TZM GmbH plays an important role in AIQNET, acting as an interface between data generation and data storage. Could you please explain the technical aspects of the UMG to me? What exactly does the device do, and what is its specific role day to day in the clinics?

Bastian Mazzoli:
The UMG is responsible for transmitting and translating data. As an interface, it establishes a connection between medical devices and platforms such as AIQNET so that data can be transferred. In the medical technology industry in particular, every manufacturer creates its own data construct. For example, you can have four different ventilators from four different manufacturers that speak four different languages. The UMG translates these different languages into one standard. To a certain extent, this has grown out of our history because we have been translating the various languages of the devices for other companies for 20 years. However, our product, the UMG, doesn’t translate into another company language, but into one standard language. This standard is called HL7, and hospital information systems or patient data management systems, for example, can also work with it.  

 We are currently mainly active in intensive care units, as a lot of devices are used here. In the past, nurses would have to write down the data by hand – from the ventilator, for example. Times were often just estimated because nurses would have other work to do before they got the chance to write up the data. Ultimately, several hours of time spent on a ventilator are lost and cannot be billed to health insurance companies. One clinic even told us that they didn’t read values directly from the device, but called them out to each other across the corridor. This can of course lead to transcription errors, which are also a problem when you write the values down by hand on slips of paper and can’t decipher them later on. Our connection ensures these transcription errors can be avoided. Everything runs in the background, and the data is automatically transferred to the system.  
 
Prof. Dr. Rainer Würslin:
The way it is being used right now, the UMG is helping implement digitalisation and is supporting nursing staff. This mainly involves taking the strain off clinics and ensuring more efficient billing, because health insurance companies no longer want handwritten records. Receipts need to be provided that indicate when and for how long a particular device was used and whether the accounts are correct. We often say that we are just a translator. We can translate so others can understand each other. As part of the AIQNET project, we can make a significant contribution to overcoming system boundaries and making medical data accessible.

The UMG has been on the market since 2017 and is now about to be recertified. What does this mean for your product?

Prof. Dr. Rainer Würslin:
The recertification should be completed in a few weeks. The process is very tedious and time-consuming, but this is exactly what gives doctors and patients the reassurance that everything is as it should be. After all, it is not just data from medical devices this is transmitted, but also important alarm signals. It is at this point, if not sooner, that we discover whether the device meets all the criteria as a medical product. The certification is based on Appendix II of the MDD (Medical Device Directive). A complete QM system (in line with ISO 13485, for example) is a prerequisite for this approval procedure. Once it is fully certified, the UMG will be a class IIb medical product.

What specific added value can you offer doctors and clinics with the UMG?

Bastian Mazzoli:
A major advantage I see for clinics is an improvement in quality. On the one hand, data quality will be better because you have the correct data available, and, on the other hand, the quality of care will be better because the staff can now truly take care of the patients instead of spending so much time on routine activities. Let’s take the alarm signals as an example. If there are ten beds in an intensive care unit, each with four items of equipment, then that is 40 devices in total, all sending data to the control centre. However, the alarm signals can often only be read on the devices themselves. This means a member of staff has to go to the relevant bed every time, check the alarm and switch it off. The workload for 40 devices is enormous, which may lead to delays in patient treatment. The centralised or mobile processing of alarm signals helps significantly boost the quality of treatment, which is a huge advantage for both staff and patients.  The great strength of TZM GmbH is the flexibility for interlinking a really wide variety of devices – in other words, creating connectivity. The UMG enables us to connect any device – be it a monitor or infusion pump – to the end system already in place in the clinic, regardless of the individual manufacturers.  
 

The UMG is being used at Charité in Berlin as part of the AIQNET project. Can you tell us where and how exactly your device has been integrated, and what experience you’ve gained already?

Prof. Dr. Rainer Würslin:
We became acquainted with the Berlin Simulation and Training Center (BeST) as part of the AIQNET project. The BeST is a division of Charité, which operates an intensive care unit (ICU) for training, research and development. It provides an opportunity to try out new techniques and treatment methods, including the “walking ICU” concept. The UMG is to be used in this concept. Instead of being permanently sedated, the patients are able to move and even get out of bed – hence the name “walking ICU”. The technology and treatment methods have to adapt dynamically to the situation and understand each other. There are approximately 12 devices that will be gradually integrated into the trial phase, which starts in April.