Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Intravenous Connectors with One-way Valves

10 Oct 2012

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning all intravenous (IV) connectors with one-way valves such as non-return, check, anti-reflux or anti-siphon/anti free-flow valves.

According to the MHRA, needle-free IV connectors are two-way valves when activated. When not activated, the system remains closed without the need for a cap. Unlike these, IV connectors with one-way valves do not have an integral membrane that closes the system. Therefore, if the IV connector with one-way valve is left un-capped, air may enter the uncapped connector.

The MHRA supplemented that valves with a lower activation pressure (e.g. anti-reflux, check, non-return valves) are even more susceptible to air entrainment if left uncapped than higher activation pressure valves (e.g. anti-siphon/anti free-flow valves). These devices have been confused with needle-free IV connectors (with an integral membrane) leading to instances of air emboli. Therefore, the MHRA reminded all medical and nursing staff to:-

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON192152

Posted on 10 October 2012

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