Tag Archives: MDRO Infections

FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions d/t Multi-drug Resistant Organisms

Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

The Food and Drug Administration (FDA) is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  The agency is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational FMT.

Summary of the Issue

  • Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of the individuals died.
  • FMT used in these two individuals were prepared from stool obtained from the same donor.
  • The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use. After these adverse events occurred, stored preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.

Information for Health Care Providers and Patients

In July 2013, FDA issued guidance stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT to treat Clostridium difficile (C. difficile) infection in patients who have not responded to standard therapies. The guidance states that FDA intends to exercise enforcement discretion provided that the treating physician obtains adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks. FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of MDROs by FMT and the resultant serious adverse reactions that may occur.

Patients considering FMT to treat C. difficile infection should speak to their health care provider to understand the potential risks associated with the product’s use.

Additional Protections for Investigational Use of FMT

  • Because of these serious adverse reactions that occurred with investigational FMT, FDA has determined that the following protections are needed for any investigational use of FMT:
    • Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
    • MDRO testing of donor stool and exclusion of stool that tests positive for MDRO. FDA scientists have determined the specific MDRO testing and frequency that should be implemented.

Reporting Adverse Event

FDA encourages all health care providers administering FMT products to report suspected adverse events to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

June 13, 2019

Xenex Improving Patient Safety In The Operating Room

Interest in understanding the role of the operating room (OR) environment in transmission of surgical site infections (SSIs) has increased greatly in recent years. Numerous studies have shown that standard cleaning practices leave significant levels of contamination on OR surfaces and can contribute to SSIs, the most expensive hospital acquired infection (HAI) to treat. Xenex Disinfection Services’ patented pulsed xenon Full Spectrum ultraviolet (UV) disinfection technology has been proven to quickly destroy the viruses, bacteria, mold, fungus and bacterial spores in ORs that cause SSIs.

Traditional cleaning practices leave behind dangerous pathogens such as Clostridium difficile (C.diff), methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). A study conducted at Cambridge Health Alliance, a Harvard Medical School Teaching Affiliate, demonstrated that pulsed xenon UV light disinfection can significantly decrease OR contamination. The study showed that Xenex’s germ-zapping robot reduced surface contamination in the OR by 81 percent, and that while between-case contamination in the OR continued to rise from case to case with standard cleaning, it was reduced to almost zero when the Xenex robot was used between cases.

Xenex will demonstrate its germ-zapping robot at the Association of Perioperative Registered Nurses (AORN) Surgical Conference & Expo in Denver, CO, March 7-10, 2015. Hospitals using Xenex for OR disinfection will discuss how they are eliminating the microorganisms that cause infections and make patients and healthcare workers sick.

Xenex has teamed up with AORN to host an educational session as part of the AORN Leadership Development series. On Tuesday, March 10, Julie Tonsager, OR Team Lead at St. Cloud Surgical Center, will share the facility’s two-year journey in evaluating UV technology. She will discuss the steps they took to ensure a successful implementation in their ORs.

“The risk of post-op infection poses a great risk to patients and healthcare facilities alike. We have proven repeatedly that hospitals using our room disinfection technology are reducing patient risk because they are destroying the microorganisms that cause infections. Most importantly, hospitals using our robots are reporting infection rate reductions of more than 50 percent as outcome studies in peer reviewed medical journals,” said Dr. Mark Stibich, Chief Scientific Officer of Xenex. “Unlike other UV disinfection systems, the Xenex robot utilizes pulsed xenon and kills C.diff spores in less than five minutes. The robot’s five-minute disinfection cycle enables it to disinfect areas and rooms quickly so it can be used throughout the entire facility, including multi-bed wards, to enhance patient and healthcare worker safety.”

Uniquely designed for ease of use and portability, a hospital’s environmental services staff can operate the Xenex robot without disrupting hospital operations and without using expensive chemicals. With a five-minute disinfection cycle, the robot has helped disinfect 30-62 hospital rooms per day (according to Xenex customer reports), including patient rooms, operating rooms, equipment rooms, emergency rooms, intensive care units and public areas. More than 250 hospitals, Veterans Affairs and DoD facilities in the U.S. are using Xenex robots, which are also in use in skilled nursing facilities, ambulatory surgery centers and long term acute care facilities.

There are now ten peer reviewed studies confirming the efficacy of the Xenex Germ-Zapping Robot in the healthcare environment, including three studies showing a decrease in C.diff, MRSA and MDRO infections when the hospital used the Xenex robot for room disinfection.

About Xenex Disinfection Services

Xenex’s patented pulsed xenon Full Spectrum UV room disinfection system is a pesticidal device used for the advanced cleaning of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. The Xenex mission is to eliminate harmful bacteria, viruses and spores that can cause hospital acquired infections in the patient environment, and to become the new standard method for disinfection in healthcare facilities worldwide. For more information, visit www.xenex.com.


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