FDA Completes UDI Pilot, But Anxieties Over Data Requirements Remain

Full article reprinted from "The Gray Sheet" - October 26, 2009

Participants in a six-week pilot program for a unique device identification database expressed some anxiety about the volume and type of information required for the program, according to MJ Wylie, director of global data standards at GHX. Read more...

FDA Completes UDI Pilot, But Anxieties Over Data Requirements Remain

Full article reprinted from "The Gray Sheet" - October 26, 2009

Participants in a six-week pilot program for a unique device identification database expressed some anxiety about the volume and type of information required for the program, according to MJ Wylie, director of global data standards at GHX.

The e-health company collaborated with FDA to conduct the pilot, results of which will be available in the next two to three weeks, Wylie said Oct. 21 at the UDI Conference in Orlando, Fla.

Wylie noted that the six participating manufacturers, including Becton Dickinson, Covidien and GE Healthcare, were concerned not just by the amount of data they would need to provide, but actually locating the information, which may not be maintained in a centralized system, or even documented at all.

The pilot, which included data on 621 devices, was aimed at assessing the feasibility of collecting and storing unique device identification data from the initial creation by the supplier to the point of use of the product at five hospitals.

The 2007 FDA Amendments Act required FDA to establish a system for unique identifiers on device labels, but did not include guidance on what information should be collected or which products might be exempt. It is hoped such a system, which will necessitate some type of scannable bar code to track devices, will reduce medical errors, improve adverse event reporting and lead to smaller, more targeted recalls.

Options for UDI labeling include bar codes, radiofrequency identification and direct part marking.

Since FDAAA became law, the agency has struggled to develop a consensus from manufacturers and hospitals on how to create a system that every stakeholder could use.

FDA had hoped to issue a proposed rule on UDI this year, but it has backed away from meeting a specific timeframe.

Clarity, Standards Needed For Database Definitions

Firms that participated in the pilot also noted that FDA must clarify the definitions to be used in the database, according to Wylie. For example, the agency would need to define the term "hazardous materials."

The agency also needs to settle on the standards the definitions should meet, she added. Most stakeholders agree that either the GS1 or the Health Industry Business Communications Council standards should be used.

In addition, the six suppliers said they would like clarity on exactly when in the process information would be added to the database, Wylie noted.

Among the issues FDA has faced is disagreement on the amount of information suppliers should be required to include. Device industry representatives have argued that UDI rules should require no more than the bare minimum to identify a device, but hospitals want more comprehensive information in the UDI (The Gray Sheet' March 9, 2009).

During the conference, Rosalind Parkinson, administrative director of Material Systems at the Ohio State University Medical Center, said that at the very least, all supplies should carry a Global Trade Identification Number (GTIN). For situations like device recalls, more information, such as the lot number or serial number, might be required, she maintained.

Medtronic has already developed its own UDI system, and every device manufactured by the firm carries a GTIN, said Jackie Rae Elkin, who heads Medtronic's Standard Product Identification Initiatives. The company's system "uniquely identifies its products and its package configuration," she explained.

A typical UDI label for a Medtronic device includes the GTIN, expiration date, lot number and serial number, Elkin said.

Medtronic Says UDI Has Major Efficiency Advantages

Some device manufacturers are worried about the cost burden of complying with a mandatory UDI system, but Elkin indicated Medtronic's system has helped improve efficiency.

Utilizing a UDI-type system has made inventory movement through the supply chain more efficient and enhanced inventory accuracy, among other benefits. The return on investment for Medtronic has been "phenomenal," she said.

Elkin believes, however, there will be a number of hurdles for device firms seeking to implement UDI. One challenge is to engage all members of the product lifecycle and supply chain, and to continue to educate those players as the technology landscape changes, she said.

In the end, the chief concern is the "master data and its definition," she noted, "not slapping [on] bar codes."

- Brooke McManus

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