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New ISO Standard for Neuraxial and Regional Anesthesia

   

Reducing the risks of misconnections

As the leader in Regional Anesthesia products and an advocate for patient safety, B. Braun Medical is working with the International Organization for Standardization (ISO) to help develop a suite of standards for small bore connectors, known as the ISO 80369 series.

There are several categories within the ISO 80369 however, the primary focus here is on neuraxial and major regional anesthesia applications – ISO 80369-6 or NRFit™ connectors.

For many years, the small-bore connector in the medical device field has been the Luer connector, which has been used in numerous applications, such as vascular, enteral, respiratory, epidural, and intrathecal.

The consequence of this has been that devices that were never intended to be connected together can, in some circumstances, allow unintended fluids or gases to be delivered through the wrong route of administration.

Developed by the ISO through the combined global effort of clinicians, regulators, test houses and industry, the new connectors have been shown to reduce the risks of cross-connections between applications.

B. Braun Medical has been actively participating in the various committees and organizations involved with this initiative to ensure we remain well informed and well prepared to help our customers transition to products with NRFit connectors in the future.

Affected Neuraxial Devices

Patient Access

  • Epidural needles
  • Spinal needles
  • Epidural, spinal, peripheral nerve block and continuous wound infusion catheter connectors


Administration

  • Loss of resistance (LOR) syringes
  • Procedural syringes
  • Syringe caps
  • Epidural flat filter
  • Filter straw

 

 

 

 

 

NRFit™ is a trademark of GEDSA and is used with their permission