Reducing Medical Device risk with usability tests
According to IEC 62366-1:2015 and IECIEC/TR 62366-2:2016
One of the main reasons of medical device recalled are usability issues. Medical devices fault caused by design, packaging/labelling, user or malfunction are common causes of human errors, which may lead to substantial risk to users and to patients.
A medical devices manufacturing process have to take into account not only the patient clinical condition, but also the need of a device that is adequate to his skills, education and capabilities and can be used safely (Ravizza et al. 2019).
Annex I of the European regulation (EU) 2017/745 introduce new requirements in order to ensuring the appropriate efficacy of the medical device, guarantying the user safety.
What is usability?
According to ISO 9241-11 “Ergonomics of Human System Interaction Guidance on Usability”, usability is the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use.
Usability becomes an essential concept in the design process of any medical device, for the benefit of healthcare professionals, patients and all stakeholders. Medical device usability is defined by the standards IEC 62366 (IEC 62366-1:2015 and IEC 62366-2:2016) as “the characteristics or features of the user interface that facilitate use and thereby effectiveness, efficiency and user satisfaction in the intended environment of use”.
What does it mean?
In order to mitigate risks associated with correct use, use errors and/or abnormal use, IEC 62366-1:2015 (part 1) – application of usability engineering to medical devices specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors (i.e. normal use).
The IEC 62366-2:2016 – technical report contains background information and provides guidance addressing specific areas that experience suggests as being helpful for those implementing a usability engineering (human factors engineering) process, both as defined in IEC 62366-1:2015 and as supporting goals other than safety.
Why usability is important to end users?
As mentioned above and when using medical devices, human errors may lead to considerable risk for both users and patients. There are multiple techniques for the identification and assessment of user-related risks and they can be chosen according to the design phase. Cognitive processes and information processing mechanisms of users must also be considered since they may lead to errors:
- Reduce use error
- Improve performance in using device
- Reduce training effort
- Usable products reduce the stress of the user
- Improve safety
Our experts dedicated to medical devices projects are available to meet all your requests.
Usability services performed with professional or consumer users suitable for Late Formative and/or Summative Evaluation steps of the usability evaluation of the user interface, as:
- Expert reviews
- One-to-one interviews
- PCA Analysis
- Simulations
- Survey
- Task Analysis
- Usability Tests
