Recall of contaminated pads not required

Recall of contaminated pads not required

September 26th, 2011 // 12:19 pm @

A potentially deadly bacterium was detected on alcohol prep pads produced by a New York medical manufacturer three months ago, but the product was not recalled until this week because federal regulators didn’t require it, the company said Wednesday.

A day after the recall was launched Tuesday, word of it was slowly dribbling out to hospitals and clinics responsible for pulling the potentially contaminated products. Children’s Hospital of Wisconsin, for instance, was not aware of it until told by a Journal Sentinel reporter.

Professional Disposables International of Orangeburg, NY, said it detected Bacillus cereus, a bacterium that was responsible for killing a 2-year-old Houston boy last year, on its non-sterile alcohol prep pads in June.

The same bacterium was found on wipes produced by Wisconsin-based Triad Group, leading to a nationwide recall and at least six federal lawsuits – including by the family of the Houston boy – alleging the product caused illness or death.

A Journal Sentinel investigation this year found that the U.S. Food and Drug Administration – the agency in charge of protecting public health – had known about critical issues at Triad for at least a decade but failed to take any enforcement action.

A review by the newspaper of FDA inspection records at Professional Disposables similarly found ongoing problems but no enforcement action.

An official at Professional Disposables said Wednesday the FDA has tolerated a low level of Bacillus cereus – and other organisms – on non-sterile topical products and the company’s pads tested in June were within that range.

However, the agency recently changed its policy to zero-tolerance for the bacteria on such products, said Melanie Leibowitz, PDI’s vice president for regulatory affairs.

The recalled Triad alcohol wipes were labeled sterile, and thus subject to a different standard

An FDA spokeswoman declined to comment on the agency’s position on Bacillus cereus, saying only that the agency was aware of PDI’s voluntary recall.
Supplier investigated

Bacillus cereus is a spore-forming bacterium undaunted by heat or high concentrations of alcohol. It lingers dormant in the soil but springs to life when it finds nourishment. If ingested, it typically causes vomiting or diarrhea before the body’s natural defenses knock it out. In the bloodstream, it can be fatal.

Professional Disposables, which picked up business and had been supplying Wisconsin hospitals after Triad was raided by U.S. marshals and closed in April, halted shipments of the contaminated pads and now is recalling products shipped earlier, Leibowitz said.

“We have taken this precaution and recalled the product,” she said. “We have been working with FDA for some time, knowing the agency has a concern about this.”

Leibowitz said PDI is investigating if the contamination was connected to one of its suppliers, Tudor Converted Products Inc. of Summerville, S.C. reported Tuesday that Triad also used Tudor as a supplier. An employee at Tudor said late Wednesday no one was available to comment.
Inspection problems

Professional Disposables has been cited for problems in its New York plant, going back six years, according to the FDA inspection reports obtained by the Journal Sentinel through an open records request.

Over the eight inspections, regulators repeatedly found problems such as PDI not following its testing procedures, failing to properly track its products and not having adequate control of its production. Inspectors were back in the plant in June. That report was not available Wednesday.

Leibowitz said the issues noted by the FDA during inspections were not “significant,” but she added the company quickly fixed them.

Professional Disposables, which also does business as Nice-Pak, has had at least two voluntary recalls since the beginning of 2010 and also withdrew a product from the market, the Journal Sentinel reported earlier.

In February, PDI recalled more than 19,000 cases of antiseptic wipes and towelettes that had an insufficient amount of the active ingredient, benzalkonium chloride, according to an FDA enforcement report.

In August 2010, the company withdrew 30 lots of Sani-Cloth Bleach Wipes due to a quality concern, according to the company. In early 2010, Professional Disposables recalled 403,266 packs of Up & Up baby wipes that had an uncharacteristic off odor, the FDA noted.

Leibowitz said PDI and FDA agreed on the current recall earlier this month, and it was launched on Tuesday.

However, Tracy Cleveland, director of materials services at Children’s Hospital of Wisconsin and its nearly 100 facilities, said he knew nothing of the recall until contacted Wednesday by a Journal Sentinel reporter.

Cleveland immediately called PDI and was directed to a website that initially could not be found through typical search engines and was not connected to the company’s main website. However, late Wednesday a prominent notice of the recall appeared on the company’s website.

Cleveland said Children’s Hospital did not have any of the non-sterile pads, but he was reaching out to his counterparts at hospitals to make sure they knew about the recall, even though official notification was expected Thursday.

He said a day in such recalls can be life-saving.

“It really is important,” Cleveland said. “If there is a child already immunocompromised, you don’t want to introduce another bacteria.”

Cleveland said typically companies move much faster on recalls. He was surprised nothing had been done months after the tests confirming bacteria. Cleveland already was concerned about depending on PDI as the sole source of sterile wipes. He has been looking for another source and said this recall confirms the need for one.

“It is on my radar,” Cleveland said. “It is a pretty loud ping today.”

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