A massive recall of potentially contaminated alcohol prep products by a second manufacturer is raising questions about an entire category of medical supplies, non-sterile pads and swabs. According to Dr. Christine Nyquist, a Colorado infection control director who blew the whistle on dangerous bacteria in alcohol wipes last fall, there is no place for a non-sterile alcohol prep pad in a hospital setting.
According to Dr. Nyquist and a number of other microbiology experts, the growing debate is whether the non-sterile pads and wipes routinely used in hospitals, clinics and private homes to clean skin before shots and other procedures should be curtailed – or even banned – because of the potential for infection. While sterile pads have had some problems, the non-sterile pads pose a much larger safety problem. Barry A. Friedman, a microbiologist and sterilization expert who advises drug and device manufacturers, observed:
I don’t believe non-sterile products such as this should be used in a situation where you are using injectables. I have a feeling what we’re seeing is the tip of the iceberg.
The comments by Drs. Nyquist and Friedman follow the recent recall of nearly 300 million individual non-sterile alcohol prep products manufactured and distributed by Pacific Disposables International Inc. of Orangeburg, N.Y. The recall, which dates back two years, was initiated because the pads may have been contaminated with Bacillus cereus, a potentially life-threatening bacterium, according to the federal Food and Drug Administration. A hemophiliac patient reported developing a bacterial infection caused by Bacillus cereus after PDI alcohol prep pads tainted with the germ were used during an infusion, according to an FDA inspection report. An FDA official said that the company was urged to recall the products in June, but didn’t respond until September.
The PDI recall follows this year’s highly-publicized global recall of hundreds of millions of alcohol and iodine wipes and pads made and sold by the Triad Group and H&P Industries, Inc. of Hartland, Wis. The presence of Bacillus cereus bacteria in Triad prep products has been blamed for deaths and devastating infections in patients nationwide. Federal officials shut down these companies in June to prevent distribution of tainted medical wipes and other supplies.
Triad and H&P Industries recalled both sterile and non-sterile products, and FDA investigators found that the companies didn’t validate processes that should have ensured sterility and prevented other contamination. In the overall alcohol prep market, about 70 percent of products are sterile, and about 30 percent are non-sterile, according to Melanie Leibowitz, the senior director of regulatory affairs for PDI Inc.
Current rules from U.S. Pharmacopeia, which sets international standards, prohibit objectionable organisms in non-sterile products if they cause illness or degrade a product’s effectiveness. Tests for certain organisms, such as Staphylococcus aureus and E. coli, are required. But until recently, Bacillus cereus was tolerated at very low levels, which were found in the non-sterile PDI products. The FDA appears to be cracking down on the bacterium in the wake of the H&P Industries crisis.
At press time, FDA officials hadn’t commented specifically on the PDI issue or on whether they are scrutinizing all manufacturers more closely for Bacillus cereus contamination. As it stands now, Bacillus cereus can be considered objectionable depending on the particular product and its use, an agency spokeswoman said. In a statement, FDA officials said they are monitoring and evaluating the use of alcohol prep products. Earlier this year, FDA issued warnings to health care providers reminding them to be careful about using non-sterile pads in patients with depressed immune systems, before catheter insertions or before surgery.
The FDA also warned that pads packed in kits with injectable drugs may not be sterile. That can create confusion for health care workers and home users, who may assume the products are sterile, according to Dr. Nyquist. In some cases, the pad packaging doesn’t indicate whether it’s sterile or not. It was reported that some hospital infection control experts would wait for the FDA, or some other government agencies, to announce any formal changes in policy before deciding whether to continue using non-sterile alcohol pads and wipes.
Dr. Nyquist was part of the Colorado Children’s Hospital team that detected the connection between unusual Bacillus cereus infections in sick children and Triad Group alcohol wipes. Dr. Nyquist takes the position that all “alcohol prep pads should be sterile.” The FDA must take action to make sure that this problem is resolved. In the meanwhile, the debate over the issue continues. Because of the importance from a health and safety perspective, we will continue to monitor this issue.
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