Screening for viruses and communicable diseases has experienced great advances in recent years, enabling a high number of people to be tested faster, more safely and prevent the spread of infection. ISO is at the forefront of developing standards that will help healthcare organizations and governments respond more rapidly and capably to pandemics and emergencies.
Worldwide vaccine campaign puts spotlight on syringes
As the biggest vaccination campaign in history gets underway, all hands are on deck to secure and supply the billions of syringes needed for the COVID-19 vaccines.
For many of us, it is the biggest pandemic of our lifetime. For all of us, it is the greatest vaccination campaign in history. At the time of writing, around five hundred million people have already been vaccinated against COVID-19, and some ten billion doses have been ordered. Shortage of supplies means that some low-income countries may have to wait years to receive anything, further increasing the divide when it comes to access to healthcare.
COVAX, an initiative co-led by Gavi, the Coalition for Epidemic Preparedness Innovations and the World Health Organization (WHO), aims to help bridge that divide and ensure global equitable access to COVID-19 vaccines. Working with the United Nations Children’s Fund (UNICEF) as a delivery partner, it is touted as the “largest procurement and supply operation in history”. Producing enough vaccines, clearly, means enough syringes as well, and it is no surprise to hear that there is talk of a global shortage.
ISO works closely with many international organizations, including UNICEF and WHO, as well as national regulators, manufacturers, pharmaceutical companies, patients and healthcare workers, to develop recommended guidelines for the safe and secure manufacture and use of all kinds of syringes, including those used for COVID-19 vaccines.
We spoke to Paul Jansen, Chair of ISO’s expert committee ISO/TC 84, Devices for administration of medicinal products and catheters, about the global challenges of providing quality syringes to vaccinate the world in record time.
UNICEF is sending a billion syringes around the world as part of the COVAX initiative to vaccinate millions of people in developing countries. In addition, countries everywhere are rolling out their own vaccination campaigns. That’s a lot of syringes. Where is the world at when it comes to supplies?
It certainly is a major source of concern because we have to remember that the other vaccinations, such as those for children and so on, haven’t gone away. There are estimates that some eight to ten billion syringes will be needed for the COVID-19 vaccine alone.
That said, manufacturers everywhere have been rapidly adding capacity and ramping up supply. What’s more, there are some new materials being deployed, such as plastic polymers, that should further increase the global supply. I believe that we will have enough to ensure that vaccinations are not constrained.
With existing manufacturers increasing their volumes and newcomers on the market, how can we be certain that all these newly manufactured syringes are safe and effective?
WHO has issued a number of guidelines on the use of the types of syringes they recommend, such as the WHO guidelines on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in healthcare settings, published in 2016. These guidelines describe what WHO considers to be unsafe practices and give recommendations on safe ones. They advocate the use of syringes that are made according to the definitions and requirements of several ISO standards to ensure they meet internationally agreed levels of safety and quality.
These include ISO 23908, Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling, which provides internationally agreed minimum standards to reduce the risk of injury from sharps. In addition, the ISO 7886 series, which specifies properties and requirements for sterile single-use hypodermic syringes, also covers auto-disable syringes (ISO 7886-3) and syringes with reuse prevention features (ISO 7886-4). The auto-disable syringes are also those being used in the COVAX initiative.
These standards are highly useful tools for syringe manufacturers to ensure they comply with WHO recommendations as well as global best practice. They also assist new manufacturers with what is required to manufacture a product that is fit for use with vaccines, saving them huge amounts of time. This is extremely important because we cannot afford to have a single wasted effort given the high quantities required for the millions and millions of vaccines.
Why is there a need for so many syringes when many of the vaccines come in vials? Why can’t syringes be re-used?
Reusing syringes increases the risk of bloodborne diseases such as hepatitis B and C and HIV. WHO has been urging the use of single-use syringes, also known as auto-disable syringes or “smart” injections, for some time. Reuse of syringes and inadequate sharps waste management were stated as key risk factors for infection of both patients and healthcare workers in the WHO guidelines. Thus, they strongly recommend single-use syringes, as specified by standards ISO 7886 and ISO 23908. These standards define the requirements for manufacturers of these products with regard to performance and fitness for purpose of safety syringes.
What is the future of syringe technology? And how is ISO addressing this?
There are developments in the area of new materials, specifically with plastic polymers, which have benefits when it comes to manufacturing as they enable the creation of syringes to more precise specifications. We are also seeing new technology where, for example, the polymer syringe has a micro-layer of glass on the inside. This provides syringes that meet dimensional specifications as well as a traditional glass-drug contact surface.
What is perhaps also relevant to the current COVID-19 vaccine campaign is the potential use of needle-free injectors. This is where the medication is injected by pressure and high velocity, or a mechanical motion to impart kinetic energy to the product, so that it penetrates the skin virtually painlessly. This is extremely interesting when it comes to vaccinating large populations quickly, as it has the potential to administer shots faster. It is also reassuring for needle-phobic people as there are no needles. This type of injector could also be very useful if the vaccine is, at any point, recommended for children.
Development is ongoing in terms of how needle-free injectors could be used with the COVID-19 vaccine and I believe they could be available in the next year or two. To that end, late last year, the committee consulted with a range of stakeholders, including WHO and CDC (Centers for Disease Control and Prevention), to check if our current standard for this technology, ISO 21649, Needle-free injectors for medical use – Requirements and test methods, was still relevant. We established that there are new understandings, market trends and technology developments that need to be taken into account, so we have embarked on a fast-tracked project to review and update the standard as quickly as possible. This means that any company wishing to support delivery of COVID-19 vaccines with needle-free technology will have the necessary guidance to make the appropriate injectors.
The COVID-19 pandemic has really reinforced the importance of international collaboration and the need to continue working closely with our partner organizations, such as WHO. COVID-19 is a truly global problem which knows no borders. Only by working together can we make a real difference.
More and more, health systems are addressing the concept of patient-centered care and ISO is at the forefront of this development.