Episode #241 The Impact of ISO 80369-6 Neuraxial Connectors: Patient Safety Challenges and Opportunities

Hello and welcome back to the Anesthesia Patient Safety Podcast. My name is Alli Bechtel, and I am your host. Thank you for joining us for another show. Has your institution made the change to ISO 80369-6 neuraxial connectors yet? Last week, we talked about some of the issues that came up in Japan before and after making the switch to the new standard for neuraxial connectors and we are continuing the conversation today.

Before we dive further into the episode today, we’d like to recognize Blink, a major corporate supporter of APSF. Blink has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, Blink- we wouldn’t be able to do all that we do without you!”

This is Part 2 in our 2-part series on making the change to ISO 80369-6 and the lessons learned from the implementation in Japan. Our featured article is from the October 2024 APSF Newsletter, and it is “Switchover to ISO 80369-6 (neuraxial applications) in Japan: Lessons Learned from Unwittingly Being First” by Sachiko Omi and colleagues. To follow along with us, head over to APSF.org and click on the Newsletter heading. The fourth one down is Newsletter archives. From here, scroll down to the October 2024 Newsletter and then scroll down until you get to our featured article today. I will include a link in the show notes as well.

Let’s do a quick review of ISO 80369 which is the standard created in response to medical errors from misconnections and misadministration between enteral, respiratory, urinary, blood pressure, neuraxial, and intravenous patient care systems. The exact standard that we are discussing is related to neuraxial connectors which are included in the standard ISO 80369-6. This new standard has been rolled out in different areas around the world, including Japan.

For a nice additional review on this standard, you can check out the ASRA Pain Management Newsletter Article by Brain Harrington published on July 27, 2018. I will include a link in the show notes. Did you know that Hermann Luer (does his name sound familiar?) filed a patent for a precise syringe design with the United States Patent Office in 1897? This design was later modified by Farleigh Dickinson and the Becton Dickinson company into the modern Luer-Lok or just Luer connector. The benefits of this design included a secure and reliable small-bore connection that was easy to attach and detach. Since then, the luer connector has been used for intravascular, neuraxial, enteral, medical gas, and monitoring applications. Did you work in the operating room today? Did you use a Luer connector during your day?

As we mentioned last week, there was a big downside to this amazing connector that could be used for multiple different applications and that was the risk for misconnections and misadministration of medications. Some of these misconnections could involve the blood pressure monitor with an intravenous access leading to an air bolus or more commonly, wrong route medication errors between intravenous and the spinal or epidural space which can have devastating effects either way. The intention behind this new standard was to prevent wrong route medication errors. The new connector is intended to be used for neuraxial and major regional anaesthesia and is called “ner-fit” ( NRFit^®) which looks like a luer connector, but it is smaller with a unique design that is not compatible with luer connectors.

These new  NRFit^® connections are commercially available now and used in Japan as we discussed last week as well as in California. Starting on January 1, 2017, use of the new connectors was mandated in the state of California.

For all anaesthetists in Australia and New Zealand, this change is happening here too. Luer connectors that are currently in use in hospitals in Australia and New Zealand are being discontinued. At the same time, hospitals and healthcare facilities are encouraged to make the switch to ISO 80369-6 connectors. I will include a link to the information provided by the Australia New Zealand College of Anaesthetists in the show notes as well.

Let’s return to the article again because if you remember from last week, there were quite a few issues with the implementation of the new standard. Some of these issues before the switchover were related to awareness, guidance by the manufacturer, product range and availability, and mistranslation and poor communication. After the switchover, some of the issues included problems with the device breaking, errors in drug administration, different clinical feel with the new connectors, hard to differentiate the connections between the luer and new connectors due to the smaller size, color confusion, less convenient and more complicated to use, increased costs, and lack of systems for product reporting and support.

Despite these many issues, no patients were harmed due to the switchover due to vigilance and problem-solving by the anaesthesia professionals using the new connectors. The authors report that there were several cases of breakages and leakage, but the anaesthesia professionals ensured that patients remained safe. In addition, there was an increased risk for medication misadministration due to lack of availability of connector sets with connectors and pre-filled syringes, but diligence by the anaesthesia team helped to keep patients safe. The switchover added a layer of stress to routine anaesthesia care depending on the availability of the connectors and syringes, poor translation, color labelling confusion, and wasted resources.

Here are the major considerations following the switchover in Japan:

1. Insufficient clinical involvement during the ISO 80369-6 standard formulation process and the Japanese domestic implementation process. Once the standards were set, there was little discussion of how to proceed with the switchover.
2. Imbalanced perspectives between the clinicians, manufacturers, and regulatory agencies. Manufacturers may have thought that it was acceptable and unavoidable to produce fittings that complied with the standard but were difficult to use especially by uninformed users. If clinicians were aware of these problems, they may have discovered these problems before implementation and use during patient care.
3. Lack of clinical feasibility trials. It was absolutely necessary to perform these studies using products from various companies before domestic implementation to avoid patient harm and physician liability. Instead, clinical feasibility trials before implementation were denied. This occurred due to the incorrect perception among regulatory agencies and manufacturers that these trials would violate competition laws. Adequate preparation, support, and information about the new products would have gone a long way towards a smoother implementation process.
4. Lack of transparency. There was a lot working against this implementation. Regulatory agencies thought that clinical feasibility trials were unnecessary since the new products complied with the new ISO standard. Manufacturers did not inform clinicians of the “small” change in how the new products fit together. And Clinicians were not aware of this situation in Japan and had no place to address these concerns. At the ISO level, the consensus-building process is only available within the group, but compliance with the produced standards is mandatory and strongly supported by local administrative agencies in Japan. Currently, clinicians who are required to follow the standards can purchase ISO’s official publications (that may be too technical for many clinicians to understand) to learn more about them. This process needs to be improved if we are going to avoid learning how to use new products and troubleshooting liquid leaks and cracked connections due to extra-strong fittings while providing patient care during implementation of the new standard.

So, what is the role of clinicians during domestic implementation of ISO standards? We know that challenges related to new standards may involve meeting local health care requirements, usability, and patient safety. Important considerations include product availability, changes in functionality from preexisting standards, education level, and scope of professional responsibility. Clinical feasibility studies are an important part of protecting patients and validating the efficacy of the new standards. The authors tell us that “effective integration of ISO standards requires balancing manufacturer efficiency with comprehensive clinician involvement and responsive domestic adoption processes.” When the clinician involvement piece is missing from the puzzle, there may be significant challenges as we have seen in this case.

There is another example of this is Japan with the new standard for enteral applications. Once again, the connectors are smaller in diameter, and this has led to challenges with administering blended diets and aspirating stomach contents. This switchover began in 2019, and completion was delayed. The Ministry of Health, Labour, and Welfare introduced its own noninterchangeable connection in 2000 that worked well clinically but was forced to switch to the new standard. By May of 2022, Japan changed to allow the old and new standards and there is still confusion about this today. The authors highlight that in 2000, Japan introduced its own noninterchangeable enteral connection standard that could be used clinically without issues. Unfortunately, this already-proved Japanese standard was not adopted by ISO and instead the new ISO standard was a design that could not be used for all clinical cases.

Let’s review what we have talked about. ISO issued a series of ISO 80369 standards designed to physically restrict connections between syringes, needles, and other small-diameter components do their intended purposes only. In 2018, Japan became the first country to complete the switchover to the new standard for neuraxial connections. This was done largely without clinician support or clinical feasibility trials leading to issues that arose before the switchover and persisted afterwards related to lack of information and product breakage and leaks. There was no significant patient harm related to the new connectors, but there were serious concerns that cannot be ignored. There is a call to action for clinicians and medical societies including the JSA and APSF to become more involved and highlight the need for clinician input in ISO, industry, and domestic regulatory agencies. When medical societies become more fragmented, it is harder to work together which has led to an imbalance in government and industry. This example highlights the importance of clinicians working with manufacturers for perioperative devices approved by ISO. Anaesthesia professionals need to remain vigilant when new products are introduced for patient care with consideration for how a product is used and the quality of the product in order to keep patients safe.

Have you used the  NRFit^® connectors? Is your hospital, state, or country thinking of making the switchover to the new standard? We hope that you continue to keep patients safe during anaesthesia care with the new connectors. Before we wrap up for today, we are going to hear from one of the authors again. Sachiko Omi provides some perspective on how clinicians can contribute to ISO.

[Omi] “I think there are two main areas for all of us to consider – formulation and implementation of ISO standards related to anesthesia care. There are roles for anesthesiologists, medical associations such as APSF, and ISO in these processes. Clinicians have a unique and essential role in formulating products that are practical and safe when used with patients. Unlike many other industrial products, where dimensions, forms and material quality are important, clinicians know that how they are applied is crucial for safety and effectiveness. In other words, the clinician's opinion must be fully reflected at all stages of standard development. ISO has a mechanism to incorporate the input of clinical experts, but participation by anesthesia experts has been very limited. Perhaps we are just too busy, but we have to find the time for the sake of our patients. If we don’t, manufacturing and marketing will continue to be the primary movers of the formulation of standards.

Unbelievably, no clinical feasibility trials involving anesthesia experts were performed in Japan before implementation. The rollout was led by government and industry, without adequate clinical input or testing. Please read the article for how this affected both anesthesiologists and patients.

[Bechtel] I also asked Omi, “What do you envision going forward with regards to this important area?” Let’s take a listen now.

[Omi] “I hope your listeners will hear the warning bells from our experience with ISO 80369 in Japan and that they will become energized to become involved in ISO. Indeed, ISO 80369-2 was issued recently, and its implementation is imminent in some countries. We, as anesthesia clinicians, need to become involved so we can make sure the changes truly contribute to patient safety within the parameters of our working environment.

How can ISO become truly international? ISO standards apply worldwide, but each country is different and needs to become actively involved for both patient safety and their own sanity. Are the new standards going to help your patients, or will they cause confusion or stress the system? These are questions for us, as anesthesiologists, to answer. Not someone else.”

[Bechtel] Thank you so much to Omi for contributing to the show today, sharing your insights, and working to improve anesthesia patient safety around the world. This is an important call to action for anesthesia professionals to be knowledgeable and involved in the development and implementation of anesthesia patient safety standards.

If you have any questions or comments from today’s show, please email us at [email protected]. Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice. We hope that you will visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today.

The APSF Newsletter is the official journal of the Anesthesia Patient Safety Foundation. Readers include anesthesia professionals, perioperative providers, key industry representatives, and risk managers. It is free of charge and available in a digital format with a focus on anesthesia-related perioperative patient safety issues. The deadline for the June 2025 APSF Newsletter is right around the corner on March 1st! Check out the guide for authors over at APSF.org for more information and I will include a link in the show notes as well. Who knows, you could be the next APSF Newsletter author, and we might be featuring your article on a future Anesthesia Patient Safety Podcast! So, what are you waiting for, go ahead and submit your article today!

Until next time, stay vigilant so that no one shall be harmed by anesthesia care.

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