A Closer Look at Medical Device Labelling Verification

Ensuring the labelling on medical products is accurate and consistent is a demanding process that requires meticulous attention.

 Norbert Sparrow

Yet, too many medical device manufacturers still rely on some form of manual checking despite the potential for human error and printer malfunction, writes Warren Ward-Stacey of Prisym ID in a guest blog just published on medtechinsider. This is not a sustainable business model in a highly regulated industry, he writes in Print and Hope Is Not an Effective Strategy for Medical Device Labelling Compliance.

Ward-Stacey cites a recent vision systems survey conducted by Prisym ID, a company that develops integrated in-house printing systems with lifecycle traceability, in which more than 45 percent of respondents said that their organisations either sometimes or frequently had quality control issues with their labels during the production process. Two thirds cited human error as the cause. This should come as no surprise, he writes, given the inconsistency in label print/check processes across the medical device industry.

Ward-Stacey cites one potential example of labelling error that could have serious consequences. Printers are known to garble data and mechanical issues can cause creasing or faded type. "What is the potential impact on a clinician looking to embed a device within a patient when the measurement advice has been misprinted as 12 rather than 1.2, caused by print underburn which has led to fading?" he asks.

Failed audits, product recalls, and potentially crippling lawsuits are among the compelling reasons for medical device manufacturers to put in place a single, end–to-end process that streamlines label verification and provides a single audit log of all label design, creation, and inspection masks, writes Ward-Stacey.

I would be interested to know if you agree with his premise that too many medical device manufacturers are living in the past when it comes to label verification. Based on your experience, is there room for improvement? Are there other ways to ensure compliance beyond an end-to-end system?

Focused on medical packaging design and technology?

Norbert Sparrow, Editor in Chief, UBM Canon

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