HFE and Risk Management

Studies show that the frequencies and consequences of use-related hazards of medical devices might far exceed those resulting from device failures. This necessitates the incorporation of Human Factors Engineering (HFE) principles in the device design process. HFE identifies and addresses potential use-related hazards that arise due to interactions between the user and the device.

Most designers only consider the most apparent (e.g., fire) or well-known use problems and thus limit to only relatively few user actions that cause device failure. According to the FDA, use-related hazards occur for one or more of the following reasons:
• Use of devices in ways that were not anticipated,
• Devices are used in an anticipated way, but inadequately controlled,
• The user's physical, perceptual, or cognitive abilities are not sufficient for the device use,
• The user’s expectations or intuition about device operation are inconsistent with actual device use,
• The effects of the use environment on device operation is not understood by the user, or
• The user’s physical, perceptual, or cognitive capacities are exceeded when using the
device in a particular environment.

The device-user system, thus consists of three major components:
1. Use environments,
2. User characteristics and
3. Device user interface characteristics.
The interactions of these components can thus result in a safe, effective, or unsafe and ineffective use of the device. This can be depicted in the following image.

HFE approaches can be incorporated into the design of medical devices within the risk management process to account for the changes in the device-user system. FDA defines risk management as the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risk.
HFE incorporation into risk management can be achieved by four steps:
• Identify use- related hazards that are anticipated (derived analytically) and unanticipated (derived empirically),
• Describe the hazardous use scenarios that can occur,
• Develop and apply strategies that can control these use-related hazards, and
• Demonstrate safe and effective use of the device (validation).
The risk management process by which use-related hazards can be addressed is shown below,

A more detailed description of the process can be found in the FDA document, "Medical Device-Use Safety: Incorporating Human Factors Engineering into Risk Management."