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 have 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 and using it to improve treatment outcomes. This includes the facilitation of enhanced cooperation and exchange of knowledge 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 (CMOs) and relevant specialist departments. They are tasked with developing and reviewing internal standards and policies relating to quality. Furthermore, they continuously measure and assess the quality of care at our dialysis clinics on the basis of 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 further indicator of our culture of quality improvement, we implement and monitor quality parameters so that the quality of care remains on a consistently high level. As part of

this approach, we regularly share aggregated data on the quality of care as well as our financial results with executives in the individual operating segments as well as with our Management Board. In addition, we publish selected results of our treatment analyses on a quarterly basis to provide transparency on the quality of patient care.

For Fresenius Medical Care, patient health and product safety means creating a safe and healthy clinical environment. The quality and safety of our products and services are the foundation of our business success. Depending on the target market and the country of production, Fresenius Medical Care is subject to different rules and regulations.

To fulfill our commitment to customer health and product safety while complying with the numerous relevant regulatory requirements, our processes are embedded in comprehensive quality management systems (QMS). These QMS enable all of our products and procedures to 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.

To allow us to provide our products and processes with a high quality, Fresenius Medical Care is committed to adhering to its Global Quality Policy, which is a key component of our QMS. The policy reflects our commitment to providing uncompromised product and service quality, while maintaining compliance with relevant regulations. By approving the Global Quality Policy, the heads of the Global Manufacturing, Quality & Supply (GMQS) and Global Research and Development (GRD) functions, who are also members of the Management Board, confirmed their commitment to implementing a harmonized quality management system and maintaining its effectiveness.

As regulatory requirements vary around the world, our QMS are managed at a regional or local level. Responsibility always lies with the Head of Quality of the corresponding region. As part of this approach, local sites are subject to management reviews and regular internal quality audits performed by personnel who are not directly involved in the processes. Furthermore, our manufacturing sites in all regions undergo external audits by notified bodies and authorities such as the U.S. Food and Drug Administration (FDA) or the German Ministry of Health. Any cases of non-conformance are forwarded to the respective department to determine and implement appropriate corrective and preventive actions in due time.