OR Manager March 2022 - 7

Patient Safety
the Association for the Advancement
of Medical Instrumentation (AAMI)/
American National Standards Institute
(ANSI) standard (ST) 91- " AAMI/ANSI
ST 91 " -is coming soon.
Even though the Multisociety guideline
pertains to GI endoscopes, it spells
out practices that healthcare workers
need to be aware of when reprocessing
all endoscopes, says Ofstead. In
addition, AORN has signed onto this
guideline.
Key recommendations in the Multisociety
guideline focus on three areas:
All personnel
* should receive model-specific training
and competency testing-this
is no small task, says Ofstead, because
most institutions have many
different kinds of endoscopes, and
they come with different reprocessing
instructions
* must comply with infection prevention/control
recommendations
* should wear gloves whenever handling
endoscopes-there is good
compliance with glove-wearing in
the OR, she says, but personnel in
some outpatient departments are
handling fully reprocessed endoscopes
with their bare hands. This
is no longer permissible in the new
guideline.
Reprocessing suite layout, equipment
* there has to be a dedicated reprocessing
space with separation of
dirty and clean areas-this means
endoscopes cannot be cleaned or
disinfected in patient care areas,
and soaking endoscopes in a basin
of disinfectant in patient care rooms
or anywhere else is no longer acceptable,
Ofstead says. The only
time personnel can use manual
soaking in disinfectant is when the
automated endoscope reprocessor
(AER) is broken or when there is an
emergency situation
* HLD should be done in an AER.
Reprocessing practices
* initiate manual cleaning within 60
www.ormanager.com
FDA reports since April letter
With the FDA letter raising awareness of
FDA reports released since the April 1 letter
10
15
20
25
30
35
40
5
Oct
2020
Nov
2020
Dec
2020
Jan
2021
Feb
2021
Used with permission from Ofstead and Associates
© 2022 Ofstead & Associates, Inc. | Ureteroscope Webinar for OR Manager
minutes after a procedure or follow
IFU for delayed reprocessing-this
involves extended soaking and extra
cleaning steps
* use model-specific cleaning devices
(brushes)-personnel cannot use
one brush for every endoscope or
every channel
* perform visual inspection with
lighted magnification-this applies
to every endoscope, every time
* sterilize all devices classified as
Critical according to Spaulding-Ofstead
notes that urological endoscopes,
in particular ureteroscopes,
should be classified as Critical because
they are coming into contact
with the kidney, which is sterile tissue.
As such, they should be sterilized,
not just disinfected
* completely dry endoscopes using
10 minutes or more of pressureregulated
forced-air between uses-
this should be done before they go
into the sterilizer or before they go
into storage, whether or not they are
going to be used again that day, she
says.
" There are some new things in this
updated guideline, " notes Ofstead,
" and it's stronger than we have seen
before in the field. "
issues and the new Multisociety guideline
in place, Jacobs asks, have things
gotten better in the field?
Ofstead answers that from her perspective,
things have not improved.
Her team reviewed new reports of
adverse events related just to ureteroscopes
released by the FDA since April.
There were 20 to 25 reports a month
until August and October, when they
increased to more than 35 reports, and
that uptick continued through the fall
(sidebar, FDA reports released since
the April 1 letter).
" This indicates that either the problems
haven't gone away or that more
people are filing reports since they
heard about the risks, " she says.
Between April and October,
Mar
2021
Apr
2021
May
2021
Jun
2021
Jul
2021
Aug
2021
Sep
2021
Oct
2021
the
FDA's Manufacturer and User Facility
Device Experience (MAUDE) database
had 177 new MDRs, and 105 were for
reusable flexible ureteroscopes, including:
*
five patient injuries or exposures
* 11 reprocessing breaches
* 18 ureteroscopes with residual contamination
in spite of reprocessing
* 72 damaged ureteroscopes.
The FDA also reported six new MDRs
on semi-rigid or rigid reusable ureteroscopes,
including:
* two reports of infections (one report
Continued on page 8
OR Manager | March 2022
7
Number of ureteroscope MDRs
http://www.ormanager.com
OR Manager March 2022

Table of Contents for the Digital Edition of OR Manager March 2022
