News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed

Clinical laboratories and microbiologists will want to be on the alert for this deadly infectious agent that has killed patients through blood infections

Healthcare continues to struggle with the issue of how much to disclose to the public when new and deadly infectious agents are identified in a limited number of patients. Timely disclosure of new pathogens is a matter of great concern to clinical laboratory scientists, microbiologists, and clinical pathologists because their laboratories get specimens from infected patients and they must correctly identify rare or emerging pathogens to help minimize the spread of disease.

This is why many medical laboratory professionals were surprised to see national news headlines recently about a particularly deadly new form of a pathogen. The Centers for Disease Control and Prevention (CDC) has been dealing with one particularly nasty example of Candida auris, or C. auris. This “superbug” fungus has been appearing in hospitals and healthcare clinics across the globe and it has killed people.

The news coverage of C. auris focused on two elements:

  • First, how the pathogen was recognized by such healthcare agencies as the CDC.
  • Second, why CDC and others did not issue a public alert to hospitals, physicians, and other caregivers once it was known that C. auris was responsible for the death of several patients.

Once C. auris takes hold, it can enter a patient’s bloodstream or wounds and cause life- threatening complications like sepsis. When hospitals rooms are not properly decontaminated, life-threatening hospital-acquired infections (HAIs), also known as nosocomial infections, can occur.

Incidences of HAIs have been on the rise in the past few years. Dark Daily has reported on this disturbing trend many times.

The New York Times (NYT) reported on one such HAI that had tragic consequences. A patient admitted to Mount Sinai Hospital in New York for abdominal surgery was later discovered to have contracted C. auris. He was immediately isolated and spent 90 days in the hospital before passing away. Tests showed that Candida auris was everywhere in his room.

“Everything was positive—the walls, the bed, the doors, the curtains, the phones, the sink, the whiteboard, the poles, the pump,” Scott Lorin, MD, President and Chief Operating Officer at Mount Sinai Brooklyn Hospital, told the NYT. “The mattress, the bed rails, the canister holes, the window shades, the ceiling, everything in the room was positive,” he said.

The hospital had to use special cleaning equipment to sterilize the room and even found it necessary to tear out some ceiling and floor tiles to annihilate the fungus, the NYT reported.

Media News Coverage of ‘Culture of Secrecy’ 

When this deadly fungus first emerged in America, it was not disclosed to the public for a lengthy period of time. Then, when details of deaths in hospitals due to the superbug went public, the national news media reacted but then went silent. Why?

The New York Times (NYT) covered the debate over public disclosure of outbreaks involving drug-resistant infections at healthcare facilities in “Culture of Secrecy Shields Hospitals with Outbreaks of Drug-Resistant Infections.”

In that article, the NYT states that “under its agreement with states, the CDC is barred from publicly identifying hospitals that are battling to contain the spread of dangerous pathogens.” So, the CDC is prevented from revealing to the public the names and locations of facilities that are dealing with C. auris. And state governments typically do not share that information either. 

The NYT article also states, “The CDC declined to comment, but in the past officials have said their approach to confidentiality is necessary to encourage the cooperation of hospitals and nursing homes, which might otherwise seek to conceal infectious outbreaks.”

And that, “Those pushing for increased transparency say they are up against powerful medical institutions eager to protect their reputations, as well as state health officials who also shield hospitals from public scrutiny.”

“Who’s speaking up for the baby that got the flu from the hospital worker or for the patient who got MRSA from a bedrail? The idea isn’t to embarrass or humiliate anyone, but if we don’t draw more attention to infectious disease outbreaks, nothing is going to change,” Arthur Caplan, PhD (above), told the NYT. Caplan is Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU School of Medicine in New York City. (Photo copyright: NYU Langone Health.)

Common Yeast Infection or Killer Superbug? Both!

C. auris grows as a common yeast infection. However, it can be life threatening if it enters the bloodstream.

“The average person calls Candida infections yeast infections,” William Schaffner, MD, Professor and Chair, Department of Preventative Medicine at Vanderbilt University Medical Center, told Prevention. “However, Candida auris infections are much more serious than your standard yeast infection. They’re a variety of so-called superbugs [that] can complicate the therapy of very sick people.”

The CDC reports that, as of May 31, 2019, there have been a total of 685 cases of C. auris reported in the US. The majority of those cases occurred in Illinois (180), New Jersey (124), and New York (336). Twenty more cases were reported in Florida, and eight other states—California, Connecticut, Indiana, Maryland, Massachusetts, Oklahoma, Texas, and Virginia—each had less than 10 confirmed cases of C. auris.

The CDC states the infection seems to be most prominent among populations that have had extended stays in hospitals or nursing facilities. Patients who have had lines or tubes such as breathing tubes, feeding tubes, or central venous catheters entering their body, and those who have recently been given antibiotics or antifungal medications, seem to be the most vulnerable to contracting C. auris.

The fungus typically attacks people who are already sick or have weakened immune systems, which can make it challenging to diagnose, the CDC notes. C. auris infections are typically diagnosed with special clinical laboratory testing of blood specimens or other body fluids. Infections have been found in patients of all ages, from infants to the elderly.

Data from the CDC indicates that C. auris can cause bloodstream infections, wound infections, and ear infections. Common symptoms that indicate a person has Candida auris include fever, chills, weakness, low blood pressure, and general malaise that do not improve with antibiotics.

“A patient’s temperature may go up, their blood pressure can go down, and they have complications of a pre-existing illness because of Candida auris,” Schaffner told Prevention.

The CDC reports that more than one in three patients with invasive C. auris dies. Even though the mortality rates for Candida auris are high, it is unclear whether patients are dying from the infection or from their underlying illnesses. “Whatever the cause, having Candida auris doesn’t help a patient in any way,” Schaffner noted.

The CDC states that it and its public health partners are working hard to discover more about this fungus, and to devise ways to protect people from contracting it. Average healthy people probably don’t need to worry about becoming infected with Candida auris. However, individuals who are at high risk, and healthcare professionals, microbiologists, and pathologists, should be on the alert for this new superbug strain of fungus. 

—JP Schlingman

Related Information:

A Mysterious Infection, Spanning the Globe in a Climate of Secrecy

Culture of Secrecy Shields Hospitals with Outbreaks of Drug-Resistant Infections

Candida auris: A Drug-Resistant Germ That Spreads in Healthcare Facilities

A Deadly Superbug Fungus Called Candida auris Has Been Detected in 12 States—Here’s What You Need to Know

A Deadly Fungal Infection Called Candida auris Is Spreading across the Globe, and No One Knows How to Stop It

Study: Colonized Candida auris Patients Shed Fungus via Skin

The Deadly Yeast Infection You Must Know About

What You Need to Know Candida auris, a Dangerous Fungal Infection That’s on the Rise

With Candida auris, a Lack of Transparency Could Make Things Worse

Could Proximity of Toilets to Sinks in Medical Intensive Care Units Contribute to Hospital-Acquired Infections?

ETH Zurich Develops Implantable Molecular Device Capable of Monitoring Blood pH and Regulating Insulin Production in Mice; May One Day Allow Pathologists to Remotely Monitor Patients

Prototype could provide glimpse of radically different future for patient monitoring and present new opportunities for pathologists and medical laboratory scientists

Are pathologists and medical laboratory scientists ready for a new diagnostic paradigm? Instead of specimens transported into a central medical laboratory, how about in vivo real-time monitoring of patients with chronic diseases, where pathologists are able to remotely spot changes in a patient’s condition as they happen and alert physicians to take timely action?

Researchers are combining several technologies to create sensor-based systems for in vivo real-time monitoring of body processes. In Basel, Switzerland, a team at ETH Zurich’s Department of Biosystems Science and Engineering created an implantable sensor for continuous monitoring of blood pH that is paired up with a gene feedback mechanism to produce the necessary amount of insulin. The dual function device has been described as a “molecular prosthesis.” The purpose of this device is to monitor patients with diabetes.

While ETH Zurich’s prototype needs more development before it will be ready for clinical uses, the university’s research shows pathologists and medical laboratory scientists how fast new capabilities are being developed that can eventually support a radically different approach to patient diagnosis and patient monitoring. Use of such real-time in vivo diagnostic devices could allow laboratory professionals to remotely monitor patients and trigger clinical interventions when the biomarkers being tracked indicate such a need.

Device Monitors Blood Acidity: Responds to Diabetic Acidosis by Producing Insulin

What is particularly intriguing about the device created by the Swiss university’s bioengineers is that it is capable of both diagnostic and therapeutic actions. Both modules of the device—the blood pH sensor and insulin production mechanism—are constructed from biological components, such as various genes and proteins. These are incorporated into cultivated renal cells. The researchers then embedded millions of these customized cells in capsules that can be used as implants in the body.

According to an ETH news release, the pH sensor transmits a signal to trigger the production of insulin if pH values fall below 7.35, a low pH value specific for type 1 diabetes. Once blood pH returns to the ideal range, the sensor turns itself off and the reprogrammed cells stop producing insulin.

In tests using mice with type 1 diabetes, the ETH device was able to successfully monitor the blood’s acidity and respond to diabetic acidosis by producing insulin. Mice with capsules implanted produced the amount of insulin appropriate to their individual acid measurements, enabling them to have hormone levels comparable to that of healthy mice. The implant also compensated for larger deviations in blood sugar. The system design and test results were published in an August 7, 2014, Molecular Cell article.

ETH Prototype Shows the Possibility of Creating Applications for Humans

Despite the promising results, Martin Fussenegger, Ph.D., Professor in ETH Zurich’s Department of Biosystems Science and Engineering, says the university will need an industrial partner in order to consider commercial development of the molecular device.

“Applications for humans are conceivable based on this prototype, but they are yet to be developed,” stated Fussenegger in the news release. “We wanted to create a prototype first to see whether molecular prostheses could even be used for such fine adjustments to metabolic processes.”

Martin Fussenegger, Ph.D

Martin Fussenegger, Ph.D., Professor in ETH Zurich’s Department of Biosystems Science and Engineering, says the initial results of studies in mice of ETH Zurich’s implantable molecular device for regulating blood pH levels through a closed loop pH sensing and insulin production mechanism shows promise. (Photo copyright ETH Zurich)

Until recently, most progress in diabetes care focused on improvements to continuous glucose monitors and insulin delivery systems, with implantable, long-lasting sensors for continuous monitoring on the horizon. ETH Zurich’s implantable molecular device would represent a major leap forward.

Diabetes in U.S. Continues to Increase

A 2014 report from the U.S. Centers for Disease Control and Prevention (CDC) shows that diabetes is on the rise, with 29.1 million people (9.3% of the U.S. population) living with diabetes. By comparison, in 2010 there were an estimated 26 million people in the U.S. with diabetes.

The CDC says that nearly 28% of people with diabetes are undiagnosed, which increases risk for heart disease, stroke, blindness, kidney failure, amputation of toes, feet or legs, and early death.

The report also estimates that the total cost in medical bills and lost work and wages due to diabetes and related complications adds up to $245 billion, up from $174 billion in 2010.

“These new numbers are alarming and underscore the need for an increased focus on reducing the burden of diabetes in our country,” said Ann Albright, Ph.D., R.D., Director of the CDC’s Division of Diabetes Translation, in a CDC news release. “Diabetes is costly in both human and economic terms. It’s urgent that we take swift action to effectively treat and prevent this serious disease.”

Ann Albright, Ph.D., R.D

Ann Albright, Ph.D., R.D., Director of the Centers for Disease Control and Prevention’s Division of Diabetes Translation, stresses the importance of continued diabetes research. (Photo copyright CDC)

The need for new methods to control diabetes was underscored in a 2010 study published at PubMed Central (PMC) on the U.S. National Institutes of Health’s National Library of Medicine (NIH/NLM) website. It painted a “sobering picture of the future growth of diabetes.”

“Under an assumption of low incidence and relatively high diabetes mortality, total prevalence is projected to increase to 21% of the U.S. adult population by 2050,” the authors wrote. “On the other hand, if recent increases in diabetes incidence continue (middle incidence projections) and diabetes mortality ratios are relatively low, diabetes prevalence will increase to 33% by 2050.”

The study blames the rise in diabetes in the U.S. in part on demographic changes brought about by an aging population—older adults are more likely to develop diabetes—an increase in minority populations that report higher diabetes rates, and reduced mortality rates for those living with the disease.

In Vivo and In Vitro Diagnostics Continue to Merge

Dark Daily has reported on the evolution of implantable diagnostic tests for some time. As we noted in “In Vivo Pathology Testing Might Use Injectable Microbeads to Detect Excessive Glucose Levels” (Dark Daily, January 1, 2011), pathology researchers continue to find novel ways to integrate in vivo and in vitro diagnostic tests. This trend does not appear to be slowing.

Implantable diagnostic technology continues to develop, which should indicate to clinical laboratories the possibility that disease diagnosis and monitoring is shifting away from centralized laboratories and towards medical communities and patients’ homes. The added twist in the new in vivo device created by researchers at ETH Zurich is that, after the diagnostic component of the device has tracked a change in the biomarker, the device can then automatically produce the appropriate therapy, also in real time and in vivo.

—Andrea Downing Peck

Related Information:

Sensitive Acid Sensor Controls Insulin Production

A Molecular Implant for pH Sensitive Insulin Production

New CDC Diabetes Report

Diabetes Latest

In Vivo Pathology Testing Might Use Injectable Microbeads to Detect Excessive Glucose Levels