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:
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Items |
Content |
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1 |
Description of prospective user, purpose, environment, and user training |
Prospective user |
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Prospective instruction of use |
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Prospective operation environment |
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Prospective user training |
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2 |
Description of user interface |
Icons |
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User interface instruction |
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Instruction for use and labels |
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Operation procedure |
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3 |
Summary of known operation issues of similar medical devices |
Old models |
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Similar products |
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Design changes specific for post-market use error |
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4 |
Hazards and risk analysis related to medical devices operation |
Use error |
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Degree of injury and severity |
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Risk management measurements |
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Evidence of risk management measurements validation |
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5 |
Summary of early (formative) analysis and evaluation |
Method of evaluation |
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Evaluation result and corresponding design changes |
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Contributive discoveries of human factors/usability engineering validation testing |
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6 |
Description of critical task |
Process of identifying critical task |
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List of critical tasks |
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Classify critical tasks using the degree of injured severity |
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Usage scenarios of critical tasks |
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7 |
Human factors validation testing/summative evaluation |
Test method |
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Test goal |
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Subjects |
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Test environment |
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Instruction for use |
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Training |
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Test result |
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Analysis and discussion |
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8 |
Conclusion |
Summary of human factors/usability engineering evaluation |
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Residual risks |
| RECOMMEND READING |
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- TW: Guidance for Pre-clinical Testing of Soft Contact Lenses - TW: TFDA Release Guidance for Pre-clinical Testing of Power Kits on Mechanical Wheelchair
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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