Medical Device Translation – Validation

Device labeling is a difficult issue for manufacturers, and the prime cause is the insistence on national language by individual countries. The impact of translation and localization on these items is often not as carefully identified, controlled, verified, and validated as they should be. For devices and diagnostics that are to be sold across the EU and non-EU European countries, this poses practical and legal difficulties. The driver for full, comprehensive and local-language labeling is the possibility of litigation if something goes wrong. Yet there is limited space on labels and, the more information that is included, the less the user is likely to read or, more importantly, absorb the information.

Medical Device Validation

The purpose of translation validation is not to correct grammar, spelling, or other linguistic errors—this should already have been done by a translator. Rather, validation is meant to ensure that terminology and text are being used correctly in the context of the medical device field.

Even translators with years of experience translating in a specific field generally do not have the day-to-day knowledge of how a medical device is being used in hospitals or medical clinics. Translation validation has been one of the most difficult issues to resolve, and even today it causes delays for the translation managers at many medical device firms.

Who will set the correct terminology for the device in each country and review (validate) the translations to ensure that it is technically accurate? Should a company rely on its distributor or staff from the in-country office or should it talk directly to physicians or medical specialists in each country? Medical translations require specific knowledge of how a medical device works. The purpose of the translation validation is not to correct grammar, spelling, or other linguistic errors—this should already have been done by a translator. Rather, validation is meant to insure that the terminology and text are being used correctly in the context of the medical field.

Accuracy Testing

Many companies take on accuracy checking by using their own translation validators. Some may refer to this as an in-country review in which the documentation, or other translated material, is reviewed by an independent, native speaker from the market country. Ideally, this will be a physician, medical specialist, or someone with experience in the specific field. This type of testing often comes in the form of readability testing; however, there are instances in which companies and translation service providers are performing actual user interface testing.

It is important to note that at this stage of the development, translation validation is strictly a textual one. Once the initial translations have been made, the validation phase is not the time to make changes to the text. It is not the job of the validators to make any changes, only to ensure the technical accuracy of the translation and the proper use of terminology. Changes to the product messaging should be made before the translation process ever begins. Under the EU directives, all language versions should contain the same information, if a validator in one country insists on making additions or changes to the instructions for use, these must be incorporated into all of the other languages as well. In extreme cases, this may result in the notified body have to approve the revised source text.

Many medical translation companies work with medical specialists for this type of validation, as an additional service. But because validation has always been a difficult issue for OEMs and translation companies, an OEM may want to look into third-party companies to address medical translation validation. For example, some companies offer accuracy-testing measures. One company distributes patient questionnaires to focus groups from international populations to evaluate the nuance and the cultural sensitivity. Other services may include back translation. The text is translated into the market language and then back into English. The two versions of English text are then compared to verify that the translations match.

For higher risk devices, or higher risk aspects of a device, additional validation processes or resources may be considered appropriate to further mitigate risk. For instance, certain devices may require validation through in-country clinical practitioners with familiarity in the use of the device type, or a representative cross-section of users for home use devices. Such a practitioner-conducted validation can be further expanded into a comprehensive in-country usability study with representative users in the relevant locale (with additional emphasis for home use or high risk devices). This type of validation can also be of valuable for evaluation of human factors/use errors that can lead to field incidents in one country, which can help determine if localization changes are needed in other countries to prevent similar incidents.

Representative localization validation techniques are listed below in order of decreasing strictness:

1. In-country usability validation with representative users.
2. In-country expert validation: Full functionality and usability validation testing by a qualified practitioner in the target country.
3. Expert-assisted linguistic validation: Linguists conduct validation protocol under supervision of a device expert.
4. Linguist review validation: Expert trained linguists carry out validation on device or a device emulator.
5. Linguist validation: Linguists review documentation, source and target and conduct self-guided validation.

Linguistic validation methodology

We use a number of different methods of validation, depending on client requirements. The full-blown process described below is best practice for surveys and clinical trial documentation. Nevertheless, many of our medical device clients use some variant or some pieces, of the comprehensive validation methodology described below:

1. Two translators, who are native speakers of the target language, and are experienced in translating medical device material, independently translate the document.
2. After both translations are complete, the two translators compare their translations and produce a third translation jointly. This process of discussion and review is known as "harmonizing" and the resulting third translation is referred to as the "harmonized translation."
3. The harmonized translation is then given to a native English-speaking translator for translation back into English. This document is referred to as the "back-translation."
4. A project manager compares the original English to the back-translation and either approves or questions each item in the back-translation.
5. The project manager discusses concerns with the three translators, who may change the translation, change the back-translation, or leave the translation as is, as long as they provide a justification to the project manager. A new harmonized translation and back-translation may be created.
6. A survey research expert (or the author, if available) compares the original English to the harmonized back-translation and either approves or questions the translation.
7. If portions of the back-translation are not approved, then the translation is sent back to the three translators who may change the translation, change the back-translation, or leave the translation as it is, providing a justification to the survey research expert. This process is repeated until all translation issues have been resolved and the revised back-translation is approved.
8. Local users, selected by the client, review the translation to identify any additional concerns. If the local user requests changes, steps 1-3 are repeated until all concerns have been addressed and all revisions are approved by the designated medical device expert.