Originally Published PMPN April 2005
EDITORIAL
Are Hopes Universal for Medical Device Bar Codes?
Medical device packagers, bar coding or other coding standards may be coming your way. While the thought of yet another standard—voluntary or not—may be disheartening, someone else may have already done some of the hard work.
The Health Industry Business Communications Council (HIBCC; Phoenix) reports that FDA's Center for Devices and Radiological Health (CDRH) invited it along with other trade groups to discuss "the feasibility of a voluntary uniform system of unique identification for medical device equipment." At press time, bar coding and radio-frequency identification were slated for a preliminary discussion scheduled for mid-April.
Is there good news, you ask? Many of the technical kinks of universal coding are being worked out in the drug industry as it complies with FDA's bar coding rule.
For instance, printing unit bar codes and grading them to ISO standards right on the packaging line is a reality. This seemed next to impossible just a few short years ago, when FDA first proposed bar codes. (For more on pharmaceutical bar coding, see our annual Bar Coding Supplement starting on page 49.) Printing methods and related support have also advanced quickly, giving packagers-turned-printers much-needed assistance.
AIM Global was also invited to CDRH's meeting. (The group will provide an update on this meeting and other such efforts on its new healthcare portal, www.aimglobal.org, in late April.) Donna Lee, chair of AIM Global's Healthcare Action Group, spoke to PMP News before the meeting. "FDA is bringing together the people who write standards and use them," she explained. "It is a great start to have such a meeting before any agency mandate." Lee also sits on HIBCC and HDMA committees. She currently serves as market intelligence specialist of HandHeld Products Inc. (Skaneateles Falls, NY).
Some items Lee expected to be raised include the advantages and disadvantages of a voluntary system, the data that could be included in such a system, and how the system could connect to patient safety activities.
The biggest task will be standardization. "It is important to standardize how the data are structured and what data are included in that structure," says Lee. The challenge for the medical device industry will be to decide between HIBCC's Health Industry Bar Code alphanumeric system or the Uniform Code Council's Universal Product Code numeric system, or to allow both. This will be a tougher call in the device industry than it was in the pharmaceutical industry—medical devices do not have the equivalent of a universal National Drug Code (NDC) system.
Lee points out some other unique aspects to medical device coding. Coding technologies, whether they are bar codes or RFID tags, must withstand terminal sterilization. Codes may also need to be marked directly on medical devices, especially if they are reusable.
Medical device manufacturers, however, will benefit from the inroads that pharmaceutical bar coding is making in hospitals. Because of FDA's bar code rule for drugs, "hospitals are already performing—or preparing for—automatic identification," says Dan Mullen, AIM Global's president.
And bar coding shouldn't shock the medical device industry, given the fact that many manufacturers are complying with the Department of Defense's Universal Product Number (UPN) requirements, adds Mullen.
But medical device packagers, be sure to tell CDRH your concerns about and hopes for a voluntary system.
And get ready for the benefits that universal coding can bring—increased patient safety, real-time inventory management, and improved supply-chain security.
Daphne Allen, Editor
Copyright ©2005 Pharmaceutical & Medical Packaging News
