Doctors use medical endoscopes to see problems inside the body and to perform a variety of tests and examinations. All medical scopes involve some sort of tube, either flexible or rigid, with a tiny camera that allows the doctor to see and take pictures of the affected area inside the body. Scopes are also used to perform medical procedures such as tissue sampling, placing other medical devices, destroying small tumors, and surgery. Duodenoscopes, bronchoscopes, colonoscopes and gastroscopes are all considered endoscopes.
A variety of dangerous infections are associated with the use of medical scopes: E. coli bacterial infections, Pseudomonas bacterial infections, Klebsiella bacterial infections, other multi-drug resistant organisms (MRDO), and CRE (Carbapenem-resistant Enterobacteriaceae) infections, also known as “superbug” bacterial infections. Resistant to antibiotic treatment, these infections can cause widespread damage throughout the body, and unfortunately many patients have died from those infections.
Patients treated with reusable endoscopes that have not been properly processed (cleaned and sterilized) have been diagnosed with superbug infections — super because they are resistant to treatment with antibiotics. Outbreaks of antibiotic-resistant bacterial infections from tainted duodenoscopes have been reported this year at UCLA and Cedars-Sinai medical centers in California, and outbreaks occurred in the last three years in Philadelphia, Pittsburgh, Seattle and Chicago, as well as in other hospitals in the US as well as other countries. And these are the outbreaks we know about.
A USA Today investigation reported that some duodenoscope-associated infections aren’t catalogued because hospitals and health departments can’t make a definitive link to the devices. Countless others never get detected, mistaken for other, more routine infections. And even when infections are confirmed as scope-related, they sometimes go unreported because hospitals and health departments aren’t necessarily required to alert federal authorities.
The FDA first warned in 2009 about the risk of cross-contamination — patients being exposed to the body fluids and tissue contaminants of other patients — from failure to properly clean and sterilize medical scopes between uses. In February of 2015 the FDA issued a Safety Communication about one specific type of endoscope, the duodenoscope.
The FDA warned that duodenoscopes carry an inherent risk of infection and may remain infected even after precisely following the manufacturer’s processing instructions.
Recent medical publications and adverse event report associate multidrug-resistant bacterial infections in patients who have undergone (treatment) with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly,” the FDA advisory says. “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
The devices are also known as ERCP endoscopes, as they used for one medical procedure, the ERCP, which stands for endoscopic retrograde cholangiopancreatography. The FDA describes the ERCP as “[T]he least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.”
The duodenoscope has a lever with a hinge that allows the doctor to angle a small tube into the pancreatic or bile duct. This hinge is very difficult to access and therefore difficult to clean on a microscopic level. The FDA issued its warning after receiving 75 reports of infections associated with duodenoscopes from January 2013 to December 2014.
In August 2015 the FDA issued another, stronger Safety Communication regarding duodenoscopes and superbug infections. Health care providers are given more specific instructions on how to safely and properly reprocess duodenoscopes to prevent infections. The agency also issued warning letters in August to manufacturers Olympus, Hoya/Pentax and FujiFilm for a variety of violations including failing to report infections linked to their scopes.
The three primary duodenoscope manufacturers, Olympus America, Fujifilm Medical Systems and Hoya Corp./Pentax Life Care Division, were ordered in October 2015 by the FDA to conduct post-market surveillance studies in clinical setting to figure out what part of device processing is allowing bacteria to thrive.
If you believe that you or someone you love has contracted an antibiotic-resistant infection after a duodenoscope procedure, contact the medical device lawyers at Thornton Law Firm for a free case consultation. Call 1-888-341-1405 or tell us your story using our contact form here. Time limits apply to these claims, so seek legal advice immediately.
On September 17, 2015 the FDA issued a Safety Communication about infections associated with reprocessed flexible bronchoscopes. Approximately 500,000 bronchoscopy procedures are performed in this country each year. Bronchoscopes are thinner than some other medical scopes and are threaded in through the nose or the mouth to let the doctor see and treat the patient’s throat, larynx, trachea, and airways.
The new safety alert about bronchoscopes warns that improperly cleaned flexible bronchoscopes could transmit deadly infections from patient to patient. The FDA received 109 reports of infection or device contamination associated with flexible bronchoscopes between 2010 and 2015. However, in 2014 alone the FDA received 50 reports of infections or device contamination associated with bronchoscopes. Some of these 50 reports “indicate persistent device contamination despite following the manufacturer’s reprocessing instructions”. As a result, the FDA urges health care providers and their staff, infection control specialists, and patients to strictly adhere to the manufacturer’s specifications for cleaning and sterilizing reprocessed flexible bronchoscopes. The alert also warns against using devices with damage or mechanical issues.
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If you or a loved one has been diagnosed with an infection after a procedure using a bronchoscope, you may have a claim for damages. Contact the medical device lawyers at Thornton Law Firm for a free, no-obligation case evaluation at 1-888-341-1405. Or tell us your story using our online contact form for a prompt, thorough evaluation of your legal rights.