BD Hylok™ Glass Prefillable Syringe for Hyaluronic Acid
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BD Hylok™ Glass Prefillable Syringe offers 1mlL, 3ml, 5mL and 10mL formats, a data package to support development and registration, and a syringe verified for steam sterilization.1* The system addresses issues of needle disconnection, leakage, and syringe luer-lock adaptor rotation, considered as top priorities by hyaluronic acid manufacturers.3,5
BD HylokTM Glass Prefillable Syringe for Hyaluronic Acid Features and Benefits
- Screw-on tip cap: Intuitive+ tip cap is preferred by users over a standard clip-on tip cap6+
- New bonding technology: Strongly affixed Luer-Lock Adaptor7++
- New Luer-Lock Adaptor thread design: Connection performance° for hyaluronic acid injections is validated in Human Factor studies6
- Glass barrel: 72% of decision makers°° in the hyaluronic acid industry expressed a preference for glass over plastic for their syringes according to an international study5
*Terminal steam sterilization cycles at 121°C/2 cycles/20 min. Functional tests relating to closure system and luer-lock adaptor connectivity with a minimum sample size of n=30 were conducted to validate resistance of BD Hylok™ glass prefillable syringe and stopper to steam sterilization.
**As part of a total of n=170 questionnaires were collected in 8 countries namely USA, UK, France, Germany, Italy, Spain, South Korea and China. 87 Dermatologists, 43 Rheumatologists and 40 Orthopedic surgeons were interviewed across the regions.
During the study Healthcare Professionals who experienced a “high leak” situation occasionally or relatively often are considered as those who have “experienced leakage.” As defined in the reference study, a high leak situation is where hyaluronic acid leaks from multiple locations and more than 5 bubbles are observed during injection. A middle leak situation is where hyaluronic acid leaks from multiple locations and 3-5 bubbles are observed. A low leak situation is where hyaluronic acid leaks from 1-2 locations and 1-2 bubbles are observed.
+ First use, without Instructions for Use.
++Comparable products indicate 3 widely used glass prefillable syringe brands with Plastic Rigid Tip Cap (PRTC) based design.
Human factor results from 34 hyaluronic acid injections performed by dermatologists: No luer lock adaptor rotation or disconnection, no needle disconnection (on sufficient tightening) was experienced during injection. For trained intended users, intended uses and environmental conditions as defined in the Human Factors.
°°Breakdown of sample size (n=36) by decision making functional role: 17.5% Production/manufacturing, 12.5% R&D, 25% Quality, 12.5% General management, 17.5% Sales and marketing, 15% Procurement.
- BD Hylok™ Design verification results [Internal Report]. Pont-de-Claix, Becton Dickinson and Company, 2019.
- Monheit, G. D., & Coleman, K. M. (2006). Hyaluronic acid fillers. Dermatologic therapy, 19(3), 141- 150.
- Understand Dermatologists & Rheumatologists perception of HA PFS leakages and the value associated to a leakage/breakage free HA PFS. [Voice of Customer Research, n=170, Regions: US, EU, South Korea, and China]. Pont de Claix, FR: Becton Dickinson and Company; 2018.
- A simulated validation study of needle connectivity of BD Hylok™ [Internal report, n=43]. Pont-deClaix, FR: Becton Dickinson and Company; 2017.
- A glass syringe that optimizes needle connection & minimizes risks of leaks [Voice of Customer research] Pont de Claix, FR: Becton Dickinson and Company; 2017.
- A simulated study of usability of BD Hylok™ [internal report]. Pont-de-Claix, FR: Becton Dickinson and Company; 2015.
- BD Hylok™ and BD Hylok™ competitor syringes performance evaluation [Internal reports, n=30 for both]. Pont-de-Claix, FR: Becton Dickinson and Company; 2018.
