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Hospitals’ Use of Non-Sterile Wipes, Swabs, Questioned in Wake Of Recalls | 24-7-news.com cialis online

Hospitals’ Use of Non-Sterile Wipes, Swabs, Questioned in Wake Of Recalls

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Massive recalls of potentially contaminated alcohol prep products are presenting issues concerning hospitals’ use of non-sterile wipes and swabs.

We previously reported that U.S. Marshalls seized $6 million worth of medical products from H&P Industries Inc., which does business as Triad Group, at the behest of the U.S. Food and Drug Administration (FDA). The raid was prompted by the failure of H&P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations. Triad Group issued several massive recalls of tainted alcohol prep pads, alcohol swabs, alcohol swabsticks, and other products sold under various brands and because of potential Bacillus cereus contamination.

H&P Industries also issued a Povidone Iodine Prep Pad recall because of concerns they could be contaminated with Elizabethkingia meningoseptica, which is associated with flesh eating bacteria disease, meningitis in newborn infants, and pneumonia in ventilator patients.

We also recently wrote that Professional Disposables International Inc. (PDI) issued a large recall over possible Bacillus cereus contamination, recalling all lots of five types of nonsterile antiseptic alcohol prep pads. Almost 300 million products were involved

“Is there any place for a non-sterile alcohol prep pad in a hospital setting?” said Dr. Christine Nyquist. “We believe there isn’t,” she added. Nyquist is an infection control director who brought attention to the potential dangers brewing in alcohol wipes last year, noted msnbc.com. Nyquist and other microbiology experts are involved in a larger debate over non-sterile pads and wipes popularly used in hospitals, clinics, and patient homes to clean skin before shots and other procedures, noted msnbc.com. Experts now wonder if product use should be minimized or banned.

“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 serves as an advisor to drug and device manufacturers. “I have a feeling what we’re seeing is the tip of the iceberg,” Friedman added, wrote msnbc.com.

The PDI recall followed a bacterial infection caused by Bacillus cereus in a hemophiliac patient after a tainted PDI alcohol prep pad was used during an infusion, said msnbc.com, citing an FDA report. Although PDI was urged to issue a recall in June, it did not respond until September, said an FDA official, wrote msnbc.com. Bacillus cereus was also found in Triad prep products and has been linked to a number of deaths and very serious infections in patients across the company, said msnbc.com.

Current U.S. Pharmacopeia rules—the group sets international standards and bans “objectionable” organisms in non-sterile products if those organisms are known to cause illness or degrade a product’s efficacy—test for organisms, such as Staphylococcus aureus and E. coli. Previously, said msnbc.com, the group “tolerated” Bacillus cereus at very low levels.

This year, the FDA issued warnings to the medical community about exercising care when using non-sterile pads in patients with weakened immune systems when inserting catheters or prepping patients for surgery, said msnbc.com. The FDA also warned that pads in kits containing injectable drugs might not be sterile; a problem for those in the medical community believing the products are sterile, said Nyquist, who noted that pad packaging does not always indicate a product’s sterility.

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