“The concerns for the comfort of haemodialysis patients was obvious from the beginning. To give them comfort and modesty in a mixed unit, but most important of all, the vest giving security with restricted movement to the neck line both during the night and day for both male and female patients, alleviating the possibility of having to replace the neck line, causing even more discomfort and anxiety for the patients concerned.” 
Dorothy (Tookie Renal Patient Ambassador) 

The Tookie Vest is a patient and clinician driven innovation, designed to support patients fitted with a Central Venous Catheter (CVC) undergoing haemodialysis (HD) to provide enhanced line security. The Tookie Vest is designed to help prevent catheter displacement but also to aid the patients to continue to live ‘#ALifeMoreNormal’ as the vest helps to discretely secure the lines, offering modesty and dignity, freedom, independence and reassurance.

The Tookie Vest was originally designed to prevent inadvertent catheter fallout in paediatric oncology patients, a product that was supported by the Yorkshire & Humber AHSN through funding and access to specialist clinical and design advice.

The AHSN for the North East and North Cumbria (AHSN NENC) have since provided support and advice via ‘The Innovation Pathway’ for the development of the adult HD vest.

The key outcome is the development of a wearable medical device which is CE Marked and ready for a qualitative and quantitative evaluation study, which ultimately could assist 25,000 adults with a CVC for HD across the UK (Source: Renal Registry). The proof of concept pilot study is planned to start by the end of the 2018/19 financial year.

MedConNecT North have also facilitated further connections with clinicians, and Tookie are now working with the Great North Children’s Hospital in Newcastle with Dr Yincent Tse and Dr Heather Lambert, Consultant Paediatric Nephrologists. Together they have developed a paediatric version of the Renal Vest, which has also been CE marked.

In addition, Tookie Limited has been awarded an NHS Supply Chain Framework contract for Tookie products which is now live and has recently achieved ISO 9001 status.

Challenge / problem identified

Haemodialysis is an intervention used for people who are diagnosed with, or are approaching, kidney failure. It is a method of removing waste products and extra fluid, which build up in the blood when the kidneys are no longer able to function properly (Kidney Research UK). Treatment is regular and therefore easy access to blood vessels via a catheter is required in order to provide adequate haemodialysis (HD), which is ultimately a life-saving therapy.

There are 61,000 patients in the UK with Renal Replacement Therapy, of which 25,000 are fitted with a Central Venous Catheter (CVC)1. Complications of CVC use are well documented, especially that of inadvertent catheter displacement, with around 20% of patients affected2.  Each line reinstatement costs the NHS approximately £3,000.003, whilst also affecting the patient’s quality of life.

  1. Renal Registry
  2. Audit conducted by Dr Saeed Ahmed, City Hospitals Sunderland NHS Foundation Trust
  3. City Hospitals Sunderland NHS Foundation Trust).
Actions taken

The Tookie vest was originally designed for paediatric oncology patients, and one of the main challenges encountered was redesigning the vest for adult Haemodialysis (HD) patients.

The key partners in the adult HD project are:

  • MedConNecT North
  • The National Institute of Health Research Clinical Research Network, North East and North Cumbria (NIHR CRN: NENC)
  • City Hospitals Sunderland NHS Foundation Trust
  • Tookie Limited
  • The AHSN for the North East and North Cumbria (AHSN NENC).

MedConNecT North are one of the delivery partners of the AHSN NENC Innovation Pathway and helped Tookie Limited by connecting the company with a specialist renal clinicians Dr Saeed Ahmed and Dr Rachel Davison together with the Research and Innovation Team at City Hospitals Sunderland NHS Foundation Trust. They helped to facilitate patient focus groups in collaboration with the Trust in order to further develop and design the product for use in an adult renal population. The MedConNecT North team continues to work jointly with the Trust and the company and will be coordinating evaluation studies to test the impact of the vest on clinical outcomes and patient quality of life.

To overcome this, City Hospitals Sunderland NHS Foundation Trust’s renal research team and the Research and Innovation (R&I) department, supported by MedConNecT North arranged for the Tookie team to hold patient centred focus groups to re-design the vest and create an adaptable product that could be used within this patient population. Focus groups took place, during which time many prototypes were considered by the research team and the final design has now been CE Marked.

The vest will now go through formal evaluation via clinical research studies conducted in collaboration with the NIHR CRN: NENC and City Hospitals Sunderland NHS Foundation Trust.

Impacts / outcomes

The Tookie Vest is now ready for a qualitative and quantitative evaluation study. This National Institute for Health Research (NIHR) portfolio adopted, multi-centre, proof of concept study will explore the unmet need of the renal patient to provide a suitable wearable vest to improve their Quality of Life (QoL) and enhance mechanisms that enable the efficient delivery of their treatment. The study will also assess the impact of the garment on clinical outcomes (for example, fall-out rates).

The outcomes for the a patient should be an increase in:

  • comfort
  • line security
  • modesty
  • dignity
  • freedom
  • independence
  • reassurance.

The financial benefits are being reviewed as part of a wider evaluation. What is known at this stage is that 20% of patients become affected by inadvertent line fall out and that each line reinstatement costs the NHS approximately £3,000. It is hoped that this innovation will help to reduce the amount of line reinstatements required and the study will inform the understanding of its value proposition to the NHS.

In 2017, Tookie Limited became a member of the ‘IP 100 Club’ and were the Medilink North West Runner up in the Start-Up award category. The collaboration with City Sunderland Hospitals was showcased at Venturefest in Newcastle and was awarded runner up in the NHS Bright Ideas Awards in the NHS and Industry Partnership Category in November last year (2017).

In January 2018 Tookie Limited took the Innovation Award in the Medilink Northern Powerhouse Healthcare Business Awards, which automatically shortlists Tookie into the National Awards held on 25 April 2018.

Plans for the future

The next step is the design and implementation of the proof of concept pilot study. Specialist researchers from the National Institute for Health Research (NIHR) Clinical Research Network (CRN) have been drafted in to strengthen the research team and to prepare the evaluation study protocols for the next phase of work. The aim is to have the proof of concept study open by the end of the 2018/19 financial year. The recruitment period will be short, and so the analysis and results are expected within six months of the study end date.

Dr Saeed Ahmed suggests, “Tookie and City Hospitals Sunderland NHS Foundation Trust would promote the research and the use of the innovation in the 35,000 patients on Renal replacement therapy. A significant number of these patients will use a central venous catheter for dialysis. We would hope to have the innovation endorsed by the Renal Association, British Renal Society and Vascular Access Society of Britain and Ireland. This would help in adoption of the innovation in the fifty-two Renal Units in the UK.”

Tookie has been asked to investigate the design and development of a suitable apparel for Renal PD patients and furthermore, work is continuing at Sheffield Children’s Hospital to develop and implement a suitable apparel for respiratory patients based on the same core principles of line security and enhanced Quality of Life (QoL).

A suitable device for Peripherally Inserted Central Catheter (PICC) line protection is also being developed with Leeds Hospital for adults, and Sheffield Children’s Hospital.

Start and end dates

May 2016 – March 2017

Find out more

Charlotte Fox, Innovation Manager, City Hospitals Sunderland NHS Foundation Trust
E: charlotte.fox@chsft.nhs.uk

Rachel Forrest Research Operations Manager (Medical Technology), NIHR CRN: NENC /MedConnecT North
E: rachelforrest@nhs.net

Stephen Tooke, Commercial Director, Tookie Limited
E: Stephen.Tooke@tookie.co

Media contact
Donna Smith, Communications team, AHSN NENC
E: Donna.smith@ahsn-nenc.org.uk