Integrating Human Factors into Design Controls of Medical Devices

AAMI TIR59:2017 - Integrating human factors into design controls medical devices

Human factors, or ergonomics, strives to understand the interactions among humans and the other elements of a system. Integrating human factors engineering, otherwise known as usability engineering, into product design takes into account the ways in which a person’s physical characteristics and behavior will influence how he or she will make use of a product. While there may be a natural inclination for this in any kind of design, incorporating the many factors of the interdisciplinary science can establish a particular approach that considers many important and otherwise overlooked concerns.

The application of human factors engineering for the design of medical devices is a fascinating pursuit, as it encourages the manufacturer to consider the human-device interface on the side of the physician or professional who is utilizing the device, not that of the patient undergoing treatment. This approach ultimately supports the performance of both the professional and the device. A new technical information report, AAMI TIR59:2017 – Integrating human factors into design controls, provides aid for manufacturers in addressing human factors.

AAMI TIR59:2017 seeks to offer guidance on integrating human factors engineering/usability engineering (HFE/UE) into a manufacturers design process and quality system, highlighting the importance of consistency and alignment of processes throughout a manufacturer’s product development process. This helps to assure recognition and compliance with industry best practice, applicable Food and Drug Administration (FDA) regulations, and recognized standards.

AAMI TIR59:2017 provides background and applicable information in accordance with 21 CFR 820.30, a FDA regulation that requires medical device manufacturers to establish and maintain procedures that ensure that specified design requirements are met. While the AAMI document does not cover all elements within the regulation, it does address, in detail, specific design controls from the CFR that overlap functionality with HFE/UE processes. This factors in different implications, such as those associated with risk management.

AAMI TIR59:2017 is not a standard but a technical information report (TIR), as it was released without undergoing the formal consensus process of committee approval, public review, and comment resolution. This means that its information may need further evaluation by experts, but its release is valuable for the medical technology industry, as professionals may have an immediate need for it.

Many technical information reports have been written and published by the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI-accredited standards developing organization devoted to the proper production quality of medical instruments and the procedures in which they are used. Some of the prominent TIRs published by AAMI include:

AAMI TIR45:2018 – Guidance on the use of AGILE practices in the development of medical device software
AAMI TIR12:2020 (R2023) – Designing, testing, and labeling medical devices intended for processing by health care facilities: a guide for device manufacturers
AAMI TIR30:2011 (R2016) – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
AAMI TIR17:2017 (R2020) – Compatibility of materials subject to sterilization
AAMI TIR42:2021 – Evaluation of particulate associated with vascular medical devices

AAMI TIR59:2017 – Integrating human factors into design controls is available on the ANSI Webstore.

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