We believe healthcare providers deserve a flexible endoscopy solution that is 100 percent sterile.
Now more than ever, health systems and regulators have had to heighten their focus on infection control and patient safety — and with good reason.
While the risk of device-related infection is considered rare, studies show that certain types of flexible endoscopes pose a greater likelihood of microbial transmission and increase the chances of cross-contamination if they are not adequately reprocessed.
There is a better way to perform endoscopy. Healthcare systems deserve a sterile solution that provides convenience, flexibility, and attractive economic benefits. We believe each patient deserves a new, sterile endoscope — and we are proud to help the efforts to increase patient safety around the world.
FDA, Endoscope Manufacturer Issue ‘Urgent’ Urology Recall
A voluntary recall and urgent field safety notice have been issued instructing customers to discontinue high-level disinfection and, in some cases, liquid chemical sterilization of some flexible urological endoscopes. The notice lists 28 products, including flexible cystoscopes and ureteroscopes. The U.S. Food and Drug Administration followed with a letter to healthcare providers detailing the recall and underscoring the reprocessing recommendations. Customers without access to “an appropriate sterilization method” are being asked to discontinue the use of these endoscopes and return them.
LATEST ENDOSCOPY INFECTION CONTROL UPDATES
FDA Shows Concerns with Safety Communication Updates
[NEW FDA UPDATE] Just announced this month, the U.S. Food and Drug Administration (FDA) released an updated Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies (also known as 522 studies).
The FDA once again is asking duodenoscope manufacturers and healthcare facilities to transition to single-use instruments.
Other FDA Communications
Pulmonology: The FDA in 2021 updated a safety communication on reprocessing flexible bronchoscopes, recommending that healthcare providers consider using single-use bronchoscopes. Download our white paper that explores the implications of these new recommendations and its impact on patient safety, costs, workflow complexity and turnaround time.
- Urology: Infections Associated with Reprocessed Urological Endoscopes: FDA investigation into “numerous” medical device reports (MDRs) describing patient infections and other possible contamination issues.
New Research Study Provides Alarming Review of FDA Adverse Event Reports
A new study released by infection control expert Lawrence F Muscarella, PhD, reviewed medical device reports submitted to the Food and Drug Administration’s (FDA) adverse events database, also known as the Manufacturer and User Facility Device Experience (MAUDE) database, describing actual or potential contamination of a flexible endoscope. This study aimed to present the most comprehensive investigation and analysis to date of adverse events associated with a flexible endoscope.
What did the analysis reveal? Among other findings, the number of adverse event reports submitted to the FDA since 2014 has increased significantly for six endoscope types.
Human Factors in Reprocessing
Reprocessing flexible endoscopes is an arduous process that includes more than 100 individual steps. Manufacturers and regulatory bodies maintain these steps must be strictly adhered to, to ensure the delicate medical devices are adequately cleaned and disinfected between uses. And regulatory agencies are increasing their scrutiny of reprocessing protocols as reported cases of device-related infections prompt new investigation.
Ensuring patient safety, it is clear, requires a comprehensive approach to reprocessing endoscopes — because as long as flexible endoscopes require reprocessing, there will be risk for human error. These “human factors” include harsh working conditions, the pressure placed on technicians for fast turnaround, and a lack of training and support for reprocessing staff.
Splash Risks in Reprocessing
Sterile processing personnel who handle reusable medical instruments may be exposed to patient tissue, blood, and fluids even when they are outfitted in the recommended personal protective equipment (PPE). That’s according to an evaluation of PPE effectiveness for endoscope reprocessing staffers conducted by Cori L. Ofstead, president and CEO of Ofstead & Associates, and lead author of a paper published in the American Journal of Infection Control.
The pilot project found that routine reprocessing activities generated “substantial” splashing, with droplets dispersed up to five feet away from decontamination sinks, according to the research. Currently recommended PPE did not adequately protect sterile processing department personnel from exposure to clean water and cleaning solution during simulated activities.
New Study: Single-Use Bronchoscopes Can Cut Hospital Readmissions by 53%
Hospitals that perform bronchoscopies can reduce readmission rates by over half, and potentially lower costs, by adopting single-use flexible bronchoscopes. That’s according to a new abstract that was submitted and presented at the recently completed CHEST 2021 Annual Meeting.
If the margin of safety for endoscope reprocessing is so small that perfect compliance with >100 pages of the manufacturer’s instructions for use is required, then the endoscope design is too complex, the microbial load is too high, and the process is too unforgiving to be practical in the real world .
William A. Rutala, PhD, MPHX
Single-Use Infection Control Videos and Podcasts
Duodenoscope Contamination: A Systematic Review of The Evidence
Dr. Iman Andalib on eliminating patient cross-contamination in ERCP with Single-Use
Study: Single-Use Bronchoscopes Can Reduce Hospital Readmission Rates by 53%
Evidence-Based Strategies to Eliminate Bronchoscopy-Related Infections
Evidence-Based Strategies to Eliminate Endoscopy-Related Infections in a Urinary Health Practice
Evidence-Based Strategies to Eliminate ERCP-Related Infections