Home Hemodialysis Systems: MedSun Small Sample Survey Summary
MedSun: Newsletter #54, November 2010

Survey Topic: Home Hemodialysis Systems
Year Conducted: 2010


Background
As the home care sector continues to expand, so will the use of advanced medical device technology in the home environment. In order for the Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) to ensure that medical devices are used safely and effectively in the home setting, the purpose of this survey was to learn about device issues faced by professional home care providers, as well as those issues potentially encountered by informal caregivers who use Home Hemodialysis (HHD). Since dialysis treatments at home can be self-initiated, managed or used with the assistance of a trained caregiver, often a family member, CDRH is interested to learn about users’ experiences with these systems.

Surveys were conducted with eight health care professionals to gather information about home care providers’ and users’ experiences with hemodialysis systems used in the home environment. Questions focused on the following topics:
*Device performance and experience
*Prescription and Discharge
*Training and Labeling
*Water treatment compatibility
*Patient outcome

Summary
Overall, respondents have had good experiences with patients receiving HHD. Fresenius and NxStage systems were cited as the most commonly used systems. NxStage system users have more favorable opinions, especially because they don’t require a specialized water system and are small and portable. While respondents seemed very happy with the materials and support provided by the manufacturer(s), it is interesting to note that additional materials are often developed (sometimes by the patient) to supplement what the manufacturer provides. Respondents feel that the more recent material is better than what was provided in the past.

Prescription, discharge planning and training tends to vary as a function of the facility’s procedures. For the most part, a physician – commonly a nephrologist – prescribes the patient with HHD and then the dialysis nurses will further assess the patient and their home environment to determine if they are a good candidate for the treatment. Patient training will then ensue, often times in the dialysis clinic or center by nurse educators. Majority of the respondents also require a family caregiver be trained along with the dialysis patient. Training tends to be very individualized to best cater to the patient and patient caregiver’s abilities and needs. Depending on the individual and on the system, training duration may vary, anywhere from 1.5 to 8 weeks. One respondent notes that most patients demonstrated understanding in 3-4 weeks; by the 4th or 5th week, patients were able to do their own treatment unobserved. Whereas the survey questions primarily focus on how the facility trains patients and caregivers, one respondent commented favorably on the training provided to their nursing staff by Fresenius and NxStage.

Respondents feel it is important that patients have HHD as an option because it provides them with more independence and a better quality of life. Majority of the respondents advocate home care as opposed to receiving care in a center because it is one-on-one treatment. Respondents generally feel that the patient’s commitment, motivation and support play a vital role in their success. In fact, some respondents encourage making use of support networks so that patients and caregivers can learn from one another.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


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Small Sample Survey Questions

Device performance and experience

o Have you or your patients experienced difficulty using these systems in the home?
o What home hemodialysis systems do you currently use, or are most familiar with? Manufacturer? Brand? Type?
o Which systems have resulted in better patient outcomes?

Prescription

o If these systems are being used in the home, how are they typically prescribed?
o Are patients monitored by home care nurses or aides when these devices are used in the home setting?
o What is involved in the discharge planning with the caregiver or patient when they go home from the hospital with this system?
o What do you usually tell your patients about using these systems?
o Do patients express concern if using these systems themselves in the home?

Training and Labeling

o Have patients and their caregivers been trained?
o If so, by whom?
o Does the training take place in the hospital before discharge or when the patient is already at home?
o Is training mandatory for patients and caregivers who use the device in their home?
o If so, please describe the training. For example, was it video-based, hands-on, demo? What materials were provided?
o Do these systems have labels or other written instructions for use? If so, are the labels written for a lay audience?
o In your opinion, what challenges have you observed with caregivers’ ability to understand and follow device instructions? With the patients’ ability (if they self administer the treatment)?
o What do you think could be done to better inform patients of the risks/benefits associated with using these systems, especially in the home setting?

Water treatment compatibility

o Which water treatment systems are used with the hemodialysis systems you currently use, or are familiar with?
o Do these typically come with the hemodialysis system, or are they purchased separately?
o If purchased separately, have you or your patients experienced compatibility issues?
o Have you seen complications with the hemodialysis system versus the water treatment system?

Patient outcome

o In your opinion, are patient outcomes dependent upon specific patient characteristics, i.e. patient age, capabilities, caregiver or provider support?
o In your opinion, do you think that a patient could perform hemodialysis at home by themselves?



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