Auto-disable syringes are not for needle programmes

WHO and its partners recommend the use of auto-disable syringes, "bundled" with the supply of vaccines when donor dollars are used, in all mass immunization campaigns, and also strongly advocate their use in routine immunization programmes. Because of the relatively high price of auto-disable syringes, WHO's Technical Network for Logistics in Health recommends that activities be initiated to encourage the transfer of production technology for these syringes as a means of promoting their use and enhancing access to the technology. The present article examines factors influencing technology transfer, including feasibility, corporate interest, cost, quality assurance, intellectual property considerations, and probable time frames for implementation. Technology transfer activities are likely to be complex and difficult, and may not result in lower prices for syringes. Guidelines are offered on technology transfer initiatives for auto-disable syringes to ensure the quality of the product, the reliability of the supply, and the feasibility of the technology transfer activity itself.

UNICEF is working to buy 1 billion syringes by the end of 2021 for COVID-19 vaccination efforts in countries participating in the COVAX Facility.  Although the vaccines secured by the Facility may vary in their formulation and storage requirements, the syringes will all be of the auto-disable (AD) type, approved by the World Health Organization.   

AD syringes are recommended for immunization programmes because they are designed to prevent re-use by locking automatically after a single use. They are the best way of ensuring that people receive their shots safely, without a risk of contracting an infection due to contaminated needles. The AD syringes bought for this immense operation are similar to those routinely procured and delivered by UNICEF for the vaccination of children worldwide.

Joint efforts for safe injection

Until a few decades ago, children were vaccinated using safety syringe, which exposed them to the risk of transmission of bloodborne diseases like Hepatitis B and HIV. “Sometimes, these used syringes were resold and reused, and we have encountered instances of children using them as toys”, tells Robin Nandy, UNICEF Chief of Immunization.

According to a study sponsored by WHO in 2014, up to 1.7 million people contracted hepatitis B, up to 315 000 with hepatitis C, and 33,800 with HIV through unsafe injections.

The situation started to improve in 1999, when UNICEF, the World Health Organization and the United Nations Population Fund (UNFPA) jointly called for the improvement in injection safety standards. In a statement, the organizations noted that AD syringes were already available and affordable and declared that they should be the device of choice for administering vaccines in both routine services and during mass campaigns.

Since then, several initiatives have driven progress in injection safety for immunization. An example of collective advocacy was taken by the Measles and Rubella Initiative (M&RI), launched in 2001 and led by the American Red Cross, the United Nations Foundation, the U.S. Centers for Disease Control and Prevention, UNICEF and the World Health Organization. The partnership required that safe injection equipment, including AD syringes, were used as part of the support they provided countries to carry out vaccination campaigns.

With the support of major donors, UNICEF has been playing a key role in the global effort for safe injection. The number of auto disable syringe UNICEF procured grew from 11 million in 1997 to around 600-800 million per year. UNICEF is also the world’s largest buyer of AD syringes, procuring 40% of the global market. This growth has been accompanied by a significant price drop. Three decades ago, UNICEF paid US$ 0.12 per unit of an AD syringe. The price has since fallen to US$ 0.03 per unit.

“All these developments have been the result of a global programmatic decision to use AD syringes for immunization supported by a variety of stakeholders”, says Robert Matthews, head of the Medical Devices Unit in UNICEF Supply Division. He explains that a number of elements, including funding from donors like Gavi and M&RI, have helped influence and shift the market away from traditional disposable reusable syringes towards the use of AD syringes for immunization.

Through COVAX, UNICEF is keeping its commitment to safe injection by exclusively buying AD syringes for the COVID-19 vaccination. “With safe injection equipment we strive to guarantee that the good intention embodied in the vaccine does not do harm”, says Robert.

As you may have seen in the media recently, the World Health Organisation (WHO) has launched new guidelines on medical injections and a global campaign to switch all medical and vaccination injections to syringes that cannot be used more than once. These "safety-engineered syringes" may, for example, include a weak spot in the plunger that causes it to break if the user attempts to pull back on the plunger after the injection. Others have a metal clip that blocks the plunger so it cannot be moved back, while in others the needle retracts into the luer slip type syringe barrel at the end of the injection. Using these syringes in medical settings will, according to WHO, protect millions of people from becoming infected with HIV, hepatitis and other diseases through the re-use of unsterile equipment by doctors and medical staff, especially in the poorest health systems in the world. Their ambitious aim is that every country should have transitioned to these new syringes by 2020.

 

However, these recommendations and this campaign explicitly do not apply to needle and syringe programmes for people who inject drugs (the population most impacted by HIV, hepatitis and other diseases transmitted through contaminated injecting equipment). It has been demonstrated and proven on many occasions that these auto-disable syringes are unsuitable, ineffective and undesirable in these programmes – clients simply do not like them, they are often harder to use, and they cost more. For example, drug preparation and injection amongst people who inject drugs routinely involves more than one retraction or depression of the syringe plunger, making auto-disable syringes inappropriate. Several peer-reviewed studies have also documented the inadequacy of auto-disable syringes for people who inject drugs – see this informative briefing from the USA's Harm Reduction Coalition for more information.

As a result, and after intensive lobbying by the NNEF and other civil society partners around the world, the WHO guidelines (available here) include the clear exemption that health systems must set "policies and standards for procurement, use and safe disposal of disposable [i.e. not auto-disable] syringes in situations where they remain necessary as described above, including in syringe programmes for people who inject drugs". Similar disclaimers appear in the accompanying leaflet and press release – but this has not been picked up in the media reporting, such as the recent BBC article.

So in short, auto-disable or auto-retract syringes remain unsuitable for needle and syringe programmes. Of course, the message must continue to be that every syringe is intended to be single use, and programmes should continue to use low dead space syringes as before.