They aren't always produced in sterile environments, can cause
infections, experts say.
Antiseptics are meant to keep
bacteria and other pathogens from entering the body through breaks in the skin,
but sometimes these products can be contaminated with the very organisms they're
supposed to guard against, new research shows.
In the Dec. 6 issue of the New England
Journal of Medicine, scientists from the U.S. Food and Drug
Administration detail recent outbreaks that have occurred in products
such as single-use alcohol swabs and pre-surgery antiseptics.
"It is important that health care providers be
aware that topical antiseptic products, if contaminated, pose a risk of
infection and that particular microbes isolated from clinical specimens have
been traced to the contamination of such products," the FDA experts wrote
in the report.
How can products that are
supposed to kill germs contain germs?
"Nothing is 100 percent.
Bacteria are really diverse and they're adapted to living in different
environments," said Dr. Bruce Hirsch, an attending physician in infectious
diseases at North Shore University Hospital in Manhasset, N.Y.
However, Hirsch added that he
believes the FDA "should require sterilized manufacturing whenever
possible."
Currently, companies that produce
antiseptic products aren't required to manufacture these products in sterile
environments.
The regulations surrounding the
production of antiseptic products were designed in the 1970s. At the time, it
was assumed that antiseptic products didn't need to be produced in a sterile
environment, because experts believed that any pathogens present would be
killed by the antiseptic.
But, according to the FDA
researchers, a number of outbreaks associated with these products have been
reported in medical
journals and to the U.S. Centers
for Disease Control and Prevention. The authors also noted that there are
probably more outbreaks related to these products than have been reported,
because this method of contamination is quite difficult to detect.
"Sometimes it's really
tricky to trace where an organism came from," explained Dr. Mohamed Fakih,
medical director of infection prevention and control at St. John Hospital and
Medical Center in Detroit. He said that most hospitals use one product to clean
the skin before surgery, but even if that product is contaminated, not everyone
will get sick from it. And, because everyone—both the sick and healthy—had the
same product used on their skin, it's difficult to isolate the antiseptic as
the cause of the infection.
In the case of single-use
products, such as an alcohol swab, by the time someone has reported an
infection, the packaging is gone and can't be tested for contamination, Fakih
added.
Contamination of these products
can occur during manufacturing or at the point of use, according to previous
research. Products that have been found to be contaminated include iodophors
(antiseptics that contain iodine), alcohol products, chlorhexidine gluconate
(used in hand sanitizers and as a pre-surgical antiseptic), and quaternary
ammonium (an antiseptic used to clean surgical and medical procedure
equipment).
The FDA is currently reviewing
whether or not sterile manufacturing should be mandated for topical antiseptics that are meant to
be used on broken skin, such as from injury, medical procedures or surgery.
Public hearings on the subject are scheduled for Dec. 12 and Dec. 13.
Fakih said he believes that these
products should be manufactured under sterile conditions. If the FDA doesn't
mandate sterile manufacturing processes, he said it would be very helpful if
they at least mandated that labeling contain information about whether or not
the product was manufactured in sterile conditions. He said it's very difficult
to find that information right now.
Hirsch said when using these
types of products, it's important to remember that "exceptions are
exceptions. The products we're using are safe and helpful, and make a positive
difference, but there's no 100 percent guarantee."
More information: To learn more about the public hearing on the
issue of antiseptic products, visit the U.S. Food and Drug Administration's website.
"Antiseptic products can be
contaminated, study says." December 6th, 2012. http://medicalxpress.com/news/2012-12-antiseptic-products-contaminated.html
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