FDA Safety Alert about Infections Tied to Reprocessed Urological Endoscopes

On April 1, 2021, the US Food and Drug Administration (FDA) issued a safety alert in the form of a letter to health care providers regarding infections linked to reprocessed urological endoscopes. In this announcement, the FDA notes they have received numerous Medical Device Reports (MDRs) that describe patient infections post procedure or other possible contamination issues associated with reprocessing these devices.1

“We are very concerned about the three reported deaths—outside of the United States—associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue.”2 -- Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health

What are the scopes in question?

Used to view a patient’s urinary tract, the scopes specifically called out by the FDA safety alert are cystoscopes, ureteroscopes and cystourethroscopes. These are key devices in urology that allow the physician to visualize and treat areas of interest.

Cystoscopes

  • - Inserted into the bladder, via the urethra.
  • - Commonly used for removing bladder stones, or for treating bladder cancer.

Ureteroscopes

  • - Inserted through the bladder and into the ureter.
  • - Commonly used to find and sometimes treat kidney stones and other urinary tract problems.

Cystourethroscopes

  • - Inserted into the bladder, via the urethra.
  • - Commonly used to diagnose problems and to perform biopsies using surgical instruments passed through the tube.

Cystoscopes, ureteroscopes and cystourethroscopes are the urology endoscopes highlighted by the FDA letter to health care providers

Hundreds of flexible and semi-rigid urological endoscopes such as cystoscopes, uretheroscopes and cystoureteroscopes from leading device manufacturers such as Olympus, KARL STORZ and Richard Wolf have been validated in both the STERRAD NX® System and STERRAD® 100NX System. Visit the STERRAD® Sterility Guide for a list of validated urological endoscopes.

An important note from the FDA:

The problems the FDA has identified with urological endoscopes and duodenoscopes may apply to similar devices. Therefore, the agency is also reviewing information on other types of endoscopes.2

What preceded this action?

Since 2017, the FDA has received over 450 Medical Device Reports (MDRs) which describe patient infections post procedure or other possible contamination issues associated with reprocessing these urological devices.1 Three of those adverse events included patient death; all three describe patients who developed Pseudomonas aeruginosa infections post procedure; one involved a cystoscope that did not pass a leak test.1

Where do endoscope reprocessing failures occur?

Check out this video on the hidden points of failure in endoscope reprocessing to learn more about where endoscope reprocessing failures typically occur.

FDA Recommendations (view full detail here):

  • Carefully follow IFU reprocessing instructions, including precleaning, leak testing, cleaning, and either sterilization or disinfection + rinsing + drying
  • Do not use damaged devices or those that fail leak test
  • Develop schedules for routine inspection & maintenance
  • Discuss benefits/risks associated with procedures involving reprocessed urological endoscopes with patients
Follow IFUs Carefully
Don't use damaged devices, failed leak test
Routine inspection & maintenance schedules
Discuss risks with patients

What will the FDA do next?

Per the safety alert, "the potential causes and contributing factors associated with the reported infections or contamination issues are under review, including reprocessing methods, reprocessing instructions in the labeling, and device design."1 They encourage health care providers to report any adverse events or suspected adverse events experienced with cystoscopes, ureteroscopes and cystourethroscopes devices using the MedWatch Voluntary Reporting Form.

ASP Recommendations

Given overwhelming evidence of potential points of failure in endoscope reprocessing via traditional high-level disinfection, ASP’s recommendation is simple:

1What can be sterilized should be sterilized
2What cannot be sterilized should be reprocessed in an advanced AER/ECR

This aligns with FDA recommendations. U.S. Food and Drug Administration guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff states, “Users should be instructed to thoroughly clean [semi-critical devices] and then reprocess them by sterilization. If the device design does not permit sterilization (e.g., device materials cannot withstand sterilization), then high level disinfection should be used.”3

Sterilization compared to HLD

Disinfection and sterilization is necessary to ensure the safe reuse of medical devices. Sterilization is a process that destroys or eliminates all forms of microbial life whereas disinfection eliminates many or all pathogenic microorganisms, except bacterial spores.

Sterilization
High-level disinfection
Low-level disinfection
Sterilization
High-level disinfection
Low-level disinfection

STERRAD® Systems: Modality of Choice for Endourological Procedures?

STERRAD® 100NX System with ALLClear® Technology and STERRAD NX® System with ALLClear® Technology delivers a concentrated load of hydrogen peroxide sterilant through long and narrow lumens to terminal sterilize flexible endoscopes.

In a retrospective study, Is plasma sterilization the modality of choice of sterilization today for endourological procedures such as ureterorenoscopy and retrograde intrarenal surgery? A single-center retrospective evaluation of 198 patients, researchers evaluated the rate of septicemia or infection-related events in patients undergoing ureterorenoscopy (URS) and retrograde intrarenal surgery (RIRS) procedures with the use of low-temperature plasma sterilization. Within that study, researchers noted, “Sterilization of endoscopic instruments is not only important but also challenging because of the material they are made of and the narrow lumen sizes.”4

On review of their results, the research team determined "STERRAD NX® [Systems] based on [hydrogen peroxide gas plasma] (HPGP) technology is a highly efficacious method of sterilization of instruments including heat liable instruments such as endoscopes."4

There are hundreds of flexible endoscopes from leading manufacturers that have been validated for use in STERRAD® Systems. In order to be validated for terminal sterilization in STERRAD® Systems, the device manufacturer and ASP jointly perform a series of validations such as sterilization efficacy and material or functional compatibility. ASP’s experienced scientists and microbiologists challenge instruments to ensure they demonstrate a sterility assurance level (SAL) of 10-6 and perform rigorous repeated-cycles testing.

Let us check your scope inventory and tell you what can be sterilized.

Get a Consultation: Scope Sterilization
STERRAD® 100NX

Automated Solutions for High-Level Disinfection of Endoscope Reprocessing

AEROFLEX™ AER

Eliminate manual test strips with ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER)

According to research by Cori Ofstead and associates,5 multiple points of failure in endoscope reprocessing center around minimum recommended concentration (MRC) testing. Automating MRC testing specifically addresses a large number of failures noted in the Ofstead study (see below). ASP AEROFLEX™ AER is the only AER with an AUTOSURE™ MRC Monitor, an automatic MRC monitoring system that eliminates the use of manual test strips.

Endoscope reprocessing errors mitigated by AUTOSURE™ MRC Monitor:

  • Skipping MRC testing
  • Improper storage of test strips
  • Non adherence to guidelines for test strip testing prior to every reprocessing cycle and variability in test strip types and pass/fail conditions
  • Difficulty interpreting test strips, especially among color-blind professionals
Get a Consultation: ASP AEROFLEX™ AER
AEROFLEX™ AER

Get automated leak detection with EVOTECH® Endoscope Cleaner and Reprocessor (ECR)

Two important factors stand out on our review of the FDA letter to health care providers: the importance of leak testing to identify potentially-damaged scopes, and the presence of p. aeruginosa contamination (which can occur from a contaminated water source) in the scopes involved in the three patient deaths. ASP EVOTECH® Endoscope Cleaner and Reprocessor (ECR) includes technology that specifically addresses both.

  • Automated leak detection
  • Bacterial water filteri

During automated leak detection, the endoscope is tested for gross leaks at the start of the cycle, before any solutions are introduced into the endoscope. When the system has determined the endoscope can be safety reprocessed, the EVOTECH® ECR cycle begins. Leak monitoring continues throughout the cycle. A positive pressure is maintained throughout the cycle to prevent fluid invasion during the cycle.

All water that goes through the EVOTECH® ECR system is filtered through a 0.2 micron filter to ensure bacteria-free water is pumped through the endoscope channels during final rinses. A rotating spray arm circulates the filtered water over the surface of the endoscope to remove any remaining high-level disinfectant. The final rinses cannot be turned off.

Other reasons EVOTECH® ECR is recommended over manual HLD:

  • Automated brushless cleaningii adds helpful redundancy to manual cleaning and reduces human error/variability that occur during manual cleaning
  • Dual independent basins for 2X reprocessing
  • Automated minimum effective concentration (MEC) monitoring (no test strips required)
  • Report documented and printed at completion of each cycle
Get a Consultation: EVOTECH® ECR
AEROFLEX™ AER

i ASP AEROFLEX™ AER also comes standard with a water filter.

ii Does not eliminate pre cleaning or manual cleaning; Health Care facilities should follow their own policies and procedures related to the reprocessing of endoscopes to ensure they are complying with all steps recommended by the device manufacturers and are consistent with current standards and guidelines. Not all endoscopes can be automatically cleaned but may be high-level disinfected. It is recommended that endoscopes with open/closed elevator wire channels be manually cleaned as per manufacturer’s instructions in addition to using the cleaning cycle of the EVOTECH® System. Please refer to the EVOTECH® ECR User Guide and specific connection diagrams for more detailed information regarding cycle capabilities.

Remember, when it comes to endoscope reprocessing safety, ASP recommends:

1What can be sterilized should be sterilized
2What cannot be sterilized should be reprocessed in an advanced AER/ECR

If you’d like a consultation, quote or demo of anything covered in this blog, let us know.

Speak to an Expert

Helpful Resources

Here are some resources available on the ASP website you can use to help educate your teams on these important issues.

References

  1. US Food and Drug Administration, Infections Associated with Reprocessed Urological Endoscopes – Letter to Health Care Providers: https://www.fda.gov/medical-devices/letters-health-care-providers/infections-associated-reprocessed-urological-endoscopes-letter-health-care-providers, Accessed April 5, 2021.
  2. US Food and Drug Administration. (2021, April 1). FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes [Press release]. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-investigating-reports-infections-associated-reprocessed-urological-endoscopes.
  3. U.S. Food and Drug Administration. (2015, March 17). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff.
  4. Parikh, K. P., Jain, R. J., & Parikh, A. K. (2020). Is plasma sterilization the modality of choice of sterilization today for endourological procedures such as ureterorenoscopy and retrograde intrarenal surgery? A single-center retrospective evaluation of 198 patients. Urology annals, 12(2), 122–127. https://doi.org/10.4103/UA.UA_61_19
  5. Ofstead CL., Hopkins KM., Buro BL., Eiland JE., Wetzler HP., Challenges in achieving effective high-level disinfection in endoscope reprocessing. Am J Infect Control 2019;000:1-7. Research funded by ASP.
AP-2100070-2