Fresenius Medical Care

As the world’s leading provider of dialysis care and products, Fresenius Medical Care has a special commitment to maintaining the best possible quality standards for its patients and customers. To meet these demands and the numerous regulatory requirements, Fresenius Medical Care has implemented comprehensive quality management systems in its regions, which reflect both the specific local conditions and the company’s global responsibility. These systems regulate and monitor compliance with quality and safety standards for all products and procedures, from development, production, and regulatory approval to clinical application, customer training and handling complaints.

The quality management system combines internal regulations and processes with the specification of external standards – such as ISO 9001:2000 for quality management systems and ISO 13485:2003 for medical products. We also apply the guidelines issued by the U.S. Food and Drug Administration, the EU Medical Device Directive (MDD) and Good Manufacturing Practices (GMP), and international rules for the safe and high-quality manufacture of pharmaceutical products and medical devices. Today, our sites are already certified to various regional quality standards. This enables products to be supplied flexibly to different markets, thus increasing the reliability of supply. The GMO division described in the procurement management section will be intensifying these multiple certifications within Fresenius Medical Care. Another focus is to harmonize quality management generally, e. g. to achieve supra-regionally comparable processes and systems for quality assurance and quality improvement.

To assess quality in dialysis care, Fresenius Medical Care uses quality parameters that are generally recognized throughout the dialysis industry. One example is the so-called Kt/V value, which shows the cleansing performance of the dialysis treatment. This is calculated by analyzing the relationship between the duration of treatment and the amount of specific toxic molecules that were removed from the blood. The number of days patients are hospitalized is also crucial for determining treatment quality, because they are particularly cost-intensive and can significantly reduce the quality of life of dialysis patients. Constantly measuring these and other parameters helps us to further improve our standards in providing dialysis treatment.

The quality management implemented at our sites and at our dialysis clinics is regularly audited. In Europe, this is handled by the TÜV. These conformance and certification experts check our corporate headquarters, the production plants as well as sales organization and clinical organizations as part of their annual audits. In the United States our clinics are audited by the Centers for Medicare and Medicaid Services (CMS), the bodies responsible for the public health care program. In 2010, our laboratory services subsidiary, Spectra Laboratories, was the first medical test laboratory in the United States to be certified to ISO 15189:2007 which defines the quality standards for medical laboratories. Nephrologists rely on extensive laboratory tests in order to be able to tailor the dialysis therapy to the patient’s individual needs.

In the International segment our dialysis care business is marked by the penetration of new markets and regions. The legal and health care systems differ from country to country and newly acquired dialysis centers might not conform to our quality and management standards. For this reason we launched the NephroCare Excellence Initiative in 2010. The aim is to introduce our quality standards efficiently and systematically at newly acquired clinics and to improve risk management through compliance with quality standards. In this way we want to harmonize the procedures at our clinics generally and to further improve the quality of the care we provide.

We also monitor the effective implementation of our quality management systems through regular internal audits performed by employees who are specially qualified and trained for this purpose. Furthermore, through regular patient and customer surveys, we obtain valuable feedback, for instance, on the acceptance of our customer, delivery, and technical customer service.

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