Duodenoscope “Scope” Infection Lawsuit | Duodenoscope Lawsuit Lawyer
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In November 2015, the U.S. Food and Drug Administration (FDA) ordered a recall on the machines that wash and disinfect endoscopes, the medical devices that were traced to an infectious outbreak over the past year. The agency directed Custom Ultrasonics, Inc. to recall an estimated 2,800 automated endoscope reprocessors (AERs) and advised hospitals and outpatient clinics to use alternative methods to clean the endoscopes. The duodenoscopes recall order was due to the Pennsylvania-based Custom Ultrasonics’ violation of the Federal Food, Drug, and Cosmetic Act. The FDA said it was taking the action to minimize the risk of patient infections associated with the endoscopes, including duodenoscopes.
Duodenoscopes that were not properly cleaned and disinfected were contaminated with Carbapenem-resistant enterobacteriaceae (CRE), a “superbug” bacteria that is nearly resistant to antibiotics. The CRE infection was transmitted to patients who underwent a routine endoscopic retrograde cholangiopancreatography procedure (ERCP). Patients were sickened and some died due to the serious infection from the “superbug” bacteria.
Southern Med Law Duodenoscope “Scope” Infection Lawsuit case reviews
Southern Med Law is now offering free, no-obligation duodenoscopes “Scope” infection lawsuit case reviews to anyone who suffered from the CRE infection or whose loved one died after undergoing a procedure in which endoscopes, including duodenoscopes, or scopes as they are widely called were used. If you or a loved one suffered a CRE infection due to contaminated duodenoscopes, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation duodenoscopes “Scope” infection lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Duodenoscopes or Scopes and automated endoscope reprocessors (AERs)
A duodenoscope is a flexible, lighted tube that is inserted through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). The device is often used in patients suffering from gallstones or pancreatic cancer who undergo an endoscopic retrograde cholangiopancreatography procedure (ERCP). This type of procedure allows doctors to examine the pancreatic and bile ducts. Duodenoscopes are manufactured by Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division
CRE Bacterial Infections allegedly caused by Duodenoscopes or “Scopes”
Duodenoscopes, also known as ERCP endoscopes, become contaminated when they are not properly cleaned between patients. Olympus Corp.’s TJF-Q180V duodenoscope was allegedly associated with a CRE infection outbreak that occurred from October 2014 to January 2015 at UCLA’s Ronald Reagan Medical Center. Two patients died and 39 patients were sickened by the infection. The 180 duodenoscope was also allegedly linked to a CRE infection outbreak at Cedars-Sinai Medical Center in Los Angeles in March, and at the Virginia Mason Medical Center in Seattle from 2012 to 2014.
The FDA said it has been monitoring the association between contaminated duodenoscopes and the transmission of the CRE infection. The agency said it received 75 medical device reports involving possible bacteria transmission from duodenoscopes to 135 patients. In August 2015, the FDA provided health care facilities with additional methods to clean and disinfect duodenoscopes since the reprocessor machines were not properly sanitizing the instruments.
Duodenoscopes “Scope” Infections And FDA Alert
In its November 2015 safety alert, the FDA said it inspected Custom Ultronics’ facility in April 2015 and found violations, some of which were related to the “inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The FDA previously inspected the company’s facility and found violations, but the agency allowed Custom Ultronics to correct the violations. In its most recent press release, Dr. William Maisel, the chief scientist for the FDA’s Center for Devices and Radiological Health, said the agency was taking action because Custom Ultronics “failed to meet its legal and regulatory obligations.”
Duodenoscope “Scope” Infection Lawsuits
Duodenoscope infection lawsuits are being filed against Olympus Corp. and Custom Ultrasonics over contaminated duodenoscopes that have sickened or fatally injured patients on which the medical devices were used. The Duodenoscope lawsuits allege the CRE infection was transmitted to patients because Olympus made and sold a defectively designed product that is difficult to properly clean and disinfect. The lawsuits further contend that Customs Ultrasonics equipment does not adequately clean and disinfect the medical devices.
Southern Med Law has worked hard to develop a strong reputation in healthcare litigation. It is Southern Med Law’s first-hand knowledge of medicine that has made the law firm an aggressive and effective advocate for those who were harmed due to negligent pharmaceutical manufacturers. If you or a loved one suffered a CRE infection due to contaminated duodenoscopes, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation duodenoscopes “Scope” infection lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203