OR Manager March 2022 - 6

Patient Safety
Ureteroscope
Continued from page 1
The FDA, in its letter, says it wants
to raise awareness among healthcare
providers about the risk of infections
associated with reprocessed urological
endoscopes, including cystoscopes and
ureteroscopes. The agency also says it
has received and is investigating numerous
Medical Device Reports (MDRs)
that describe post-procedure patient
infections or other possible contamination
issues associated with reprocessing.
The
FDA emphasizes the importance
of following the manufacturer's labeling
and reprocessing instructions for use
(IFU) for these devices and their accessory
components.
Evidence/contributing factors
Evidence cited by the FDA in its April
2021 letter includes receiving more
than 450 MDRs on urological endoscopes
since 2017 that resulted in:
* patient infections
* three deaths
* microbial contamination.
Factors the FDA says may have contributed
to the adverse events include:
* inadequate endoscope reprocessing
* maintenance issues
* device design
* reprocessing instructions.
" It's sounding a lot like the situation
with duodenoscopes, except, urological
endoscopes don't have the complex
elevator mechanisms the scopes used
for ERCP [endoscopic retrograde cholangiopancreatography]
have, " notes
Ofstead.
She and her team researched the
FDA's database because they wanted
to know if the problems that led the
agency to release the letter were mostly
associated with cystoscopes or with
ureteroscopes. They found that from
October 2020 through March 2021,
the FDA was receiving more than 20
reports every month that were related
just to ureteroscopes (sidebar, Evidence
behind the FDA's healthcare provider
letter).
" This stacks up to a lot of problems
with flexible ureteroscopes, " Ofstead
says.
Recommendations
Also in its April 2021 letter, the FDA
lists a number of recommendations for
reprocessing urological endoscopes
that organizations could use while it
was determining the root causes of the
problems.
The recommendations include:
* carefully following reprocessing IFU
for precleaning at the point of care,
leak testing, cleaning, and sterilizaEvidence
behind the FDA's health care provider letter (April 1, 2021)
Ureteroscope MDRs reported October 2020-March 2021
* FDA received >450 medical device reports
(MDRs) on urology scopes since 2017:
§ Patient infections
§ 3 deaths linked to urology scopes
§ Microbial contamination
* Factors that may be contributing:
§ Inadequate endoscope reprocessing
§ Maintenance issues
§ Device design
§ Reprocessing instructions
© 2022 Ofstead & Associates, Inc. | Ureteroscope Webinar for OR Manager
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OR Manager | March 2022
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https://www.fda.gov/medical-devices/letters-health-care-providers/infections-associated-reprocessed-urologicalendoscopes-letter-health-care-providers
tion
or HLD plus drying
* increasing awareness of reprocessing
instructions for reusable accessories
*
stopping the use of damaged devices
because they can harm patients
*
developing schedules for inspection
and maintenance
* informing patients of risks associated
with reprocessed urological endoscopes
*
submitting MDRs for any adverse
events experienced with urological
endoscopes to MedWatch
(https://www.accessdata.fda.
gov/scripts/medwatch/index.
cfm?action=reporting.home).
Ofstead says the recommendation
to inform patients of risks associated
with reprocessed urological endoscopes
was somewhat of a surprise, and that it
raised some questions for her:
* " Does your informed consent process
currently tell patients they are
at risk of infection or injury related to
the endoscope? "
* " If it doesn't, how is it going to impact
your patient intake process and
procedural efficiency if you start explaining
the findings and risks to
your patients? "
* " How do you think they are going to
respond? "
New standards/guidelines
Lane Jacobs, an expert in global product
solutions for Boston Scientific, Marlborough,
Massachusetts, notes that
the evidence and recommendations
from the FDA are " sobering at least, "
and asks Ofstead what changes she
has observed.
A notable development is the
strengthening of guidelines and standards
for reprocessing endoscopes,
she says.
A new " Multisociety guideline on reprocessing
flexible GI [gastrointestinal]
endoscopes and accessories " was published
last winter, and an update of
www.ormanager.com
Number of ureteroscope MDRs
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home https://www.fda.gov/medical-devices/letters-health-care-providers/infections-associated-reprocessed-urological http://www.ormanager.com
OR Manager March 2022

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