CRE Superbug Lawsuit

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An outbreak of the superbug Carbapenem-Resistant Enterobacteriaceae, or CRE, connected to at least 2 patient deaths at a UCLA hospital has been linked to the use of contaminated medical scopes that allegedly carried the bacteria.

Update: International Team Gathered to Fight Superbug Outbreaks

August 9, 2016 – Researchers at the University of Queensland (UQ) in Australia are leading an international effort to slow the emergence of antibiotic-resistant superbugs that could kill more people than cancer by 2050. Last month, the university launched the Centre of Research Excellence (CRE) to strengthen global responses to antimicrobial resistance, gathering leading scientists and clinicians in intensive care, infectious diseases, biostatistics and clinical trials from more than 10 countries around the globe.

CRE Superbug Linked to 2 Deaths; 179 Potentially Exposed at UCLA

UCLA discovered the outbreak in late January 2015 after running tests on a patient, according to the LA Times. By mid-February, the Ronald Reagan Medical Center began notifying 179 other patients who were treated at the facility between October and January. To date, no new infections have been reported among the group; however 4 former patients were determined to be carriers of the disease, which does not put them at immediate risk. CRE is so deadly that if the bacteria reaches the bloodstream, it can kill up to half of those infected.

Specialized duodenoscopes are suspected to have spread the CRE superbug. The devices, which are inserted down the throat during endoscopic retrograde cholangiopancreatography (ERCP) procedures, are considered minimally-invasive and are credited for saving lives through early detection and treatment. However, medical experts say some duodenoscopes can be difficult to disinfect with traditional cleaning techniques because of their design, so bacteria survive and are transmitted from patient to patient. The duodenoscopes have “elevator channels” that are used to bend the device in tight spaces and allow for attachments such as catheters or guide wires. Experts suspect CRE bacteria may build up in these areas.

UCLA notified health authorities after discovering CRE bacteria in 1 patient and tracing the problem to a pair of duodenoscopes. The university said it had been disinfecting the scopes “according to standards stipulated by the manufacturer” prior to the outbreak, but it has since changed how it cleans them after the infections occurred.

“The two scopes involved with the infection were immediately removed and UCLA is now utilizing a decontamination process that goes above and beyond the manufacturer and national standards,” said Dale Tate, a university spokeswoman.

CRE Superbug Outbreak Reported at Cedars-Sinai

A second outbreak of the CRE superbug was reported at the Cedars-Sinai Medical Center in Los Angeles on March 4, 2015. At least 4 patients at the facility were infected, and 67 others may have been exposed, according to the LA Times. As in the UCLA outbreak, contaminated duodenoscopes are believed to have passed the bacteria.

“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,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union. “It’s just a little late — especially for those who got infections and maybe died as a consequence.”

 

Nationwide Outbreaks Highlight Lack of Focus on Patient Safety

Over the past 3 years, there have been about a half-dozen outbreaks affecting hundreds of people in Illinois, Pennsylvania and Washington State. Experts have questioned whether hospitals, medical device manufacturers and health officials are doing enough to protect patient safety. Consumer advocates are calling for greater disclosure to patients about the risks they face before undergoing medical procedures.

“These outbreaks at UCLA and other hospitals could collectively be the most significant instance of disease transmission ever linked to a contaminated reusable medical instrument,” said Lawrence Muscarella, a hospital safety consultant and expert on endoscopes.

Dr. Alex Kallen, an epidemiologist with the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion, said the CRE outbreak is serious given how difficult the bacteria can be to treat and that additional cases could go undetected.

“This bacteria is emerging in the U.S. and it’s associated with a high mortality rate,” Kallen said. “We don’t want this circulating anywhere in the community.”

Hospitals Not Required to Inform Patients About Superbug Outbreaks: Bloomberg News

Hospitals have no legal obligation to tell patients about the presence of pathogens at their facilities — including the CRE Superbug — due to an antiquated policy gap, according to Bloomberg News. Some hospitals have secretly investigated bacterial outbreaks for months or even years without informing their patients. For example, an outbreak that began in a Seattle hospital in 2012 wasn’t even made public until earlier this year.

Virginia Mason Issues New Quarantine Processes for Endoscopes

Between 2012 and 2014, at least 32 patients were diagnosed with a bacterial strain similar to CRE at the Virginia Mason Medical Center in Seattle. Eleven of those patients died. The bacteria was found to have been transmitted by contaminated endoscopes.

Virginia Mason has since instituted a new quarantine process that sets the devices aside for at least 48 hours so evidence of any bacterial presence can be found before they are reused. This has increased the time for equipment cleaning from a few hours to more than 2 days. The medical center has had to purchase 20 new endoscopes to compensate for the extended quarantine time.

“There is either a design issue to be addressed or a change to the guidelines for the cleaning process,” said Dr. Andrew Ross, section chief of gastroenterology at Virginia Mason. “It’s the role of the federal government to make some of those decisions.”

Olympus Updates Reprocessing Instructions for Duodenoscope Linked to CRE Outbreaks

Olympus Corp. has provided customers with new instructions for sanitizing the duodenoscopes linked to the CRE outbreaks. FDA said it is reviewing Olympus’ new guidelines as part of a broader evaluation of the duodenoscope.

Senator Urges New FDA Sterilization Guidelines

In response to the outbreaks, Senator Patty Murray (D-WA) urged the FDA to issue updated guidelines for hospitals on how to properly sanitize the duodenoscopes and develop a plan to track infections. Health authorities and industry officials have been criticized for being too slow to respond to these kinds of crises.

“Hospitals and manufacturers often take months to assess what to do, with the infected patients being the last to know,” Muscarella said. “Bringing patients into the loop and answering their questions is important for hospitals to prevent outbreaks.”

An FDA spokesperson said the agency was working to reduce infection rates while maintaining access to the important medical tool. FDA is “actively engaged with the manufacturers of duodenoscopes used in the U.S. and with other government agencies such as the CDC to develop solutions to minimize patient risk associated with these issues.… The FDA believes the continued availability of these devices is in the best interest of the public health,” the spokesperson said.

Chicago Hospitals Report New Way to Battle Superbug

Over the past 3 years, a group of Chicago hospitals has managed to cut their number of CRE infections in half, according to Reuters. Now U.S. health officials want that kind of campaign to go nationwide. “When it comes to antimicrobial resistance, for many of the threats that we face, we know what to do,” CDC Director Tom Frieden said. “We just need to get it done.”
Click here to learn more.

FDA Issues New Rules for Cleaning Medical Scopes

On March 12, FDA issued a press release announcing new rules for sanitizing the medical scopes suspected of passing the CRE superbug from patient to patient. The new guidelines specify 6 criteria manufacturers should follow when reusing medical devices to reduce the risk of infections:

  • Labeling should reflect the intended use of the device
  • Reprocessing instructions for reusable devices should advise users to thoroughly clean the device
  • Reprocessing instructions should indicate the appropriate microbicidal process for the device
  • Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed
  • Reprocessing instructions should be comprehensive
  • Reprocessing instructions should be understandable

Click here to learn more.

Second U.S. Case of ‘Superbug’ Gene Found in NY Patient

June 29, 2016 – A New York patient is the second person in the U.S. to be infected with bacteria carrying a ‘superbug’ gene, according to a study published this week in the journal American Agents and Chemotherapy. The gene was found in an E. coli sample taken from the patient, whose name and condition hasn’t been released.

Pennsylvania Woman Diagnosed with CRE Infection

May 31, 2016 – A 49-year-old woman who was admitted to a Pennsylvania clinic with symptoms of a urinary tract infection (UTI) is the first American confirmed to have developed a CRE infection, according to the Washington Post. There’s still no indication of how the bacteria got into the woman’s system, and she said she has not traveled outside the U.S. within the last 5 months. The CDC and Pennsylvania Department of Health are investigating to determine whether the patient may have passed the superbug on to others she came into contact with.

Coordinated Response Could Reduce CRE Infections by 75%, Study Finds

April 13, 2016 – A simulation of how the CRE superbug might spread among healthcare facilities found that coordinated efforts prevented over 75% of infections that would have otherwise occurred over a 5-year period, according to a study published last month in the American Journal of Epidemiology.

CRE Superbug Found in LA Sewage Plant, Could Threaten Coastline

March 14, 2016 – The Environmental Protection Agency (EPA) has discovered a deadly superbug — the same one that caused outbreaks at UCLA and 2 other LA-area hospitals last year — in sewage treatment plants. New research shows that CRE bacteria may flourish in these environments, where wastewater is treated before being released into streams, lakes and oceans.
“It’s like a neighborhood watch program where neighbors work with and watch out for each other,” said Bruce Y. Lee, MD, MBA, associate professor in the Bloomberg School’s Department of International Health. “This approach tends to be more effective than a homeowner doing it alone. When it comes to health care facilities and superbugs, the same principles of communication and coordination apply.”

“This is a national problem,” said Dr. James McKinnell, an infectious disease specialist from Harbor-UCLA Medical Center and the Los Angeles Biomedical Research Institute (LA BioMed). “The CDC reports this is an urgent public health threat.”

Pentax Updates Endoscope Cleaning Instructions

February 19, 2016 – Following multiple reports of drug resistant bacteria linked to endoscopes used for ERCP procedures, PENTAX Medical has been working with the FDA to validate the reprocessing procedures for Pentax endoscopes. These instructions include new procedures for cleaning, high level disinfection and sterilization.

FDA Approves Modified Olympus Endoscope

January 15, 2016 – The U.S. Food & Drug Administration (FDA) has approved the Olympus TJF-Q180V duodenoscope with design modifications to reduce the risk of bacterial transmission. The agency also issued updated information (PDF) for healthcare providers about reprocessing procedures for Olympic duodenoscopes.

FDA Orders Recall of Endoscope Washer Over Infection Risk

November 13, 2015 – The U.S. Food & Drug Administration has ordered the recall of nearly 3,000 automated endoscope reprocessors (AERs) manufactured by Custom Ultrasonics over concerns that the devices have not been proven to be effective at preventing the transmission of infections. The agency also issued a Safety Communication urging healthcare facilities to use other methods to reprocess its scopes. Click here to learn more.

Orange County Woman Files Lawsuit Against Olympus Corp. Over UCLA Superbug Outbreak

A Newport Beach woman is suing Olympus Corp., accusing the company of causing the CRE superbug outbreak earlier this year at the Ronald Reagan UCLA Medical Center. Plaintiff Staci Simos filed the complaint June 26 in Los Angeles Superior Court, alleging that she developed a CRE infection after undergoing a routine procedure with a Q18OV duodenoscope last October at UCLA.

Duodenoscopes Still Risky: FDA Panel

May 14, 2015 – An FDA advisory panel warned today that patients who undergo ERCP procedures requiring the use of a duodenoscope continue to face serious health risks, according to the Los Angeles Times. Testimony from doctors and researchers came as the FDA and Olympus Corp. took sharp criticism for not managing the situation more effectively.

What You Need to Know About CRE

Enterobacteriaceae are a family of bacteria found in the human intestinal tract. When these bacteria spread outside the intestines, they can cause pneumonia, bloodstream infections, urinary tract infections (UTIs) and meningitis. Enterobacteriaceae are among the most common causes of bacterial infections in humans. However, some experts say that overuse and misuse of antibiotic medications cause some bacteria to become resistant to conventional treatments.

Who is at Risk?

Fortunately, most healthy people are not at risk for developing CRE infections. Such infections are generally seen in patients who have been exposed in hospitals or long-term care facilities. In these environments, CRE infections typically occur among sick patients who are being treated for other conditions. Patients who require ventilators, urinary or IV catheters, as well as patients who require long-term treatment with antibiotic medications are among those at highest risk for CRE infections.

Symptoms

In clinical environments, CRE can represent an infection or colonization. This means that the bacteria can be found on the body, but it is not causing any telltale symptoms or disease. Colonizing strains only cause infections if they gain access to parts of the body that are usually sterile such as the bladder, lungs or bloodstream.

CRE infections are typically associated with the following symptoms (which vary based on the infected site):

  • Cough if in the lungs
  • Urinary symptoms if in the bladder
  • Generalized symptoms like fever and chills

Do Any Antibiotics Work Against the Superbug?

There are a number of antibiotic medications that may help fight CRE infections; however, these drugs may also cause kidney damage. Some CRE strains are resistant to all antibiotics. On the other hand, some patients contract the bacteria without ever having an infection.

How To Prevent Infection

Cleanliness should always be your first line of defense. If you’re a patient in a hospital, remind staff to wash their hands and sterilize all instruments, and never share a room with an infected patient, according to the CDC.

If you come down with a severe infection after medical treatment in another country, be sure to talk to your doctor about the treatment you received. Some strains CRE are more common overseas than in the U.S.

Additionally, some researchers believe doctors should avoid prescribing antibiotics whenever possible. The ubiquitousness of antibiotics allowed CRE and other superbugs to develop resistance to them in the first place, according to some experts.

Is it Still Safe to Have Endoscopic Procedures?

To date, no CRE infections have developed following colonoscopy, sigmoidoscopy or upper endoscopy procedures. All of the infections occurred during ERCPs. Endoscopes used in the procedures were not decontaminated during the cleaning process and the superbug was passed from patient to patient via the scope.

It’s important to note that the endoscopes used during ERCP procedures are not the same as those used for colonoscopy, sigmoidoscopy or EGD. This is an important distinction because duodenoscopes are more complex devices, and as such, require a more thorough cleaning process.

UCLA Continues to Struggle With Patient Safety Concerns

Olympus Medical Systems Group, the company that supplies UCLA’s duodenoscopes, said it was working with the FDA, physician groups and hospitals to resolve these safety concerns. The company said all of its customers “receive instruction and documentation to pay careful attention to cleaning” the scopes.

UCLA said it moved quickly to address the CRE superbug once the problem surfaced. The university said it alerted health authorities immediately after the bacteria were detected. However, even before the current outbreak, the Ronald Reagan Medical Center has struggled with patient safety concerns. In 2012, a reputable healthcare quality organization gave the facility a failing grade on patient safety.

Olympus Endoscopes Sold Without FDA Approval

Olympus never received clearance to sell its TJF-Q180V duodenoscope, the device linked to the CRE superbug outbreak, according to CNN. The company began selling the device in 2010, but it was until 3 or 4 years later that the FDA learned the company had not applied to have it approved.

“Can you imagine a prescription drug getting out on the market that didn’t go through the approval process?” asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic. “Devices need to be regulated more vigorously. This is really disturbing.”

Superbugs Could Kill More People than Cancer by 2050: Study

Superbugs like CRE, E. coli, malaria and tuberculosis could kill more than 10 million people annually by 2050 if antibiotic overuse trends continue, according to a new report. “There can be no doubt now that antimicrobial resistance is one of the biggest (risks) that we, all of us, face,” said Nick Stern, president of the British Academy, professor of economics and government at the London School of Economics, and former chief economist of the World Bank.

CRE Infections Increasing in Children

October 21 – Young children are acquiring the antibiotic-resistant CRE superbug at a rate much higher than in the past, according to a study published this month in the CDC’s Emerging Infectious Diseases (PDF) journal. The greatest increase in superbug infections were seen among critically ill children between the ages of 1 and 5 being treated in intensive care units, with CRE rising from a 0% rate in 1999-2000 to 4.5% in 2011-2012.

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