Safeflow

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Luer activated valve developed as needlefree injection port in IV applications

Safeflow is a needle-free valve that can be used for infusion and transfusion therapy. It is designed for aspiration, injection, or gravity flow of fluids upon insertion of a male luer fitting.

The valve allows multiple usage through activation of the needle-free connector by attaching a luer slip / luer lock connector such as a syringe.

Advantages

Luer-Slip and Luer-Lock compatible
Easy access for Luer-Slip and Luer-Lock connections.1,2

Flexibility
Suitable for several IV procedures (e.g. Luer Lock connections, etc.).
Small size allows easy integration into different medical devices.
Can be offered alternatively for stylets or other closing cones. 1,2

Tested for 300 activations
Allows multiple access for direct aspiration or fluid injection 2,7,9,20

Compatibility
Compatible with MRI, lipids and blood.1,2,14,15,16

Smooth surface for easy disinfection
Can be disinfected according to CDC, national or hospital guidelines and is alcohol resistant.1,5,9,14,15

Pressure resistance
Pressure resistant up to 2 bar.
Straight valve suitable for high pressure application.1

Flushing
Can be effectively flushed from blood or fluids.1,17,18

Changing interval
Safeflow can be replaced according to CDC or national guidelines or hospital protocol.1,7,9

Pediatric use
The device can be used for all patients for which infusion therapy is prescribed. No gender or age related limitations. Safeflow can be used for adults, pediatric and neonates.1

Risk Prevention

Sharps Injury
Provides convenient and safe needle-free IV access for injection, aspiration or parallel infusion, while reducing the risk of needle stick injuries. Needle-free multiple access for injection, aspiration or parallel infusions as a closed system.1,2,3,5,6,7

Particulate Contamination
The needle free access helps to prevent the risk of particulate contamination by preventing coring of membranes.1,2,3,4

Air Embolism
A closed system helps to reduce the risk of air embolism due to the self sealing valve which avoids intake of air.1,2,3,5,6,7

Chemical contamination
Reduces the risk of chemical contamination as the valve prevents spillage / drug exposure. 1,2,3,5,6,7

Microbial contamination
Effective barrier to microbial contamination when swabbed with alcohol pad.
Helps to prevent bloodstream infections.5,9,10,11,12

DEHP Exposure
Not manufactured with PVC, DEHP or Latex / Natural rubber.1,2

Medication Error (right dose of medication due to flow rate)
Allows rapid delivery and optimal flow rates. The Safeflow Luer activated valve provides a straight fluid pathway resulting in uninterrupted fluid flow providing flow rates of 360 ml/min.1,2,13

1 Internal data

2 Halkey Roberts, Robertsite® Needlefree Valves Book, Technical Data Sheets

3 American Nurses Association – Independent Study Module: Needlestick Safety and Prevention written by Mary Foley, MS, RN and Annemarie T. Leyden, EdD, RN

4 Cornman, Lois J., and Donna M. Inglot. "One hospital's solution." RN, Nov. 1994, p. 50+

5 Abstract - Evaluation of the microbial barrier properties of the female valve Safeflow signed by Prof. Dr. med. M. Exner and Dr. rer. nat. J. Gebel, Report DMT 2014-131, 23.02.2015

6 Closed system test by means of Sodium Fluorescein – Chemical Tightness of Safeflow female valve signed by Dr. rer. nat. J. Brünke Quality Labs BT GmbH Nuremberg, Report 1816.5, 06.10.2015

7 Halkey Roberts, Robertsite® Multiple Activations Evaluation, 300 times

8 Robertsite® Needlefree Valves Book, White Papers, 2015

9 Robertsite® 7 Day Microbial Challenge Evaluation, Halkey Roberts, Robertsite®

10 Yébenes J et al., „Resistance to the migration of microorganisms of a needle-free disinfectable connector“; AJIC 26, vol. 31, no. 8 (2003): 462

11 Kaler W, Chinn R, Successful Disinfection of Needleless Access Ports: A Matter of Time c

12 Jarvis W, MD. Choosing the Best Design for Intravenous Needleless Connectors to Prevent Bloodstream Infections. Infection Control Today, August 2010 (http://www.infectioncontroltoday.com/articles/2010/07/ choosing-the-best-design-for-intravenous-needleless-connectors-to-prevent-bloodstream-infections.aspx.)

13 Eloot, Sunny et al., How much is catheter flow influenced by the use of closed luer lock access devices?, Nephrol Dial Transplant (2007) 22: 3061–3064, doi:10.1093/ndt/gfm314, Advance Access publication 27 June 2007
(Remark: Swan-Lock® = Safeflow)

14 Bayer Material Science, Makrolon® Rx1805, Polycarbonate (PC), File No.: KU28034-0409 en Issue 2004-09-09 (replaces ATI 8034 dated 1999-08-20)

15 Bayer Corporation, Plastics Division, Makrolon® Rx-1805, Polycarbonate Resin, Lipid-Resistant, Radiation-Stabilized Medical Grade, 412-777-2000, 1999

16 Halkey Roberts, Hemodialysis Test

17 Halkey Roberts, Flushing Study for Robertsite® Swabable Valves, Robertsite® Needlefree Valves Book, White Papers

18 Summary of Biocompatibility Test Results ISO 10993-1 Standard Testing Procedures, Halkey Roberts, Robertsite® Needlefree Valves Book, White Papers, 2015

19 Halkey Roberts, High Pressure Application for Swabable Valve, P. Miller, July 2010
The Robertsite Tube End valves P/N 245540024 were assembled per HRC production procedures and accessed by a standard luer (ISO594-2) connector. During pressure testing there was no leakage or damage to the valve. After exposure to 400psi and 1200psi internal pressure, Robertsite valves passed the HRC specification for back pressure seal performance (30 psig minimum).

20 Robertsite® - Stem Shelf Life Evaluation, Halkey Roberts, Robertsite® Needlefree Valves Book, White Papers, 2015
Bayer Material Science, Makrolon® Rx1805, Polycarbonate (PC), File No.: KU28034-0409 en Issue 2004-09-09 (replaces ATI 8034 dated 1999-08-20)