FDA Issues Guidance, Advice On Avoiding Catheter Tube Errors

Federal regulators have proposed new guidelines regarding the use of small-bore connectors, which allow for the connection between a variety of medical devices, including catheters, after recognizing a steady increase in patient injury and death due to mechanism failure. 

A new set of small-bore connector guidelines (PDF) were issued by the FDA on February 11, 2015, in an effort to mitigate the risk of misconnection injuries caused by small-bore connectors intended for various medical devices.

The FDA announced it has witnessed a steady increase in patient injuries and deaths occurring from medical mistakes linked to these connectors, leading the agency to call for reforms.

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Small-bore connectors, commonly called Luer connectors, are devices that adapt many different delivery systems to tubes or catheters that administer food, medicine, and various other therapies to patients in health care settings. The connectors have been known to cause patient injuries and even death because the connectors are compatible between different delivery systems, increasing the chance of connectors performing a specific function to be switched to another medical device.

Injuries and fatalities occur when medicines, liquid feeding formulas, or air are accidentally delivered through the wrong tubing. These errors are typically called tubing misconnections, wrong route errors, catheter misconnections, or Luer misconnections.

The FDA’s proposed guidelines recommend that manufacturer’s design and test enteral connectors based upon the Association for the Advancement of Medical Instrumentation (AAMI) standards to ensure that each proposed enteral connector is physically incompatible with non-enteral devices. The FDA claims that the injuries caused by unintended connections between devices that have different uses are preventable if they are not adaptable and are labeled properly.

Further detailed in the guidance are mechanism design recommendations that suggest the connectors be made of rigid or semi-rigid materials that would decrease the connector’s flexibility and elasticity. According to the report, connectors made with a modulus of elasticity either in flexure or in tension greater than 700 MPa will reduce the likelihood of forced fits between devices that are not intended to connect with one another.

The FDA also recommends more detailed labeling to be applied to devices that simplify interpretation of connector usage to avoid potential confusion. Strategies that have been suggested by AAMI include using a phrase stating the device is to be used in connection with a specified machine. Other AAMI recommendations include color-coding and eliminating the words “enteral-only” and “Non-IV” from the labeling as these terms may be misleading to healthcare workers who could mistake them to be compatible with all enteral devices.

Although the FDA’s new guidance does not establish any legally enforceable responsibilities on manufacturers because no specific regulatory or statutory requirements are cited, the agency believes that manufacturer’s should be encouraged to follow these suggestions and design products in accordance with AAMI standards to help reduce the frequency of connector hazards. The FDA claims they will continue working with the industry and the standards community to promote the development of connectors that may not be so easily misused.

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