How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains.

The Food and Drug Administration (FDA) is trying to shed further light on cases where two or more medical devices packaged together in what the agency calls a "comfort kit" would have to meet unique device identifiers (UDI) labeling requirements.

Under the draft guidelines, convenience kit, the administration tries to solve, "applies to two or more different medical devices packaged together for convenience of the user when they are destined to remain together and not full, substituted, reconditioned, sterilized, or otherwise or modified before the equipment is used by an end user. "

Individual devices in these kits are exempt from the labeling requirement, as long as UDI is included on the label on the packaging of the kit.

The new position of the FDA, which he said is "a change in policy," clearly indicates that since the publication of the rule of UDI, the agency decided that the term "comfort kit" does not include implantable devices and instruments that is "provided by the label in games or trays as sterile and sterilized and repeatedly reconfigured (or cleaned and sterilized) before use."

The agency explained its change of opinion pointing out that the main purpose of Rule UDI is to provide a system that can adequately controlled and identify medical devices through the distribution and use, especially about adverse events.

The Food and Drug Administration (FDA) is trying to shed further light on cases where two or more medical devices packaged together in what the agency calls a "comfort kit" would have to meet unique device identifiers (UDI) labeling requirements.

Under the draft guidelines, convenience kit, the administration tries to solve, "applies to two or more different medical devices packaged together for convenience of the user when they are destined to remain together and not full, substituted, reconditioned, sterilized, or otherwise or modified before the equipment is used by an end user. "

Individual devices in these kits are exempt from the labeling requirement, as long as UDI UDI is included on the label on the packaging of the kit.

The new position of the FDA, which he said is "a change in policy," clearly indicates that since the publication of the rule of UDI, the agency decided that the term "comfort kit" does not include implantable devices and instruments that is "provided by the label in games or trays as sterile and sterilized and repeatedly reconfigured (or cleaned and sterilized) before use."

The agency explained its change of opinion pointing out that the main purpose of Rule UDI is to provide a system that can adequately controlled and identify medical devices through the distribution and use, especially about adverse events.

Examples:

A first aid kit containing bandages, cold compresses, scissors and an oral thermometer is regarded as a practical kit for compliance purposes UDI.

However, a non-orthopedic tray sterile or device together at the time of writing the rule UDI was seen as a kit, is now not considered a kit of convenience and all its components and devices must have an IDU because " devices are not intended to remain packed together, but are intended to be decompressed before being placed on trays for surgery and sterilized before use, with periodic replacement tray 185 for subsequent surgery and recovered ".

But anterior cruciate ligament (ACL) disposable kit consisting of a single use sterile instruments such as guide child guide pins of the tip of the drill, taken tunnel, and transplantation which are used for ACL reconstructive procedures and are packed and sealed in a single container it is regarded as a practical kit for compliance purposes UDI.

Finally, FDA proposed example of reusable medical devices packed together, which would not be convenient kit.