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. Enteral administration devices that use typical luer connectors have the highest observed misconnection rate of any application, and this is where regulators identified the most improvement potential when they began to explore new methodologies. Over the last decade, the FDA has released several reports on enteral misconnections and the importance of small-bore connector changes including safety considerations and letters for manufacturers and healthcare professionals.
The new enteral feeding connectors were designed to improve patient safety using a non-traditional orientation and larger dimensions that do not allow connectivity with the typical male or female luer connectors; the new specifications will not join with the common conical luer (ISO 594) fitting standards or any other connectors approved for clinical use. Administration sets and syringes still have a female connector end that fits into a male patient-access feeding tube port.
The Global Enteral Device Supplier Association (GEDSA) created and trademarked the ISO 80369-3 compliant ENFit™ brand. Qosina offers a variety of ENFit™ male and female parts including connectors, stopcocks, caps, adapters and syringes, among others. These parts are available for immediate delivery with low minimums and short lead times on components for single-use systems.
The ENFit™ connector has been tested using a strict validation process that includes human factors research, usability analysis, performance testing, misconnections assessment and computer-aided design techniques. Based on feedback from manufacturers and stakeholders, ISO 80369 has been implemented successfully across Europe. To further promote standards adoption, GEDSA created the “Stay Connected” campaign to provide resources including FAQs, transition checklists and webinars.
As part of its “Stay Connected” campaign, GEDSA acknowledges that the transition process is a team effort that requires careful communication. Even if manufacturers are following guidelines and adopting changes, an orderly transition is only made possible with support from the whole system: manufacturing, supply chain, industry and healthcare providers alike. Implementing ISO 80369-3 compliant components is a significant step towards reducing tubing misconnections and saving lives.
The U.S. movement toward full ISO 80369 implementation has been slow, and there are continually new updates from regulators; regardless, we are prepared. ISO 80369-3 requires time when it comes to design, in-house testing, documentation and implementation, and Qosina has that documentation for you. Knowing the potential barriers farther down the road, we are driving this change to make it easier for engineering teams to adopt new standards and improve the safety profile of their devices.
To learn more about the products Qosina offers to address ISO 80369-3, visit https://www.qosina.com/enfit, or call us today and speak with one of our knowledgeable customer specialists.