Painkillers Linked To Erectile Dysfunction

It might be worthwhile thinking about cutting back on the use of non-steroidal anti-inflammatory drugs (NSAIDs).

Men who regularly take pain relievers such as ibuprofen and aspirin may be at increased risk for erectile dysfunction, new research suggests, published in this Journal of Urology article, Regular Nonsteroidal Anti-Inflammatory Drug Use and Erectile Dysfunction.

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Spent Nuclear Fuel Storage - A Danger In The US

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Japan's situation just highlights the dangers we've got here in the United States, reports this LA Times article, Unsafe at any reactor - U.S. nuclear plants are storing increasing amounts of highly radioactive spent fuel in pools that are vulnerable to accident or attack. New safety policies are needed.

I guess this is yet another conversation around setting priorities. I was just reading about how environmentalists want to shut down a local golf course to save endangered frogs and snakes, Sharp Park Golf Course - Environmental Controversy.  After reading about the U.S.' situation with spent nuclear fuel, I think we need raise this nuclear issue above things like protecting endangered species. 

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Sharecare.com - Expert Wellness Info

I'm a little slow getting this post out. I ran across this while reading the December issue of the AARP Bulletin. An article mentioned this website:   Sharecare ( http://www.sharecare.com/ ).

About Sharecare states:

"Our mission is to answer the world's questions of health and achieve a collective wisdom by developing a comprehensive database of all of the questions of health and wellness and actively recruiting industry experts to answer them. Leading physicians, nurses, hospitals, clinics, authors, healthcare companies and non-profits connect, interact and share their collective expertise encouraging consumers to ask, learn and act upon questions of health."

I made a quick tour of the site. It feels elegant and polished. I found it easy to navigate. At a glance it seems to offer up quickly accessible information to topics of interest.

Happy hunting!

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Top 10 - Reasons Why CAPA or Deviation Investigation Systems Fail

• FDA cGMP QSR GMP Training - online training courses taught by SkillsPlus International Inc.

I ran across this post on The QA Pharm Blog,  The Top Ten Reasons the Deviation Investigation System Fails. It's a good read amongst some other pretty thought-provoking posts.

In a nutshell:

"Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails: . . . "

You might also be interested in:
Root Cause Analysis for Better Investigations by SkillsPlus Intl Inc.

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FDA - Monitoring Japan - Radiation Safety

The FDA has a public health page in light of the situation in Japan, FDA - Radiation Safety - Food Safety and Medical Products.

The Q and A format speaks to foods exported from Japan, and has some information about potassium iodide (KI).

iOSAT Potassium Iodide Tablets, 130 mg (14 Tablets)

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US Radiation Map For Average Citizens

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Given recent events, my eye is drawn to anything nuclear or radiation-related.

I stumbled across the Radiation Network's National Radiation Map that depicts environmental radiation levels across the United States. The map also shows locations of nuclear sites.

Interesting stuff, and be aware of the disclaimer:

The operator of this web site, can not independently verify that the Radiation Levels, or any Radiation Alerts, that are displayed on this Radiation Map are correct and valid.  Among other possibilities, Geiger counter malfunctions or proximity of the counters to certain medical procedures or to radioactive items can cause high readings at a Monitoring Station.

You might also be interested in:
A Wikipedia list of the world's nuclear reactors

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Radiation Risk - To Potassium Iodide or Not - KI

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Updated June 26, 2020

Call me paranoid. Many years ago, I bought a bunch of KI (potassium iodide) for our household. We live in earthquake country, the San Francisco bay area, and there are certainly nuclear plants in CA.

If you're thinking about taking KI, you'll want to read up on it first:  Potassium Iodide (KI) - CDC.gov

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Are You An Aggressive Pedestrian?

Image via WikipediaThis NPR podcast made me stop to think about it (start listening at the 10 minute mark): Your Health Podcast: Sidewalk Rage And Dangerous Cheese

Go to Dr. Leon James' Pedestrian Psychology and Safety site, and assess yourself against the Pedestrian Aggressiveness Syndrome Scale (PASS). You'll have to scroll down the page a little. The research shows that the pedestrian aggressiveness syndrome is made of 15 pedestrian behaviors. This Scale can indicate how aggressive you are as a pedestrian and what type of pedestrian personality makeover you need. Ask yourself how many of these bad pedestrian behaviors apply to you on a regular basis.

Additional Reading:
Wall Street Journal - Get Out of My Way, You Jerk! - Researchers Study 'Sidewalk Rage,' Seeking Insights on Anger's Origins and Coping Techniques

You might also be interested in:  Be Careful and Stay Safe (Learning To Get Along)

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Failed FDA Inspections - 483s - Failure or Out Of Compliance!?

The stats are pretty shocking! But what does it really mean? ... Which Drugmaker Fails Most FDA Inspections? 

Ed Silverman and commenters are having a lively conversation on the topic.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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FDA - Final MDDS Rule - Federal Register Full-Text

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Updated August 7, 2023:

The original link broke.

You might also be interested in:
MDDS Rule - a webpage on FDA.gov

- - -  the original post follows below  - - -

The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.

Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].

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FDA Issues MDDS Final Rule

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Updated March 11, 2021

Links broke in the original post. 

People also search for MDDS Rule - FDA.gov

---  original post follows below  ---

FDA finalizes regulation for certain software, hardware used with medical devices - Rule provides more predictable path to market.

The FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.

Here's a thought-provoking article, Final MDDS rule deems hospitals medical device manufacturers. In this article, it mentions, "The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following: . . ."

As of this writing, the Medical Device Data Systems rule will be published in the Federal Register. Read the rule here: Medical Devices; Medical Device Data Systems - FDA Final Rule (PDF).

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FDA Orange Book 2011 - It Just Arrived!

Updated April 16, 2019:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

I've been watching and waiting for this to be released.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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Food Poisoning - A Collection Of Everything You Need To Know

Image via WikipediaI follow the Marler Blog (commentary on food poisoning outbreaks and litigation).

You might be interested in his latest post, a collection of information, Everything you always wanted to know about food poisoning but were afraid to ask.

You might also be interested in:  Death in the Pot: The Impact of Food Poisoning on History

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