The International Organization for Standardization (ISO) in 2010 published the ISO 80369-1 standard providing general requirements to prevent misconnections between small-bore connectors used in various applications.
ISO 80369-5 Blood Pressure Fittings
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What is ISO 80369, and How Does It Affect You
Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems. These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care.
Unfortunately, because Luer connectors are ubiquitous, easy-to-use and compatible between different delivery systems, clinicians can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Such errors have occurred in diverse clinical settings, causing serious patient injuries and deaths. The Food and Drug Administration (FDA), The Joint Commission (TJC), the Institute for Safe Medication Practices (ISMP), the United States Pharmacopeia (USP), the ECRI Institute and others have all received reports of misconnection errors. The problem is well-known and well documented. Yet despite efforts on the part of FDA and other organizations to reduce misconnections through education, protocol and monitoring, the use of Luer connectors in incompatible medical delivery systems continues to create situations where dangerous misconnections can, and do, occur.
To further reduce the occurrence of these misconnections, FDA is actively participating in an international effort to develop and implement standards for noninterchangeable connectors for small bore medical connectors. A joint working group established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) leads this effort to develop a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, these connectors will facilitate correct connections and eliminate incompatible tubing misconnections.
Until standards are completed and manufacturers design and produce products that can’t be misconnected, all interested parties must continue their efforts to keep these dangerous misconnections from happening. "Actions must be taken at the patient bedside, within all levels of health care organizations and throughout the channels of regulation, manufacturing and distribution of these devices in order to eradicate the serious problem of tubing misconnections," said Peter B. Angood, M.D., Vice President and Chief Patient Safety Officer for The Joint Commission (TJC).
- U.S. Food and Drug Administration
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