Medical Devices Training Manager, Morriston Hospital, Swansea Bay University Health Board.
Head of Pharmacy, Neath Port Talbot Hospital, Swansea Bay University Health Board.
Br J Nurs. 2021 Jul 22;30(14):S14-S22. doi: 10.12968/bjon.2021.30.14.S14.
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.
在英国，药品和保健品管理局将用于冲洗静脉（IV）套管和 IV 接入装置的“预充式注射器”归类为“边缘”设备，并就如何控制措施有助于降低风险提供了一些建议。《药品法》（1968 年）和《医疗器械法规》试图解决这些设备的法律地位，并允许每个雇主确定允许使用这些设备的员工群体。反过来，这可能有助于解决有关规定和记录其使用的必要性的异常情况。本文描述了威尔士的一家大型大学保健委员会如何实施产品和实践的变更，并探讨了采用和使用符合 CE 标记的预充式、无菌氯化钠注射器代替手动配制 IV 冲洗液（CE 标记表示符合欧洲法律要求的设备）的问题。探讨了使用单个组件或单个预充式设备是否可以实现简化和具有成本效益的方式来管理 IV 套管和血管接入装置的冲洗。还确定了其他风险因素，并根据当前指南和法规澄清了法律地位。由于安瓿和小瓶中的 0.9%氯化钠被归类为仅限处方药物，因此需要通过正式处方或患者组指令来控制给药。在将这些预充式注射器作为 CE 标记的医疗器械用于冲洗 IV 套管和 IV 接入装置之前，需要每个雇主机构仔细考虑并签署同意。
