The continuous development of medicine in most fields requires physicians to apply the latest methods and technology to ensure patients’ safety. In the field of anesthesiology we are pioneers in the application of measures that guarantee the security of our patients, making possible the greatest reduction in mortality seen among all other specialties. This objective has been achieved thanks to the introduction of changes such as the one presented in this review article.
The specific NRFit® connections for neuraxial and other regional anesthesia applications prevent wrong route medication errors to occur. These medication errors have been related to a high morbidity and mortality rate. This article reviews this new technology based in our own two-year experience at Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Madrid) as well as a literature review using PubMed, UpToDate and ClinicalKey.
El continuo avance de la medicina en todos los campos requiere por parte de los médicos la aplicación de métodos y tecnología que hagan de la seguridad del paciente una garantía. En el campo de la anestesiología somos pioneros en la aplicación de medidas que garantizan la seguridad, haciendo posible la mayor reducción en la mortalidad de entre las observadas en el resto de las especialidades. Este objetivo se ha logrado gracias a la introducción de cambios como el que presenta este artículo de revisión.
Las conexiones modificadas NRFit® permiten la administración de fármacos destinados a bloqueos nerviosos, haciendo practicamente imposible los errores de medicación por infusión a través de un acceso equivocado, de gran morbimortalidad. Este artículo revisa esta nueva tecnología, ya obligatoria en otros países de nuestro entorno, desde la experiencia de más de dos años de uso en el Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Madrid) y una búsqueda bibliográfica en PubMed, UpToDate y ClinicalKey.
Anaesthesiologists have always led the way in implementing new safety measures and overcoming entrenched attitudes. The early pioneers of the science and art of medicine were well aware of how their knowledge should be used. The phrase "Primum non nocere”, attributed to Hippocrates of Cos, perfectly encapsulates the philosophy of administering treatment without harming the patient.
Patient harm is still the worst possible outcome of a doctor’s care. According to the latest studies, around 4,800 deaths per year in Span can be attributed to medical errors.1–3 Harm is often the result of the right treatment being administered incorrectly by an inexperienced practitioner, leading to critical, potentially fatal, errors. At other times, errors occur when the practitioner is distracted. Whatever the cause, we doctors still make mistakes and cause harm to people who place their life in our hands.
All this compels us to continue studying and investing in R&D to minimize these types of errors. In this article, we review the new NRFit® tubing connectors for medical devices used to administer neuraxial and peripheral nerve blocks and other regional anaesthesia procedures and to monitor or remove cerebrospinal fluid for diagnostic or therapeutic purposes. These devices can eliminate or at least drastically reduce the likelihood of wrong-route errors and avoid their devastating consequences.
The first NRFit® connectors were introduced in the Príncipe de Asturias University Hospital over 2 years ago. We hope that our positive experience in drastically reducing medication errors will inspire other centres to start using these life-saving devices.
Historical perspectiveNowadays, patient safety is synonymous with anaesthesiology, and anaesthesiologists are experts at avoiding medical errors and saving thousands of lives each year.
In 1950, Beacher and Todd performed a pioneering study to investigate the prevalence of anaesthesia-derived deaths worldwide,4 and reported the alarming rate of 1 death for every 1,561 anaesthesias. More recent studies estimate that 2–4 deaths per million are anaesthesia-related.5,6 Although these mortality rates are still a deadly enemy, the panorama has changed radically in the last 75 years. Now, ours is now the only speciality that meets safety targets similar to those outlined in the Six Sigma approach described by Motorola in the 1980s,6,7 in which the company set itself the aim of reducing manufacturing defects to 3.4 per million products. This is consistent with the current rate of anaesthesia-related deaths, and places our speciality at the forefront of patient safety.
Introducing a paradigm shift in safety involves investigating the accidents that occur and identifying and analysing their possible causes. In his article “Preventable Accidents in Anesthesia: Study of Human Factors”,8 Dr Jeffrey Cooper of Massachusetts General Hospital adapted the critical incident analysis technique used in aviation to critical errors in anaesthesia. Using this method, errors are analysed objectively by focussing on the processes leading up to the error without blaming the people that made the mistake.8,9 Medical errors are currently processed in the same way once they have been reported to a safety notification system. The most widely used notification system in Spain is the Spanish System of Safety Notification in Anaesthesiology and Resuscitation (SENSAR, in its Spanish acronym),10 although other national and regional systems have also been developed.
Once the processes that have led to a critical error (resulting in morbidity or mortality) have been studied, it is mandatory for professionals to implement the resources needed to prevent the same processes from being repeated in the future. As the Stoic philosopher Lucius Anneus Seneca said Errare humanum est, persevere autem diabolicum”, which is often translated as “To err is human, but to persist in error is diabolical”. There is no point investigating these processes in depth unless measures are taken to correct the error and prevent or at least drastically reduce the possibility of it ever happening again. Returning to the world of aviation, the American company Boeing11,12 realized that many critical accidents were caused by minor pilot distractions that could easily be remedied by going through a check list prior to taxi and take-off. Thus the check list was born, a system that was later introduced into anaesthesia and intensive care by Dr Peter Pronovost in 2001.11,12 This initiative put him on the cover of The New Yorker12 and earned him an article claiming that his work had already saved more lives than many laboratory scientist. The surgical check list is carried out in all operating rooms prior to the surgical incision, and prevents a repeat of errors that have caused so much morbidity and mortality in the past.
Prevalence of medical errorsThe topic of medical errors has been widely discussed in the literature. The landmark study in this regard is “To err is human” published by the US Institute of Medicine (now the National Academy of Medicine) in 1999.13 According to the authors, medical errors are the seventh cause of death in the United States, and are directly responsible for a shocking 98,000 deaths per year. The authors of an article published in 2013 estimated the real toll to be far higher - around 400,000 deaths per year,14,15 prompting members of the original 1999 study committee to admit that they had underestimated the real figures.16
Three major studies on the prevalence of medical errors have been published in Spain: the ENEAS study (phases I and II), the APEAS study, and the EVADUR study.1–3 The latter includes data from emergency departments, which were excluded from the other 2 studies.
Medication errors are the most common medical errors in anaesthesiology.1–3 This should come as no surprise, given that anaesthesiologists are probably responsible for directly administering the widest variety of drugs. Wrong-route errors, especially those involving potentially highly toxic i.v. local anaesthetics, are associated with a particularly high rate of mortality and morbidity.
Several studies have pointed out that modern technology can prevent most of these errors.1–3 In the aforementioned APEAS study, medication errors accounted for 37.4% of medical errors in Spanish hospitals, and estimated that 42.6% of these errors were preventable.
Given this historical context, in this review we describe the steps taken to change the procedures that can give rise to wrong-access errors. The study of these types of errors and how to practically eliminate them led to the creation of NRFit® connectors, which are designed exclusively to connect to neuraxial anaesthesia systems.
What is NRFit®?NRFit® is a range of small-bore connectors designed, as specified ISO 80369-6, to be used with medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.17,18
NRFit® connectors are 20% smaller in diameter than Luer connectors, although the diameter of the syringe remains unchanged. The NRFit® tip is flush with the collar, while the Luer tip extends beyond the collar (Fig. 1). These modifications make it impossible to fit NRfit® to devices with a Luer or other type of connector, such as the ENFit® (ISO80369-3), which is used exclusively for the administration of enteral nutrition.
The NRFit connectors are 20% smaller in diameter than Luer connectors, although the diameter of the syringe remains unchanged.26
The ISO standard only defines the shape and dimension of these connectors, but not the required colour scheme. Nevertheless, all NRFit® connectors are yellow and are printed with the NRFit logo, making them unmistakeable and thus increasing patient safety (Fig. 2)
There are currently several laboratories in Spain supplying a wide range of material suitable for NRFit® connectors, including all the material for neuraxial block techniques (intradural and epidural anaesthesia), peripheral nerve blocks (needles and catheters for patient-controlled anaesthesia [PCA]) and other techniques. The quality of the materials remains the same because only the connectors have been changed.
Is NRFit® worth the cost? Why change to these connectors?Any change that increases patient safety in such a potentially dangerous setting as the operating room is both cost-effective and ethically mandatory. In the case of medication errors, in 2006 the US Institute of Medicine estimated the cost of treating each preventable error at $8,75919 - a disastrous figure to which must be factored in the number of QALY's (quality-adjusted life years) lost by each patient.
In terms of cost, changing to the new connectors would not involve such a large outlay as, for example, purchasing advanced mechanical or electronic equipment, because it simply involves replacing the connectors already included in the hospital’s budget with these new devices. Any minor increase in expenditure is justified because these devices avoid wrong-route errors and improve patient safety.
No-one nowadays would argue against purchasing a state-of-the-art ultrasound machine in a chronic pain unit or an operating room, despite the expense (usually considerable) and the need for staff training (these devices are operator-dependent), because it is clear that the improvement in patient safety will compensate for the initial outlay.
In contrast, introducing the new NRFit® tubing connectors involves making a minor change in an existing, widely used, familiar connector,20 so staff will rapidly adapt to the new design. Furthermore, it does not require costly training, because the touch and feel required to use the new connectors is similar to the existing ones, so the safety benefits would be immediate.
NRFit® connectors are the first improvement in regional anaesthesia safety that involves minimal expense, requires minimal adaptation, and provides immediate safety benefits. In 2014, a multicentre study performed in the United Kingdom and published in Anaesthesia in 2019 evaluated the ease with which healthcare personnel became familiar with the new NRFit connectors.20 The authors concluded that the new connectors performed at least as well as Luer connectors, and were no more difficult to use.
Situation in other countriesNRFit® connectors are now widely used in Europe and the USA, but have not yet completely replaced the Luer design. Up until a few months ago, very few laboratories manufactured these new devices, but now the new connectors together with a wide range of accessories needed to perform central and peripheral nerve blocks are now sold by several companies.
In Europe, the first country to make the new connectors mandatory was the UK. In August 2017, the UK’s National Health System issued a patient safety alert to all public hospitals in the country (NHS/PSA/RE/2017/004)21 describing the benefits of the new connectors and calling on all centres to transition to the new devices by 2017 at the latest. The decisive action taken by the British authorities was prompted by several cases of medication errors.
The use of NRFit® is not yet mandatory in other European countries, and the lack of a European directive to enforce their use is slowing down the transition to this new safety measure. The time taken by national and international health administrations to implement the change may well differ, but the objective is the same: to use the same specific, standardized connector for neuraxial, perineural, and other regional anaesthesia devices.
In the US, California spearheaded the transition to NRFit® by passing a law mandating the use of these connectors in all epidural procedures performed in the State after 1 January 2017.22 This law was passed on 13 August 2015, the same year in which ISO 80369-6 was published, after several cases of wrong-route errors had been widely reported in the media.
In 2020, Japan joined the growing list of countries switching to NRFit® in all regional anaesthesia procedures.23 Two years previously, in March 2018,20 the Japanese authorities had prohibited the sale of regional anaesthesia material with Luer connectors and Luer converters after March 2020,23,24 giving Japanese hospitals just 2 years to adapt to the new system. Japan’s Pharmaceuticals and Medical Devices Agency drew up the NRFit® Transition Checklist for Nurses and Clinicians to help hospitals achieve these goals.25
Despite this legislation and growing evidence that these new devices reduce drug administration errors, the NRFit® range of connectors is still a novelty that has yet to be definitively introduced into routine clinical practice.20 A search in PubMed performed at the time of writing this review showed that there is as yet scant mention of this new technology in the literature. More studies and analyses are needed to quantify the real reduction in wrong-route errors and in costly complaints and claims. This evidence will probably speed up definitive implementation of these connectors.
Situation in Spain. Experience in our hospital. Implementation modelsAs mentioned above, only a few hospitals in Spain have introduced NRFit® into routine clinical practice. Those that have done so, have used two well-defined implementation models: total switch to NRFit® and partial transition. Total switch involves replacing all the neuraxial, perineural, and other regional anaesthesia material with new material with specific connectors. Partial transition involves switching the material used in only one type of block, generally epidural, and maintaining Luer connectors
for the remaining regional anaesthesia procedures. Spanish hospitals have opted for either total or partial implementation models.
At the Príncipe de Asturias University Hospital in Alcalá de Henares (Madrid), we have been implementing the second model for more than 2 years, i.e., all the material used for epidural anaesthesia or analgesia has now been changed to NRFit®.
The staff in our department rapidly adapted to the new connectors and did not require any training in the use of the new system. Neither was there any need to change the anaesthesia technique - the same syringe is used, albeit with a different connector, so there was no difference in the “feel” of loss of resistance. The nursing staff also familiarised themselves rapidly with new material. In addition to epidural anaesthesia sets, we now have 2, 5 and 10 mL syringes with NRFit® connectors as well as low resistance syringes and 18 G 12 and 15 cm Tuohy needles for overweight patients (Fig. 3). The pharmacy department also delivers PCA pumps with the new connectors, so that the levobupivacaine and fentanyl infusion can only be administered through an epidural catheter with an NRFit® connector. Connection errors, therefore, are practically impossible, and this has helped us prevent a repetition of past errors registered in the SENSAR database and with the safety committee. As an additional safety measure, all the NRFit® material is colour-coded in yellow.
The biggest challenge probably involved including the new NRFit® material into the already full operating room anaesthesia carts. Now, however, the carts have been re-arranged so that all the material needed for intravenous medication (transparent Luer syringes) and nerve blocks (yellow NRFit® syringes) is easily located.
We opted for a partial transition, but the advantage of the complete switch model is that adaptation is compressed into a single process. In our case, we will change our plexus and spinal needles to the NRFit® system within a few months. This is the final step in the transition from Luer to NRFit®. However, this means that we will have to go through the adaptation process again which, though short, will require some re-arrangement of our anaesthesia carts.
Medication errors in our hospital are notified to the SENSAR database and to the safety committee (through anonymous safety incidents). Since the implementation of the NRFit® connectors, no cases of wrong-route errors have been reported in the operating room, post-anaesthesia care unit, delivery room, or wards.
ConclusionsRecent developments in the field of regional anaesthesia have led to the introduction of new regional anaesthesia tubing connectors. The NRFit® is the first device designed specifically to eliminate wrong-route errors associated with regional anaesthesia that can have such devastating consequences for patients. Switching to these new device has no significant budgetary impact and can also reduce the additional costs, morbidity and mortality derived from these errors. National healthcare authorities need to introduce measures to accelerate the adoption of this new system.
Anaesthesiologists have always pioneered patient safety and introduced adequate safety measures. The new NRFit® connectors can effectively prevent medical errors and clinicians should call on hospital authorities to implement these new systems. NRFit® connectors are gradually being introduced at both the national and international level, and the topic is increasingly discussed at conferences, symposiums, and other events. Switching over to these new safety connectors is non-negotiable for healthcare professionals concerned about the safety of their patients and the unnecessary risks to which they are exposed.
Conflict of interestThe author declares no conflict of interest.
