Proposed ban finalized: FDA bans use of all powdered medical gloves in U.S hospitals.

image courtesy: Mcfarlane Medical Equipment

The US FDA issued a very important rule on Friday banning the use of powdered gloves beginning January 19, 2017. The FDA stated in the press release “While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.”[1]

The ban includes powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.

The ban is not for powder used in manufacturing process that is not a part of the finished product.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s 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.”

Earlier, the ban was proposed on March 21, 2016 but was not finalized.[2]

Before proposing the ban, FDA considered all available scientific evidence in disease causation due to powder which included a thorough review of literature. FDA has also received several public petitions from 1997 to 2011, requesting a ban due to multiple health issues in doctors and healthcare workers.

Over the year’s organizations such the American Academy of Allergy, Asthma, and Immunology(ACAAI), the National Institute for Occupational Safety and Health (NIOSH), the American College of Surgeons (ACS), and the American Nurses Association have all issued statements against the use of powdered gloves. CDC also joined the team, issuing a statement on NRL sensitization and recommending that non-powdered rubber latex gloves would be more efficient.

Moreover, health care systems such as the Cleveland Clinic network of nine hospitals, the Johns Hopkins Hospital and University of Virginia Healthcare systems have all restricted or banned the use of powdered NRL gloves in their systems. In Europe, Germany and the United Kingdom have also taken steps against use of powdered NRL gloves.

All powdered gloves are associated with multiple health risks like acute severe airway inflammation, granulomas, peritoneal and other tissues adhesions including tubal adhesions and infertility.  Allergic reactions include asthma, allergic rhinitis, conjunctivitis, and dyspnea. Additionally, the latex sensitive individuals experience cutaneous reactions upon skin exposure to the latex allergenic proteins adherent to the powder.

Surgical gloves made room in doctor’s armamentarium in the year 1889, and have played an important role in protecting both patients and health care personnel in medical field since then. Various types of powder lubricants have been used so that they can be donned easily. The first was powder made from Lycopodium spores (club moss spores) and later replaced by talcum powder (chemically hydrous magnesium silicate). Both were replaced by modified cornstarch as they were recognized to cause wound granulomas and adhesion formation.  Cornstarch is currently the most commonly used type of absorbable glove powder.

FDA encourages people in heathcare industry to use non-powdered gloves which contains minimum amount of powder (no more than 2 milligrams). Non-powdered gloves are easily available in the market and FDA believes “This ban would likely have minimal economic and shortage impact on the health care industry. Thus, a transition to alternatives in the marketplace should not result in any detriment to public health.”

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FDA also believes that the ban will not incur any additional expenses on the part of society and it will be beneficial in terms of cost and reducing the number of complications.  Annual net benefits between $26.8 million and $31.8 million in healthcare cost  is expected by FDA.

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[1] https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder

[2] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466.htm