Tuttlingen – The cleanliness of a medical device is more than a visual impression. It can be documented using measurement and limit values. Manufacturers need data, laboratories supply data, and in between – there is always a gap. More precisely, a gap in understanding that the ExpertTable CleanMed wants to close.
Companies order tests they don't need and get results that cannot be interpreted. Although the statement is exaggerated, it clarifies a basic problem in the medical technology industry. On the one hand, the regulations require manufacturers to document cleanliness with analysis results in black and white. On the other hand, it is not always clear to them whether and why the steps are necessary and what the analyzes ultimately say. The ExpertTable CleanMed does not want to put up with this situation.
Initiated and coordinated by MedicalMountains GmbH, the ExpertTable emerged from the ZIM project of the same name and has been dedicated to the diverse aspects of purity and cleanliness in medical technology for around three years. The subject is as important as it needs explanation. Even basic terms such as "endotoxins" or "cytotoxicity" cannot do without more detailed explanations. Therefore, at the CleanMed meetings, there is always the thought of how more understanding can be created. "It is important to everyone to make the relationships between specifications, processes and results transparent," reports Marena Hauser. The project manager of MedicalMountains GmbH holds the organizational threads in her hands. "It's incredibly valuable to bring the different perspectives and experiences together," she reports, because there are manufacturers and suppliers involved, but also laboratories. “They have maintained an intensive dialogue with their customers for a long time. This openness is exemplary.”
Marena Hauser finds it regrettable that this is not the case everywhere in the industry. "Where should the smaller companies in particular get the knowledge from if not through the support of experts?" asks the project manager. One CleanMed approach is the “Laboratory Guidance” that is currently being developed. The brochure summarizes information about regulations, standards and analytics and thus provides important guidance. The next step should now follow this step. "The highly complex topic of cleanliness of medical devices can be most effectively advanced in a network," says Dr. Oliver Podlech (CleanControlling Medical GmbH & Co. KG) on behalf of the other CleanMed partners to the point. The network currently includes 18 companies - other manufacturers are welcome. "We want to know what's burning on their minds," says Marena Hauser, "to enter into dialogue with them and, if necessary, to actively cooperate." The input, especially from small and medium-sized manufacturing companies, can be very helpful for the further development of the ExpertTable be - and in return its output for them all the more.
Depending on how the need is, consultation days or an information series are conceivable, says Marena Hauser. A better understanding of the requirements for purity on the one hand and the needs of the industry on the other create the basis for growing together in the face of challenges. "When everyone sits down at a table, brings in their experience and knowledge and looks for pragmatic solutions, a lot can happen."
Medical technology manufacturers who would like to contribute their concerns or ideas to the ExpertTable CleanMed can obtain further information from Marena Hauser at +49 7461 969721-64 or hauser@medicalmountains.de .
