Connectors are important parts of many medical devices. Good connector design is critical to the safe and effective use of these devices. Tubing misconnections can result in serious patient injury or death.
The FDA, the international standards community and the medical device industry are taking actions to reduce the likelihood of tubing misconnections. This includes the development of standardized connector designs for specific medical applications so they cannot be interconnected with devices for other medical applications.
Standards for Small-Bore Connectors
The FDA recognizes the AAMI Provisional American National Standards AAMI/CN3(PS):2014 "Small-bore connectors for liquids and gases in health care applications" – Part 3: Connectors for enteral applications and AAMI/CN20:2014 - Part 20: Common test methods.
These AAMI Provisional American National Standards cover Parts 3 and 20 of the International Standards Organization (ISO) 80369 series, which are currently in final development. Once the final version of ISO 80369-3 and ISO 80369-20 is approved by ISO, these provisional standards will be replaced by a parallel adoption of ISO 80369-3 and ISO 80369-20.
- Part 3 specifies the dimensions and recommendations for the design and functional performance of small-bore connectors for enteral use.
- Part 20 specifies test methods to support the performance requirements for small-bore connectors.
The FDA anticipates recognizing future standards for other small-bore connector applications as they are developed.
Part one of the ISO 80369 series (recognized by the FDA on March 14, 2011) provides:
- General requirements for small-bore connectors for liquids and gases in health care applications
- A framework for testing connectors of different medical applications against each other to ensure non-interconnectability, and
- Specific misconnection testing methods
Guidance for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors Relevant to Small Bore Connectors for Enteral Applications
The FDA's newly released final guidance: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications provides recommendations to manufacturers, FDA reviewers, and others involved in manufacturing devices that use small-bore connectors for enteral feeding. This guidance also provides guidance for those submitting or reviewing premarket notification submissions [510(k)s] for these types of devices.
The FDA's final guidance recommends that:
- Devices with connectors that are part of, or form connections to, enteral feeding tubes conform to AAMI/CN3:2014 (PS) Part 3. However, conformance to the standard is not a requirement.
- Manufacturers design and test enteral connectors based upon AAMI/CN3:2014 (PS) and AAMI/CN20:2014 (PS) to ensure that each proposed enteral connector is physically incompatible with non-enteral devices.
- Manufacturers of enteral connectors that do not meet AAMI/CN3:2014 (PS), also known as proprietary connectors or transition connectors, continue to design and test the devices based upon the AAMI/American National Standards Institute (ANSI)/International Organization for Standardization (ISO) 80369-1 standard "Small-bore connectors for liquids and gases in health care applications — Part 1: General requirements.
The final guidance also includes recommendations for:
- Connector materials
- Inadequacy of color-coded and labeled connectors
- Side ports, transition connectors, adapters, and syringes
- Usability and human factors testing
Recommendations for Those Submitting or Reviewing Premarket Notification Submissions (510(k)s) for Small-bore Connectors for Enteral Applications
Manufacturers with an existing 510(k) clearance for devices with connectors that are part of, or form connections to, enteral feeding tubes, have modified the connector to conform to AAMI/CN3:2014 (PS) Part 3, and the modifications would trigger the need for a new 510(k), FDA does not intend to object if firms submit a declaration of conformity to AAMI/CN3:2014 (PS) Part 3 in an "add-to-file" to their existing 510(k) rather than submitting a new 510(k). Please note that the FDA is not accepting "add-to-file" submissions for declarations of conformity to the ISO 80369-1 standard.
- These connector modifications could include material changes that under the FDA's guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, may require submission of a new Special 510(k).
- Any testing that is not covered by the AAMI/CN3:2014 (PS) Part 3 standard, such as biocompatibility assessment and overall device performance testing, needs to continue to be conducted as part of the design verification/validation to ensure that products are safe and perform as intended. This testing must be captured as part of the design history file in accordance with design controls (21 CFR 820.30).
- Please note that a manufacturer may choose to submit a 510(k) for review, even in situations where providing a declaration of conformity (as outlined above) would be appropriate. The policy of submitting a declaration of conformity is an alternative approach for allowing a product to be marketed and applies only to connectors specified above.
Manufacturers are encouraged to follow the Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards for preparing declarations of conformity.
An "add-to-file" is a no associated user-fee amendment to the previously cleared 510(k), hereafter referred to as an amendment. Including the following information in an amendment to your previously cleared 510(k) will facilitate CDRH review of your submission:
- Cover letter clearly noting the purpose of the document is as stated: "510(k) amendment for small bore connectors in conformity with standard issued on February 11, 2015"
- Clear identification of the affected products and associated 510(k) numbers
- A declaration of conformity to AAMI/CN3:2014 (PS) Part 3 (see the Required Elements for a Declaration of Conformity to a Recognized Standard)
The amendment has no associated user-fee, but is subject to eCopy requirements. Therefore, you must submit two copies of your 510(k) amendment to the address below. One of your two copies must be submitted in electronic format. The FDA does NOT return the submission after review. You should retain a copy of your amendment for your records. Submissions should be sent to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
When considering submission of an amendment as outlined above, please keep in mind the following:
- The declaration of conformity must certify that the device is in conformity with AAMI/CN3:2014 (PS) Part 3.
- In the event a manufacturer creates or modifies device connectors such that they do not fully conform to the AAMI/CN3:2014 (PS) Part 3 standard, or has modified their device in ways other than a change to the connector relating to compliance with the AAMI/CN3:2014 (PS), Part 3 standard, FDA expects the manufacturer to submit a 510(k) for FDA review when a 510(k) submission is required.
- No additional clearance letter is given as the result of a 510(k) amendment. However, the manufacturer will first receive an acknowledgement of receipt when the amendment is received by the Document Mail Center, and then once the FDA determines that the amendment is complete and no additional information is needed, an additional acknowledgement will be sent via email to the manufacturer with notification that the submission has been closed.
- Manufacturers may base declarations of conformity on the manufacturer's own testing and analysis or on that of a third party, such as a testing laboratory or certification body. Manufacturers should not assume that a master file would contain testing to support conformity.
- To be efficient and least burdensome, we encourage manufacturers to consider "bundling" amendments. In other words, a manufacturer may submit one amendment for multiple related devices that may be "bundled," if appropriate (For additional information on a bundled submission, refer to FDA's Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission).
- If a declaration of conformity to AAMI/CN3:2014(PS) is submitted as an amendment to a "legacy device" 510(k), FDA anticipates future disuse of the legacy device with the introduction of the AAMI/CN3:2014(PS) compliant device. However, the "legacy device" does remain a legally marketed device.
- Because an amendment should not be submitted for a proprietary or transition connector, a Declaration of Conformity for a transition connector that will be packaged with a AAMI/CN3:2014(PS) compliant device should not be submitted in the 510(k) amendment.
Devices with small-bore connectors remain subject to the following requirements:
- GMP requirements (21 CFR 820), including design controls (21 CFR 820.30). Manufacturers' continuing obligations under the quality system regulations in 21 CFR 820 require control of supply and outgoing product for compliance with design specifications. Compliance with these obligations may be evaluated during routine inspections. Registration and listing (21 CFR 807).
If a manufacturer creates or modifies device connectors such that they do not fully conform to the AAMI/CN3:2014 (PS) Part 3 standard, e.g., proprietary and transition connectors, FDA expects the manufacturer to submit a 510(k) for FDA review when a 510(k) submission is required. For more information on when to submit a 510(k), refer to FDA's guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device.
If a manufacturer has modified their device in ways other than a change to the connector relating to compliance with the AAMI/CN3:2014 (PS), Part 3 standard, a new 510(k) may be needed. Manufacturers should refer to FDA's guidance Deciding When to Submit a 510(k) for a Change to an Existing Device to determine if a new 510(k) is needed for those specific changes.
For manufacturers with a device cleared with specifications in full conformity with the AAMI/CN3:2014 (PS) standard before the standard was approved and/or recognized (prior to February 11, 2015), manufacturers should consider submitting an amendment with a declaration of conformity, but it is not required.
Manufacturers with new devices intended for enteral feeding should submit 510(k) submissions to the FDA and receive the agency's clearance prior to marketing.
Additional FDA Recommendations:
The FDA believes manufacturers should provide the necessary safeguards to ensure safe use of these devices and products.
All manufactures are encouraged to:
- Assess the risks of misconnections for these devices
- Carefully consider both temporary and long-term options to mitigate the risk
More information is available at Global Enteral Device Supplier Association (GEDSA) StayConnected2014.org