Medical Design Briefs - December 2021 - 35

Validation of Extraction Methods
One of the new requirements in
AAMI ST98 is that cleaning extraction
methods should be validated. AAMI
TIR30:2011 presents different methods
for performing an extraction; however,
it does not mention that the methods
need to be validated or how to perform
the validation. Per the new standard,
ST98, two possible approaches for validating
an extraction method are spike
recovery and exhaustive extraction.
The use of spike recovery for validating
an extraction method involves soiling
a medical device with a known
amount of soil. The soils used for spiking
are the same soils that are tested in
the endpoint testing. Using this method,
the extraction efficiency is a comparison
between the amounts of soil recovered
to the amount of soil added.
The use of exhaustive extraction for
validating an extraction method involves
performing extractions several times on
the same soiled device. The amount of
Preparation of medical
devices for the automated
washing process. (Credit:
Eurofins)
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Medical Design Briefs - December 2021

Table of Contents for the Digital Edition of Medical Design Briefs - December 2021

Medical Design Briefs - December 2021 - Intro
Medical Design Briefs - December 2021 - Cov4
Medical Design Briefs - December 2021 - Cov1a
Medical Design Briefs - December 2021 - Cov1b
Medical Design Briefs - December 2021 - Cov1
Medical Design Briefs - December 2021 - Cov2
Medical Design Briefs - December 2021 - 1
Medical Design Briefs - December 2021 - 2
Medical Design Briefs - December 2021 - 3
Medical Design Briefs - December 2021 - 4
Medical Design Briefs - December 2021 - 5
Medical Design Briefs - December 2021 - 6
Medical Design Briefs - December 2021 - 7
Medical Design Briefs - December 2021 - 8
Medical Design Briefs - December 2021 - 9
Medical Design Briefs - December 2021 - 10
Medical Design Briefs - December 2021 - 11
Medical Design Briefs - December 2021 - 12
Medical Design Briefs - December 2021 - 13
Medical Design Briefs - December 2021 - 14
Medical Design Briefs - December 2021 - 15
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Medical Design Briefs - December 2021 - 18
Medical Design Briefs - December 2021 - 19
Medical Design Briefs - December 2021 - 20
Medical Design Briefs - December 2021 - 21
Medical Design Briefs - December 2021 - 22
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Medical Design Briefs - December 2021 - 28
Medical Design Briefs - December 2021 - 29
Medical Design Briefs - December 2021 - 30
Medical Design Briefs - December 2021 - 31
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Medical Design Briefs - December 2021 - 33
Medical Design Briefs - December 2021 - 34
Medical Design Briefs - December 2021 - 35
Medical Design Briefs - December 2021 - 36
Medical Design Briefs - December 2021 - 37
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Medical Design Briefs - December 2021 - Cov3
Medical Design Briefs - December 2021 - Cov4
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