Direct Part Marking
The agency’s proposal would require most medical devices distributed in the United States to bear UDI, and in certain instances UDI would need to be marked directly on the device. These include devices that would remain in use for extended periods of time and would be likely to become separated from their labeling, the draft reads.
Under FDA’s proposal, UDI may consist of two parts: a device identifier and a production identifier, when present on the label of the device, which may be a lot or batch code, a serial number, an expiration date, and/or a manufacturing date.
Because DPM involves marking the actual device, rather than just a package or label, packaging professionals would need to work closely with their colleagues to ensure success. “Packaging departments have typically managed product identification and coding, but because in DPM’s case you are impacting the product, it really requires a marriage between product and packaging engineering,” explains Peter Tomicki of Zimmer Holdings Inc. Manufacturing and Quality teams as well as regulatory experts would also need to be involved.
“The challenge is to understand the device material and select the best method of applying DPM in a manner that does not impact safety and efficacy,” says Tomicki.
In addition, “print quality must be sufficient to meet ISO standards,” he says. While DPM is not new, there may be some challenges with legacy approaches that do not offer the high resolutions needed for UDI.
Options include chemical, mechanical, and laser etching, each with different characteristics and resolutions, he says.
Manufacturers also need to determine whether adding or changing to a new marking method would require an additional regulatory filing, he adds.
Next, UDI teams would need to develop processes to ensure that DPM data align with those encoded on primary packaging and are aggregated properly, Tomicki says. They would also need to be aggregated to other packaging levels as well.
Device size, too, could be an issue, especially if FDA requires the DPM to include human readable text. “Size could be a key constraint. DPM is possible for larger items, with flat surfaces,” says Tomicki. “But it will be much more challenging for small medical devices and those that have rounded surfaces, such as screws and pins.”