How Does Usability Testing Apply to Medical Devices?

Usability Testing :
Usability testing is a process that involves testing how simple and safe a medical device is. It is a requirement to test usability on medical devices to ensure that the device itself meets government standards.
Factors that affect the usability of a product includes the following: time, resources, and efficiency. If an incident occurs during these usability tests, potential reasons and the cause of the incident are assessed. Usually, a medical device should be tested by at least 5 users. From these tests, the observer can interpret whether if the design of the medical device or user-interface is safe and easy to use.
Usability testing should also include not only testing the device during its prototype stage but also testing the device after the device itself has been created. Furthermore, testing the device’s instructions is also a good idea, especially since the instructions itself may contain faults. These faults may result in the unsafe use of a medical device. When the medical device is released to the public, it doesn’t mean one should stop testing the product. Devices can be refined based on users’ criticism and feedback.
Testing the medical devices’ software is also equally important, as the software can fail to run. When the software fails to run, a run-time error has occurred. In other words, a run-time error occurs when the program has been executed, is running, and fails to continue the complete execution of the program. Programs used for medical devices, such as the IV pump, must be thoroughly tested to eliminate any run-time errors.
Interestingly enough, other software programs can confirm that there are no run-time errors in the medical device program. This allows medical software engineers to debug and fix their programs so that the medical device is safe and easy to use.
Medical devices that are intended for good ease of use will limit user errors. Negative results are bound to happen because of user error than of other device failure modes.
Trial and error in this context refer to the mental decision-making shortcuts we create because of cooperating with our condition. It is training we increase through involvement. The creators distinguish 14 trial and error that can be utilized to assess medical device usability

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