Health professionals make mistakes that can have a catastrophic impact on patients, but, as Kohn et al (2000) noted, ‘to err is human’. In the vast majority of cases, human errors are made by well intentioned, highly trained skilled personnel. The onus is on humans to design systems to ensure that patients are safe from accidental injury.
Misconnection or wrong route administration of drugs is an issue that dogs medical practice globally. The consequences of wrong route administration may be fatal instead of merely inconvenient or financially costly. The use of the same luer small-bore connectors, be they accessing the parenteral, enteral, or neuraxial system, has led to a number of ‘serious untoward incidents’ over the years. The International Organization for Standardization (ISO) has been developing specific connectors for each individual route. The first to be seen in UK hospitals, ISO 80369-3:2016 (ISO, 2016a), was the implementation of a unique connector and purple-themed administration system for all oral and enteral products, ENFitTM.
Since the publication of the ISO 80369-6:2016 (ISO, 2016b) and subsequent manufacturing by industry, it is now possible to adopt a unique connector system, NRFit™, for all neuraxial applications, be they sampling or administration of medication. This article will look at the background to the ISO standard, give information from early adopter sites on how this transformational change in practice might be made and illustrate the benefits to patient safety using patient scenarios.
History of small-bore neuraxial connectors
The luer connector is an extremely versatile connector for joining a wide range of medical liquid and gas connecting tubes. It has been in use for over 100 years since it was designed by Karl Schneider of the H. Wulfgang Luer Company in France, and incorporated into a glass syringe. As more and more devices with luer connections have been used, unintended administration of substances via inappropriate routes has occurred. In 2001, at Queen's Medical Centre, Nottingham, vincristine was given to a patient via the intrathecal route instead of intravenously. This resulted in the death of the patient (Holbrook, 2003). Norfolk (2003) stated that it was the 23rd similar incident reported worldwide and Dyer (2001) the 14th in 15 years in the UK. Donald M Berwick, Chief Executive Officer at the Institute for Healthcare Improvement, Boston, USA, wrote: ‘Preventing errors lies in redesign—not exhortation’ (Berwick, 2001).
NHS Improvement and NHS England (2020) publish a list of ‘Never Events’, including ‘administration of medication by the wrong route’. Data for the incidence of this Never Event is published on its website. Figure 1 summarises data from recent years.
Neuraxial procedures involve the use of medical devices to administer medications to the cerebrospinal fluid (CSF) or epidural space, and to monitor or remove CSF for therapeutic or diagnostic purposes (ISO 80369-6) (ISO, 2016b).
In 2009, the UK's National Patient Safety Agency (NPSA) issued a two-part patient safety alert (NPSA/2009/PSA004B) (NPSA, 2009). These mandated NHS facilities to stop using luer devices for neuraxial procedures. Part A covered spinal procedures, with an implementation target date of 1 April 2011 (later deferred to 2012). Part B covered epidural procedures with a widened remit to cover all regional anaesthetic procedures, with an implementation date of 1 April 2013. The goal of the move to a unique connector was to remove the risk of misconnection and/or wrong administration, thereby improving patient safety and saving lives. The NPSA alerts posed major issues for hospitals because the NPSA was unable to specify any national or international standard adaptor, there was no central catalogue of available equipment, and it was unable to offer any guidance on how to implement the mandate. The result was that each hospital was left to go it alone, to try to find out what equipment was available and then to implement change.
Within the UK, various manufacturers developed and marketed solutions to the non-luer connector for neuraxial systems. This led to the development of several different systems: Correctinject™ Safety System (Smiths Medical), UniVia™ (BD) and Surety™ (Intervene—now owned by GBUK) adopted by Pajunk, Vygon, Blue Box, B. Braun and Sarstedt, the predominant system being Surety. The presence of multiple systems raised a number of issues and led the NPSA to issue a further alert warning of the dangers of cross-connectivity and incompatibility. Given these issues, many NHS hospitals chose not to adopt a non-luer system or comply with the NPSA mandate.
Health service commissioners in other countries have realised the value of moving away from the luer connector and the value of a world standard design. This added impetus to the development of the ISO standard neuraxial connector (ISO 80369-6) that has been given the trademark name NRFit. The NRFit connector looks similar to a luer connector, but is about 20% smaller. The unique design reduces the risk of cross-connection with other connectors such as luer connectors or enteral connectors. The slip male connectors have a collar surrounding the connector. See Figure 2 and Figure 3.
The adoption of NRFit has given manufacturers the confidence to invest in re-tooling their manufacturing facilities and the range of devices available in the NRFit format has steadily increased to reach the stage where it is possible for NHS hospitals to now adopt the NRFit system with the confidence that they can get a robust supply of all the items they require (although there are still one or two items outstanding).
Making the conversion: the experience of one hospital in England
The publication of the alert by NPSA (2009) was the start of a major process for NHS organisations. In fact, early adopters have had to undergo the change twice. Like many other patient safety issues, in order to achieve the process it is essential to have:
NPSA alerts mandate NHS facilities to make changes. Management take these alerts extremely seriously and when they are unable to comply they have to place the items on the hospital's risk registers. There are sometimes further inducements. For example, use of non-luer equipment was part of the oncology Commissioning for Quality and Innovation (CQUIN) target, a system used by the Department of Health and Social Care (DHSC) to allocate extra funding for hospitals using best practice (NHS England, 2020). This financial incentive encouraged hospitals to convert to non-luer equipment, but many chose to do this only for spinal equipment.
Within Sheffield Teaching Hospitals, there was strong engagement from management and clinicians and a neuraxial working group was formed. The group involved all stakeholders (representatives from each directorate, one consultant anaesthetist, matrons from both oncology and anaesthetics, senior supplies officers, pharmacy sterile services managers and hospital risk managers). Members were selected based on their extensive knowledge and experience in order to better anticipate and respond to issues as they arose.
There were engineering and supply issues. To understand these one must realise that manufacturers' core aim is to maximise profit. Items with limited market potential take low priority or may be omitted from portfolios completely, regardless of how essential an item is considered to be in a specific clinical setting or the ability of hospitals to implement the NPSA mandate. For example, clinicians administer many therapeutic agents into the CSF. Whereas anaesthetists will draw up and administer these immediately, oncologists, guided by best practice, and have their drugs made up in pharmacy sterile production units. Some hospitals, such as Sheffield Teaching Hospitals, have production units on-site and drugs are administered on the day of production. However, many, such as those administered by NHS Wales, have drugs made up in centralised regional production units. Drugs must be stored for many hours or a few days. In order to store drugs in a syringe for more than 8 hours, the syringes and their caps need to pass stringent integrity testing (for microbiological and dye intrusion) and chemical stability. These tests are laborious and expensive and although all manufactured NRFit syringes held the CE mark and were fit for clinical use, it was not until January 2020 that there was one (from B. Braun) that had completed integrity and stability testing.
The NHS is a major stakeholder in the UK health industry; however, when looking at the world health industry, it makes up a small share of the market. The NPSA move to exclude luer equipment from neuraxial procedures was years ahead of other countries and only applied to the UK. Manufacturers were slow to develop and produce the new equipment, and NHS facilities were unable to comply with the mandate.
From the outset, hospitals tried to compare the items they were using with those available in a non-luer form. Clinicians become accustomed to the feel of a particular needle. From the experience within Sheffield Teaching Hospitals, clinicians in one department would have strong opinions about the advantages of a particular needle, while in another department the clinicians would have equally strong opinions about the advantages of another. In fact, even within one department, there may be several manufacturers' versions of a similar needle to suit individual clinicians. Although all needles were available in the luer format, it was possible for each department to order their preferred option. However, once formal trials were undertaken, it was often found that the preferred spinal needle would only be available in one non-luer format while the preferred epidural would be available in another.
Difficult decisions had to be made in order to move forward, these involved accepting a smaller portfolio of equipment, accepting that some items would not be available and required explanations to clinicians that they could only have their favourite spinal needle if they used an alternative epidural needle.
The group worked through issues and produced modifications to practice while minimising the risk to patients. An example that caused much angst was the CSF drain system. This is used in many neurosurgical, cardiothoracic and radiological departments. Even by June 2020, there was no non-luer version available. The neuraxial working group therefore strengthened the standard operating procedure to minimise the risk of a wrong-route administration.
When planning for a change, effective dissemination of information is essential. The working group discovered that many people use the simple spinal needle in ways one would never expect. Radiologists use them for needle aspirations; surgeons use them as X-ray markers. Dissemination of information was made through consultant directorates and nurse manager forums using face-to-face meetings, emails and poster campaigns.
The working group also held detailed planning meetings with the hospital supplies team, risk managers, clinicians and representatives of the manufacturers. It was felt that the best way to implement the change was in a one-step move in order to minimise the risks of having incompatible kit during the procedure. However, this increased the waste of unused luer kit that had been removed from the clinical areas.
On the day of the conversion, the manufacturer's representatives were on site and brought extra stock. The supplies team found the most effective method for conversion was for them to bring in extra staff themselves and move through the hospital replacing new for old on the exchange trolleys and in clinical rooms. There were a few anomalies, such as wards whose previous usage of an item had been small requesting extra stock as they admitted previously nipping to adjacent areas to borrow items.
Once the changes were settled in place, an evaluation began. One recurring issue was discovering rogue items of old luer kit. There were a number of reasons for this:
The change to Surety within the Trust was successful; however, there were lessons to learn and in the years before the release of NRFit, manufacturers had begun co-operating within the remit of a special interest group convened by Barema, the Association for Anaesthetic and Respiratory Device Suppliers. This group included the lead pharmacist for NHS Wales sterile services, clinicians and senior managers from the manufacturers.
As far as corporate competition rules would allow, manufacturers disclosed the items of kit that they were going to manufacture and estimated the date when a robust supply would be available.
Perhaps naively, the neuraxial working group had expected the driving force on implementing the change would be the DHSC. But this was not the case. Neither were the specialty bodies such as the royal colleges. This left individual hospitals to work through issues themselves. In summer 2017, hospitals were informed of the immediate cessation of production of Surety syringes at a time before any of the needle manufacturers were ready with their NRFit epidural versions. This was not important for many hospitals who had only converted their spinal equipment as some manufacturers were ready with their NRFit versions. However, a small number of hospitals were left without this vital equipment, which required assistance directly from the DHSC. The DHSC came to an agreement with GBUK to ensure the company would produce another batch of Surety equipment.
Despite all these difficulties, in spring 2018, Sheffield Teaching Hospitals completed the conversion to NRFit. With 18 months use, health professionals have found the NRFit design to be very good. The NRFit has a male-female funnel shape connection like many small-bore connectors. However, clinicians using the Surety equipment found that during epidural procedures the syringe would have insufficient grip on the needle and would fall off. This was fed back to the working group through the Datix patient safety incident system. The NRFit has a good connection that does not leak. In addition, since manufacturers have the confidence that NRFit is an international standard, they have invested in the expensive moulding tools rather than bonding an adaptor on to an existing luer needle, as was the case in many Surety devices. This means disconnection and leakage around the adaptor is not an issue.
Why all hospitals should make the move to NRFit
Now that NRFit equipment is widely available from several manufacturers there are many reasons why adopting the ISO 80369-6 connectors should be a priority for all clinicians treating patients with neuraxial applications as described by the Global Enteral Device Supplier Association (GEDSA) (2015: 5):
How might an organisation implement the change to NRFit?
NHS Improvement (2017) produced an informative slide set and video that can be viewed on YouTube. Several members of the Association for Anaesthetic and Respiratory Device Suppliers (Barema) special interest group worked on a simple step-by-step guide to assist other hospitals in making the change that was made available from many sources, including the websites of the Royal College of Anaesthetists and Barema (Sharpe et al, 2016). This is summarised by a flow diagram in the white paper produced by the ISO/TC 210—IEC/SC 62D/Joint Working Group 4 (2017).
How could patient safety be improved by using NRFit?
The following scenarios provide examples of how patient safety could be improved using NRFit.
Scenario 1
MB is a 23-year-old man receiving intrathecal chemotherapy for leukaemia. The hospital has already implemented a policy of only allowing the drugs for the intrathecal procedure to be present in the treatment room. It has banned any intravenous element of the chemotherapy from being present contemporaneously. The operator will infiltrate the skin on the patient's back with lidocaine 2% prior to inserting the spinal needle. This means there is a luer syringe present in the treatment room containing medication. MB has a peripherally inserted central catheter (PICC) in situ to facilitate blood draws and the intravenous elements of his chemotherapy. The intrathecal chemotherapy has been supplied in a syringe with an NRFit male end. The spinal needle has an NRFit female end. It is therefore impossible for the chemotherapy to be administered through the PICC as the syringe will not connect to the IV luer connection. It is impossible for the subcutaneous lidocaine 2% to be given intrathecally as the luer syringe will not connect to the NRFit-compliant spinal needle. The intravenous element of the patient's chemotherapy will only be brought into the room once the intrathecal chemotherapy is complete. The intravenous medication will be drawn up in a luer-type syringe and will therefore be completely incompatible with the spinal needle, making it impossible to connect it even if brought into the room in error.
It should be noted that it would be theoretically possible for the subcutaneous lidocaine 2% to be given intravenously. However, as only the intrathecal chemotherapy is being given in this episode of care, there should be no requirement to flush the PICC line and use the lidocaine-containing syringe in error.
Scenario 2
JS is a 35-year-old woman who is in labour. As she is diabetic, she has an intravenous infusion via a volumetric infusion pump for hydration and an insulin sliding scale infusion given via a syringe driver infusion pump in place. An anaesthetist has inserted an epidural using an NRFit-compliant kit. A midwife is now able to connect an epidural infusion with patient controlled bolus using a dedicated yellow epidural pump and NRFit-compatible giving set. It is impossible to connect the epidural infusion to the IV access and impossible to connect the IV infusion or insulin sliding scale to the epidural access.
It should be noted that the end of the NRFit giving set ends in a bag spike, making it possible for any type of infusion bag to be added to the epidural infusion. Vigilance is therefore required when setting up the infusion to ensure the correct fluid is selected. Epidural infusions usually contain local anaesthetic and opioids. The local anaesthetic can be deadly if infused intravenously. There is a risk whenever bags of local anaesthetic are supplied for epidural or regional infusion that they may be inadvertently administered intravenously. Storage of these bags of infusate must be secure and separate from intravenous fluids. To mitigate the risk of infusate bag confusion, the drugs could be supplied in a unique-to-pump cassette. It is important to recognise the cassette could still be filled with the incorrect medication and for many organisations the facilities to fill the cassettes are not available. However, a prefilled commercial cassette solution is available from some compounding providers.
Scenario 3
PJ is a 60-year-old man having an emergency laparotomy for small bowel resection. Bilateral rectus sheath catheters were placed during surgery. A regional analgesia infusion is to be attached in recovery room. The patient has multiple sites of access: an arterial line, central venous line, peripheral IV and nasogastric tube. The rectus sheath catheters are attached to an NRFit splitter, then to a single NRFit filter and then to an NRFit-compatible giving set from a regional analgesia pump. The regional analgesia infusion cannot be attached to anything other than the rectus sheath catheters because of the unique connectors on the filter. The nasogastric tube, arterial or central lines cannot be connected to the rectus sheath catheters as the female NRFit connector on the rectus sheath system cannot accept male luer or enteral connectors.
The risks with the infusate bag for the regional analgesia pump are the same as for the epidural scenario above, and could be mitigated in the same way.
Conclusion
NRFit unique small-bore connectors represent a long overdue change in practice that upgrades patient safety and reduces the risk of serious harms, including death. Given the lack of progression towards a complete ‘end-to-end’ solution that includes the ‘bag spike’ for connecting infusate, the risks of wrong administration of medication have not been completely removed. The use of custom cassettes for some manufacturers' pumps may reduce that risk further but present other logistical challenges. The implementation of a change to NRFit within an organisation should go smoothly if planned and executed meticulously with the involvement of all stakeholders.