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Interview with Prof. Clemens Bulitta on hygiene Because of the coronavirus, the topic of hygiene has been on 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 regard, 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 must bring developments in terms of hygiene to the 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 noncritical products. This will certainly become a major issue for manufacturers of medical devices. This is also demonstrated by 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. Are there already some initial approaches to hygienic design in the industry? Yes, the first manufacturers have already initiated activities in this regard and in the in the Association of German Engineers (VDI), I am leading a technical committee that deals with the management of areas in medical facilities that are relevant to hygiene. Here, we are working on two projects on the classification of such areas and products as well as their hygienic design. So you can see: The issue has already gained momentum. I assume that in the future, corresponding design, construction and material aspects will become increasingly important for the development of 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 along 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, but also 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 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 USA 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 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 become 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 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/ LINAK.COM/MEDLINE-CARELINE