Summary Safety Review - Topical Antiseptic Products - Risk of Infection

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2014-07-25

issue

A safety review was initiated to evaluate the currently available information regarding the possible risk of infection associated with the use of topical antiseptic products intended for skin preparation before an operation (preoperative) or before an injection (preinjection). This review was prompted by a United States (U.S.) Food and Drug Administration (FDA) safety alert1 issued on November 13, 2013. The alert informed consumers of the ongoing evaluation of infrequent but continuing reports of infection resulting from antiseptic products used to clean the skin during preoperative preparation or preinjection preparation.

Background

Approved use of topical antiseptic products in Canada

Topical antiseptics are antimicrobial substances used to destroy or reduce harmful microorganisms such as bacteria or fungi on the skin. These products are used by both consumers and health care professionals. In Canada, there are several types of topical antiseptics. The current review focusses only on preoperative and preinjection topical antiseptic skin preparations.

There are a variety of topical antiseptic products licensed by Health Canada for preoperative or preinjection skin preparation. These products often contain ethyl alcohol, isopropyl alcohol, povidone-iodine, and chlorhexidine gluconate. They may be packaged in single-use forms such as individual swabs, wipes, pads, or sponges, or multiple-use forms such as a multi-use container. Antiseptics that are sterile will be labelled as such, with the word sterile appearing on the label. Health Canada has developed a document used as referencing standards for topical antiseptic products: Human-Use Antiseptic Drugs Guidance Document. This document outlines the requirements of antiseptic products including specific labelling.

Risk of infection

When used properly, antiseptic products are safe and effective in reducing the number of microorganisms on the skin prior to surgery or injections. If they become contaminated from improper handling, storage or use; however, harm can occur. Cases of infection associated with contaminated antiseptic products from improper handling, storage or use have been reported in the U.S.

Microorganisms in the contaminated antiseptic product can be transferred into the body and may cause infections. Infections can occur at the injection or the operation site, such as at the skin (cellulitis), the joints (septic arthritis), or the intravenous (IV) site (phlebitis).  Other infections may involve the blood (bacteremia) and other organs in the body (sepsis). Some of these complications are considered serious and can be fatal. Complications from the use of contaminated antiseptics can affect both healthy persons and those with chronic illnesses. Patients who have recently had surgery, or require regular skin disinfection for daily injections (such as persons with diabetes), intravenous treatments (such as persons receiving chemotherapy), blood transfusions, and/or dialysis, are more likely to be vulnerable to complications arising from infections.

Objective

To summarize the available evidence concerning the risk of infection from contaminated antiseptic products intended for preoperative or preinjection skin preparation. This review considered Canadian adverse reaction reports, scientific and medical literature, and what is known about the use of these products both in Canada and internationally. Existing strategies currently available to minimize this risk were also considered, including a review of safety information available to consumers and health care professionals.

Key findings

Canadian reports of infections associated with the use of topical antiseptic products

As of July 31, 2013, Health Canada received 4 reports involving topical antiseptic products intended for preoperative or preinjection skin preparation and symptoms related to infection. All 4 reports were considered serious. Three of these reports involved antiseptic products that were possibly contaminated during their manufacturing and were not related to improper handling, storage or use by users. These products were recalled in 2011 in Canada and the U.S.  In the fourth Canadian report, there was not enough information to link the cause of the infection to the use of a contaminated antiseptic product. Overall, Health Canada could not confirm any reports of infections associated with improper handling, storage or use of topical antiseptic products. Literature specific to Canada on the use of these products is not available.

Scientific reports

In the scientific and medical literature, there are several reports of infection associated with the use of topical antiseptic products intended for preoperative or preinjection skin preparation that have been contaminated from improper handling, storage or use. Many of these reports are hospital-based and from the U.S. Examples of improper handling, storage or use include: diluting the antiseptic product with contaminated water, failing to use a clean (sterile) technique during its use or preparation, using dirty containers to prepare solutions, storing solutions with cotton gauze and storing products without a lid.

International data

According to the safety alert issued by the FDA, there were 88 reported cases of infection associated with the use of contaminated topical antiseptic products intended for preoperative or preinjection skin preparation, including 4 deaths. To decrease the risk of infection, the FDA recommended that health care professionals and patients follow all directions on product labels. They also recommended that manufacturers of these products voluntarily revise their labels and package these products in single-use containers.

Conclusions and actions

  • Topical antiseptic products for preoperative or preinjection skin preparation are safe and effective; however, if proper care is not taken when using them, they can become contaminated and cause serious, subsequent infections.  Although Health Canada could not confirm any Canadian reports of infection associated with improper handling, storage or use of topical antiseptic products, proactive measures are being taken due to the availability of products in Canada similar to those in the U.S., where cases of infection associated with improper handling, storage or use of topical antiseptic products have been reported.

    Health Canada actions:

    • Health Canada has issued a communication to Canadians to remind all users of the safe use of these products.
    • Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified for these products.

References

  1. Guidance Document - Human-Use Antiseptic Drugs. Ottawa (ON): Health Canada; 2009. (accessed 2014 Jul 11).
  2. Weber DJ, Rutala WA, Sickbert-Bennett EE. Outbreaks associated with contaminated antiseptics and disinfectants. Antimicrob Agents Chemother 2007;51(12):4217-24.
  3. Triad group issues a voluntary nationwide recall of all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks due to potential microbial contamination. Silver Spring (MD): US Food and Drug Administration; 2011 Jan 5. (accessed 2014 Jul 11).
  4. FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. Silver Spring (MD): US Food and Drug Administration; 2013 Nov 13. (accessed 2014 Jul 11).
  5. Chang CY, Furlong LA. Microbial stowaways in topical antiseptic products. N Engl J Med 2012;367(23):2170-3.
  6.  Notes from the field: Contamination of alcohol prep pads with Bacillus cereus group and Bacillus species ― Colorado, 2010. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2011;60(11):347.
  7.  Allergy injection-associated Mycobacterium abscessus outbreak ― Texas, 2009. Arlington (VA): Infectious Diseases Society of America; 2010 Oct 22. (accessed 2014 Jul 11).
  8. Arjunwadkar VP, Bal AM, Joshi SA, et al. Contaminated antiseptics ― an unnecessary hospital hazard. Indian J Med Sci 2001;55(7):393-8.

Footnotes

  1. FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. Silver Spring (MD): US Food and Drug Administration; 2013 Nov 13. (accessed 2014 Jul 11).
  2. This list of references is not intended to be exhaustive. References have been selected as suggestions for further reading and reflect the most current information at the time of the safety review.

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