One of the most misunderstood and misapplied requirements with respect to UDI is related to the Direct Marking (DM) requirement.
The primary (default) location for a device’s UDI is on the label of the device (and its packaging, if any), and in many situations, this adequately addresses the need to identify the device through distribution and use. However, some devices are separated from their labels (packages) – and used (and reused) many times, often over an extended period of time. The original use case for this additional requirement is reusable surgical instruments – devices that are removed from their packaging, used, and reprocessed/reused many times, and where the identification and traceability of a specific instrument would be very beneficial, especially, for example, in cases of transmittable diseases (e.g., Creutzfeldt–Jakob disease [CJD]). There are certainly many other devices (e.g., endoscopes, tracheostomy tubes) where this identification is also critical.
Direct Marking Unique Device Identifier Regulations
The first issue that must be understood is the DM requirement is in addition to having a UDI on the device’s label and package.
The U.S. FDA’s UDI regulation states:
801.45(a) A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
In November 2017, the U.S. FDA published additional guidance that explained, for U.S. UDI implementation, what “used more than once” and “reprocessed before each use” mean. Importantly, the guidance excluded single patient use devices from “used more than once” – and excluded those devices that are only cleaned between patient uses from “reprocessed before each use.” However, we have seen situations where the reprocessing guidelines distributed by the manufacturer have not been reviewed in many years – and are not current with respect to the FDA’s current thinking on device reprocessing. We encourage manufacturers to (re-)assess the reprocessing guidelines before deciding whether cleaning alone is sufficient reprocessing. The U.S. FDA has several guidance documents on this topic.
The other area where we see confusion is related to the device's label. In some situations, the device’s label is on the device itself. This may not always be obvious as many incorrectly believe that a label is a sticky piece of paper on the package of the device. In reality, label is a regulatory concept and refers to the location in which regulatory information (e.g., name of the device, name of manufacturer) exists. In some situations, this information is on the device itself, which means that the device’s UDI goes on the device at this level. Moreover, an additional or different UDI is not also required to be on the device since the label on the device serves both purposes. Therefore, when assessing the relevance of the DM requirement, it is critical to first evaluate whether the device’s label is (or should be) in the device itself. However, in these situations, it is also critical to understand that the label requirements take precedence; it is the label requirements (and deadlines) that must be met.
In a related blog post, we look at the evolving global UDI landscape.
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