Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, 9 April 2013

Many Hospital Deaths Caused by Staff's "Alarm Fatigue"

Many Hospital Deaths Caused by Staff's "Alarm Fatigue"
Anyone who has spent any time in a hospital knows that the rooms are filled with a variety of noises - the whirring of machines, the occasional cough from a patient and a near-incessant barrage of beeping. While the flood of noises may be annoying to a visitor or even a patient staying in hospitals, the effect can be dangerous for the people who work there. According to a recent report by the Joint Commission, "alarm fatigue" may cause hospital staff to miss signs that a patient is in distress, leading to patient injuries and even death.
The Food and Drug Administration (FDA) asserts that there have been over 560 deaths related to alarms. The Joint Commission says that there have been 80 deaths and 13 injuries related to alarms. Because the hospitals report the incidents themselves, the Joint Commission acknowledges that the number may be much higher. The commission, which is responsible for giving and maintaining hospitals coveted accreditation, also notes that ignoring the beeps may set off a chain reaction. That may, in turn, lead to a death or injury, but it is more difficult to attribute the beginning of the chain reaction to beeping alarms.
The Associated Press notes that devices may beep for any number of reasons: they may not be working or there may be an emergency. Since there is a lack of standardization and an abundance of technology, there is very little way for staff members to differentiate among the beeps, leading to a significant portion of the problem.
"Alarm fatigue and management of alarms are important safety issues that we must confront," Dr. Ana McKee, the executive vice president and chief medical officer of The Joint Commission, said in a statement. "The recommendations in this Alert offer hospitals a framework on which to assess their individual circumstances and develop a systematic, coordinated approach to alarms. By making alarm safety a priority, lives can be saved."
The organization suggests a number of steps: hospitals should issue guidelines for alarm settings, staff should check, inspect and maintain medical devices equipped with alarms; and that the hospitals should have a system in place for monitoring beeping alarms, among others.

News Source: www.counselheal.com

Wednesday, 27 March 2013

Temporary tattoos can cause long-lasting allergic reactions: FDA

Temporary tattoos can cause long-lasting allergic reactions: FDA
That temporary henna tattoo may leave a longer-lasting physical effect than you had hoped for, and it may not be pretty, the Food and Drug Administration said Monday.

That’s because an extra ingredient included in the longer-lasting “black henna” tattoos in wide use today — hair dye including p-phenylenediamine, or PPD — can cause nasty allergic reactions in some people, including redness, blisters, oozing lesions, increased sensitivity to sunlight and permanent scarring.  Reactions can occur right after a tattoo is applied to the surface of the skin or can appear up to two or three weeks later, the FDA reported.

Henna is a reddish-brown pigment that comes from the flowering plant Lawsonia inermis, which is native to tropical and subtropical regions of Africa and Asia.  People have used natural henna as a cosmetic and a dye for hair and fabrics for thousands of years.  But so-called black henna, often used in tourist destinations and other specialty shops, is a different product and may not include natural henna at all. A key ingredient in the temporary tattoos is dye containing PPD, the same stuff used to color hair, to make the embellishments darker and longer-lasting.

Though the FDA consumer alert dealt with tattoos, PPD also causes allergic reactions elsewhere.  A growing number of people, including me, break out in itchy welts when they color their hair with PPD-containing dyes. In my experience, this includes pretty much any product that effectively covers gray, even those advertised as "natural."

A recent study in the Journal of the German Society of Dermatology identified PPD as the culprit in the cases of seven people who developed allergic reactions to hair and eyelash dyeing.  All had histories of sensitization to PPD after receiving black henna tattoos. It took about six years post-sensitization for the reaction to the hair dye to appear.  The authors of the report added that PPD allergies could “have occupational impact, especially for hair dressers and cosmeticians.”

Some states have regulations overseeing temporary tattoos but others don’t, the FDA update reported.  The agency asked people who suffer reactions to temporary tattoos (or other cosmetics) to notify MedWatch or a regional consumer complaint coordinator or to call 1-800-FDA-1088, to report the problem.

News Source: www.latimes.com

Saturday, 16 March 2013

'Sugar-free' baked goods, with sugar? What is a dieter to do?

'Sugar-free' baked goods, with sugar? What is a dieter to do?
As if studying product labels to keep tabs on calories, carbs and fat grams wasn't painful enough, now dieters have this to worry about: one bakery's "goodies that taste good without being bad" are actually quite naughty, after all.

Clifton, N.J.-based Butterfly Bakery promises careful eaters that its sugar-free, no-sugar-added and gluten-free baked goods "will turn your dietary restriction into a dietary indulgence."

An indulgence, indeed: on Wednesday, the Food and Drug Administration said that tests on samples of Butterfly Bakery products showed that foods labeled as "sugar free" had sugar and that claims about sugar and fat content were false and misleading -- and that the agency obtained a consent decree that effectively shut down operations at the company "for unlawfully distributing mislabeled food products, such as muffins and snack cakes."
Problems with the goodies had been ongoing for years. According to a warning letter issued by the agency in 2011, analysis in FDA laboratories showed that a Butterfly Bakery product called "No Sugar Added Blueberry Muffins" had 170% more saturated and unsaturated fat than the label purported (9.44 grams, as opposed to 3.5 grams) , that another product called "Sugar Free Double Chocolate Chip Muffins" also had far more fat than labeled, and that neither goodie properly warned consumers about the presence of a milk product, sodium caseinate, in the recipe.  Serving sizes were mislabeled as well.

According to the FDA release, Butterfly Bakery will not be able to process or distribute food until its operations are proven to comply with the law.  The FDA may also assess damages against the company.

Butterfly Bakery's website is currently "under construction."  But in a statement posted on its Facebook page on Wednesday, the company “acknowledged” the FDA claims and said that it had been working with the FDA since 2011 to try to ensure compliance. The statement noted that “only 3 out of Butterfly's 45 items were sited [sic]” and added that the bakery was “confident that our product claims were true.”

So in the meantime, what's a dieter to do?  This post from ABC News quoted an FDA spokesperson who said that finding added fat and sugar in products that purport to be sugar-free was not a common occurrence. That means you should be able to eat those diet treats without worrying about it.

One way to always know what's in that treat you're eating: stick with fresh fruit.

News Source: www.latimes.com