OTTAWA, July 25, 2014 /CNW/ - Health Canada is reminding healthcare
professionals, caregivers and consumers of the safe use of topical
antiseptics used to clean the skin before an operation (preoperative)
or before an injection (preinjection). These products can be considered
safe and effective; however, if proper care is not taken when using
them, they can become contaminated and cause serious, subsequent
This class of topical antiseptics is used to remove microorganisms such
as bacteria or fungi on the patient's skin prior to injections or
surgery. In Canada, these products are available as single-use or
multi-use products, and contain ingredients such as ethyl alcohol,
isopropyl alcohol, povidone-iodine, and chlorhexidine gluconate.
Topical antiseptics that are sterile will be labelled as such, with the
word sterile appearing on the label.
Health Canada is aware of the recent U.S. Food and Drug Administration
(FDA) Drug Safety Communication on over-the-counter topical antiseptic
products. The U.S. FDA has confirmed 88 cases of infections linked to
the contamination of antiseptics, including four deaths. These cases
included serious, life-threatening complications such as infection of
the lining of the abdominal organs (peritonitis), infection in joints
(septic arthritis) , wound infections, indwelling catheters needing
replacement, injection site infection, and bacteria in blood. To date,
Health Canada has not received any confirmed adverse reaction reports
of infection linked to the use of topical antiseptics contaminated by
improper use, handling, or storage.
To minimize the risk of infection, Health Canada reminds Canadians to:
Read all product labels and follow all labelled directions;
Discard single use products after a single application;
Do not dilute products after opening them;
Do not use products that have been sitting exposed in open containers;
Do not use products after their expiration dates.
Consumers and care givers should contact a healthcare professional if
there are any questions or concerns regarding the proper use of topical
antiseptics for preoperative or preinjection skin preparation.
Additional information for healthcare professionals:
Healthcare professionals are reminded that:
In-house infection control policies and procedures for proper sterile
technique, use, handling and storage of topical antiseptics, should be
In the event of culturing an unusual organism in a post-procedural
infection setting, contamination of antiseptics should be suspected.
Report health or safety concerns:
To report a side effect to a health product to Health Canada:
Call toll-free at 1-866-234-2345
Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Stay connected with Health Canada and receive the latest advisories and
product recalls using social media tools.
Related Web content
SOURCE: Health Canada
For further information:
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