How Human Factors Lead to Medical Device Adverse Events

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A nicely written article on "Human Factors."

How Human Factors Lead to Medical Device Adverse Events « QD Syringe Systems™:

"The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device."

'via Blog this'

You might also be interested in:
The Human Factors Program at FDA

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Tell Stories . . . - Free GMP Training Tip

GMP Labeling's Spring 2011 Newsletter is a good read:

Using Stories, Anecdotes, and Metaphors to Make your GMP Training Come Alive (pdf) - By David C. Markovitz

Lots of good ideas!

You might also be interested in:
The Adult Learner, Sixth Edition: The Definitive Classic in Adult Education and Human Resource Development

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New HIV Antibodies Hold Promise For Vaccines

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Scientists at the Scripps Research Institute report promising findings in their research report, Broad and Potent Neutralizing Antibodies from an African Donor Reveal a New HIV-1 Vaccine Target. According to this LA Times news article, Antibodies found that prevent HIV from causing severe AIDS, this means that they have isolated two so-called broadly neutralizing antibodies (bNAbs) that can block the action of many strains of HIV, the virus responsible for AIDS. Other bNAbs against HIV have been discovered before, but PG9 and PG16 are the first to be isolated in over 10 years from donors in developing countries, where most new HIV infections occur. Also, the previously identified bNAbs bind to spots on the virus that are hard to target with vaccines. These new antibodies, which are more potent than other antibodies described to date while maintaining great breadth, attach to a novel, and potentially more accessible site on HIV to facilitate vaccine design. 

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FDA Releases Revision To Q8 Pharmaceutical Development Guidance

The FDA released this guidance revision, Guidance for Industry Q8(R1) Pharmaceutical Development, which is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that was published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex. This guidance is intended to provide guidance on the contents of section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use). 

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Integrating Human Factors Engineering Into Medical Devices (video)

Checkout this free video, Integrating Human Factors Engineering Into Medical Devices. Human factors is the science and the methods used to make devices easier and safer to use. The FDA has a patient safety mission of distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. The FDA works with manufacturers to help ensure the application of Human Factors engineering to the design of new products. It also helps device users through identification and investigation of use-related errors. This is a nice primer and video lesson on all things about human factors.

   

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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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FDA QSR Human Factors Reqs - Intro

Updated April 17, 2019

The links in the original post broke.

You might also be interested in:
Human Factors and Medical Devices on FDA.gov

---  original post follows below  ---

OK, now I get it. I understand this topic quite a bit better after reading Human Factors MD's "FDA Human Factors Requirements." This is applicable for medical devices that need to follow the FDA's regulations on Do It By Design: An Introduction to Human Factors in Medical Devices and Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Even better, the folks at Human Factor's MD, cite section 820.30 of the QSR, in paragraphs c, f, and g, and walk us through the meaning and application of those paragraphs. Did you find it helpful too? These three paragraphs cover . . .

• design input
• design verification
• design validation

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Quality by Design (QbD) For Analytical Methods (video)

Updated 3/10/2020:

This topic is seriously out of date.  This thread started in 2008.

You might also be interested in this FDA slide presentation from 2011:
Quality by Design Approaches to Analytical Methods -- FDA Perspective

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Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

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Updated 6/25/2015:

This post didn't age well, the links in the original post are no longer found.

You might also be interested in:   QbD Considerations for Analytical Methods - FDA Perspective

=========  original post below =========

Maribel Ross, Senior Editor with Pharmaceutical Technology, discusses the FDA's quality by design (QbD) initiative as it applies to analytical methods with one of the top experts in this area, Dr. Moheb Nasr, Director of FDA's Office of New Drug Quality Assessment, in this PharmTech TV video, "Live From 2008 AAPS: Analytical Methods for QbD."

#FDA #GMP #training #cGMP

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