Usability: Medical Devices vs. Users

Usability: Medical Devices vs. Users

A medical device should be used without making use errors which compromise with medical care. A medical device is not expected to be complete error free. However, the designing and manufacturing companies are expected to aggressively seek out potential errors and apply a reasonable effort to mitigate the potential hazard. Therefore, designing and manufacturing medical devices companies must understand an important place of usability or how people interaction with a medical device.

To approach a result of safe and effective use, as well as limiting use error, designing and manufacturing medical devices engineers would consider three major components: device users, device use environments and device user interfaces.

The intended users of a medical device should be able to use the device without making use errors. As a result, maintaining or using medical device must be operated under professional caregivers, such as physicians, nurses, physical therapists; professionals who install and set up the devices and those who clean, maintain, repair, or reprocess them; or non-professionals who are trained to operate devices on themselves to provide self-care or family members. For example, Bridge Disability Ministries medical equipment center is a place where receives donation medical devices, such as commodes, wheelchairs, walkers, hospital bed, etc. The center will clean, repair, test and then reprocess them to others who needed. To make sure an intended users of a medical device should be able to use the device without making use errors. It is important for the center to control quality of a medical device after refurbishing to make sure that the device is fully function as it is. Because there are a lot of volunteers working in the center to help clean, center manager always consider the quality of medical devices by have them tested by himself or employees assigned by the manager before handling them to a customer. In addition, a customer, who is either a person who come to pick up a medical device for his/her relative or for his /her own would be carefully instructed to use the device by an employee who working in the center.

The second component is the environment which a medical device is used. A medical device might be used in clinical environments or non-clinical environments, community settings or moving vehicles. For example, a power scooter is designed to help a user able to mobility access different communities. Therefore, a battery that could able to use for a long distance throughout a day is an important property. A used scooter would be need to test a battery. At Bridge Disability Ministries equipment center, a center employee would give his advises about changing to new batteries depending on user needs and his/her limited pocket. Another property needed for a power scooter is ability to break the scooter into parts, or fold it to an affordable size that fix into a car trunk. This is so important feature that helps the user able to use it in a community center far away from home.

The last component is device user interface which includes all elements of interaction between the user and the device while user setups the device (unpacking, setup, calibration), uses the devices, or performs maintenance on the device (cleaning, replacing a battery, repairing parts). Come back to the example above about a power scooter, to break the scooter into parts or folder it and put into a car trunk, the user would do it without an extra tool needed. The scooter also is designed to have a comfortable seat, adjustable arm rest, a big enough foot rest, easy to maneuver directions etc.

To making the considerations above to be practical, FDA has stringent requirements for testing human factors and usability. The FDA testing will identify areas for design improvements to reduce errors. Therefore understanding the FDA usability standards is very important on the way to design and develop medical devices. Even though there are cost and complexity of incorporating the FDA standards, the process would help avoid the high cost associated with device recalls and making changes to designs late in the development process.

Resources:

1.       Human factors Considerations. Fda.gov. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/ucm124829.htm. Accessed July 25, 2016.