractory of incinerators.
• Radioactive waste could lead to contamination of incinerators and equipment.

The responsibility for segregation lies with the generator and the activity should take place at or as near as possible to the source of generation.

Correct containerisation and labelling is imperative

A person responsible for the segregation of healthcare waste should ensure that

• Correct containers are available for staff so that waste can correctly be separated
• That the containers are available in the area where the waste is generated
• That health-care workers are trained in the correct use of containers
• That all containers are correctly and clearly labelled
• That segregation is continuously monitored and enforced.

The following containers must be provided for the categories listed:

All Human Anatomical Waste should be placed in a waste container that is colour-coded RED.

• Ideally, the packaging should comprise of a primary inner packaging, which must be leakproof.
• The primary packaging should then be placed into a secondary inner packaging, which should also be watertight.
• An absorbent material in sufficient quantity to absorb all the contents of the primary inner packaging should be placed in the secondary inner packaging as well.
• The inner packaging should then be placed into an outer packaging, which should be strong enough to contain the contents.
• The outer packaging should then be appropriately labelled so as to identify the contents.
• A weight limit of 15kg must be adhered to
• Lids should be secured to the bases by means of sealing non-PVC tape.
• All outer containers must be marked with the International Bio-Hazardous Symbol

All infectious non-anatomical waste must be placed in a container that is colour-coded YELLOW

• The packaging should once again comprise of an inner and an outer packaging
• The inner packaging should be a strong leak-proof plastic liner
• The outer packaging should be a rigid cardboard box or other rigid receptacle

• The outer packaging should be appropriately labelled so as to identify the contents.
• A weight limit of 15 kg must be adhered to
• Lids should be secured to the bases by means of sealing non-PVC tape.
• All outer containers must be marked with the International Bio-Hazardous Symbol

Sharps must be placed in specially designed sharps containers which are colour coded YELLOW as they do not contain Human Anatomical Waste.

• Sharps containers must be sturdy enough to resist punctures during use and transportation to disposal site.
• It should be identified as containing sharps
• Lids must be capable of being securely sealed
• A fill line should appear on the container
• Add –on could include a wall mounting bracket and handles

The containers should be located in such a way that it allows for the safe and convenient disposal of sharps.

The entire needle and syringe should be disposed of.

Recapping, separation and bending of the needle is not recommended as these are dangerous procedures

As chemical waste does not make up the bulk of Hazardous healthcare waste produced in the Healthcare sector, and is not suited for disposal by means of incineration or other disposal technologies suitable for HCW, I shall not cover this item in detail.

• Chemical waste must be segregated from other HCW and stored in compatible leak-proof containers which are appropriately labelled

Cytotoxic and Genotoxic waste and associated contaminated material (syringes, Tubing, containers vials, ampoules etc) must be packaged as follows.

• The waste must be packaged separately, e.g. one type per container
• Containers containing compatible waste that will not react must then be placed into an openhead container which should be filled with an absorbent material such as vermiculite
• The individual containers and bulk container should then be clearly labelled "CYTOTOXIC WASTE" or " GENOTOXIC WASTE"

Pharmaceutical waste should be collected in the same way as Cytotoxic waste especially when dealing with liquids.

Solid pharmaceutical waste should be double bagged and colour coded green

Pressurised containers should be returned to the manufacturers or alternatively sent to a company specialising in the safe disposal of hazardous waste.

Radioactive waste must be segregated at the point of origin into

• Inactive waste
• Low level waste
• High level waste

Low level radioactive waste should be placed into a primary container such as a thick plastic bag, which should be sealed.

The filled bag should then be placed into a suitable box, which should be sealed.

The waste may then be disposed of at a suitably licensed facility.

Healthcare waste should be handled in such a way that it poses no threat to the people involved in the management of the waste stream, the public in general and the environment.

Handling is normally necessary in order to move the waste to a place of safekeeping where it is accessible for transportation to a disposal facility.

A person in the Health-care environment should be made responsible to ensure that handling of waste is done safely and efficiently and those good housekeeping standards are maintained.

• Waste containers may only be moved once they have been properly sealed and labelled
• Waste should not be moved through patient care areas and areas that are clean.
• Trolleys or carts should be used and these should be well maintained and clean.
• Trolleys and carts should never be overloaded.
• An emergency cleanup procedure should be in place and should be followed in case of an emergency.
• Where chemical waste is handled, a Material Safety Data Sheet (MSDS) must be available to all persons handling chemical waste.
• Incompatible chemicals must not be handled together.

All staff generating and handling health-care waste must be given regular training in the correct segregation methods, the use of containers and the safe handling of the waste.

Records should be kept of the staff trained and the nature of the training conducted.

It is essential that records be kept of the following:

• The amount of waste generated per category
• The amount of waste generated per section e.g. Maternity, ICU, Renal etc
• The costs involved
• Incidents involving health-care waste.

All staff handling Healthcare waste should at all time wears appropriate PPE

Basic PPE would include:

• An overcoat or overalls or a uniform
• Closed shoes
• Leather or Rubberised gloves
• A thick apron is recommended

When dealing with chemical waste safety glasses and latex gloves should be worn in addition to the above.

Storage of health-care waste is a temporary measure between the point of generation and transportation to a disposal facility.

The storage area must be well identified and its location should be known to everybody working in the health-care facility.

A person should be made responsible for the management of the storage facility and waste in storage.

Only the designated storage are may be used for storage of waste.

Waste should be cleared from the storage area regularly on a FIFO system

The storage area must comply with the following criteria.

• The area must be large enough to contain all the waste generated in the healthcare facility in at least two days.
• The access doors to the storage are should be marked with the Bio-Hazardous symbol and a sign should indicate that access is restricted to authorised personnel only.
• The area must be totally enclosed and lockable
• Adequate ventilation and lighting is essential
• All waste must be stored in specially demarcated areas until it is removed for disposal.
• Separate storage areas must be provided for infectious, chemical, and radioactive wastes.
• The are should be maintained in a clean and tidy condition and should be disinfected on a daily basis.
• Infectious waste especially anatomical waste must be stored in a cool place.
• Refrigeration at 4⁰ C may be required if problems are experienced with odours.
• Storage areas must be vermin, insect and rodent proof
• The area must be inaccessible for animals and birds.
• The floor must be easily cleaned, hard, impermeable and well drained.
• Waste storage areas must be separated from supply areas and food preparation areas.
• There must be a water supply
• Equipment to adequately deal with spills must be available.
• Easy access for waste collection vehicles is essential taking into account overhead pipes etc.
• The area should allow for easy movement of trolleys and carts used to convey the waste to and from the storage area.

Unless action is take to improve on the standards currently in place, more and more contractors will attempt to enter this market. Chances are that they will be just one of the many fly-by-night companies having no regard for the well-being of the communities they operate in. These companies use normal unmarked open or cargo vehicles to transport their waste today and transport foodstuffs for another client tomorrow. They don’t have a clue what risks are involved in the handling and transportation of the waste. They take no steps to safeguard their staff and have no emergency plans in place.

These contractors don’t have guaranteed access to any disposal facilities and are in constant search for someone to dispose of their waste at the cheapest rate. These contractors do not use a closed loop manifest system simply because they are unable to prove to their clients that the waste had been safely disposed of.

It is this scenario that leads to the poor image of the industry and ultimately the state it is in today.