Medical responsibility

Fresenius Medical Care is uniquely organized around the needs of people living with kidney disease, with broad and deep expertise in comprehensive patient care. We are grounded in science. Our clinical experts, researchers, scientists, mathematicians and caregivers are relentlessly focused on our vision to create a future worth living for patients, worldwide, every day. By assuming medical responsibility, we continue to lead the way in transforming the industry. At our core, we are driven to translate science into everyday clinical practice that benefits our patients and generates sustainable value for health care systems we operate within.

The well-being of our patients is our priority, and key to our success all over the world. To continuously deliver on this commitment, it is important that we also coordinate the interpretation of clinical science and medical practice patterns on a global basis. For this reason, we established the Global Medical Office to enhance our patient-focused care delivery business model. This function, led by our Global Chief Medical Officer, marks an important milestone in the company’s evolution and will ensure that we harness the full potential of our global, vertically-integrated approach to achieve the best clinical outcomes for our patients, their families and the payor community. This office is tasked with evaluating coordinated data from clinical science research and medical practice on a global basis to improve treatment outcomes. This includes facilitating cooperation and knowledge transfer across the entire Fresenius Medical Care network.

The 2019 Global Annual Medical Report explores the power of interconnected thinking, a core feature of the Fresenius Medical Care DNA and company culture. This more fulsome, collaborative vision results in exponentially greater capacity for understanding and innovation, setting us apart in our ability to effect positive change in the care of people with advanced kidney disease.

One of the key pillars of our growth is addressing our patients’ changing needs. Many patients would rather be treated at home so that they can lead a life as normal as possible instead of receiving regular treatment at a dialysis clinic for several hours, several days a week. Patients want a more informed choice and options beyond in-center hemodialysis that fit their life circumstances. By acquiring NxStage in 2019, we have expanded our product portfolio with an innovative technology for home dialysis. This enables us to offer our patients greater flexibility and more individual treatment. Home dialysis improves our patients' quality of life.

However, not every patient chooses home therapy or is in the medical condition to do so. Patients may choose or require different modalities throughout their full life journey. There are the following treatment options for the entire patient lifetime journey:

In the end, our goal is to provide every patient the right care at the right time and in the environment he or she prefers. Read more about different dialysis treatment options here.

At regional level, responsibility for the quality of our dialysis care services lies with our Chief Medical Officers, the Chief Clinical Office, and the interdisciplinary patient care teams. They develop and review internal standards and policies relating to quality. Furthermore, they continuously measure and assess the quality of care at our dialysis clinics based on generally recognized quality standards and international guidelines. These include the Kidney Disease: Improving Global Outcomes (KDIGO) foundation, the Kidney Disease Outcome Quality Initiative (KDOQI), the European Renal Best Practice Guidelines (ERBP) as well as industry-specific clinical benchmarks and our own quality targets.

As a health care company, our success depends on our health care services improving outcomes. To this end, we have defined a set of quality parameters, which we continuously monitor to make sure that the quality of care remains on a consistently high level. As part of this approach, we regularly provide executives in the individual operating segments as well as our Management Board with aggregated data on the quality of care. In addition, we publish selected results of our treatment analyses on a quarterly basis to create transparency on the quality of patient care and to emphasize the importance of our social responsibility towards our patients at Fresenius Medical Care.

Quality management in our product business covers the entire product’s lifecycle from research and development to production and application. We strive to create a safe and healthy clinical environment and take the quality, safety and efficacy of the medical and pharmaceutical products that we develop and manufacture very seriously.

Our operations are subject to extensive governmental regulation in virtually every country in which we operate. To fulfill our commitment to product quality and safety while complying with the numerous relevant regulatory requirements, our processes are embedded in comprehensive quality management systems. As a result, all of our products and procedures comply with quality and safety standards from their development to market approval, manufacturing and use in clinics, through to training customers and dealing with complaints.

Another cornerstone of our commitment to product quality and safety is our Global Quality Policy, which was jointly developed and approved by Global Manufacturing, Quality & Supply (GMQS) and Global Research and Development (GRD). As a key component of our quality management system, the Global Quality Policy describes our overarching quality objectives and reflects our commitment to providing uncompromised product and service quality, while maintaining compliance with relevant regulations.

To produce safe products with a reliable quality, our plants are subjected to regular external quality audits and reviews in accordance with local requirements. In addition to audits carried out by notified bodies and authorities, including the U.S. Food and Drug Administration (FDA), the German Ministry of Health and other applicable national health authorities, our local sites are subject to management reviews and regular internal quality audits. Any cases of non-conformance detected as part of these quality audits are forwarded to the respective department to determine and implement appropriate corrective and preventive measures.