Safe use of topical antiseptics for preoperative and preinjection skin preparation

Starting date:

July 25, 2014

Posting date:

July 25, 2014

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

General Public

Identification number:

RA-40775

• Issue
• What industry professionals should do
• Report health or safety concerns
• Media enquiries
• Public enquiries

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.

What industry professionals should do

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 followed;
• 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.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709