The ANSI/AAMI HE75:2009 document describes human factors as the way in which the elements of human knowledge, such as emotional, intellectual, and physical and the sensory are used to optimize the production of devices, systems, and many others concerned with them. Human factors take not only the ways in which these human elements are used to raise productions, but also the way in which the limitations of these factors come into play. It is a field that is essentially concerned about the interaction between humans and devices or machines.
Given the nature of this description, it is not surprising that human factors are important to areas such as design and aesthetics. It is an important aspect of user interface. User interface has gained a lot of acceptability and popularity following the emergence of the field of IT, but it can be used in a number of other areas. Since there is almost no area of production or science in which the user does not come into the picture; human factors can be a major factor in creating and shaping user interface for a number of products.
A major factor in medical devices
In the area of medical devices, human factors come into play in a prominent way. Although, strictly speaking, medical devices are not products into which the aesthetics is considered critical in determining consumer behavior in the way it is for say, clothing; design is an indispensable factor. Design plays a very major role in the user interface of medical devices, because these products have to be designed to absolutely precise specifications. A small deviation or variation can cause harm to humans, given the nature of the uses of medical devices. Errors can result in major consequences for patients, and subsequently, to the organization manufacturing the devices.
When it comes to medical devices, the FDA has the primary responsibility of regulating them with the intention of ensuring their safety and effectiveness. Incorporating the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. On account of this, human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.
FDA’s regulations talk about human factors in medical devices
21 CFR 820.30 emphasizes that human factors need to be taken into consideration for the following:
– Design input: Ensuring that the needs of the patient and any others who may use the product are taken into consideration
– Design verification: Making sure that the criteria for performance set for the medical are being consistently met, and
– Design validation: Ensuring that the device conform to predefined user needs as well as intended uses, as also making sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.
In addition, the FDA has also emphasized the area of human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.
Explore the area of human factors in medical devices
Curious about how human factors play a role in medical devices? Want to explore the area in-depth and stretch your knowledge and imagination of human factors in medical devices? A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer this learning.
The Director of this seminar is Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA. Over the course of these two days, Virginia will cover all the important areas relating to human factors in medical devices. To enroll for this important learning session, just log on to
Human Factors and Predicate Combination Products. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
A complete explanation of regulations and uses of human factors in medical devices
The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products. Those in charge of crucial functions in medical devices, such as Quality Assurance, Regulatory Affairs, Device Engineering, Device Manufacturing and Pharma/Medical Devices will gain a great deal of learning from this seminar.
Virginia will cover the following areas at this seminar:
o Overview of Human Factors and the FDA perspective
o Human Factors Methods and Device Product Life Cycle
o Human Factors and Risk Analysis & Management
o Human Factors: What Devices Require Human Factors Evaluation and Validation?
o Human Factors and Combination Products Submitted in an ANDA.