BD Sterifill Advance™ Polymer Prefillable Syringe for Intravenous Drugs
Make BD Sterifill Advance™ a part of your drug launch strategy
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The BD Sterifill Advance™ Polymer Prefillable Syringe for Intravenous Drugs supports your “First-Mover ” strategy with usability data from human factors and reports on compatibility with syringe pumps.4††
This data can help you streamline your drug filing process and address relevant questions from regulatory bodies on combination product usability.†† BD Sterifill Advance™ Polymer Prefillable Syringe has been validated for intravenous manual injections for 5, 10, and 20ml and syringe pump based infusions for 20 and 50ml in human factors studies.3‡,2§
Differentiate your drug-prefilled device combination
BD Sterifill Advance™ Polymer Prefillable Syringe features and benefits:
- Cyclo Olefin Polymer
- Screw-on tip cap that is preferred by healthcare workers over conventional push-on rubber tip cap1**
- Time associated with drug preparation can be reduced in comparison to conventional, immediate use syringes and vials/ampules2†
- Available in sizes 5, 10, 20 and 50ml
* Stakeholder respondents include risk managers & infection control nurses, intensive care nurses, business/ department managers, pharmacists, and anesthesiologists according to a quantitative survey (n=147) on “Drivers of use of prefilled syringes” conducted in UK, France and Germany. Types of drugs covered were from drug categories including cardiac, anesthetics, pain etc. in the survey.
** The simulated study was a single session, randomized with n=60 HCWs experienced with a daily practice of administering 50mL infusions. During this study, HCWs performed 8 simulated infusions with BD Sterifill Advance™ 50mL syringes. Tip cap satisfaction levels of HCWs were measured through a scoring of 0 (very dissatisfied) to 10 (very satisfied) wherein 90% of HCWs gave BD screw-on tip cap a score of 8.
† An observational study (with HCWs, n=28) comparing preparation using BD Sterifill Advance™ with conventional, immediate use syringe was conducted. On average, preparation time for 5mL BD Sterifill Advance™ was 1:50 min whereas for the 5mL immediate use syringe it was 2:56 min. Similarly, for 20mL BD Sterifill Advance™ it was 1:09 min whereas for the 20mL immediate use syringe, it was 2:23 min. BD Sterifill Advance™ barrel is not intended to be filled with drugs containing metabisulfite preservatives
‡ A 2013 clinical study was designed to demonstrate the compatibility (flow characteristics) of BD Sterifill™ 50mL (renamed to BD Sterifill Advance™ 50mL prior to commercial launch) with a panel of electric syringe pumps available on the market for 4 flow rates (1, 5, 25 and 100mL/h) through a total of n=150 simulated Water for Injection (WFI) infusions as per ISO 7886-2. Tested syringe pumps were Perfusor space (B Braun), Module DPS (Fresenius Kabi), Poliot A2 (Fresenius Kabi), Injectomat (Fresenius Kabi) and GH+ Alaris (Becton Dickinson). BD Sterifill Advance™ barrel is not intended to be filled with drugs containing metabisulfite preservatives
§ Human factor results from intravenous, subcutaneous and intra-articular manual injections performed by 15 experienced nurses indicates no technical incident or adverse event was recorded for manual use (5,10 and 20ml) and for pump use (20ml). The difficulty encountered by nurses to select the correct program on the syringe pump highlights importance to provide training to end-users on the use of pump.
††First-Mover’ refers to being first-to-market in a geography with a drug-prefilled syringe combination. Reports referenced are for BD Sterifill Advance™ polymer prefillable syringe summary data on compatibility with syringe pumps. Summary of results can be provided; more information is available on request. Human factor studies for BD Sterifill Advance™ are conducted with Water-for-Injection.
- A simulated study of usability of a new plastic syringe for infusion with electric pump [Internal Document, n=60]. Pont-de-Claix, Becton, Dickinson and Company, 2014.
- BD Sterifill Advance 5,10 and 20mL Human factor Executive Summary [Human factor study, n=28]. Pont-de-Claix, FR: Becton Dickinson and Company; 2016.
- A simulated study of performance and acceptance of a new plastic syringe for infusion with electric pump. [Internal Document, n=150]. Pont-de-Claix, Becton, Dickinson and Company, 2013.
- System Integration Challenges in Combination Products for Injectable Drugs [Internal study], Le Pont-de-Claix, France; Becton Dickinson and Company, 2019
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