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Regulatory Update - Connectors for liquids and gases

Tuesday, August 2, 2022

Learn strategies for development and testing to ensure predictable performance.

To help reduce verification and validation burden, you can mitigate the risks associated with misconnections and supply interruptions.

Medical and in vitro diagnostic devices of various classifications and intended uses incorporate connectors for liquids and gases: luer locks, barb connectors, compression fittings, ENFit® connectors, quick disconnect connectors, and more. When designing medical devices with fluid or gas paths, the integrity of the connections, compatibility with the intended fluid or gas, and biocompatibility are the key attributes for verification and validation testing. Additionally, the type of connector should account for the potential risk of misconnections. Fortunately, there are numerous options to consider for such connections and applicable standards on which to rely for product development: ISO 80369-1 and collateral standards, ISO 18562-1 and collateral standards, ISO 5356-1, ISO 20695, ISO 5361, ISO 5366, ISO 5359, ISO 5367, and CEN EN 1615:2000. Many standards for connectors are recognized by the FDA and harmonized in the European Union.1, 2, 3

Reduce potential risks and misconnections by simplifying connector selection

A holistic approach to connector selection and verification may include a combination of design verification and validation for the finished device, vendor component certification, and the use of connectors that meet FDA-recognized or EU-harmonized standards for liquid and gas connectors. Connectors must be fit for purpose and selected to ensure that risks associated with misconnections are mitigated.

The use of the same connector type or connection interface in multiple connections for a single medical device, diagnostic device, or bioprocessing system may simplify sourcing and product development where this does not create risks such as misconnections. For example, tensile testing of the attachment of a luer lock to tubing may be performed on one representative construct if the same tubing, luer lock, and method of attachment is utilized in multiple features of the device. Where the same type of connector is used in multiple applications within a device, the connections may be identified via labeling or color coding. For example, connectors and connector caps of the same design and polymer are offered in various colors and allow the user to readily identify the appropriate use of the connector with adequate instructions for use or operating instructions.

Resources for selecting the appropriate connectors include research for common use of connectors in the industry, FDA guidance, best practices and industry guidelines, and the standards referenced above. For example, the FDA has issued a safety communication regarding the use of ENFit® low-dose syringes and recommends the use of an appropriate adaptor for some connections.4 More generally, the FDA maintains a webpage with information regarding connectors.5 The Institute for Safe Medication Practices issues various guidelines outlining best practices for administration of medication and drug compounding, many of which address connections.6 It is recommended to review your post-market data for applicable risks regarding connections in similar devices or performing an external post-market search (e.g., FDA MAUDE7 or TGA DAEN8) to identify risks for connectors used in similar competitive products.

Lastly, Qosina—an established vendor of myriad connectors—can recommend connector solutions that are tried and true and fit for purpose for your specific application.

Leveraging these resources at design inspection may reduce time, risks, and resources later in the product lifecycle.


References

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm ↩
  2. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en ↩
  3. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en ↩
  4. https://www.fda.gov/medical-devices/safety-communications/potential-medication-overdose-enfit-low-dose-tip-syringe-fda-safety-communication ↩
  5. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-connectors ↩
  6. https://www.ismp.org ↩
  7. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm ↩
  8. https://www.tga.gov.au/database-adverse-event-notifications-daen ↩