The FDA has proposed banning powdered gloves in healthcare, a move that should protect patients and healthcare workers from latex allergens and was nevertheless criticized as long-delayed.
Consumer advocacy group Public Citizen, which asked the FDA to ban powdered latex gloves in 1998 and again in 2011, was particularly critical of the delay.
“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.”
Powder is typically added to gloves to ease donning and removal, but can spread latex allergens if aerosolized and inhaled. 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 postsurgical 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.
The proposed ban applies to powdered surgical gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves. Non-powdered surgical 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.
The FDA has determined that the ban, if finalized, would 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.
No glove shortage projected
Given the critical role gloves play in protecting patients and healthcare workers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage, and the economic effect 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 have 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 coworkers 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.
The FDA rule is available for comment at: 1.usa.gov/1UFPuMn.
Updates to Dental Infection Control Guidance
The CDC issued new summarized infection control guidelines for dental settings, citing the rare but real risk of transmission to patients and personnel. (http://1.usa.gov/22YZkKW)
There have been some highly publicized outbreaks in dentistry, including the first documented case of hepatitis C virus infection via cross-transmission between patients in a dental office in 2013. Public health investigators found the Tulsa, OK, dental practice was riddled with infection control problems, including injection practices that could contaminate multidose vials and multiple sterilization issues. Then there was the infamous Florida Dental Case in 1990, when the late Kimberly Bergalis and five other patients contracted HIV after receiving care from an HIV-positive dentist. The case was never definitively solved — partly due to the absence of dental records — though the initial molecular epidemiology seemed to suggest the patients were infected by the HIV-positive dentist.
“In most cases, investigators failed to link a specific lapse of infection prevention and control with a particular transmission,” the CDC states in the guidelines. “However, reported breakdowns in basic infection prevention procedures included unsafe injection practices, failure to heat sterilize dental handpieces between patients, and failure to monitor (e.g., conduct spore testing) autoclaves.”
The guideline summarizes current infection prevention recommendations and includes a checklist that can be used to evaluate compliance.
All dental settings, regardless of the level of care provided, must make infection prevention a priority and should be equipped to observe standard precautions and other infection prevention recommendations, the CDC underscores. The guidelines summarize current infection prevention recommendations and includes a checklist that can be used to evaluate compliance. Key sections include the following:
- Infection prevention program administrative measures.
- Infection prevention education and training.
- Respiratory hygiene and cough etiquette.
- Updated safe injection practices.
- Administrative measures for instrument processing.
The FDA has proposed banning powdered gloves in healthcare, a move that should protect patients and healthcare workers from latex allergens and was nevertheless criticized as long-delayed.
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