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Antiseptic skin preparation products can be contaminated by microbes, a problem the FDA will address at an upcoming public hearing.

There have been recent reports of microbial contamination of topical antiseptic products that are used before surgery, before an injection, and to reduce the risk of skin infection, and some of the products have been recalled, according to Christina Chang, MD, MPH, and Lesley-Anne Furlong, MD, of the FDA's Center for Drug Evaluation and Research in Silver Spring, Md.

Such contamination, which can occur during manufacturing or during storage, preparation, and use by healthcare professionals, has resulted in outbreaks of infection and even death in some cases, they wrote in a perspective in the Dec. 6 issue of the New England Journal of Medicine.

Next Wednesday and Thursday, the to discuss how to deal with the issue of microbial contamination of antiseptic skin products, which are not currently required to be manufactured using sterile processes.

"It is important that healthcare providers be aware that topical antiseptic products, if contaminated, pose a risk of infection and that particular microbes isolated from clinical specimens have been traced to the contamination of such products," Chang and Furlong wrote. "The isolation of unusual organisms (e.g., Bacillus cereus) after the use of topical antiseptic products should trigger an investigation of possible contamination stemming from an antiseptic product."

In the 1970s, when the FDA was making regulations for drug ingredients that were on the market but had not been approved by the agency, it was thought that antiseptic drug products would not be contaminated by microbes because of their pharmacologic activity.

Reports in recent years have disputed that notion, however, as infections tied to contaminated antiseptic drug products have resulted in a range of outcomes from localized infections at injection sites to fatal systemic infections.

"The reports implicate all commonly used antiseptic categories, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products," Chang and Furlong wrote.

In August 2009, an FDA advisory committee discussed whether products used on non-intact skin should be required to be produced in sterile conditions. Committee members looked at cost, effects on the active drug ingredients and the product packaging, and uncertainties about the scope of the problem, but did not make a final determination.

Chang and Furlong noted that, "although the scope of nosocomial infections associated with contaminated antiseptic products is difficult to assess, it is most likely broader than has been indicated by postmarketing reports and the medical literature."

There are several possible reasons for that, they said:

• Healthcare professionals may not consider antiseptic skin preparations as potential sources of infection because of the nature of the products.
• Cases may be under-reported because of the high threshold of suspicion needed to start an investigation into the source of an infection.
• Many of the products come in single-use containers that will be thrown away before an investigation can begin.

"Confirmation of contamination often requires the testing of other units from the same manufacturing lot as the suspect product; however, contamination may not occur consistently within a lot, confounding the infection work-up," the authors wrote.

They said other reasons that infections resulting from tainted antiseptic skin products may be under-recognized include variations in the rates of postoperative infection based on the type of procedure and other factors, the potential inability to capture infections treated in ambulatory settings, and the fact that reporting nosocomial infections is voluntary.

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