What is ISO 80369?
The U.S. Food and Drug Administration, The Joint Commission, the Institute for Safe Medication Practices, the United States Pharmacopeia, and the ECRI Institute have all received reports of misconnection errors. ISO 80369 is the development of standardized connector designs for small-bore connectors for liquids and gases, so they cannot be interconnected with devices for other medical applications. These standards are critical to the safe and effective use of these devices for the safety and health of your patients.
ISO 80369 is divided into seven sections. The first section (Part 1) identifies the general requirements for small-bore connectors, and the following six identify specific requirements for connectors falling into one of the following general application areas: Part 2) breathing and driving gases; Part 3) enteral (feeding tube) applications; Part 4) urethra and urinary; Part 5) limb cuff inflation or non-invasive blood pressure; Part 6) neuraxial applications; and Part 7) intravascular or hypodermic applications. Other standards may be added later, if warranted by patient safety risk and clinical need.
FACTS about ISO 80369-1 and ISO 80369-3
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Did You Know:
The FDA recommends that hospitals use enteral connectors that are not interchangeable with other connectors and eliminate the risk of misconnections. This recommendation applies to connectors compliant to both ISO 80369-1 and ISO 80469-3. Neither standard is mandated or recommended over the other.
Although ENFit® continued to prevent misconnections, it presented various clinical problems into the marketplace including bacterial contamination and usability issues from having to use a cleaning brush. Nelson Labs and Children’s Mercy Kansas City have both released reports documenting the contamination issues.
The National Coalition for Infant Health performed a demonstration that ENFit® connectors are not efficient in a NICU setting and can take several minutes to change and clean compared to non-ENFit®, safety options.