OR Manager March 2022 - 8

Patient Safety
Continued from page 7
had multiple patients becoming infected)
*
four damaged ureteroscopes (one
with a patient exposure).
The MDRs were associated with various
brands and models.
New FDA Safety Communication
for reprocessing bronchoscopes
On June 25, 2021, the FDA posted
a new Safety Communication on " Flexible
bronchoscopes and updated recommendations
for reprocessing " that was
similar to the April letter for urological
endoscopes.
Between July 2015 and January
2021, the FDA received 867 new
MDRs, and there were seven deaths
related to infections or device contamination
associated with reusable flexible
bronchoscopes.
In the Safety Communication, the
FDA recommends the following:
* consider sterilization rather than
HLD-Ofstead notes that OR managers
and OR personnel need to
know that the FDA is now calling for
sterilization rather than HLD for bronchoscopes
*
follow manufacturer IFU
* perform routine inspections and
maintenance
* do not use damaged devices
* discuss risks with patients
* consider single-use bronchoscopes
in high-risk situations.
Ofstead adds that she is not sure
how the FDA defines high-risk situations,
but in her view,
it is high risk
anytime an endoscope is inserted into a
sterile area like a lung or a kidney.
New evidence from the field on
endoscope reprocessing
There is new evidence from the field
showing the problems associated with
reprocessing safety and effectiveness
for reusable endoscopes, says Ofstead.
Breaches have been documented by
8
OR Manager | March 2022
several federal agencies, including the
FDA, Centers for Medicare and Medicaid
Services (CMS), and the Office of
Inspector General (OIG) for the Veterans
Administration healthcare system.
Among the breaches noted were:
* no precleaning of endoscopes after
procedures
* no flushing of endoscope channels
with detergent and water as recommended
in the IFU
* lack of instrument maintenance and
inspection
* improper storage of fully reprocessed
endoscopes
* inadequate infection control, insufficient
training, and lack of adherence
to the dirty-to-clean workflow
* no reference manuals available
* no hand sanitizer or hand-wash stations
available for reprocessing personnel
*
personal protective equipment (PPE)
breaches and PPE that wasn't convenient
to personnel.
There is also new evidence showing
the benefits of single-use flexible ureteroscopes,
including that they:
* eliminate risk of cross-contamination
* are clinically equivalent to reusable
ureteroscopes in procedural outcomes
and complication rates
* reduce repair costs for reusable ureteroscopes
when used occasionally
* have comparable environmental impact.
Reducing
risks
To reduce the risks to patients and personnel,
the use of sterile single-use
ureteroscopes should be considered
in some circumstances, particularly for
overnights and weekends when delayed
reprocessing might be an issue, says
Ofstead.
Facilities also should be moving to
sterilization rather than HLD, and personnel
should be noticing and repairing
damage to ureteroscopes before they
harm patients.
Organizations also have to provide
For more information, download
the whitepaper " Ureteroscope Reprocessing
Effectiveness, " brought
to you by Boston Scientific and OR
Manager.
https://www.ormanager.com/partner-content/ureteroscope-reprocessing-effectiveness/
References
CMS.
Capital Medical Center. June 19,
2020. 28518.
Davis N F, McGrath S, Quinlan M, et
al. Carbon footprint in flexible ureteroscopy:
A comparative study on
the environmental impact of reusable
and single-use ureteroscopes.
J Endourol. 2018;3293):214-217.
Day L W, Muthusamy V R, Collins C, et
al. Multisociety guideline on reprocessing
flexible GI endoscopes and
accessories. Gastrointest Endosc.
2021;93(1):11-33.e16.
FDA. Flexible bronchoscopes and
updated recommendations for reprocessing:
FDA safety communication.
June 25, 2021.
FDA. Infections associated with reprocessed
urological endoscopes-letter
to healthcare providers. April 1,
2021.
Kumarage J, Khonyongwa K, Khan A,
et al. Transmission of multi-drug
resistant Pseudomonas aeruginosa
www.ormanager.com
personnel with reprocessing training
and competency testing for every single
model of endoscope, she says, and
ensure that " proper steps are done for
every endoscope, every time, no exceptions. "
ORM
-Judith M. Mathias, MA, BS, RN, is the
clinical editor of OR Manager. Previously,
she was clinical editor of the AORN
Journal and a cardiac surgical nurse at
Rose Medical Center, Denver, and
Massachusetts General Hospital, Boston.

https://www.ormanager.com/partner-content/ureteroscope-reprocessing-effectiveness/ https://www.fda.gov/medical-devices/safety-communications/flexible-bronchoscopes-and-updated-recommendations-reprocessing-fda-safety-communication https://www.fda.gov/medical-devices/letters-health-care-providers/infections-associated-reprocessed-urological-endoscopes-letter-health-care-providers http://www.ormanager.com

OR Manager March 2022

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