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Frequently Asked Questions

   

Q: Who is GEDSA and what is the role of the StayConnected Initiative?

Q: What’s the new International Organization for Standardization (ISO) standard 80369-6?

Q: What’s the new California State Legislation (AB 444)?

Q: What types of products are affected by the new ISO 80369-6 standard?

Q: What products are affected by the new California State Legislation AB 444?

Q: Are any products NOT included in the new ISO 80369-6 standard?

Q: Are there any neuraxial applications that will remain Luer in the short term until an NRFit version is available?

Q: When do U.S. customers have to switch according to the new ISO Standard?

Q: When do California customers have to switch according to the new California state law?

Q: What are the penalties for California customers who don’t comply?

Q: When will B. Braun have products with NRFit connectors available?

Q: Will B. Braun have sufficient inventory?

Q: Are there any adapters (Luer to NRFit) allowed according to the ISO Standard?

Q: When will B. Braun discontinue the current Luer products?

Q: How will we help customers manage the transition?

Q: Is there any color that will be associated with NRFit?

Q: Will other manufacturers be ready with their NRFit products (i.e. epidural pump tubing)?

Q: What are some things B. Braun is doing to help customers differentiate between Luer and NRFit products?

Q: Are there any other important visual changes to B. Braun products?

 

 

 

 

   Q: Who is GEDSA and what is the role of the StayConnected Initiative?

A: StayConnected is the implementation branch of the Global Enteral Device Supplier Association (GEDSA) which is a federally tax exempt non-profit trade association StayConnected was established in part to help introduce the new ISO standard connectors and facilitate adoption of the new 80369-6 connectors with the healthcare community. GEDSA, which is composed of leading manufacturers and distributors of medical devices, is united by a shared desire to increase patient safety and optimal delivery of neuraxial treatments and procedures. GEDSA speaks with a unified voice to communicate with government agencies, professional associations, healthcare institutions and member suppliers regarding issues that face device manufacturers, suppliers and distributors.

GEDSA will lead StayConnected, a joint communication initiative on behalf of the industry to ensure consistency and avoid any confusion as new, safer connectors are introduced in the market.

Through GEDSA, and where possible, the industry has agreed to:

  • Coordinate market communications
  • Use a common brand name for the ISO 80369-6 connector (NRFit™)
  • Introduce devices with NRFit connectors to the market around the same time
  • Where possible, use yellow device coloring to help identify NRFit components in a kit.

Visit http://www.stayconnected.org to learn more.
 

   Q: What’s the new International Organization for Standardization (ISO) standard 80369-6?

A: The goal of this standard  is to reduce the risk of misconnections and increase patient safety by helping to make neuraxial and regional anesthesia products incompatible with medical devices meant for other applications (i.e. IV).

Commonly referred to as products with NRFit connectors, the small bore connector on these devices may look similar to a Luer connector but are about 20% smaller in diameter.
 

   Q: What’s the new California State Legislation (AB 444)?

A: Starting Jan.1, 2017, this law prohibits health care facilities from using an epidural connector that would fit into a connector other than the type it was intended for, unless it’s an emergency. California health facilities have to switch to epidural products with NRFit connectors by Jan. 1, 2017.

0. CA Legislation AB444.pdf

0. Cali Dept of Public Health LNC-Al.pdf
 

   Q: What types of products are affected by the new ISO 80369-6 standard?

A: Devices used to administer medications and to take samples from neuraxial sites (central nervous system including intracranial and spinal canal such as epidural and intrathecal), major peripheral nerve local anesthetic blockade and continuous wound infiltration. This includes anesthetic delivery, monitoring cerebrospinal fluid (CSF) pressure, and removing CSF for therapeutic or diagnostic purposes.

   Q: What products are affected by the new California State Legislation AB 444?

A: The California law specifically relates to Epidurals. However, B. Braun is launching spinal, epidural and CSE products with NRFit to ease the transition for health systems.
  

   Q: Are any products NOT included in the new ISO 80369-6 standard?

A: Some devices aren’t covered in the scope of the new standard because  they’re not intended to inject into the epidural or spinal spaces. The most relevant of these are products used for the skin wheal application.  These will remain Luer.

Examples may include:

  • Spinal introducer needle
  • Hypodermic needles
  • Filter straw meant to draw up skin wheal medication
  • 3mL syringe used for skin wheal

   Q: Are there any neuraxial applications that will remain Luer in the short term until an NRFit version is available?

A: All medical devices that connect to the neuraxial route will eventually need to convert to products with NRFit connectors. A small number of low-risk specialty devices/applications may continue to use Luer in the short term.
 

   Q: When do U.S. customers have to switch according to the new ISO Standard?

A: B. Braun customers (other than California) will have approximately three years to convert to products with NRFit connections. California customers have to convert prior to January 1, 2017 due to state legislation regarding epidural products.
 

   Q: When do California customers have to switch according to the new California state law?

A: Prior to Jan. 1, 2017.
 

   Q: What are the penalties for California customers who don’t comply?

A: Unfortunately, there are no clear answers regarding penalties or enforcement of the law. However, it could be a liability for hospitals to continue to use Luer products when NRFit is available on the market.
 

   Q: When will B. Braun have products with NRFit connectors available?

A: California: Epidural, spinal and combined spinal epidural products with NRFit connectors will be available beginning October 2016 to help customers comply with the state legislation deadline of Jan. 1, 20171.

Products with NRFIT - Phase 1.xls

All Other States: Additional neuraxial products as well as peripheral nerve block products will be available from B. Braun beginning Jan. 1, 2018.

 

   Q: Will B. Braun have sufficient inventory?

A: Yes. Initial stock will be available beginning in October for existing California B. Braun customers. Inventory production has accounted for 100% conversion of existing B. Braun customers in California.
 

  Q: Are there any adapters (Luer to NRFit) allowed according to the ISO Standard?

A: No. These adapters are not allowed because it would be counter-productive to the safety initiative.
 

  Q: When will B. Braun discontinue the current Luer products?

A: Over the next three years, we’ll continue to manufacture both Luer and NRFit products.
 

  Q: How will we help customers manage the transition?

A: B. Braun sales representatives will work closely with customers to identify the best NRFit cross and make customers aware of any changes from existing product. B. Braun will work to ease the transition and develop a conversion schedule that’ll be agreed upon by the customer and sales representative.
 

  Q: Is there any color that will be associated with NRFit?

A: Although color coding is not included in the ISO standard, many manufacturers have agreed to use yellow product coloring where possible to help identify NRFit products.

B. Braun products incorporating yellow:

  • 20mL procedural syringe
  • Epidural filter
  • Catheter connector (cap)
  • Filter straws & needles (cap)

Does NOT include yellow:

  • Plastic LOR syringes –package labeling and product labeling will indicate NRFit
  • Glass syringes –package labeling and product labeling will indicate NRFit
  • Spinal and epidural needles –package labeling will indicate NRFit

  Q: Will other manufacturers be ready with their NRFit products (i.e. epidural pump tubing)?

A: Although GEDSA members agreed to have products available around the same time, it’s important that the customers reach out to each of their suppliers to gather information regarding specific product availability.
 

  Q: What are some things B. Braun is doing to help customers differentiate between Luer and NRFit products?

A: Color Coordination – yellow product coloring where possible

Product Labeling – syringes are labeled as NRFit along with Slip or Lock on the barrel

Caps – where product coloring wasn’t feasible, we used yellow caps

Translucent Stylet Hubs – vs. opaque coloring like today

Products for Skin Wheal (Luer) – Luer products for skin wheal application are contained in a separate baggie within the kit (see outlined section below).

Package Labeling – NRFit products will be labeled as such and will have new reorder numbers and product codes ending in “N”.

 Q: Are there any other important visual changes to B. Braun products?

A: Spinal Syringe – Current syringe is plastic with a plastic Luer Slip tip. NRFit syringe upon initial launch will be glass with a metal NRFit Slip tip.

Luer 5mL Plastic Spinal Slip

NRFit 5mL Glass Spinal Slip

Slip Tip Syringes in General – Syringes with Slip tips will now have a collar on it, following ISO design. Because it may be difficult to tell the difference between Slip and Lock, B. Braun syringes will now have the tip type printed on the barrel of the syringes (i.e. Lock or Slip).

Luer 5mL Glass Slip

NRFit 5mL Glass Slip

Spinal Needle Improvements – Pencan and Spinocan spinal needles will now incorporate a prism within the hub to allow for CSF visualization. In addition, a new bonding process was used, resulting in a better fit for the introducer needle, allowing for more usable spinal needle length.

 

 

 

 

 

 

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