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HuckleB

(35,773 posts)
Mon Mar 21, 2016, 05:06 PM Mar 2016

The FDA, for only the second time ever, wants to ban a medical device. Here’s why.

Source: Washington Post

Powdered medical gloves — the kind used in surgery or to examine patients — would be ordered off the market under a new proposal by the Food and Drug Administration. That would put the gloves in an exclusive club — only one other device has been banned by the agency: prosthetic hair fibers in 1983.

When an already approved device turns out to pose higher-than-expected risks, the agency usually tries to correct the problem by adding a warning to the label or changing how the device is used. But in the case of the gloves — and the hair fibers — the FDA concluded that no labeling fixes would do the trick. The hair fibers, intended for implantation into the scalp, did not stimulate hair growth or conceal baldness and could cause infections, the agency concluded at the time.

The use of powdered medical gloves has been declining in recent years, and the agency doesn't expect any disruption in clinical care if they are banned. The powder is designed to make it easier to pull the gloves on and off, but it also poses "an unreasonable and substantial risk of illness or injury to health-care providers, patients and other individuals who are exposed to them," the agency said.

The FDA said the aerosolized powder on latex gloves can spark respiratory allergic reactions. Powdered synthetic gloves don't pose that risk, but may result in airway and wound inflammation and post-surgical adhesions — fibrous scar tissue, the agency said.

Read more: https://www.washingtonpost.com/news/to-your-health/wp/2016/03/21/what-do-powdered-surgical-gloves-and-prosthetic-hair-fibers-have-in-common-the-fda-doesnt-like-them/



Luckily, I haven't had to wear these for years.
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PatrynXX

(5,668 posts)
1. wear the non latex ones with powder all the time
Mon Mar 21, 2016, 05:16 PM
Mar 2016

as I handle negatives to scan them and negatives don't like fingerprint oil the powder sure helps.. that and save money so I don't have to rip the gloves off. Silly thing to ban. I better stock up


bad as silly as someone suing over a wood product thats in most cheese products to prevent caking. hey nothing harmful. if you ate paper when you were younger probably not gonna hurt as a powder

HuckleB

(35,773 posts)
2. There seems to be a few very good reasons for it.
Mon Mar 21, 2016, 05:41 PM
Mar 2016

I'm not sure it has anything to do with your negatives.

PatrynXX

(5,668 posts)
4. well if I use the non powdered ones
Mon Mar 21, 2016, 07:13 PM
Mar 2016

I can't hold the negatives properly, I start to sweat and it breaks out in a rash. the powder stops that. and I use non latex. usually only one brand two.. so not sure if they all use this version of powdering..

can't say these are the exact ones but they are the clear type http://www.ebay.com/itm/1000-Powder-Free-Vinyl-Gloves-Foodservice-Grade-Non-Latex-Nitrile-Exam-X-Large-/120934428042?hash=item1c2840ed8a:m:md_CSCZX5Pzh1OaKLlkrAew it's possible we are talking about different types. ones on mine say surgical but some are food service as well

PatrynXX

(5,668 posts)
6. well the powder is on the inside
Mon Mar 21, 2016, 07:32 PM
Mar 2016

so is the harm to me or to the patient. more like, ban them for certain uses not all uses. you are correct there

CreekDog

(46,192 posts)
12. you're a doctor or scientist in the medical field, correct?
Tue Mar 22, 2016, 02:42 AM
Mar 2016

obviously you aren't expecting us to discount medical and scientific opinions because you handle negatives all day?

are you?

 

Mika

(17,751 posts)
3. Some of the talc used on gloves contains small amounts of asbestos.
Mon Mar 21, 2016, 06:02 PM
Mar 2016

Stopped using powdered gloves a long time ago.



Baobab

(4,667 posts)
7. Latex is a sensitizer that causes all sorts of immune system problems
Mon Mar 21, 2016, 08:15 PM
Mar 2016

Natural rubber contains proteins that cause the immune system to imprint on both it AND other things it encounters at the same time. It builds up in a non-linear manner at at some point, something clicks and then after that when it sees either of them it can overreact severely. Medical professionals invest hundreds of thousands of dollars in their educations and then imagine suddenly not being able to be around rubber.

I once had a girlfriend who was allergic to rubber. She could not be around rubber at all. She had to carry an injector with some powerful drug in case she started going into anaphylactic shock.

mwooldri

(10,303 posts)
11. If an infant has a significant operation early on in life...
Tue Mar 22, 2016, 02:34 AM
Mar 2016

... I'm told that the chances of them developing a latex sensitivity is high. My eldest son went through a bladder reconstruction (as well as hip reconstruction and genitalia reconstruction) at birth. He has a latex sensitivity. ... though he has also developed an allergy to a lot of other things too.

Baobab

(4,667 posts)
13. It may be possible to wind it down, by reducing all inflammation..
Tue Mar 22, 2016, 02:42 AM
Mar 2016

many phytonutrients may systemically reduce inflammation. many antioxidants.. NAC (glutathione precursor) I have no idea.. just speculating out loud.

LeftyMom

(49,212 posts)
14. Oh, maybe that's why I have mine? I never thought about it that way.
Tue Mar 22, 2016, 02:53 AM
Mar 2016

I had a series of surgeries from a few days old on, to correct a birth defect and then to correct various related issues and new problems caused by drug side effects.

I always assumed it was heredity in my case, my mother is allergic to every damned thing under the sun.

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