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Reports of Spread of Deadly Bacteria by Contaminated Scopes Not Provided Promptly

April 01, 2015

When manufacturers of pharmaceuticals and medical devices receive reports of adverse events or side effects, the makers of these medical products have an obligation to report this information to the Federal Drug Administration (FDA). The FDA investigates such reports and aggregates data to determine if regulatory action is needed, such as issuing a safety notice, requiring warnings on labels, or mandating a product recall.

This system only works effectively to protect the public when companies that manufacture medical devices and drugs comply with their obligation to disclose such information. An article recently published in USA Today indicates that reports of contaminated medical scopes linked to the spread of a potentially fatal superbug were not provided to the FDA until months after the incidents, and not at all in some cases.

Federal law requires manufacturers of medical devices to file reports within thirty days of discovering their product might pose risks to the public. According to USA Today, the transmission of a drug-resistant bacteria via duodenoscopes to patients in eight separate hospitals between 2012 and 2014 were not reported until months after the outbreaks occurred. There were even incidents that were never reported according to the article.

The FDA is currently conducting an ongoing investigation into the spread of the CRE (carbapenem-resistant Enterobacteriaceae) bacteria via the medical devices. The bacteria is extremely dangerous because it is resistant to virtually all types of antibiotics. CRE also has an alarmingly high fatality rate of forty percent. The FDA is investigating the potential for the fatal bacteria to get trapped in the scope's crevices. The agency has indicated that contamination and cross-infection between patients can occur, even when cleaning and disinfection of the scopes has occurred.

William Maisal, deputy director of the FDA's Center for Devices and Radiological Health, indicated, "[w]e are aware that there are reported duodenoscope-associated infections that have occurred for which we have not received MDRs [Medical Device Reports], and we are looking into whether some of those reports should have been submitted."

Atlanta Personal Injury Attorney David Montlick commented, "[t]he delayed reporting is alarming because Medical Device Reports are intended to be an early warning system to protect consumers." According to Montlick, manufacturers that fail to provide such reports can impede the FDA's ability to identify trends that can threaten consumer safety. Montlick and Associates has diligently pursued its goal of being the top personal injury law firm in Atlanta for more than thirty years.

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Category: Montlick Law

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Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.