Design of medical equipment

Safeguarding lives with standardized design

Prepare for the unpredictable with medical device design standards

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Healthcare standards for safer syringes

Some 16 billion injections are administered around the world every year, each one bringing with it a risk of transmitting disease. Reusing syringes increases that risk exponentially. With the global rollout of the COVID-19 vaccinations, never has the safety of injections been more critical. There are many reasons to enhance the safety of administering injections. The price and chronic shortage of medical supplies force desperate measures, which include the 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. To reduce the risks of injury and disease transmission, the World Health Organization (WHO) launched in 2015 a new policy on injection safety, calling on the international community to switch to safety-engineered syringes, whenever appropriate. It issued highly detailed injection safety guidelines, which outlined several safety features for syringes that not only protect the recipient of the injections but the healthcare worker who administers them as well. WHO stressed that the transmission of infection is not just limited to developing countries as reuse of syringes occurs in many places. The adoption of safety-engineered syringes is critical to protecting people worldwide from becoming infected with HIV, hepatitis, and other diseases. This should be an urgent priority for all countries. Key Standards for Safety Engineered Syringes Published in 2015, the WHO guidelines on the use of safety-engineered syringes for intramuscular, intradermal, and subcutaneous injections in healthcare settings provide basic rules for syringes with “sharps injury protection” features. It defers to the definitions of BS EN 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. This standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single-use, introducers for catheters, and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. In addition, the BS ISO 7886 series, which specifies properties and requirements for sterile single-use hypodermic syringes, also covers auto-disable syringes (BS ISO 7886-3) and syringes with reuse prevention features (BS 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 standardized 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 standards are updated regularly to ensure they continue to meet the needs of manufacturers and users. They also take into account any new technologies that will contribute to reducing the risk of transmissible diseases. In your compliance-critical industry, ensure you are meeting the industry safety standards. A BSI Knowledge subscription gives you instant access to the resources you need to improve the safe design, manufacture, and distribution of safe syringes. Build your own custom collection of standards, or opt for access to over 4,800 documents in our GBM05 Sciences & Healthcare module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. Shaping the Future of Syringe Safety But it doesn’t stop there. BSI’s involvement in expert committees continually evolving and evaluating its work to develop standards that meet the needs of injection use in more and more settings. Whatʼs more, though developed standards were originally focused on devices for use by healthcare professionals, 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 that have met the WHO’s 2020 deadline to transition to safety-engineered syringes. It also paves the way for achieving some of the UN’s Sustainable Development Goals while saving lives in countries where the re-use of syringes remains high. Ensure your organization’s syringes meet minimum requirements for quality and safety, by adding these standards to your collection today.