Giovanna Forte FRSA explains how a simple design intervention is set to transform healthcare across the world
Public Health England and NHS Improvement released a new piece of research in May 2017. The paper reveals that 45% of Gram-negative blood infections are caused by simple, common Urinary Tract Infection (UTI).
UTI, often caused by E.coli, is one of the most common ailments, accounting for 1-3% of all GP consultations. UTI is the second most common clinical indication for empirical antibiotic treatment in primary and secondary care, and urine samples constitute the largest category of specimens examined in most medical microbiology laboratories.
Around one in three women have had a UTI by the age of 24 and around half of all women report at least one UTI sometime during their lifetime; if undiagnosed it can have a detrimental outcome on pregnancy. Without targeted treatment, UTI can evolve into a chronic condition that wrecks lives - and it can lead ultimately to sepsis.
Despite this, urine collection commands no national protocol, leading to contamination rates of up to 70% in the UK, with an average of 22.5%; that’s nearly one in four patients who will not be correctly diagnosed by their first specimen – and possibly not their second or third, either. Who knew?
Indeed, who knew that despite the serious implications of simple Urinary Tract Infection, the hit-and-miss collection of this diagnostic specimen is so inaccurate that its reliability has become a national lottery?
In 2002, an NHS GP in Suffolk identified the reason for so many repeat appointments and retests of his female patients presenting with UTI. Dr Vincent Forte found a high prevalence of contamination in urine samples, and deduced that the method of collecting the specimens was largely to blame, because without patient cooperation around “start-stop-aim-start”, the midstream required for accurate diagnosis could not be guaranteed; samples were being contaminated with first-void urine, rendering them pointless.
Dr Forte invented what is now the highly engineered Peezy Midstream urine collection device. What began as a simple flushable paper funnel, the principle of which rejected first-flow urine, collected midstream and ejected the remainder, became the basis for a ten-year research and development process to get the device absolutely right. To help achieve this, Forte Medical brought in MedTech design experts Maddison.
Initial investigations into flushable corn-starch polymer became redundant when the material was shown to be too novel – and at the time, too expensive – to achieve the desired result. When 1,000 corn-starch prototypes failed, Polypropylene took its place.
The first Peezy Midstream was a funnel formed by flat-sheet film, with a unique container-acceptor, incorporating an overflow duct. The killer ingredient to the device however, was a small compressed sponge, specified to expand once 8-10ml of urine had passed through the base of the funnel. The expanded sponge blocked the outlet to direct midstream into the collection tube, with excess diverted through a separate, integral outlet.
Peezy Mark I was evaluated up and down the UK; nurses and patients loved it but even at a selling price of around £1.20 - it was too expensive to satisfy the NHS need for cost savings. Peezy Mark II was designed as a single-cavity injection moulded piece, with the same mechanisms and features; this reduced the production price by 50%.
More evaluations and a trial at the Pennine Acute Hospitals NHS Trust, demonstrated a reduction in mixed growth contamination from a historic 23% to 5%; the results showed a higher rate in men than women which led to further design analysis and modifications to the mould, which included improvements to handling and performance gathered from evaluations in myriad hospitals and clinics.
Peezy Mark III was released in 2015 at a selling price of around 90p; it is a highly ergonomic device, which automatically collects the most accurate and hygienic urine specimen available today from men and women, from the elderly and the very young, transferring urine from patient to laboratory analyser without need for decanting. Indeed, Peezy complies in every way with Public Health England’s UK Standards for Microbiology Investigation of Urine 2016, which stipulates a requirement for routine midstream, collected by way of non-touch, no-spill methods. There is no way to meet these criteria other than by using Peezy Midstream.
Last year at Barts Health NHS Trust, Consultant Urological Surgeon Professor Frank Chinegwundoh MBE, collaborated with the Trusts’ Microbiology team to run a Quality Improvement Audit of 66 patients. The result? A reduction in historic urine specimen contamination from 17.5% to 1.5%, representing a huge improvement in the speed and quality of diagnosis and targeted treatment, whilst reducing incidences of repeat specimens (1).
This simple solution to the biggest problem that health providers do not know they have, took ten years and £2.6m to get right; it was achieved not by a multi-national with deep pockets, but by a start-up funded largely by friends, family and a handful of Angel Investors, along with the goodwill of design and manufacturing partners. It has been no easy task, not least given the austere economic climate prevalent since the company’s foundation. The end result however, is a unique, heavily patented medical device that is MHRA registered and USA FDA listed.
Our work in this area of diagnostic medicine has led us into dialogue with medical researchers and academics, with whom collaborations are being forged over new devices to capture first void urine, stool specimens, and finally a Peezy Detector for accurate and hygienic sports dope testing. This portfolio is called The Specimen Collection and our need for investment continues.
Common sense surely dictates that if the basics are not right, the rest cannot follow as it should, but in the world of diagnostics, accurate urine specimens fight for attention over robotics, apps and other high-tech healthcare solutions perceived to be of greater value than the delivery of integrity across basic medicine.
Peezy Midstream is a highly engineered, simple-to-use funnel that achieves right first time analysis, diagnosis and treatment, minimising the unnecessary drain on hospitals and GP surgeries of retests, repeat appointments and other resources. It also has the potential to reduce broad-spectrum antibiotic use through targeted prescribing and now, to prevent sepsis and save lives.
Thanks to the Association of British Healthcare Industries (ABHI), our market in the USA has taken months to open up, as opposed to years in the UK; we also have evaluations underway in Switzerland, Germany, Italy, Austria and Australia. At last, however, NHS opinion formers are waking up to the huge impact that an accurate urine specimen can deliver; microbiologists are offering to collaborate, investigate and encourage use of Peezy Midstream because quite simply, clinical improvements and savings across the whole patient pathway are so huge.
Without the curiosity and dedication of an NHS GP, without the experience of Maddison Design, without the ingenuity and enterprise of our British manufacturing partners, this award-winning, game-changing MedTech innovation would never have seen the light of day.
Today, millions of patients can benefit from preventative, basic medicine and healthcare providers can save millions on retests. That may not be such good news for the private and public/private laboratories that profit from volume testing, but is a life-saver for those who risk contracting blood infections from UTI, for pregnant women and the elderly who rely on accurate urine screening for optimum health and wellbeing.
Design is all, not just in the day-to-day, but in the nitty gritty of medical devices and the complex world of right-first-time medicine. In our case, excellent British design and manufacture is transforming healthcare across the world: do not underestimate the power of design.
(1) Barts Health NHS Trust: Quality Improvement Audit of 66 patients 2016