UFI for medical devices
Device manufacturers s are preparing the way for bar coding

A significant percentage of medical device manufacturers are bar coding their products at some level, which could encourage hospitals to invest in scanning technologies, according to an AdvaMed survey.

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

The survey found, however, that 78% of the 41 respondents 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 code. 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 of less than $30 million.

“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 survey report states. “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.”

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.

Use of radio-frequency identification (RFID), however, is virtually nonexistent. “It appears the medical device industry is not ready to embrace this technology,” the report states. “For every question on the survey asking about the use or planned use of bar code labeling, there was a corresponding question about the use or planned use of RFID. There were no responses to any of these questions pertaining to product labeling with RFID.”

The survey may allay fears that mandating bar codes on unit-of-use packaging could prompt manufacturers to discontinue or reduce the use of such packages. But only 2% of respondents said they would reduce their unit-of-use packaging if bar codes were mandated. The vast majority, 91%, said they would not change anything.

The results also revealed that some device firms might be conducting their bar code operations improperly. Almost 10% of respondents said they do not check the bar codes that they produce to ensure they are providing high-quality, scannable codes. And a few could be mismatching standards and symbologies.

Both the Uniform Code Council's EANUCC standard and the Health Industry Business Communications Council's HIBC Supplier Labeling Standard are widely used in the device industry. However, several respondents said they were using one standard but listed symbologies identified with the other. “These cases could be indicative of either the survey respondent not being certain of the name of the standard or misuse of the standard,” the report states.

Source3: Erick Swain, Medical Device & Diagnostic Industry Magazine