auto-disable syringes what to look for

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

auto-disable syringes what to look for

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