The FDA’s recently proposed rule1 to ban powdered latex gloves was welcomed by occupational health advocates, but there was some sentiment that the FDA was finally addressing a problem clinicians long since had to solve themselves.

“Latex allergies have dropped a lot in the last few years — it was really tough about eight or nine years ago,” says Bobby Quentin Lanier, MD, executive medical director of the American College of Allergy, Asthma, and Immunology (ACAAI). “Latex gloves were very common and there were some manufacturing issues that made it really bad. We had lots of issues with healthcare workers. It has gotten better over the last few years. From a surgery standpoint probably 97% — maybe even a little bit more than that — now is done with non-latex and non-powdered gloves. We have noticed since we began a campaign against this years ago that the epidemic of latex allergy has waned tremendously. This is just the final piece of it.”

Indeed, there are still healthcare facilities using powdered latex gloves, which pose a threat of allergic reactions in healthcare workers. Thus, the Association of Occupational Health Professionals in Healthcare (AOHP) welcomed the ban and didn’t quibble about the timing.

“AOHP does support the ban because there are facilities that continue to use powdered latex gloves and healthcare workers are reacting to powder,” says MaryAnn Gruden, MSN, CRNP, NP-C, Cohn-S/CM, a member of the AOHP’s executive board. “We need to do everything that we can to ensure a safe working environment for our staff.”

Still, the FDA action after the latex allergy problem has been largely resolved “seems to be over a decade overdue,” says William G. Buchta, MD, MPH, medical director of the Employee Occupational Health Service at the Mayo Clinic in Rochester, MN. “The latex allergy epidemic has long dwindled, largely due to latex-safe policies in medical centers, such that we rarely, if ever, use powdered gloves.”

NEGLIGENCE?

Consumer advocacy group Public Citizen, which asked the FDA to ban powdered latex gloves in 1998 and again in 2011, was less diplomatic in responding to the agency action.

“The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is,” Sidney Wolfe, MD, co-founder of the Washington DC-based advocacy center’s Health Research Group said in statement. “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.”

In proposing the ban in a document that is open for comment through June 20, 2016, the FDA cited the risks of inflammatory responses, hypersensitivity reactions, and allergic reactions, including asthma, allergic rhinitis, conjunctivitis, and dyspnea, posed by powdered latex gloves.

“FDA has determined that these risks are important, material, and significant risks in relation to the minimal potential benefits of greater ease of donning and doffing and decreased tackiness,” according to the proposed rule. “In relation to the state of the art of alternative non-powdered gloves that do not present risks of inflammatory responses, hypersensitivity reactions, and allergic reactions, we conclude that these risks are substantial and unreasonable.”

FDA has determined that this ban, if finalized, should apply to devices already in commercial distribution and devices already sold to the ultimate user, as well as to devices that would be sold or distributed in the future. This means that powdered gloves currently being used in the marketplace would be subject to the ban and enforcement action.

At any rate, many healthcare facilities have already moved away from powdered gloves. A report by Global Industry Analysts of San Jose on the disposable glove market in 2010 found that only 7% of gloves in the U.S. market were powdered. Some 92% of exam gloves were powder-free and 94% of surgical gloves were powder-free, despite the increased cost of powder-free gloves, the report says. The trend is apparently continuing as a 2014 report by the same company cites the following findings:

  • Powder-free gloves witness strong demand against a backdrop of growing concerns over health risks posed by glove powder.
  • Development of lighter and comfortable synthetic gloves triggers a shift in demand away from natural rubber latex gloves.
  • Better performance, cost effectiveness, and anti-latex policies in hospitals spur demand for nitrile gloves.
  • Aging population and rising number of surgeries performed worldwide fuel sales of polyisoprene surgical gloves featuring superior strength, puncture resistance, and tactility.

While use of these gloves is decreasing, the FDA decided they “pose an unreasonable and substantial risk of illness or injury to healthcare 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 surgical gloves. Non-powdered surgeon gloves and non-powdered patient examination gloves will not be included in the ban and will remain Class I medical devices, according to the FDA.

“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health said in a statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

Public Citizen’s Wolfe had a withering response to this contention, noting that there was ample evidence to take the action years ago, meaning that “hundreds of thousands of health workers and patients would have been spared preventable, often life-threatening adverse reactions.”

AEROSOLIZED PROTEIN

Powder is typically added to gloves to ease donning and removal, but can spread latex allergens if aerosolized and inhaled. “When people take gloves off they kind of pop them and the powder gets in the air — that’s enough to give people in a tight setting like an operating room problems,” Lanier says.

Although powdered synthetic gloves do not present the risk of latex allergic reactions, these gloves “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,” the FDA noted.

In proposing to ban powdered gloves, the agency cited information gathered in a 2011 review of the literature and request for comment on the issue in determining the gloves “are dangerous and present an unreasonable and substantial risk.”

In addition, given the critical role medical gloves play in protecting patients and healthcare providers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage, and the economic effect of a ban would not be significant. The ban is also not likely to affect medical practice because many non-powdered protective glove options are currently available.

The process of making powder-free latex examination and surgical gloves basically removes most of the allergenic protein from the glove, explains Robert G. Hamilton, PhD, DABMLI, professor of medicine at Johns Hopkins University School of Medicine in Baltimore. There are still trace amounts of powder resulting from glove manufacturing, but the powderless gloves should stop development of latex allergies in workers and patients.

“You eliminate 99% of the powder so you are not creating an aerosolized allergen situation and there is very little if any protein there,” he says. “So by switching over to a powder-free latex glove it essentially eliminates the issue. It doesn’t eliminate it totally for people who are already allergic to latex. They have to work in an environment where there is no latex at all. For the general public that are not allergic to latex, the powder-free glove should be satisfactory.”

Johns Hopkins is one of the first healthcare systems nationally to switch to non-latex gloves completely. The hospital made the move in 2007, and has remained latex glove- and powder-free to eliminate the risk of exposure to patients and employees who may have developed natural rubber latex allergy during the 1990s, Hamilton says.

As universal (now standard) precautions were widely adopted in that decade, latex gloves were extensively used in most medical institutions. Facilities that are still using latex gloves haves successfully adopted policies to accommodate allergic healthcare workers, he said.

“Normally, if an individual working in a healthcare environment has a severe latex allergy, the co-workers and the facility adopt a latex-safe policy for that area — the workspace of that person,” he says. “That’s been very successful in most institutions. Those that don’t accommodate these individuals can run into legal problems, as these people go to court. Ultimately, the hospital or medical center accommodates them because there are laws in place not to discriminate against individuals [with latex allergies],” he says.

That may have been a factor in the massive transition to powder-free gloves prior to the FDA ban, but dropping latex gloves completely requires additional expenditures for the non-latex options.

“We use nitrile, neoprene, and some vinyl gloves for examination gloves,” he explains. “The gloves that are used today by the surgeons in our institution are made from oil — they are synthetic polyisoprene and non-powdered. They are much more expensive, so we had to essentially spend another $1 million a year to convert from the surgical gloves that they were using.”

Johns Hopkins strongly supports the proposed FDA ban as does the ACAAI.

“I’m generally opposed to any sore of regulation personally, but this one we looked at it and said this is not necessarily a bad idea,” Lanier says. “I can’t find anybody with an opposing view.”

The FDA rule is available for comment at 1.usa.gov/1UFPuMn.

REFERENCE

  1. FDA. Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove. March 22, 2016: 1.usa.gov/1UFPuMn.