Medical Device Labeling Survey by Crimson Life Sciences Exposes Serious Translation Risks


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Medical Device Labeling Survey by Crimson Life Sciences Exposes Serious Translation Risks

BioSpace
March 19, 2009

BOSTON & SAN FRANCISCO – Crimson Life Sciences, a division of TransPerfect, today announced the results of a two-year audit survey designed to measure the risks associated with labeling translation for device manufacturers. The comprehensive analysis spans 21 languages, dozens of labeling audits, and over a million translated words. Crimson’s audit survey found that the average “serious error rate” was 400% higher than the serious error rate associated with the current industry best practice. A serious translation error is one that may result in patient harm.

According to Crimson President, Marc H. Miller, “These results suggest that many manufacturers have substantial liability and recall risks hidden within their translated labeling.” Based on the world’s only Notified Body-endorsed method for translation audit, Crimson regularly assists manufacturers seeking to identify errors and evaluate labeling risk. Labeling errors are a leading cause of device recalls.

The current best practice for labeling translation is defined by Crimson’s patent-pending risk management process. Crimson is the first translation company certified to ISO 13485, ISO 14971, and ISO 9001. Based on a proprietary QA methodology (BackEdit™), Crimson is the only company to hold an official Notified Body endorsement for effective translation risk management. Miller adds, “Our regular production audits demonstrate that BackEdit™ reduces the risk of serious translation error by over 60% versus standard processes.”

Economic Pressures Increase Patient Risk

Experts agree that the risk of safety-related translation errors is elevated by the poor economic climate. Explains Miller, “Under current conditions, manufacturers are tempted to base supplier selections exclusively on cost—and suppliers may be tempted to cut corners.” The resulting degradation in quality has prompted regulators to take a closer look at supplier control. Says Dr. Harvey Rudolph, a 25-year FDA veteran and co-author of ISO 14971 (risk management), “Supplier control issues are getting special attention in ISO 13485 registration audits, and all regulators are expressing newfound concerns about supplier risk management.”

To underscore the patient safety importance of translated labeling, Miller points to a highly-publicized adverse event in Germany, “47 patients were forced to undergo knee revisions because they were implanted without bone cement. The manufacturer was blamed because they shipped the device without a German language IFU.” Miller also notes a recent study by the Dutch Healthcare Inspectorate that indicated a 50% failure rate in the risk management function of Class III (high risk) labeling. “Because poor quality translations may be more hazardous than none at all,” he said, “many auditors now consider labeling to be as important a safety issue as sterilization. It is our hope that manufacturers can use this information to begin benchmarking their labeling quality, reduce risk, and improve international patient safety.”

Labeling Audits for Improved Patient Safety and Risk Management

Crimson provides labeling translation and audit services to a number of the world’s largest device manufacturers. Crimson’s audit method is based on the SAE J2450 translation quality standard and has been awarded official Notified Body approval. More information on managing labeling translation risk is available by contacting Marc H. Miller (mmiller@crimsonlanguage.com). Dr. Harvey Rudolph (hxrudolph@prodigy.net) provides risk management and ISO 14971 compliance consulting services.

About Crimson Life Sciences

Crimson is a division of TransPerfect Translations and is the world’s largest translation practice devoted exclusively to Class II and Class III medical devices and List A and List B IVDs. TransPerfect is the world’s largest privately held language services provider with 56 offices worldwide.

 

 
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