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FDA Knew That Medical Devices Prone to Spreading Superbug

Medical Devices Prone to Spreading Superbug and FDA Knew

superbugExperts in hospital-acquired infections say that the Food and Drug Administration, which approves new drugs and medical devices, knew about problems cleaning a device called a duodenoscope, which has been at the center of Superbug outbreaks at UCLA and Seattle, among others.

Allegedly, the FDA knew about complications cleaning the medical devices since 2009. The duodenoscopes are inserted into the mouth and down the throat, and are supposed to help doctors examine patients for an assortment of throat, stomach, and bowel problems without having to operate on them.

In 2013 and 2014, the FDA received 75 reports of adverse events associated with the medical devices, which resulted in harm to 135 patients through hospital-acquired infections. However, the FDA acknowledged that health care providers do not always submit reports of adverse events or hospital-acquired infections, so that is likely an underestimate.

Hospitals at the center of superbug outbreaks have been accused of serious patient harm and hospital error, and in response have begun to clean the duodenoscopes and endoscopes more thoroughly than the FDA recommends. Many hospital safety experts have also called for the FDA to change its guidelines around medical device cleaning to help prevent such outbreaks of superbugs, especially CRE (Carbapenem-resistant enterobacteriaceae) in the future.

“I would be in favor of the FDA putting out more stringent rules,” said Dr. John Greene, an infectious disease specialist at Moffitt Cancer Center in Tampa, Florida. The center saw its own superbug outbreak in 2012 related to duodenoscope procedures.

Rather than discuss a medical device recall or better cleaning measures, on Thursday, February 19th, the FDA issued a “safety communication” to warn healthcare providers about the potential cleaning issues around the duodenoscopes. The communication recommended a procedure called “reprocessing” which would more thoroughly sterilize medical devices.

“The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents,” the communication said.

Other hospitals which have suffered outbreaks include the University of Pittsburg Medical Center in 2012, and Virginia Mason Medical Center this past January, in which 32 people were infected with CRE over two years, and 11 died, due to improper cleaning of duodenoscopes.

“People have a right to know that’s intrinsic or inherent,” said Art Caplan, a bioethicist at New York University’s Langone Medical Center. “If my spouse died because of an infected piece of medical equipment or dental equipment, I would like to know. I would even like to examine a lawsuit.”

The Strom Law Firm Can Help Those Suffering from Hospital Errors

Each year, nearly 100,000 people die as a result of surgical errors, and many more suffer devastating personal consequences. Surgical errors, hospital acquired infections, defective medical devices and medical malpractice can ruin you and your loved ones’ lives, demanding time away from work and thousands of dollars in medical bills. If you or a loved one has suffered pain, patient death, and continuing health problems after surgery, especially due to a defective or unclean medical device, you may be entitled to compensation for your injuries. The attorneys at the Strom Law Firm can help. We offer free consultations, so contact us today about your medical malpractice concerns. 803.252.4800.



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