The Department of Health and Social Care commissioned the NHS Clinical Evaluation Team (CET) to provide clinical insight into everyday healthcare consumables, with a focus on quality, safety and value in reducing waste (Department of Health (DH), 2016). The CET brought together health professionals across a range of areas: clinical nurse specialists in tissue viability, vascular access and intravenous (IV) therapy, infection control, theatres and clinical procurement, as well as paramedics, physical therapists and podiatrists.
This programme—of which I was privileged to be part—was launched in April 2016. Its tenure ended in October 2018 after it had successfully published more than 30 invaluable reports. Its members delivered independent evaluations, providing high-quality, unbiased and trusted clinical product comparisons.
The CET reported directly to the Clinical Reference Board (CRB) under the leadership of Professor Mandie Sunderland, CRB Chair and Chief Nurse at Nottingham University Hospitals NHS Trust. The CRB is a fundamental part of the NHS National Customer Board, which was instrumental in guiding the work of the project.
This CET initiative was prompted by Lord Carter's report, which found unwarranted variation in productivity and performance between NHS hospitals (Carter, 2016).
The CET reviewed everyday healthcare consumables used in the NHS, identifying products that enable staff to provide the highest standard of patient care and deliver the best outcomes for the NHS.
I led on the evaluation of safety peripheral intravenous cannulas/catheters (SPIVCs). This product was identified for inclusion in the work plan because it is used in high volumes and a wide variety of these products are available in the NHS supply chain catalogue. The NHS spends approximately £4.5 billion per year on clinical products in the acute sector alone, of which approximately £29 million goes on peripheral intravenous cannulas/catheters (PIVCs).
Studies have demonstrated that up to 90% of all inpatients require the insertion of an intravenous (IV) access device to facilitate therapy administration; these devices are also used for diagnostics and monitoring (Alexandrou et al, 2015; iData Research, 2015).
SPIVCs are not without risks and complications and PIVC-related infections can set back the healing process and worsen patients' health. Although infection rates are low, owing to the high volume of the devices used the overall problem could prove significant. The NHS is trying to reduce the risk of PIVC-related complications and one way is by choosing innovative, appropriate devices. It is evident that improving the safety and quality of health care depends on implementing evidence-based practices; however, few studies into the clinical acceptability and design of PIVCs have been undertaken with sufficient rigour and clinical criteria. There are more than 200 varieties of PIVCs in the NHS Supply Chain (2019) catalogue and there are distinct differences between them, but many of these relate to engineering design rather than clinician-defined criteria and high-quality evidence.
Since the formation of the CET clinicians had had a greater input into product selection. Throughout the CET programme, health professionals on the shop floor and specialist practitioners have been pivotal in achieving the goal of providing a tool to aid the selection of the most appropriate device to ensure the highest quality patient outcomes.
This article offers an overview of the work of the CET, with a focus on SPIVCs, and looks at how the process will continue in future.
Need for device review
The continuous rise in healthcare complexities of today's patient population as well as the financial climate in the NHS, not to mention the uncertainties of Brexit, make it ever more challenging to meet the physical and psychological needs of individual patients. Technological advancement in recent years has contributed to improving patient care, most certainly in IV therapy; however, these advances may have increased the volume of unwarranted variations. Although the PIVC market continues to grow, there is a lack of consensus and clinical guidelines within the NHS. On the one hand, standardisation is key; on the other, individual trusts will have their own criteria for selecting PIVCs and certain patient groups will have specific requirements, both of which complicate standardisation.
The ethos of this project is to have the best-quality devices for patients based on current evidence. It was fundamentally created for the NHS and purposefully aimed to capture true representation of clinical opinion and take that information and turn it into clinical criteria. These are the clinical criteria against which PIVC devices are now evaluated. The evaluation process, based on a clinical pathway, is considerable and built on extensive engagement with NHS clinicians.
PIVC insertion is the most commonly performed clinical procedure in hospitals across the world, with about 1.2 billion inserted every year (Alexandrou et al, 2015). The PIVC is perceived as a basic device, yet it is a critical component of patient care in both hospital and ambulatory care settings. Consequently, technological advancement concerns not only devices, such as SPIVCs used to deliver infusions, but also staff development and the application of evidence-based practice (Nursing and Midwifery Council, 2015). This necessitates skilled patient assessment to choose and match the correct vascular access device to individual patients' clinical requirements, especially with paediatric patients (Carr et al, 2011; Alexandrou et al, 2015).
The process of SPIVC selection varies between individual hospitals and other healthcare organisations across the country, as well as between local units and departments. Most NHS organisations have product selection groups and procurement teams who make the decisions and who will choose one type of vascular access device over another depending on its unique, characteristic features (Barton et al, 2017). A distinct feature of SPIVCs is their sharp-safety mechanism, which must comply with EU Directive 2010/32 (Council of the European Union, 2010) on the prevention of needlestick and sharps injuries.
This clinical review focused on evaluating and exploring the design and clinical acceptability of SPIVCs in practice. Establishing what clinicians want will inform suppliers to innovate and improve their products and will also apprise procurement teams to ensure that they are buying the right quality products more effectively and that these products are fit for purpose (Carter, 2016; NHS Clinical Evaluation Team, 2018).
The five-stage clinical review pathway
Stage 1: CET work plan appraisal
Product inclusion was established at this stage, in view of individual products already in use in practice. One of the questions asked was: Does it have a clinical impact and patient impact? If so, is it an everyday product?
Stage 2: intelligence gathering
This stage included a review of academic literature, national guidance, professional body guidance, national and international standards and published independent laboratory test results. Also, at this stage, supplier engagement events were undertaken, where we shared our processes with the suppliers of the products selected for the review. This included calls to action to ensure suppliers had ‘ward-ready’ samples for the evaluations.
Stage 3: stakeholder engagements
A range of activities were conducted at this stage. A series of clinical conversation events were held at NHS trusts across the country. Collaborative and partnership working was a key feature of this stage. We engaged with specialist clinicians, targeting IV practitioners and vascular access specialist teams, including the members of the National Infusion and Vascular Access Society. We also used other methods, such as focused clinical visits and attendance at events and forums, to network with specialist groups and gain a more in-depth understanding from a clinician's perspective.
Stage 4: clinical criteria development
The criteria, which were formulated and shared with clinicians who attended the open days and took part in the conversations, were posted on the CET's website workspace, where they could be accessed freely by anyone. Feedback from clinicians was taken on board and the amended criteria were then shared with suppliers to notify them of the standards against which their products will be evaluated.
This is the stage at which the evaluation modes were determined and assigned. The three defined modes are simulated practice, clinical in use and independent laboratory testing, all of which were used in the evaluation of SPIVCs. Furthermore, this is also the stage at which the evaluation methodology was determined and the benchmarks against which the products will be evaluated were confirmed, before the final clinical criteria are published.
Stage 5: Product evaluation, review results, completion and publication
This is the final stage during which the SPIVCs were scored for performance against each criterion during evaluation activities and events.
An independent laboratory in Wales was commissioned to support us and two tests were conducted. The first was the stiction test, a portmanteau of the term ‘static friction’, also known as stationary friction (this is the static friction that needs to be overcome to enable a stationary object to move). This was designed to assess the initial stiction test that has been evident with some designs of cannulae, which can result in premature dislodgement. Testing was performed on three replicates and the mean was calculated at the initial 20 mm (at needle withdrawal) for the purpose of the report.
The second was the needle penetration test. In this test, the force required for the needle and cannula to penetrate a 0.12 mm-thick acetate film was measured in three replicates and the mean force calculated.
In addition to the simulated clinical evaluations, clinical in-use evaluations were conducted in three large acute NHS trusts over a 4-month period using a modified Likert scale method (Table 1).
| Rate levels of clinical acceptability* |
|||||
|---|---|---|---|---|---|
| Clinical criteria | Strongly agree | Agree | Disagree | Strongly disagree | Comments |
| The needle cover is easy to remove | |||||
| It is easy to identify needle bevel orientation with clear view of bevel up | |||||
| Blood flashback is clearly visible in the flashback chamber | |||||
| The cannula is easy to advance into the vessel | |||||
| It is easy to pull/withdraw the needle after the cannula is sited | |||||
| It is easy to disengage the needle from the catheter hub | |||||
| It is easy to feel/hear audible click of the safety mechanism when it is engaged | |||||
| The device safety mechanism can be activated using one hand only | |||||
| The safety mechanism is not retractable or reversible | |||||
| The cannula design is intuitive, with easy to understand instructions | |||||
| Staff name (optional) Job title Clinical area | |||||
During this final stage, the data were consolidated and summarised to provide overall results with average scores, which were then included in the report that captures the CET process. The results were also placed in a draft matrix for CET moderation, passed to suppliers for comments on factual outputs, legal approval (as required) and publication.
The aim was to provide a toolkit, so those reading the reports could make an informed decision about which PIVC type they may wish to purchase based on the clinical criteria pertinent to their patient group(s) and clinical environment.
It was made clear from the outset that the report is intended to be used as a tool, not to dictate to care providers on product selection. Furthermore, it aims to aid in the selection of the most appropriate device for high-quality patient outcomes, and improve the understanding of which devices are and are not comparable. It is not about getting the cheapest PIVC; the savings come in the volume of procurement that we can make by choosing the right device that is fit for purpose.
This programme has provided a vital contribution, enabling NHS providers across the country to overcome the many challenges they currently face. The is a large range of choices in the NHS Supply Chain catalogue, and the NHS CET report provides a unique tool to enable clinicians and trusts to act efficiently and effectively, while using the best quality and most cost-effective PIVCs.
Conclusion
To date, the majority of studies and research conducted into PIVCs have centred on care and management in economically developed nations. Clinical design and acceptability studies are often carried out by industry as part of commercial promotion of one product against another.
The comparison of studies reviewed at stage 2 of the project was noted to cover a limited number of PIVCs—not all those in the NHS Supply Chain catalogue had been evaluated against the same clinical criteria. The report is intended to inform and encompass the views of clinicians working across the NHS, which will significantly improve the PIVC procurement process, with a consequent high impact on patient care. In addition, by highlighting unmet clinical needs, this report will pave the way and support innovation from clinicians and industry.
Moving forward, clinical engagement and collaboration will carry on, now that clinicians are involved in the Category Towers in the NHS Supply Chain and the Clinical and Product Assurance Team. These are an integral part of the supply chain management functions and will both ensure and assure quality, safety and value for the NHS (DH, 2017).
I have learnt much working on the programme, alongside senior clinicians from around the country. The outcome of the programme has been a true validation of the words of Professor Sunderland, who led on the project: ‘Quality, safety and value are at the heart of our work and it's important that we use our clinical experience to deliver high standards of care while reducing cost and waste in the NHS. The financial strain on the NHS is considerable, and the CET is uniquely placed to address this by effectively evaluating product ranges’ (NHS CET, 2018).