The FDA, the standards community, notably the International Organization for Standardization (ISO), and the medical device industry are taking actions to reduce the likelihood of medical device misconnections. These actions include the development of standardized connector designs for specific medical applications intended to physically prevent connections with devices used for other medical applications. The FDA participates in standards development for connector designs because of the direct association between the connections and other medical devices.
Standards for Small-Bore Connectors
Many different types of medical devices incorporate small-bore connectors. Small-bore connectors are parts used to connect medical devices such as tubing, syringes, and other accessories that deliver fluids and gases for patient care. Small-bore refers to the small size of the diameter opening (less than 8.5 millimeters) of the connector.
Two standards provide overarching recommendations for small-bore connectors:
- ISO 80369-1:2016, “Small-bore connectors for liquids and gases in healthcare applications” - Part 1: General requirements - specifies general provisions for small-bore connectors and methodology for assessing design characteristics to reduce the risk of misconnections between medical devices or accessories. The FDA recognized this standard on March 14, 2011.
- ISO 80369-20:2015, “Small-bore connectors for liquids and gases in healthcare applications” - Part 20: Common test methods - specifies test methods to support small-bore connectors’ functional requirements. The FDA currently recognizes this standard.
Examples of Medical Devices that Use Connectors
The FDA anticipates recognizing additional standards for specific small-bore connector applications as they are developed. These standards are expected to include specific dimension and performance requirements for the respective medical device or medical application. Listed below is a description of the medical device or medical application and status information about the relevant international design standard:
Blood pressure cuffs and other non-invasive blood pressure devices are used to inflate the blood pressure cuff to test a patient’s blood pressure. IEC 80369-5:2016 was published in March 2016 to provide specifications for the small-bore connectors used with blood pressure cuffs.
Breathing or respiratory systems such as anesthesia machines and ventilators used to facilitate a patient’s breathing. Work on the international standard for breathing and respiratory systems is still underway. The FDA anticipates recognizing this standard once it is finalized.
Enteral devices deliver liquid nutrients or medicine to the stomach or intestines in patients who are unable to eat or drink by mouth or need supplemental nutrition. Feeding tubes are often inserted into the patient’s abdomen. Patients use pre-packaged food purchased from nutrition manufacturers or blend their own diets at home.
ISO 80369-3:2016 was published in July 2016 and the FDA recognizes this standard. This standard provides specifications for connectors intended for enteral applications. Manufacturers are now transitioning to the new standard to address the misconnection issue and reduce the risk of misconnections between enteral and non-enteral devices.
Intravascular or hypodermic devices, such as arterial or intravenous (IV) lines, which are generally used to deliver medications or fluids through a patient’s neck, chest or veins in the arm. ISO 80369-7:2021, is being finalized and will provide manufacturers with specifications for intravenous and hypodermic applications.
Neuraxial devices, such as epidural catheters, are used to deliver medicines or anesthesia to neuraxial sites, such as the epidural space, or are used to monitor or remove cerebral-spinal fluid for therapeutic or diagnostic purposes. ISO 80369-6:2016, was published in March 2016, to provide specifications for designing connectors for use with neuraxial devices. The FDA recognizes this standard.
Limb tourniquet cuffs are compression devices used to apply pressure, such as to the radial artery, to help stop bleeding after a procedure. IEC 80369-5: 2016 “Small-Bore Connectors for Liquids and Gases in Healthcare Applications - Part 5: Connectors for Limb Cuff Inflation Applications,” was published in March 2016 to specify dimensions and requirements for the design and functional performance of connectors used in limb cuff inflation.