when procuring Auto-Disable (AD)

What to look for Syringes

BD is a medical technology company that serves

As a global leading manufacturer of injection devices, BD is committed to their safe use and disposal

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.

As a global leading manufacturer of injection devices, BD is committed to their safe use and disposal. Reuse of disposable syringes and needles leads to the transmission of blood-borne pathogens such as hepatitisB, 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 denes auto-disable syringes as syringes that are automatically rendered unusable after having delivered a prescribed dose of vaccine.*

*WHO standard performance specication E8/Ds1

BD Auto-Disable (AD) devices include the BD SoloShot Syringe Family and the BD UniJect Prelled Injection Device. BD seeks to support international efforts to reduce the 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 wellbeing of future generations.

BD SoloShot LX Syringe

BD SoloShot IX Syringe

BD Uniject Device

commitment

hope

BDs objective is to provide high quality AD syringes, ensuring that our customers needs for performance and service quality are fullled and exceeded. We have 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 hopes our AD devices and services will help ensure the health and well-being of future generations

Important Variables for Procurement of Auto-Disable Syringes

Performance quality
Functioning as intended
It 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 design
It is important that the auto-disable syringes do not require signicant 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.

BD products are designed, developed, tested and validated to meet and exceed standards

Highest quality standard

It is important that auto-disabling syringes supplied to the eld maintain consistent high quality standards and that productionrun 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 specications. 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 certication and are routinely audited by local and international regulatory bodies.

Reference BD Colombia clinical trial in 2001 Bulletin of the WHO, 1995, 73:57-63 Bulletin of the WHO, 1999, 77:29-33

2 3

Passive locking clip design that does not require additional disabling step

BD Needle Bevel & Tip

High quality needle

Permanently attached needle

Minimal dead space

Rendered unusable after single-use

Preset volume and bold single scale markings Patented V-Clip Auto-Disable mechanism Clear barrel

BD provides great value to customers with easy-to-use, reliable and affordable products

Individual sterile package

Latex-free LATEX New ISO color-coded, tamper-resistant plunger rod

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 efcacy of the product should be considered of greater importance. There is no use in paying more 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.

reliability

value

Service quality
Manufacturing Expertise
It is important to partner with a company that can address a countrys or agencys needs and respond to emergencies with available 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.

BD has a reliable worldwide distribution system which ensures on-time product delivery

Proven record of meeting customer expectations

The public health eld 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 their needs 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 needs

From 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.

safety

quality

 Affordability
BD has a proven record of providing products at reasonable and affordable prices.

Excellent technical support and training

When 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 and safe 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, we have conducted immunization safety training programs in more than 50 countries

BD Auto-Disable Devices
A Complete Range of Auto-Disable Devices
Catalogue #
BD SoloShot IX
With ISO color-coded plunger rod for immunization*

Size
0.5mL 0.5mL 0.5mL 0.5mL 0.5mL 0.5mL 1.0mL 1.0mL 0.05mL 0.1mL 0.1mL 0.05mL-0.1mL dual scale 0.25mL 0.5mL 0.5mL 0.5mL 1.0mL 1.0mL 1.0mL 1.0mL

Gauge
23G (0.60mm) 24G (0.55mm) 25G (0.50mm) 25G (0.50mm) 25G (0.50mm) 24G (0.55mm) 22G (0.70mm) 23G (0.60mm) 27G (0.40mm) 27G (0.40mm) 27G (0.40mm) 27G (0.40mm)

Needle Length
1 (25mm) 3/4 (20mm) 1 (25mm) 1 (25mm) 5/8 (16mm) 1 (25mm) 1 (25mm) 1 (25mm) 3/8 (10mm) 3/8 (10mm) 3/8 (10mm) 3/8 (10mm)

BD SoloShot LX
BCG Auto-Disable Syringe

301860 301889 301865 3018851 301887 301898 301888 TBA 301792 301793 3025991 303212

BD SoloShot LX
For BCG vaccine administrations

BD Uniject
Prefilled injection device

BD SoloShot IX
Auto-Disable Syringe for immunization with color-coded plungers for different needle gauges*
1

471443 471412 471508 471413 471414 471415 471416 471458

25G (0.50mm) 25G (0.50mm) 23G (0.60mm) 23G (0.60mm) 25G (0.50mm) 23G (0.60mm) 23G (0.60mm) 22G (0.70mm)

5/8 (16mm) 5/8 (16mm) 1 (25mm) 1 1/4 (31mm) 5/8 (16mm) 1 (25mm) 1 1/4 (31mm) 1 1/2 (38mm)

* ISO color codes for needle gauges: black for 22G, blue for 23G, purple for 24G and orange for 25G With Chinese graphics

BD Uniject
Prelled Injection Device

Making a World of Difference

As the worlds leading manufacturer of injection devices, BD is closely tied to the success of immunization programs worldwide, and is dedicated to the continuous promotion of safe injection practices. Our locations across the world link BD to geographic, cultural and political challenges posed by immunization efforts. BD is committed to innovative and safe vaccine delivery technologies and would like new improvements to reach and benefit people all around the world, helping all people live healthy lives.
1 Becton Drive, MC204 Franklin Lakes, NJ 07417 tel: 201.847.5891 fax: 201.847.4845 30 Tuas Avenue 2 Singapore 639461 tel: 65.6861.0633 fax: 65.6860.1593 Denderstraat 24 B-9320 Erembodegem Aalst Belgium tel: 32.53.720211 fax: 32.53.720200 Carretera General San Martin 16500 Sitio 33, Colina Santiago, Chile tel: 562.460.0380 fax: 562.460.0306 Unit 401-403, 318 Pidemco Tower 318 Fuzhou Road Shanghai, Peoples Republic of China tel: 86.21.6391.2678 fax: 86.21.6391.2698 Signature Towers B, 6th Floor South City I, Gurgaon 122001 Haryana, India tel: 91.124.238.3566 fax: 91.124.238.3224

Visit us at: www.bd.com/immunization

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