Online Safety Community

Article on “Human factors as a factor in medical devices 2017”


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.

Source

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 http://www.globalcompliancepanel.com/control/globalseminars/~produc... . 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?

 Human Factors and Combination Products

o  Human Factors and Combination Products Submitted in an ANDA.

Views: 21

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

Mark Nilson posted events
4 hours ago
Mansi Rao posted a blog post

Microsoft Security

Security Decades of experience In today’s complex and regulated environment, businesses need to focus on building more secure solutions that deliver value to their customers, partners, and shareholders—both in the cloud and on-premises. Microsoft has decades-long experience building enterprise software and running some of the largest online services in the world. We use this experience to implement and continuously improve security-aware software development, operational management, and…See More
4 hours ago
knorr kendra posted a blog post

How To Find Safe And Secure Auto Loan Company For Bad Credit

Car is a luxury and everyone desires to have a car but everyone cannot afford due to bad credit or no credit history. People want to purchase cars but due to bad credit history, they are unable to get a loan from the company. Thus it is important to find a car loan finance company that provides car loans to people even with bad…See More
7 hours ago
Training Doyens posted an event
Thumbnail

Executive Presence - Key to Getting Promoted at 26468 E Walker Dr, Aurora, Colorado 80016-6104

March 7, 2018 from 1pm to 2pm
OVERVIEWToo many managers do not have the promotable trait called Executive Presence. There are numerous definitions – some focus simply on the communication skills others focus on skills that are too tactical. Leaders need to project the Executive Presence to motivate and challenge their direct reports. Learn the key skills for Executive Presence – that reflect your readiness to be promoted.WHY SHOULD YOU ATTENDHas this happened to you?  You realize that everyone around you is getting promoted…See More
8 hours ago

Forum

Gig Economy

The career world has rapidly changed and these days, long-term careers and people working in just one job are slowly but steadily becoming a thing of the past. In fact, according to research, in the…Continue

Tags: field, engineer, IT, freelance, economy

Started by Mohd Azher yesterday.

How to Repair MySQL InnoDB Table That Has Issues?

When trying to run: delete IdentityRequest *I get an error of sailpoint.tools.GeneralException: null index column for collection: sailpoint.object.IdentityRequest.itemsDoing a select * from…Continue

Tags: course, sailpointonline, sailpoint

Started by Soujanya Naganuri on Tuesday.

Occupational Health and Safety 7 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tony Ferraro on Sunday.

About sailpoint software

An identity management system refers to an information system, or to a set of technologies that can be used for enterprise or cross-network identity management. Additional terms are used synonymously…Continue

Tags: sailpoint

Started by sujathayarlagadda Feb 16.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

Tags: security, campus

Started by Jen McDade Feb 6.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service