PPE

FDA forbids medical powdered gloves

Abstract: the US FDA has issued a final regulation to ban the use of medical powdered gloves from January 19, 2017. The FDA proposed the ban in March, citing growing evidence that the gloves pose a serious risk to patients, including airway and wound inflammation, postoperative adhesions and allergic reactions. This is the second medical device banned by FDA after it banned synthetic wool fiber in 1983. 1n April, the FDA proposed to ban the use of a type 111 device, electrical stimulation device, for the treatment of self mutilation or aggressive behavior, although the final ban is still pending

“this ban is designed to protect patients and healthcare workers from risks they are not aware of,” said Jeffrey Shuren, head of FDA’s Center for device and radiological health< However, Michael carome, director of the public health research group, criticized the FDA for taking too long to issue the ban. They have twice called on the FDA to ban powdered gloves, the first in 1998 and the second in 2011 “although we are glad to see the FDA release this final regulation, the FDA’s 18 year delay in eliminating these dangerous products from the market is enough to show that they are not caring. The harm we see today from corn flour and latex used in surgical gloves and patient examination gloves was scientifically proven as early as 1998. ” Carome said< Specifically, the FDA said it would ban the sale, distribution and manufacture of all powdered surgical gloves, powdered patient inspection gloves and absorbable powder used for surgical glove lubrication, although it pointed out that the ban would not apply to powdered ray protective gloves in addition, the ban will not apply to the powder used in the manufacture of powder free gloves, as long as a small amount (no more than 2mg powder per glove) is used to make the finished product “based on a careful assessment of the current benefits and risks of powdered gloves, including the current alternatives that can avoid the risk of powdered gloves, FDA has determined that it has met the standard of banning powdered gloves,” FDA wrote. The FDA said it received about 100 comments in favor of banning powdered gloves most of the comments against banning powdered gloves claim that powderless gloves are more difficult to wear and more uncomfortable. However, the FDA rejected these requests, indicating that the research supports the performance features of the powder free gloves and their ease of wearing the FDA also rejected the claim that powdered gloves should not be banned because the new less powdered gloves are safer than high powdered gloves” Some studies have shown that gloves that reduce the amount of powder continue to present irrationalities and great risks to patients and medical staff. ” To facilitate the ban, the FDA said it also revised the classification of medical gloves to distinguish between powdered and non powdered gloves, because the current classification does not distinguish between the two

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