Jensen Localization had the pleasure to meet Dr F.P. Wieringa at the latest Medical Devices Innovation Programme (MDIP) that took place in Munich this year.
IEC member Dr F.P. Wieringa chaired the October 14th MDIP session. He is involved in the NeoKidney Project of the Dutch Kidney Foundation to create a portable device for hemodialysis at home or when travelling.
We asked him to give his opinion about localization for our blog, as his concerns about the proper use of localization are commonly shared by us.
On the topic of localization he states the following:
“Localization is important. IEC 60601-1: 2005, which is the basic standard for all electro-medical equipment states in clause 184.108.40.206 that instructions for use shall be in a language that is acceptable to the intended operator“.
As we know, from experience, if the translation of a medical device is poor or incorrect the user will not be able to operate it the expected way. A typical example is when nurses of many hospitals tend to add stickers on devices such as scans and x-ray machines to know how to use the most basic functions and avoid the problematic ones. This issue could be avoided with clear and easy to understand instructions in the user´s language. You can learn more about this and other examples of good communication on this article by Dr Wieringa and other authors. Just click on the link and search for “user instruction” to reach this section about stickers on equipment.
Localization becomes even more important if you are designing equipment for home care, where lay persons are the intended operators. Dr Wieringa pointed out that the dedicated collateral standard on home care equipment, IEC 60601-11: 2015, emphasises this by stating:
“As required by the general standard and its USABILITY collateral standard, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, accompanying documents for use in the home healthcare environment should focus on the characteristics of the intended lay operator to make the accompanying documents most effective for them” (text from the rationale of clause 7.1 in Annex A.2).
During his opening lecture on the MDIP event, the book Evaluation Of New Technology in Health Care was discussed. We encourage you to get your free copy of this very interesting subject.
Website visitors can also download a PDF Summary and a PDF version of the book.
Jensen Localization would like to thank Dr F.P. Wieringa for his time on helping us in producing this article and sharing his expertise on such a complex subject like home medical devices development.
At Jensen Localization we have long experience translating and localizing instruction manuals and making them acceptable for the intended operator of any medical device. Do not hesitate to contact us if you need further information and let us know how we can help you.