FDA Bans Powdered Surgeons' Gloves
FDA Bans Powdered Surgeons' Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating Surgeons' Gloves
If you or a someone you know suffered an injury or adverse reaction due to powdered surgeon gloves, powdered patient examination gloves, or absorbable powder for lubricating surgeons' glove, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages.
The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit over these devices and our personal injury lawyers are offering a free consultation to anyone who sustained an injury associated with these products. Parker Waichman urges you to contact one of our lawyers today to protect your legal rights.
FDA Bans Certain Powdered Gloves and Absorbable Powder for Surgical Gloves
According to The Federal Register, the U.S. Food and Drug Administration (FDA) has issued a final rule that becomes effective on January 18, 2017 in which the agency determined that the following items present an "unreasonable and substantial risk of illness or injury" and that this risk "cannot be corrected or eliminated by product labeling or a change in labeling. Because of this, these devices have been banned:
- Powdered Surgeons' Gloves
- Powdered Patient Examination Gloves
- Absorbable Powder for Lubricating a Surgeon's Glove
Medical gloves are important in protecting patients and health care personnel in the United States, notes The Federal Register. "Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients," The Federal Register pointed out. An array of powders is used to lubricate gloves for the purpose of easing the donning the gloves; however, the powder presents various risks to patients and health care workers. Risks include inflammation, granulomas, and respiratory allergic reactions.
A complete review of all available information supports the FDA's findings that powdered surgeons' gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove should be banned. The agency also found that the risks posed by these devices, including to health care workers and patients involve "sensitization to natural rubber latex (NRL) allergens, surgical complications related to peritoneal adhesions," as well as "other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder," and found these adverse events to be "important, material, and significant in relation to the benefit to public health from their continued marketing," according to The Federal Register. The FDA concluded that there are "viable non-powdered alternatives" not associated with the risks presented with glove powder. The agency also found "that the risk of illness or injury posed by powdered gloves is unreasonable and substantial" and believes the ban would not cause significant economic issues or shortages on the health care industry and that the move to alternative products should not lead to any public health detriment.
Bloomberg's Bureau of National Affairs (BNA) wrote that the FDA rarely uses its authority to ban devices and this ban represents the second time the agency has banned a medical device. The first time the FDA implemented a ban was over 33 years ago. At that time, the agency banned prosthetic hair fibers. "A medical device ban completely prohibits current and future sales, distribution, and manufacturing of a medical device," according to Bloomberg BNA. The agency has authorization to implement a medical device ban when that device is intended for human use and the FDA finds that "the device presents an unreasonable and substantial risk of illness or injury that can't be corrected by changing the device's labeling."
Manufacturers typically remove devices from the U.S. market, not the FDA. Meanwhile, the FDA has proposed another ban on the use of electrical stimulation devices to treat "self-injurious or aggressive behavior," according to MedScape.
"Banning powdered glove products is not expected to impose any costs to society, but is expected to reduce the number of adverse events associated with using powdered gloves," the agency wrote. "The primary public health benefit from adoption of the rule would be the value of the reduction in adverse events associated with using powdered gloves," the FDA wrote.
Advocacy Group Calls Ban Overdue
The health advocacy group, Public Citizen, indicated that, while it welcomed the final rule, it was unhappy that the FDA did not ban the gloves in 1998 when the group first sought a ban. "The agency's 18-year delay in acting to remove these dangerous products from the market represents reckless negligence," Michael A. Carome, director of Public Citizen's Health Research Group, told Bloomberg BNA on December 19, 2016. "There is absolutely no new scientific information today that we didn't have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves. And alternatives to powdered medical gloves have existed for decades," Carome noted. He also added that, "The FDA had the legal authority to ban powdered gloves in 1998. The agency should have used that authority to protect hundreds of thousands of hospital workers and patients who have been exposed to the powder. Had the FDA initiated the process of banning powdered medical gloves in 1998 instead of 18 years later, hundreds of thousands of health workers and patients would have been spared preventable, often life-threatening adverse reactions."
The current ban was first proposed in March 2016 and MedScape notes that professional societies have long advocated for a ban and that a number of large health systems and most individual clinicians have either restricted or completely stopped use of the banned products.
"While medical gloves play a significant role in protecting patients, healthcare providers, and other individuals in close proximity, powdered gloves are very dangerous for a variety of reasons," the FDA wrote in a statement.
Powder used within all types of gloves has been tied with a number of potentially significant adverse events that include severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage, granulomas, and peritoneal adhesions, according to MedScape. The FDA pointed out that proteins in aerosolized glove powder might cause respiratory allergic reactions.
Help for Victims of Powdered Surgeon and Patient Exam Gloves and Absorbable Powder for Surgeon Glove Lubrication
Parker Waichman is offering free case evaluations to victims of powdered surgeons' gloves, powdered patient examination gloves, or absorbable powder for lubricating a surgeon's glove. If you or someone you know suffered injury due to these devices, we urge you to contact us as soon as possible. Simply fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with us today.