The Global Harmonization Task Force (GHTF) is seeking public comment on its discussion paper “Unique Device Identification (UDI) System.” GHTF says that the goal of the document is to “pave the way for the establishment of UDI in the medical device sector.”
The FDA Amendments Act of 2007 requires FDA to create a UDI system for medical devices. The agency has not set a deadline for the establishment of this system, but it did hold a public workshop in February 2009 to collect feedback from stakeholders.
According to the GHTF paper, UDI would improve patient safety by reducing device- related errors, make it easier to identify devices in case of adverse events, and help facilitate traceability. The organization argues that a successful system would be globally applicable, and free of regional adaptations.
GHTF offers guidance for establishing a UDI system (see the sidebar “Essential Principles for a UDI System [7]”). For example, it suggests that the GS1 system and the health industry bar code (HIBC), which are internationally accepted coding systems, be adopted and implemented.
The Health Industry Business Communication Council (HIBCC) supports GHTF’s recommendation of both of these codes. It says, “The fact that a large percentage of manufacturers are already using one of these standards means that widespread compliance will be achievable in the shortest time frame and the lowest cost to the industry.”
However, HIBCC does want clarification from GHTF about the section that says UDI codes should include a combination of static information (device identifier) and dynamic information (product identifier). HIBCC says that more-specific guidelines should be provided “on the class of product that warrants the inclusion of a machine-readable bar code or RFID tag for the dynamic component of the UDI.” HIBCC suggests that the dynamic component be mandated for such devices as implants, but not for more basic products such as drapes and dressings.
Also, HIBCC says that GHTF should allow for country-specific requirements in the UDI database (UDID). The GHTF document calls for a UDID that is publicly available and free of charge.
To facilitate global data exchange, GHTF proposes that regulators in all jurisdictions use the same identification attributes. But HIBCC says that this overlooks the need to accommodate certain country-specific requirements. For example, a UDID in Australia should include the attribute of rebate codes, which are assigned to implants for insurance purposes.
GS1 Healthcare, another bar code organization, says it welcomes harmonization. “It will make the healthcare supply chain worldwide safer and more efficient if a global UDI system without regional adaptations is implemented,” according to Ulrike Kreysa, director, healthcare for the GS1 global office. The deadline for submitting comments in response to the GHTF document is March 31, 2010.
To read the GHTF document, visit www.ghtf.org/ahwg/ahwg-proposed.html [8]