FDA Clears Duodenoscope With Disposable Elevator Piece

The U.S. Food & Drug Administration (FDA) has announced it has cleared the first duodenoscope with a sterile, disposable elevator component: the Pentax Medical Video ED34-i10T2.

It is expected that the inclusion of such a component will help reduce infections associated with cleaning, disinfection and sterilization of duodenoscopes as the disposable component reduces the number of parts that must reprocessed between uses.

As Infection Control Consulting Services (ICCS) states in its recent special report on "10 of the Scariest Healthcare Infections and Threats," duodenoscopes have become synonymous with infections, some of which have contributed to patient deaths. Despite the issue receiving significant attention over the past several years, ICCS noted in April that duodenoscope reprocessing remains a significant infection prevention challenge. In August, FDA issued a safety communication advising hospitals and endoscopy facilities to transition away from fixed endcap duodenoscopes and begin using duodenoscopes with disposable components.

As Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, states in an FDA release, "Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices. … We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other healthcare facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess."

In October, FDA cleared GI Scientific's ScopeSeal duodenoscope protective device. As the company notes, it is the first device for protecting the distal end of a duodenoscope from contamination during endoscopic retrograde cholangiopancreatography (ERCP) procedures. ScopeSeal is a single-use disposable device that sealings the infection prone distal end of the Olympus duodenoscope used in ERCP procedures.

Cancer Patients More Vulnerable to Dangers of Influenza

An article in The Washington Post highlights the increased risk cancer patients face if they contract the flu.

This topic is particularly timely as the Centers for Disease Control and Prevention (CDC) recently noted that seasonal influenza activity in the United States is increasing. We can anticipate this to remain the case for at least the next few months, if history holds true.

About 650,000 cancer patients receive chemotherapy in a U.S. outpatient oncology clinic annually. CDC states, "Patients receiving chemotherapy are at risk for developing infections that may lead to hospitalization, disruptions in chemotherapy schedules, and even death."

The Washington Post article notes, "Although chemo and radiation can extend cancer patients' lives and help stamp out the disease, the treatments can put their lives at risk. Chemo and radiation kill cancer cells, but they can also wipe out patients' immunity." Furthermore, patients are particularly susceptible between one week and 12 days following chemo — a time when even minor infections can quickly become serious and possibly deadly.

The article shares guidance on safe practices to help protect cancer patients from the risks of flu on matters including handwashing and vaccinations. An Infection Control Today article shares additional tips on issues including personal protective equipment (PPE) and medication handling.

Study: Probiotics Linked to Bloodstream Infections in ICU Patients

The results of a new study indicate that the use of probiotics in intensive care units (ICU) can cause bloodstream infections.

The study, published in Nature Medicine, was initiated following the detection of cases of bacteremia in Boston Children's Hospital's ICU caused by Lactobacillus, according to a news release. Lactobacillus a type of bacteria commonly found in probiotics.

A genomic investigation, coupled with bacterial DNA analysis, revealed that for a small percentage of ICU cases, the live bacteria in the probiotic formulations were associated with bloodstream infections. As the release notes, researchers suspect that the bacteria entered the bloodstream from the GI tract, but that it is also a possibility that they entered via patients' central lines.

To reduce the likelihood of probiotic-linked bloodstream infections, Boston Children's undertook a number of initiatives, including establishing new protocols requiring nurses to wear gloves before handling probiotic capsules, changing gloves before administering probiotics, covering central lines (when used) with a clean drape before opening the capsules and cleaning surfaces where the probiotic was prepared with a disinfectant.

It is commonplace for child and adult patients in the ICU to receive probiotics. As a Nutrition in Clinical Practice study notes, "Probiotics offer promise to ICU patients for the prevention of antibiotic-associated diarrhea, Clostridium difficile infections, multiple organ dysfunction syndrome and ventilator-associated pneumonia." 

More Seattle Children's Surgical Patients Contract Infections

Another surgical patient at Washington's Seattle Children's has contracted an infection from the presence of Aspergillus mold, according to news reports.

Furthermore, the hospital is monitoring another patient who might have contracted aspergillosis — the disease caused by the mold.

Seattle Children's has struggled to contain the fungus. Three patients were sickened by Aspergillus earlier this year, and three patients were infected in 2018. One of those patients died this past spring, notes The Seattle Times. The hospital has attempted to address the issue by closing its operating and procedure rooms and run tests.

Following this latest incident, Seattle Children's issued a statement, noting that routine air test results revealed the presence of Aspergillus in three of its operating rooms and two procedural areas. The hospital states, "The rooms in which Aspergillus was detected have been closed and out of an abundance of caution, we are only performing emergent surgeries in the operating rooms that have advanced in-room filtration."

The hospital has postponed or diverted some of its surgical cases and indicated plans to close all of its operating rooms soon to perform an investigation into its air handling system.

Infection Control Consulting Services (ICCS) emphasizes the importance of ongoing maintenance for air handling systems in the hospital environment, including facilities that provide services to immunocompromised patients and those undergoing surgery. If facilities identify contamination of air being fed into the hospital, it must be addressed immediately as even a small problem can snowball quickly.

CDC Issues 2nd Antibiotic Resistance Threats Report: 12 Key Takeaways

The Centers for Disease Control and Prevention (CDC) has released its second "Antibiotic Resistance Threats in the United States" report and there are a number of significant issues raised.

The report, first published in 2013, is intended to serve as a reference for information on antibiotic resistance, provide current U.S. antibiotic resistance burden estimates, highlight emerging areas of concern and identify actions required to address these areas.

While the Infection Control Consulting Services (ICCS) team is still reviewing and digesting the report, here are 12 of its key takeaways:

1. Antibiotic-resistant bacteria and fungi cause nearly 2.9 million infections and 36,000 deaths in the United States annually. Essentially, a person in the United States gets an antibiotic-resistant infection every 11 seconds and every 15 minutes someone dies.

2. When Clostridioides difficile (C. diff), bacteria associated with antibiotic use is included in these figures, the U.S. toll of all the threats identified in the report exceeds 3 million infections and reaches nearly 49,000 deaths.

3. More people in the United States are dying from antibiotic-resistant infections than previously estimates.

4. CDC identifies 18 organisms associated with antibiotic resistance threats and organizes them into one of three categories: urgent, serious and concerning. Five organisms were identified as urgent, 11 as serious and two as concerning.

5. CDC developed a "watch list." This is a new resource intended to identify antibiotic-resistant threats with the potential to spread or become a challenge in the United States. Three organisms were included on the list.

6. CDC expressed its concerned about rising resistant infections in the community, including drug-resistant gonorrhea and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, which have shown increases since 2000.

7. CDC is alarmed about the emergence and spread of new forms of resistance, particularly shared among organisms through genetic mobile elements. CDC notes that these antibiotic-resistant organisms can share their resistance genes with other organisms and make them untreatable.

8. In 2018, CDC's Antibiotic Resistance Lab detected a resistant organism that required a public health investigation every four hours.

9. Prevention efforts have reduced deaths from antibiotic-resistant infections by 18% overall and by nearly 30% in hospitals since 2013.

10. Eighty-four percent of U.S. hospitals report having a stewardship program meeting all seven of CDC's "Core Elements of Hospital Antibiotic Stewardship."

11. Antibiotic prescribing in outpatient settings declined 5% from 2011 to 2016 and outpatient prescribing to children declined 16% from 2011 to 2017.

12. CDC proposed five core actions it feels will better prepare the United States for the resistance that will continue to emerge worldwide: 1) infection prevention and control; 2) tracking and data; 3) antibiotic use and access; 4) vaccines, therapeutics and diagnostics; and 5) environment and sanitation. As CDC notes, "Addressing [these] needs will help the United States and global community combat antibiotic resistance."

Review the 2019 "Antibiotic Resistance Threats in the United States" report here.