Online Safety Community

Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of human knowledge. Both the ways in which these elements are used to enhance production, as well as the limitations inherent into them are factored in. In essence; human factors deal with how humans and devices or machines interact with each other.

Since human factors places the human mind at the center; design and aesthetics play a very prominent role in this discipline. Being an important element of user interface; human factors and user interface have risen in prominence after the explosion of the field of IT. It however, can be put into use in several other areas. The user being the fulcrum of any area of production; human factors has the potential to be a major factor in creating and shaping user interface for a range of products.

Use in medical devices

Do human factors matter in medical devices

How about the area of medical devices? We have seen that user interface and aesthetics are core ingredients of human factors. Are these the major determinants for the field of medical devices? Yes and no. Yes, because the user is of critical importance in medical devices. A wrong instruction or wrong usage can severely compromise the use of medical devices and can go the extent of even causing harm to the user.

No, because when it comes toanother equally important element of human factors, namely aesthetics, the interplay between medical devices and human factors may not appear so pronounced. Yet, while role of aesthetics may not be all that critical to medical devices; there is a related aspect, and that is design.

The role of design is very prominent when it comes to the user interface of medical devices since medical devices have to be designed to absolutely precise specifications. Even small deviations or variations can result in harm to humans. Both the patient and the organization manufacturing the devices need to face consequences as a result of these.

As far as medical devices are concerned, the FDA is tasked with regulating them for ensuring their safety and effectiveness. The incorporation of theprinciples 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. It is because of these factors that 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 on human factors in medical devices

FDA_s regulations on human factors in medical devices

Under 21 CFR 820.30; the FDA emphasizes that human factors need to be taken into consideration for the following:

  • Design input: To ensure that the needs of the patient and any others who may use the product are taken into consideration

 

  • Design verification: To make sure that the criteria for performance set for the medical are being consistently met, and

 

  • Design validation: To safeguard that the device conform to predefined user needs as well as intended uses, and to also sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

The FDA has also been placing emphasis on human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Full learning on 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 complete learning on human factors in medical devices.

Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA, will be the Director of this seminar. To gain knowledge of how human factors related to medical devices, please register for this seminar by visiting Do human factors matter in medical devices?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.

Virginia will cover the following areas at this seminar:

  • Overview of Human Factors and the FDA perspective
  • Human Factors Methods and Device Product Life Cycle
  • Human Factors and Risk Analysis & Management
  • Human Factors: What Devices Require Human Factors Evaluation and Validation?
  • Human Factors and Combination Products
  • Human Factors and Combination Products Submitted in an ANDA.

Views: 11

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

rodriguezcecelia posted blog posts
7 hours ago
Emma Miah posted a blog post

Best Ways to Preserve Food at Commercial Level

A well-plated dish is all the all the more enticing to the faculties! It upgrades the general understanding of eating. Likewise, when your sustenance is outwardly engaging, it animates your stomach related squeezes, and augments the body's assimilation of the supplements, while expanding the delight you encounter from…See More
12 hours ago
John Robinson posted blog posts
12 hours ago
Chandra kala posted an event

Hurricane Safety and Survival Tips - Severe Weather Precautions at Online

September 29, 2017 from 10am to 11am
This webinar will review the most critical safety elements associated with planning for, surviving and recovering from natural disasters, such as Hurricane Harvey we have seen recently in Texas. Learn how to protect yourself, your family and your employees, what to expect, and how to minimize the disruption from severe weather events.Areas Covered in the Webinar:Why having an Emergency Action Plan that includes severe weather events is critical to a business or organization. We will review some…See More
12 hours ago

Forum

Differences between Sap devoloper and Sap technical consultant.?

What are the main Differences between Sap devoloper and Sap technical consultant.?Continue

Tags: training, differences, sap

Started by emmablisa Sep 6.

Black Belt Training Course in Reno

Welcome to MSys Training! We thank you for visiting MSys LSSBB training page. Attend our 4 days Lean Six Sigma Black Belt (LSSBB) training program with 100% pass rate, high quality course material,…Continue

Tags: sigma, six

Started by rodriguezcecelia Aug 25.

QlikView 12.10 Service Release 8 and QlikView Governance Dashboard 2.0.4 now available

Hello all,Qlik announced that QlikView 12.10 Service Release 8 [SR8] is now available on Qlik download site.   SR8 is a…Continue

Started by Madison Quinn Aug 22.

PMP Certification Boot Camp Los Angeles

Welcome to MSys Training, North America’s leading training provider. Read some of our reviews on www.trustpilot.com. MSys’ PMP® program…Continue

Tags: PMP

Started by rodriguezcecelia Aug 22.

Safety - A Prerequisite 11 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Tara safe Aug 16.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service