The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has released draft guidance that redefines “convenience kit” for industry and agency staff, creating a stricter interpretation of the term for unique device identifier (UDI) labeling and data submission requirements. In September 2013, the FDA published a final rule, establishing a unique device identification system and requirements for UDI labeling.
According to this rule, a UDI should be available “to identify a device in both easily readable plain-text and in a form that can be entered into an electronic patient record or other computer system via an automated process when the device is used by an end user.” However, each device packaged within a “convenience kit” did not have to include an individual UDI as long as a UDI appeared on the label for the kit itself. In the preamble to the final rule, the FDA defined a convenience kit as “two or more different medical devices packaged together for the convenience of the user.”
The draft guidance issued on Jan. 4, 2016, narrows this definition to include only medical devices that are packaged together for the convenience of the user “where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.”
This means that although prepackaged devices such as non-sterile orthopedic device trays and sets were considered convenience kits based on the original definition, they would not meet the definition of the term in the draft guidance because any implants not chosen for surgical use and any reusable instruments are generally sterilized, reconfigured into new sets, and used again. According to the FDA, “the overarching objective of the UDI rule, as required by section 519(f) of the FD&C Act, is to provide a system to adequately identify medical devices through distribution and use.”
If instruments and devices are separated from their original packaging and used again, they would not be able to be identified and tracked through this system, the agency reasoned. Examples of convenience kits based on the proposed new definition include first aid kits and disposable anterior cruciate ligament (ACL) kits. Comments and suggestions on the draft guidance can be submitted through www.regulations.gov until April 4, 2016.