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Developing standards to help care providers

Manufacturing Group | December 26, 2013

Novation is helping to develop new standards to prevent tubing misconnections.

Novation is working with industry leaders on new design specifications to reduce tubing misconnections significantly, which is expected to have an enormous impact on the health care supply chain and patient safety. 

With the advent of new medical technology, a typical patient could be connected via tubes or catheters to several delivery systems to receive medication, nutrients, and fluids. A universal tube connector, commonly known as a Luer connector used throughout every hospital in the U.S., allows therapeutically dissimilar devices to be easily connected. The problem is just that: since the connector easily fits most devices, health care providers can inadvertently connect one delivery system to another which serves a completely different function.  Tubing misconnections, also referred to as small bore misconnections or wrong route errors, have become a serious patient safety issue, one that can be fatal, and one that is believed to be seriously underreported.  

"Novation is pleased to be working with several organizations to develop standards to help care providers reduce the chance for error and potential harm to patients," said Stephanne Hale, senior clinical manager, Novation. "While the vast majority of the hospital members we surveyed indicated they have taken steps to prevent tubing misconnections in their facilities, developing new standards to drive unique connectors for each delivery system will make it much more difficult, if not impossible, to connect unrelated delivery systems.  We will be working with health care organizations to help them prepare for new products, which are expected to come to market in late 2014."

The group developing the small-bore misconnection standards consists of clinicians, manufacturers, and regulators, including the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO) with the Association for the Advancement of Medical Instrumentation (AAMI), and members of the medical device industry. Collectively, the group is developing the 80369 series, which will require small-bore connector designs involving the Luer connector to be specific to the applications they were intended for and not a universal fit.

Source: Novation

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