
Kristina Fant
Director, Biological Safety – GBA Key2Compliance
For any device that comes in contact with either a patient or a user, it is crucial to assess possible biological risks early in the development process.
However, there are a lot of misunderstandings that we commonly encounter in our daily work with different medical device manufacturers. See below for our top five list!
1. “All materials are biocompatible, and we have statements for it, we do not need to do anything else”
Actually, there is no such thing as a biocompatible material – compatibility is by definition related to the context of use! Further, it is the final device which needs to be safe. Apart from materials, you also need to look at processing aids, contaminants from production, possible degradation of materials during processing, residues from the packaging, and so on, to understand and assess possible biological risks.
2. “We have done all the tests, we are done”
This is still a very common belief, although it is clearly emphasized in ISO 10993-1 that a biological evaluation is not a “check-box exercise”, and that simply conducting tests for all applicable biological endpoints do not meet the expectations for a biological evaluation. Rather, it should be a thorough risk assessment activity where detailed information on materials and processes is scrutinized, before the need for any novel testing can be determined.
3. “We do not need this yet; we are too early in the development process”
It is “never” too early to start thinking about biocompatibility. This is actually a design input requirement. Also, by planning early for how you want to evaluate possible biological risks and how you will show later that the results are still applicable for the current device, you can save a lot of resources (and headaches!).
4. “Our device is class I; we do not need this documentation”
All devices in contact with a patient or a user need to be safe in their intended application. This is true also for low-risk devices! The amount of information required might be less for a low-risk device, but you still need to do your biological risk assessment and have the documentation available.
5. “We have a biological evaluation plan and report, we are done with biocompatibility”
Your biological evaluation needs to be up to date, and as soon as any changes are planned, an assessment of the possible impact on the device biocompatibility need to be made, preferably by updating the Biological Evaluation Plan. In this way it will also be easy to determine whether new test data is needed and if so what kind of data. When all information is available, a conclusion on the impact of the change is made in the Biological Evaluation Report. You can read more about this process in our previous blog post about change management.
If you feel unsure about whether your company’s documentation meets regulatory expectations, we at GBA Key2Compliance are happy to do a review and give a second opinion. We can also help you with setting up a tailored testing strategy, e.g. using novel methods (NAMs) to avoid animal tests as far as possible. Of course we can also be your full-service provider, handling your whole development project including preparing all necessary documentation related to biocompatibility and toxicology. Contact us today!
Want to learn more?
Take part in our Advanced Biocompatibility course on December 12th!