How Human Factors Lead to Medical Device Adverse Events

• Respected FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

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

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Medical Device Premarket Review - FDA Draft Guidance

For the first time, the U.S. FDA (Food and Drug Administration) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.

In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer’s ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.

Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.

Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.

The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.

Learn more:
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

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.

   

Return Home: http://drughealth.blogspot.com/ 

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

Return Home: http://drughealth.blogspot.com/