Medical Device Link.

Originally Published PMPN October 2004

NEWS

A newly published report by AdvaMed (Washington, DC) reveals that a high number of medical device manufacturers are bar coding their products.

The report, “Automatic Identification in the Medical Device Supply Chain,” was based on a survey of 41 respondents. The survey found that 78% already apply bar codes at some level of packaging. In addition, 83% of Class I devices, 86% of Class II devices, and 76% of Class III devices made by the respondents have some form of bar codes. More than 80% of firms with more than $30 million in sales per year use bar codes, though that figure drops to 54% for companies with revenues under $30 million. More than 80% of respondents said they bar code some or all of their products at the unit-of-use level and at the shelf-pack level. About 50% do so at the shipper carton level, though less than 20% do at the pallet level.

“For many years hospitals have said that they were waiting for more products to be bar coded before they would begin developing their own systems for scanning bar codes,” the report said. “According to survey responses, by the end of 2005, a significant amount of unit-of-use products will be bar coded. This should create the critical mass of bar coded products that both distributors and hospitals need.”

The survey results also showed that some firms may not be properly conducting their bar code operations. Close to 10% of respondents said they do not check the bar codes that they produce to ensure they are producing high-quality, scannable codes. In addition, several could be mismatching both standards and symbologies. The Uniform Code Council’s EAN.UCC standard and the Health Industry Business Communications Council’s HIBC Supplier Labeling Standard are widely used in the medical device industry. However, several respondents said they were using one standard but listed symbologies identified with the other. The report’s authors wrote that, “These cases could be indicative of either the survey respondent not being certain of the name of the standard, or misuse of the standard.”

According to the survey, radio-frequency identification (RFID) use is not yet prevalent. “It appears the medical device industry is not ready to embrace this technology,” the report stated. The survey could calm fears that mandating bar codes on unit-of-use packaging could prompt manufacturers to discontinue or reduce unit-of-use packaging. However, only 2% of respondents said they would reduce their unit-of-use packaging if that happened. Of those polled, 91% said they would not change anything.

AdvaMed conducted the survey as a follow-up to its 2002 discussion with FDA about whether bar codes should be required on medical devices. FDA mandated them for prescription pharmaceuticals but followed AdvaMed’s recommendation not to do so for devices. The organization had argued that it would be too cumbersome to put them on lower-risk devices, and the patient-safety benefits of doing so were unclear.

Copyright ©2004 Pharmaceutical & Medical Packaging News