Several important steps were introduced that contributed to achieve these positive results.

During the time when the study was carried out the Toul Meditech air flow technology was used for more than 5000 joint replacements and over 3000 spinal surgeries, as well as other surgeries. The Toul Meditech air flow technology has become a part of the Hospital’s infection control system according to Dr. Lukas Maansson, who is one of the authors of the study.

To read the article go to:

https://bmjopenquality.bmj.com/content/10/4/e001134

The study measured the presence of lint fibers in 99 eyes undergoing cataract surgery with a mobile LAF device compared with 50 eyes in a control group without the LAF device.

The difference of total lint fibers found free-falling directly onto the sterile field between the LAF group (0 fibers of 99 eyes) and the control group (6 fibers of 50 eyes) was statically significant (P = .014). The percentage of eyes in which lint fibers were found freefalling directly onto the sterile field was also calculated: 0% and 6% for the LAF group and the control group, respectively. The difference was statistically significant (P = .014).

The conclusion was that the mobile LAF device (Operio) was highly effective in reducing the number of particulate matter and lint fibers within the sterile surgical field when used during cataract surgery.

To read the article go to:

https://pubmed.ncbi.nlm.nih.gov/34156771/

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
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 based at Wye Valley NHS Trust, also in Hereford.

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. After working in Bath and Nottingham, 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: with Mr. V.T. Thaller at the Plymouth Royal Eye Infirmary; and with Professor Dinesh Selva, Dr Garry Davis and Dr James Muecke at the Royal Adelaide Hospital, Adelaide, Australia, widely regarded as one of the best training opportunities in this field in the world.

He is an examiner for the Royal College of Surgeons of Edinburgh and is Fellowship Director of the Hereford International Clinical Fellowship in Ophthalmology & Oculoplastics. He is the author of two successful ophthalmic textbooks and over 60 scientific ophthalmic papers.

Dr. Bredehorn-Mayr oversees ophthalmology practices in Aschersleben, Halberstadt, Staβfurt and Halle. With a lack of ophthalmologists in the region, he has a lot of patients and travels from clinic-to-clinic daily.

“We have small operating theaters In Aschersleben and Halberstadt, from which, we can carry out small procedures, such as intravitreal injections. And we have access to a very modern operating theatre in Magdeburg that we can hire, which we use for cataract surgery. However, for the operating theaters in Aschersleben and Halberstadt, it is not easy to create a complete very high quality operating theater environment, with clean room characteristics. This gave me the idea to look for a smaller tool that makes clean air,” he explained. “Before becoming familiar with Toul Meditech Operio®, I became aware of the SurgiCube®, while looking on the Internet. Before you build up something like this, you look for the opinions and feedback of people who have the same idea. And then I noticed that the SurgiCube® was associated with Dr. Gerrit Melles. I have known Mr. Melles since he was an assistant in Rotterdam, The Netherlands. I know he is a genius, so I was reassured that it must be a very good product.”

Following this, Dr. Bredehorn-Mayr contacted Ramon Hilberink of SurgiCube® and Toul Meditech in Vierpolders, The Netherlands, who visited Halberstadt to give a small demonstration of the product. Dr. Bredehorn-Mayr then had the opportunity to visit a private clinic in Delft, also in The Netherlands, to explore the product being used in clinical practice. Alongside use of the SurgiCube® for ophthalmic surgeries like cataract surgery, the Delft clinic also has a dedicated procedure room equipped with a Toul Meditech Operio®, which is used for intravitreal injection therapies.

“It was amazing,“ he said. “I decided that the Toul Meditech Operio® would be very good for the intravitreal injections that we need to do in my clinics in Germany. The other alternative was to build a very big conventional air conditioner in the operating rooms at a cost of something like €30,000 to €40,000. The Toul Meditech Operio® was much less expensive.”

A Small But Effective Solution
“The most important point is that you have a small machine that is making very clean air in the area that you are working in. It’s a small solution, but also the cost-benefit is significant, of course,” he remarked, “I have two operating theaters in Halberstadt and Aschersleben, and a Toul Meditech Operio® in both places. We have already completed more than 3,000 intravitreal injections since acquiring the Operio®.”

Additional Use
The two systems were first used in the operating theaters to provide really clean laminar flow directly during operations, but with the onset of the Covid-19 pandemic, they proved their added-value.

“Having sterile air on the field of operations is amazing, because you can be sure that no particle is coming from elsewhere, and the sterility is so directed to your focus in the operations. That gives me a very good feeling,” said Dr. Bredehorn-Mayr.

“Additionally, now, after operating has finished, we place the machines in diagnostic and patient-related areas in our clinic, because they remove particles that may carry bacteria and Covid-19 viruses,” he added. “Therefore, I have very clean air in my practice. The pandemic has had a big impact: we have less patients, we need more space to guarantee the social distancing, we have a lot of measures to implement to protect against Covid-19, and there is an anxiety within my team and my patients. It’s a very big stress. Therefore, with the Operio® on the floor, you have a better feeling about it all.”

Biography: Dr. Timm Bredehorn-Mayr

Dr. Timm Bredehorn-Mayr is a leading Ophthalmologist in Germany. He is Chief of four ophthalmology practices in Aschersleben, Halberstadt, Staßfurt and Halle in Germany. After graduating in Medicine (Magna cum laude) from CAU Kiel and at the Georg-August-University in Göttingen, Germany, he specialized in ophthalmology in prestigious clinics in Leiden, the Netherlands and Halle-Wittenberg in Germany. During this time, he developed his expertise in corneal transplantation and other cutting-edge ophthalmology techniques.

For six years, Dr. Bredehorn-Mayr was Medical Director for the DSO-G (Non-Profit Society for Tissue Transplantation). He was also Deputy Head of the Halle Eye Bank. Following this, he was appointed Consultant of Strabology, Children and Neuro-ophthalmology at the University of Ophthalmology MLU in Halle-Wittenberg, Germany, and became Director of the Halle (Saale) Eye Bank.

Since 2014, Dr. Bredehorn-Mayr has been an ophthalmologist in free practice working in Aschersleben, Halberstadt, Staßfurt and Halle, in Germany.

Dr. Bredehorn-Mayr has authored or co-authored over 30 scientific publications in ophthalmology. He has also co-authored two books on eye banking – one in German and one in English: “Augenbanken”: Hsg. von Wilhelm F. W., Duncker G. I: W., Bredehorn T., de Gruyter Walter Berlin 2002; and “Eye banking“: Hsg. von Bredehorn-Mayr T., Duncker G. I. W., Armitage W. J. Karger Basel, 2009.

Before the Trust purchased the Toul Meditech Operio®, its ophthalmology team utilized one clean room for carrying out intravitreal injections, but with significant rising demand for the injections for a variety of retinal disorders, this set up became insufficient.

“The number of patients requiring intravitreal injections was increasing at a significant pace. We often worked weekends and evenings to catch up with the workload, and that proved very tiring,” explained Mr. Kashani. “To cope with demand, we were going to have a second clean room, but the cost of installing ventilation would have been huge, and it would have taken a long time to get this approved through the numerous panels and committees involved. Then, somebody mentioned that a device existed, which could help change a room into an environment suitable for injections, as long as certain criteria were met: The Toul Meditech Operio®. We traveled up to Aintree Hospital, in Merseyside, UK, to see the machine there in action. It was great. So, we purchased one, and have actually recently acquired our second one.”

“The Toul Meditech Operio® has made life a lot easier, because we are able to convert almost any room that meets the specifications, into an injection room, and deliver those much needed injections safely,” he continued. “As it turned out, after we bought the system, the ventilation completely stopped working in our first injection room, so we weren’t able to use it anymore. Without the Operio®, we would have had to use an operating theater, which is obviously not a very good setting for delivering high volume intravitreal injection therapy.”

Growth in demand for intraocular injections
The demand for intravitreal injections has changed drastically in the last decade as treatments for macular degeneration and other retinal disorders have been approved and included in healthcare guidelines.

“Patients with retinal disorders, which account for most cases of blindness in the UK, had sudden access to sight-saving injections. At present we carry out around 7,000 to 8,000 episodes of injections per year. That’s a huge workload to get through! In every session, you can complete between 12 to 20 injections,” remarked Mr. Kashani. “Quite often, clinic rooms are occupied for other procedures. So, the nice thing about Toul Meditech Operio® is that you can also move it around, if you want to, as long as the other criteria within the room match the conditions specified by the Royal College of Ophthalmologists. That gave us flexibility and accessibility. We were able to essentially manage the intravitreal injection service without having to necessarily work at weekends or evenings, and it allowed us to maximize our capacity during the week.”

“The Toul Meditech Operio® brought us additional capacity quickly and cost-effectively. Swift solutions are essential for patients that are time critical. They're very important. You can't even wait a week with some of these patients. You have to have a solution right at
hand,” he added. “You don't need that much space to do Anti-VEGF injections, but at the same time, one in 1,000 can lose their sight and go blind from them, so patient safety is very important to us. We want to be able to deliver care in a safe setting.”

As retinal injections are so time-critical and because there are so many patients who need treatment, the burden of disease on patients and clinicians, and commissioners in the East Sussex region is significant.

“It is also very important to modernize the intravitreal injection service as the patient numbers will increase year on year across the service with most patients requiring monitoring or treatment for the next 2-3 years,” said Mr. Kashani. “By modernizing, I mean designing up to date treatment protocols, training non-medical injectors and employing something like the Toul Meditech Operio® to enable you to use clinical rooms or areas that you wouldn't normally for delivering treatment and injections’’

“And managing cost is also extremely important,” he said. “Operating theaters are expensive to set-up and run and for retinal injections, you don’t really need that much space. The Operio® enable us to free-up the theater for other things.”

Navigating the Pressures of the Pandemic
When the Covid-19 pandemic took a hold, Mr. Kashani’s team had to move out of the East Sussex NHS Trust’s acute sites, but with the Toul Meditech Operio® and access to a Community Hospital, they could continue their work.

“Pre-Covid-19, it would be unthinkable to delay injections for a time-critical condition, but when the pandemic hit us, there were new considerations about who we should treat and who we should delay treatment. These were unthinkable times. We had to adapt very quickly in order to manage that risk, but because we were able to use the Community Hospital, and we had the Toul Meditech Operio®, we had extra capacity,” said Mr. Kashani. “The retinal injection service was one of the only services that was running fully alongside the emergency service. Everything else came to a halt for a good few months, but we were lucky enough to be able to deliver our treatment for time-critical conditions in a timely manner for those patients who wanted to attend clinics. However, there is still a backlog, which will continue post-Covid. If retinal injections were to take up operating theatre space, the ophthalmology service would never recover, but with the right set up and equipment like the Operio®, some of the diagnostics and even treatment delivery could be done in the community.”

Keeping Up the Pace
The Toul Meditech Operio® has undoubtedly made a significant difference to the work of Mr. Kashani and his team.

“The Toul Meditech Operio® is one of the best things that we have purchased,” he said. “With the Operio®, we can by-pass so many things that might slow us down. The device is very user-friendly for surgeon and patient. It has proven data of minimizing infection and enables us to work with tight budgets. We can use different areas of the clinic, which has been transformative in the Covid-19 pandemic. It has really helped us.”

Mr. Shahram Kashani

Mr. Shahram Kashani is a Consultant Ophthalmic Surgeon at the East Sussex NHS Trust in the UK. He is a general ophthalmologist with a specialist interest in complex cataract surgery with premium lens implant and management of challenging retinal disorders. He also consults privately at the Eastbourne Eye Clinic in Eastbourne, UK.

Mr. Kashani is a UK-trained ophthalmologist, who graduated from St George’s Hospital Medical School in London in 1998. He has extensive experience in managing general ophthalmic pathology, having trained at various other prestigious ophthalmic units in London including Kings College Hospital, Charing Cross and Western Eye Hospital, Chelsea and Westminster Hospital as well as three years at the world renowned Moorfields Eye Hospital, where he was also selected and completed advanced subspecialty fellowship training in management of eye conditions including macular degeneration, diabetic eye disease, retinal vein occlusions, inflammatory eye disease and complex cataract surgery.

Mr. Kashani has an active interest in research and has produced over 40 peer reviewed publications and over 25 national and international presentations. He is a Member of the European Society of Retinal Specialists (EURETINA) and European Society of Cataract and Refractive Surgeons (ESCRS) and attends national and international meetings regularly to keep his professional development with the latest technology in his field. He is one of only a handful of surgeons who has achieved the prestigious membership status of the Royal College of Physicians, as well as obtaining the fellowship status from the Royal College of Ophthalmologists.

Mr. Kashani has won several awards for his teaching skills and has particular interest in developing the role of optometrists and nurse specialists in delivering modern ophthalmic care.

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