Reshaping Safety for Neuraxial and Regional Anesthesia
To help improve patient safety and help reduce the risk of misconnections, Luer connectors on medical devices used for neuraxial applications are changing to meet new international design standards.
Designed to Reduce the Risk of Misconnections
As a leader in Regional Anesthesia products1 and an advocate for patient safety, B. Braun Medical continues to work 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 series; 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.2,3,4
Developed by the ISO through the combined global effort of clinicians, regulators, test houses and industry, the new connector was designed 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.
Design Information & Impacted Devices
New Design Standards Per ISO 80369-6
- Longer than Luer connector
- 20% smaller connector diameter
- Collared slip syringes
B. Braun Design NRFit Indicators
- Yellow product coloring or yellow caps where feasible
- New needle stylets will be a transparent color rather than opaque as seen in Luer needles
- Addition of prism in spinal needle hub for cerebral spinal fluid (CSF) identification
- New product codes will end in “N” to designate NRFit
- NRFit denoted on syringe barrel
- Product labeling indicates NRFit components
Impacted B. Braun Devices
- Epidural needles
- Spinal needles
- Catheter connectors
- Slip syringes
- Lock syringes
- Loss of resistance (LOR) syringes
- Filters, filter straws, filter needles
Excluded B. Braun Devices
- Spinal introducer needles
- Hypodermic needles
- Filter straws meant to draw up skin wheal medication
- 3 mL syringes used for skin wheal
Products Available For Sale
Epidural, spinal and combined spinal epidural products with NRFit connectors are available now.
All healthcare facilities in the United States, among other countries, are expected to begin converting in order to meet the ISO standard. California has already taken legislative action by mandating that healthcare facilities convert to these new standardized epidural products by Jan. 1, 2017.
B. Braun has been at the forefront of preparing for this change. We’ve taken an active role in helping our customers comply with the evolving industry safety standards, including transitioning to products with NRFit™ connectors in a timely manner.
NRFit™ is a trademark of GEDSA and is used with their permission
1 2019Q2 All Regional Anesthesia Products – Total Market HC & OPM Dollars (GHX, IQVIA [MDSA] & B.Braun Actual Data)
2 GEDSA. Frequently Asked Questions. Retrieved from http://stayconnected.org/frequently-asked-questions.
3 Tran, M. (2009, November 18). NHS Trust Prosecuted over New Mother's Death from Wrong Drug. The Guardian. Retrieved from https://www.theguardian.com/society/2009/nov/18/nhs-cabrera-wrong-drug-childbirth.
4 Anger as Fatal Jab Doctor Freed. (2003, September 23). BBC News. Retrieved from http://news.bbc.co.uk/2/hi/health/3133076.stm.