PROACTIVE Concerned about safety, many facilities stopped using powdered gloves long before the proposed ban.

When the FDA announced in March that it was proposing to ban most powdered gloves because they pose an unreasonable and substantial risk of illness or injury to healthcare professionals and patients, some experts wondered, What took you so long? "It should have been done as soon as evidence demonstrating patient harm was recognized," says Terry Roth, BSN, RN, CNOR, executive director of perioperative services at Hoag Orthopedic Institute in Irvine, Calif.

Delayed action
The proposed ban applies to powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove.

Cornstarch powder is sometimes added to gloves to help make them easier to don and doff, says the FDA, which notes the powder on natural rubber latex gloves carries protein that can cause respiratory allergic reactions. Powdered synthetic gloves don't cause allergic reactions, but are associated with possible adverse events that have been linked to the use of all powdered gloves, including airway and wound inflammation, and post-op adhesions that form when fibrous scar tissue grows between internal organs and tissues.

"This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of," says Jeffrey Shuren, MD, the FDA's director of the 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."

Should the FDA have acted sooner? Sidney Wolfe, MD, the founder and senior adviser of the Washington, D.C.-based advocacy organization Public Citizen's Health Research Group, helped petition the FDA 18 years ago to do away with powdered surgical gloves. The group called for a ban again in 2011, arguing that "cornstarch powder can inflame wounds and promote infection, and cornstarch-induced adhesions can produce intestinal obstruction, pelvic pain and infertility in patients operated on by personnel wearing cornstarch-powdered surgical gloves."

But it wasn't until March — 5 years after posting a request for comments and information based on such petitions — that the FDA concluded that the risks associated with the gloves called for dramatic action.

"The fact that it took the FDA 18 years to propose a ban highlights how recklessly negligent the agency is," says Dr. Wolfe. "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."

The delay might not be surprising when you consider the FDA has prohibited only one other medical device in its 110-year existence: prosthetic hair fibers in 1983. Typically, when safety concerns arise, the FDA's first choice is to update labeling or provide "black box" warnings. But the risks associated with powdered gloves can't be corrected through new or updated labeling, says the agency.

Moreover, Public Citizen noted in 1998 that labels warning that the gloves should be washed to remove cornstarch before use were "routinely ignored by the vast majority of health workers." It cited a 1992 study that showed only 17% of surgeons and 21% of the surgical nursing staff washed their gloves after donning them.

That's the real problem, says Tom Paolella, a spokesperson for glove manufacturer Ansell. "Unfortunately, many wearers of powdered surgical gloves do not follow the proper protocol for use, which is to rinse hands in sterile saline after donning," he says. "Since the 1970s, many national and international standards have required manufacturers to label sterile glove packages with a specific warning to remove the powder. Despite these warnings, many users do not comply with this instruction."

LONG HISTORY Healthcare advocates first petitioned the FDA to ban powdered surgical gloves 18 years ago.

Significant threat?
The cornstarch powder used with gloves is particularly problematic to those who have latex allergies, according to Public Citizen, because it combines with latex protein and allergens during manufacturing. The organization says that's led to "well-documented and frequently reported adverse reactions," including rhinitis, asthma and anaphylactic shock, "often caused by breathing in the cornstarch powder."

Lori Groven, MSPHN, RN, CIC, infection preventionist at TRIA Orthopaedic Center in Bloomington, Minn., feels that the proposed ban is appropriate. "There's enough scientific research that outlines the dangers of using powdered gloves, especially those also containing latex," she says.

Ms. Groven notes, however, that the overall threat probably "isn't as serious as it may have been 10 or 20 years ago, simply because most organizations have stopped using powdered gloves in light of the evidence against them." Her facility, she says, got rid of the gloves well before the proposed ban came about. "I've worked in several states, and I cannot remember the last time I saw a powdered glove."

Ms. Roth says her facility is also phasing them out, adding that, "those who are knowledgeable of the difficulties with these gloves welcome the transition away from them."

Powdered latex gloves account for a shrinking, but still significant, share of the U.S. surgical glove market, according to Cardinal Health. The company says the overall share of surgical powdered gloves sold decreased from 32% in 2008 to 20% in 2013. In a company survey, the most common reasons given by those still using powdered surgical gloves were that they had worked well in the past and that respondents hadn't seen any serious adverse effects.

"The surgeons who use powdered gloves might be a hard bunch to crack and resistant to change," says Ms. Groven, "so I feel like that might be a barrier. But there are good alternatives out there. Hopefully that would help ease the pain of forced change." Physicians may notice a positive change, as well, since less-serious risks from exposure to powder — including dermatitis and dry, itchy, irritated skin — have also been observed.

A ban, says the FDA, would also have little economic impact on glove manufacturers, because so many viable options are on the market. Indeed, spokespeople for several leading glove manufacturers say their companies are already actively promoting powder-free gloves.

'Better late than never'
If the FDA, which could have legally banned the gloves in 1998, had taken action then, says Public Citizen, "hundreds of thousands of healthcare workers and patients would have been spared preventable, often life-threatening adverse reactions."

"Better late than never," points out Ms. Groven. "I feel like the big push for patient safety in the last few years has enlightened many medical professionals to some of the risks that they were not aware of previously. Now, latex is another story. I feel that's the next hurdle — getting people to use only non-powdered latex-free gloves." OSM