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 that can cause severe skin infections, pneumonia and even death.
UQ last month 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 over 10 countries.
“World health authorities estimate 10 million deaths a year will be caused by antimicrobial resistant superbugs by 2050, compared to 8.2 million from cancer,” said UQ School of Medicine and Pharmacy Professor Jason Roberts. “Our research aims to slow this dire trajectory and buy more time for researchers developing new antimicrobials, a process which takes at least 13 years. The situation is urgent – increasingly we are seeing patients infected with bacteria that are resistant to all our antimicrobials.”
Roberts said resistant superbugs, such as the CRE, must be battled on multiple fronts, including closer monitoring and better use of existing antibiotics. This is particularly important in difficult-to-treat cases and at-risk groups, according to Roberts.
The goal of the Centre for Research Excellence is for experts in basic, clinical and translational science to collaborate and generate new approaches to treating patients, which can then be shared with physicians around the globe. The centre links Australian research leaders with their counterparts in other countries to streamline the translation of evidence-based research findings into clinical practice. Roberts said the centre also hopes to train large numbers of new researchers, in addition to medical and pharmacy interns and undergraduates in antimicrobial practice.
“We will also be working to develop international capacity by fostering post-graduate and post-doctoral fellow research,” he said.
The Centre for Research Excellence is funded by the National Health and Medical Research Council (NHMRC), and will use research facilities at the Royal Brisbane Women’s Hospital (RBWH) Herston campus.
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
Virginia Mason Medical Center in Seattle has joined a lawsuit against Olympus America, claiming the device maker put patients at risk by failing to disclose design flaws in ERCP duodenoscopes suspected of passing the CRE superbug in several recent outbreaks.
From 2012 to 2014, at least 39 patients at Virginia Mason Medical Center were sickened by drug-resistant strains of E.coli bacteria, 11 of whom died, according to the Advisory Board. The facility identified duodenoscopes made by Olympus America as the likely source of contamination.
Richard Bigler was among those who died of a bacterial infection caused by an Olympus duodenoscope, according to a lawsuit filed on behalf of his widow. In a rare move for a hospital, Virginia Mason joined Bigler’s lawsuit on May 11.
Virginia Mason denies any wrongdoing in Bigler’s death, saying Olympus failed to disclose the instrument’s design flaws or tell the facility its reprocessing instructions were inadequate. The complaint alleges that Olympus knew of the problems with the duodenoscope and issued warnings in Europe, but failed to do the same in the U.S.
“Olympus failed to inform our organization about this safety risk associated with its product,” said Andrew Ross, head of gastroenterology at Virginia Mason. “Their silence on this important issue was unethical, irresponsible, and put patient lives at risk.”
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
A group of Chicago hospitals has managed to cut the number of infections caused by the superbug Carbapenem-Resistant Enterobacteriaceae, or CRE, by half. Now U.S. health officials want that kind of campaign to go nationwide.
A collaboration between Rush University Medical Center and Cook County health officials has dramatically reduced the spread of CRE, according to the Chicago Sun-Times. The Chicago Antimicrobial Resistance and Infection Prevention Epicenter (CARPE), a CDC-funded research program, tested patients for the superbug immediately after they were admitted and then 2 weeks later. The superbug is resistant to most antibiotics, and was passed from patient to patient in several recent outbreaks via a specialized medical device called a duodenoscope.
The hospitals then isolated patients who had been infected with CRE, bathed them in a special analeptic wipe called chlorhexidine gluconate, and required staff to wear protective gear while treating them. After 3 years of applying this method, the facilities cut their CRE infections by half, results the agency would like to see across the country.
“When it comes to antimicrobial resistance, for many of the threats that we face, we know what to do,” CDC Director Tom Frieden told Reuters. “We just need to get it done.”
The Obama administration has called on hospitals to reduce CRE infections by 60%, and other antibiotic resistant infections like Clostridium difficile and Staphylococcus aureus by at least 50% by 2020, according to FiercePharma. But not all experts are convinced this goes far enough to address the problem.
The proposal requires the FDA and Department of Agriculture to reduce use of antibiotics to promote growth in animals used for food. However, many antibiotics are approved for both growth promotion and disease prevention, which may create a loophole that the administration’s plan fails to address.
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
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 new study.
According to the study, which was published this week in the journal American Agents and Chemotherapy, the superbug gene was found in an E. coli sample taken from a New York patient whose name and condition haven’t been released. The first case in the U.S. was identified last month in a Pennsylvania woman.
The mcr-1 ‘superbug’ gene is especially dangerous because of its ability to make bacteria resistant to colistin, an antibiotic used to treat drug-resistant infections, including the “nightmare bacteria” CRE, according to the Huffington Post.
What is alarming about mcr-1 discoveries in the U.S. is that bacteria can share resistance genes, and if the gene finds its way into CRE bacteria, it could create a bacterium that is resistant to virtually all types of antibiotics. In the Pennsylvania case, the bacteria that carried the superbug gene was vulnerable to antibiotics and the patient was able to be treated.
Last year, Chinese researchers identified the superbug gene in both farm animals and humans patients. At the time, the gene was known to have spread to at least 19 countries. Antibiotic resistance is currently responsible for about 23,000 deaths worldwide each year, according to Reuters.
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 in the American Journal of Epidemiology.
For the new study, researchers at Johns Hopkins Bloomberg School of Public Health in Baltimore simulated how CRE would likely spread across facilities in Orange County, CA, under 3 scenarios:
- The 1st included no interventions.
- The 2nd involved interventions at individual healthcare facilities, including testing incoming patients for CRE infection. For patients who test positive, contact precautions such as gloves and gowns are implemented.
- The 3rd scenario used the above 2 interventions, with the addition of coordinating efforts among facilities when CRE infection cases reach a certain number.
The researchers determined that a coordinated approach prevented 2,789 (77%) total infections by the 5th year, while moderate control measures prevented 408 transmissions (21.3%) after 5 years. Adding no new infection-control measures in the event of a CRE superbug outbreak (scenario 1) would result in CRE bacteria being present in nearly all Orange County facilities within 10 years, according to the study.
“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.”
While there has not yet been a severe CRE superbug outbreak in 2016, within the first 6 months of 2012, 3.9% of acute care hospitals and 17.8% of long-term acute care hospitals reported at least 1 infection. Additionally, the bacteria has been confirmed in at least 48 states.
The primary threat of superbugs like CRE is that they are antibiotic-resistant; the bacteria are currently responsible for approximately 2 million illnesses and 23,000 deaths annually in the U.S., according to CDC. There is growing concern that without inter-facility coordination — including the development of patient information sharing protocols — an outbreak could spread rapidly in light of patient transfers and mobility.
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 hospitals — in municipal sewage treatment plants. New research shows that CRE bacteria may flourish in these facilities, where wastewater is treated before being released into streams, lakes and oceans.
Last fall, scientists at the EPA detected CRE bacteria in a sewage treatment plant in Southern California, according to CBS News. The bacteria was suspected to have been brought there with millions of gallons of raw sewage from local hospitals, where the superbug caused multiple infections. Although the treated water was never tested specifically for CRE, experts say it’s possible that the treatment process didn’t eliminate all of the bacteria.
“It’s scary,” said Dr. James McKinnell, an infectious disease specialist from Harbor-UCLA Medical Center and the Los Angeles Biomedical Research Institute (LA BioMed). “What you’re seeing is more evidence of this type of bacteria setting up shop in our community.”
CRE is a family of germs normally found in the intestinal tracts of humans and other mammals. When these bacteria spread outside the gut they can cause severe systemic infections including urinary tract infections (UTIs), bloodstream infections, wound infections and pneumonia, especially in people with compromised immune systems. CRE bacteria kill up to 50% of patients who become infected, according to the CDC.
Hospital patients and those in long-term care facilities or nursing home are most likely to contract CRE; however, now that the bacteria has been found in sewage treatment plants, many more people may be at risk.
“An environmental source of CRE transmission is out in the general population now,” McKinnell said. “This is clearly an emerging problem.”
McKinnell and colleagues are working with the CDC to develop preventive measures to help reduce the occurrence of CRE superbug and other drug-resistant bacteria in California and across the U.S.
“This is a national problem,” McKinnell said. “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
June 29, 2015 – A Newport Beach woman is suing Olympus Corp., accusing the medical device maker for an outbreak of the CRE superbug at Ronald Reagan UCLA Medical Center that infected her and at least 6 other patients, killing 2.
Plaintiff Staci Simos filed the complaint against Olympus last Friday in Los Angeles Superior Court, alleging that she developed a CRE infection after undergoing a routine procedure with a duodenoscope last October at UCLA.
The lawsuit alleges products liability, negligence, fraud and seeks unspecified damages against Olympus. At least 3 other complaints related to the UCLA superbug outbreak have been filed against the company since March.
Olympus spokesman Mark Miller said the company didn’t request FDA approval for changes made to the device because it was not required to do so. However, the device maker had responsibilities to patients such as Simos, according to the lawsuit.
“After each use, the Q18OV scope necessarily requires cleaning and disinfecting before it can be used on a new patient,” the suit states. “A manufacturer of a medical device like an endoscope … has an obligation to develop and validate a (cleaning) protocol and to incorporate this protocol into the product’s labeling.”
Olympus “failed to take these critical steps with the redesigned Q18OV scope,” according to the lawsuit.
Feds Expand Investigation into Superbug Outbreaks
June 9, 2015 – The U.S. Justice Department is seeking thousands of pages of documents from manufacturers of a specialized medical scope linked to a series of deadly outbreaks of the Carbapenem-Resistant Enterobacteriaceae, or CRE superbug.
Three manufacturers of duodenoscopes — Olympus, Pentax and FujiFilm — have recently been subpoenaed as part of the probe, according to USA TODAY. A subpoena also was delivered to Virginia Mason Hospital in Seattle, the site of one of the worst outbreaks of antibiotic-resistant bacterial infections associated with contaminated endoscopes.
The subpoenas do not reveal specifically what’s being investigated; however, the document sent to Virginia Mason relates to healthcare violations as defined in federal criminal statutes. Last month, Olympus received a subpoena relating to its duodenoscope manufacturing process, but the broader scope of the investigation has not been made public.
According to the Virginia Mason subpoena, the investigation is being handled by the U.S. attorney’s office in Newark, N.J. The Justice Department has not confirmed or commented on the probe.
The subpoenas were issued in response to growing concerns over the safety of duodenoscopes, which are used in 650,000 medical procedures annually, most often to treat tumor or gallstone blockages in the bile and pancreatic ducts. The devices were first linked to outbreaks of bacterial infection in January, which have since been reported at hospitals in Chicago, LA, Seattle, Pittsburgh, Hartford and other cities. Most cases involved the CRE superbug, a deadly antibiotic-resistant bacteria with mortality rates of 40% or more.
Investigators have found that bacteria can become lodged the duodenoscopes, even after following manufacturing-recommended cleaning protocols, and transmit infections from patient to patient. In May, an FDA advisory panel determined that the instruments cannot be effectively cleaned as currently designed; however, the panel stopped short of advising a recall because infection risks are low and the scopes remain the only option for many important medical procedures.
FDA has received at least 142 reports of infections passed by duodenoscopes since 2010; however, each report can account for multiple cases in a single outbreak, so the actual number of infections is unclear. To date, at least 30 patients have died after developing CRE or other similar bacterial infections that were passed by the scopes, including 11 in the Virginia Mason outbreak and another 15 in a 2008 outbreak at a Florida hospital.
“I’m pleased that the Department of Justice is moving forward with an investigation,” said Senator Patty Murray, (D-WA). “Patients need to be able to trust that the devices used for their treatment are safe and effective.”
Duodenoscopes Still Risky: FDA Panel
May 14, 2015 – An advisory panel to the U.S. Food & Drug Administration (FDA) warned today that patients who require routine medical procedures continue to face serious health risks from specialized medical scopes linked to multiple outbreaks of the deadly CRE superbug.
Testimony from doctors and researchers came as the FDA and Olympus Corp., manufacturer of the duodenoscope suspected of passing the CRE superbug in a number of recent outbreaks, took criticism for not taking control of the situation.
A day of technical presentations was contrasted by the testimony of a North Carolina woman whose husband recently died of a CRE infection. “His battle was more than I could bear to watch,” Carla Warner said, pointing the finger at Olympus and the FDA. “They have failed me, my family, and my husband paid the ultimate price with his life.”
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.
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 Failed to Report Endoscope Superbug Infections for 3 Years, FDA Says
August 19, 2015 – Federal regulators have learned that Olympus Corp. received reports of patients developing life-threatening CRE superbug infections but waited nearly 3 years to disclose the events, according to a new letter published by the U.S. Food & Drug Administration (FDA).
According to the letter, Olympus Corp. failed to alert the FDA about a cluster of 16 bacterial infections in patients who underwent treatment with the company’s duodenoscopes. Olympus didn’t report the incidents until this year, when it came under scrutiny for a series of more recent outbreaks.
The agency’s letter adds fuel to a controversy ignited earlier this year over superbug infections linked to duodenoscopes, which are used in more than 500,000 routine medical procedures annually.
According to the FDA, Olympus in May 2012 received a report involving 16 patients who developed bacterial infections “of which some resulted in abscesses, after undergoing an endoscopic procedure with your firm’s devices.”
But the company didn’t inform health authorities until this year, violating requirements to report adverse events linked to medical devices within 30 days, FDA said, adding that Olympus apparently lacks the proper protocol for reporting such problems.
The alleged violations were uncovered during inspections in March and April at 4 Olympus facilities, 2 in the U.S. and 2 in Japan. According to the FDA, Olympus subsequently responded to the agency’s findings; however, the company’s response “did not include documentation or evidence of the corrective actions and did not provide evidence of implementation.”
Olympus, which is currently facing numerous lawsuits over infections allegedly caused by its duodenoscopes, issued a brief statement pledging to cooperate with the FDA.
“We are reviewing the FDA’s warning letter so that we can provide the required response in a timely manner,” the company said.
Two other duodenoscope manufacturers – Pentax Medical and Fujifilm Holdings Corp. – received warning letters from the FDA after inspections at the companies’ plants earlier this year. The timing of the inspections and subsequent letters suggest a potential crackdown by the FDA, which has been accused of acting too slowly in response to the superbug outbreaks.
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 much higher rate than in the past, a new study shows.
CRE bacteria is found most often in inpatient care settings (i.e., hospitals and long-term healthcare facilities) and is resistant against most antibiotic medications. As a result, about half of patients who become infected with the superbug die from resulting complications, according to the Centers for Disease Control and Prevention (CDC).
Although there is a growing body of research on CRE infection in adults, until now little has been done on the effects in children.
“No one has looked at the impact of the rise of CRE in pediatric patients in the U.S and prior to our study, there was no data outside of single institution surveys on the epidemiology of CRE in U.S. children,” said Dr. Latania Logan, lead author of the study.
For the study, which was published in this month’s edition of the CDC’s Emerging Infectious Diseases journal (PDF), a research team led by Logan looked at a nationwide database of reports from 300 microbiology laboratories to access the presence of CRE bacteria in more than 300,000 cultures obtained from children between 1999 and 2012.
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 (ICUs), with CRE rising from a 0% rate in 1999-2000 to 4.5% in 2011-2012. In all patients aged 1 to 17, the rate increased from 0% to .47% during that time period.
The type of CRE infections with the greatest increases were those of the bloodstream and lower respiratory tract, such as pneumonia, where the increases were from 0% in 1999-2000 to 3.2 and 2.3% in 2011-2012, respectively. According to Logan, this is significant because in up to half of cases where the superbug reaches the bloodstream, the patient dies from the infection.
“CRE overall are a very urgent threat not only to the United States but to the world. There are very few antibiotics available to treat these infections, and even less are available to children,” Logan said. “In our study, we found that CRE infections remain low in the pediatric population overall, but have significantly increased in number across children of all ages and in all healthcare settings.”