Medical Design Briefs - February 2023 - 18

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1.503
Oil Negative 1.605
Saline Test
Article
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1.365
1.590
Table 1. Results summary.
the field of medical device testing. While
the use of RhE for irritation testing is
still an emerging field, there are ongoing
efforts to establish standardized
methods for producing and testing RhE.
As more data becomes available and the
use of RhE becomes more widely accepted,
it is possible that FDA may begin to
accept RhE testing as a viable alternative
to traditional animal-based methods.
As of today, FDA does not have an official
position on the use and acceptance
of the RhE test in place of the rabbit irritation
test, but will consider the results of
the method if appropriate validation and
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18
110
100
90
80
70
60
50
40
30
20
10
Positive
Control
Saline
Negative
Oil
Negative
Saline Test
Article
Oil Test
Article
Fig. 1 - With the RhE test, the tissues have less variability between test specimens, making repeatability of test
results more consistent over the inherent variability of animals.
www.medicaldesignbriefs.com
Medical Design Briefs, February 2023
evidence can be provided to demonstrate
equivalency with the animal model.
Much progress has been made over
the past years to demonstrate the validity
of the RhE test method to replace
the rabbit irritation model. We are
nearing the time where universal acceptance
of this test is a real possibility,
and this year might indeed by the year
of the rabbit.
This article was written by Thor Rollins,
Sr. Director of Toxicology and E&L
Consulting, Nelson Laboratories, Salt
Lake City, UT. For more information,
visit www.nelsonlabs.com.
0.006
0.003
0.066
0.120
0.037
3.4%
100%
100%
90.8%
99.1%
0.4%
0.2%
4.1%
8.0%
2.3%
I
NI
NI
NI
NI
Optical Density
Mean
Standard
Deviation
Percent Viability
Mean
Standard
Deviation
Category
-
Mean Viability (% of Negative Control)
http://info.hotims.com/84476-732 http://www.nelsonlabs.com http://www.medicaldesignbriefs.com

Medical Design Briefs - February 2023

Table of Contents for the Digital Edition of Medical Design Briefs - February 2023

Medical Design Briefs - February 2023 - Cov1A
Medical Design Briefs - February 2023 - Cov1B
Medical Design Briefs - February 2023 - Cov1
Medical Design Briefs - February 2023 - Cov2
Medical Design Briefs - February 2023 - 1
Medical Design Briefs - February 2023 - 2
Medical Design Briefs - February 2023 - 3
Medical Design Briefs - February 2023 - 4
Medical Design Briefs - February 2023 - 5
Medical Design Briefs - February 2023 - 6
Medical Design Briefs - February 2023 - 7
Medical Design Briefs - February 2023 - 8
Medical Design Briefs - February 2023 - 9
Medical Design Briefs - February 2023 - 10
Medical Design Briefs - February 2023 - 11
Medical Design Briefs - February 2023 - 12
Medical Design Briefs - February 2023 - 13
Medical Design Briefs - February 2023 - 14
Medical Design Briefs - February 2023 - 15
Medical Design Briefs - February 2023 - 16
Medical Design Briefs - February 2023 - 17
Medical Design Briefs - February 2023 - 18
Medical Design Briefs - February 2023 - 19
Medical Design Briefs - February 2023 - 20
Medical Design Briefs - February 2023 - 21
Medical Design Briefs - February 2023 - 22
Medical Design Briefs - February 2023 - 23
Medical Design Briefs - February 2023 - 24
Medical Design Briefs - February 2023 - 25
Medical Design Briefs - February 2023 - 26
Medical Design Briefs - February 2023 - 27
Medical Design Briefs - February 2023 - 28
Medical Design Briefs - February 2023 - 29
Medical Design Briefs - February 2023 - 30
Medical Design Briefs - February 2023 - 31
Medical Design Briefs - February 2023 - 32
Medical Design Briefs - February 2023 - 33
Medical Design Briefs - February 2023 - 34
Medical Design Briefs - February 2023 - 35
Medical Design Briefs - February 2023 - 36
Medical Design Briefs - February 2023 - 37
Medical Design Briefs - February 2023 - 38
Medical Design Briefs - February 2023 - 39
Medical Design Briefs - February 2023 - 40
Medical Design Briefs - February 2023 - 41
Medical Design Briefs - February 2023 - 42
Medical Design Briefs - February 2023 - 43
Medical Design Briefs - February 2023 - 44
Medical Design Briefs - February 2023 - 45
Medical Design Briefs - February 2023 - 46
Medical Design Briefs - February 2023 - 47
Medical Design Briefs - February 2023 - 48
Medical Design Briefs - February 2023 - 49
Medical Design Briefs - February 2023 - 50
Medical Design Briefs - February 2023 - 51
Medical Design Briefs - February 2023 - 52
Medical Design Briefs - February 2023 - 53
Medical Design Briefs - February 2023 - 54
Medical Design Briefs - February 2023 - 55
Medical Design Briefs - February 2023 - 56
Medical Design Briefs - February 2023 - 57
Medical Design Briefs - February 2023 - 58
Medical Design Briefs - February 2023 - 59
Medical Design Briefs - February 2023 - 60
Medical Design Briefs - February 2023 - 61
Medical Design Briefs - February 2023 - 62
Medical Design Briefs - February 2023 - 63
Medical Design Briefs - February 2023 - 64
Medical Design Briefs - February 2023 - 65
Medical Design Briefs - February 2023 - 66
Medical Design Briefs - February 2023 - Cov3
Medical Design Briefs - February 2023 - Cov4
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