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Health Canada Health products

Safe use of topical antiseptics for preoperative and preinjection skin preparation

Issued July 25, 2014
Issue
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 infections. 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.
Hazard description
Contamination - Product safety