When regarding all the different areas of interest that go into a Human Factor study including HF formation and HF validation, it is especially important to also consider the evaluation of Use-Related risk. The goal of use-related risk analysis will help identify critical tasks that should be further evaluated in a HF study. Two use-risk evaluation methods frequently used are Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).

Critical tasks: these tasks are defined as tasks, which if preformed incorrectly by the user, could lead to adverse medical effects. Therefore, it is crucial to unique considerations for each combination product.

Intended users and use environments: This guideline encompasses who should be qualified to use such a product with minimal risk done to the patient. Depending on the complexity/ sensitivity of the device, it could be used by the patient him/herself or have to be administered by a health care professional. A clean and controlled environment is also desired but not always obtainable so this variable must also be considered in use-related risk analysis.

Training: Trained use of a new product is used as a way to minimize and control risks that were unavoidable in the design of the device. Training for the use of a product can encompass anything from what is involved to use product to how often training session should occur.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM484345.pdf