The Cedars-Sinai Medical Center, a non-for-profit hospital and health research center in Los Angeles, Calif., recently reported that four patients tested positive for a drug-resistant bacteria infection, while 67 more may have been exposed. According to the center, patients acquired the infection after they had undergone procedures involving specialized medical scopes.
The center said that it started investigating its patients suspected of having been infected with drug-resistant bacteria, or superbugs, after UCLA’s Ronald Reagan Medical Center reported last week that seven patients were diagnosed with similar infections related to contaminated medical scopes.
Cedars-Sinai said that one of the four patients diagnosed with CRE-infection died, but the death was not related to the superbug. Currently, the other three patients were given the green light to return to their homes, a Cedars spokesperson said.
The announcement will most likely put additional pressure on the Food and Drug Administration (FDA) which was finger pointed for not listening to previous warnings about the medical instruments.
U.S. Superbug Epidemic
However, the Cedars-Sinai Medical Center’s superbug outbreak is not the first of its kind to be reported in the U.S. healthcare facilities. In 2013, Wisconsin Department of Health Services reported that five people were infected with NDM1, a drug-resistant “superbug” belonging to the carbapenem-resistant Enterobacteriaceae (CRS) class.
Also, over the same year, an antibiotic-resistant strain of Klebsiella pneumoniae killed seven people including a 16-year-old at the NIH Clinical Center outside Washington, D.C.
But the most recent superbug outbreak was reported Wednesday by the Ronald Reagan UCLA Medical Center, where seven patients were infected with CRE, while two of them eventually died. All patients caught CRE after routine endoscopic treatments involving two medical scopes that were contaminated even though they had been properly cleaned.
But these health care settings are just a few of the locations were superbug infections silently killed thousands of patients. According to the Centers for Disease Control and Prevention (CDC), superbugs infect more than 2 million people in the U.S. and the infections result in death in more than 23,000 cases every year. So, it may not be an exaggeration to qualify the problem as national epidemic.
Healthy People Rarely Get infected
Drug-resistant bacteria also called superbugs are bacteria resistant to a wide range of antibiotics making the treatment more costly, less efficient and even resulting in death. Superbugs are scientifically known as CREs, or carbapenem-resistant Enterobacteriaceae. Escherichia coli (E. coli) belongs also to the Enterobacteriaceae family, which is a normal gut bacteria that can mutate and acquire antibiotic-resistance.
The most popular CREs are KPCs (Klebsiella pneumoniae carbapenemase) and NDMs (New Delhi Metallo-beta-lactamase), which render carbapenems ineffective after breaking them down.
According to the CDC, healthy people normally do not get infected with such bacteria. Instead the most affected group involves people with an already weakened immune system, most of them being patients from nursing homes, hospitals, and other healthcare facilities.
But the most exposed patients are the ones employing medical devices that require cleaning such as bladder catheters, breathing machines, vein catheters, and duodenoscopes, as well as patients that are already on a long course of antibiotics.
The most viral types of CREs are immune to almost all available antibiotics and, according to a CDC report, they can lead to the death of infected patients in up to 50 percent cases.
Superbugs can dwell outside health facilities
But there are some superbugs that wreak havoc outside hospitals such as the drug-resitstant Staphylococcus aureus. These bacteria can acquire immunity to methicillin-based antibiotics and can lead to serious complications such as skin and blood stream infections, or even pneumonia.
When someone gets a MRSA-caused skin infection they usually experience swollen and painful pimples or boils that are hot when touched, while the bacteria can spread through every skin cut or scrape. Usually, people carrying MRSA can recover, but some may experience life-threatening situations.
According to the CDC, more than 80,000 new cases of MRSA infections are reported every year nationwide, while 11,000 deaths are related to such infections on a yearly basis.
More Hospitals May Be Affected
But lawmakers and consumer rights advocacy groups are mostly concerned by superbug infections caught by means of CRE-contaminated medical scopes since those cases could have been preventable. Experts believe that the Cedars’ report may be followed by a cohort of other disclosures as hospitals investigate medical records and link infections to their CRE-carrying scopes.
“It’s highly likely many hospitals around the country have had outbreaks, and they haven’t been able to connect the dots until this problem was disclosed at UCLA. It’s just a little late — especially for those who got infections and maybe died as a consequence,”
argued Lisa McGiffert from the Safe Patient Project at Consumers Union.
Superbug-carrying ERCP patients
UCLA and Cedars-Sinai patients were infected with CRE after having undergone a medical procedure called endoscopic retrograde cholangiopancreatography (ERCP). During an ERCP, a medical fiber-optic scope is threaded down the patient’s oesophagus and through the digestive tract to either diagnose or treat problems such as cancers, life-threatening bile duct obstructions, and gallstones.
The scopes used in ERCPs are different from the instruments employed in routine endoscopies or colonoscopies. According to the official data, about half of million people undergo an ERCP every year.
Epidemiologists at Cedars-Sinai reported that the infected patients may have caught the superbug from an Olympus duodenoscope, which was in use since August 2014. The same model of scope was linked to CRE infections at UCLA and Virginia Mason Medical Center.
The Scopes Had No FDA Approval
Surprisingly, FDA recently acknowledged that it hadn’t given its approval on the Olympus scope, which had been used in ERCP procedures since 2010. Additionally, the agency said it will not recall the product because too many doctors and hospitals are already using it and a recall may lead to a product shortage.
Also, the incidence of superbug infections is extremely low as compared to the 500,000 ERCP procedures safely performed every year, the Japanese scope maker reported
When asked why its scopes had no federal approval, the maker of Olympus replied that its actual version of the scope was a 2010 redesign of an older scope dubbed TJF-Q180V duodenoscope. So, the company didn’t believe that an additional federal approval was necessary. Currently, FDA requested that the company would file for such approval, which is now pending.
A FDA spokesperson also announced that the agency will collaborate with Cedars hospital, the CDC, and the local authorities to find out more about the superbug infections, and the cleaning and disinfection procedures.
But according to medical device experts and health officials, Olympus scopes boost the risk of superbug infections because their design makes it extremely hard to obtain a proper cleaning, even manually.
Even FDA warned, after the UCLA report, that the scopes weren’t safe even if doctors followed the maker’s cleaning instructions because many bacteria get trapped in the minuscule crevices on the tip of the scope.
On Wednesday, Cedars-Sinai reported that its staff meticulously observed the manufacturer’s instructions, while LA county investigators said that the cleaning protocol was flawlessly followed at the hospital. LA health officials also urge county hospitals to look for CRE infections in all their ERCP procedure records.
Currently, two Capitol Hill Republicans asked FDA to disclose what its future steps toward the redesign of the devices and the limitation of further superbug spread are. They also want to know whether the agency knew beforehand that the scopes’ design was prone to lead to infections.