PROVE SCIENTIFICHE e REFERENZE

del flusso laminare focalizzato TOUL

 

La letteratura su TOUL è ampia, multidisciplinare e in continua crescita.

Tutti gli studi sono stati condotti in completa autonomia dai centri clinici.

Si riporta solo una piccola parte delle pubblicazioni disponibili.

Achieving room air quality of room class 1b using a mobile sterile ventilation unit in a room class II surgical unit (Boppre et al., 2024).

Scientificamente validato – Classe di purezza dell’aria Ib (ISO 5)

I nostri sistemi mobili a flusso laminare (Laminar Air Flow) sono stati validati in uno studio clinico indipendente e soddisfano in modo comprovato i requisiti della classe di purezza dell’aria chirurgica Ib (ISO 5).

La validazione è stata eseguita da rinomati esperti di igiene ospedaliera, tra cui il Prof. Axel Kramer (membro della Commissione per l’Igiene Ospedaliera e la Prevenzione delle Infezioni presso l’RKI) e il Prof. Martin Exner, presidente della Società Tedesca per l’Igiene Ospedaliera.

I risultati mostrano chiaramente che, con l’utilizzo dei nostri sistemi mobili, la carica microbiologica nel campo operatorio e sul tavolo strumenti può essere ridotta allo stesso livello di un impianto di ventilazione fisso di sala operatoria – in modo sicuro, efficiente e scientificamente comprovato.
Condizioni sterili conformi alla classe Ib (ISO 5) possono quindi essere ottenute senza necessità di grandi investimenti strutturali.

Obiettivo: Valutare se un’unità mobile di ventilazione sterile (MSVU) possa garantire i requisiti microbiologici della classe 1b (ISO 5) nell’area del campo operatorio e del tavolo strumenti, sostituendo un impianto di ventilazione centralizzato.

Metodi: 26 interventi chirurgici (varici, ernie). Confronto tra tre condizioni: posizionamento ottimale MSVU (M1 e M2), posizionamento scorretto (M3) e sistema spento (M4). Misurazioni tramite piastre di sedimentazione (CFU) e conta particellare.

Risultati principali:
– Riduzione CFU: M1 -88,4%, M2 -91,5%, M3 -65,2%
– Riduzione particellare media: -66%
– Nessuna differenza fuori dall’area sterile (M4)
– Nessun Gram-negativo rilevato, solo flora cutanea.

Conclusione: L’MSVU in una sala RC II (ISO 7) consente di raggiungere parametri equivalenti a RC Ib (ISO 5). Soluzione efficace, sicura, flessibile ed economica per ridurre il rischio infettivo anche in chirurgie ambulatoriali.

Riduzione delle infezioni con flusso laminare focalizzato

Impact of a laminar air flow portable device on post- intravitreal injection endophthalmitis rate.

Un importante studio monocentrico condotto presso l’Università di Milano – Ospedale Luigi Sacco e pubblicato sul British Journal of Ophthalmology (2025) ha analizzato 101.976 iniezioni intravitreali (IVI) eseguite tra il 2017 e il 2023.

L’obiettivo era valutare l’impatto del flusso laminare mobile TOUL Operio sulla riduzione delle infezioni post-procedurali (endoftalmiti) in un ambiente ambulatoriale sterile.

I risultati sono stati scientificamente validati (p=0,04):

  • Prima dell’introduzione di Operio (33.478 IVI):0,033% di endoftalmiti
  • Con Operio (68.498 IVI):0,013% di endoftalmiti
Riduzione delle infezioni con TOUL Flusso laminare focalizzato

L’incidenza di endoftalmite è diminuita da 0,033% a 0,013%, corrispondendo a una riduzione del rischio del 63,2%, statisticamente significativa (p = 0,04).

Lo studio è stato condotto in condizioni uniformi, in un unico centro di riferimento, dove l’unica variabile introdotta tra il periodo pre e post-intervento è stata l’installazione del flusso laminare mobile TOUL Operio.

Questa configurazione ha permesso di isolare in modo chiaro l’effetto del dispositivo, dimostrando che il flusso laminare focalizzato TOUL migliora la qualità dell’aria sopra il campo operatorio e il tavolo strumenti, riducendo significativamente la contaminazione microbica.

Safety of intravitreal injections with the mobile laminar airflow device Operio after more than 10.000 injections.

Zero infezioni dopo oltre 10.000 IVI con TOUL Operio.

In uno studio condotto presso l’Università di Perugia sono state analizzate 10.016 iniezioni intravitreali (IVI) eseguite con il flusso laminare mobile Operio:

• 0 casi di endoftalmite (0,00%).

L’ESPERIENZA DELL’ORTOPEDIA – GIUGNO 2021

Dr. Lukas Mansson – Drammen, Norway

Studi clinici ed esperienze dirette di chirurghi che usano TOUL.

PREVENTING COMPLICATIONS in Orthopedic surgery.

Dr. Lukas Mansson

Some years ago, the Vestre Viken Hospital, in Drammen, Norway, recognized the benefits of the Toul Meditech Operio® for orthopedic surgery. Dr. Lukas Mansson, Chief of Services for the Department of Orthopedic Surgery and Emergency Medicine and Orthopedic Surgeon at the Hospital, has used the system since it was installed in 2015, and values the contribution that it has made to infection control, as well as cost savings.

A Better Option for Clean Air

Orthopedic surgery is carried out in two different hospitals within the Vestre Viken Hospital Trust.

“With inconsistent data regarding the performance of LAF (Laminar Air Flow) ceilings, we looked for alternatives in the market and found out about Toul Meditech Operio®,” said Dr. Mansson. “It became a choice between a LAF ceiling and the Toul Meditech Operio® . Toul Meditech Operio® stood out for three main reasons. Firstly, there was good and consistent data published on its performance. Both preclinical and subclinical papers. Secondly, it appealed because it gives us better control of the clean air in the operation, that can be focused on the surgery site and on the instrument table. And the last point that was relevant was cost. On life-cycle cost, the Operio® offers savings.”

Infection Control System

The Toul Meditech Operio® has become a part of the Hospital’s infection control system. “We have a very efficient or effective infection control program and have reduced the risk of many infections through this,” remarked Dr. Mansson. “It’s hard to say which part has contributed to what in a complex system, but we have been able to achieve a relatively low incidence of circo synovial infection in the context of joint replacement that is class leading on a global scale. That, of course, is the main benefit of the Toul Meditech Operio®. It is part of a very good system.”

Since 2015, the Vestre Viken Hospital has used the Toul Meditech for more than 5,000 joint replacements and over 3,000 spinal surgeries, as well as other surgeries. It is now used for all joint replacements and spinal surgeries.

No Downtime

“Without the Toul Meditech Operio® , that would not have been possible, because that was an old (20 years old) day surgery unit, which was originally designed for non-ultraclean surgery” said Dr. Mansson. “With the Toul system, we were confident that we had a clean air system that we could employ to utilize all the space that we had.”

Adopting New Technology

Within a short space of time, the Toul Meditech® was easily integrated into the surgical processes of the orthopedic department.

“With Toul Meditech Operio®, you do have to look through your processes. You have to ensure that the nurses and surgeons that use the system really know and understand it,” emphasized Dr. Mansson. “However, if you accept it and learn how to use it, you can

maintain good efficiency, but you need to adapt it to your work level, or adapt your work- level to that kind of equipment.”

COVID-19 Pandemic

The COVID-19 pandemic has had an impact Norway, although so far not as severely as some other countries.

“Considering the effects of the pandemic on the world in general, we have a huge backlog on elective surgeries on a global scale and of course, every technology that can reduce the risk of major surgery complications helps capacity in this context,” said Dr. Mansson. “Some orthopedic conditions already require enormous amounts of resources to treat, with long surgeries, and long stays at the hospital, but one of the biggest cause of waste in the healthcare environment is major complications, as well as over overtreatment, So everything we can do to reduce complications will free up capacity to address that backlog. I think it’s extremely important that during the post-pandemic period we consider that we look at infection control and learn as much as possible from the pandemic experience. Infection control must be regarded as an essential system. And in infection control with regards to surgery, I would predict surgery with the Toul Meditech Operio®, can be a cost-efficient part of that.”

Dr. Lukas Mansson

Dr. Lukas Mansson is the Chief of Services for the Department of Orthopedic Surgery and Emergency Medicine at the Vestre Viken Hospital, Drammen, Norway. He is also an orthopedic surgeon, mainly in hip, shoulder and trauma surgery.

Dr. Mansson has worked at the Hospital for 16 years. He has worked as an orthopedic surgeon at several different hospitals before that, in both Norway and Sweden.

L’ESPERIENZA DELL’OFTALMOLOGIA – GIUGNO 2021

Mr. Simon Madge – UK

Studi clinici ed esperienze dirette di chirurghi che usano TOUL.

A breath of FRESH AIR during the pandemic

Mr. Simon Madge 

 

Mr. Simon Madge is a Senior Consultant Ophthalmic Surgeon based in Hereford in the UK. He holds significant roles in both private and National Health Service (NHS) practices in the area. During the initial stages of development of the Covid-19 pandemic, he was responsible for overseeing the departmental responses to the epidemic. Using a Toul Meditech Operio® enabled Mr. Madge’s teams to continue with essential sight-saving surgery throughout this period, when so many healthcar facilities had to close.

Mr. Madge first became aware of the Toul Meditech Operio® at the American Academy of Ophthalmology Annual Meeting 2019 in San Francisco, US.

“I had been looking for something like the Toul Meditech Operio® for quite some time, and I was quite surprised to see it in action,” he remarked. “It was very clear from the way that they were demonstrating it, using a particle counter to show how clean the air was, that it could easily be used to facilitate modern cataract surgery, as well as any other sort of intraocular procedure.”

While the Operio® answered the equipment needs that Mr. Madge had already had for some time, the timing of him discovering that it was available couldn’t have been better in the light of the ensuing pandemic a few months later.

Making Sight Saving Procedures Possible

When the Covid-19 pandemic started to impact the UK, many healthcare facilities were unable to continue their normal activities. The Toul Meditech Operio® provided the opportunity to keep going, creating a safe environment for cataract surgery.

“When Covid-19 hit in Hereford, we were unable to use our ophthalmic operating theater, because it was located next door to an intensive care unit,” explained Mr. Madge. “Even after the first Covid wave had come and gone, we still had a period of about four or five months, where due to a variety of local protocols, we couldn’t get into the ophthalmic theater, and we had to choose between doing nothing, which of course, we knew was a very bad idea, or being innovative and act. We chose the latter. And the Toul Meditech Operio® allowed us to set up a safe, effective, and relatively high throughput cataract service within a standard NHS outpatient clean room – in other words, outside of an operating theatre. And that combined with some other innovative features of our pathway enabled us carrying out many hundreds of cataract operations in that sort of environment, with no infective complications, and a very high patient satisfaction.

“It really got us ‘back on our feet’ again and restored sight to hundreds of people. Otherwise, we would have been paralyzed as a service,” he added. “I know, from subsequent discussions with lots of other ophthalmologists around the country, that some of them are still feeling that way – paralyzed, almost after a year after the pandemic started.”

Cleanest Possible Surgical Field

With a laminar air flow, Toul Meditech Operio® was developed especially for operation environments, in which demands on sterile and clean air are elevated.

The horizontal ultraclean laminar airflow is directed directly over the surgical site and instruments. This creates a barrier against particles that could harbor infective agents. With this surety, Mr. Madge uses the system for his work in private as well as NHS settings.

“Toul Meditech Operio® provides us with the cleanest possible surgical field better than standard operating theaters in many, many respects, and allowed us to resume private cataract surgery when the rest of the country was closed for business,” he remarked. “We’re still using it, because we believe it is not only a great way forward from a financial perspective, but actually gives us the cleanest possible air for our surgery.

Better Experience for Specialist and Patients

With inherent flexibility, the Toul Meditech Operio® is easy to maneuver, maintain and use. Specialists like Mr. Madge like the ergonomics of the system that benefit their own convenience and workflow, as well as patient comfort.

“It is a very, very flexible device. you can move it wherever you like, very simply and very quickly. It’s very easy to clean, and very easy to change the filters. The fact that you can move it around so quickly means that you can achieve superb efficiency in use,” said Mr. Madge. “With our own pathway in place within private practice, we were able to achieve well over two patients per hour, without any sensation of patients feeling rushed in anyway. It provides a very bespoke and positive patient experience and seems to go very well. I’m well aware that more than two operations per hour can be achieved with certain other parameters, but that’s all we were striving for in this particular outpatient department.”

Fraction of the Costs

Another important element of the Toul Meditech Operio®’s appeal is the cost savings that can be achieved compared to conventional air conditioning systems.

“If you go down the traditional model of having a ceiling-mounted or even roof-mounted theater air conditioning system, which blows relatively sterile air through an entire room, your capital costs are going to be in the order with hundreds of thousands of pounds, along with tens of thousands of pounds on an annual basis for maintenance. That will achieve a room that is pretty sterile, but if there are then patients walking into that room in their shoes, their jeans, and their clothes, as happens normally in cataract surgery, it really begs the question: Why try to achieve a completely sterile room?” said Mr. Madge. “What the Toul Meditech Operio® does is create a sterile field for the areas that need to be sterile – the surgical field and the instruments. I honestly don’t mind if my patients feet aren’t bathed in sterile air, because it has no consequence to the outcome of the procedure in any way, shape or form. However, the Toul Meditech Operio® gives me ultraclean air, exactly where I need it, at a fraction of the cost.”

Extra Capacity for Post-Covid-19 Waiting Lists

While keeping operations running during the pandemic has helped treat hundreds of patients and minimize patient waiting lists, once the pandemic is under control, there will still be many more to treat. Mr. Madge is considering using the Toul Meditech Operio® to run an additional clinic for any extra capacity required.

“In terms of getting through the numbers of patients who might have been waiting for procedures, it would be lovely to open up an additional theater in a clean room in outpatients to help get through that,” he said. “If we have the space, that’s what I will certainly choose to do. We would have the main operating theater for larger procedures, and we could continue with straightforward cataracts within an outpatient clean room environment. Within our private practice, the benefits of the Toul Meditech Operio® from a quality perspective are so great, that we plan to continue using it. I think the Toul Meditech Operio® is great and one of the best innovations there’s been in the market.”

Mr. Simon Madge

page3image31309376

Mr. Simon Madge is a Senior Consultant Eye Surgeon and Director of Hereford Vision Surgical Group, in Hereford, the UK,(www.HerefordVision.com). He is also Senior Consultant in Ophthalmic Surgery with an NHS practice.

He studied medicine at Jesus College, Cambridge University, graduating with a Double First Class degree in Medical Sciences in 1994, before studying clinical medicine at Magdalen College, Oxford University. After initially training in general internal medicine and gaining Membership of the Royal College of Physicians, he then started specialist training in ophthalmology. He completed his Higher Surgical Specialist Training on the Peninsular Rotation (Devon), gaining Fellowship of the Royal College of Ophthalmologists in 2007

In addition to his training in cataract / refractive surgery, he undertook two Fellowships in Eyelid, Lacrimal and Orbital Surgery.

L’ESPERIENZA DELLA CHIRURGIA PLASTICA – MAGGIO 2020

Dottor Marianelli – Clinica Leonardo a Vinci

ESPERIENZA DELL’OFTALMOLOGIA CON FLUSSO LAMINARE – MAGGIO 2020

Professor Staurenghi – Ospedale Sacco a Milano