This week has been an interesting one for my family. After being so careful over the last 2years SARS-Cov2 has finally reached our household with my son and wife testing positive this week. Both are fit and well thankfully (apart from the odd cough and achy muscles), but it has meant that we have all been testing ourselves daily with the Lateral Flow tests.
This daily ritual re-enforces the need for effective usability studies to be carried out for in vitro diagnostic medical devices, such as the lateral flow tests, to make sure that these devices can be used quickly, effectively, and safely by any untrained personnel. Under the EU IVD Regulation 2017/746/EU, usability in built into the performance evaluation and clinical performance using the standards IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices, and ISO 14971:2019 Medical devices — Application of risk management to medical devices among others.
One of our expert consultants Anne-Marie Turner considers why usability is important to the IVD design and development process:
“Usability studies are important as they validate the safe and effective use of a device against the intended purpose by gaining evidence from the users, it is a measure of effectiveness, efficiency, and satisfaction to demonstrate that no harm occurs.”
A key part of this is really understanding your intended purpose, including your intended user and intended use environment. Knowing these basic details for your device really does make a difference, as you can really focus on the key risk elements which need to be considered:
- How will a lay-user actually use this test?
- Are the instructions clear enough?
- How may they be harmed by using the device?
- How can we reduce as far as possible the risk of getting an incorrect result?
The IVDR goes further than the IVDD in really asking manufacturers to consider the usability of devices as part of the Post Market Surveillance activity once the device is being sold on the market. Pro-active assessment of real word user experiences should be performed as a regular part of PMS to fully understand, and react to, any changes in the way the devices are being used, and for what purpose.
Anne-Marie sums it up nicely by adding “usability is there to ensure the safety aspects for people using it”, and in that respect, I am very proud to be in an industry that ensures the lateral flow tests we use on ourselves, and our children are designed to be as safe and effective as possible.
Stay safe all!
Stuart
Anne-Marie has worked with many IVD companies designing usability studies as part of the wider design and development process. Contact [email protected] to learn more.
