Misconnections: What is ISO 80369 and how does it affect you?


Healthcare facilities depend on a slew of catheters, tubing and delivery devices in all levels of chronic and emergency care management. The ISO 80369 standards are the result of 10 years of design-driven work towards prevention of misconnections between small-bore connectors in liquid and gas healthcare applications. This series of standards, some of which are still in development by the International Organization for Standardization (ISO), aim to improve patient safety in enteral, respiratory, urinary, blood pressure, neuraxial and intravenous systems.

In a typical hospital setting, some patients have many lines connected to them delivering a variety of medicines and nutrients. Many of those devices and systems utilize universal luer lock connectors with male and female tapered fittings to form leak-proof connections. Luers, originally designed in the spirit of collaboration, were standardized across the world to simplify engineering and design partnerships.

Though the design was implemented with good intentions, its widespread overuse across multiple applications contributed to adverse events. The universality of this small-bore connector is useful for efficiency and cost savings, but allows healthcare workers to mistakenly connect one device used for one application to another device used for another application and potentially harm a patient.

Now, ISO is assessing ways to ensure parts are non-interconnectable and providing design specifications based on device application. If you are using any small-bore connectors that deliver gas or fluids to patients and are using luers in non-IV applications, this standard may impact you. For more information on the standards by specific application, click here.

Going forward, continued collaboration can encourage the adoption of these standards for the health and safety of the patient. According to the FDA, 2 deaths, 24 serious injuries and 32 device malfunctions related to enteral misconnections alone were reported within the last decade. The administration is concerned that many instances of misconnections are not reported correctly or fail to be reported at all. While healthcare professionals are on the frontlines of care, manufacturers are responsible for designing to minimize error on the hospital floor.

Determining when to submit documentation to make a change on an existing device is not a simple decision. Modifications made with the intent to affect safety and effectiveness of a device require a 510(k) submission to the Food & Drug Administration, accompanied by extensive documentation and cost implications. For additional information on when to submit a 510(k), review this FDA guidance.

Whether you’re planning to transfer a device over to comply with an ISO 80369 standard or develop a system from scratch, Qosina will partner with you to prioritize patient safety. Our extensive experience simplifies the back end, so you can continue to do what you do best—developing.

For helpful information on identifying medical device misconnections, review the FDA’s case studies.

To learn more about how Qosina can help you implement ISO 80369, contact us at info@sales.com.