Citing Safety Risks, FDA Adopts New Standards for Small-Bore Connectors

Regulatory NewsRegulatory News | 12 February 2015 |  By 

Even small devices can cause big problems. That's the conclusion of a new guidance document issued this week by the US Food and Drug Administration (FDA), which is trying to make "small-bore connectors" safer.


The devices—technically a medical device—are used to temporarily connect two otherwise incompatible medical devices, FDA explains in its final guidance document, Safety Considerations to Mitigate the Risks of Misconnections with Smallbore Connectors Intended for Enteral Applications.

For example, a small-bore connector might connect an IV tube implanted in a patient's arm to a bag of saline solution, or a feeding tube implanted in a patient's stomach to enteral nutrition.

The problem, FDA explains in the guidance, is that the "use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses." This, FDA added, has had fatal consequences for some patients.

Device connectors have been on FDA's radar for other, related reasons in recent years. For example, in April 2013 the agency released a guidance establishing a new standard intended to ensure that pre-filled glass syringes would be able to connect to receiving devices like Luer locks. Regulators recounted that incompatibility between the products had in some cases delayed treatment of patients in life-threatening situations.

A New Standard for Enteral Devices

FDA's latest guidance, though, confronts the opposite of that problem—devices are too easy to connect together, which has resulted in some patients receiving the incorrect treatment to an improper area.

Now regulators have put the device industry on notice, saying that they’re toughening standards meant to prevent a mismatched connection. "Color-coding, labeling and tagging attached to the device, by themselves, are no longer sufficient to satisfy safety concerns regarding misconnection hazards associated with connectors," FDA explains in the guidance.

Instead, all devices—including small-bore connectors already on the market—will need to comply with new standards developed by the Association for the Advancement of Medical Instrumentation (AAMI) and adopted this week by FDA.

The standards, AAMI/CN3:2014 (PS) Part 3 and AAMI/CN20(PS):2014, aren't available online, but a synopsis of the standards on AAMI's website indicates that the standards call for different physical designs for each connector, and the abandonment of a "universal design."

FDA said devices requiring modification to meet the new standard will be able to submit a declaration of conformity to the standard to modify their existing 510(k) application. This policy will allow companies to update their devices without needing to file a new 510(k), FDA said.


Safety Considerations to Mitigate the Risks of Misconnections with Smallbore Connectors Intended for Enteral Applications (FR)


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