Terminology and product liability

chain liabilityThere’s no denying that terminology inconsistency could not only undermine customer trust in our products, but also have serious legal implications for a business when its documentation –such as user manuals, technical manuals, online help, training, tutorials, etc.– uses different terms for products that are published or marketed internally or externally, nationally or internationally. There could be a high risk of injury or damages if measures are not taken from the beginning of the manufacturing process to make sure that terminology is managed properly. This will avoid having after-sale issues and eliminate the risk of costly remedial measures such as unnecessary customer support service calls or even product recalls.

By avoiding errors in technical texts, terminology management will reduce the risk of liability claims, damage compensations (financial loss), safety procedures, product failure, and even human injury or loss of life. It becomes even more critical when you are selling “intelligent products” such as software, medical devices, pharmaceutical products, etc. Mistranslations in medical texts or user’s manuals for heavy machinery, for example, could cause serious injuries or even death. Therefore, maintaining consistency and accuracy in terminology is vitally important to the health and safety of patients, and even more so when we are dealing with many languages.

In order to maintain its position in the market, nationally and internationally, a business should comply with terminology requirements to ensure that its product information and documentation is reliable and will not give way to possible legal actions.

In 2007, the FDA had to recall a device due to terminology inconsistency. The manufacturer’s reason to recall was “Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)”. Not only was this costly but also it damaged the image of the manufacturer, and it possibly caused other major issues.

To avoid these problems, the best way to proceed is to manage terminology from the beginning and comply with quality standards, general standards (such as the widely known ISO 9000 series), industry standards (such as DIN 2345 for contracts between translators and clients and EN 15038 for translation service providers that ensures the consistent quality of the translation service) and translation quality metrics (such as the SAE J2450 standard for translations of automotive service information).


Sources and further reading:

  1. Focus on Terminology Management. Neglect it at your own peril. Uwe Muegge. Read here.
  2. FDA Class 3 Recall BioPlex 2200 Syphilis IgG Kit. Read here.
  3. Economic Aspects of Terminology Management by Dr. Frieda Steurs. Read here.
  4. Multicorpora in pharmaceutical/medical scenarios. Read here.
  5. Technical translations: challenges and possible solutions (Blog entry by Octopus translations)
  6. Terminology precision. A key favor in product usability and safety, by Barbara Inge Karsch and Gabriele Sauberer. Read here.
  7. Are they worthy What terms belong in a termbase? by Hanne Smaadahl. Read here.

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