Learn how ISO 80369 standards improve patient safety by preventing small-bore connection errors in medical devices. Discover its impact on manufacturers and healthcare.
Small-sized connectors are used to connect medical devices. Though rare, small-bore misconnections can lead to injuries or even patient death. ISO 80369 was created to reduce the risk of connection errors. The adoption of ISO 80369 was a big step toward improving patient safety. It introduces unique connector designs for different medical applications.
Medical device manufacturers had to redesign their products to ensure they complied with the new requirements, whereas healthcare professionals had to learn how to use new connectors correctly. Though medical device manufacturers and healthcare professionals faced significant challenges once ISO 80369 was introduced, there is no denying that it has had a positive impact on patient safety.
Earlier, the universal luer connector was used in the healthcare sector to standardize connections. Though the connector maximizes convenience, it increases the risk of two incompatible devices being connected, which can result in medical errors (such as enteral nutrients or medications being administered through the wrong route) with serious consequences. It was only a matter of time before experts in the healthcare industry felt the need to standardize small-bore connector designs.
The other two main objectives (in addition to improving patient safety) of ISO 80369 were:
a) to create a regulatory framework that enables medical device manufacturers to import and export medical devices without worrying about design discrepancies, and
b) to help ensure healthcare professionals have peace of mind knowing that small-bore connectors are designed to prevent connection errors, so they could focus on delivering care.
There are several parts of ISO 80369; each part targets a specific medical connection facilitated by small-bore connectors.
ISO 80369-1 establishes general requirements that all small connectors should meet and specifies medical applications for which connectors should be used.
This part of ISO 80369 discusses standardized test methods that should be used to assess the performance of small connectors according to criteria established by other parts. Testing helps ensure that connectors meet all quality and safety standards.
This section aims to prevent accidental connections between respiratory systems and other medical devices by specifying requirements that connectors used in anesthesia and ventilation applications should meet.
It introduces changes to the design of connectors for enteral feeding devices to reduce the risk of medication errors due to connection errors.
This establishes design standards that connectors used in urinary drainage devices should meet.
This section applies to limb cuff inflators and other blood pressure measurement devices. It aims to prevent connections between the connectors of these devices and other medical devices.
This part aims to ensure that connectors used in neuraxial procedures aren’t accidentally connected to other devices by establishing requirements they should meet.
It specifies requirements (regarding dimension and design) that connectors used in intravenous and hypodermic applications should meet.
Nel PreTech Corporation is dedicated to helping medical device manufacturers ensure compliance with stringent industry standards for their connectors, specifically luers. By integrating our advanced dimensional inspection services into the manufacturing process, we guarantee consistent quality and reliability. Our precise 3D scanning technology allows us to measure the physical dimensions of luers with exceptional accuracy, detecting any defects early and enabling swift corrective actions. The deliverables for our dimensional inspection services include comprehensive reports detailing measurements, tolerance checks, and compliance status, ensuring that every batch meets the required specifications and maintains the highest standards of safety and performance.
When it comes to dimensional inspections, there is no room for error. We follow best practices for conducting dimensional inspections. Our operators are trained in the use of scanners and other inspection equipment. We use a range of inspection tools designed to capture the minutest details.
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