Safety of injections

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Safety of Injections

World Health Organization, Geneva, 1998

GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION EXPANDED PROGRAMME ON IMMUNIZATION LL

The Global Programme for Vaccines and Immunization thanks the donors whose unspecified financial support in 1997 has made the production of this document possible.
Ordering code: WHO/EPI/LHIS/96.05 Rev.1
Printed : December 1996
Revised: October 1998

This document is available on the Internet at the GPV Document Centre web-site:
http://www.who.ch/gpv-documents/
Copies may be requested from:
World Health Organization
Global Programme for Vaccines and Immunization
CH-1211 Geneva 27, Switzerland
Fax: +22 791 4193/4192; E-mail: gpv@who.ch
© World Health Organization 1998

This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes.

The views expressed in documents by named authors are solely the responsibility of those authors. LLL

Contents
WHO-recommended policy: Safety of injections in
immunization services......................................................................................... 1
1. Selection of injection equipment.............................................................. 2
1.1 Types of equipment................................................................................... 2
1.2 Auto-destruct syringes with fixed needles................................................. 2
1.3 Standard disposable syringes..................................................................... 2
1.4 Sterilizable Syringes .................................................................................. 2
1.5 Needle-free injectors................................................................................. 3
1.6 Safety containers for the disposal of used syringes, needles and sharps .... 3
1.7 Incineration equipment ............................................................................. 3
2. Critical use and disposal procedures......................................................... 4
2.1 Auto-destruct and standard disposable syringes and needles .................... 4
2.2 Sterilizable syringes and needles ............................................................... 4
2.3 Transport and disposal of contaminated sharps ........................................ 5
3. Supervision and evaluation......................................................................... 6
3.1 Supervisory visits ...................................................................................... 6
3.2 Assessment of injection practices .............................................................. 6
3.3 Routine monitoring................................................................................... 6
4. Budgeting and supply................................................................................... 7
4.1 Disposable injection equipment................................................................. 7
4.2 Reusable injection equipment.................................................................... 7
4.4 Safety containers ....................................................................................... 7
4.4 Distribution system................................................................................... 7
4.5 Advance budget......................................................................................... 7
Annex 1: Critical questions for supervisory checklist to determine
injection safety...................................................................................................... 8

WHO-recommended policy:
Safety of injections in immunization services

An injection should only be given if it is necessary -- and each injection that is given must be safe.

· An injection for immunization is necessary.

· An immunization injection is safe when the vaccine is injected with the appropriate equipment and according to the recommended procedures for injection, sterilization and disposal.
The proper techniques for immunization injections have been specified in a previous document (EPI/PHW/84.03 Rev. 1). The scope of this document is, therefore, limited to the selection of injection equipment and the procedures which are critical1 for the safe use of the equipment. This document should be read in conjunction with the WHO-UNICEF policy statement for mass immunization campaigns (WHO/EPI/LHIS/97.04 Rev.1).

"Critical" in this case refers to the most important of many sterile procedures which are already recommended in WHO/EPI training documents.
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1. Selection of injection equipment

1.1 Types of equipment

The following equipment can be used to administer injectable vaccines:
· Auto-destruct syringes with fixed needles
· Sterilizable syringes and needles
· Standard disposable syringes and needles

The following additional equipment is necessary to assure safety:
· Safety boxes for the collection of used syringes, needles and sharps
· Incinerators

Each type of equipment is safe only if users follow the critical procedures specified for its use. (See sections 2-4.)

1.2 Auto-destruct syringes with fixed needles
The auto-destruct syringe is the recommended type of disposable equipment for parenteral administration of vaccines. This type of syringe is the equipment of choice for conducting mass immunization. The auto-destruct syringe presents the lowest risk of person to person transmission of bloodborne pathogens because itcannot be reused.

1.3 Standard disposable syringes
Standard disposable syringes and needles should only be used for immunization only in settings where it is guaranteed that they will be destroyed after a single use, as verified by monitoring of consumption and supervision of disposal. WHO warns governments and donor agencies that the reuse of standard disposable syringes and needles places the general public at high risk of disease and death.

1.4 Sterilizable Syringes
Sterilizable syringes can be used for routine immunization sessions where compliance with cleaning and sterilization procedures between each use can be assured, as verified by supervisory visits and by routine use of ‘time, steam & temperature’ (TST) control spots. Sterilizable syringes are neither practical nor economic for mass immunization sessions and should not be used for this purpose.

1.5 Needle-free injectors
Needle-free injectors designed for use with multi-dose vials and with a multiple-use fluid path should not be used for immunization. These injectors have an inherent risk of bloodborne disease transmission. Needle-free injectors designed for use with mono-dose pre-filled cartridges, or mono-dose cartridges for filling at the point of use, with a disposable fluid path may be used for immunization. These injectors do not share the same risk of contamination and disease transmission as the multi-dose injectors.

1.6 Safety containers for the disposal of used syringes, needles and
sharps Puncture resistant containers for collecting and disposing of used disposable and auto-destruct syringes, needles and other injection materials must be provided and used in all immunization activities. These containers reduce the risk posed by contaminated needles and syringes to health staff and to the general public.

1.7 Incineration equipment
Auto-combustion type of incinerators which achieve temperatures in excess of 8000 Celsius are preferred to destroy all contaminated sharps, including syringes and needles used for immunization. This equipment ensures the most complete destruction of used sharps while also reducing environmental pollution.

1 More than 120 immunizations per session
2 Confirmed in animal tests: field trials in progress to confirm risks in humans.
3 Currently used in the USA but not yet widely available: cost in use high.
4 Meeting WHO Standard Performance Specification E10/IC.1 or E10/IC.
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2. Critical use and disposal procedures

2.1 Auto-destruct and standard disposable syringes and needles
A sterile packed syringe and a sterile packed needle must be used for each injection and effectively destroyed according to the following critical procedures:

2.1.1 Immediately after a single use, place each syringe and needle in a Safety
puncture-resistant container. Do not attempt to recap the needle.

2.1.2 Do not use disposable syringes and needles from damaged or punctured
sterile packs, or which have passed the manufacturer’s expiry date.

2.2 Sterilizable syringes and needles A sterile syringe and a sterile needle must be used for each injection. The critical procedures for handling, cleaning, sterilizing and disposing of reusable syringes and needles are outlined below:

2.2.1 Immediately after injection, flush water through the syringe and needle.
Take the syringe apart and drop it and the needle into a bowl of water. After the immunization session, wash all the syringe components in clean water before loading them for sterilization. Use forceps, not fingers, to pick the syringe components and the needle from the water and place them in the sterilizer.

2.2.2 Steam sterilize reusable needles, syringes and forceps at 121°C-126°C for
20 minutes, according to the instructions of the sterilizer manufacturer. Steam
sterilization kills all harmful viruses, bacteria, and spores1, including those that cause abscesses, tetanus, hepatitis B, and HIV.

2.2.3 Approved sterilization indicators (Time, Steam and Temperature : TST
control spots) must be included in each sterilization cycle. Inspect the indicator at the time of use and attach it to the immunization report.

2.2.4 Dispose of syringes which leak, become too stiff to use or have faded
graduations and also dispose of needles which have become blocked, blunted or hooked. Do not attempt to re-sharpen needles. Boiling and other methods of high level disinfection will not destroy certain spores.

2.3 Transport and disposal of contaminated sharps

2.3.1 The recommended method of disposal of used syringes and needles is
destructive incineration at temperature above 800 degrees Celsius. Where
incinerators are not available, contaminated sharps should be burned in a pit, drum or constructed hearth. The compound in which the incineration takes place must be secured.

2.3.2 Incineration or burning should be conducted as close to the point of use as possible and as soon after the immunization session as practical. Contaminated sharps must be collected and stored in safety puncture-resistant containers which are preferably incinerated with the syringes.

2.3.3 Contaminated sharps should not be transferred from container to
container. If containers are transported by vehicle, the vehicle should be protected against contamination or disinfected before being used for other purposes.

3. Supervision and evaluation
Systematic supervision and periodic evaluation of injection practices are vital to ensure safety.

3.1 Supervisory visits At least twice each year, make supervisory visits to each health centre, using a checklist which includes a review of injection safety to improve performance (See Annex 1 : Critical questions for supervisory checklist).

3.2 Assessment of injection practices
Include an assessment of safe injection practices, injection equipment and the equipment supply system in every EPI programme review and other evaluation activities.

3.3 Routine monitoring
Routinely monitor and investigate all injection-related adverse events to improve the quality and safety of injections and assist supervisory procedures.

4. Budgeting and supply
An uninterrupted supply of sufficient injection equipment is critical to the safety of immunizations. The measures which should be taken to assure the availability of adequate supplies include the following:

4.1 Disposable injection equipment
At central and intermediate stores, keep a reserve stock of equipment—at least 10% of the quantity used in each supply period. At peripheral stores keep a reserve stock that is sufficient for at least one month of immunization activities.

4.2 Reusable injection equipment
Keep a minimum level of syringes and needles in stock equal to the largest number of injections given at a single session, plus an additional 10% reserve. Provide sufficient fuel for sterilization and spares parts for the maintenance of steam sterilizers.

4.4 Safety containers
Provide safety puncture-resistant containers1 in sufficient quantities to all health units for the collection and incineration of contaminated syringes and needles.

4.4 Distribution system
Establish a distribution system for all injection equipment which is the same as that for vaccines, with the following characteristics:
· a timetable of regular supply dates an estimate of routine needs based on rates of use, planning of needs for special immunization activities, and · a record of current stock levels.

4.5 Advance budget
One year in advance, establish an adequate budget for the supply of sufficient injection, sterilization and disposal equipment to cover routine immunization, special immunization activities and, if necessary, the restoration of reserve stocks. Constructed according to WHO/EPI Standard Equipment Specification E10/IC.1.
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State of the world's vaccines and immunization

WHO/GPV/96.04 * DISTR: GENERAL

World Health Organization * United Nations Children's Fund
Geneva 1996

THE NUTS AND BOLTS OF IMMUNIZATION

Safe injections initiative
Almost a billion injections are given to women and children each year through national immunization programmes in developing countries. In 1994, WHO reported that surveys carried out in four of its six regions indicated that up to a third of immunization injections were unsterile and therefore unsafe.

But immunization injections account for less than 10% of injections administered within the health sector. And medical injections have an even worse safety record. More than half of all non-immunization injections in developing countries are believed to be unsafe.

Up to a third of immunization Surveys carried out for WHO and UNICEF a disturbing pattern of unsafe injection practices that can put the lives of both children and health workers at risk. Contaminated needles and syringes are sometimes reused putting children at risk of cross infection with blood-borne diseases such as hepatitis B and HIV. In one health centre in Romania health workers were found to be packaging used disposable syringes for resale using a hot iron to reseal the packaging. Elsewhere, reusable plastic syringes are inadequately sterilized and injections are sometimes wrongly administered resulting in injection-site abscesses. Improper disposal of contaminated needles and syringes is another problem placing the wider community at risk. Meanwhile, the incidence of accidental needlestick injury to health workers is alarmingly high an estimated 5 needlestick accidents for every 100 injections.

A survey carried out for UNICEF in Eastern Europe in 1992-93 revealed that almost 50% of health centres were giving unsafe injections and/or using vaccine of doubtful potency. In 13% of health
centres there were no disposable syringes and no sterilizing equipment either. The study also revealed that children especially orphans were being subjected to an excessive number of injections
in addition to immunization an average of 115 injections in all during their first year. One orphan had been given over 500 injections.

In 1994, a conference in Côte d Ivoire involving more than 50 African countries endorsed the so-called Yamoussoukro Declaration on the safety of injections. Under this declaration, immunization

167

STATE OF THE WORLD'S VACCINES AND IMMUNIZATION

Programme managers and workers pledge to ensure that every injection is sterile and the public pledge to demand the right of access to injections that are safe. The Declaration also sets a target
of 95% safe injections by the year 1997.

UNICEF, which supplies injection equipment to many developing countries, now recommends the use of auto-destruct syringes instead of disposable, single-use syringes in order to avoid the haz-
ards of unsafe injection practices. The advantage of these syringes is that they cannot be reused or recycled for sale. But they are more expensive than either disposable or reusable (sterilizable) syringes and once contaminated they still require safe disposal. Over the past 3-4 years, annual sales of auto-destruct syringes have increased more than tenfold from 5 million to 60 million today.

But by the year 2000 a new device the low workload jet injector is expected to revolutionize the business of giving injections. Adapted from a more powerful model first developed for the mass immunization of military personnel during the Second World War and from a smaller device used by diabetics for the daily injection of insulin, this device can project high-speed 100 metres a second intramuscular injections, penetrating the skin without the use of needles.

High workload jet injectors are already used in some countries mainly when large numbers of people are immunized during outbreaks or in refugee camps. Low workload jet injectors could be marketed for about US$ 300, and used for about 20,000 injections without needing maintenance providing two years service in the average health centre. The device will be cheap, convenient, avoid the risks of needlestick injuries, and leave nothing behind for disposal. It also holds out the prospect of use with vaccines in powder form measles vaccine, for example which are currently at the research stage. It may also be used at a future date to deliver several vaccines at the same time by mounting multiple vaccine vials on the injector.

However, tests have shown that the existing models already in use are not risk-free. Although no needle is used, some children have been found to bleed raising the spectre of cross-infection unless the metal cap is sterilized or changed before any subsequent immunizations. When tested on animal models the metal cap was found to be contaminated after 1 in 7 injections.

168 THE NUTS AND BOLTS OF IMMUNIZATION

Tests are now being carried out by WHO in collaboration with the US Centers for Disease Control and the UK Public Health Laboratory Service on both high workload and prototype low workload jet injectors in an effort to eliminate the risk of contamination. Two possible adaptations are the development of a disposable plastic head or a disposal sheath to ensure that the device remains sterile. Meanwhile, Phase I laboratory tests are already under way and limited field trials are scheduled to take place during 1996 and 1997 in Brazil and the Philippines.

WHO website

Researchers Recommend Curtailing Massive Unsterile Injecting Warn of Possible Disease Mutations as a Result of Unsafe Practices

FARMINGDALE, N.Y.--(BUSINESS WIRE)--Sept. 13, 2000--

The Farmingdale-based UNIVEC Corporation (Nasdaq:UNVC), the internationally recognized maker of auto-disable syringes, is heralding Preston Marx, Ph.D. and Ernest Drucker, Ph.D. on the release of their paper, "The Injection Century: Consequences of Massive Unsterile Injecting for the Emergence of Human Pathogens" at the Royal Society in London at a meeting entitled "Origins of HIV and the AIDS Epidemic."

In the paper, these world-renowned scientists substantiate UNIVEC's long held claim that "continued massive unsterile injecting has the capacity to significantly alter the global ecology of infectious diseases, accelerating epidemic spread of human pathogens." According to Dr. Marx, Tulane University's Director of AIDS Research and Chief of Virology, and Dr. Drucker, Director of the Division of Community Health at New York City's Montefiore Medical Center, the introduction of antibiotics in the 1950's led to an abrupt and massive increase in unsterile injections and transmission of several newly emerged human pathogens, significantly HIV and Hepatitis B and C. The doctors warn that new strains of HIV or other pathogens could emerge as a result of current practices.

"In addition to facilitating the spread of existing diseases," say Drs. Marx and Drucker, "massive unsterile injecting may also have fostered the creation of new ones."

"We hypothesize that the massive increase in unsterile injecting in Africa associated with the introduction of antibiotics in the 1950's was the modern `event' that allowed several weakly pathogenic simian virus, long native to Sub Saharan Africa, to increase in pathogenicity and complete their genetic adaptation to human hosts, emerging as the first epidemic strain of HIV by 1959."

Joel Schoenfeld, Chairman of UNIVEC, said, "these respected experts confirm our call for the exclusive use of auto-disable syringes in mass immunization programs and for clinical use. As the World Health Organization estimates, unsafe injections cause approximately 30,000 new HIV infections, 8 million HBV infections and 1.2 million HCV infections world-wide every year."

"Why does the world's medical community continue to ignore these figures?," said Schoenfeld. "What it should do is stop the practice of allowing multi-use syringes in every immunization and clinical program the world over. Only when we adopt an auto-disable syringe policy, to be mandatory in all mass vaccination programs, will we contribute significantly to the scourge of disease around the world."

The UNIVEC technology is for auto-disable syringes that can effectively deliver vaccines in a safer manner than with traditional syringes. The UNIVEC syringe prevents re-use and the needless spread of disease. The devices can deliver predetermined doses from 0.05 to 1cc needed to deliver medication, including vaccines, which may prevent contagious diseases from spreading.

UNIVEC is a world leader in auto-disable syringes and is leading the global movement for a conversion to auto-disable syringes from traditional multi-use syringes. Traditional multi-use disposable syringes are acknowledged by the World Health Organization to be responsible for the spread of disease to millions of people each year. CONTACT: UNIVEC Corporation Joel Schoenfeld, 631/777-2000 UNIVEC@UNIVEC.com

HCVets@aol.com
Revised: October 27, 2008 .All information is posted without profit or payment for research and is for educational purposes only, in accordance with Title 17 U.S.C. section 107.

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