By Clare Naden
Some 16 billion injections are administered around the world every year1), each one bringing with it a risk of transmitting disease. Reusing a syringe increases that risk exponentially. ISO is tackling the problem with standards for single-use syringes and a set of requirements to prevent unintentional needle-stick injuries. Some of these standards are being updated to make them even more fit for purpose.
A 2014 study sponsored by the World Health Organization (WHO), which focused on the most recent available data, estimated that in 2010 up to 1.7 million people were infected with hepatitis B virus (HBV), up to 315 000 with hepatitis C virus (HCV) and as many as 33,800 with HIV through an unsafe injection. While in the developed world, most injections are administered safely, injection practices worldwide vary widely, with reuse of injection equipment, poor handling of needles after use and informal cleaning still posing a problem in some regions.
This is nothing new. The WHO launched its WHO Injection Safety Programme and the Safe Injection Global Network (SIGN) back in 2000 already, in a bid to achieve safe and appropriate use of injections throughout the world. At the start of the programme, it was believed that around 40 percent of injections were administered with reused injection equipment, contributing to millions of new HBV and HCV cases and hundreds of thousands of cases of HIV.
The WHO initiative led to the development of many new designs of syringes with features claimed to disable the syringe after its first use. However, not all of them fulfilled the single-use objective. ISO had already published standards for traditional types of syringes without auto-disabling features, so it seemed only natural that it should extend the series with new standards for syringes with auto-disabling features.
ISO’s expert committee on injection systems recognized that reuse of syringes wasn’t the only risk to address. The infection by accidental needle-stick injury was a very real health hazard, especially for healthcare providers and people who come into contact with needles or other sharps2) in medical facilities or public places.
Path to prevention
Based on the WHO initiatives, ISO’s expert committee on syringes was investigating the risks of reused syringes and the fact that the existing standards for single-use hypodermic syringes (ISO 7886-1 and ISO 7886-2) and hypodermic needles (ISO 7864) did not specifically address the risk of reuse. The committee agreed on the development of new standards to reduce these risks and thus prevent the spread of deadly diseases such as HBV, HCV, and HIV.
Although standardization work in that field began many years ago, there is a continued need to address unsafe injection practices on a global scale. It is no random coincidence, then, that abolishing the reuse of syringes is a key target in the United Nations Sustainable Development Goals (UN SDGs), which form part of the UNʼs 2030 Agenda for Sustainable Development adopted by world leaders in 2015. SDG 3 for good health and well-being pledges to “end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases, and combat hepatitis, waterborne diseases and other communicable diseases” by 2030. Preventing the reuse of syringes, and avoiding unintended needle-stick injuries, will clearly help towards this goal.
William Dierick, who initially led the standards development work on auto-disabling syringes as part of ISO technical committee ISO/TC 84, Devices for administration of medicinal products and catheters, says the committee’s philosophy was – and still is – to focus on patient safety and ensure that the requirements of the standards are the most up to date. “Where there are new technological improvements or features, or new types of medicinal products, we aim to be there to adapt the standards in order to ensure patients receive the safest and most effective care,” he says.
“This is why we involve all parties when developing our standards, including health authorities such as the Food and Drug Administration (FDA), international organizations like the WHO and the United Nations International Children’s Emergency Fund (UNICEF), manufacturers of both drugs and devices, and end users such as patients and healthcare workers,” he adds.
This inclusive approach is one of the reasons why Danish Standards, which holds the secretariat for ISO/TC 84, entered into a twinning project with the Standards Association of Zimbabwe (SAZ) in order to encourage involvement of the African continent in the development of standards for safer medical devices. Chaired by Zimbabwe, the partnership led to the successful release of ISO 23908 for sharps protection features and ISO 23907 for sharps containers, which provide a welcome complement to other standards in the field, such as ISO 21649 (needle-free injectors) and the ISO 7886 series (hypodermic single-use syringes).
There are many reasons to enhance the safety of administering injections. The price and chronic shortage of medical supplies force desperate measures, which include reuse of single-use injection equipment. Moreover, scientific studies reveal that administering injections is not only a risk for medical personnel but also for ancillary staff such as cleaners, laundry workers or laboratory technicians.
In an attempt to reduce the risks of injury and disease transmission, the WHO launched in 2015 a new policy on injection safety, calling on the international community to switch to safety-engineered syringes, whenever appropriate, by 2020. It issued highly detailed injection safety guidelines, which outlined a number of safety features for syringes that not only protect the recipient of the injections, but the healthcare worker who administers them as well.
The WHO stressed that the transmission of infection is not just limited to developing countries as reuse of syringes occurs in many places. “Adoption of safety-engineered syringes is absolutely critical to protecting people worldwide from becoming infected with HIV, hepatitis and other diseases. This should be an urgent priority for all countries,” said Dr Gottfried Hirnschall, Director of the WHO HIV/AIDS Department, in a press release issued at the time the guidelines were launched.
A standard language
Published in 2015, the WHO guidelines on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in healthcare settings provides basic rules for syringes with “sharps injury protection” features. It defers to the definitions of 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). This makes it a highly useful tool both for the manufacturers that produce them and for users who can rest easy in the knowledge that the syringes meet minimum requirements for quality and safety.
The WHO document references safety-engineered syringes according to their ISO definition to provide an exact characterization of the safety mechanism of each type of syringe and allow a common understanding between all guideline users. These ISO standards are updated regularly to ensure they continue to meet the needs of manufacturers and users, and take into account any new technologies that will contribute to reducing the risk of transmissible diseases.
But it doesn’t stop there. William Dierick says the committee is continually evolving and evaluating its work to develop standards that meet the needs of injection use in more and more settings. “We also have other standards that focus on the requirements for devices to be used by specific groups, such as visually impaired patients and certain age groups,” he adds.
“Whatʼs more, our standards were originally focused on devices for use by healthcare professionals, but with the increased number of devices for self-administration, we decided to expand the work to include pen-injectors, auto-injectors and body-worn injectors. This will lead to more efficient and convenient administration of the medicinal products, with great benefits for healthcare systems and patients.”
All of this bodes well for countries as they approach the WHO’s 2020 deadline, urging them to transition to safety-engineered syringes whenever appropriate. It also paves the way for achieving some of the UN’s Sustainable Development Goals while saving lives in countries where the reuse of syringes remains high.
1) WHO Injection Safety Fact Sheet.
2) Sharp: medical instrument (scalpel, lancet or syringe needle) that is sharp or may produce sharp pieces by shattering.
This article first appeared on the ISO website and is published here with permission. Please visit the ISO Website www.iso.org for more information.