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."