The main purpose of human factors engineering (or so-called usability engineering) is to understand how human interact with medical devices and how user interface would affect this interaction. In addition, human factors engineering is often regarded as a part of risk management to minimize potential use errors that cause harm.

When preparing product registration, manufacturers shall consider the different concepts when  applying human factors engineering evaluation to medical devices, such as the following items:

Items

Content

1

Description of prospective user, purpose, environment, and user training

Prospective user 

Prospective instruction of use

Prospective operation environment

Prospective user training

2

Description of user interface

Icons

User interface instruction

Instruction for use and labels

Operation procedure

3

Summary of known operation issues of similar medical devices

Old models

Similar products

Design changes specific for post-market use error

4

Hazards and risk analysis related to medical devices operation

Use error

Degree of injury and severity

Risk management measurements

Evidence of risk management measurements validation

5

Summary of early (formative) analysis and evaluation

 Method of evaluation

Evaluation result and corresponding design changes

Contributive discoveries of human factors/usability engineering validation testing

6

Description of critical task

Process of identifying critical task

List of critical tasks

Classify critical tasks using the degree of injured severity

Usage scenarios of critical tasks

7

Human factors validation testing/summative evaluation

Test method 

Test goal

Subjects

Test environment

Instruction for use

Training

Test result

Analysis and discussion

8

Conclusion

Summary of human factors/usability engineering evaluation

Residual risks

RECOMMEND READING

TW: Guidance for Pre-clinical Testing of Soft Contact Lenses

- TW: TFDA Release Guidance for Pre-clinical Testing of Power Kits on Mechanical Wheelchair

References:
公告「醫療器材人因/可用性工程評估指引」 
Role of human factors/usability engineering in medical device design
FDA comprehensive regulatory: Human factors and medical devices

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