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 Collaborates On Nanotech Initiative

The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. I'm glad to see this. Until nanotechnologies are better and more deeply understood, it makes sense to me that the best minds thinking about nanotech are collaborating. More FDA Information: FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative - Overarching goal: developing an efficient pathway for safe and effective nanoengineered medical products 

Related Posts: Should The FDA Oversee Nanotechnology Dietary Supplements? Go For Gold - I Mean Nanoparticles And Drugs FDA - FAQs About Combination Products 

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NIH NIAAA Wants Re-Thinking Drinking (video)

Take some advice from these testimonials:

• "Sometimes we do things out of habit and we don't really stop to think about it. This made me think about my choices."
• "It emphasized that drinking is not bad in and of itself—it's how much you're doing it and how it's affecting your life."
• "I thought the strategies for cutting down were really good. It gives you tools to help yourself."

Learn more about the NIH & NIAAA's new initiative to help rethink drinking, "Rethinking Drinking - Alcohol and your health. The website is pretty robust and easy to use.

• Download the free brochure: Rethinking Drinking - Alcohol and your health (pdf)
• The site features interactive tools, such as calculators for measuring alcohol calories and drink sizes. NIAAA is part of the National Institutes of Health. "About 3 in 10 U.S. adults drink at levels that elevate their risk for alcoholism, liver disease, and a diverse array of other physical, mental health, and social problems. Yet, many people give little thought to their drinking habits and the attendant risks" notes NIH Acting Director Raynard S. Kington, M.D. "These new materials remind all of us to think about how alcohol may be affecting our health"

If you don't have time to check out the website, listen to this ABC News video to learn more, "Do you drink too much? A new government initiative to help you rethink your drinking" (video)"

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FDA Warns - Avoid Burning - MRI and Drug Patch Interaction

Updated November 22, 2022

The original links broke.

You can still read about the same topic here:

• FDA advisory: Transdermal drug patches with metallic backings may cause burns during MRI - Healio
• What Patients Should Know Before Having an MRI Exam - FDA.gov

---  the original post follows below  ---

If you wear drug patches, watch out! You don't want to get burned. If you wear them into an MRI machine, the patch could burn you, warns the FDA in their alert, FDA Warns About Risk of Wearing Medicated Patches During MRIs.

FDA recommends that patients who use medicated patches (including nicotine patches) do the following:

• Tell the doctor referring you for an MRI scan that you are using a patch and why you are using it (such as, for pain, smoking cessation, hormones)
• Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
• Tell the MRI facility that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment.

Additional Info by the FDA & others: FDA Public Health Advisory Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Transdermal Drug Patches with Metallic Backings Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009 

Related Posts: Are You Safe In An MRI Machine? 

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FDA Says - Unwise To Ignore Form 483

I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”. 

Related Posts: Medical Device Sponsors - FDA Trends and Tips To Avoid 483s More FDA 483 Resources - Comments and Pearls from Validation Online FDA 483 Inspectional Observations - learn from these examples 

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