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Background
It is vital to understand the range of use for an instrument before asking how it
is reprocessed. During a mock survey at an ambulatory surgery center (ASC), it was
discovered that a gamma-detection probe used on intact skin was also used in conjunction
with a sterile sheath on sterile tissue during invasive procedures. Low-level disinfection
(LLD) was performed in between use. Although LLD was appropriate after use on intact
skin according to the Spaulding Classification, the end user incorrectly perceived,
and was reinforced by the vendor, that a sterile sheath negated the need for sterilization
after use on sterile tissue.
Methods
To understand the scope of the issue, 81 areas that order sterile ultrasound probe
covers were specifically asked how probes were used and reprocessed to assess whether
appropriate reprocessing was occurring. A multidisciplinary group was formed to review
the probes’ instructions for use (IFU), identify solutions to correct inappropriate
reprocessing techniques including education and resource procurement, and formulate
a plan to implement the standard of care across the health system.
Results
A risk assessment was created outlining the reprocessing method required for ultrasound
probes based on its intended use in addition to its previous use. Reprocessing changes
were made to 9 ultrasound probe types used in 2 hospitals and 2 ASCs.
Conclusions
Asking whether an ultrasound probe “touched” mucous membranes or sterile tissue to
assess compliance with reprocessing was incomplete due to end-users’ misunderstanding
of the effect a sterile sheath had on reprocessing requirements. End-users’ believed
the device was not “touching” mucous membranes or sterile tissue if a sterile sheath
was used. By changing the phrasing of the question to include how the probe is used,
our health system was able to successfully identify probes that required a higher
level of reprocessing based on the intended use of the probe.
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Article Info
Identification
Copyright
© 2020 Published by Elsevier Inc.
