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"This article describes how one large university health board in Wales implemented a change in products and practice and explores the issues around adopting and using CE-marked pre-filled, sterile syringes of 0.9% sodium chloride in place of manually drawing up an IV flush (the CE mark indicates devices that conforms with European legal requirements)" Lee and Terry (2021).

IV flushing with pre-filled syringes

Abstract:

In the UK, the Medicines and Healthcare products Regulatory Agency classifies ‘pre-filled syringes’ for flushing Intravenous (IV) cannulas and IV access devices as ‘borderline’ devices and offers some advice on how control measures can help mitigate risks. The Medicines Act (1968) and Medical Device Regulations try to address the legal position of these devices and allow each employer to identify those groups of staff allowed to use them. In turn, this may help address anomalies around the need to prescribe and document their use. This article describes how one large university health board in Wales implemented a change in products and practice and explores the issues around adopting and using CE-marked pre-filled, sterile syringes of 0.9% sodium chloride in place of manually drawing up an IV flush (the CE mark indicates devices that conforms with European legal requirements). Whether the use of individual components or a single pre-filled device can lead to a streamlined and cost-effective way to manage the flushing of IV cannula and vascular access devices was explored. Additional risk factors were identified, and the legal status clarified in line with current guidelines and regulations. As 0.9% sodium chloride in ampoules and vials is classified as a prescription-only medicine, the administration needs control via formal prescription or a patient group direction. Adopting and using these pre-filled syringes as CE-marked medical devices requires careful consideration and sign-off from each employing authority, before implementing them for flushing IV cannulas and IV access devices.


Reference:

Lee PT, Terry J. Changing practice to using pre-filled syringes for flushing IV cannulas. Br J Nurs. 2021 Jul 22;30(14):S14-S22. doi: 10.12968/bjon.2021.30.14.S14. PMID: 34288752.