【Gaofenzi.org短讯】近期相关报道显示美国FDA放大招彻底禁止在医疗领域使用有粉的塑料橡胶手套。医用塑料橡胶手套主要有无粉末和有粉末两种之分，因为有粉手套穿脱方便，所以受到医生的青睐，但关于有粉手套所致伤口肉芽肿和术后粘连等问题的报道不绝于耳，基于此风险，美国FDA近期终于下决心拟在全美禁用医用有粉手套，虽然很早以前就有专家层提议过。
这次美国FDA将有粉的合成手套和天然胶乳手套均拉入“黑名单”，“有粉手套”强调无论是玉米淀粉还是滑石粉，一律封禁。这一禁令仅适用于外科手术和检查病人时所用的有粉手套，不包括美国市场上没有的防辐射有粉手套。颁布这个禁令的主要目的是为了保护患者和医疗卫生人员免受有粉手套带来的伤害。
小编评：FDA这一提议今后必将被更多国家效仿，所以对于有粉手套产业或许有些影响。
FDA原文：
Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.
The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
Powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.
As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which – if finalized – would ultimately remove them from the marketplace completely.
In making the determination that these products are dangerous and present an unreasonable and substantial risk, the FDA considered all available evidence, which included a thorough review of the available scientific literature and comments received on a February 2011 Federal Register Notice. In addition, given the critical role medical gloves play in protecting patients and health care providers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant. The ban is also not likely to impact medical practice, because many non-powdered protective glove options are currently available.
The FDA has determined that the banning standard would not apply to powdered radiographic protection gloves. The agency is not aware of any powdered radiographic protection gloves that are currently on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves will also not be included in the ban and will remain Class I medical devices. Therefore, the FDA is also proposing amendments to their classification regulations to clarify that they apply only to non-powdered gloves.
The proposed rule is available online at www.regulations.gov for public comment for 90 days.