Preventing Surgical Fires
Collaborating to Reduce Preventable Harm
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| Photo Courtesy of the Anesthesia Patient Safety Foundation |
FDA Requests Label Changes and Single-Use Packaging for Some Over-the-Counter Topical Antiseptic Products
The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of FDA’s ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or pre-injection skin preparation. These products are marketed as solutions, swabs, pads saturated with a solution, and applicators containing a solution. Commonly used products contain isopropyl or ethyl alcohol, povidone iodine, poloxamer-iodine, benzalkonium chloride, benzethonium chloride, or chlorhexidine gluconate as a single agent or in combination with alcohol.
FDA is also asking manufacturers to voluntarily revise the product labels for topical antiseptics to indicate whether the drug is manufactured as a sterile or nonsterile product. We believe this will assist health care professionals in making informed decisions about using these products. Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms.
When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection.
Health care professionals should consider these topical antiseptics as a possible source of infection when trying to determine the cause of postoperative or postinjection infections.
For further information, please visit: OTC topical antiseptics.
For FAQs, please visit: Questions and Answers.
See also FDA article intended to raise awareness of the issue, published in the New England Journal of Medicine; Microbial Stowaways in Topical Antiseptic Products, Chang CY, Furlong L-A. Microbial stowaways in topical antiseptic products, N Engl J Med 2012;367:2170-3.
Thank you. The Preventing Surgical Fires Initiative Workgroup
FDA's Safe Use Initiative leads the Preventing Surgical Fires Initiative, in partnership with other FDA offices and 26 external stakeholder groups. The Preventing Surgical Fires Initiative was launched to increase awareness of the risks of surgical fires and promote the adoption of risk reduction practices throughout the healthcare community.
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