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Safer spinal needles with BD UniVia™ Connection - Safety and performance without compromise


 
BD UniViaTM safety anaesthesia connection has been developed to create a safer anaesthesia environment, for neuraxial drug delivery, helping to reduce the risk of wrong route medication errors, retaining the same feel, technique and performance characteristics as the conventional BD anaesthesia devices.
 
The Safety Anesthesia Connectors (BD UniVia™) project was initiated to develop regional anesthesia drug delivery products that reduce mis-connection related medication error risks. These devices connect only to BD UniVia™ non-Luer devices, and don’t connect to standard Luer devices.
 
The quality of the BD UniVia™ design has been challenged by BD simulated user study, independent clinical evaluation and laboratory tests. 
 
Performance in clinical setting:
 
Simulated user study of BD UniVia™ Spinal needles. [Ref. 1]
 
BD conducted a simulated evaluation of our new safer spinal anaesthesia system. A summary of the results, which involved 49 clinicians, is detailed below.
 
Reduce the risk of wrong-route medication errors - All 100% agreed that the new BD safer spinal anaesthesia system will prevent or reduce the risk of misconnection between a BD conventional syringe and a BD safer spinal needle.
Same technique - According to 46 clinicians, the new BD system is intuitive to use and the connection technique of the BD safety anaesthesia systems is identical to the connection technique of a BD conventional system. 45 clinicians agreed that it takes a single procedure in order to feel comfortable using the new BD system.
Same feel – 94% of clinicians agreed or strongly agreed that the new BD system is as easy to use as a BD conventional system. A majority of clinicians agreed that the new BD system feels identical to a BD conventional system.
Same trusted performance - In the same study, 46 clinicians agreed that the BD safety anaesthesia system performs the same as BD conventional systems. 48 clinicians agreed that the BD safety anaesthesia system will have no negative impact on their clinical practice.
 
      Clinical Evaluation of BD UniVia™  Spinal kits.
 
A clinical evaluation was conducted in Blackpool Victoria Hospital [Ref. 2] comparing data 12 months before, and 12 months after the introduction of BD UniVia™ kits in obstetric wards. An estimated 703 needles have been used in obstetrics. The authors concluded:
 
“The ‘safe’ spinal needles have achieved their purpose by eliminating administration of wrong injectate into the intrathecal space.  Overall the introduction of the BD Whitacre spinal kit with UniVia™ connection was received with a high level of satisfaction in our department.” [Ref 2]
 
Laboratory tests
 
BD UniVia™ has undergone independent laboratory tests to assess cross-connection, physical leak and microbiological integrity. It has successfully passed all challenges.
 
Interconnectivity testing was performed by STML.  LINK:  http://medidex.com/medical-devices/784-non-luer-test-data-2012.html
 
Physical leak tests were performed by SMTL.  LINK:    http://medidex.com/medical-devices/784-non-luer-test-data-2012.html
 
Physical Integrity Testing (Microbiological Integrity), performed by Wickham Laboratories
 
 
Physical Integrity Testing (Dye Intrusion), performed by Quality Control North West
 
 
 
[Ref. 1]
Onia, R.; Wu, Y.; Parvu, V.; Eshun-Wilson, I.; Kassler-Taub, K. A simulated evaluation of a non-Luer safety connector system for use in neuraxial procedures.  British Journal of Anaesthesia (2012) 108 (1):134-9
[Ref. 2]
Susnerwala I.; Cross R.; Wiggans S. The Big Bang: outcomes after the introduction of ‘safe’ spinal needles. Proceedings of the Anaesthetics Research Society Meeting 16th – 17th May 2013. British Journal of Anaesthesia 111 (4): 686-7
 
For further details and Test Results, please contact Rachael Harvey, BD UniVia™  Project Lead UK & Europe.    
Email: Rachael_harvey@europe.bd.com.  Tel: +44 (0) 1865 748844. Mob: +44(0) 7825 919021
 

 

 

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