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Single-use injection devices
Chapter 54
Single-use injection devices J.J.B. Pierre Blaisa, Michael Chengb a
INNOVAL Failure Analysis, Ottawa, ON, Canada, bBiomedical Engineer, Patient Safety/Education Advocate, Ottawa, ON, Canada
Introduction More than a third of all medical or dental procedures entail the injection or withdrawal of fluid. Annually and assuming single use, this corresponds to >20 billion procedures worldwide, where a syringe-like device is employed and discarded. Instrument-grade reusable glass/metal syringes, the ancestors to current “disposable” plastic-body syringes, disappeared from clinical practice during the 1970s. Since then, their plastic successors gradually improved in design and quality to the point where many such products create the illusion of suitability for multiple cycles of service. Predictably, reuse takes place and the practice is not limited to economically disadvantaged environments. Regional variations in healthcare traditions impact on problems created by syringes. Inappropriate use and reuse are more prevalent but not limited to developing countries. A good management scheme described in Chapter 49 by Cheng et al. (2019) can be applied to the planning and delivery of single use injection devices in community immunization programs.
Rationale for development of reuse prevention features; emerging problems Morbidity from the reuse of “disposables” was the rationale for commercialization of fluid injection devices embodying features that forbade reuse. These developments took place during the late 1990s and are continuing today with the release of novel designs. The nonreusable feature is particularly attractive in the context of narcotic addiction abatement programs. Cost considerations are not always a limiting factor because of incentives provided through national, international, and benevolent agencies. As a result, injection devices with self-disabling characteristics are now distributed worldwide. Some present unfamiliar safety problems are encountered even in wealthy industrialized countries. Certain designs of syringes are unsuited for many medical procedures. Others are optimized for specialized applications. The self-disabling feature can increase patient or professional user risks in some instances. Yet, conventional Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00055-9 Copyright © 2020 Elsevier Inc. All rights reserved.
and self-disabling syringes are sometimes intermingled. Moreover, on cursory examination, many self-disabling products are not easily differentiated from conventional syringes, thus introducing new risk factors. Notwithstanding any of the above, the need for conventional syringes and specialized injection devices remains and standards have not comprehensively addressed the problems of diversity and reliability. For these reasons, continuing vigilance and reexamination of this sector must be maintained at the clinical, procurement, regulatory, and disposal levels. These issues complicate the management of morbidity caused by the usage of unsuitable or unfamiliar products, reuse of potentially infectious devices and dispersal of syringe/needle-related or “sharps” waste material. Institutional and private practices must parry against waste-related injuries (needle sticks) through better product management and waste disposal protocols. Matters relating to injection device safety are formalized in Safe Injection Global Network (SIGN) documents (http:// www.injectionsafety.org/). The life cycle management concept proposed in Chapter 31 for widely distributed medical equipment appears well suited for injection devices.
Syringe use, disposal, and safety Therapeutic injection-related procedures resulting in the instillation of pharmaceuticals or large volume parenterals account for more than 85% of all medical acts that employ syringe-like devices. About 5% are given for immunization purposes, a clinical sector which is distinct in terms of syringe designs and clinical protocols. Specialized equipment is increasingly employed for serial immunization programs and distorts the statistics of syringe consumption. The balance is made-up of events where syringe use takes place incidental to assorted procedures subject to singularities such as radiographic, anesthetic, dermatologic, endodontic, and other specialized applications. In developing countries and based on local surveys of the late 1990s, it is estimated that about two-thirds of 357
358 SECTION | 5 Safety
injection-related procedures may employ recycled or casually reused injection equipment. In 2000, the WHO reported about 250,000 new cases per year for iatrogenically associated Human Immunodeficiency Virus (HIV)-related complications. More recent surveys suggest lower figures primarily because of better availability and lower point-ofuse costs of injection material. Current immunization programs have effectively controlled the problem in many geographic jurisdictions. Still, the spread of Hepatitis B and C and HIV remain a concern. An injection for immunization ought not harm to the recipient or expose the healthcare worker to an infective complication or result in waste that pose supplemental dangers to the community or the environment. The reuse of injection equipment without effective cleaning, disinfection, and monitored re-sterilization is contrary to established medical guidelines. Careless disposal of used injection equipment contravenes basic scientific and environmental principles. It is also contrary to regulations in most jurisdictions. However, enforcement of such regulations is not always consistent or effective. The responsibility ultimately falls on the user, more so if it is a knowledgeable user.
Preventing the reuse of single-use injection equipment The reuse of single-use medical devices remains a worldwide problem. In industrialized countries, the reprocessing and reuse of medical devices for a range of applications has raised serious concerns, and regulatory agencies have initiated measures to control syringe and needle reuse. In the United States, the Food and Drug Administration (FDA) now requires the reprocessing of a single-use device to follow the same regulatory requirements as those applicable to the original manufacturing specifications of the device. In developing countries, international health agencies fear the reuse of injection equipment to be a major contributor to the spread of effectively controlled infective vectors. Manufacturers design devices that are labeled “single-use” with the intention that they will not be reused. The problem is even more acute in regions affected by wars and civil unrest. The principal reasons for not reusing include the following: ● ● ●
●
Devices may not be taken apart for exhaustive cleaning. Single-use devices may not be properly resterilized. The mechanical integrity and/or functionality of some single-use devices may not stand up to rigorous reprocessing. The cleaning chemicals or sterilizing agents could affect the reprocessed devices, the medication, or the patient.
Sterility, functionality, and possible hazards caused by chemical reactions after reprocessing are important issues.
Most disposable injection syringes are made of plastics that cannot withstand high-temperature sterilization. With ethylene oxide gas sterilization, the bio-burden after syringe use varies a great deal from syringe to syringe, which renders reliable resterilization impractical. Other points of concern include the invasive needle that critically contacts blood, the piston rubber seal, and the lubricant, each of which could harbor pathogens. In addition, the deformity of the needle after use is likely to degrade its functionality. The risks of infection associated with the reuse of single-use injection equipment are extremely high. The seriousness of the spread of diseases caused by the reuse of single-use injection equipment led to The World Health Organization-United Nations Children’s Fund-the United Nations Population Fund (WHO-UNICEF-UNFPA) joint statement on the use of auto-disable (AD) syringes in immunization services (http://www.injectionsafety.org/). The AD syringe (PATH, 2000) has a built-in mechanism that is designed to give a single dose of vaccine, after which the syringe is permanently locked or disabled. Such a mechanism prevents the reuse of contaminated syringes and needles and eliminates their unauthorized packaging and resale. Currently, many types of AD syringes are commercially available. Increasingly, AD syringes are used in therapeutic and other injections. In many models, it is essential to completely eject the medication in the syringe in order to render the syringe nonreusable.
Preventing sharps injuries To avoid needle-stick injury after injection, the used needle should be immediately deposited into a safety box or container to prevent direct access, not recapped. Safety boxes must be made of puncture-proof material. While single-use syringes and needles should never be reused, it is possible to consider the recycling of safety boxes. However, special boxes and decontamination procedure must be strictly followed (see http://www.noharm.org/). The use of safety boxes should not be regarded as the end of the safe disposal of used needles or syringes. Final appropriate and safe disposal requires systematic considerations.
Ultimate safe and appropriate disposal of sharps waste The ultimate disposal of injection equipment can be part of the institution-wide health-waste disposal system. Safety boxes containing used sharps must be disposed of in a manner that is consistent with protecting the environment. The Appendix below provides a comparison of various methods for the disposal of sharps waste. It should be noted that each method has its strengths and weaknesses, and no single waste disposal solution is best. Healthcare facility administrators must identify the most appropriate disposal
Single-use injection devices Chapter | 54 359
technologies depending on the local regulations, the size of healthcare facilities, the location (e.g., urban vs rural), and the availability of construction material for building incinerators or pits or to encapsulate waste. Geographical factors are also important and include the ease of access to final disposal sites and the nature of the soil where the health facility is located (e.g., sandy, muddy, flood-prone, or rocky ground.) Some of the current options, such as incineration, are considered unacceptable by a number of environmentalist groups. Health waste disposals are important issues and alternative technologies are being researched and developed (see http://www.noharm.org/).
Application of life cycle management In health projects such as an immunization program or any therapeutic program involving injections, ensuring product quality of vaccines and injection equipment is not enough
to ensure safety. All aspects of immunization, including product quality, storage, handling, administration of injection, and disposal must be considered. In fact, the life cycle management concept developed for major medical equipment can be useful here. This concept calls for the inclusion of other essential elements for good management (see Fig. 3 in Chapter 49). For example, introducing an injection safety component at the planning phase of health projects involving injections is a proactive way to ensure safety. The different essential elements in the life cycle management concepts, from planning to disposal, can apply. In Table 1, major management items are cross- referenced to various publications available in the Toolbox of the SIGN. These publications are neither standard nor exhaustive, but they contain detailed descriptions of the management items to illustrate the applicability of the concepts.
TABLE 1 Life cycle management applied to injection equipment. Essential element for major equipment (life cycle management)
Injection equipment application
Planning
Situational and needs assessment Qualified healthcare workers? Real need for medication? Oral alternative? Behavioral change? Injection equipment security Adequate storage? Disposal: Safety boxes Disposal facilities Communication strategies
Acquisition
Procurement steps, price negotiation Quality assurance criteria
Delivery
Shipment damage?
Incoming inspection
Specified goods?
Inventory and documentation
Master inventory Distribution records
Commissioning
Proper storage and safeguard Good distribution practices to health facilities
Training of users
Appropriate use Safe use Continued
360 SECTION | 5 Safety
TABLE 1 Life cycle management applied to injection equipment—cont’d Essential element for major equipment (life cycle management)
Injection equipment application
Monitoring and risk management
Monitor risks, such as: Breakage Needle-stick Incomplete ejection to disable syringe Splash of blood or medication Reuse Safety boxes for used sharps
Maintenance
Adequate resupply Injection equipment security Maintain number matched to medications
Replacement disposal
Appropriate disposal Safe disposal
Planning for safe disposal in various countries includes assessment of the disposal situation in each country. Once the supply of injection equipment has been determined, injection equipment security, safety boxes, and disposal facilities are considered as follows: Injection equipment security. Matching the quantity of medications or vaccines with the supply of injection equipment to ensure enough devices for all medications or vaccines without the need to reuse equipment. The lack of access to safe injection equipment frequently leads to reuse. Safety boxes. Sufficient number of safety boxes must be supplied to contain the sharps immediately after use. The use of the safety box is not the end of the disposal responsibility but a part of the safe use phase. Final disposal. The means and facilities for the final disposal of the safety boxes containing used sharps must be determined at the planning stage. The disposal procedures must ensure personal safety and protect the environment.
Discussion The life cycle management table provides a simple, onepage checklist for key items of the whole management system (see Table 1). Details of key items that are specific to a certain health program or project can be added for customized consultation. This one-page picture also allows any
health worker to see the relevance of his or her role in the overall system, an important first step toward increasing the system efficiency and effectiveness. The life cycle management approach, originally developed for major medical equipment, also applies to nonmajor, but essential medical devices and may be extended to additional devices.
Appendix. Comparison of methods for the disposal of sharps waste Waste burial pit or encapsulation
Simple
Potential of being unburied
Inexpensive
No volume reduction
Low-tech
No disinfection of wastes
Prevents sharpsrelated infections or injuries to waste handlers or scavengers
Pit may fill quickly Not adapted for nonsharp infectious wastes Presents a danger to community if not properly buried Inappropriate in areas of heavy rain or if water table is near the surface
Single-use injection devices Chapter | 54 361
Burning (<400°C), including:
Brick-oven burners
Incomplete combustion
Drum burners
May not completely sterilize
Pit burning
Results in heavy smoke
Relatively inexpensive
May require fuel or dry waste to start burning
Minimum training required
Potential for toxic emissions (i.e., dioxins or furans) if waste stream is not properly managed
Reduction in waste volume Reduction in infectious material Incineration (>800°C)
Almost complete combustion and sterilization of used injection equipment
Relatively expensive to build, operate, and maintain
Reduces risk of toxic emission
May require fuel or dry waste to ignite
Greatly reduces volume of sharps waste
Potential for toxic emissions (i.e., dioxins or furans) if waste stream is not properly managed
Reduces occupational risks to waste handlers and scavengers
Fluid splash back and needle manipulation ma create opportunities of blood borne pathogen transmission
Manual technologies available
Used needles/ syringes need further treatment for disposal Safety profile is not established
Melting in industrial ovens
Greatly reduces volume of sharps waste
Expensive
Autoclave steam sterilization followed by shredding
Sterilizes used injection equipment
High capital cost
May reduce waste volume
Requires electricity
Potential needlestick injuries during needle removal
Requires electricity
High operational costs High maintenance
Requires trained personnel to operate
Compliant with local environmental laws Needle removal/ needle destruction
Plastic and steel may be safely recycled for other uses after treatment (e.g., for buckles and coat hangers)
Further reading Cheng, M., 2003. Guide for the Quality Assurance of Single Use Injection Equipment. http://digicollection.org/hss/documents/s15250e/s15250e.pdf. Cheng, M., Gaamangwe, T., Napke, E., Lehtiniemi, L., Moher, B., Erskine, J., Chan, A., Kahlaf, B., Moonsoo, Y., 2019. A systems management framework for medical device safety and optimal outcomes, Chapter 49. In: Clinical Engineering Handbook. 2nd Edition. K4Health, 2004. Safe Injection and Waste Management. https://www. k4health.org/sites/default/files/Safe%20Injection%20and%20 Waste%20Management%2. PAHO. Immunization Toolkit—https://www.paho.org/immunization-toolkit/. WHO. Injection Safety Tools and Resources: https://www.who.int/ infection-prevention/tools/injections/training-education/en/.
Single-use injection devices J.J.B. Pierre Blaisa, Michael Chengb a
INNOVAL Failure Analysis, Ottawa, ON, Canada, bBiomedical Engineer, Patient Safety/Education Advocate, Ottawa, ON, Canada
Introduction More than a third of all medical or dental procedures entail the injection or withdrawal of fluid. Annually and assuming single use, this corresponds to >20 billion procedures worldwide, where a syringe-like device is employed and discarded. Instrument-grade reusable glass/metal syringes, the ancestors to current “disposable” plastic-body syringes, disappeared from clinical practice during the 1970s. Since then, their plastic successors gradually improved in design and quality to the point where many such products create the illusion of suitability for multiple cycles of service. Predictably, reuse takes place and the practice is not limited to economically disadvantaged environments. Regional variations in healthcare traditions impact on problems created by syringes. Inappropriate use and reuse are more prevalent but not limited to developing countries. A good management scheme described in Chapter 49 by Cheng et al. (2019) can be applied to the planning and delivery of single use injection devices in community immunization programs.
Rationale for development of reuse prevention features; emerging problems Morbidity from the reuse of “disposables” was the rationale for commercialization of fluid injection devices embodying features that forbade reuse. These developments took place during the late 1990s and are continuing today with the release of novel designs. The nonreusable feature is particularly attractive in the context of narcotic addiction abatement programs. Cost considerations are not always a limiting factor because of incentives provided through national, international, and benevolent agencies. As a result, injection devices with self-disabling characteristics are now distributed worldwide. Some present unfamiliar safety problems are encountered even in wealthy industrialized countries. Certain designs of syringes are unsuited for many medical procedures. Others are optimized for specialized applications. The self-disabling feature can increase patient or professional user risks in some instances. Yet, conventional Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00055-9 Copyright © 2020 Elsevier Inc. All rights reserved.
and self-disabling syringes are sometimes intermingled. Moreover, on cursory examination, many self-disabling products are not easily differentiated from conventional syringes, thus introducing new risk factors. Notwithstanding any of the above, the need for conventional syringes and specialized injection devices remains and standards have not comprehensively addressed the problems of diversity and reliability. For these reasons, continuing vigilance and reexamination of this sector must be maintained at the clinical, procurement, regulatory, and disposal levels. These issues complicate the management of morbidity caused by the usage of unsuitable or unfamiliar products, reuse of potentially infectious devices and dispersal of syringe/needle-related or “sharps” waste material. Institutional and private practices must parry against waste-related injuries (needle sticks) through better product management and waste disposal protocols. Matters relating to injection device safety are formalized in Safe Injection Global Network (SIGN) documents (http:// www.injectionsafety.org/). The life cycle management concept proposed in Chapter 31 for widely distributed medical equipment appears well suited for injection devices.
Syringe use, disposal, and safety Therapeutic injection-related procedures resulting in the instillation of pharmaceuticals or large volume parenterals account for more than 85% of all medical acts that employ syringe-like devices. About 5% are given for immunization purposes, a clinical sector which is distinct in terms of syringe designs and clinical protocols. Specialized equipment is increasingly employed for serial immunization programs and distorts the statistics of syringe consumption. The balance is made-up of events where syringe use takes place incidental to assorted procedures subject to singularities such as radiographic, anesthetic, dermatologic, endodontic, and other specialized applications. In developing countries and based on local surveys of the late 1990s, it is estimated that about two-thirds of 357
358 SECTION | 5 Safety
injection-related procedures may employ recycled or casually reused injection equipment. In 2000, the WHO reported about 250,000 new cases per year for iatrogenically associated Human Immunodeficiency Virus (HIV)-related complications. More recent surveys suggest lower figures primarily because of better availability and lower point-ofuse costs of injection material. Current immunization programs have effectively controlled the problem in many geographic jurisdictions. Still, the spread of Hepatitis B and C and HIV remain a concern. An injection for immunization ought not harm to the recipient or expose the healthcare worker to an infective complication or result in waste that pose supplemental dangers to the community or the environment. The reuse of injection equipment without effective cleaning, disinfection, and monitored re-sterilization is contrary to established medical guidelines. Careless disposal of used injection equipment contravenes basic scientific and environmental principles. It is also contrary to regulations in most jurisdictions. However, enforcement of such regulations is not always consistent or effective. The responsibility ultimately falls on the user, more so if it is a knowledgeable user.
Preventing the reuse of single-use injection equipment The reuse of single-use medical devices remains a worldwide problem. In industrialized countries, the reprocessing and reuse of medical devices for a range of applications has raised serious concerns, and regulatory agencies have initiated measures to control syringe and needle reuse. In the United States, the Food and Drug Administration (FDA) now requires the reprocessing of a single-use device to follow the same regulatory requirements as those applicable to the original manufacturing specifications of the device. In developing countries, international health agencies fear the reuse of injection equipment to be a major contributor to the spread of effectively controlled infective vectors. Manufacturers design devices that are labeled “single-use” with the intention that they will not be reused. The problem is even more acute in regions affected by wars and civil unrest. The principal reasons for not reusing include the following: ● ● ●
●
Devices may not be taken apart for exhaustive cleaning. Single-use devices may not be properly resterilized. The mechanical integrity and/or functionality of some single-use devices may not stand up to rigorous reprocessing. The cleaning chemicals or sterilizing agents could affect the reprocessed devices, the medication, or the patient.
Sterility, functionality, and possible hazards caused by chemical reactions after reprocessing are important issues.
Most disposable injection syringes are made of plastics that cannot withstand high-temperature sterilization. With ethylene oxide gas sterilization, the bio-burden after syringe use varies a great deal from syringe to syringe, which renders reliable resterilization impractical. Other points of concern include the invasive needle that critically contacts blood, the piston rubber seal, and the lubricant, each of which could harbor pathogens. In addition, the deformity of the needle after use is likely to degrade its functionality. The risks of infection associated with the reuse of single-use injection equipment are extremely high. The seriousness of the spread of diseases caused by the reuse of single-use injection equipment led to The World Health Organization-United Nations Children’s Fund-the United Nations Population Fund (WHO-UNICEF-UNFPA) joint statement on the use of auto-disable (AD) syringes in immunization services (http://www.injectionsafety.org/). The AD syringe (PATH, 2000) has a built-in mechanism that is designed to give a single dose of vaccine, after which the syringe is permanently locked or disabled. Such a mechanism prevents the reuse of contaminated syringes and needles and eliminates their unauthorized packaging and resale. Currently, many types of AD syringes are commercially available. Increasingly, AD syringes are used in therapeutic and other injections. In many models, it is essential to completely eject the medication in the syringe in order to render the syringe nonreusable.
Preventing sharps injuries To avoid needle-stick injury after injection, the used needle should be immediately deposited into a safety box or container to prevent direct access, not recapped. Safety boxes must be made of puncture-proof material. While single-use syringes and needles should never be reused, it is possible to consider the recycling of safety boxes. However, special boxes and decontamination procedure must be strictly followed (see http://www.noharm.org/). The use of safety boxes should not be regarded as the end of the safe disposal of used needles or syringes. Final appropriate and safe disposal requires systematic considerations.
Ultimate safe and appropriate disposal of sharps waste The ultimate disposal of injection equipment can be part of the institution-wide health-waste disposal system. Safety boxes containing used sharps must be disposed of in a manner that is consistent with protecting the environment. The Appendix below provides a comparison of various methods for the disposal of sharps waste. It should be noted that each method has its strengths and weaknesses, and no single waste disposal solution is best. Healthcare facility administrators must identify the most appropriate disposal
Single-use injection devices Chapter | 54 359
technologies depending on the local regulations, the size of healthcare facilities, the location (e.g., urban vs rural), and the availability of construction material for building incinerators or pits or to encapsulate waste. Geographical factors are also important and include the ease of access to final disposal sites and the nature of the soil where the health facility is located (e.g., sandy, muddy, flood-prone, or rocky ground.) Some of the current options, such as incineration, are considered unacceptable by a number of environmentalist groups. Health waste disposals are important issues and alternative technologies are being researched and developed (see http://www.noharm.org/).
Application of life cycle management In health projects such as an immunization program or any therapeutic program involving injections, ensuring product quality of vaccines and injection equipment is not enough
to ensure safety. All aspects of immunization, including product quality, storage, handling, administration of injection, and disposal must be considered. In fact, the life cycle management concept developed for major medical equipment can be useful here. This concept calls for the inclusion of other essential elements for good management (see Fig. 3 in Chapter 49). For example, introducing an injection safety component at the planning phase of health projects involving injections is a proactive way to ensure safety. The different essential elements in the life cycle management concepts, from planning to disposal, can apply. In Table 1, major management items are cross- referenced to various publications available in the Toolbox of the SIGN. These publications are neither standard nor exhaustive, but they contain detailed descriptions of the management items to illustrate the applicability of the concepts.
TABLE 1 Life cycle management applied to injection equipment. Essential element for major equipment (life cycle management)
Injection equipment application
Planning
Situational and needs assessment Qualified healthcare workers? Real need for medication? Oral alternative? Behavioral change? Injection equipment security Adequate storage? Disposal: Safety boxes Disposal facilities Communication strategies
Acquisition
Procurement steps, price negotiation Quality assurance criteria
Delivery
Shipment damage?
Incoming inspection
Specified goods?
Inventory and documentation
Master inventory Distribution records
Commissioning
Proper storage and safeguard Good distribution practices to health facilities
Training of users
Appropriate use Safe use Continued
360 SECTION | 5 Safety
TABLE 1 Life cycle management applied to injection equipment—cont’d Essential element for major equipment (life cycle management)
Injection equipment application
Monitoring and risk management
Monitor risks, such as: Breakage Needle-stick Incomplete ejection to disable syringe Splash of blood or medication Reuse Safety boxes for used sharps
Maintenance
Adequate resupply Injection equipment security Maintain number matched to medications
Replacement disposal
Appropriate disposal Safe disposal
Planning for safe disposal in various countries includes assessment of the disposal situation in each country. Once the supply of injection equipment has been determined, injection equipment security, safety boxes, and disposal facilities are considered as follows: Injection equipment security. Matching the quantity of medications or vaccines with the supply of injection equipment to ensure enough devices for all medications or vaccines without the need to reuse equipment. The lack of access to safe injection equipment frequently leads to reuse. Safety boxes. Sufficient number of safety boxes must be supplied to contain the sharps immediately after use. The use of the safety box is not the end of the disposal responsibility but a part of the safe use phase. Final disposal. The means and facilities for the final disposal of the safety boxes containing used sharps must be determined at the planning stage. The disposal procedures must ensure personal safety and protect the environment.
Discussion The life cycle management table provides a simple, onepage checklist for key items of the whole management system (see Table 1). Details of key items that are specific to a certain health program or project can be added for customized consultation. This one-page picture also allows any
health worker to see the relevance of his or her role in the overall system, an important first step toward increasing the system efficiency and effectiveness. The life cycle management approach, originally developed for major medical equipment, also applies to nonmajor, but essential medical devices and may be extended to additional devices.
Appendix. Comparison of methods for the disposal of sharps waste Waste burial pit or encapsulation
Simple
Potential of being unburied
Inexpensive
No volume reduction
Low-tech
No disinfection of wastes
Prevents sharpsrelated infections or injuries to waste handlers or scavengers
Pit may fill quickly Not adapted for nonsharp infectious wastes Presents a danger to community if not properly buried Inappropriate in areas of heavy rain or if water table is near the surface
Single-use injection devices Chapter | 54 361
Burning (<400°C), including:
Brick-oven burners
Incomplete combustion
Drum burners
May not completely sterilize
Pit burning
Results in heavy smoke
Relatively inexpensive
May require fuel or dry waste to start burning
Minimum training required
Potential for toxic emissions (i.e., dioxins or furans) if waste stream is not properly managed
Reduction in waste volume Reduction in infectious material Incineration (>800°C)
Almost complete combustion and sterilization of used injection equipment
Relatively expensive to build, operate, and maintain
Reduces risk of toxic emission
May require fuel or dry waste to ignite
Greatly reduces volume of sharps waste
Potential for toxic emissions (i.e., dioxins or furans) if waste stream is not properly managed
Reduces occupational risks to waste handlers and scavengers
Fluid splash back and needle manipulation ma create opportunities of blood borne pathogen transmission
Manual technologies available
Used needles/ syringes need further treatment for disposal Safety profile is not established
Melting in industrial ovens
Greatly reduces volume of sharps waste
Expensive
Autoclave steam sterilization followed by shredding
Sterilizes used injection equipment
High capital cost
May reduce waste volume
Requires electricity
Potential needlestick injuries during needle removal
Requires electricity
High operational costs High maintenance
Requires trained personnel to operate
Compliant with local environmental laws Needle removal/ needle destruction
Plastic and steel may be safely recycled for other uses after treatment (e.g., for buckles and coat hangers)
Further reading Cheng, M., 2003. Guide for the Quality Assurance of Single Use Injection Equipment. http://digicollection.org/hss/documents/s15250e/s15250e.pdf. Cheng, M., Gaamangwe, T., Napke, E., Lehtiniemi, L., Moher, B., Erskine, J., Chan, A., Kahlaf, B., Moonsoo, Y., 2019. A systems management framework for medical device safety and optimal outcomes, Chapter 49. In: Clinical Engineering Handbook. 2nd Edition. K4Health, 2004. Safe Injection and Waste Management. https://www. k4health.org/sites/default/files/Safe%20Injection%20and%20 Waste%20Management%2. PAHO. Immunization Toolkit—https://www.paho.org/immunization-toolkit/. WHO. Injection Safety Tools and Resources: https://www.who.int/ infection-prevention/tools/injections/training-education/en/.