Patient Safety by Fresenius Medical Care Where new benchmarks are set

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1 Cardioprotective Haemodialysis Patient Safety by Fresenius Medical Care Where new benchmarks are set Cardioprotective Haemodialysis

2 Protect your Patient Cardioprotective Haemodialysis Wide-ranging cardioprotection The reduction of risk factors for cardiovascular diseases (CVD) is core to the development of dialysis systems and products at Fresenius Medical Care. Outstanding cardioprotection must be reflected in all levels of product development and application. There have been tremendous improvements in the quality and efficacy of haemodialysis (HD) therapy in recent years. Despite this, cardiovascular diseases (CVD) remain the leading cause of death for patients with end-stage renal disease (ESRD). Cardioprotective Services Over 30 years experience in dialysis at your service. Products State-of-the-art technologies enable advanced cardioprotective therapies. Project Planning and Consulting Training and Education Technical Services Water Quality Service (WQS) Medical Information Services CorDiax Product line: CorDiax and 5008S CorDiax - FX CorDiax dialysers - BCM-Body Composition Monitor Classix Product line: S classix - FX classix dialysers Therapy Data Management System (TDMS) Online Purification Cascade (OPC) 2

3 Moreover, both overall and cardiovascular mortality are markedly greater in ESRD patients than in the general population. This is why we put Cardioprotective Haemodialysis on the SPOT. A comprehensive approach that includes services, products and therapies is needed to achieve the best therapeutic performance meaning improved clinical outcomes and better quality of life, enhanced control of therapy costs, and simpler, safer handling. Haemodialysis Outcomes Achieving better outcomes with cardioprotective therapies. Therapies Cardioprotective therapies designed by the world market leader in haemodialysis. Reduced mortality risk Fewer cardiovascular complications Optimised use of resources High-Flux dialysis ONLINE HDF Advanced Fluid Management 3

4 Protect your Patient Patient Safety by Fresenius Medical Care Where new benchmarks are set Despite continuous improvements in haemodialysis technology, morbidity and mortality rates among patients with chronic kidney failure are still unacceptably high. Besides advanced treatment options, which may significantly improve patient outcomes and survival rates, confidence about the safety of dialysis treatment is of utmost importance. Thus, safety should be a self-evident, non-negotiable aspect of dialysis. External bleeding Optimised monitoring of the venous path with Venous Access Monitoring (VAM) Sophisticated wetness detector VenAcc allows blood loss to be detected quickly Sensors and the machine s front doors enable the fast recognition of leakages in the extracorporeal blood system It goes without saying that Fresenius Medical Care conforms to basic safety requirements as set out in medical standards. The challenge is to think beyond state-of-the-art technologies and approach wellknown problems with innovative solutions, striving for superior patient safety. With the new 5008 CorDiax*, Fresenius Medical Care offers intelligent safety features that ease daily routines, whilst at the same time supporting the nursing staff s responsibility as therapy providers. Paravasal bleeding Early detection of paravasal bleeding with Dynamic Pressure Monitoring Haemolysis Reduced risk of mechanical haemolysis by closing the security gap between blood pump and venous bubble catcher with Blood Line Kinking & Filter Clotting Detection Coagulation Non-invasive, air-free arterial pressure monitoring reduces the blood-air interface Fluid removal Balancing chamber guarantees highly precise fluid removal during treatment Continuous monitoring of the tightness of the hydraulic system by leakage sensors and integrity tests avoids uncontrolled fluid loss PRODUCTS * also applicable to 5008S CorDiax 4

5 Fresenius Medical Care provides greater safety during all forms of treatment for both patients and operators. What s more, as the world market leader in dialysis, with over 30 years of expert knowledge, we are committed to setting new benchmarks in patient safety because conforming to standards alone is not enough! Safety creates confidence. 5

6 Protect your Patient External bleeding "Patients with dementia often do not understand the dialysis process. Sometimes they pull out the needle " What if dialysis machines could feel the position of the venous needle? PR O D S CT U 6 Safety_Concepts_12_12_GB.indd :16

7 Sudden dislodgement of the venous needle, partial disconnection of the Luer-Lock connections or any other untight connections can cause the patient to lose a critical amount of blood. The 5008 CorDiax and 5008S CorDiax offer various novel solutions to minimise the risk of external blood loss: SPOT on: Optimised control of the venous path with Venous Access Monitoring (VAM). Early detection of venous needle dislodgement much more likely. Venous Access Monitoring (VAM) The regular pressure monitor in conventional dialysis machines is typically set to detect pressure drops greater than 30 mmhg. Frequently, a disconnected or dislocated venous needle only causes a slight drop in venous pressure below 30 mmhg. As a result, there is an increased risk of blood loss due to undetected venous needle dislodgement. VAM also includes a sophisticated alarm management system: an alarm is activated if the monitored signals show exceptional or abnormal variations to the previous pressure profile. If this warning is sounded, the blood pump is stopped immediately. This gives the nursing staff sufficient time to react appropriately to critical pressure changes. Whilst arterial and venous pressure monitoring is standard in all dialysis machines, VAM sets a new benchmark in patient safety: by combining arterial and venous pressure signals with an adaptive algorithm, VAM enables dynamic and highly-sensitive monitoring of the venous pressure. In this way, VAM indicates sudden, small drops in venous pressure of approximately 15 mmhg, even when the venous pressure does not exceed the lower alarm limit. This increases the probability of early detection of venous needle dislodgement.* VAM makes a progressive contribution to superior patient safety by monitoring the most sensitive point of dialysis the venous access. Using VAM to prevent undetected venous needle dislodgement for a highly-safe dialysis. * Overall, VAM results in a higher level of security on the venous access. However, the user is still responsible for the patient's safety. 7

8 Protect your Patient External bleeding VenAcc The venous needle is more likely to become disconnected or dislocated in those with a higher risk of venous needle dislodgement, such as patients undergoing long-term home or nocturnal dialysis, as well as restless or confused patients. Fresenius Medical Care has developed a special wetness detector, VenAcc, which is capable of detecting blood loss directly. Its disposable, self-adhesive sensor patch for blood detection is connected to the control unit. If the sensor patch of the VenAcc detects fluid, the control unit will trigger an alarm via wireless connection on the 5008 CorDiax or 5008S CorDiax, and the blood pump will be stopped immediately to prevent serious blood loss. The VenAcc is an optional device in the 5008 CorDiax and 5008S CorDiax. Door concept with leakage sensor Blood loss can also be induced by leakages in the extracorporeal blood tubing system, e.g. due to untight Luer-Lock connections or leaking blood tubing systems. With Fresenius Medical Care s door concept, it is possible to identify leakages quickly, hence preventing serious external blood loss. As the doors at the front side of the 5008 CorDiax and 5008S CorDiax prevent fluid from spilling, the fluid runs down and touches the leakage sensor in the dialysis machine s drain gutter. The leakage sensor is capable of detecting minimal amounts of fluid and activates the alarm. Drain gutter with leakage sensor PRODUCTS 8

9 Benefits for the patient: Diminished risk of critical blood loss due to venous needle dislodgement or leakages in the blood tubing system High patient safety due to minimised tolerated blood loss to the environment Benefits for the user: Optimised monitoring of the venous path Higher probability of early detection of venous needle disconnection or dislocation VAM is a fully integrated feature in the 5008 CorDiax and 5008S CorDiax, resulting in no need for disposables, convenient handling and no additional costs Improved safety for patients who have an increased risk of venous needle dislodgement Faster recognition of leakages in the extracorporeal blood system Protection from blood spillages SPOT on: Increased safety for high-risk patients thanks to additional wetness detector, VenAcc. Faster recognition of leakages in the extracorporeal blood tubing system. 9

10 Protect your Patient Paravasal bleeding "I remember one patient who suffered from an undetected perforation of the vessel during dialysis..." What if the venous needle could navigate to the ideal position? PR O D S CT U 10 Safety_Concepts_12_12_GB.indd :16

11 Undetected paravasal blood loss is a serious complication during dialysis: when the venous needle perforates the vessel, blood leaks out into the surrounding tissue and causes large haematomas. However, there is a way to make internal bleeding visible from the outside: SPOT on: Early detection of paravasal bleeding with Dynamic Pressure Monitoring. Dynamic Pressure Monitoring Paravasal bleeding causes a rise in venous pressure. Sophisticated Dynamic Pressure Monitoring is able to detect these critical changes in venous pressure, minimising the risk of large haematomas. Moreover, Fresenius Medical Care s Dynamic Pressure Monitoring opens the door to a new, intelligent way of pressure monitoring: by assessing of pressure history, the 5008 CorDiax and 5008S CorDiax are able to differentiate between short-term, uncritical pressure changes, where the treatment can be continued without interruption, and critical alarm situations where the user needs to be informed immediately. Benefits for the patient: Outstanding patient safety by avoiding undetected paravasal blood loss Prevention of large haematomas Benefits for the user: Early detection of paravasal bleeding No treatment interruption due to non-critical pressure variations 11

12 Protect your Patient Haemolysis "A good example of an invisible dialysisrelated complication is haemolysis." What if a blood line could express its discomfort? PRODUCTS 12

13 One of the serious complications that can arise during dialysis is mechanically induced haemolysis caused by kinking of the blood tubing. Conventional dialysis machines do not often detect the kinking of the blood line between the blood pump and the venous bubble catcher which could potentially cause haemolysis. Blood Line Kinking & Filter Clotting Detection Fresenius Medical Care closes this safety gap by providing the Blood Line Kinking & Filter Clotting Detection feature. This safety feature monitors the extracorporeal tubing system from the blood pump to the inlet of the venous bubble catcher without the need for a pre-filter pressure sensor. Blood Line Kinking & Filter Clotting Detection analyses changes in the blood flow conditions within the extracorporeal circuit. Possible reasons for these changes include kinking of the bloodline and clotting in the dialyser. When these occur, the Blood Line Kinking & Filter Clotting Detection activates an alert and asks the user to check the tubing and the dialyser. The 5008 CorDiax and 5008S CorDiax monitor the complete extracorporeal blood circuit and enable to detect the risk of haemolysis arising as a result of the kinking of bloodlines or the start of haemoconcentration. SPOT on: Reduced risk of haemolysis by monitoring the complete extracorporeal blood circuit. Early detection of filter clotting. Benefits for the patient: Improved safety due to monitoring of the complete extracorporeal blood circuit Lower extracorporeal blood volume as an additional pressure sensor is not required Benefits for the user: Faster detection of potential haemolysis risks Rapid intervention possible in the event of kinking Easy handling due to standard blood tubing system 13

14 Protect your Patient Coagulation "Sometimes patients have to wait quite some time before they can go home. The bleeding takes so long to stop after the needle is pulled out..." What if blood had a bodyguard? PR O D S CT U 14 Safety_Concepts_12_12_GB.indd :16

15 Contact with any material foreign to the body or contact with air increases the likelihood of blood coagulating within the extracorporeal blood circuit. As a consequence, anticoagulants are given to prevent clotting. The amount of heparin should be as low as possible, meaning the air and blood contact during dialysis needs to be minimised. SPOT on: Non-invasive, air-free arterial pressure monitoring minimises risk of blood coagulation. Non-invasive, air-free arterial pressure monitoring The 5008 CorDiax and 5008S CorDiax by Fresenius Medical Care enable the arterial pressure to be measured without a blood-air interface. Non-invasive, air-free arterial pressure monitoring considerably diminishes the risk of blood clotting. In addition, the extracorporeal blood volume is reduced as an arterial expansion chamber is not required. Benefits for the patient: Higher safety due to reduced risk of blood coagulation Reduced risk of potential cross-contamination due to sealed design of the pressure dome Benefit for the user: Easy handling of pressure dome Arterial pressure dome 15

16 Protect your Patient Fluid removal "Dialysis patients often suffer from circulatory disturbances due to the removal of water." What if a dialysis machine could continuously balance the patient s fluid status? PR O D S CT U 16 Safety_Concepts_12_12_GB.indd :16

17 Removal of excess water is one of the key tasks of a dialysis machine. The removal of a precise amount of fluid is crucial for the well-being of the patient, as too much ultrafiltration could potentially result in hypotension or muscle cramps. In ONLINE HDF this task is even more complex, as the balance between the total fluid withdrawn from the patient and the fluid volume substituted has to be adhered to exactly. SPOT on: Prevention of uncontrolled fluid loss due to precise measurement of the ultrafiltration volume during treatment and a leakage-free hydraulic system. Balancing chamber The balancing chamber is the heart of the leakagefree hydraulic system in Fresenius Medical Care s dialysis machines. Symbolically, the balancing chamber can be understood as a closed system s doorman, only allowing an inflow of fresh fluid when exactly the same amount of spent fluid has left the system regardless of whether the fresh fluid will be used as dialysis fluid or substitution fluid. Following this basic principle of volumetric control, the ultrafiltration (UF) pump is authorised to work independently from any existing dialysate flow with the highest possible precision, that determines the accuracy of the UF control. Benefit for the patient: Fewer intradialytic complications by avoiding uncontrolled fluid loss Benefit for the user: Easy to determine the achieved ultrafiltration rate due to high measurement accuracy As a result, each patient loses only the precise amount of fluid prescribed. 17

18 Protect your Patient Insights "Egoism is the most convincing driving force for the development of safety features in dialysis." What if a dialysis patient would engineer a dialysis machine? Dr Pascal Kopperschmidt: Physicist Development Engineer at Fresenius Medical Care Dialysis patient since Safety_Concepts_12_12_GB.indd :17

19 What does safety mean for a dialysis patient? Safety is the most essential aspect of dialysis to influence health, quality of life and long-term survival. Haemodialysis is a physically and emotionally exhausting process. Therefore, it is crucial to have confidence in the medical staff, in the materials and in the device itself. Patients know that whilst nobody can guarantee 100 % safety, but anybody can give a promise at least. What is the challenge for a dialysis patient developing a dialysis machine? The patient s perspective is different from that of the developer. In the clinical routine, the patient is the focal point and is surrounded by medical assistance and technological equipment. Technology will prolong a patient s lifespan, as long as certain basic rules are followed. From the developer s perspective, technology is in the focus. Following a well-structured development process, the device is brought to market once capital constraints, legal reviews and technical feasibility studies are finalised. Merging the different aspects of the patient and the developer introduces a very personal, anthropogenic touch into the formal development process. The challenge for a developer with terminal renal function is to face dialysis-related issues professionally, even if these issues may at some point have an impact on his own treatment. the dynamics of extracorporeal pressures. Consequently, medical staff are alerted when the tip of the needle or the catheter has left its proper location. With VAM, a dialysis machine is, for the first time, able to protect patients from severe blood loss with a degree of certainty never reached before. How do you benefit from being a part of the development team at Fresenius Medical Care? The road to success is not a path you find but a trail you blaze. This quote by Robert Brault is perfectly fitting for the research and development team at Fresenius Medical Care. As part of this team, I have the privilege to share my experiences as a physicist and dialysis patient with my colleagues. Occasionally, I use my experience as a patient to sway certain decisions. I myself am a user of the products we have developed, and the fact that I have played a role in their design makes me feel more relaxed as I undergo dialysis. If I am confident with the product, others may be as well. We work hard and we play hard together. This is why I feel at home in the development team, working with others who have become more than just colleagues. What is behind Venous Access Monitoring (VAM) and why is it so important in dialysis? An accidentally dislodged venous needle or disconnected catheter may cause patients bleeding to death. The associated pressure drop is often too small to be detected by conventional monitoring. The Venous Access Monitor reduces the risk of undetected blood loss during dialysis. VAM embodies a sophisticated algorithm equipped with several criteria to evaluate 19

20 Head office: Fresenius Medical Care Deutschland GmbH Bad Homburg v. d. H. Germany Phone: +49 (0) Fax: +49 (0) F GB (2.0 BG-E&B 12.12) Copyright 2012 Fresenius Medical Care Deutschland GmbH certified, PEFC/