Safety syringes: a safe and effective way to reduce needlestick injuries

The World Health Organization (WHO) recommends the use of safety syringes with built-in safety features to prevent reuse, in order to eliminate or minimize the risk of infection for healthcare workers and patients. Promoting a safe working environment is a priority for healthcare systems today, especially in light of the shortage of doctors and nurses in Italy and the rest of Europe.

Standards and Regulations for Safety Syringes

The design and manufacturing requirements for syringes are defined by the International Organization for Standardization (ISO). Specifically, the standard EN ISO 23908:2013 provides requirements and test methods to evaluate the performance parameters of cut protection features for disposable hypodermic needle devices, catheter introducers, lancets, and other needles used for blood collection.

In the European context, the standard EN ISO 23908:2013 is listed among the “existing harmonized standards for review” by May 27, 2024, as part of the European Commission’s proposal for the standardization of Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). This review pertains to technical solutions for safety mechanisms to be applied in the design and manufacturing of devices, ensuring compliance with Sections 11.1 and 22.2 of Chapter II of Annex I of Regulation (EU) 2017/745. The standard applies to devices intended for the administration and/or extraction of bodily fluids/blood and/or medicinal substances.

Ensuring Uniform Application of Standards

Given the importance of needlestick injuries, it is crucial to avoid gaps in the interpretation of the MDR regarding general safety and performance requirements. To this end, the General Council of Spanish Nurses and the European Biosafety Network have published an Interpretive Guide aimed at ensuring consistency in the implementation and interpretation of the MDR regarding the requirements defined in Annex 1, Sections 11.1 and 22.2.

Technological Innovation for Needlestick Injury Prevention

Currently, there are medical devices available on the market that fully comply with the quality and safety standards established by regulations. Roncadelle Operations, an Italian company with over two decades of experience in developing minimally invasive and safe devices for drug administration/self-administration, utilizes cutting-edge technologies and production facilities to ensure safe and effective products.

The Safer® passive safety syringe with retractable needle is one of these devices. It features several safety characteristics that ensure accurate drug dosage, allow the needle to automatically retract at the end of injection, prevent contact between the operator and the patient, and prevent device reuse.

Conclusions

To minimize the risk of needlestick injuries and protect healthcare workers and patients from potential serious infections, appropriate measures need to be implemented. This includes consistent interpretation and universal implementation of the Sharps Directive 2010/32/EU, the Medical Device Regulation (EU) 2017/745, and the updated ISO 23908 standard by May 2024. Furthermore, it is important to promote the widespread use of safety syringes and the elimination of unsafe devices. Finally, the introduction of national surveillance can help ensure the procurement and use of safety devices, monitor the phenomenon of accidental exposures, and collect updated data on needlestick injuries.