Coronavirus has brought the topic of hygiene to the forefront of everyone’s mind. Do you think it will remain in the public consciousness in the long term?
The coronavirus has certainly put even greater focus on hygiene and infection-prevention awareness. However, this issue has already been in the spotlight multiple times and not only in professional circles. There have been numerous reports and articles in the media in recent years, particularly in terms of multi-resistant pathogens and the problem of hospital-acquired infections. So I think that there has been some recognition of this issue for a while now. However, there was a lack of drive to act consistently in this area, which is definitely no longer the case.
Will this affect the properties of medical devices and their use?
Yes, the focus will increasingly shift towards medical devices and their use. Because our modern medicine is highly engineered and many of these highly engineered products are not really hygienically designed. This is often a problem when it comes to processing these items, i.e. cleaning, disinfecting and, if necessary, sterilising them. Incidentally, this does not only apply to medical devices.
Does this mean that the industry is facing major challenges and needs to bring hygiene developments to market as quickly as possible?
I believe that hygienic design and specific requirements for processing through to validated processing instructions are not only relevant for sterile and almost sterile medical devices, but also for non-critical products. This will certainly become a major issue for manufacturers of medical devices. This is also evident in the work on the international standard ISO 17644, which is currently developing corresponding regulations in this area. A guideline from about 5 years ago issued by the U.S. Food and Drug Administration (FDA) has already put more emphasis on the topic of processing.
Katja Eberhardt in conversation with Prof. Clemens BulittaHave there already been initial approaches made to hygienic design in the industry?
Yes, the first manufacturers have already initiated activities in this regard and in the Association of German Engineers (VDI), I am leading a technical committee that manages areas in medical facilities that are relevant to hygiene. We are working on two projects in particular that involve classifying such areas and products as well as their hygienic design. So as you can see: The issue has already gained momentum. I assume that in future, corresponding design, construction and material aspects will become increasingly important for developing such products.
Exactly what role does design play to make a product hygienic?
This includes the roughness of the surface, geometry, joining and connection technology, the resistance of materials against cleaning and disinfecting agents, stability against heat and much more - depending on the area of application and the treatment process. The food industry is already way ahead in this respect. Many of these subjects have already been regulated by standards.
Does this mean that the food industry is a good example?
Yes, this is handled differently in the food industry. Hygienic design has long been established there. The principle is clear: Design measures are intended to ensure that dangerous microorganisms, as well as general dirt or similar, do not get into food products under any circumstances. For this reason, machine and plant manufacturers, together with food producers and food technologists, have developed a series of DIN standard sheets from the German Mechanical Engineering Industry Association (VDMA). But a rethink is now also taking place in the medical technology industry and we hope that we can make a first step and important contribution here with our VDI technical committee and the guideline project on hygienic design.
Do you think that mechanical cleaning will play a more significant role in the future than it does today?
Mechanical cleaning or general processing, where disinfection and sterilisation are also required, is easier to standardise than manual processes, which are always person-dependent. Person-dependent always means that it is time-consuming and can lead to errors. Mechanical processing therefore offers numerous advantages: Principally, the preferred processing method is automated processing, especially for low-germ and sterile medical devices. This is because it is the only way to reliably guarantee that the process is controllable and safe and that the result is always the same. Manual processes, such as those often used for medical beds, couches and similar systems, are much more prone to errors. The result in terms of hygiene is not so good. I believe it will be important in the future to make work processes efficient and to bear costs in mind.
In some countries, the use of washing tunnels is more common than in others. Do you think that the current crisis situation will lead to a rethink here?
The crucial question will be, what are the benefits of using a washing tunnel for me? If there are advantages from the perspective of efficiency and profitability, then this is always a very compelling argument. If the potential lies on the qualitative side, many people will be hesitant because it is of course an initial investment and processes have to be converted. I can imagine that due to the increasing hygiene awareness and perhaps also due to requirements made ultimately by the legislator, the quality aspect will become increasingly important, which will mean that there is no way around such an investment. I believe that something like this will definitely pay off. However, it is difficult to make such an argument in Germany: Our system is still very cost-driven and you only ever see the initial investment. The lifecycle costs are not usually taken into account. Often there is simply not enough space to accommodate washing tunnels in the facility.
Do you have an idea of what items other than hospital beds could be used in washing tunnels?
Washing tunnels could also be used for non-fixed treatment chairs, commode chairs, couches and tables, for example. However, the future is not only the washing tunnel, but also automation in general. There are projects in robotics that will perform an automatic cleaning process: The cleaning tool comes to the product and not the other way around. Things like that will come onto the market. There might be something like a hood to perform the cleaning process on site - the mobile washing robot. There are also research projects where driverless transport systems bring hospital beds into washing tunnels. That is a work in progress.
To what extent does automation already play a role alongside washing tunnels?
Well, this is an exciting topic. Currently, surface cleaning by means of wet cleaning or wet wipes is the preferred method for processing surfaces and objects. However, there are various research projects underway on the role of alternative approaches, such as UVC light or cold plasma. On the other hand, these approaches have an impact on the product design, such as plastics ageing due to UVC light. That means that the processing is complex with many influencing factors.
Prof. Clemens Bulitta explains how bacteria can be detected on surfaces with measuring instruments.That is why it is really important to define the goal or the result of the processing procedure and to derive a validated processing procedure from it or based on it. Moreover, manufacturers must do this themselves and make it available to users.
Is this regulated in the ISO 17644 standard you spoke of earlier?
Yes, these are basically the instructions for manufacturers with regard to the preparation process.
What are the requirements for a preparation process?
In principle, any hygiene and infection-prevention measure should be strong, efficient and effective, i.e. it should not be prone to errors, should not require additional effort and should achieve an excellent result. If a washing tunnel or other methods can do this, they will certainly prevail.
What is your personal opinion - will we have to prepare for pandemics like the coronavirus in the future? Can we protect ourselves from this and, if so, how?
Such pandemics have always existed and will always exist. The frequency may increase. We can only protect ourselves if we take a closer look at the system as a whole. There is the One Health approach, where the systemic interrelationships of humans, animals, the environment and health are considered and taken into account across disciplines. If you understand what the correlations are, you can, for example, prevent a pathogen from jumping from one species to another and becoming dangerous. If we succeed, we will have achieved a great deal.
We need to find ways to live with pandemics, as we have now done with the coronavirus. I am impressed by how quickly and how much we have already learned about the SARS-CoV2 virus and are thus able to deal with the situation in a targeted manner. The spring lockdown was certainly the right thing to do. With the knowledge gained, it is now possible to lead an almost normal life in many areas, provided that simple hygiene rules such as the AHA rules (German acronym for distance, hand hygiene, everyday masks) and ventilation are followed to prevent the rapid spread of infections. This can be the strategy. We just have to find clever ways without doing harm and limiting our lives too much.
Prof. Clemens Bulitta
His motto: “Dimidium facti, qui coepit, habet: sapere aude, incipe” “
He who has begun is half done; dare to know; begin!” (Horace)
Prof. Bulitta has extensive international experience and knowledge in clinical medicine, the healthcare industry and the medical technology industry. After completing his human medicine studies in Heidelberg, the US and Switzerland, he graduated from the University of Heidelberg Medical Faculty. Then he pursued further training in surgery at the Accident Surgical University Hospital in Essen and the General Surgical University Hospital in Mainz.
From 1999 to 2001, Prof. Bulitta worked as a Research Fellow at the Massachusetts General Hospital of Harvard University in Boston, USA, as part of a scholarship from the German Research Association. At the beginning of 2001, he joined the Siemens AG healthcare sector. He initially worked there as a healthcare consultant for several years. He has subsequently held various management positions in the areas of business development, clinical marketing and product management for the surgery business. Since 2010, he has been responsible for global project and partner management for angiography systems in the operating room, so-called hybrid operating rooms, at Siemens.
Since 2012, he has held the professorship for “Diagnostic Systems and Medical Technology Management“ at the East Bavarian Technical University of Amberg-Weiden. Since the summer semester of 2014, Prof. Bulitta has been the director and academic advisor for the bachelor’s degree course in medical technology.
Since January 2015, he has been managing the newly founded Institute for Medical Technology at the East Bavarian Technical University of Amberg-Weiden.
More at: www.oth-aw.de/bulitta/ueber/
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