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ePaper created 2012-12-05, 10:23:52 | version 1.24.0
03 If silicone rubber tubes are made for medical devices, which are to be used for say dialysis equipment, there doesn’t seem to be any difference to making tubes for other uses at first. However, these tubes are used on people, and this is where the difference between them and standard tubes occurs. Any production error can, in the worst case, cost a human life, and it is for this reason that extreme care is required during the manufacture of medical devices and complete traceability for each pro- duction step is important. Those who make medical devices are therefore obliged to have a system in place which complies with EN ISO 13485 in addition to a management system based on ISO 9001. The system complying with this standard supplements the existing procedures based on ISO 9001 with extra elements which fulfil the demands for medical devices. One of these elements is the obligation to record production steps in detail and keep this information for an extended period of time, so that in the event of a legal case, any little detail, which could have resulted in a problem can be traced in a legally incontestable manner. A risk management system complying with EN ISO 14971 is used to assess the risks arising from the intended use of medical devices. This system extends familiar procedures from automotive uses and involves looking at the risk which might remain to the patient after extreme care and compliance to all relevant standards have been applied and has to be accepted, if the use of the product is to be at all appropriate and beneficial. Fulfilling these and other extensive requirements, which are specified by the Medical Devices Act (MPG) in Germany enables us to confirm compliance with the Medical Devices Directive (“CE mark”) for relevant products and launch these products directly onto the market responsibly. This means that we aren’t just a manufacturer of tubes with certain dimensions, but ultimately also responsible for any prob- lems caused by a non-compliant product, including people who become ill as a result of them. This is why only certain facilities, whose suitability has been checked (validated), will be used in the purpose of manufacturing medical and pharmaceutical devices. The number of people who make and monitor these products will also be limited, so that production can be kept as constant as possible and taken care of by people with many years of production experience. Overall, the area of medical and pharmaceutical devices is a very challenging field and it certainly necessitates changes in several respects (e.g. clean room technology). But if these changes are implemented correctly it can and should also be a good example and a role model for other areas. — Dr. Hanns-walter Tunger WHAT DOES “MANUFACTURING MEDICAL DEVICES” MEAN? DR. HANNS-WALTER TUNGER INTRODUCES HIMSELF Name: Dr. Hanns-Walter Tunger Position: Research & Development, Medical Device Advisor and safety officer Title: Dr. rer. nat., Graduate Industrial Chemist Training: Degree in chemistry at the University of Hamburg, 1995 doctorate in Hamburg in liquid crystalline materials Interests: Furniture building, model building and cooking (international cuisine) Goals at BIW: To expand the medical devices department, particularly against the back- ground of a dynamic regulatory environment. To prepare the market launch of BIW’s own silicone rubber product lines for the medical technology in- dustry. To continue developing BIW’s existing clean room technology.