NNocturnal Home octurnal Home HemodialysisHemodialysisNNocturnal Home octurnal Home HemodialysisHemodialysis

Draft PANEL DISCUSSIONDraft PANEL DISCUSSION

POINTSPOINTS

June 8, 2005June 8, 2005

Device DesignDevice DesignDevice DesignDevice Design

1.1. Standard hemodialysis delivery devices contain Standard hemodialysis delivery devices contain monitors and alarms to assess blood pressure, monitors and alarms to assess blood pressure, pulse, venous and arterial pressures, blood and air pulse, venous and arterial pressures, blood and air leaks temperature, dialysate and blood flow, leaks temperature, dialysate and blood flow, ultrafiltration rate, acid and bicarb pumps, end of ultrafiltration rate, acid and bicarb pumps, end of treatment, and other parameters particular to the treatment, and other parameters particular to the specific device. Please consider and discuss the specific device. Please consider and discuss the need for the following additional safety features in need for the following additional safety features in nocturnal home hemodialysis (NHD) treatments nocturnal home hemodialysis (NHD) treatments and provide suggestions for additional features. and provide suggestions for additional features. You should take into consideration the importance You should take into consideration the importance of human factors when discussing these features.of human factors when discussing these features.

Blood AccessBlood AccessBlood AccessBlood Access

a.a. Additional safeguards to prevent Additional safeguards to prevent blood access disconnections;blood access disconnections;

b.b. Alarms to detect fluid Alarms to detect fluid (blood or (blood or dialysate)dialysate) leaks, and a moisture leaks, and a moisture detector at the site of hemodialysis detector at the site of hemodialysis access;access;

Central MonitoringCentral MonitoringCentral MonitoringCentral Monitoring

c.c. Software incorporated in the NHD Software incorporated in the NHD device allowing connection to the device allowing connection to the Internet for remote monitoring;Internet for remote monitoring;

d.d. Central monitoring of treatment and Central monitoring of treatment and patient parameters, such as blood patient parameters, such as blood pressure, pulse, venous and arterial pressure, pulse, venous and arterial pressures;pressures;

User-Friendly DesignUser-Friendly DesignUser-Friendly DesignUser-Friendly Design

e.e. Instructions displayed on the machine itself Instructions displayed on the machine itself that are clear, and easy to follow, for that are clear, and easy to follow, for treatment set up, discontinuation, treatment set up, discontinuation, troubleshooting, and disinfection of the troubleshooting, and disinfection of the device;device;

f.f. Sensitive and loud alarms with clear Sensitive and loud alarms with clear explanations of what they mean and how to explanations of what they mean and how to respond;respond;

g.g. A justification for leaving out any standard A justification for leaving out any standard alarms or features found in traditional alarms or features found in traditional hemodialysis equipment.hemodialysis equipment.

Device Design Device Design (cont’d)(cont’d)Device Design Device Design (cont’d)(cont’d)

2.2. The quality of the water to be used to prepare dialysate is The quality of the water to be used to prepare dialysate is crucial for any dialysis treatment. Please discuss the water crucial for any dialysis treatment. Please discuss the water purification needs for the NHD procedures, including the purification needs for the NHD procedures, including the following:following:

a.a. Type of water treatment equipment Type of water treatment equipment (for preparation of water and (for preparation of water and verification of its quality)verification of its quality) appropriate for nocturnal home use; appropriate for nocturnal home use;

b.b. Due to the potentially higher exposure of patients to the processed Due to the potentially higher exposure of patients to the processed water, consideration as to whether the water quality water, consideration as to whether the water quality recommendations should be different for nocturnal home use as recommendations should be different for nocturnal home use as opposed to conventional, in-clinic use; and,opposed to conventional, in-clinic use; and,

c.c. Procedures on how to handle changes to the water quality and Procedures on how to handle changes to the water quality and composition by municipal water suppliers.composition by municipal water suppliers.

CLINICAL STUDY DESIGNCLINICAL STUDY DESIGNCLINICAL STUDY DESIGNCLINICAL STUDY DESIGN

3.3. FDA proposes that manufacturers evaluate NHD FDA proposes that manufacturers evaluate NHD

devices in clinical trials. The purpose of these devices in clinical trials. The purpose of these

studies is to evaluate the incidence of adverse studies is to evaluate the incidence of adverse

events, the devices’ ability to deliver prescribed events, the devices’ ability to deliver prescribed

treatments, and the patients’ ability to conduct the treatments, and the patients’ ability to conduct the

treatments as prescribed in a home nocturnal treatments as prescribed in a home nocturnal

hemodialysis setting, after appropriate training. hemodialysis setting, after appropriate training.

Please consider the following aspects of the Please consider the following aspects of the

clinical study design, and provide input on the clinical study design, and provide input on the

following elements of the study:following elements of the study:

CLINICAL STUDY DESIGN CLINICAL STUDY DESIGN (cont’d)(cont’d)CLINICAL STUDY DESIGN CLINICAL STUDY DESIGN (cont’d)(cont’d)

a.a. Study design Study design (e.g., retrospective or prospective;(e.g., retrospective or prospective;

b.b. Need for a control group and if so, appropriate type of control Need for a control group and if so, appropriate type of control (e.g., (e.g., prospective, historical, patient at their own control);prospective, historical, patient at their own control);

c.c. Appropriate sample size;Appropriate sample size;

d.d. Inclusion/exclusion criteria Inclusion/exclusion criteria (e.g., exclusion of patients previously (e.g., exclusion of patients previously on home dialysis);on home dialysis);

e.e. Frequency and duration of treatments;Frequency and duration of treatments;

f.f. Study duration;Study duration;

g.g. Safety endpoints;Safety endpoints;

h.h. Effectiveness endpoints; and Effectiveness endpoints; and

i.i. Length of follow-up.Length of follow-up.

CLINICAL STUDY DESIGN CLINICAL STUDY DESIGN (cont’d)(cont’d)CLINICAL STUDY DESIGN CLINICAL STUDY DESIGN (cont’d)(cont’d)

4.4. Please address these additional issues and discuss whether or not they should be Please address these additional issues and discuss whether or not they should be considered in a clinical trial:considered in a clinical trial:

a.a. Need for dialysate additives, such as phosphate, and monitoring Need for dialysate additives, such as phosphate, and monitoring requirements for these levels;requirements for these levels;

b.b. Type of anticoagulant appropriate for home use Type of anticoagulant appropriate for home use (e.g., dose, bolus, and (e.g., dose, bolus, and monitoring issues);monitoring issues);

c.c. Type of hemodialyzer membrane and permeability;Type of hemodialyzer membrane and permeability;

d.d. Type of monitoring Type of monitoring (no partner present, partner awake, no partner but using (no partner present, partner awake, no partner but using remote monitoring, no partner or remote monitoring);remote monitoring, no partner or remote monitoring);

e.e. Vascular access choice and location, and risks associated with these;Vascular access choice and location, and risks associated with these;

f.f. Practice of hemodialyzer reuse; andPractice of hemodialyzer reuse; and

g.g. Psychological effects Psychological effects (e.g., impact of treatments on patients, such as loss (e.g., impact of treatments on patients, such as loss of social interaction and the effects of the increased responsibility on the of social interaction and the effects of the increased responsibility on the patient, and the impact on and the reaction of the family members living in patient, and the impact on and the reaction of the family members living in the house).the house).

TRAININGTRAININGTRAININGTRAINING

5.5. The training of patients and their partners The training of patients and their partners (if (if

applicable)applicable) is crucial in performing NHD treatments. is crucial in performing NHD treatments.

Please comment on the training needs for this Please comment on the training needs for this

modality in terms of the important aspects to be modality in terms of the important aspects to be

included in the training program, how long the included in the training program, how long the

training period should be and what criteria should be training period should be and what criteria should be

used to determine if a patient has been adequately used to determine if a patient has been adequately

trained and is ready to begin self-care at home. trained and is ready to begin self-care at home.

Please also consider who should do the training and Please also consider who should do the training and

how they should be qualified.how they should be qualified.

LABELINGLABELINGLABELINGLABELING

6.6. Device labeling directed towards the patient should Device labeling directed towards the patient should

include information on NHD and on the device, include information on NHD and on the device,

including instructions for the use and care of the including instructions for the use and care of the

device, how to deal with alarms and how to run device, how to deal with alarms and how to run

treatments. Please discuss other important aspects treatments. Please discuss other important aspects

of NHD and the value of including them in the Lay of NHD and the value of including them in the Lay

User’s Manual User’s Manual (e.g., treatment (not device) risks, (e.g., treatment (not device) risks,

psychological effects of the treatments, vascular psychological effects of the treatments, vascular

access information).access information).

LABELING LABELING (cont’d)(cont’d)LABELING LABELING (cont’d)(cont’d)

7.7. The physician labeling The physician labeling (prescribing information)(prescribing information) typically typically

includes the indications for use, contraindications, warnings includes the indications for use, contraindications, warnings

and precautions, instructions for use and clinical data on the and precautions, instructions for use and clinical data on the

use of the device. For NHD, there is other important use of the device. For NHD, there is other important

information that clinicians need to know, such as the need information that clinicians need to know, such as the need

for alarms that may not be part of the NHD device for alarms that may not be part of the NHD device (e.g., (e.g.,

circuit disconnect alarms, fluid leak or moisture detection circuit disconnect alarms, fluid leak or moisture detection

alarms),alarms), the need for a partner or for remote monitoring, the need for a partner or for remote monitoring,

vascular access requirements, and the need for dialysate vascular access requirements, and the need for dialysate

additives additives (e.g., phosphorus).(e.g., phosphorus). Please discuss whether or not Please discuss whether or not

this and/or other treatment information should be part of the this and/or other treatment information should be part of the

physician labeling.physician labeling.

RISK ANALYSISRISK ANALYSISRISK ANALYSISRISK ANALYSIS8.8. FDA has identified the following potential risks associated with FDA has identified the following potential risks associated with

NHD, in addition to those related to conventional hemodialysis:NHD, in addition to those related to conventional hemodialysis:

a.a.Increased risk of inadvertent disconnections;Increased risk of inadvertent disconnections;

b.b.Increased blood loss from increased frequency of treatments;Increased blood loss from increased frequency of treatments;

c.c.Potential increased rate of vascular access infection due toPotential increased rate of vascular access infection due to increased use of access; and increased use of access; and

d.d.Psychological effects Psychological effects (e.g., impact of treatments on patients,(e.g., impact of treatments on patients, such as loss of social interaction and the impact of increasedsuch as loss of social interaction and the impact of increased responsibility on the patient)responsibility on the patient) requiring need for adjustment or requiring need for adjustment or discontinuation of therapy.discontinuation of therapy.

To aid FDA in the development of a guidance document on To aid FDA in the development of a guidance document on NHD, please comment on the completeness and NHD, please comment on the completeness and appropriateness of this list.appropriateness of this list.