Hepatitis C Triad Prep Pads; Questions On The FDA Handling Of Problems

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Hepatitis C Triad Prep Pads; Questions On The FDA Handling Of Problems

Questions Raised About FDA Handling of Triad ProblemsBy Gever, Senior Editor, MedPage TodayPublished: February 23, 2011Although FDA inspectors had reported a host of quality-control problems at Triad Group long before it recalled millions of contaminated alcohol-based prep pads, swabs, and jellies, the agency mysteriously took no corrective action, according an MSNBC.com report.Citing FDA inspection reports provided by an anonymous source, the website alleged that the agency knew about "shoddy sterilization practices" at Triad Group's plant in 2009, yet did not issue a warning letter or alert customers or physicians.On January 5 of this year, Triad announced a recall of all

lots of isopropyl alcohol prep pads, swabs, and swabsticks -- labeled as sterile as well as non-sterile -- because of potential contamination by Bacillus cereus bacteria. The company cited a single case of non-life-threatening skin infection as the reason for the recall.The firm's products were sold under the Triad name and as house brands for Cardinal Health, CVS, Walgreens, and other retailers and distributors. The recall was later expanded to include lubricating jellies sold by Triad as sterile.Firms such as Genentech that had packaged their injectable drugs with Triad prep products were then forced to issue their own alerts.But since the recall was announced, additional reports of infections associated with the products have

come to light -- including at least one death, according to MSNBC.com.The website described a two-year-old Texas boy who died of meningitis attributed to B. cereus infection. The boy's parents are now suing Triad.It also reported on a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December, the website indicated. He too has filed suit against Triad, with Genentech also named as a defendant.The MSNBC.com report said that FDA inspectors had found "as early as July 2009" that sterilization procedures in Triad's plant in Hartland, Wis., were not being followed.The company had claimed to use gamma radiation to sterilize its products but the inspectors were unable to validate the process, MSNBC.com said.Inspectors reportedly also found that the company

had shipped products that failed to meet specifications, and had failed to investigate complaints about faulty products from customers and to relay them to the FDA as required.However, no warning letters or other follow-up action by the FDA ensued.Contacted by MedPage Today, an FDA spokesman could not immediately confirm or deny the MSNBC.com report or answer other questions about Triad, but promised a response in due course.Officials at Triad Group could not be reached for comment. The company's Internet homepage indicated its website had been taken down for maintenance.MSNBC.com quoted the FDA spokesman as saying the agency had not received any adverse event reports about Triad products prior to the recall. During the first month afterward, about 100 were filed, including 50 describing infections and one involving a fatality.The spokesman said the number of reports was typical for publicly announced recalls. Only one report

specifically identified B. cereus, according to MSNBC.com.He also told the website that another inspection had been conducted Jan. 7 that disclosed "deviations from our current good manufacturing regulations," but he did not provide specifics. An investigation is ongoing, he said.http://www.medpagetoday.com/Washington-Watch/FDAGeneral/25020

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