Comparative Hypodermic Needle Sharpness Among Major Brands

Comparative Hypodermic Needle Sharpness Among Major Brands:

Results of an Independent Study Background This study compared needles made by Terumo with those made by Becton, Dickinson and Company (BD), It is generally accepted that needle sharpness is a Covidien (manufacturer of Kendall™ and Monoject™ key feature of any well-designed syringe with needle. brands), and Nipro Medical Corporation. To ensure Sharper needles provide patients with more comfortable objectivity, tests were conducted by DDL, an injections, thereby providing both patient and clinician independent laboratory in Eden Prairie, Minnesota, with a more satisfying injection experience. under controlled conditions in accordance with Does needle sharpness vary from brand to brand? Are applicable standard good laboratory practices.* one manufacturer’s needles generally sharper than those of another? These questions are answered by Sharpness test methodology this study, which assessed and quantified comparative This evaluation was based on the hypothesis that needle sharpness among major brands commonly used a sharper needle would require less force to penetrate in today’s clinical settings. standardized, surrogate skin material.

The test scenario most important to The 2 tests (with and without vial penetration) involved patient comfort—skin injection quantitatively measuring the force needed to penetrate this material. To quantify relative sharpness, penetration Needles and syringes are commonly used for drawing up force was measured using Instron® testing equipment medications, mixing medications, accessing ports, and with a load cell—a standard device for measuring skin injection. The goal of this study was to determine needle penetration force. relative needle sharpness specifically for skin injection— the use that most affects patient comfort. Penetration forces were measured for conventional needles and allergy and insulin syringes with attached Because standard skin injection practice may include needles, ranging in diameter from 20G to 31G. One using a single needle or 2 separate needles for hundred samples from various lots were used for each medication draw and injection, this study simulated manufacturer and gauge size. Tests were conducted both both techniques. with and without vial penetration. For both scenarios, the • With vial penetration: to simulate the common end points were the same: peak penetration force and practice of drawing up and injecting medication with drag force of needles through surrogate skin material. the same needle. This method is the only option when All sample needles were sterile and of saleable quality. using syringes with a permanently attached needle. *Needle Sharpness Study for Terumo Medical Corporation on Insulin, Allergy and Conventional Needles; 2008. • Without vial penetration: to simulate drawing up medication with 1 needle, which is then discarded and replaced with a fresh needle for the injection. 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.

‡Hypodermic needles with and without vial penetration; allergy and insulin syringes with vial penetration. All Competitors Terumo vs Covidien (Kendall/Monoject)

Number of direct product comparisons* Number of direct product comparisons*

35 10 9 30 Te rumo needles proven sharper Terumo needles proven sharper 8 in 82% of comparisons 25 in 85% of comparisons 7 20 6 5 15 4 10 3 2 5 1 0 0 Terumo sharper Terumo equivalent Terumo less sharp Terumo sharper Terumo equivalent

Terumo SuperiorityAll Competitors vs Competitors Terumo vs Covidien (Kendall/Monoject)

Number of direct productAll comparisons* Competitors NumberTerumo of direct prvsoduct Covidien comparisonsTerumo *(Kendall/Monoject) vs BD Terumo vs Nipro Medical Corporation 35 10 Number of direct product comparisons* Number of direct product comparisons* Number9Number of dirof ectdirect product product comparisons comparisons** 30 Te rumo needles proven sharper Terumo needles proven sharper 8 in 82% of comparisons 3525 in 85% of comparisons 10 147 9 9 6 8 3020 Terumo needles proven sharper 12 Te rumoTerumo needles needles proven proven sharper sharper Te rumo needles proven sharper 8 5 7 15 in 85% of comparisons 10 in 82%in 86% of comparisonsof comparisons in 89% of comparisons 25 7 4 6 2010 6 38 5 5 2 15 5 6 4 4 1 3 10 0 3 04 2 2 5 Terumo sharper Terumo equivalent Terumo less sharp 2 Terumo sharper Terumo equivalent 1 1 0 0 0 0 Terumo sharper Terumo equivalent Terumo less sharp TerumoTerumo sharper sharper TerumoTerumo equivalent equivalent Terumo sharper Terumo less sharp

All Competitors Terumo vs CovidienTerumo (Kendall/Monoject) vs BD Terumo vs Nipro Medical Corporation

Number of direct product comparisons* NumberNumber of ofdir directect pr oductproduct comparisons comparisons*Terumo* vs BD NumberTerumo of direct pr vsoduct Nipr comparisonso Medical* Corporation

35 1014 9 Number of direct product comparisons* 9Number of direct product comparisons* 8 30 Terumo needles proven sharper 12 Te rumoTerumo needles needles pr ovenproven sharper sharper Te rumo needles proven sharper 8 7 25 in 85% of comparisons 10 in 82%in 86% of ofcomparisons comparisons 9 in 89% of comparisons 147 6 6 8 20 12 8 Terumo needles proven sharper 5 Te rumo needles proven sharper 5 7 15 10 6 in 86% of comparisons 4 in 89% of comparisons 4 6 3 10 83 4 5 2 2 5 2 4 61 1 3 0 40 0 0 2 Terumo sharper Terumo less sharp Terumo sharper Terumo equivalent Terumo less sharp 2 TerumoTerumo sharper sharper TerumoTerumo equivalent equivalent 1 0 0 Terumo sharper Terumo equivalent Terumo sharper Terumo less sharp *Hypodermic needles with and without vial penetration; allergy and insulin syringes with vial penetration.

Terumo vs BD Terumo vs Nipro Medical Corporation Conclusion Number of direct product comparisons* Number of direct product comparisons*

14 Needle9 sharpness is determined by many factors, which from brand to brand. The finding of this study, conducted 8 12 Terumo needles proven sharper Te rumo needles proven sharper may7 include quality and type of material used, bevel by an independent testing laboratory in accordance 10 in 86% of comparisons in 89% of comparisons 6 8 design,5 manufacturing process, and other variables. with applicable standard good laboratory practices, is 6 4 No3 two brands are exactly alike in terms of these that Terumo needles, on average, are by far the sharpest 4 factors,2 and it is clear that needle sharpness varies overall, compared with those of the major competitors. 2 1 0 0 Terumo sharper Terumo equivalent 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.