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Regulatory News | 21 March 2016 | By Michael Mezher
The US Food and Drug Administration (FDA) on Monday announced its intent to ban the use of most powdered medical gloves, citing an "unreasonable and substantial risk" to patient health.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Jeffrey Shuren, director of the Center for Devices and Radiological Health.
The proposed ban would apply to all powdered surgeon's gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeon's gloves, though it would exclude powdered radiographic protection gloves.
FDA says the gloves should be banned in light of evidence tying powdered gloves to "an extensive list" of potential risks, including airway and wound inflammation, as well as post-surgical adhesions. The agency also warns that powder from natural latex gloves can cause allergic reactions when it enters the air.
Additionally, the agency says the ban would not apply to powders used during manufacturing, so long as only trace amounts (no more than 2mg of powder per glove) make it into the finished product.
FDA has only banned one other medical device in its history. In 1983, the agency banned the use of prosthetic hair fibers, citing risks to patient health and fraudulent claims of medical performance.
FDA says it also plans to amend the classification regulations covering the various types of gloves to make them specific to non-powdered gloves, as the classifications currently do not differentiate between the two.
Responding to FDA's announcement to ban the gloves, Sidney Wolfe, director of the advocacy group Public Citizen, which in 1998 filed the first of several citizen's petition calling on FDA to ban powdered gloves, called the agency "recklessly negligent" for taking so long to move forward with the ban, adding that "there is absolutely no new scientific information today that we didn't have in 1998."
Through September 2015, FDA says it received 3,780 adverse event reports for all medical gloves (powdered and non-powdered). The agency received the most adverse events in 1999, the same year its draft guidance was issued, and says that since 2003, it has received fewer than 100 adverse event reports for gloves per year.
However, FDA says that it is able to move to ban the gloves in part due to the increased availability of non-powdered gloves in a variety of materials. Additionally, FDA says it does not expect significant cost increases due to banning powdered gloves as non-powdered alternatives are available at a similar price.
For more than a century, various types of powder have been used make it easier for users to take gloves on and off. According to FDA, cornstarch is currently the most common powdered lubricant used for medical gloves.
FDA has long considered powdered gloves to pose a risk to patients; however, according to a report released by the agency in 1997, powdered gloves were not banned at the time due to concerns about alternative methods of lubrication and fears that a ban might lead to a shortage.
In a 1999 draft guidance, FDA opted to set limits on the amount of powder that the gloves could contain based on the American Society for Testing and Materials' D6124 standard and required labeling stating how much powder was present on the gloves.
Per the draft guidance, FDA allowed gloves to be labeled powder-free or powderless if they contained less than 2mg of powder. In contrast, the agency says that powdered gloves contain between 120mg and 400mg of powder and other particulates.
While FDA never finalized the guidance, instead replacing it with its 2008 guidance Medical Glove Guidance Manual, the agency says it received fewer adverse events related to powdered gloves and saw fewer companies seeking to market such gloves.
In 2011, after receiving several citizen's petitions, FDA issued a request for comments from the public on the benefits and risks to using powdered gloves. At the same time, the agency published a new draft guidance recommending voluntary warnings for powdered surgeon's and powdered patient examination gloves.
FDA Press Release
Federal Register Notice
Tags: Powdered gloves, Banned devices