Bar Code Rule Reflects How Devices and Drugs Differ

Originally Published MDDI May 2003

NEWSTRENDS

FDA is not planning to apply to devices its proposed rule requiring all prescription drugs to be bar coded. There is a chance, however, that the agency will propose a separate rule regarding bar coding on medical devices. 

The proposal, issued in the March 14, 2003 Federal Register [68 FR: 12499-12534], would mandate bar codes on all prescription drugs and biologics (including vaccines), as well as any over-the-counter drugs that are commonly used in hospitals. The rulemaking is part of FDA's initiative to reduce medical and medication errors. 

FDA considered whether to include medical devices in the rule after Secretary of Health and Human Services Tommy G. Thompson received letters advocating that they be covered. 

The letters were submitted by Premier Inc. (San Diego), a group purchasing organization, and the Health Industry Business Communications Council (HIBCC), a Phoenix-based standards organization. 

Nevertheless, during and after a June 2002 public meeting on the issue, device manufacturers generally opposed the inclusion of devices in such a rule because they present different issues compared with drugs, biologics, and blood products, says FDA. The device industry also called for more study of such issues, and some comments advocated a separate rule or voluntary guideline. 

As one example of the complicating issues, devices are divided into classes representing different degrees of risk. So bar codes on low-impact devices such as bandages may not impact safety. Also, manufacturers may not want devices that are reprocessed by a third party to maintain the original bar code on the reconditioned device or package. As a third example, device manufacturers often use HIBCC standards for their bar codes, whereas pharmaceutical manufacturers tend to use Uniform Code Council standards. 
Comments from hospitals and healthcare providers generally supported requiring bar codes on devices, though some asked to defer action on devices so as not to slow down the rulemaking process for drugs. 

As a result, the agency decided to omit devices (and biologics that are regulated as devices) from the rulemaking in order to continue to study whether to develop a separate rule for devices. The proposal calls for linear bar codes that conform to UCC standards, in keeping with current practices of much of the pharmaceutical industry but which would have been inconsistent with what many device manufacturers practice. 

A copy of the FDA proposal can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/02n-0204-npr00001-vol1.pdf.   Comments must be submitted by June 12, 2003.


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