ISO80369-5 was developed as an international standard to prevent cuff connection errors with different types of medical devices that use the same or similar connectors. Whilst connection errors were few and far between they could have fatal consequences.
The US Food & Drug Administration (FDA) reported several real life incidents involving misconnections.
In one a blood pressure cuff was accidentally connected to an Intra Venous (IV) catheter.
A patient had an IV catheter in their arm but no IV fluids had been started. The patient also had an automatic BP cuff fitted on the same arm for continuous monitoring. The BP cuff tubing was disconnected from the blood pressure monitor while the patient went to the bathroom.
When she returned, her spouse accidentally connected the BP cuff tube to the IV catheter and approximately 15 mL of air was delivered to the IV catheter by the blood pressure monitor.
Unfortunately the patient died from a fatal air embolus, despite resuscitation efforts.
As a precaution and so this can’t happen again new ISO connectors are being introduced on blood pressure cuffs to ensure correct device connections, even in complex working environments and avoiding fatal consequences.
Japanese company A&D Medical are one of the first manufacturers of clinically validated digital blood pressure monitors to have introduced ISO-80369-5 connectors to their blood pressure cuffs and monitors.
The latest UA-651SL Plus is compliant with the ISO80369-5 regulation. It features A&D Medicals latest 4th generation Electric Control Exhaust Valve (ECEV) which precisely controls cuff deflation.
This low cost digital monitor can use 4 different cuff sizes for arm sizes ranging between 16cm – 45cm, including small, adult and large cuffs.
In the UA-651SL Plus A&D Medical are one of the few manufacturers to have a model that can use small, adult and large adult cuffs.
It’s important to note that ISO80369-5 cuffs cannot be used with non-compliant ISO80369-5 blood pressure monitors and they are not interchangeable with earlier models.