The instructions for use also known as IFUs are an important part of the medical translation. These are the important documents that talk about the information that a user needs to safely and effectively use the medical device or medicine. These include information about the intent and purpose of the devices and equipment. It may include medicines as well. This deals with the usage of the devices, their adverse effects, and storage instructions for medicines. Also, these are an important part of device labeling and require to comply with regulations in the target market.
The authorities provide the IFUs as part of the risk management process of medications and other devices. They ensure that users are educated about the medicines and methods to consume along with storage. These are also important to educate the users about potential risks attached to the product and their safe use.
IFUs come in different types. It may vary with the product. The IFUs for medical usually include the information about following:
- The purpose of the device
- Assembling and using the medical devices
- Cleaning and maintenance of the device for effective use
- The adverse effects of the device
- Storage instructions for the use of the device
Therefore, the medical companies as well as the translators must understand the requirements and go through the whole text before indulging in the translation.
Some important factors to consider while translating IFUs are as follows.
Offering precise instructions
The medical translator should be aware of the responsibilities which come with the translation of IFUs. These types of medical documents require clear and precise translation. The instructions need to be transparent, accurate, and precise. Also, the content must be easily readable in terms of word selection. The words should be simple and easy which are easily understood by laymen. These should be without ambiguities and errors. The errors in such documents can lead to severe consequences. Therefore, the translation should be clear and precise.
Using effective medical writing technique
Medical companies should ensure that they hire professional medical translator services. These individuals should be aware of reliable and strategic medical writing techniques. They should be able to write precisely conveying the intended meaning in limited words. Moreover, they should properly follow the principles of medical writing. It may include using plain language, and an active tone with short and brief sentences. Convincing the text in bullet points can be helpful. They should also use headings. Most importantly translation should adhere to the style guide, terminology, and the proper layout and formatting of the original documents.
Focus on clarity
Clarity is particularly important in the translation of medical device IFUs. Translation for this type of document especially asks for clarity as the user needs to understand the functions and medication usage and storage for effective use. The language used should be straightforward and also the terminology needs to be consistent and should carry similar meaning and significance at different points to make customers comfortable and trusted.
Working with human translators
Machine translation tools have become quite a norm with the increasing popularity of artificial intelligence. Though it is beneficial in many terms and should be used dully. But, for accurate, precise, and contextual medical documentation translation, it is important that you as a medical company only use human translators. The translation should only be executed by human translators who have relevant experience and subject matter expertise with the required proficiency in the source as well as target languages. Using machine translation or hiring inexperienced budding translators can compromise the quality and reliability of the documents.
Clear healthcare labeling
For medical document translation online and otherwise, it is important that you as a medical company understand the healthcare labeling. Moreover, you should ascertain that the team of translators that you have hired for the translation also understands the right way and techniques of labeling. Also, the translation of the IFU needs to be clear, concise, and consistent and for that device, its components, indication warnings, and precautions should be sorted and matched with device packaging and other accompanying documents.
Staying updated with international medical device documentation
As medical devices and medicines go all over the places and countries thus the translation is inevitable for a smoother launch and expansion to new territories. Therefore, translators must be aware of the changes in medical device documentation internationally. Translations should also comply with the latest regulations and standards set for medical devices in the target markets. There are different formats for translating the content in different countries. Additionally, there are different language versions, content, and format with quality management systems for IFUs.
Last but not least, legal compliance is a must. The relevant regulatory authorities in the respective regions should be checked for the latest developments. Overlooking the right and legal way of translating content can be disastrous. Hence, understanding the legal requirements, going through regulations, and complying with these can help immensely in smoother and seamless translations and launches overseas.
It is quite challenging to translate content into short and precise sentences. The translation of IFUs is hence a draining and mind-boggling task. The translators should ensure that they follow certain practices to deliver a quality translation.