ISO 80369-7 Compliance Update
As we await the publication date of the second edition of ISO 80369-7, we want to apprise you of the current status, compliance testing and how we can assist you.
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If you are currently using any small-bore connectors in a kit, set, or line that drive gas or pressurized fluids to patients, or you are using luer fittings in non-IV applications, this may impact you. This standard involves some key changes from component suppliers, which may include designing new connectors or modifying existing connectors to meet the updated specifications.
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 were written with the goal of preventing misconnections between small-bore connectors in liquid and gas healthcare applications.
This series of standards aims to improve patient safety in enteral, respiratory, urinary, blood pressure, neuraxial and intravenous systems.
Luer connectors are commonly used in the medical field, but their uniform design across multiple device types has resulted in serious misconnection issues. This article discusses the implementation of ISO 80369-compliant fittings with unique connection geometries that help to prevent these critical misconnections of tubes and catheters.
Industry organizations, regulatory agencies, manufacturers and healthcare facilities have the responsibility to eliminate misconnections that can cause serious injury for patients. The ISO 80369 series of standards were designed to prevent misconnections of medical devices and ensure patient safety. ISO 80369-3 specifically addresses enteral and gastric medical device applications by defining the geometry, material characteristics and performance of a new standard connector pair.
In a highly regulated space like medical device design and manufacturing, safety standards are frequently updated to stay in step with innovation and minimize risk for patients. Regardless of the size or scope of the project, your design needs to be reviewed for a combination of cost consideration and evidence of adherence to the current safety standards and regulatory updates.
U.S. medical facilities have been slow to accept ISO 80369, but now device manufacturers are paving the way for easy adoption. Find out how McLaren Health Care successfully implemented a new connector strategy with minimal disruption to day-to-day operations.