UNIQUE IDENTIFICATION INFORMATION FOR DEVICES COULD PUT MANUFACTURERS AT A DISADVANTAGE
Encoding unique device identification (UDI) on devices would likely benefit all device stakeholders, except manufacturers, concludes a recent report conducted by Eastern Research Group (ERG) for the FDA. For that reason, the FDA and other government agencies would need to coordinate the effort for it to become a reality.
In 2004, the FDA mandated bar code identifiers on pharmaceutical labeling to reduce medical errors and improve drug safety. At that time, the agency asked industry for feedback about whether that practice should be extended to devices. The agency hesitated to issue a similar standard for devices because they lack identifying systems comparable to the National Drug Code (NDC) system used to identify drugs. The NDC was instituted in the 1970s by the FDA and identifies the labeler, product and package.
Most devicemakers are small companies with fewer than 20 employees and fill small niche markets, according to a 2002 census report that listed 5,394 device manufacturers. The industry is also quite diverse, with devices ranging from expensive capital equipment such as X-ray machines to simple items such as bandages and tongue depressors, according to the report. Because of this diversity and the evolving nature of devices, classification other than by risk category has not been forthcoming.
Both AdvaMed and the Medical Device Manufacturers Association oppose mandatory barcodes or automatic identification systems "because of the enormous diversity of medical devices and associated safety needs," the report says. AdvaMed also noted in its comments to the FDA that the agency already requires traceability for devices that carry the most risk. The group also said that manufacturers are evolving toward enhanced device identification systems at the pace set by their customers' needs.
Distributors are generally supportive of efforts to implement device identification but they also opposed mandatory labeling requirements, according to the report.
For UDI to be successful, collaboration from all industry stakeholders would be necessary, ERG said. Right now, this is unlikely to happen because of the possible competitive disadvantages to manufacturers, it concluded.