Frequently Asked Questions

HHD can be performed during the day with or without a care partner or overnight while you and your care partner sleep (nocturnal home hemodialysis)*. A care partner is not a medical professional and can be a friend, spouse, colleague, or family member.

If patients choose to do home hemodialysis, either they and/or their care partners will need to take on the responsibility for tasks that would normally be taken care of by center staff when receiving treatment in-center. They will need to perform all aspects of the dialysis treatment from start to finish, including setting up the dialysis equipment, needle sticks, responding to and resolving all system alarms, and system disassembly at the end of treatment.

In addition, they must monitor their blood pressure, ensure that proper aseptic technique is followed, and follow all of the training material and instructions given to them by their training nurses. If a patient is using a care partner both the patient and care partner will be trained by their provider and need to know how to respond to any health emergencies that might happen during treatment at home, including dizziness, nausea, hypotension (low blood pressure), and fluid or blood leaks.

To do home hemodialysis successfully, patients must take care to ensure that they have a clean and safe environment for their treatments. They will also need to set aside space in their home for the needed supplies.

*Work with your doctor and care team to determine the best treatment option for you.

Patient training will be provided by the patient's clinic and depending on what is happening at the patient’s clinic, their care and home training teams will work to get them into training for PD or HHD as quickly as possible. In some cases, training may begin in-center with an overview of each system and therapy, a review of the first few elements of training, and the answering of questions.
The decision to do home dialysis is made between a patient and their doctor. There is no recognition or nomination program needed to go home but a prescription from a physician is required. If there is interest, the center can introduce patients to their home training team either on site or at another center within their network. Patients can then learn more about training and when they would be able to start.
HHD can be performed during the day with or without a care partner (solo home hemodialysis) or overnight while you and your care partner sleep (nocturnal home hemodialysis). Solo treatments, performed without a care partner during waking hours, require additional equipment and training. Patients also have the ability to perform their treatments overnight while they sleep, which is referred to as nocturnal treatments. Patients who perform nocturnal treatments are required to have a care partner, along with additional equipment and training. Working with their care teams, patients can determine which therapy is right for them. NxStage HHD equipment is the first and only cleared by the FDA for both nocturnal and solo therapies.
Home hemodialysis treatments offer more flexibility, as patients are not tied to a specific block of time on their treatment days. Patients can work with their doctor to find a flexible treatment schedule that best works for them.
There are no restrictions on performing HHD using a central venous catheter (CVC). While fistulas and grafts are the more common and recommended access options, many patients use a CVC to perform their treatments successfully and safely at home. In fact, lots of patients start HHD therapy using a CVC with a plan to have a permanent access placed in the future. For other patients, a CVC is the only access option available to them. The access type used for HHD is determined based on conversations between patients and their doctors. Patients will be trained by their clinic to manage and care for their access no matter what type of access they are using.

Patients are prescribed the dialysis therapy that is best for them. Based on their needs, their doctor will decide how frequently they will need to perform their therapy, how much and what kind of dialysate they will use, how long the treatment will last, and what their weight at the end of each treatment should be.

Treatment times will vary based upon your patient's body size and their prescription. A typical more frequent treatment uses 20 to 30 liters of dialysate and takes 2½ to 3 hours to complete.

Most PD patients are not required to have a care partner.
Past abdominal surgery doesn’t automatically disqualify a patient from doing PD. Interested patients who have had a prior surgery can work with their doctor to assess their ability to do PD treatments.

Every prescription is based on the individual’s particular needs. Patients can work with their doctor to determine what home modality option best fits their clinical and lifestyle needs and how often they will be required to treat. HHD and PD Dosing Calculators, available for healthcare professionals only, can help prescribers provide dosing considerations for both home therapies. Each calculator provides individualized therapy options based on the clinical information entered.

For most patients, supplies and equipment are covered by their insurance or Medicare, but it is important to review coverage with the insurance provider. Social workers may be able to provide more guidance and help patients with this process.
Many patients may be candidates for home therapy, including patients with pre-existing conditions or disabilities. Interested patients should discuss this with their care team, who can help determine what is best for them.
There are no universal restrictions in place regarding a certain body type or weight range requirements to perform treatments at home. Adjustments are made for each individual patient. Interested patients should discuss this with their care team, who will review their specific needs prior to training.
Patients who select a home therapy are not required to have any residual renal function to perform home therapies. Interested patients, should talk to their doctor who can work with them to select and adjust their dialysis program to make sure they are receiving the best treatment possible.
Many families have found HHD or PD treatment plans that work for them. Some prefer to do treatments during the day once children are at school or in the evening while watching TV or talking as a family. If there is interest in home therapies, it is important to explore all the options available that best fit a patient’s life and lifestyle.

There are some risks with all medical procedures and treatments however, serious adverse events in home dialysis are relatively rare.1 HHD and PD equipment are designed for safety and there are both procedural steps and system alarms in place to help prevent any adverse events from occurring. The home training nurse will review all the precautions and procedures needed to avoid and prevent any adverse events. Patient retraining and periodic technique checks may also help to mitigate these risks.

References:

  1. Tennankore KK, et al. Am J Kidney Dis. 2015;65(1):116-121.

The NxStage Versi HD is just over a foot tall, measuring approximately 18 inches high by 15 inches wide by 16 inches deep. It easily fits into any room at home without any home modifications, and can also be packed into a car or checked (with the appropriate preliminary steps and protective case) for airplane travel. The system plugs into a standard 110V electrical outlet.

The PureFlow SL dialysate purification system is about the size of an end table, and the System One cycler sits on top of it. The PureFlow SL is not portable for travel.

Storage space is required for the disposable supplies, such as cartridges, sacks of concentrated dialysate, and bags of premixed dialysate (for back up and travel), as well as access-related supplies and saline bags.

There are no restrictions on the use of well water for HHD patients using NxStage equipment. Patient source water is tested while the patient is training, and any necessary adjustments can be made depending on the quality of the water. Source water must meet the US EPA Safe Drinking Water Act (SDWA) guidelines. There may be cases where certain source water does not meet the outlined standards and, in those cases, bagged dialysate may be used for treatments.

NxStage's Versi HD is the first and only portable hemodialysis machine cleared specifically by the U.S. Food & Drug Administration (FDA) for home hemodialysis, solo home hemodialysis, and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy.

When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify the process by using ordinary tap water to create dialysis fluid. Unlike conventional hemodialysis systems, Versi HD requires no special infrastructure to operate. Under the guidance of their physician, patients can use Versi HD, with their trained partners, where, how and when it best meets their needs, including while they're sleeping - at home or on vacation and at a medically appropriate treatment frequency. Versi HD is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and efficacy have been demonstrated by experience with more than 21 million treatments with thousands of patients around the world1.

References:

  1. Data on file. NxStage Medical, Inc. 2020.

Versi HD is designed to deliver hemodialysis therapy in a home setting. It consists of the following elements:

  • A small control unit containing a fluid pump and a touch screen user interface (referred to as the cycler).
  • A disposable dialyzer and tubing set (referred to as the cartridge).
  • PureFlow SL dialysate preparation system or in premixed dialysate bags for travel.
  • PureFlow is the only system designed, tested, and validated to produce ultrapure water from tap water, accommodating most home water sources.

For each treatment, a new cartridge is inserted into the cycler, where it is prepared for use or primed prior to treatment. The dialysate is generally prepared in advance, in batches, by the PureFlow SL, and is then connected to the cartridge.

During treatment, the cartridge tubing is attached to the patient's blood access. Blood and dialysate pass through the filter to clean the blood. Used dialysate, wastes known as effluent and excess fluids removed from the blood are routed through a waste line on the cartridge and into a drain.

Therapy is complete when the prescribed dialysate volume has been delivered. Daily supplies are thrown away, and the cycler is simply wiped down after use.

VersiHD is the latest version of the home hemodialysis cycler from NxStage. Designed for simplicity, the VersiHD cycler’s compact size and functionality are complemented by a touchscreen interface that allows for responsive key presses and advanced on-screen displays.While the touchscreen buttons are the same buttons patients are familiar with across all of our cycler systems, on the VersiHD touchscreen, the buttons illuminate only when they can be adjusted or pressed during operation enhancing clarity and confidence during treatment. The VersiHD and System One S cyclers are also capable of higher dialysate flow rates.
It is important that the treatment area remain clean to help avoid the risk of an infection. Some people choose to designate one room or area as their treatment space and keep it clean. This does not mean the entire house or dwelling needs to be spotless at all times. Interested patients’ home training care teams will also teach them how to properly care for their designated treatment area.
Even if a center doesn’t offer home training, center staff can often connect an interested patient to a home training program in their network. It is possible for patients to move to a home training center; they are not required to stay at their center especially if another therapy option might be a better fit for them.
This is a common concern; however, many people with needle-phobia have have successfully trained on HHD, overcome their fears, and been successful at home. Cannulation teams and experts in certain centers can also help address these concerns.
For some people, the decision to go home is made with their doctor prior to needing dialysis, while others make the decision later in their dialysis journey. There is no defined progression or pathway for treatment plans. Patients should talk to their care team if they are interested in learning more.
Patients are trained by their dialysis center. Training goes at the pace of the individual learner and includes product, therapies, how to handle emergencies, and disease state education. Training typically takes 4 weeks for HHD and 2 weeks for PD. Patients don’t go home until both they and their care team are confident they can perform their treatment safely.
Home therapy is currently being enjoyed by thousands of HHD and PD patients. Training includes product, therapies, how to handle emergencies, and disease state education. Training goes at the pace of the individual learner and typically takes 4 weeks for HHD and 2 weeks for PD. Patients don’t go home until both they and their care team are confident they can perform their treatment safely.
Training typically takes 4 weeks for HHD and 2 weeks for PD and can be adapted to fit a patient’s schedule based on the center’s availability. Training goes at the pace of the individual learner and includes product, therapies, how to handle emergencies, and disease state education.
Many patients on home therapies participate in water activities. Patients should follow the guidance of their doctor on what water activities can be enjoyed safely.
Patients on either home therapy are allowed to take showers, but they should follow the guidance of their doctor on what method is best based on their specific care plan and needs.

Patient have access to Fresenius Technical Support and Customer Service for PD equipment questions and NxStage Technical Support and Customer Service for HHD equipment questions.

Fresenius Medical Care Product Training and Technical Support
1-800-227-2572
Fresenius Customer Service
1-800-323-5188

Fresenius Medical Care Technical Support
1-866-697-8243
Opt. 1 Technical Support
Opt. 2 Customer Service
Patient Consultants: 1-888-200-6456

Some storage space is needed for treatment supplies. Many patients use a closet or underbed area for storage and clinic staff can help access space if needed. Home patients treat in many types of settings, from large homes to small apartments, RVs, and mobile homes. Connecting a current home patient to a NxStage Patient Consultant can also help to ease a prospective patient’s concerns.
There are no home decor restrictions to home therapy, including having carpet.
Many patients are also pet owners. However, it is recommended to keep pets out of the dialysis treatment area.
There is no education requirement to be on a home modality and both HHD and PD patients have a wide range of education backgrounds.

A patient's center, care team, technical support, and customer service are all available resources that a patient can access while dialyzing at home.

If a patient is experiencing a medical emergency during a treatment they should contact 911. For equipment concerns, or issues patients can contact technical support, available 24/7, 365 days a year. Customer service is available Monday–Friday during normal business hours to answer questions regarding deliveries, inventory, or travel.

Typically, no physical home modifications, such as plumbing or electrical, are needed for either PD or HHD.
Many patients who have experienced in-center treatments may have missed a treatment or been told at one point they were not compliant. Often, strict scheduling may be part of the reason. When compared to in-center, home modalities can be scheduled on treatment days during the times that work best for them, providing an added level of flexibility. It is important for all interested patients to talk to their care team and determine if home dialysis is an option for them.

Many people who select a home therapy report feeling better physically when performing more frequent treatments1,2 and studies confirm there is a higher likelihood of being added to the kidney transplant waiting list on HHD and receiving a transplant on PD.3-5

References:

  1. Hall YN, Larive B, Painter P, et al. Effects of six versus three times per week hemodialysis on physical performance, health, and functioning: Frequent Hemodialysis Network (FHN) randomized trials. Clin J Am Soc Nephrol. 2012;7(5):782-794.
  2. FHN Trial Group. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010;363(24):2287-2300.
  3. Sinnakirouchenan R, Holley JL. Peritoneal Dialysis Versus Hemodialysis: Risks, Benefits, and Access Issues. Adv Chronic Kidney Dis. 2011;18(6):428-32.
  4. Bonenkamp AA, van Eck van der Sluijs A, Hoekstra T, et al. Health-Related Quality of Life in Home Dialysis Patients Compared to In-Center Hemodialysis Patients: A Systematic Review and Meta-analysis. Kidney Med. Published online Feb. 11, 2020.
  5. Weinhandl ED, Liu J, Gilbertson DT, Arneson TJ, Collins AJ. Survival in Daily Home Hemodialysis and Matched Thrice-Weekly In-Center Hemodialysis Patients. J Am Soc Nephrol. 2012;23(5):895-904.
There are no medical training requirements for care partners. Care partners can be spouses, friends, or neighbors. The only requirement is that they attend training sessions for the specific duties they decide to take on. Many people on home therapy prefer to perform their own treatments but choose to have a care partner present in the event of a problem or issue during treatment.

The reported benefits of home hemodialysis (HHD) may not be experienced by all patients.

The NxStage System is a prescription device and, like all medical devices, involves some risks. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. When vascular access is exposed to more frequent use, infection of the site, and other access related complications may also be potential risks. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream, and blood loss due to clotting or accidental disconnection of the blood tubing set.

Home hemodialysis with the NxStage System during waking hours may not require a care partner, provided a physician and a qualified patient agree that solo home hemodialysis is appropriate. Patients performing nocturnal treatments are required to have a care partner. Care partners are trained on proper operation and how to get medical or technical help if needed.

Certain risks associated with hemodialysis treatment are increased when performing solo HHD because no one is present to help the patient respond to health emergencies. If patients experience needles coming out, blood loss, or very low blood pressure during solo HHD, they may lose consciousness or become physically unable to correct the health emergency. Losing consciousness or otherwise becoming impaired during any health emergency while alone could result in significant injury or death. Additional ancillary devices and training are required when performing solo HHD.

Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow and/or increased treatment time, and delayed response to alarms when waking from sleep.

Patients should consult their doctor to understand the risks and responsibilities of performing these therapies using the NxStage System.

The reported benefits of peritoneal dialysis may not be experienced by all patients.

Peritoneal dialysis does involve some risks that may be related to the patient, center, or equipment These include, but are not limited to, infectious complications. Examples of infectious complications include peritonitis, and exit-site and tunnel infections. Non-infectious complications include catheter complication such as migration and obstruction, peritoneal leaks, constipation, hemoperitoneum , hydrothorax, increased intraperitoneal volume, respiratory, and gastric issues. It is important for healthcare providers to monitor patient prescriptions and achievement of adequacy and fluid management goals.

Patients should consult their doctor to understand the risks and responsibilities of performing peritoneal dialysis.

The Liberty® Select peritoneal dialysis cycler is indicated for acute and chronic peritoneal dialysis. The stay-safe® PIN connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during peritoneal dialysis exchanges. The stay•safe PIN connectors are indicated for acute and chronic peritoneal dialysis.

APM2100 Rev. D