December 2011
Issue 14

While Pharma Counts down to California, the Medical Device Industry Prepares for Imminent UDI Regulation

California's State Board of Pharmacy (CA BoP) met in early December to begin preparing for implementation of the state's electronic drug pedigree requirements, and FDA joined the discussion with its hopes for a supply-chain-wide track-and-trace system. But with pharmaceutical companies still operating under a January 2015 CA deadline, the real news maker these days is FDA's pending unique device identification (UDI) regulation. A draft version of UDI may be released before the year is out, says John Roberts director, healthcare, GSI US.

Roberts presented on the regulation's status and using GS1 standards in a GS1 Healthcare US webinar, "Preparing for UDI with GS1 Standards."

"This will happen. The manufacturers are geared up for it and all industry is on board. The only thing we are waiting for is for the regulation to be issued," Roberts said.

UDI requirements FDA has been presenting, outlined most recently in a September work shop with industry, are the basis for the draft regulations.

Additionally, the Global Harmonization Task Force (GHTF) has released its guidance to regulatory authorities on a UDI system for medical devices that is "a good indication of what the FDA rule will look like," Roberts said.

Also addressing harmonization of medical device regulation, the global International Medical Device Regulators Forum (IMDRF) was formed this year with the goal of building on GHTF's work.

FDA, and GHTF, call for a unique ID applied to all levels of packaging down to the lowest level for patient use or unit-of-use. Coding is in human readable and/or in automatic data capture form. ISO standard coding systems including GSI and HIBCC are allowed. The requirements are technology neutral as to the carrier.

For meeting the mandate, GS1s global trade identification number (GTIN) can be used to identify a product uniquely at every level of packaging, Roberts said.

The UDI is defined as including a device identifier, and a product identifier for denoting dynamic production information: lot, expiry date, manufacturing date, and serial number.

FDA has signaled that higher product risks classes will require an identifier with some dynamic information, Roberts said.

Combo products and kits require a unique ID on the device or kit and on each component or packaged device. Hospitals will have to apply UDIs to devices they repackage.

A global UDI data base will contain defined static product data elements and product information. The identifiers will provide a link to the production information maintained by the supplier, Roberts said.

Industry's preparation for UDI has been advanced by the Healthcare Transformation Group, the collaboration of Geisinger Health System, Intermountain Healthcare, Kaiser Permanente and the Mayo Clinic, which has focused on implementing GS1 Global Location Number and GTIN Sunrise dates.

"We are encouraged by the providers and manufacturers that have already declared their readiness to meet the goals. HTG has asked their top 20 suppliers to reach the goals prior to year end," Roberts said.

Roberts characterized the UDI initiatives by FDA, IRSTR, and HTG as part of a "perfect standards storm" developing around medical devices and pharmaceuticals, that includes FDA's SNI and traceability initiatives and California's pedigree mandate.

FDA in addition is revisiting its 2004 linear bar code rule for hospital unit doses. The agency is soliciting comments on allowing 2D codes that might include more information than the NDC.

"Data Matrix is favored by the manufacturers as some find it easier to print, and of course it can carry more data in a smaller space. There was very little knowledge of 2D codes and 2D scanners in 2004, nor of camera scanners. And GS1 did not adopt the GS1 DataMatrix until January 2005. That all has changed in seven years," Roberts says.

Roberts noted in the webinar that GS1 resources to help industry prepare for new guidance include the Online Healthcare Provider Tool Kit, with how-to guides for GLN, GTIN, GDSN and UNSPSC, and the Online Healthcare Supplier Tool Kit (How-to Guides for GLN, GTIN, and GDSN).

GS1 plans to provide written guidance on the UDI regulation after the regulation is revealed upon publication, he said.

And as far as California's electronic drug pedigree law goes, the CA BoP's Enforcement Committee will hold a series of meetings beginning in March 2012 that will discuss regulations to address the following provisions:

  • Inference.
  • Decommissioning.
  • Drop Shipments.
  • Linkage between Invoice and Shipping Notice.
  • Grandfathering Lists.

"We expect to hear from industry on these issues, and we would like to see working groups form," says Virginia Herold, CA BoP's executive director. "We want industry input."

David Vaczek
Senior Editor


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