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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.”
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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| We are in. image courtesy: shopdirectsource.com |
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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.
