National Health Service estimates 73% of 65-million urine specimens collected annually in the UK are contaminated
Wanting to know why so many female patients that present with urinary tract infections (UTIs) require repeat appointments, Dr. Vincent Forte, a family GP and forensic physician who worked for the National Health Service (NHS) for 26 years, began investigating. He determined that the standard urine specimen collection cup is primarily the cause of poor-quality medical laboratory test results.
Forte realized that the method of collecting the specimens was largely to blame, with the required “start-aim-start” midstream collection technique required by traditional polypropylene specimen cups at the root of the problem.
That realization led to the development of a unique “midstream” urine collection device that eliminates the problem of first-void urine contaminating samples, according to a blog post on the Royal Society for the encouragement of Arts, Manufactures and Commerce (RSA) website written by Forte Medical of London’s Founding Director and Chief Executive Officer Giovanna Forte, Vincent Forte’s sister.
65-million Specimens Deemed Unreliable
Healthcare professionals, whether working in clinical laboratories and anatomic pathology groups or hospitals and out-patient clinics, often are among the first to notice when gaps in the quality or integrity of medical laboratory test results exist. However, in this case, it was a general practice physician rather than a medical laboratorian or in vitro diagnostics (IVD) manufacturer that set out to solve the problem of poor urine specimen collection, which The Daily Telegraph reports results in 73% of the 65-million urine specimens collected annually by the NHS being unreliable. That’s 47.5-million unreliable medical laboratory specimens collected and tested yearly in the United Kingdom.
Accurate Urine Collection Brings Billions in Savings
Vincent Forte concluded that the quality gap in urine specimen collection for his female patients was preventing accurate first-time analysis, diagnosis, and targeted treatment. In 2001, he set out to re-engineer urine collection cups. His first design—“a simple flushable paper funnel, which rejected first-flow urine, collected midstream, and ejected the remainder”—established the underlying design principle behind the patented Peezy Midstream product, Giovanna Forte stated in the RSA blog post.
Giovanna Forte noted that the first version of the device, marketed in 2010, was a “funnel formed by flat-sheet film, with a unique container-acceptor,” with overflow duct and incorporating a compressed sponge that rejects the first 8-10 ml of urine. While the product was well received, Forte says the selling price was too expensive to meet the NHS requirement for cost savings. By 2012, the product evolved into an injected-modeled design, which cut production costs by 50%. By 2014, the ergonomically designed funnel was improved to incorporate the two most common urine collection tubes.
In a Forte Medical presentation, Giovanna Forte predicted that accurate urine collection could result in a £1.2-billion (US $1.56-billion) savings to the NHS.
A Design Week article described the testing process for developing the midstream specimen collection device as “similar to launching a website in beta,” with initial testing resulting in changes such as the creation of a flatter, rounder handle to make the product easier to hold.
“Within the NHS, I was allowed to attend clinics where evaluations were taking place and speak directly to the patients. This allowed me to find out what they thought of everything from instructions for use to the collection system itself,” Vincent Forte stated in the Design Week article. “All the information was fed back into our design engineers, who proposed an improved product made more simply at a lower price.”
Today, Forte Medical offers two midstream urine collection devices used by both men and women:
1. Peezy Midstream PE40, which collects urine into a traditional 30ml universal container; and
2. Peezy Midstream PE50, which collects urine into a lab-friendly 10ml primary tube designed to fit in laboratory analyzers.
“This simple solution … took 10 years and £2.6-million [US $3.38-million] to get right. It was achieved not by a multinational with deep pockets, but by a startup funded largely by friends, family, and a handful of angel investors, along with the goodwill of design and manufacturing partners,” Vincent Forte stated in the RSA blog post.
Specimen Capture Methods Lead to Careless Infection Control
In an article published on News Medical, an online, open-access medical information provider, Giovanna Forte points out another flaw in traditional urine collection systems.
“Thrusting one’s hands willingly into our own urine is hardly common practice. That we are expected to do so in order to capture an important specimen essential to diagnosis hardly chimes with the concept of modern medicine and leads to pretty shabby infection control by any standards,” she stated.
The Peezy Midstream is a Medicines and Healthcare Products Regulatory Agency (MHRA) approved product in the UK, and is FDA listed in the United States. As a Class 1 “Container, Specimen Mailer and Storage, Non-Sterile” device, the Peezy Midstream is “510(k) exempt” and did not require FDA review before being marketed in this country.
Still to come are clinical trials and papers in peer-reviewed medical journals that support the function of this medical device to improve patient care. It is notable, though, that the National Health System in the UK is collaborating with Forte Medical in certain ways to determine how the device can improve patient care. Dark Daily would like to hear from any medical laboratories in the UK and USA that are using this device when urine specimens are collected.
—Andrea Downing Peck