Is the FDA doing enough to stop the spread of the deathly superbug through scopes?

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Superbug

It is national news that the use of endoscopes are causing drug-resistant superbugs in individuals which have caused serious and significant injuries, including death.  Recently, it was at UCLA’s Ronald Reagan Medical Center where at least 7 patients were infected, two died from the drug-resistant “superbug” and 179 patients may have been exposed to the dangerous bacteria through the use of contaminated medical scopes.  It is through “reprocessing” where  individuals do a detailed, multistep process to clean and disinfect or sterilize the reusable ERCP endoscopes (also called duodenoscopes) that the superbug was not being eliminated.

Thus, the FDA wanted to raise awareness among health care professionals, including those who do the reprocessing of the scopes, that the complex design of ERCP endoscopes (also called duodenoscopes) may not make for an effective reprocessing.  Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Even  hand cleaning  meticulously  the scope prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.  What is perplexing is the medical scopes in question, known as duodenoscopes, are used in more than half a million procedures each year in the United States as the “least invasive way” of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones and other conditions. The light, flexible tubes are typically threaded through the mouth, throat, stomach, or into the top of the small intestine. Unlike other endoscopes, they have a movable “elevator” mechanism at one end that allows the instrument to treat problems with fluid drainage.  But that intricate design also can make the devices difficult to sterilize, the FDA said. In fact, parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.

The affected patients suffered from a drug-resistant superbug known as CRE, or Cabapenem-Resistant Enterobacteriacae, during “complex endoscopic procedures” to diagnose and treat diseases in the pancreas between October and January at the hospital, UCLA’s Health System. UCLA told the LA Times which first reported the deadly infections, that it detected the bacteria recently while conducting tests on a patient and alerted both the California and Los Angeles County health departments. An internal investigation revealed that two medical endoscopes may have transmitted the infection, though the scopes had been sterilized in line with the manufacturer’s standards, it said.  Health officials sent out letters this week to 179 patients who were possibly exposed to the bacteria through one of the endoscopes, Los Angeles County Department of Public Health said in a statement.

The CRE superbug has been described as a form of “nightmare bacteria” by Tom Frieden, head of the Centers for Disease Control and Prevention. “Our strongest antibiotics don’t work and patients are left with potentially untreatable infections,” he said. CRE infections, most of which happen in hospital settings, can lead to infections in the bladder or lungs, causing coughing, fever or chills. And, according to the CDC, the bacteria kills nearly half of patients who get infections in the bloodstream.

Over the past couple years, similar outbreaks have occurred when contaminated scopes were used at Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died. Although it was unclear whether the outbreak in Seattle contributed to the deaths, the hospital stressed that medical professionals there, too, had cleaned the instruments according to the manufacturer’s stipulations.

The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE). In total, from January 2013 through December 2014, the FDA received 75 Medical Device Reports (MDRs) encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes. It is possible that not all cases have been reported to the FDA.

What is disturbing  is that the FDA first alerted doctors using the scopes back in 2009 that they could be transmitting bacteria, even after proper cleaning, CNN reported.  But — this agency, responsible for regulating all medical devices, has not taken any action.  This is alarming since the FDA has several options to take, including taking the scopes off the market to demanding the manufacturers improve their designs or upgrade their recommended cleaning protocols.  It will take the FDA’s action to ensure that the pricey approach adopted in Seattle at the Virginia Mason Medical Center is applied universally. CDC, FDA, hospitals and all medical providers must engage in broader and more coordinated information sharing, and then act quickly and decisively with strategies to contain the bacteria and treat victims. Even though scopes may have been a factor in the spread of various bacteria between patients for years, it’s a CRE diagnosis that will get everyone to pay attention get a thorough investigation to get to the source. Why? CRE kills up to 40% of infected individuals  once it spreads into the bloodstream.

In the interim, the FDA recommends health care providers should: 

  • Discuss with patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
  • Thoroughly disinfect duodenoscopes between uses and have in place a comprehensive quality program for reprocessing.
  • Take a duodenoscope suspected of being associated with a patient infection following ERCP out of service and meticulously disinfect it until it is verified to be free of pathogens.
  • Submit a report to the manufacturer and to the FDA via MedWatch, if the provider suspects that problems with reprocessing a duodenoscope have led to patient infections.

Want to read more about the recall?  Click here to read the FDA recall: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

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