A massive recall of potentially contaminated alcohol prep products by a second manufacturer is raising sharp questions about an entire category of medical supplies: non-sterile pads and swabs, infection experts say.
“Is there any place for a non-sterile alcohol prep pad in a hospital setting?” said Dr. Christine Nyquist, a Colorado infection control director who blew the whistle on dangerous bacteria in alcohol wipes last fall. “We believe there isn’t.”
Nyquist and other microbiology experts say a debate is brewing about 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 perhaps banned —
because of the potential for infection. While sterile pads have had problems, too, non-sterile products may raise alarms from the start.
“I don’t believe non-sterile products such as this should be used in a situation where you are using injectables,” said Barry A. Friedman, a microbiologist and sterilization expert who advises drug and device manufacturers. “I have a feeling what we’re seeing is the tip of the iceberg.”
Nyquist’s and Friedman’s comments follow the recall last month 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. The company was urged to recall the products in June, an FDA official said, 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.
Bacillus cereus bacteria found in Triad prep products have been blamed for deaths and devastating infections in patients nationwide. Federal officials shut down the firms 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 federal Food and Drug Administration investigators found that the company 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, estimated 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. Until recently, Bacillus cereus was tolerated at very low levels, which were found in the non-sterile PDI products, Leibowitz said. But the FDA appears to be cracking down on the bacterium in the wake of the H&P Industries crisis.
“It is a zero-tolerance program that we’ve been communicated,” she said.
FDA officials wouldn’t comment specifically on the PDI issue or on whether they’re 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, a spokeswoman said. In a statement, FDA officials said they’re 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 agency 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, Nyquist said. In some cases, the pad packaging doesn't indicate whether it's sterile or not.
Some hospital infection control experts said they’d wait for FDA or other government agencies to announce any formal changes in policy before deciding whether to continue using non-sterile alcohol pads and wipes.
“Before you make a broad position statement, you want to make sure you have all your evidence,” said Linda Greene, a registered nurse and board member of the Association of Professionals in Infection Control.
But others said they’re acting now. Nyquist was part of the Colorado Children’s Hospital team that detected the connection between unusual Bacillus cereus infections in sick kids and Triad Group alcohol wipes.
“We switched over entirely to sterile prep pads,” said Nyquist, who urged other hospitals in her region to do the same. “It’s consumer beware. Our position is that alcohol prep pads should be sterile.”