New standards set to improve safety of medical device connections in clinical settings

by Clare Naden on
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Operating room with surgeons and medical heart rate monitors
Feeding tubes, catheters and IV drips are just some of the essential delivery devices used in medical settings that save lives every day. But even minor errors in their connectors can have devastating consequences. A new range of ISO standards aims to mitigate the risk.

Delivery systems for food, liquids, medications and gases, such as oxygen, are important medical devices that patients and health professionals rely on every day. In order to deliver the product intended, these systems rely on the correct choice and use of connectors.

Historically, one type of connector was used for many different applications, but following a series of accidents in the 1990s, the medical community recommended that different connectors be used for different applications in order to reduce the risks, a recommendation subsequently endorsed by the US Food and Drug Administration (FDA). This means that a different connector would be used for breathing systems, for example, than for intravascular or hypodermic tubes.

Now, that risk is reduced even further with a new series of standards in progress, and the first of those specific to an application – neuraxial applications, such as anaesthetics – has just been published. Developed in collaboration with the International Electrotechnical Commission (IEC), the ISO 80369 series, Small bore connectors for liquids and gases in healthcare applications, has a number of parts for specific small-bore connectors.

Scott Colburn, Convenor of the joint working group ISO/TC 210/JWG 4 that is developing these standards and Director of the Center for Devices and Radiological Health (CDRH) Standards Program of the FDA, has played a key role in developing this series to respond to concerns about the risks of incorrect delivery and “wrong route” medication errors.

“This series aims to improve the safety of the delivery of liquid and gases in healthcare settings. It draws information and inspiration from a number of international and European standards in the field, but is the first International series of standards of its kind,” he said.

“Part 6 specifies the requirements for connectors used in neuraxial applications intended to administer medications to neuraxial sites, wound infiltration, anaesthesia delivery, other regional anaesthesia procedures and to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. Use of the standard will thus reduce the risk of the wrong product being administered, potentially saving lives.”

The other standards in the series that are already published include Part 1, General requirements, which specifies the requirements for the designs and dimensions of small-bore connectors and Part 20, Common test methods, which supports the performance requirements.

Other upcoming standards in the ISO 80369 series include:

Part 2: Connectors for breathing systems and driving gases applications

Part 3: Connectors for enteral applications

Part 7: Connectors for intravascular or hypodermic applications

ISO 80369-6 is available from your national ISO member or through the ISO Store.