Download Comparative Hypodermic Needle Sharpness Among

Comparative Hypodermic Needle
Sharpness Among Major Brands:
Results of an Independent Study
Background
It is generally accepted that needle sharpness is a
key feature of any well-designed syringe with needle.
Sharper needles provide patients with more comfortable
injections, thereby providing both patient and clinician
with a more satisfying injection experience.
Does needle sharpness vary from brand to brand? Are
one manufacturer’s needles generally sharper than
those of another? These questions are answered by
this study, which assessed and quantified comparative
needle sharpness among major brands commonly used
in today’s clinical settings.
The test scenario most important to
patient comfort—skin injection
Needles and syringes are commonly used for drawing up
medications, mixing medications, accessing ports, and
skin injection. The goal of this study was to determine
relative needle sharpness specifically for skin injection—
the use that most affects patient comfort.
Because standard skin injection practice may include
using a single needle or 2 separate needles for
medication draw and injection, this study simulated
both techniques.
• With vial penetration: to simulate the common
practice of drawing up and injecting medication with
the same needle. This method is the only option when
using syringes with a permanently attached needle.
• Without vial penetration: to simulate drawing up
medication with 1 needle, which is then discarded
and replaced with a fresh needle for the injection.
This study compared needles made by Terumo with
those made by Becton, Dickinson and Company (BD),
Covidien (manufacturer of Kendall™ and Monoject™
brands), and Nipro Medical Corporation. To ensure
objectivity, tests were conducted by DDL, an
independent laboratory in Eden Prairie, Minnesota,
under controlled conditions in accordance with
applicable standard good laboratory practices.*
Sharpness test methodology
This evaluation was based on the hypothesis that
a sharper needle would require less force to penetrate
standardized, surrogate skin material.
The 2 tests (with and without vial penetration) involved
quantitatively measuring the force needed to penetrate
this material. To quantify relative sharpness, penetration
force was measured using Instron® testing equipment
with a load cell—a standard device for measuring
needle penetration force.
Penetration forces were measured for conventional
needles and allergy and insulin syringes with attached
needles, ranging in diameter from 20G to 31G. One
hundred samples from various lots were used for each
manufacturer and gauge size. Tests were conducted both
with and without vial penetration. For both scenarios, the
end points were the same: peak penetration force and
drag force of needles through surrogate skin material.
All sample needles were sterile and of saleable quality.
*Needle Sharpness Study for Terumo Medical Corporation on Insulin, Allergy and
Conventional Needles; 2008.
Terumo Superiority by Needle Type
Needle/Syringe
Finding of Terumo Superiority
Conventional
Hypodermic Needle
Terumo needles were found to be, on average:
The sharpest among brands tested (22G–27G)†
10% sharper than similar needles from BD (22G–30G)
16% sharper than similar needles from Covidien (Kendall/Monoject) (22G–27G)†
13% sharper than similar needles from Nipro Medical Corporation (22G–27G)†
13% sharper than similar needles from BD (30G)
Allergy Syringe With
Attached Needle
Terumo needles were found to be, on average:
12% sharper than similar needles from BD (27G)
Insulin Syringe With
Attached Needle
Terumo needles were found to be, on average:
14% sharper than similar needles from BD (30G–31G)
15% sharper than similar needles from Covidien (Kendall/Monoject) (30G–31G)
30G
hypodermic needles not included because researchers were unable to acquire 30G Covidien (Kendall) and Nipro Medical Corporation hypodermic needle samples
on the open market or locate a mix of lot numbers that complied with test protocol.
†
Results: Terumo needles, on average,
are proven the sharpest
This study provides a clear and unequivocal answer to
the question “Are one manufacturer’s needles generally
sharper than those of another?”
In the overwhelming majority of direct product
comparisons‡—29 out of 34, or 85%—Terumo needles,
on average, were demonstrated to be the sharpest
by a statistically significant margin. The data
above and on the back cover confirm the
superior sharpness of Terumo needles
in a broad range of needle sizes
commonly used by clinicians.
ypodermic needles with and without vial penetration;
H
allergy and insulin syringes with vial penetration.
‡
r
arp
r
lent
15
4
3
2
1
0
10
5
0
Terumo sharper
Terumo Superiority
vs Competitors
All Competitors
Terumo
vs BD
Terumo vs Covidien
(Kendall/Monoject)
Number of direct product comparisons*
All Competitors
Terumo needles proven sharper
in 85% of comparisons
35 25
30 20
Terumo needles proven sharper
in 85% of comparisons
25 15
20 10
15 5
10 0
Terumo sharper
5
Terumo equivalent
Terumo less sharp
0
Terumo sharper
Terumo equivalent
10
of direct
product
comparisons*
Number
of direct
product
comparisons*
9 Number
Terumo needles proven sharper
8
in 82% of comparisons
10 14
7
9 12
6
Terumo
needles
proven
sharper
Terumo
needles
proven
sharper
8 5
in 82%
of comparisons
in 86%
of comparisons
7 10
4
6 38
5 2
4 16
3 04
2
Terumo sharper
Terumo equivalent
2
1
0 0
Terumo
sharper
Terumo
sharper
Terumo less sharp
Terumo
vs BD
Terumo vs Covidien
(Kendall/Monoject)
Number of direct product comparisons*
Terumo vs BD
Terumo vs Nipro Medical Corporation
10 14
9Number of direct product comparisons*
12
Terumo
needles
proven
sharper
Terumo
needles
proven
sharper
8
in 82%
of of
comparisons
in 86%
comparisons
147 10
2
8
Terumo needles proven sharper
in 86% of comparisons
6
9
Number of direct product comparisons*
8
9
8
7
6
4
5
2
4
3
0
Terumo
sharper
Terumo
sharper
Terumo
equivalent
Terumo
equivalent
Terumo vs Nipro Medical Corporation
Number
of of
direct
product
comparisons*
Number
direct
product
comparisons*
126
5
104
83
2
61
40
Terumo less sharp
Terumo vs Covidien (Kendall/Monoject)
Number of direct product comparisons*
35
Number of direct product comparisons*
30
Terumo equivalent
Terumo
equivalent
Terumo
equivalent
2
1
7
6
5
Terumo needles proven sharper
in 89% of comparisons
Terumo needles proven sharper
in 89% of comparisons
4
3
2
1
0
Terumo sharper
Terumo less sharp
0
0
Terumo sharper
Terumo sharper
Terumo equivalent
*Hypodermic needles with and without vial penetration; allergy and insulin syringes with vial penetration.
Terumo less sharp
Terumo vs Nipro Medical Corporation
Conclusion
Number of direct product comparisons*
9
Needle
sharpness is determined by many factors, which
8
Terumo needles proven sharper
7
may include quality and type
of material used, bevel
in 89% of comparisons
6
design,
manufacturing
process,
and other variables.
5
4
No3 two brands are exactly alike in terms of these
2
factors,
and it is clear that needle sharpness varies
1
from brand to brand. The finding of this study, conducted
by an independent testing laboratory in accordance
with applicable standard good laboratory practices, is
that Terumo needles, on average, are by far the sharpest
overall, compared with those of the major competitors.
0
Terumo sharper
Terumo less sharp
When you think hypodermics…
Think sharp. Think Terumo.
and Terumo are trademarks owned by Terumo Corporation, Tokyo, Japan, and are registered with the U.S. Patent & Trademark Office.
Kendall™ and Monoject™ are trademarks of Covidien, Mansfield, Massachusetts.
Instron® is a registered trademark of Illinois Tool Works Inc., Glenview, Illinois.
BD is a trademark of Becton, Dickinson and Company, Franklin Lakes, New Jersey.
©2009 Terumo Medical Corporation 8/09. All rights reserved.
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