Last Updated: November 19, 2019 6:47PM
Now that we’ve reviewed the requirement for a Summary of Safety and Clinical Performance (SSCP) under the EU Medical Device Regulations (MDR) and the language challenges that it brings, let’s focus on how you as a medical device manufacturer can meet some of these challenges while keeping you in compliance.
Who to Address in an SSCP
As mentioned in my previous post, the SSCP is expected to contain information for both patients using medical devices (when relevant) and healthcare professionals. This means that the same document needs to address different audiences with two different readability standards. The Medical Device Coordination Group (MDCG) guidance recommends separation of the content intended for patients and healthcare professionals by “page break” functionality. Regardless of the formatting specifics, as a manufacturer you will need to tackle content for two very different target audiences and readability levels in the same content piece. This poses a challenge due to the different nature of scientific and plain language health-related content.
Content for scientific and lay audiences are “linguistic opposites” since the format, the style and the terminology are different. If you plan to perform readability testing, as recommended in the guideline, you may need to split the content into separate documents as an additional process step to derive valid output from your readability tools.
What to Consider During SSCP Development & Translation
When authoring the summaries, pay special attention to readability, scientific validity, medical terminology, formatting and style, and non-promotional language. Although the MDCG guideline on SSCPs does not refer as explicitly to health literacy principles as the guideline on layperson summaries for clinical trial results, there are many common denominators for two.
If your summary will be shared with patients, start by carefully considering who you are addressing. Depending on the intended purpose of your device, you may have more than one target audience to address in your plain language part of your SSCPs.
If your device is intended for small children, your summary is should be addressed to the parents. If the user of your device is an adolescent, you may need to adjust your language to the appropriate literacy level. Audience awareness may get you a long way in terms of the correct and safe use of your devices and this is where language can be impactful.
Information should be clearly presented at a literacy level appropriate to the patients’ level of knowledge. Patients cannot be assumed to have knowledge of medical terminology. A readability test is recommended in MDCG’s SSCP guidance for content intended for a layperson audience. Transforming scientific content to plain language is no easy task; it requires a combined medical and linguistic skill set.
Examples of content required in the SSCP patient section are residual risks and side-effects, which should be explained and quantified in plain language. Other aspects that must be communicated to patients include the clinical background of the device and whether the clinical evidence is based on data for another equivalent device or derived from a clinical investigation. While healthcare professionals readily understand clinical evidence, it is unlikely that a layperson understands such terms. Take care to explain the origin of the clinical evidence at a sixth to eighth grade reading level.
Both unfavorable and favorable data must be disclosed to ensure that no bias or “skewed” results are introduced in the SSCP. Such skewed results could mislead patients on the benefits of the device.
Medical terms & acronyms
While acronyms and abbreviations are common in the scientific community, they are not suited for a summary intended for the layperson. Use of medical terms and industry acronyms should be reduced and only used if they are explained first in a plain, simple language and then followed by the medical term in parentheses.
Formatting & Style
Content organization and font type and size should facilitate reading. SSCPs should be uploaded in un-editable PDF format that does not require a license. This increases ease-of-access and reduces the risk that errors could be introduced post-publishing and then disseminated.
No claims must be made on the performance of the device that can mislead the patient. The summary must be objective to prevent any bias.
How to get help on translations
Consider centralizing your translations through a single language vendor in a flexible model that accommodates updates and revision control. This the best setup to help you comply and obtain consistent communication on the clinical and safety performance of your devices. An experienced, skilled language services provider will work with you to determine the right technology, workflows and qualified translators to ensure content consistency and readability.
As a language solutions provider for life sciences, Lionbridge knows how sensitive public disclosure can be. Translations are indispensable for ensuring that research results are accurately and appropriately communicated in all markets. Some early recommendations can be found in the whitepaper Lionbridge has published on plain language summaries for clinical trial results.
Reach out for a dialogue with our life science experts on how our language services can help you comply with this new MDR requirement.