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Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove
Copyright (c) 2008-2010 Norm Howe
Most allergies are easy to cope with by simply avoiding the trigger. Sometimes that?s easier said than done, such as in the case of a latex allergy. Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex.
For those in the healthcare profession, as well as patients who suffer from a latex allergy, every day there are materials that must be handled or avoided with caution, or suffer the consequences, ranging from a mild rash, to, worst-case scenario, anaphylactic shock.
Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis. That sap contains a protein that can trigger allergic reactions, particularly after prolonged and repeated contact. Allergic reactions run the gamut from skin redness, rash, hives, or itching, to respiratory symptoms such as difficulty breathing, coughing spells and wheezing, and, rarely, shock.
Health care workers first began using traditional latex gloves in the 1890s. The HIV epidemic of the 80s ushered in modifications in glove materials, which made them more sensitizing to those with latex allergies.
Some health care institutions responded by shifting to alternative glove materials for their workers. The U.S. Food and Drug Administration (FDA) also implemented numerous steps to address the glove allergy problem, including working with the industry to develop a consensus standard that identifies maximum protein and powder levels for medical gloves. In addition, a 1998 rule requires that all medical devices containing latex carry a statement on the label warning about the risk of allergic reactions.
Most recently, FDA cleared for marketing the first device made from a new form of natural rubber latex called guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States. The new material provides flexibility and strength comparable to latex.
Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins. Because there is no data on people?s long-term experience with the Yulex glove, which is made by the Yulex Corporation of Maricopa, Ariz., the product will carry a warning (for now) about the potential for allergic reactions.
Products such as the Yulex glove, which utilize new materials in inventive ways, are a benefit to both healthcare workers and patients. To get the FDA stamp of approval, companies such as VCI LLC can help. VCI specializes in compliance services that meet FDA standards, as well as expertise in validation, production, quality, and R&D. VCI also offers manufacturers a proactive approach to getting it right the first time--before a product even hits the shelf--thus negating the need for a reactive response down the road.
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Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com
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Top-Level Category: Health and Wellness Articles
10 Most Recent Articles Written by Norm Howe
A New Paradigm to Address the High Cost of Vendor Qualification
Written by: Norm Howe |
Distributed: 2010-01-12 |
Word Count: 1160 |
Page Views: 64
| Votes: 2 |
Rating: 2.00
The assumption today is that a BETTER audit means a LONGER
audit. There has to be another way. What's needed is a new
paradigm for vendor qualification; a tool that can drill
deeply into the vendor's operation at low cost; something
that can provide a more lasting measure of the vendor's
performance than simply an audit...
FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe |
Distributed: 2009-03-10 |
Word Count: 666 |
Page Views: 671
| Votes: 7 |
Rating: 0.86
The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track?
The Myth of the Generic SOP
Written by: Norm Howe |
Distributed: 2009-03-03 |
Word Count: 687 |
Page Views: 329
| Votes: 4 |
Rating: 2.50
What do you do when your boss tells you to write an SOP? Run and
hide? Tell her how long it will really take to write one that's
any good? If you choose the latter option, be prepared for this
"helpful suggestion": "Why don't you just download a generic
SOP from the internet?" You would have been better off taking
the former option. Here's why.
The Evolution of Process Validation
Written by: Norm Howe |
Distributed: 2009-01-27 |
Word Count: 471 |
Page Views: 961
| Votes: 11 |
Rating: 1.82
In November 2008, the U.S. Food and Drug Administration (FDA)
published draft guidance on process validation. Entitled Process
Validation: General Principles and Practices, this draft guidance
replaces the previous guidance issued in 1987. What does this
mean to you?
FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe |
Distributed: 2009-01-21 |
Word Count: 665 |
Page Views: 537
| Votes: 5 |
Rating: 4.40
The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track?
Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers
Written by: Norm Howe |
Distributed: 2009-01-05 |
Word Count: 440 |
Page Views: 339
| Votes: 4 |
Rating: 2.50
How do small Dietary Supplement manufacturers comply with the new
Dietary Supplement GMPs? The U.S. Food and Drug Administration
(FDA) announced plans to publish a compliance guide that will
provide assistance to small dietary supplement manufacturers.
Dietary Supplements Must Be Tested by Scientifically Valid Methods
Written by: Norm Howe |
Distributed: 2008-09-03 |
Word Count: 424 |
Page Views: 406
| Votes: 6 |
Rating: 1.00
Are you a Dietary Supplement manufacturer trying to figure out
what FDA means by "Scientifically Valid Method"? Here are some
hints.
FDA Cracks Down on Fake Cures
Written by: Norm Howe |
Distributed: 2008-08-14 |
Word Count: 406 |
Page Views: 777
| Votes: 15 |
Rating: 2.00
In an effort to crack down on charlatans who prey on the sick,
the U.S. Food and Drug Administration (FDA) recently issued
warning letters to 23 U.S. companies and two foreign individuals
marketing a wide range of products that fraudulently claim to
prevent and cure cancer.
Quality by Design Streamlines Pharmaceutical Manufacturing
Written by: Norm Howe |
Distributed: 2008-06-24 |
Word Count: 453 |
Page Views: 468
| Votes: 5 |
Rating: 2.80
The pharmaceutical industry wastes more than $50 billion a year
in manufacturing costs according to findings of a study conducted
jointly by Olin School of Business at Washington University and
McDonough School of Business at Georgetown University. The goal
of the study was to understand how the FDA regulates
pharmaceutical production and how those regulations may be
inhibiting advances in manufacturing. Quality by Design ensures
reduced deficiencies, quicker approvals, and improved interaction
with FDA. It also allows for continuous improvements in products
and manufacturing process, as well as a better understanding of
how APIs and excipients affect manufacturing.
Five Ways to Alienate Your Employees: A Manager's Guide To Investigating Errors
Written by: Norm Howe |
Distributed: 2008-04-23 |
Word Count: 787 |
Page Views: 410
| Votes: 6 |
Rating: 1.00
Are you a manager with too much time on your hands? Do you go
home at the end of an eight hour day with boring regularity,
leaving a clean desk and a clear conscience? Wouldn't you rather
have NO discretionary time in your life? Here are five sure-fire
tips to create fear in your employees and keep them from ever
participating openly during problem solving discussions.
All of Author's Articles on this site: Norm Howe Articles
Most Recent "Health And Wellness" Articles
Losing Weight - Take Control of Late Night Snacking
Written by: Larry Tobin |
Distributed: 2010-02-03 |
Word Count: 900 |
Page Views: 35
When it's late at night it's all too easy for that snack
to be something calorie-laden, like a big bowl of ice cream.
Unfortunately this is a decision that sets many people back.
Yet like every other behavior we've discussed, we can
control late night snacking through the formation of
healthy, specific habits. It can be as easy as 1-2-3, as
we've outlined below.
Understanding PE in Men: Is It a Psychosomatic or Physical Condition?
Written by: Bud Castillo |
Distributed: 2010-02-03 |
Word Count: 1730 |
Page Views: 49
| Votes: 1 |
Rating: 5.00
Notice: The information in this article is being provided to
help couples to understand the realities of premature
ejaculation in sexual health, and the available treatments
for it. If you are disturbed by this topic, please quit
reading this article now.
Clinical Research Consulting, Inc Provides Clinical Research Monitoring Model That is Beneficial to Industry Sponsors
Written by: Lisa Mazurka |
Distributed: 2010-02-02 |
Word Count: 503 |
Page Views: 40
Numerous pharmaceutical and biotechnology organizations use
contract research organizations (CROs) to outsource the
service of monitoring clinical trials. Clinical Research
Consulting, Inc. (CRCI) has a model that is unique than most
industry CROs. Many CROs are finding this alternative
approach beneficial and more cost effective. This article
will discuss the CRCI monitoring service model, what makes
it unique and why it continues to grow amongst industry
sponsors.
Losing Weight - A Pattern of Portion Control
Written by: Larry Tobin |
Distributed: 2010-01-28 |
Word Count: 928 |
Page Views: 57
| Votes: 2 |
Rating: 3.50
Managing our weight can be a tricky proposition. Unhealthy
food choices surround us, we don't always have the
opportunity to exercise, and society's system of three
meals a day can send our metabolism into fits. Finding a way
to take control is one of the most important steps that we
can take in our battle to keep the pounds and the inches off
our waistline.
Five Factors in Managing Diabetes Naturally
Written by: Janet Davis |
Distributed: 2010-01-26 |
Word Count: 868 |
Page Views: 61
| Votes: 1 |
Rating: 5.00
Diabetes is one of the most common chronic illnesses,
affecting millions of people worldwide and their diet has a
great deal to say about how the condition will continue to
affect them. Proper diet can help prevent the onset of Type
2 diabetes, but even in patients who have been diagnosed
with either condition, a healthy diet can reduce the side
effects and secondary illnesses that tend to crop up. Here
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Losing Weight - Redirecting Your Snacking Habit
Written by: Larry Tobin |
Distributed: 2010-01-26 |
Word Count: 929 |
Page Views: 60
| Votes: 2 |
Rating: 4.50
Take on some smart snacking tactics - like the ones
highlighted here - for six weeks to kick-start a lifelong
habit of healthy eating and feeling great.
Weight Loss - Walking off the Pounds
Written by: Larry Tobin |
Distributed: 2010-01-21 |
Word Count: 879 |
Page Views: 51
| Votes: 1 |
Rating: 2.00
Walking is a near universal opportunity to burn a few more
calories every day, everywhere we choose to go. It is the
most basic exercise. We move muscles, and those muscles burn
calories as we go. But it's such an automatic thing to do
that we often forget the benefits that a good walking
routine can provide us. So, let's take a look at five quick
ways we can take advantage of our walking habit without
going out of our way.
Four Nutrients For Healthy Eyes
Written by: Janet Davis |
Distributed: 2010-01-19 |
Word Count: 857 |
Page Views: 58
| Votes: 2 |
Rating: 4.50
Sight is incredibly important and, just like any other
function of the body, is largely dependent upon proper
nutrition. However, it also may be a part of our nutrition
that we don't actively think about supporting. Here, we
discuss four key nutrients that can help bolster eye health.
Weight Loss: How to Factor in Food Labels
Written by: Julie J. Price |
Distributed: 2010-01-19 |
Word Count: 906 |
Page Views: 58
| Votes: 2 |
Rating: 2.00
A key tool in gathering information for weight loss s the
nutrition label found on the packaging of almost every piece
of food we buy. Knowing how to read this label is a vital
skill that should be part of every grocery-shopping trip.
Here, we give you the skinny on what to look for, so you can
quickly get the info you need and get going.
Eating Healthy While Saving Money
Written by: Janet Davis |
Distributed: 2010-01-14 |
Word Count: 730 |
Page Views: 60
| Votes: 2 |
Rating: 3.00
Today, when everyone wants to watch their budget, cost
cutting is the name of the game and our diets frequently
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save money and still eat reasonably healthy foods, rather
than sacrificing one for the other.
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Bone Density and Your Well Being
Written by: Kamau Austin |
Distributed: 2006-06-15 |
Word Count: 685 |
Page Views: 29347
| Votes: 37 |
Rating: 2.62
We spend a lot of time and energy thinking of ways to reduce our
weight but we need to think about the bones that form the basic
structure of the very same body. Bone density is an important
factor in helping us stay young and on our toes. Bone density
needs to be checked as we age and if found low, adequate measures
need to be taken to improve it.
President Given the Cure for Herpes and Cold Sores ?
Written by: James Kaylon McIntyre |
Distributed: 2006-11-09 |
Word Count: 404 |
Page Views: 10297
| Votes: 13 |
Rating: 2.46
Viraway was founded by a man who is in his 70s today. As a Young
man he suffered from acute cold sores. The discomfort was so
severe that he thought they would never go away. A native
American Indian gave him a tribal mixture of herbs and told him
that this mixture would eliminate the cold sores with in two
weeks...
Two years after 60 Minutes - Is Authentic Hoodia Available?
Written by: Dan Nessel |
Distributed: 2006-10-25 |
Word Count: 733 |
Page Views: 10006
| Votes: 9 |
Rating: 3.22
In November of 2004, 60 Minutes praised Hoodia Gordonii for its
ability to suppress appetite. Within days of the segement,
everyone and their mother were claiming to have "real" hoodia
for sale. The question remains - is any authenic Hoodia
available?
Non- Surgical Options for Treating Hair Loss
Written by: Robert M. Bernstein M.D., F.A.A.D |
Distributed: 2007-10-01 |
Word Count: 1088 |
Page Views: 6218
| Votes: 7 |
Rating: 3.00
The search for new ways to help those suffering from hair loss
has captured word-wide attention. Some new techniques and
products have been proven to be of benefit, while others have
simply played on the emotional strings of those who suffer from
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Flax Oil And Gynecomastia
Written by: Will Brink |
Distributed: 2006-06-06 |
Word Count: 678 |
Page Views: 4674
| Votes: 17 |
Rating: 2.47
Q: Dear Will, I remember in your book "Priming the Anabolic
Environment" you recommended flax oil as a possible way to treat
gynecomastia or "bitch tits" in men and I know you recommend flax
oil losing fat and general health also. Would flax have equal
benefits for athletic women like me who lift weights and do you
still think it helps with gyno?
Your Lifestyle and Your Risk for Bladder Cancer
Written by: Jon M. Stout |
Distributed: 2006-12-06 |
Word Count: 937 |
Page Views: 4238
| Votes: 3 |
Rating: 2.00
Each year more and more research is conducted on how to reduce
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the sun. For other cancers, understanding how to reduce our risk
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The Natural Approach for Healing Acid Reflux Disease
Written by: Charles Stewart Richey |
Distributed: 2006-07-24 |
Word Count: 552 |
Page Views: 4124
| Votes: 16 |
Rating: 3.31
Acid reflux drugs constitute a multi-billion dollar a year
industry. Millions of people take these dangerous drugs and the
mega pharma grow richer at our expense. We can fight back by
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Losing Weight Without Gaining Stretch Marks
Written by: Kamau Austin |
Distributed: 2006-12-11 |
Word Count: 579 |
Page Views: 4041
| Votes: 20 |
Rating: 2.05
Few things can make us as elated as seeing the pounds melt way
through our efforts of eating less and exercising more. We gain
new confidence and vitality as we watch our waistlines reappear
and become reacquainted with the tops of our feet. But as the
weight falls away we can be plagued by a new assault - one we did
not see coming - stretch marks.
That 1970's Look
Written by: Kamau Austin |
Distributed: 2006-06-27 |
Word Count: 665 |
Page Views: 4016
| Votes: 14 |
Rating: 1.86
During the 70s it was quite fashionable to have eyes which were
darkly made up with heavy black or brown eye shadow. The
"raccoon-look" was worn by celebrities, models, and movie
stars. But, as we know, fashion trends come and go, and the day
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now.
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Written by: Mike Walden |
Distributed: 2006-07-27 |
Word Count: 1750 |
Page Views: 3452
| Votes: 13 |
Rating: 2.69
For years doctors have been claiming there is no connection
between diet and acne. Yet evidence from recent studies clearly
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The Role of Antioxidants in Good Health And Healthy Living
Written by: Cheryll Rice |
Distributed: 2008-01-24 |
Word Count: 718 |
Page Views: 579
| Votes: 5 |
Rating: 4.20
Everyone has heard about the importance of a balanced diet for
maintaining good health. Similarly, everyone knows that they
should be getting exercise - or at the very least adding more
activity into their days. Getting a good night's sleep is
essential - without it, you'll find that your immune system
starts to slack off a bit and you put yourself at a greater risk
for catching a cold or coming down with the flu. We all know what
we should be doing, but let's be honest: we don't do it...
What Makes Tea So Effective At Preventing Heart Disease?
Written by: Jon M. Stout |
Distributed: 2007-02-02 |
Word Count: 812 |
Page Views: 790
| Votes: 7 |
Rating: 4.00
Many bodies of research have shown that tea is effective at
preventing heart disease in several ways. Tea prevents the
oxidation of LDL cholesterol into plaque, the hard substance that
clogs our arteries, making us more susceptible to heart attacks
and strokes. Tea is also thought to have an anti-inflammatory
effect, which helps the heart in its overall function.
Which Full Face CPAP Mask is Best for You?
Written by: Chris Vasta |
Distributed: 2009-09-01 |
Word Count: 690 |
Page Views: 436
| Votes: 10 |
Rating: 4.00
If you've been diagnosed with Sleep Apnea, you are
undoubtedly trying to narrow the choice of masks. If your
mouth opens during sleep, one option would be full face CPAP
masks. The full face CPAP mask is used to deliver pressure
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face CPAP mask to use can be complex and expensive. The
number of mask options available is confounding. Based upon
comfort, fit, good seal, and durability, we recommend the
following three full face CPAP masks.
Concocting the Perfect Body Detox Plan
Written by: John Khu |
Distributed: 2009-04-21 |
Word Count: 588 |
Page Views: 317
| Votes: 7 |
Rating: 3.86
If you have recently made a committed resolve to stick to a body
detox program, then it is best to get very well prepared for it.
Otherwise, you might catch yourself doing some last-minute
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Want To Try Body Detox?
Written by: John Khu |
Distributed: 2009-08-25 |
Word Count: 595 |
Page Views: 157
| Votes: 7 |
Rating: 3.86
Ever since more and more people became aware of the harmful
effects of improper diet and toxins to the body, body
detoxification also became very popular. Although it is a
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that without the initiative of a person's mind to reinforce
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detoxification process will take a long time, or worse, not
work at all.
What Do You Recommend For Male Pattern Baldness?
Written by: Will Brink |
Distributed: 2006-05-30 |
Word Count: 430 |
Page Views: 973
| Votes: 6 |
Rating: 3.83
Q: Hello Will, I am a bodybuilder who has been experiencing
typical male pattern baldness for the past few years. A: Dear
Josh, In fact, there is a single formula for hair loss, or male
pattern baldness (MPB) that has virtually everything I would
recommend and them some!
Heavier Weight Sometimes Equals Smaller Jeans
Written by: Kamau Austin |
Distributed: 2007-02-07 |
Word Count: 1005 |
Page Views: 637
| Votes: 6 |
Rating: 3.83
A concept many women sometimes have difficulty understanding is
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look drastically different.
Get a Great Night's Sleep
Written by: George Esser |
Distributed: 2007-05-15 |
Word Count: 597 |
Page Views: 549
| Votes: 6 |
Rating: 3.83
Reasons why we need magnesium supplements to get a great night's
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Written by: Abel Travers |
Distributed: 2007-12-14 |
Word Count: 765 |
Page Views: 575
| Votes: 6 |
Rating: 3.83
Colon cleansing treatments are designed to better enable the body
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Neurotransmitter Testing: How It Help Depression, Anxiety and More
Written by: Anne Arthur |
Distributed: 2006-08-03 |
Word Count: 663 |
Page Views: 935
| Votes: 5 |
Rating: 3.80
Millions of people suffer from bipolar disorder, anxiety, panic
attacks, depression and ADD/ADHD without a known cause. If you or
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depression, mania, ADD/ADHD or even panic attacks, you owe it to
you to find the real cause of your problem. There are many
natural treatments available that effectively combat these
diseases.
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