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7/31/2019 Auto-disable Syringes What to Look For
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Whattolookforwhen procuring
Auto-Disable (AD)Syringes
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BD is a medical technology company that serves
healthcare institutions, life science researchers,
clinical laboratories, industry and the general public.
BD manufactures and sells a broad range of medical
supplies, devices, laboratory equipment and
diagnostic products.
2
As a global leading manufacturer
of injection devices, BD is
committed to their safe use and
disposal. Reuse of disposablesyringes and needles leads to
the transmission of blood-borne
pathogens such as hepatitis-
B, hepatitis-C, HIV (the virus
that causes AIDS), and other
infections, such as abscesses
and septicemia. To help prevent
reuse of disposable syringes
and needles, BD has developed
several auto-disable (AD) devices
in conjunction with the World
Health Organization (WHO)
and several other international
agencies. The WHO defines
auto-disable syringes as
syringes that are automatically
rendered unusable after having
delivered a prescribed dose of
vaccine.*
As a globalleading manufacturerof injection devices,
BD is committedto their safe useand disposal
*WHO standard performance specification E8/Ds1
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BD hopes ourAD devices and
services will helpensure the healthand well-being of
future generations
hopecommitment
BD Auto-Disable (AD) devices
include the BD SoloShot
Syringe Family and the BD
UniJect Prefilled Injection
Device. BD seeks to support
international efforts to reducethe risk of vaccine-preventable
diseases and infections from
unsafe injection practices by
providing AD products, as well as
training and education. BD hopes
our AD devices and services will
help ensure the health and well-
being of future generations.
BDs objective is to provide high
quality AD syringes, ensuring
that our customers needs for
performance and service quality
are fulfilled and exceeded. Wehave been successful in doing so,
as we have been supplying these
devices for more than 10 years,
and we have already supplied
more than one and a half billion
devices to most countries in
the developing world and to
agencies such as UNICEF, MSF,
IFRC, and JICA, among others.
This guide on important variables
to consider when carrying out the
procurement of AD syringes is
based on our vast experience
in manufacturing and distributing
them throughout the world.
BD SoloShotLX Syringe
BD SoloShot
IX Syringe
BD Uniject
Device
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Important Variablesfor Procurement of
Auto-Disable SyringesPerformance quality
Functioning as intendedIt is important that auto-disable syringes address the need they were
developed for, i.e. that they cannot be used after a full-dose
injection has been completed. In a clinical study in Colombia1,
BD SoloShotTM IX Products were disabled automatically and rendered
unusable 100% of the time after single use.
Easy-to-use designIt is important that the auto-disable syringes do not require
significant changes in the standard procedure for preparing
and administering vaccines. Studies in Pakistan2 and Indonesia3
concluded that vaccinators preferred BD SoloShotTM Syringes over
conventional disposable syringes, describing it as easier to use.
The BD SoloShotTM Syringe Familys passive locking clip design
automatically activates during normal use of the syringe, and does
not require an additional disabling step.
Highest quality standardIt is important that auto-disabling syringes supplied to the field
maintain consistent high quality standards and that production-
run samples are always equal to ideal design criteria. In this regard,
both design and manufacturing quality controls are critical.
BD products are designed, developed, tested and validated to
comply with the requirements of current ISO standards and WHO
standards and specifications. Additionally, BD SoloShotTM and
BD UnijectTM products are manufactured to the highest quality
standards. BD products comply with the requirements of the Medical
Device Directive for CE Marking. BD facilities have appropriate ISO
certification and are routinely audited by local and international
regulatory bodies.
1 Reference BD Colombia clinical trial in 2001
2 Bulletin of the WHO, 1995, 73:57-63
3 Bulletin of the WHO, 1999, 77:29-33
BD products aredesigned, developed,tested and validatedto meet and exceedstandards
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Latex-free LATEX
BD providesgreat value to
customers witheasy-to-use, reliable
and affordableproducts
valuereliability
BD NeedleBevel & Tip
Preset volume and boldsingle scale markings
Patented V-ClipAuto-Disable mechanism
Clear barrel
New ISO color-coded,tamper-resistantplunger rod
Permanentlyattached needle
Minimal
dead space
High quality needle
Individual sterile package
Passive locking clipdesign that does notrequire additionaldisabling step
Rendered unusableafter single-use
Excellent value
It is important to have affordable products on the market that
represent a low increase in the budget with respect to disposable
syringes, and can be adopted by resource constrained countries.
However, reliability and efficacy of the product should be
considered of greater importance. There is no use in payingmore for a product that fails to meet the injection safety
requirements of a public health program. BD provides great value
to customers with easy-to-use, reliable and affordable products.
These products have a proven record of excellent performance and
reliability, and they are among the most affordable products
available on the market.
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Service quality
Manufacturing ExpertiseIt is important to partner with a company that can address a
countrys or agencys needs and respond to emergencies withavailable stock. As a global leading manufacturer of injection
devices, BD maintains high-volume manufacturing capacity
and adequate inventory to meet current, as well as future,
customer demand.
Proven record of meetingcustomer expectationsThe public health field is very unpredictable, and epidemics can
develop at any time. Additionally, countries do not have perfect
forecasting systems by which they can accurately predict all of theirneeds in advance. Given this environment, it is important for a
country or agency to have access to the shortest possible lead times,
ensuring their needs are met in a timely and effective manner. BD
keeps an emergency stockpile to address unexpected demand and
has a reliable worldwide distribution system that ensures on-time
product delivery with the shortest possible lead times.
Being responsive to specific customer needsFrom the beginning, the WHO has recommended the use of a 23G x
1" needle size to simplify logistics and assure availability of product.Many countries are accustomed to using a different needle size, and
transitioning to auto-disable syringes may require a greater level of
effort. For that reason, and in order to address different country
preferences, needs and experiences, BD customizes products,
including special labeling, needle sizes and logos to support
local or international programs.
BD has areliable worldwidedistribution systemwhich ensures
on-time productdelivery
safety quality
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Affordability
BD has a proven record of providing products at reasonable andaffordable prices.
Excellent technical support and trainingWhen transitioning to the use of auto-disable syringes, it is
important for countries and agencies to partner with a company
that is committed to improving injection safety practices and
willing to provide the necessary training and education tools
to facilitate the transition. In every region and major country,
BD has an immunization team composed of associates who have
broad knowledge and experience with immunization programs andsafe injection practices. To date, we have conducted immunization
safety training programs in more than 50 countries. Our global
presence ensures excellent support for product training and
other educational needs related to the many aspects of safe
injection practices.
To date, wehave conducted
immunization safetytraining programs
in more than50 countries
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BD, BD Logo and all other trademarks are the property of Becton, Dickinson and Company. 2004 BD.Printed in USA BD 11/04 BDI 1007E
Making a World of Difference
As the worlds leading manufacturer of injectiondevices, BD is closely tied to the success ofimmunization programs worldwide, and is dedicatedto the continuous promotion of safe injectionpractices. Our locations across the world link BD
to geographic, cultural and political challengesposed by immunization efforts. BD is committed toinnovative and safe vaccine delivery technologiesand would like new improvements to reach andbenefit people all around the world, helping allpeople live healthy lives.
Visit us at: www.bd.com/immunization
1 Becton Drive, MC204Franklin Lakes, NJ 07417tel: 201.847.5891fax: 201.847.4845
30 Tuas Avenue 2
Singapore 639461tel: 65.6861.0633fax: 65.6860.1593
Denderstraat 24 B-9320Erembodegem AalstBelgiumtel: 32.53.720211fax: 32.53.720200
Carretera General San Martin 16500Sitio 33, ColinaSantiago, Chiletel: 562.460.0380fax: 562.460.0306
Unit 401-403, 318 Pidemco Tower318 Fuzhou RoadShanghai, Peoples Republic of Chinatel: 86.21.6391.2678fax: 86.21.6391.2698
Signature Towers B, 6th FloorSouth City I, Gurgaon 122001Haryana, Indiatel: 91.124.238.3566fax: 91.124.238.3224
BD Auto-Disable Devices
BD SoloShot IXAuto-Disable Syringe forimmunization with color-coded
plungers for different needle gauges*
BD SoloShot LXBCG Auto-Disable Syringe
BD Uniject
Prefilled Injection Device
A Complete Range of Auto-Disable Devices Catalogue # Size Gauge Needle Length
BD SoloShot IX 301860 0.5mL 23G (0.60mm) 1 (25mm)
With ISO color-coded 301889 0.5mL 24G (0.55mm) 3/4 (20mm)plunger rod for 301865 0.5mL 25G (0.50mm) 1 (25mm)immunization* 3018851 0.5mL 25G (0.50mm) 1 (25mm)
301887 0.5mL 25G (0.50mm) 5/8 (16mm)
301898 0.5mL 24G (0.55mm) 1 (25mm)
301888 1.0mL 22G (0.70mm) 1 (25mm)
TBA 1.0mL 23G (0.60mm) 1 (25mm)
BD SoloShot LX 301792 0.05mL 27G (0.40mm) 3/8 (10mm)
For BCG vaccine 301793 0.1mL 27G (0.40mm) 3/8 (10mm)administrations 3025991 0.1mL 27G (0.40mm) 3/8 (10mm)
303212 0.05mL-0.1mL 27G (0.40mm) 3/8 (10mm)
dual scale
BD Uniject 471443 0.25mL 25G (0.50mm) 5/8 (16mm)
Prefilled 471412 0.5mL 25G (0.50mm) 5/8 (16mm)injection device 471508 0.5mL 23G (0.60mm) 1 (25mm)
471413 0.5mL 23G (0.60mm) 1 1/4 (31mm)
471414 1.0mL 25G (0.50mm) 5/8 (16mm)
471415 1.0mL 23G (0.60mm) 1 (25mm)
471416 1.0mL 23G (0.60mm) 1 1/4 (31mm)
471458 1.0mL 22G (0.70mm) 1 1/2 (38mm)
* ISO color codes for needle gauges: black for 22G, blue for 23G, purple for 24G and orange for 25G
1 With Chinese graphics