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Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns

Management guide

Published in 2016

Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns i

Copyright This document was made possible through support providedby the US Agency for International Development (USAID) underthe Supply Chain Management System (SCMS) contract numberGPO-I-00-05-00032-00. The opinions expressed herein are thoseof the author(s) and do not necessarily reflect the views of USAID or the US government.

This document may be reproduced if credit is given to SCMS.

Published in 2016

For more information, contact [email protected].

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mailto:[email protected]

ii Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns

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Table of contents Acronyms................................................................................................... iv How to use the guide................................................................................. v

Introduction............................................................................................ v Purpose ................................................................................................. v

Waste management process ..................................................................2 1. Identify and quarantine......................................................................3 2. Inventory............................................................................................3 3. Identify waste management service(s)/contractor(s)........................ 3 4. Confer with service(s)/contractor(s) ..................................................3 5. Activity environmental authorization..................................................4

Environmental Mitigation and Monitoring Plan ..............................4 Implementation Plan ......................................................................5

6. Collection and transport ...................................................................5 On-site collection ...........................................................................5

7. Treatment and disposal ....................................................................8 Factors in selecting treatment technology.....................................8 Technologies/processes of waste treatment ................................8

8. Waste disposal systems.................................................................. 11 Sanitary landfill/engineered landfill .............................................. 11 Government-authorized landfill ...................................................12 Open, uncontrolled, non-engineered landfill ...............................12 Smelting........................................................................................12

Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns iii

Waste stream procedures ......................................................................16 Chemical waste management ............................................................16 Identification and segregation ....................................................16 Packaging (Containerization) ......................................................16 Recommended treatment/disposal options.................................17

Unusable MC kits ...............................................................................18 Characterization of the MC kits ....................................................18 Waste streams, packaging, and treatment/disposal options......22

Single-use instruments........................................................................23 Collection .....................................................................................23 Recording ....................................................................................24

Recommended disposal options.........................................................25 Method 1. Recycling ....................................................................26 Method 2. Sharps pit/concrete vault............................................28 Method 3. Controlled dump/engineered landfill .........................30

References................................................................................................33 Annex 1. Unusable/expired chemicals and pharmaceutical

products: pre-disposal list .........................................................................34

chemicals and pharmaceutical products after segregation and

repackaging for disposal...........................................................................35

Annex 2. Example of detailed inventory of unusable/expired

Annex 3. Consignment/chain-of-custody form ........................................36 Annex 4. Info to submit for metals recycling facility.................................37 Annex 5. Examples of UN certified containers.........................................41 Contributors .............................................................................................46

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Acronyms HI Health intervention

MC kit Male circumcision kit

PPE Personal protective equipment

USAID United States Agency for International Development

VMMC Voluntary medical male circumcision

WHO World Health Organization

Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns iv

Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns v

How to use the guide Introduction Some products distributed in a voluntary medical malecircumcision (VMMC) campaign, or other health interventions(HI), may occasionally be damaged or held past their expirationdate. As a result, they are no longer usable. Unusable medicalproducts (including expired/damaged: male circumcision (MC)kits, chemical/pharmaceutical, and single-use instruments)may also result from periodic “de-junking,” or routine inventoryclearance processes.

PurposeThis guide describes recommended procedures for disposing ofunusable medicals products. Procedures are in accordance withWorld Health Organization (WHO) good distribution practices(GDP 1), USG Title 22 of the Code of Federal RegulationsPart 216, commonly known as 22 CFR 216 or “Reg 216.,” andenvironmental and public health best practices.

This guide includes all processes for addressing unusablemedical products used in VMMC or other HI campaigns,including:

• Preparation and authorization • Identification and segregation • Packaging (containerization) • Recommended treatment/disposal options

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Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns 1

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Waste management process

1. Identify and quarantine

2. Inventory

3. Identify waste managementservice(s)/contractor(s)

4. Confer with service(s)/contractor(s)

5. Activity environmental authorization

6. Collection and transport

7. Treatment and disposal

8. Waste disposal systems

2

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Waste management process

Each of the following steps outlines the proper processes in preparing waste for treatment and disposal. Preparing waste for disposal is a multi-step process, as shown in Figure 1.

Wastedisposalsystems

Identifyand

quarantine Inventory

Identifywaste

managementservices

Confer with

services

Activityenvironmental authorization

Collection and

transport

Treatment and disposal

Waste disposalsystems

Figure 1



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1. Identify and quarantine Identify unusable medical products and ensure that:

1. The location where this waste is held is access-controlled and secure, and 2. The stock is clearly marked as waste and not suitable for human

consumption or veterinary use.

2. Inventory Prepare a complete inventory of unusable stock and/or expired medical products that have been set aside for disposal management. This initial list quantifies the identified waste in its original packaging. The list can then be submitted to:

1. The campaign’s management team for financial quantification, authorization, and approval—and also for investigation into the reasons for unusable and expired stock so that this can be minimized in the future

2. A suitably certified waste disposal service or contractor for acceptance and quotes

3. The country’s regulatory authority for approval

For a sample pre-disposal list, see Annex 1.

3. Identify waste managementservice(s)/contractor(s)

Identify a suitably certified waste transport, treatment, and disposal service provider(s) or contractor(s) who are equipped and meet US EPA and EU environmental protection requirements for the transport, treatment, and disposal of waste. If such a service(s) or contractor(s) are not available in country, one will need to be sought in a nearby country. Basel Convention rules will need be observed in consultation with the country’s regulatory authority for transboundary movement of hazardous waste.

4. Confer with service(s)/

contractor(s)

Confer with the selected and approved waste disposal service provider(s) or contractor(s) about their requirements for receiving the waste, i.e., how they prefer inventory to be taken, what can be pooled together to minimize volume, and what kind of repackaging is required, where warranted.

4 Disposal of unusable medical products in voluntary medical male circumcision and health intervention campaigns

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5. Activity environmental

authorization

Now that the waste has been described and quantified, the waste disposal service contractor identified, and next steps discussed, required human and financial resources will be known. This information can then be submitted to campaign management for authorization and approval, and the country’s regulatory authority can be notified accordingly.

USAID Implementing Partners are required to submit a single document for both USAID Mission and USAID Washington approval and monitoring. This document includes the following components:

• Environmental Monitoring and Evaluation Plan • Implementation Plan • Identification of subcontractors and vendors who will carry out the activity • Supporting documentation, including licenses, certifications, etc. as

needed

Environmental Mitigation and Monitoring Plan To ensure a project’s environmental requirements are observed, an EMMP has three major objectives:

• Specify the actions required to meet the environmental requirements of 22 CFR 216 for the project.

• Outline indicators or criteria that will be used to monitor whether the mitigation actions are effective and sufficient.

• Identify the parties responsible for each action and the schedule for execution.

• The EMMP template can be found at www.usaidgems.org/.../Basic%20 EMMP%20Template%20Aug2011.doc.

http:www.usaidgems.org


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Implementation Plan An Implementation Plan identifies the critical steps in developing and starting a project. It is a guide or map that helps program staff be proactive rather than reactive in developing their program and identifying any challenges along the way. The Implementation Plan consists of the following key steps.

• Scope of work • Waste inventory list • Project work plan • Disposal verifications • Operating licenses • Monitoring plan • Health and safety requirements

The waste generator is ultimately responsible for ensuring that their waste is properly treated and/or disposed of in an approved and fully compliant treatment facility.

6. Collection and transport Proper collection and transport is an important step in waste management. It requires the direct involvement of the program core staff (i.e., maintenance services, housekeeping services, and motor pool service staff, as well as the health care staff).

Waste collection practices should be designed to achieve efficient movement of waste from points of generation to storage and/or treatment while minimizing the risk to staff and the public.

On-site collection Waste should not accumulate at the point of generation. A program should establish routine waste collection and transportation system as part of the program’s waste management plan.

The following are recommendations that should be followed by health care staff directly involved in waste handling and collection:

• Waste should be collected frequently and transported to the designated storage site or waste transfer station.

• No bag or container should be removed unless it is closed off correctly (and not overfilled), correctly labeled with the point of generation identified, as well as the contents.

• Bags or containers should be replaced immediately with new ones of the same type. Replacement packaging/container stock should be readily available at all locations where waste is produced.


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On-site transport Transportation of waste within the facility may involve different methods, depending on the nature of the waste. Workers transporting the waste should be issued appropriate personal protective equipment (PPE), which could include heavy-duty gloves, coveralls, and thick-soled, steel-tipped safety boots/shoes, and should be suitably trained in how to use their PPE.

Off-site transportation The waste generator is responsible for the safe packaging and correct labeling of waste to be transported off-site for treatment and disposal. Packaging and labeling should comply with the national regulation governing the transport of special wastes and/or international requirements and must present no danger to the public during transportation. Likewise, the waste generator is ultimately responsible for ensuring that their waste is properly treated and/or disposed of in an approved and fully compliant treatment facility.

Transboundary transportation: Hazardous waste, including unusable medical products and special waste, frequently must be transported to another country for treatment and disposal due to lack of appropriate and compliant facilities in the home country. This is permissible, provided the receiving country has such compliant facilities to deal with the waste in question and there is documentation to demonstrate that the receiving country is willing to receive it. For more information and guidance, refer to the Basel Convention: http://www.basel.int/Portals/4/Basel%20 Convention/docs/text/BaselConventionText-e.pdf

Requirements for packaging and labeling for off-site collection: Waste should be packaged in correctly sealed bags or containers (see Annex: 5) so that waste categories can be visually identified and to prevent spillage during handling and transportation. Bags or containers should be sufficiently robust to hold their contents safely (e.g., puncture-proof for sharps, resistant to aggressive chemicals, etc.) and to endure normal conditions of handling and transportation, such as vibration or changes in temperature, humidity, or atmospheric pressure.

Requirements for off-site collection vehicles: Collection vehicles used to transport waste should not be used for other materials that could be seriously affected by contamination, such as food, livestock, people, etc. The vehicle should have an enclosed leak-proof body, separate from the cab where the driver and/or load assistant sit, that can be locked to secure the waste. Waste can be loaded directly into a specially designed vehicle, but it is safer first to place the waste in the appropriate container and then to load those into the vehicle.

http://www.basel.int/Portals/4/Basel%20


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All waste should be bagged in appropriate colored-coded bags or other special containers when transported. Each package should be marked or coded for easy identification. Containers should be leak-proof and fitted with self-sealing lids, where applicable, to prevent spillage. The design of the collection vehicle should conform to the following:

• The body of the vehicle should be of a size commensurate with the design of the vehicle and the waste that will be carried in whichever type of packaging.

• The vehicle should be completely enclosed and secured (open-bed trucks are not allowed), with the driver’s seat separated from the waste/ goods compartment to prevent contact with waste in a collision/accident.

• A suitable system should be in place for securing the load during transport to prevent toppling and subsequent breakages or spills.

• The vehicle should be easy to clean and the internal surface of the body should be smooth enough for steam cleaning, with all corners/ angles rounded. The vehicle should be cleaned at the end of each working day and after any spillage.

• The vehicle should be marked with the name and address of the waste carrier as well as at least two emergency contact numbers, guaranteed to be answered when called.

• The international biohazard sign should be displayed on the vehicle or container.

• A spill kit and first aid kit should be carried on board in a separate compartment in the vehicle.

Routing: Waste should be transported through the quickest or shortest possible route, which should be planned before the trip begins. After departure from the source, every effort should be made to avoid further handling of the waste. If handling cannot be avoided, it should be pre-arranged and take place in authorized and adequately designed premises. Handling requirements may be specified in the contract established between the waste generator and the transporter. An efficient and effective collection system route should consider the following:

• Collection schedule either by route or zone • Assignment of staff responsible for the zone or area • Logical planning of the route (avoid congested areas) • Transport should be scheduled during off-peak hours wherever

reasonably practicable

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7. Treatment and disposal Factors in selecting treatment technology Factors to consider when selecting treatment technology include:

• Cost • Types and quantity of waste for treatment and disposal/capacity of

the system • Infrastructure and space requirements (investment and operational costs) • Location of the treatment site and disposal facility • Social and political acceptability • Regulatory requirements

Technologies/processes of waste treatment Types of treatment technology Treatment technologies are wide ranging and can be utilized for the following processes:

Treatment technology

Sharps Chemical General VMMC metal instruments

High temperature incineration

Low temperature incineration

Chemical disinfection

Microwave

Pit or bury

Encapsulation or inertization

Steam sterilization/ shedder

Inactivation



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Definitions of technologies

Biological processes Biological processes use an enzyme mixture with organic waste, and the resulting byproduct is put through an extruder to remove water for sewage disposal. The technology is suited for large applications and the effect of differences in temperature, pH, enzyme levels, and other variables are being investigated.

Chemical disinfection Chemical disinfection may include physical maceration (shredding and grinding) and is a suitable treatment for small amounts of clinical and related waste. This treatment usually involves the grinding and shredding of waste, which is then soaked in a liquid disinfectant. Disinfectant agents used include sodium hypochlorite solutions, formaldehyde, chlorine compounds, phenolic compounds, and lime. Chemical disinfection is most suitable in treating blood, urine, stools, and sewage. Care is needed in the use of chemicals, as they pose an occupational hazard, e.g., formaldehyde is a suspected carcinogen, and sodium hypochlorite solutions are highly corrosive.

Encapsulation Encapsulation involves filling containers with waste, adding an immobilizing material, and sealing the containers. The process uses either cubic boxes made of high-density polyethylene or metallic drums, in both cases, 75 percent filled with waste and then topped up with a medium, such as plastic foam, bituminous sand, or cement mortar. After the medium has dried, containers are sealed and disposed of in an engineered landfill site. The process is particularly appropriate for the disposal of sharps and chemical residues. The main advantage of this process is that it is very effective in reducing the risk of scavengers gaining access to the waste.

Inactivation Inactivation is the process of rendering a VMMC single-use instrument unrecognizable and unusable for its original purpose before disposal (observe health and safety best practices at all times).

Inertization Inertization involves mixing waste with cement and other substances before disposal to minimize the risk of toxic substances contained in the waste migrating into surface water or groundwater. It is especially suitable for pharmaceutical products, chemicals, and incineration ash with a high metal content (in this case, the process is also called “stabilization”).


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For inertization of pharmaceutical waste, the packaging is removed, the pharmaceuticals ground, and a mixture of water, lime, and cement added. A homogeneous mass is formed, and cubes (~1m3) or pellets are produced onsite that can then be transported to a suitable storage site. Alternatively, the homogeneous mixture can be transported in a liquid state to a landfill and poured into municipal waste. The following are typical proportions for the mixture: • 65 percent pharmaceutical waste • 15 percent lime • 15 percent cement • 5 percent water The process is relatively inexpensive and can be performed using unsophisticated equipment. Other than staff, the main requirements are a grinder or road roller to crush the pharmaceuticals, a concrete mixer, and supplies of cement, lime, and water.

Microwave This technology is primarily used for the treatment of infectious waste and typically incorporates some type of size reduction device. Waste is being shredded either before or after disinfection. In this process, waste is exposed to microwaves that raise the temperature to 95–100°C (212.0°F) for at least 30 minutes. Microorganisms are destroyed by moist heat, which irreversibly coagulates and denatures enzymes and structural proteins. The efficiency of microwave disinfection must be checked routinely through bacteriological tests. The microwave process is widely used in several countries and is becoming more popular.

Radiation technology Ionizing radiation technologies are available to treat certain infectious waste. Attention must be given to the type of radiation and to protective measures to mitigate exposing workers to the radioactive source. Consideration must also be given to the disposal of radioactive material.

Steam sterilization Using steam sterilization to render infectious waste harmless is an efficient wet thermal process. This technique has been used for many years in hospitals for sterilizing reusable medical equipment. Autoclaves come in a wide range of sizes. A typical autoclave designed for infectious waste treats about 100 kg per cycle per hour. Autoclaves used in centralized treatment facilities can handle as much as 3,000 kg per cycle.


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Thermal (incineration) High-temperature incineration with air emission control: High-temperature incineration with air emission control is a method of combusting waste in a multiple-chamber device that has mechanisms for closely monitoring and controlling the combustion parameters (temperatures between 800°C and 1200°C, air emission control equipment (APC), and capacity). This treatment method is used to treat most forms of waste except mercury and aerosols. The ash is disposed of in a Government authorized landfill or is inertized by mixing it with cement. Low-temperature incineration: Low-temperature incineration is a method of combusting waste in a single- or multiple-chamber device that controls burning at 600-800°C of solid, liquid, or gaseous combustible wastes to produce gases and residues containing little or no remaining combustible materials. The ash is disposed of in a Government authorized landfill or is inertized by mixing it with cement.

8. Waste disposal systems Sanitary landfill/engineered landfill A sanitary landfill is engineered to keep waste isolated from the environment. Appropriate engineering preparations will be completed before the site is allowed to accept waste. Trained staff must be present onsite to control operations and organize deposits and daily coverage of waste. Some essential elements for designing and operating a sanitary landfill are:

• Location should be away from populated areas, in the appropriate soil type, and adequate distance away from water sources

• Waste delivery and site vehicle access to the site and its working areas • Presence of onsite staff capable of effectively controlling daily

operations • Division of the site into manageable phases, appropriately prepared, before the landfill starts

• Adequate sealing of the base and sides of the site to minimize the movement of wastewater (leachate)

• Adequate mechanisms for leachate collection and treatment systems • Organized deposit of waste in a small area, allowing wastes to be

spread, compacted, and covered daily • Surface water collection trenches around site boundaries • Construction of final cover to minimize rainwater infiltration when each phase of the landfill is completed


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Disposing of treated, unusable medical products, inertized products, encapsulated products, and ash from incinerated products is acceptable. Even sanitary/engineered landfills are not designed to treat hazardous waste. Some types of hazardous waste can destroy the synthetic liner, making it ineffective. Leachate contaminated with hazardous waste cannot be completely cleaned at the wastewater treatment facilities to which it is sent. Leachate, contaminated by hazardous waste, can potentially enter the water table. For this reason, it is recommended to use high-temperature incineration with air emission and ash controls for hazardous waste disposal.

Government-authorized landfill A government-authorized landfill is a planned land disposal site that incorporates covering waste with sand, soil, or any other convenient materials, with no burning, but with access control, basic record-keeping, and control of waste picking/scavengers. Disposing of untreated, unusable medical products is prohibited. Disposing of medical products through inertization or encapsulation, or disposing of incinerator ash, is acceptable.

Open, uncontrolled, non-engineered landfill An open, uncontrolled, non-engineered landfill is a non-planned land disposal site that doesn’t provide environmental or public protections for the safe disposal of waste. This method does not protect the local environment and therefore should not be used by USAID Implementing Partners.

Smelting Smelting is the process of heating and melting metal for reuse.

This method of disposal should only be used for VMMC single-use

instruments (stainless steel scrap metal instruments) at a government-

licensed facility.


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Waste stream procedures

Chemical waste management

Unusable MC kits

Single-use instruments


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Waste stream procedures Each of the following sections illustrate best practices to ensure the proper requirements and measures are met and to guarantee the unusable product is safely treated and disposed. Each step is described below.

Chemical waste management Pharmaceutical waste is a subset of chemical waste, and is no longer medicine; it is hazardous waste and must be disposed of in a way that is environmentally safe and permanent. The same is true for mainstream chemical waste, such as disinfectants for surfaces or antiseptic products for skin hygiene.

In disposing of these chemicals and/or pharmaceutical products, staff members and contractors need to follow proper procedures—ensuring a process that is legally compliant, well documented, and poses minimal risk to the environment and public.

Identification and segregation A detailed inventory must be compiled to prepare a packing list in case products are repackaged to meet local or transboundary transport regulatory requirements.

Take detailed inventory It is advisable to confer with the treatment/disposal facility to determine how they would prefer the inventory to be taken before creating the final inventory list (see Annex 1 & 2).

In some cases minimization may require sorting and repackaging which can require the preparation of a second inventory list.

Packaging (Containerization) It is advisable to confer with the service provider or treatment/disposal facility to determine their waste packaging preference. (See Annex 5).

Because of varied preferences in service providers and facilities, this VMMC guide is not entirely prescriptive for packaging.

Confer with the contract treatment/disposal facility to discuss packaging requirements. It generally is preferred to keep the materials in their original packaging (typically, high-density polyethylene bottles or blister


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packs); with the labels intact and package them in containers that do not leak or break easily during transit (UN certified fiber box, UN certified lined big bag, or UN plastic container [see Annex 5]). Ensure that the shipping units stack neatly and snugly in the container so it can: 1) be easily transported, 2) be packed properly to minimize toppling, and 3) withstand the weight of its contents without falling apart.

Recommended treatment/disposal optionsNote: This section describes the main methods recommended for disposing of unusable chemical products that cannot be recycled or returned to the supplier or manufacturer. The authors recommend using a service or contractor certified to carry out the actual disposal. The only three USAID approved methods of disposal are:

• Incineration at high temperature with air pollution controls• Encapsulation• Inertization

All by products from the treatment processes must be disposed of either in a government authorized landfill or engineered landfill.

Treatment technology

High temparature incineration with APC

Encapsulation Inertization

Pharmaceuticals

Pesticides

Mercury

Cytotoxic

Laboratory reagents

Benzedrine/Aromatics amines

Radioactive


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Unusable MC kits Should a stock of unused and expired MC kits (single-use or multiple-use) require disposal, the following section provides guidance on how to proceed. It is assumed that none of these kits contains pharmaceuticals.

Characterization of the MC kitsThe tables below indicate MC kit components from all types and provide visuals for clarity and cross-reference.

Table 1. MC Metal Instruments

Product Description Qty

1 Autoclave storage box Estimated size approximately 5"w x 10"l x 2"h 1

2.a

2.b

Combination needle-holder/suture scissors

Or

Needle holder/driver

And

suture scissor

Combination needle-holder/suture scissors: total length 13–15cm, working surface approximately 20mm

Total length 12–14cm, working surface 20mm

Total length 12–15cm

1

1

1

3 Toothed tissue forcepsAka “pick-ups,” “dissection forceps:” total length 13cm, working surface 15mm serrated

1

4 Mosquito clamp straightAka “snaps,” “mosquito forceps,” “hemostatic forceps:” total length 12–14cm, working surface 20–30mm

4

5 Mosquito clamp curveAka “snaps,” “mosquito forceps,” “hemostatic forceps:” total length 12–14cm, working surface 20–30mm

1

6Forceps hemostatic cross clamp

Total length 20cm, working surface 64mm 1


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Figure 2. Visual of each metal instrument

Autoclave storage box

Needle holder/driver

Dissection dissecting scissors

Suture scissors

Toothed tissue forceps

Mosquito clamp straight

Mosquito clamp curved

Forceps hemostatic cross clamp

Hemostatic clamp


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Product Description Qty

1Multipurpose container tray

Stable plastic recycle tray to conduct procedure, minimum 700 micron virgin plastic, with compartments (compartment 1 = 13 x 26, compartment 2 = 5 x 8, compartment 3 = 5 x 5, compartment 4 = 5 x 13 and the total size of the tray is 26 x 18)

1

2O-drape

Disposable 100cm x 75cm, one side absorbable and one side impermeable; the two sides are fused together.

1

3 Scalpel blade w/handleDisposable, retractable and lockable; blade type 23; total length 11cm

1

4 Gauze, plain Gauze swabs 100 x 100mm (12-ply) 20

5Gauze, petroleum jelly infused

Paranet gauze 10cm x 10cm (1-ply) 1

6 Syringe Syringe 10ml 1

7 Injection needles One each of 21G and 23G, 1.5” 2

8Suture, 3/0 braided/absorbable

Polyglycolic acid suture, 75cm, on reverse cutting needle 26mm

2

9 Surgical gloves Sterile, one each of size 8 and 7 1/2 2

10 Apron, disposable Plastic, trash-bag quality 2

11 Alcohol swabs 1 1/4" x 2 1/2", isopropyl alcohol 70% 2

12 Surgical paper tape Micropore 12 mm, 1–3m in length 1

13 Sterile prep gloves Examination glove, large 1

Table 2. Consumables


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Figure 3. MC kit consumables pack (see Table 2)

ParanetGauze Dressing

®

AlcoholSwab

AlcoholSwab

4

1

10

1112

13

2

67

8

9

53


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Waste streams, packaging, and treatment/disposal optionsOnce the project has completed the required prequalification documentation, treatment and disposal can begin with the segregation, packaging, and treatment/disposal procedures.

Since these kits are unused and uncontaminated, they do not pose an infectious hazard risk. Also, the sharps do not pose an injury risk since they are still packaged for protection. However, these unused and expired MC kits do pose the risk of misuse or damage to the program reputation should they get into the wrong hands. The VMMC program is responsible for ensuring that this category of waste is dealt with responsibly.

Segregation streams Packaging/containerization Treatment/disposal

Reusable metal (surgical) instruments

UN certified plastic container or UN certified big bag

Donate for use provided they are pre-sterilized before use.

Disposable (single-use) metal (surgical) instruments

UN certified plastic container or UN certified big bag

Route for recycling/smelting

or

Inactivation/encapsulation/burial

Needles, sutures, syringes, multipurpose trays, soft, uncontaminated components

(O-drapes, gauze, aprons, gloves, swabs, surgical tape)

UN Certified fiber lined box or UN certified big bag

Incinerate or shred and place in a government authorized landfill or engineered landfill


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Single-use instrumentsOnce the single-use metal instruments have been decontaminated, they are rendered non-infectious (non-hazardous) scrap metal (stainless steel), and can therefore be transported in a vehicle that carries usable products, provided they are safely containerized and labeled correctly for identification purposes. They should be handled, packed, and stacked with care so that the containers storing them cannot topple and/or break during transit or become wet. All packaging/containers should remain wholly intact en route to their destination.

The following symbol must be displayed on the container during transport.

Of course, the transport vehicle and driver’s competency must be suitably certified to transport goods according to the laws of the country.

Collection All decontaminated single-use metal instruments from VMMC facilities must be returned to a central or regional location for temporary, access-controlled storage until the product can be properly transported to an appropriate recycling/smelting facility, or to a facility where it will be buried in a sharps pit/concrete vault, or to a dumpsite or landfill where scavenging / picking of the products is guaranteed not to be an issue.

All decontaminated single-use metal instruments must be appropriately and securely containerized with the correct labeling.

The receptacles/containers should not be filled past three-quarters full, or the designated fill line on the container where applicable. The container of choice should be able to withstand the weight of its contents, and be comfortably carried by a person.

The transport contractor’s driver will collect the instruments according to a schedule arranged by the VMMC site manager. The instruments will be collected with the consignment/chain-of-custody form. It is the responsibility of the VMMC site manager to check the form against the removed instruments, to record the details on the form, and to sign it accordingly. The transporter assumes responsibility for the instruments once they leave the premises.


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The driver will deliver the instruments to the regional or central location. Warehouse employees will sign the consignment form and take responsibility for the instruments until they are transported to the final facility of choice, depending on which disposal option has been selected.

Recording All waste removed from the site must be accompanied by a consignment/chain-of-custody sheet or form, which is serialized for tracking and cross-referencing. It includes the following information:

• Facility name and location (SOURCE of the waste)• Date collected (REMOVED from site)• Contents of container (DESCRIPTION of waste)• Description of container (TYPE and CAPACITY/VOLUME)• WEIGHT of container (usually in kilograms—a platform scale is

recommended for this purpose)• SIGNATURES from site manager overseeing collection and transport

company representative.

A sample consignment/chain-of-custody form is provided in Annex 3.


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Recommended disposal optionsFinal disposal of all waste is critical. Failure to develop a suitable solution for the controlled disposal of HCW can lead to public health and environmental issues that could negate the project’s Environmental Monitoring and Mitigation Plan.

Treatment/disposal of hazardous waste depends on local conditions and regulations. This section describes three internationally recognized methods for the processing/disposal of single-use metal instruments (rendered scrap metal), which are not hazardous but are vulnerable to misuse if not controlled. The project encourages the most environmentally favorable option wherever reasonably practicable.

Note: All instruments no matter the option selected MUST be decontaminated and stored appropriately before disposal.


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Method 1. RecyclingRecycling is the process of turning used materials (waste) into new products to prevent wastage of potentially useful materials, thereby:

● reducing the consumption of fresh raw materials, ● reducing energy use, ● reducing air pollution (from incineration) and water pollution (from

landfilling), and ● reducing the need for “conventional” waste disposal, thereby● resulting in lower greenhouse gas emissions as compared to virgin

production.

For single-use metal instruments, recycling is the most favorable option, in line with the Waste Hierarchy (REUSE is NOT AN OPTION HERE!).

ReduceLower the amount of waste produced

RecycleUse materials to make new products

RecoverRecover energy from waste

LandfillSafe disposal of waste to landfill

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This scrap metal has value. The focus is not on acquiring a rebate as much as it is minimizing waste going to landfill and boosting recycling activities.

It is recommended that before the MC program is even launched, a legitimate metals recycler be sourced if possible. There is certain information a metals recycler would need to compile a proposal and this has been conveniently compiled in advance for MC program managers in Annex 3. This information includes: volume, weight, and quantity of the scrap metal generated.

For example, this can be calculated as follows [using the average weight of single-use metal instruments comprising a single single-use MC kit = 160-200g (180±20 g)]:

● If the metals recycler is engaged before the launch of the MC program, then the projected number of circumcisions to be achieved can be multiplied by the average weight, i.e., 180g x 150 000 male circumcisions projected for the lifecycle of the program = 27 metric tonnes, OR

● If the metals recycler is engaged during or near the end of the MC program, the number of circumcisions achieved to date can be multiplied by the average weight, i.e., 180g x 50 000 male circumcisions to date = 9 metric tonnes.

Once again, refer to Annex 3 for further guidance and information.

Procedures1. Transport collects the instruments according to a schedule arranged

by the central/ regional warehouse manager, recycling/smelting facility and/or transport company/contractor, where applicable.

2. Instruments are collected with a consignment/chain-of-custody form (Annex 1). The manager checks this form against the removed instruments, records details on the form, and signs it accordingly.

3. The transport company/contractor assumes responsibility for the instruments once they leave the premises.

4. Instruments are taken to a recycling/smelting facility, where the facility’s representative signs the consignment form and then assumes final responsibility for the instruments.

5. Recycling/smelting facility supplies a Certificate of Destruction/Reprocessing confirming that the metal has been responsibly recycled.


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Method 2. Sharps pit/concrete vaultThis method is especially suitable for disposing of untreated used sharps and decontaminated single-use metal instruments. The following procedure is recommended for the safe burial of sharps and instruments through a sharps pit/concrete vault. This is an option if a recycling solution cannot be clinched. The disadvantage of this is that the single-use metal instruments will take up a lot of space and quickly exhaust the capacity of the sharps pit/concrete vault.

Construction procedures1. Dig a pit (minimum size of 1m x 1m x 1.8m), that can accommodate

sharps and instruments for an estimated period of time without reaching the ground-water level. The site must be isolated and at least 30m away from the ground-water supply sources and dwelling units.

2. Construct concrete walls and slabs of the pit. Provide slab with an opening or manhole for easy deposition of collected sharps and syringes. The manhole should be extended a few centimeters above the soil surface to overcome infiltration of surface water.

3. Deposit the collected safety boxes filled with used sharps and instruments inside the pit/concrete vault.

4. Install a security fence around the site.5. When full, fill the pit/vault with concrete to seal. Refer to Figure 4.

Handling procedures 1. Wear the required PPE including reusable utility gloves, apron,

protective shoes, and face protection.2. Remove the decontaminated, single-use metal instruments from the

secure storage area away from other health care risk waste to reduce the potential of cross-contamination, and place into a rigid plastic container/wheelie bin.

3. Carefully transport the instruments in the rigid plastic container/wheelie bin to the pit/vault.

4. Slowly pour the instruments into the pit/vault.5. Clean the rigid plastic container/wheelie bin using standard cleaning

procedures.


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Figure 4. Construction specifications

Reference: Management of Waste from Health Care Activities, WHO, 2013

1 meter

1.8 meters

Above highest flood water level

GROUND

LEVEL

1 meter

0.1 meter thick wallsreinforced with 10mmsteel bars spaced 0.4meters horizontallyand vertically


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Method 3. Controlled dump/engineered landfill As the dry, decontaminated single-use metal instruments carry no infectious risk they can actually be disposed of in a landfill site. However, in many settings, dumpsites or landfills are not access-controlled and there are waste pickers extracting recyclables from the site. The main concern of the project is that these single-use metal instruments do not make their way back into the health care system for reuse as they are only designed for single-use. In low resource settings, it is therefore a real risk dumping these single-use instruments in a land disposal site for fear that they may be recovered and resold to health care facilities at highly reduced rates. Therefore, if this route is taken, it is therefore imperative that the single-use metal instruments are damaged, mutilated, broken into half, and/or disabled (rendering them unrecognizable and unusable for their original intended use) before being released.

Methods for mutilating or deforming single-use metal instruments for landfill disposalIn order to render the single-use metal instruments (rendered scrap metal) unrecognizable and unusable for their original purpose prior to landfilling, they will need to be mutilated or deformed first (and whilst observing health and safety best practice at all times).

This can be achieved in various ways:

• Manual: On-the-go (as this scrap metal is generated) these instruments could be broken and deformed manually, by hand, or with hand tools such as a hammer or heavy duty bolt cutters (with relevant staff wearing the correct PPE at all times). Of course, if there is a large volume to deal with at one time, deforming the instruments manually could prove both labor- and time-intensive, and excessively so.


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• Small Metal-Breaking Machine: Any benchtop or small machine used to shear or bend metal (steel) could be used, and precision or neat cutting would not be a requirement. Examples include benchtop, foot stomp metal shears, or combination benders. This method would prove faster than manual, but slower than an industrial machine.

• Industrial Metal-Breaking Machine: Machines designed to mutilate or deform metal objects (e.g., prototypes or controlled/protected property) could be used to achieve fast results for large-scale application in this instance. These types of industrial machines include stamping press, crushing, shredding, or grinding machines for metal (steel), which can function hydraulically, mechanically, or pneumatically.


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Controlled dumpA controlled dump is a planned land disposal site that incorporates covering waste with sand, soil or any other convenient materials. This site: doesn’t allow for burning of waste; is access controlled; has basic record-keeping; and has measures in place for waste picking/scavengers.

Engineered landfillAn engineered landfill is a land disposal site that has defined operational and technical controls to protect the environment and the surrounding community. This type of land disposal ensures surface water is prevented from entering the waste; extract and spreads soil to cover waste; places leachate into lagoons; spreads and compacts waste into smaller layers; and isolates waste within the confines of the area with geological measures.

Procedures1. Ensure that your single-use metal instruments have been suitably

decontaminated and packed according to protocol and that they are dry.2. Damage, disable and/or deform the instruments rendering them

unusable for their original intended use.3. Liaise with your dumpsite or landfill managers to find out how they

would like to receive the scrap metal (packaged in bags or boxes or loaded into a skip provided by them, etc.) and prepare accordingly.

4. Liaise with your dumpsite or landfill managers to arrange a suitable collection schedule with a collection frequency that fits in with your temporary storage capacity.


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References1. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011, Comprehensive guide

to steam sterilization and sterility assurance in health care facilities.

2. Management of Solid Health-care Waste at Primary Health-care Centers: A Decision-making Guide. WHO, 2005.

3. Medline Plus, http://www.nlm.nih.gov/medlineplus/mplusdictionary.html

4. PATH, “Health care waste management resources,” http://www.path.org/projects/health_care_waste_resources.php

5. Safe Management of Wastes from Health-care Activities. Annette Pruess, E. Giroult, P. Rushbrook, eds. WHO, 2013. Download in pdf from http://www.healthcarewaste.org/resources/documents/

6. South African National Standard (SANS) 10248-1:2008, Management of Healthcare Waste. Part 1: Management of Healthcare Waste from a Healthcare Facility. (https://www.sabs.co.za/webstore/standards/product.php?id=14016220)

7. The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, http://www.basel.int/

8. The Stockholm Convention on Persistent Organic Pollutants, http://chm.pops.int/Convention/tabid/54/language/en-US/Default.aspx#convtext/

9. WHO, “Proposal for Revision of WHO Good Distribution Practices for Pharmaceutical Products,” 2008. Expert Committee on Specifications for Pharmaceutical Preparations, http://www.who.int/medicines/services/expertcommittees/pharmprep/GDP_counterfeits_QAS08_252_11012008.pdf

10. WHO, “Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies, WHO/EDM/PAR/99.2,” 2009, http://www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf


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NEXES Annex 1. Unusable/expired chemicals and pharmaceutical products: pre-disposal list

Product description Include product name, manufacturer and

Stavudine, Medline Plus INC, SCMS no. 123-54-444

Strength 30mg capsules

Presentation Bottles of 500

No. of units 223

Amount (cubic meters) 2

Waste classification* P

Physical nature** S

Reason for disposal*** E

Donor US government (USG)

Local currency 12,000.00

Cost (USD) $120.00

Tracking/container no. 1,223

Disposal method (completed by HCWM advisor)

High-temperature incineration

Note Product collected from HC in northern region of the country

* C = chemical; P = pharmaceutical; O = other

** S = solid; L = liquid; P = powder; G = gas cylinder; SL = sludge

*** D = damaged; E = expired; O = obsolete; F = falsified


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NEXESAnnex 2. Example of detailed inventory of unusable/expired chemicals and pharmaceutical products after segregation and repackaging for disposal

Contents of container e.g., Codorol tubs of 1,000 tabs

No. of containers 1

Packaging type* C

Qty of items in container 32

Total weight of container (kg) 23.34

Waste classification** P

Physical nature*** S

Disposal method Waste immoblization: inertization or incineration

Donor source USAID/USG

Funding source/code xxx

NotesEach Codorol tab contains: paracetamol 500mg; codeine phosphate 8mg; sodium metabisulphite 0.08% m/m

* C = cardboard box; RP = red plastic bag; WP = white plastic bag; RSS = red specibin small 5litre; RSL = red specibin large 25litre

** C = chemicals; P = pharmaceuticals; S = special (single-use instruments); O = other

*** S = solid; L = liquid; G = gas cylinder; M = mixed product


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Chain-of-custody record for dry, decontaminated, single-use metal instruments (SCRAP METAL)

Serial no.:

Final destination (name and address) Transport company (name and address)

Product description

No. of Boxes (if relevant)

Total Weight (of Scrap Metal listed)

Source/location representative’s signature

Witness of destruction signature

Date of destruction

e.g., Scrap metal instruments

e.g., 3 x 20 litre cardboard box

e.g., 54,6 kg e.g., VMMC Site Manager signs here

e.g., Recycling Facility Operator signs here

e.g., Date this metal was smelted recorded here

Signature of point of delivery Print name and date

Signature of transport company representative Print name and date

Important: First consult with government procurement officials regarding the correct form.


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NEXESAnnex 4. Info to submit for metals recycling facilityDisposable metal instruments informationInformation for the prospective metals recycling company

BackgroundA number of voluntary medical male circumcision (VMMC) programs are being rolled out in several sub-Saharan African countries, especially those most affected by the HIV/AIDS pandemic. These male circumcision (MC) programs and campaigns have a number of implementing partners involved and are carefully planned, executed, and regulated, with every aspect aligned with international standards and best practices.

The MC kits used for male circumcision are either reusable or single-use, the distinction relating specifically to the surgical, metal instruments. The single-use metal instruments may be made of a lower quality stainless steel, which makes them unsuitable for re-sterilization and re-use. They are ONLY designed for single-use.

After use they are decontaminated and stored. They are therefore rendered non-infectious and are no longer considered hazardous waste. However, they do present a risk of misuse should they land in the wrong hands, which could concomitantly threaten the program’s reputation. The generator of waste remains responsible for that waste along its journey from cradle-to-grave, and for this reason, responsible recycling or disposal of this waste must be ensured by all parties involved, adhering to country specific laws and regulations.

In alignment with the waste hierarchy, the most environmentally favorable option would be to send these instruments for smelting/metals recycling rather than disposal.

The single-use metal instruments within the single-use MC kit are shown on the next page and detailed in the table that follows.


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Single-use MC kit

1 2 643 5

1 2 643 5

1 x Needle holder

1 x Suture scissors

1 x Metal tissue forceps

1 x Mosquito forceps curved

1 x Mosquito forceps straight

1 x Hemostatic forceps


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Composition of single-use metal instrumentsThe composition for both types of metal instruments used is as follows:

Both single-use metal instrument suppliers use stainless steel (grade 410 and 420) instruments for their kits.

• Iron (Fe) makes up the largest contribution of the metal composition with 85-86%

• Chromium (Cr) represents the second largest contribution with 12-13% of the metal composition

• The following elements contribute only trace amounts to the overall composition of the instruments (0.45% -


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Approximate weight of single-use metal instrumentsThe FOUR single-use metal instruments that are used for one MC (comprising one single-use MC kit as per the photograph above, weigh, in total, approximately:

• 160-200g (180±20 g)

Questions for the metals recycling company

1 In which sub-Saharan African countries do you operate?

2 Do you provide free collection or must the generator arrange transport of their metal waste to your recycling facility?

3 Do you provide free placement of a skip for stockpiling of this metal waste?

4 Which regions do you collect from?

5 How do you prefer to receive this waste?

6 Are there any stipulations on your part with regards to the way it is stored until such time that you can receive it? These decontaminated single-use metal instruments are currently stored in reusable plastic boxes—does this complicate collection?

7 Any other stipulations the program should be aware of?

8 What are your rebate rates?

9 If you are not locally available to the MC program in question, do you have metals recycling dealers who are and can you refer us?

10 How will you guarantee that once this metal waste is handed over to you, it will not fall into the wrong hands? Any paperwork in place to put the program at ease?

11 Do you provide a Destruction Certificate upon completion of processing of this waste?

12 Please provide contact details for the key contact person the program can communicate with for all future queries.


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NEXESAnnex 5. Examples of UN certified containersAll packaging must be UN CERTIFIED (with UN labeling) TO TRANSPORT HAZMAT/HAZADROUS WASTE.

UN Specification Marking GuideExample of a UN specification marking:

The ultimate goal when packing dangerous goods is to pack it in a manner to prevent the escape of the material contained within it. This is accomplished by utilizing UN approved packaging. International agreements for the carriage of dangerous goods require packaging to be of a design-type, certified by a national competent authority. This involves testing the packaging against the appropriate UN specifications to ensure its suitability for the carriage of certain dangerous goods.

Such packaging is often referred to as “type-approved,” “UN Approved,” or “UN certified” “POP” (performance oriented) and is marked in a particular way, prefixed by the UN Packaging symbol and followed by alpha numeric codes. It is not only important to select the correct UN approved packaging, but it is also important to use it as it was tested and carefully follow the closure information provided by the manufacturer.

UN code for fiberboard box (4G) and variable

inner-container material and configuration (V)

Solids or inner packagings

State/country authorizing mark

United Nations packaging symbol

Packing group tested and max. gross mass (kg)

Last two digits of the year of manufacture

Manufacturer certifying package

4GV/X13/S/08/USA/+AQ2121


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Part of choosing the right fiberboard box or other type of outer packaging revolves around the following information:

• The UN number or proper shipping name of the dangerous goods being shipped

• The amount of dangerous goods being shipped• The physical dimensions and weight of the inner packaging that the

substance will be shipped in

UN packaging symbol: the symbol signifies that a package has been tested and has passed UN packaging performance tests. The symbol should not be applied to a package for any other purpose, especially if that package has not been tested.

UN codes for type of packaging and material of construction: There are several different types of packaging along with several different materials in which they are constructed from. The following gives a brief overview of each:

Types of packaging1 – Drums/pails2 – Barrels3 – Jerricans

4 – Box5 – Bag6 – Composite packaging

Materials of constructionA – SteelB – AluminumC – Natural woodD – PlywoodF – Reconstituted woodG – FiberboardH – Plastic material

L – TextileM – Paper, multi-wallN – Metal (other than steel or aluminum)P – Glass, porcelain, or stoneware (not used in these regulations)


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Packing group: Packing group assignments determine the degree of danger of a dangerous goods item, so the following outlines how to determine if your dangerous goods can go inside of a UN specification package:

X – for packing groups I = great danger

Y – for packing groups II = medium danger

Z – for packing group III = minor danger

Maximum gross weight: For outer packaging intended for solids, this marking will indicate the maximum gross mass (weight) in kilograms at which the package has been tested for.

Year of manufacture: This represents the last two digits of the year in which the package was manufactured.

Origin of manufacture: This represents the country where the package was constructed.

Manufacturer code: The last part of the UN specification marking sequence represents the code for the manufacturing plant or testing facility for the package.


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Types and specificationBig bag or FIBC bag Specifications:

• UN classification: 13H4 (coated fabric with liner) with UN certification labeling

Hazmat cubic yard box Specifications:

• Completely incinerable• Includes box, liner, tie,

and nails to secure box to wooden pallet

• UN rated for packing groups I, II and III with UN certification labeling


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Hazmat closed-head plastic drumSpecifications:

• Closed-head blue HDPE plastic drum• Blue• UN 1H1/Y


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ContributorsContributors

Scott Ackerson, MA Environmental Health Specialist

Tom Layloff, PhD Senior Environmental Health Advisor

Cheryl Mayo, BS Principal Capacity Development Advisor

Steve McCracken Graphic Artist Consultant

Nicole Pahl, BSc Environmental Health Advisor

Ana de Paiva, MA Communication Specialist

Britta Ranade, MPH, MBA Environmental Health Manager

Sara Tobin, BA Senior Communication Consultant

Alexandra Tzoumas, BS Graphic Artist Consultant

Michele Weaverling, BS Senior Communication Specialist

Annex 5. Examples of UN certified containersAnnex 4. Info to submit for metals recycling facilityAnnex 3. Consignment/chain-of-custody form Annex 2. Example of detailed inventory of unusable/expired chemicals and pharmaceutical products after segregation and repackaging for disposalAnnex 1. Unusable/expired chemicals and pharmaceutical products: pre-disposal listReferencesWaste stream procedures Chemical waste management Identification and segregation Packaging (Containerization) Recommended treatment/disposal options

Unusable MC Kits Characterization of the MC KitsWaste streams, packaging, and treatment/disposal options

Single-use instrumentsCollection Recording

Recommended disposal optionsMethod 1. RecyclingMethod 2. Sharps pit/concrete vaultMethod 3. Controlled dump/engineered landfill

Waste management process 1. Identify and quarantine2. Inventory3. Identify waste management service(s)/contractor(s)4. Confer with service(s)/contractor(s)5. Activity environmental authorizationEnvironmental Mitigation and Monitoring PlanImplementation Plan

6. Collection and transport On-site collection

7. Treatment and Disposal Factors in selecting treatment technologyTechnologies/processes of waste treatment

8. Waste Disposal SystemsSanitary landfill/engineered landfillGovernment-authorized landfill Open, uncontrolled, non-engineered landfillSmelting

How to use the guideIntroductionPurpose

Acronyms

Documents

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