FDA Ban on Powdered Medical Gloves Takes Effect January 19, 2017Dec 20, 2016
On December 19, 2016, the Food and Drug Administration (FDA) published the final rule banning the use of powdered gloves in health care because exposure to the gloves poses "unreasonable and substantial risk of illness or injury." The rule goes into effect on January 19, 2017, thirty days after publication in the Federal Register.
The FDA explains the gloves pose risks to both patients and health care providers. The patient is at risk when internal organs and tissue are exposed to the powder. Patients and health professionals can suffer severe airway inflammation and hypersensitivity reactions. Powder particles may trigger an immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions), which can lead to surgical complications.
The agency proposed the ban in March 2016. Efforts were already underway to phase out the use powdered surgeons' gloves, powdered exam gloves, and absorbable powder for lubricating surgeons' gloves. Professional societies had advocated a ban, and many large health systems have already restricted or completely ended the use of these products. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the ban "is about protecting patients and health care professionals from a danger they might not even be aware of."
Dangers of Powdered Gloves
Powder is sometimes added to gloves to make it easier to put them on and take them off. But aerosolized glove powder on natural rubber latex gloves can carry proteins that may cause respiratory allergic reactions. Powdered gloves are associated with airway inflammation, wound inflammation, and post-surgical adhesions—bands of fibrous scar tissue that form between internal organs and tissues. The FDA said medical gloves "play a significant role in protecting patients," but health care providers, and other individuals in close proximity to powdered gloves are at risk.
The attorneys at Parker Waichman LLP note that talcum powder has also been associated with ovarian cancer in women who use talcum powder for feminine hygiene.
Powder used in all types of gloves has been associated with serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage, granulomas, and peritoneal adhesions. Respiratory allergic reactions can also result from proteins in aerosolized glove powder, the FDA notes.
The FDA determined that the ban would not cause a glove shortage. The ban is not likely to impact medical practice because there are non-powdered protective gloves available that provide protection, dexterity, and performance without any of the risks associated with powdered gloves. A transition to alternative gloves "should not result in any detriment to public health," according to the FDA.
Rarely Used FDA Authority to Ban Devices
Under the Federal Food, Drug and Cosmetic Act, the FDA has the authority to ban a medical device intended for human use if the agency finds substantial deception about the benefits of the device or the device poses an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling.
The FDA rarely acts on this authority and in most instances, the manufacturer initiates a device recall. The glove ban is only the second time the FDA has banned a device. The first ban was for prosthetic hair fibers. The FDA found the fibers did not stimulate hair growth or conceal baldness, but their implantation could actually cause serious infections, illness, and injuries. The FDA believed the labeling and advertising materials "misrepresented the device as safe, effective, and causing little or no discomfort, among other misleading claims."
The agency has proposed a third ban, this one on the use of electrical stimulation devices to treat self-injurious or aggressive behavior. These devices administer electrical shocks through electrodes attached to the individual’s skin to attempt to condition them to stop engaging in self-injurious or aggressive behaviors. Many people exposed to these devices have who have these devices have intellectual or developmental disabilities that make it difficult for them to communicate pain or consent. The devices are associated with are a psychological and physical risks including depression, anxiety, worsening of self-injurious behavior, pain, burns, and tissue damage. These risks cannot be eliminated through new or updated labeling, and the FDA believes a ban in necessary to protect public health.
In determining whether to ban a device, the FDA weighs the risks and benefits of the device and compares those to other devices and treatments currently in use. The agency also considers whether a change in labeling mitigates the risk. The FDA evaluates the medical literature and can also convene a panel of outside experts, discuss concerns with professional societies, and review input from health care professionals and patients. The FDA does not need actual proof of illness or injury to ban a device but only needs to find that a device presents the required degree of risk based on all available data and information.
If the FDA decides to initiate a ban on a device, a notice of proposed rulemaking must be published in the Federal Register and there must be a comment period of at least 30 days then when the interested parties can comment on the proposed ban. In some cases, the FDA can put a ban in place as soon as it is published in the Federal Register. This procedure may be used when the FDA believes exposure to the device will endanger the health of individuals. Even when a ban takes effect immediately on publication in the Federal Register, a public comment period must be provided. Interested persons may request an informal hearing to discuss the ban.
Legal Help for Adverse Events Due to Powdered Gloves Used in Health Care
If you are a patient or health care professional who has experienced airway inflammation, an allergic reaction, or other adverse event linked to the use of powdered medical gloves, the attorneys at Parker Waichman LLP can provide a free, no obligation evaluation of a potential case. To reach the firm, fill out the online form or call 1-800-YOURLAWYER (1-800-968-7529).