Module 18 2021

09/02/2021

Evaluating medical devices in Human Factors and Usability Tests? Key elements that studies and tests look at –  The intended users  The use environments  The user interfaces

Most studies and tests are performed with –  Nurses (Hospital, Care-Home, Community, Specialist etc.)  Patients with the conditions/injuries/medical condition  Personal/professional Carers who manage the patient(s) Most studies and test are performed focusing on how the drug device combination product interacts with the patients body:  Orally  Through surgery/intervention  By injection/infusion  Through the skin  By inhalation  Through absorption

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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Evaluating drug delivery devices in Human Factors and Usability Tests? Most studies and tests are performed in –  Research facilities (with viewing capability)  Actual real-life use environments  Simulated-use environments

Many drug device combination products are used where the patient needs or wants to use them. This is mainly with the Carer or Nurse or on their own – i.e. at home. Many drug device combination products require management and this is the new trend – self-management. This is not well understood! Managing medication regimes at home is extremely variable and this is what human factors aims to understand. IEC 60601-1-11:2015 focuses on home use medical devices that are electronic.

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

24

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