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 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 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 have occurred.
William Maisal, deputy director of the FDA’s Center for Devices and Radiological Health, indicated, “We 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.”
A recent congressional investigation also indicates that the scope of the problem is far more extensive than federal regulators previously suspected. According to the U.S. Food and Drug Administration, approximately 350 patients at 41 medical facilities in the U.S. and worldwide have been exposed or infected by tainted gastrointestinal scopes from Jan. 1, 2010 to Oct. 31, 2015. While the actual list sent to Congress by the FDA listed 404 patients and 44 facilities, the agency indicates that the list was assumed to include some duplicates. A prior report estimated the number of victims as 250 and the number of affected clinics and hospitals at 25.
In the wake of the scandal, new legislation has been proposed in Congress referred to as the Device Act. This new law would require companies to disclose to the FDA when safety warnings are issued in other countries concerning the cleaning or design of medical devices. The mandatory disclosure would be required even if the device manufacturer was not required to seek government approval for the change. A companion bill also is expected to be filed that imposes requirements that the cleaning instructions for medical devices be scientifically validated to ensure they are effective.
If you have been injured by a defective product, including a medical device in Jacksonville or the surrounding areas of Mississippi, our Mississippi Personal Injury Lawyers are committed to seeking the maximum compensation for victims of unsafe products. At Barrett Law, we are here to help. Contact our firm today at (601)790-1505 to schedule your free consultation, so we can answer any questions you may have regarding filing your claim.
