Infection, Recalls Prompt Calls for Ban on Non-Sterile Alcohol Prep Pads

Recent recalls of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">non-sterile alcohol prep pads, wipes and swabs have many questioning whether these products should be used at all. According to a report from MSNBC, some experts are advocating that the use of such non-sterile products should be curtailed or banned entirely.

In the past year, two companies have issued massive recalls of alcohol prep pads, wipes and swabs. Just last month, Professional Disposables International Inc., or PDI, of Orangeburg, N.Y. recalled five different types of non-sterile alcohol prep products after they were found to be tainted with low levels of Bacillus cereus bacteria. According to an earlier MSNBC report, bacterial levels detected remained well within allowed specifications and that the recall was initiated only after extensive discussion with the U.S. Food & Drug Administration (FDA).

However, according to the latest MSNBC report, a hemophiliac patient developed a Bacillus cereus infection following an infusion that involved the use of tainted PDI alcohol prep pads. In June, the FDA urged PDI to issue a recall, but the company did not respond until September.

According to MSNBC, PDI buys padding material from Tudor Converted Products Inc. of Summerville, S.C., the same firm that supplied pad material to the Triad Group and its parent, H&P Industries. Over the past year, Triad and H&P have issued numerous recalls of non-sterile pads, wipes and swabs, also for Bacillus cereus contamination. H&P officials have claimed that the bacteria found in their products came from contaminated padding from Tudor, but both Tudor and PDI have disputed those claims. As a result of the H&P/Triad recalls, a plant has shut-down and at least eight lawsuits have been filed against the companies claiming the tainted wipes caused dangerous bacterial infection.

About 70 percent of products sold in the prep-pad market are sterile, and about 30 percent are non-sterile, according to MSNBC. While non-sterile varieties must be tested for organisms like staphylococcus aureus and E. coli, low levels of Bacillus cereus were allowed until recently. But in the wake of the H&P/Triad recalls, the FDA seems to be taking a “zero tolerance” policy toward that bacterium.

Now some are calling on the FDA to ban non-sterile prep products altogether.

“I don’t believe non-sterile products such as this should be used in a situation where you are using injectables,” Barry A. Friedman, a microbiologist and sterilization expert who advises drug and device manufacturers, told MSNBC. “I have a feeling what we’re seeing is the tip of the iceberg.”

Some hospitals aren’t wanting for such a ban.

“We switched over entirely to sterile prep pads,” Dr. Christine Nyquist, a doctor at Colorado Children’s Hospital and part of the team that dicovered the connection between Bacillus cereus and Triad Group prep products. “It’s consumer beware. Our position is that alcohol prep pads should be sterile.”

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