FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm, as well as allowing manufacturers to assess and reduce risks associated with the use of medical devices.

In this release, the FDA recommends that manufacturers follow human factors engineering, or usability engineering (HFE/UE) processes during the development of new medical devices. Human factors engineering is defined by the FDA as the application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices; including mechanical and software driven user interfaces, systems, tasks, user documentation and training. The FDA recommends focusing specifically on the user interface, which includes all points of interaction between the product and the user, including displays, controls, packaging, labeling and instructions for use.

While 21CFR820.30 requires manufacturers to conduct risk analysis on a device, and document any measures implemented to reduce those risks, the FDA cites concerns with determining the probability of medical device errors associated with, or attributed to use of the device. Since many use errors cannot be anticipated until device use is simulated and observed, the FDA takes the position that the severity of the potential harm is more meaningful for determining the need to eliminate or reduce resulting harm from use errors. If the results of risk analysis indicate that use errors could cause serious harm to the patient or the device user, then the manufacturer should apply appropriate HFE/UE processes as set out in the guidance document. This guidance also applies to a manufacturer modifying a device as part of a corrective and preventative action.

According to the FDA, eliminating or reducing design-related problems that contribute to, or cause unsafe use, is part of the overall risk management process. Traditional hazards considered in risk analysis include physical, mechanical, thermal, electric, chemical, radiation and biological hazards. However, these traditional hazards are generally not dependent on how the user interacts with the device. As such, the FDA recommends that medical device hazards associated with user interaction should be included in risk management assessment. These hazards may include design components that result in the user to failing to adequately or correctly perceive, read, interpret, understand, or act on information from the device.

The FDA recommends that manufacturers consider numerous use related hazards, including exceeding the cognitive, physical, or perceptual abilities of the user; device use inconsistent with the user’s expectations about device operation; effects of the environment in which the device may be used which may not be expected or anticipated by the user; the effects of the environment in which the device may be used that effect the users physical, perceptual, or cognitive abilities, such as low light, moving vehicles, and level of training and education of the user; and use of the device in ways that could be anticipated but not considered by the manufacturer as well as anticipated, inappropriate uses of the device.

The FDA recommends that manufactures incorporate HFE/UE analysis into device design utilizing three essential steps: 1) Identification of use-related hazards, and initially unanticipated use-related hazards and determine how hazardous use situations occur; 2) Develop and apply measures to eliminate or reduce use-related hazards that could result in harm to the patient or user; and 3) Demonstrate whether the final device user interface design supports safe and effective use by conducting human factors validation testing.

Most importantly, the FDA recommends that manufacturers document risk management HFE/UE testing and design optimization processes to provide evidence that the manufacturer considered the needs of the intended users in the design of the new device, and determined that the device is safe and effective for the intended users, uses, and use environments. When required, providing information about these processes as part of a pre-market submission for a new device will reduce the need for requests for additional investigation and facilitate the FDA’s review of all HFE/UE information contained in a product submission. In addition, documentation of risk management HFE/UE testing may be invaluable in subsequent product liability litigation.

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