Case Study – Inivos

The challenge of infection control during a pandemic

Infection prevention and control has always been a key area of concern for any healthcare premises or provider; however, the COVID-19 pandemic has made this more critical than ever before.

A significant increase in the use of sanitising and disinfectant cleaning technologies has been necessary to control transmission of the virus.

One of the consequences of this additional cleaning is that, due to material incompatibility, surfaces and devices may succumb to Environmental Stress Cracking (ESC) or other degradation, ultimately leading to device malfunction.

Technology as a solution

Inivos comprise infection control experts with a mission to help hospitals to deliver better care, faster, by enabling facilities to protect people from infection.

Inivos is at the cutting edge of cleaning technologies, providing specialist hygiene products and robotic decontamination solutions to more than 50% of NHS hospital trusts in the UK and to health centres around the world. Tautvydas Karitonas, Inivos’ Head of Research and Development, believes that far more accurate and reliable data around material compatibility and chemical effects on various surfaces would allow better and safer decisions to be made.

This data would also allow for the formulation of more effective policies and instructions for the cleaning and decontamination of every object and area within the healthcare environment.

Implementation of this approach would, Tautvydas argues, ensure greater longevity of machinery and equipment, reduced costs to NHS trusts, reduced risk of staff burnout and, most importantly, more effective and reliable cleaning protocols and infection control.

“All of these benefits have the potential to save a beleaguered health service from unnecessary cost, as well as saving more lives.”

Compatibility testing is the key to developing both devices and cleaning protocols that can avoid ESC, maintaining the structural integrity of surfaces and devices. However, due to lack of standardisation, compatibility testing is not widely understood across the industry and the testing is not validated.

A brand-new laboratory for a different type of approach

Inivos recognised the need for a more research-led approach to this kind of testing, and so decided to set up their own testing branch, Test Labs, with a custom-designed laboratory to deliver this data and the results that would allow safe and certain decisions to be made in the development of medical devices and cleaning protocols.

“After the pandemic began, the testing laboratories we had previously outsourced our testing to became intensely focused on fighting the COVID-19 outbreak and did not have the available resource to carry out our tests. We realised that we could not stop developing and that we would have to create our own laboratory to ensure business continuity.”

As such, starting with an empty warehouse at the end of March 2020, the walls went up in September at the same time they put in their application for UKAS accreditation. In January 2021, less than a year from commencing the project, the Inivos laboratory officially opened, trading as Test Labs.

“We already knew we would be going for UKAS accreditation, so we used the ISO/IEC 17025 standard as the template for the laboratory, building it to the exact requirements. We were hugely motivated to provide the NHS with fast and reliable data, helping them to respond better to the pandemic. By Test Labs attaining UKAS accreditation, the NHS can be confident in the reliability and accuracy of our results.”

Accreditation as a blueprint for excellence

Tautvydas explained that the process was generally positive, starting with the Quality Manual and the purchase of various relevant standards which were used as the blueprint for the laboratory.

Next Test Labs conducted a gap analysis and went about filling the identified gaps, which during three national lockdowns presented something of a challenge.

“UKAS provided us with a really structured process, which as engineers, we responded well to. Our Assessment Team were completely unambiguous in their requirements and were supportive and helpful, pushing us to achieve the timescales we had set ourselves at the outset of this project.”

“The Quality Manual provided us with a great framework, and UKAS highlighted that with this as the starting point, everything else leads to continued improvement. Rather than being something that stops us from getting on with our jobs, we viewed the UKAS process as something that would help drive us forward to achieving our vision.”

Developing standards to keep pace with technology

Tautvydas explained that the principal driver for accreditation was to assure Inivos’ customers that they were getting reliable data that was safe to base decisions upon. However, there were other side benefits to the accreditation process.

“Technology is moving at a pace that is far outstripping the development of existing testing standards. The COVID-19 pandemic has been a steep and unforgiving learning curve. We have had to develop new products and services in real time if we were to have any hope of responding effectively to the pandemic. At the same time these responses need to be safe, therefore it is important that testing standards can be developed much faster, as the pace of technology is never going to abate. Having gone through the UKAS accreditation process, we believe we are in a position to help expedite this process.”

“One of the issues facing this industry that we have noted, is that claims about products or devices, often made by marketing departments, cannot be validated by recognised standards because they have yet to be developed. This leaves the medical sector vulnerable and unable to make the right choices for their needs and purposes.”

Next Steps for Inivos

When asked about the next steps for Inivos and Test Labs, Tautvydas is clear that this is only the beginning for this dynamic and ambitious company. “We’re not going to stop here; we intend to continue with microbiology accreditation and go into the material sciences. The NHS is hoping to build 40 new hospitals in the next 10 years. How are they going to choose what the best surface is to use in each setting?  What are the safest and most efficient methods of cleaning these surfaces? Technology must certainly be harnessed as part of the arsenal of weapons against infection, but if it is to be trusted and safe, this must be based on robust data delivered through accredited tests.”

UKAS Assessment Manager, Paula Catchpole had the following comments on Inivos’ speedy route to accreditation:

“Inivos have worked hard to create and implement a management system and to achieve their grant of accreditation within a short timeframe. The laboratory is a brand new facility and the speed in which the laboratory environment was purposed to be suitable for accredited activities was impressive.

It is great that emerging technologies are being harnessed to fight the spread of infection, and that accreditation is able to underpin quality in these technologies, ensuring competence, safety and reliability of data. It has been interesting to work with them on their journey to accreditation am happy to continue to work with them into the future”