Case study on the Knowledge Transfer Partnership (KTP) between PFE Medical and Aston University, funded by Innovate UK.

About PFE Medical

PFE Medical creates and manufactures innovative products and services for patients and healthcare providers, to improve outcomes and help save lives. The business, based in Stoke-on-Trent, was founded twenty years ago with just four employees. Since then, they have grown an extensive portfolio of endoscopy processing products. They have also developed innovative cleaning and disinfection technologies, which help thousands of patients in the UK each year.

The challenge that the KTP was set up to address

Endoscopes are long, thin instruments with a light and camera at one end that are used to look inside the body. Due to the sensitivity of the materials and electronics they cannot be sterilised in the same way as other laboratory and medical equipment and require lengthy cleaning procedures. A recent, award-winning KTP between Aston University and PFE Medical dramatically improved the effectiveness of this process through the development of a machine known as Khamsin. Khamsin is a world leader that treats and deep-cleans endoscopes in just five minutes, achieving hygiene and microbial reduction levels far superior to conventional manual procedures. It is currently in real-world trials in the West Midlands and looks set to save the NHS significant time and money.

Even with such high-powered cleaning, endoscopes can still end up with a bacterial biofilm inside them. Biofilms are large clusters of bacteria that are attached to a surface and to each other through the production of a slime layer. They show increased resistance to antibiotics as well as disinfectants and can therefore build up over time, even with effective cleaning and decontamination processes. Endoscopes with these resistant bacteria inside can lead to infections and sometimes to the death of patients.

This new KTP follows the previous work by the same partners and will trial fibreoptic probes carrying ultraviolet (UV) light to see if it is possible to detect biofilms. They will use this to develop a world-first device to inspect devices and clear them for use, improving patient safety.

Biofilm build up within endoscopes is a serious concern within the NHS and for healthcare providers around the world. If the project goal is achieved, the time taken to clean and check endoscopes will be further reduced and the life of this expensive medical equipment could be prolonged, which improves sustainability, a major strategy area in the NHS.

Why a KTP was the ideal route

The project will combine PFE Medical’s deep knowledge of endoscopes with very specialised knowledge and expertise in fibre optics at Aston University's Institute of Photonics Technologies (AIPT).

AIPT is a world-leading photonics research centre with a track record of success in medical lasers and bio-sensing for healthcare. The Institute coordinates international research and industrial projects from high-speed optical fibre systems to optoelectronics, UV and superfast lasers, nano-photonics, medical and bio-photonics.

Professor Kate Sugden is Deputy Dean of the School of Engineering & Applied Sciences and has significant experience in both industry and academia. One of her main research focus areas is on fibre optic sensing systems and she has worked as a director for two fibre optic companies. Kate’s knowledge of biomedical applications for photonics as well as practical engineering mean she is doubly qualified to guide the team as they progress.

Dr Tony Worthington is an Associate Professor in the College of Health and Life Sciences at Aston University and a member of the Cell & Tissue Biomedical Research Group. He brings extensive knowledge of healthcare associated infections and biofilms and can advise on their identification for this project. As well as the previous KTP that focused on the decontamination of endoscopes, Tony has also worked on an industry funded project looking at compounds that could prevent, control or eradicate pathogens and biofilms.

Dr David Benton is a Senior Research Fellow in Aston University’s AIPT. He spent many years working in industry, and his research expertise covers topics including laser detection and optical spectroscopy. David is an enthusiastic inventor with experience of practical applications for fibreoptics and laser detection. He has a track record in academia-industry collaborations, including KTPs, most notably in projects involving lasers and optical fibre technologies.

At PFE, Rebecca Hartley has been a product specialist for the past 10 years and is qualified as a validation engineer for decontamination. She worked as Company Supervisor on the previous KTP and brings unparalleled understanding of endoscopes to the KTP along with experience of industry needs.

What the research will involve

Based on previous research, the team believe that UV light is likely to be the best way to view inside the long interior channels of an endoscope to inspect the cleanliness and surface conditions within.

Endoscopes themselves are relatively simple devices, but they have very long tubes, so simply shining the light inside will not be enough. Inserting an optical fibre to deliver UV directly to the channel and recover induced fluorescence is currently the most promising option, but the team will need to test different UV sources and try different delivery and collection methods before finalising the optimal design. The researchers will determine the best UV wavelength for optimal detection and the team need to precisely engineer a probe to pass through the long interior channels.

What the partners say

Dr Tony Worthington, Aston University:

 “This KTP project continues the innovative and transformational work that we have done together in the endoscope cleaning and reprocessing sector. To find a way to objectively view if biofilm is present within an endoscope could be world-changing and have global impact for many patients.”

Professor Kate Sugden, Aston University:

“It was exciting to go to PFE Medical recently and see Khamsin in action, knowing that this new product came from a project that only finished last year. It will be a challenge to match the success of the last project but I am optimistic that we can draw on the combined talent and facilities once again to make a significant contribution to solving this problem.”

Rob Hartley, Managing Director of PFE Medical:

“Biofilm is a hidden killer, and we have no way to detect it currently without completely taking apart these medical devices. There is rising concern about microbial resistance and to find a way to objectively detect bacteria would be a true innovation that would have impact around the world.”