PD Safe completes successful clinical pilot in Manchester
The PD Safe device sucessfully acted as an early warning system for infection
An innovative solution designed to identify infection in dialysis patients has completed a successful pilot clinical investigation following a funding award from Health Innovation Manchester.
Manchester-based medical device company, Microbiosensor, secured £50,000 from the Energise Innovation Fund in 2016 to pilot the PD Safe device in Manchester.
The PD Safe is aimed at those on peritoneal dialysis therapy (PD) and acts as an early warning system for peritonitis, an infection that can prove fatal if left untreated.
PD is the lowest-cost and least-lifestyle-compromising form of renal dialysis available in the UK. However, less than 10% of patients on renal replacement therapy are on PD, with an average therapy duration of only five years.
Recurrent infections are a major cause of technique failure of PD and current best practice relies on patient’s self-reporting possible symptoms of infection — abdominal pain, fever and visually checking a clear plastic waste bag for signs of cloudiness in their PD waste.
It is vital that products like the PD-Safe are given support in order to transform health and social care
However, as the symptoms are not specific and not detectable until an infection has become well established; patients can find making a judgement stressful and difficult - leading to a delay in time to diagnosis and treatment.
The PD Safe aims to overcome this issue by plugging into existing PD waste fluid tubing and flagging an emerging infection at a pre-symptomatic stage via a simple colour change in a readout window.
The device uses a small dialysis waste sample from the patient to fill a series of reaction chambers containing chemicals which can detect bacteria and provide a rapid, clear colour change to alert the user to the infection.
Following the funding award, Microbiosensor has completed a successful pilot clinical investigation of the PD Safe device at the Manchester Royal Infirmary renal centre, working with consultant nephrologist, Dr Anand Vardhan, at the PD clinic.
The device successfully acted as an early warning system for infection, detecting bacteria within samples from patients, including one who was admitted to A&E within a few days as they went on to develop peritonitis.
Ben Bridgewater, chief executive of Health Innovation Manchester, said: “The PD-Safe device is an excellent example of the solutions Health Innovation Manchester aims to support in their journey to market.
“The successful pilot clinical investigation in Greater Manchester marks a great leap forward in the project which has the potential to meet the needs of local people and patients.
“It is vital that products like the PD-Safe are given support in order to transform health and social care and Health Innovation Manchester is uniquely placed to champion these innovations and connect researches, academics, business and the NHS in Greater Manchester.”
The PD-Safe device is an excellent example of the solutions Health Innovation Manchester aims to support in their journey to market
Gordon Barker, chief executive of Microbiosensor, added: “The Energise funding from Health Innovation Manchester helped Microbiosensor improve its understanding of clinical trial management at a major NHS trust and strengthen the design of a subsequent larger study at Manchester Royal Infirmary.
“It has made a significant contribution to Microbiosensor efforts to bring its novel medical device technology to market.”
Microbiosensor has also secured a £1.4m Series-A co-investment from the Northern Powerhouse Investment and the Greater Manchester and Cheshire Fund to support the company through its final product development stages.