Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors

Connectors are important parts of many medical devices. Good connector design is critical to the safe and effective use of these devices. The results of tubing misconnections are often irreversible and can result in serious patient injury or death.

In order to reduce the likelihood of a tubing misconnection, medical device manufacturers should performance test their connectors and periodically validate the connectors, even after they are on the market.

The FDA, the international standards community and the medical device industry are taking steps to reduce the likelihood of tubing misconnections. One step is the development of standardized testing to ensure that a small-bore connector cannot be misconnected to the wrong device type. A second step is the development of standardized connector designs for specific medical applications that can not be interconnected with a device of another medical application. (More information is available in the Draft Guidance for Industry referenced below.)

The FDA-recognized International Organization for Standardization (ISO) 80369-1 standard outlines general performance testing for small-bore connectors for liquids and gases in health care applications.

The FDA has also issued a draft guidance document, which recommends that manufacturers ensure the connector they are developing is physically incompatible with any other type of device and that the connector can not be forced to fit another type of device. Color-coding and tagging should only be used if the connector also meets the ISO standard.

The FDA will only approve or clear an enteral device with a new small-bore connector if it meets the ISO standard or equivalent alternative method. Additional guidance from the FDA for enteral device manufacturers is also available.