What is BS EN ISO80369-15:2017?

BS EN ISO80369-15:2017, also known as the ISO 80369-15 standard, is a part of a series of international standards that focuses on small-bore connectors for healthcare applications. The purpose of this standard is to improve patient safety and reduce the risk of misconnections between medical devices.

Importance of BS EN ISO80369-15:2017

Misconnections in healthcare settings can have serious consequences, leading to medication errors, infections, or even death. Prior to the introduction of BS EN ISO80369-15:2017, various types of medical devices used different connector systems that were compatible with each other. This lack of standardization made it easier for healthcare professionals to accidentally connect the wrong devices, resulting in potentially dangerous situations.

The implementation of BS EN ISO80369-15:2017 sets guidelines for manufacturers to develop connectors that are specific to their intended use. This reduces the possibility of misconnections and enhances patient safety by ensuring that incompatible medical devices cannot be connected together.

Key Requirements of BS EN ISO80369-15:2017

The standard specifies the design and performance requirements for small-bore connectors in healthcare applications. It focuses on enteral and respiratory applications, including feeding tubes, breathing circuits, and oxygen therapy. The key requirements include:

Mechanical Design: The connectors must have unique geometric features that prevent interconnection with other connector systems.

Color-Coding: Each connector should be visually distinguishable through color-coding or other methods, to reduce the risk of misconnections.

Force to Connect/Disconnect: Connectors should require a specific amount of force to ensure proper engagement, while allowing for easy disconnection when required.

Leakage and Pressure Resistance: The connectors must be able to withstand certain pressures without leakage or disconnection.

Implementation Challenges and Benefits

While implementing the BS EN ISO80369-15:2017 standard initially posed some challenges for healthcare facilities and device manufacturers, its benefits outweigh the difficulties. One challenge was the need to replace existing connectors with those compliant with the new standard, which involved cost and time commitments.

The implementation of this standard has significantly reduced the risk of misconnections, better protecting patients from harm. Improved patient safety leads to reduced liability for healthcare facilities and provides a greater level of confidence for both medical professionals and patients. Additionally, the standardization of small-bore connectors promotes innovation in medical devices by encouraging manufacturers to produce safer and more reliable products.

In conclusion, the BS EN ISO80369-15:2017 standard plays a critical role in enhancing patient safety in healthcare settings by reducing the risk of misconnections between medical devices. By specifying design requirements and ensuring compatibility, this standard significantly reduces potential errors and improves overall outcomes for patients receiving medical care.