In a press release on March 21, 2016 US Food and Drug Administration
(FDA) announced a proposal to ban most powdered medical gloves in USA.
The ban includes powdered surgeon’s gloves, powdered patient examination gloves
and absorbable powder for lubricating a surgeon’s glove. Both synthetic gloves
and natural rubber latex (NRL) are covered in the ban, only powdered
radiographic examination gloves are exempt.
A ban was only option to FDA as the risks associated with
the use of powdered gloves cannot be corrected through new or updated labeling.
“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.”
Surgical gloves made a 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 than. 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 of these 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.
Before proposing the ban, FDA considered all available
scientific evidence in disease causation due to powder which included a through
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.
The level and type of risks due to use of powdered gloves
vary according to the composition of gloves (synthetic
versus NRL) and its intended use (surgeon’s
glove versus patient examination glove). It
is known that powdered synthetic patient examination gloves present less risk
than powdered NRL surgeon’s gloves.
The identified risks of powdered gloves according to composition and intended use are:
1)
Risks of Absorbable Powder for Lubricating a Surgeon's Glove.
This powder, often referred to as Absorbable Dusting Powder
or ADP, has been shown to cause acute severe airway inflammation, granulomas,
and adhesions. When used on NRL gloves, powder has the ability to adhere to
latex allergenic proteins that, when aerosolized and inhaled, present
significant risks to patients, including inflammatory responses,
hypersensitivity reactions, and allergic reactions. Additionally, the latex
sensitive individuals experience cutaneous reactions upon skin exposure to the
latex allergenic proteins adherent to the powder.
2) Risks
of Powdered Natural Rubber Latex Gloves.
The powder used to lubricate these gloves bind to the
natural rubber latex protein, causing latex aerosol which causes allergic and
inflammatory responses to NRL. Allergic reactions include asthma, allergic
rhinitis, conjunctivitis, and dyspnea.
3) Risks of Powdered Synthetic Surgeon’s Gloves.
These gloves do not pose the risk of allergic reaction due
to aerosolized powder, but exposes individuals to powder by inhalation leading
to airway inflammation. Additionally surgeries and invasive examinations
deposits the powder could then results in granuloma formation in any exposed
site, as well as peritoneal and other tissues adhesions. Additional studies
show that powder may promote infection in wounds, which can lead to wound
healing complications.
4) Risks of Powdered Synthetic Patient Examination Gloves.
The patient examination gloves does not expose the patient’s
internal organs to powder but the
internal tissue are exposed during procedures such as oral, vaginal,
gynecological, and rectal examinations. In female patients the reproductive tracts
is exposed to powder leading to tubal adhesions and infertility in animal and
human studies.
Over the years 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.
The FDA published a request for comments in its notice to
include the public in Federal decision making. Comments will be accepted for 90 days from the
date of publication. The full notice and the way to post comments can be viewed
here.
FDA further proposes that the ban will not incur any
additional economical or environmental burden. The proposed rule is expected to
provide a positive net benefits range between $26.6 million and $29.3 million
due to reduced adverse effects.
It further added that the policy will also not affect the
medical practice as several non powdered alternatives are already available in
the market.
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