Gastroenterology and Renal Devices Branch Nocturnal Home Hemodialysis Draft Claudia C. Ruiz-Zacharek, M.D. Medical Officer / Nephrologist

Gastroenterology and Renal Gastroenterology and Renal Devices BranchDevices Branch

Nocturnal Home Nocturnal Home HemodialysisHemodialysisDraftDraft

Claudia C. Ruiz-Zacharek, M.D.Claudia C. Ruiz-Zacharek, M.D.

Medical Officer / NephrologistMedical Officer / Nephrologist

OverviewOverview

1.1. Background InformationBackground Information

2.2. Nocturnal Home HemodialysisNocturnal Home Hemodialysis

3.3. Clinical StudiesClinical Studies

Background InformationBackground Information

Conventional HemodialysisConventional Hemodialysis

typically in-center, 4 hours 3 X weektypically in-center, 4 hours 3 X week

Patient has a passive role during treatmentPatient has a passive role during treatment

Nocturnal Home HemodialysisNocturnal Home Hemodialysis

performed at home, typically at night, and while the performed at home, typically at night, and while the patient sleeps. patient sleeps.

Patient is the performer of the treatmentPatient is the performer of the treatment

Data from the United States Data from the United States Renal Data System (USRDS)Renal Data System (USRDS)Data from the United States Data from the United States Renal Data System (USRDS)Renal Data System (USRDS)

Prevalence of patients on hemodialysis in Prevalence of patients on hemodialysis in the United States, 2002: 281,594the United States, 2002: 281,594

0.3% (843) home hemodialysis patients0.3% (843) home hemodialysis patients

115 NHD patients in 13 centers in North 115 NHD patients in 13 centers in North America*America*

** Lockridge, et. al., Adv Ren Replace Ther 2001; 8(4):250-256.Lockridge, et. al., Adv Ren Replace Ther 2001; 8(4):250-256.

Definitions and Definitions and NomenclatureNomenclatureDefinitions and Definitions and NomenclatureNomenclature

Nocturnal Hemodialysis (NHD)Nocturnal Hemodialysis (NHD)

Nightly Hemodialysis Nightly Hemodialysis Nocturnal Home HemodialysisNocturnal Home Hemodialysis

In-center nocturnal hemodialysis, In-center nocturnal hemodialysis, Long nocturnal hemodialysisLong nocturnal hemodialysis Slow nocturnal hemodialysis, and Slow nocturnal hemodialysis, and Daily hemodialysis. Daily hemodialysis.

Definitions and Nomenclature Definitions and Nomenclature (cont’d)(cont’d)Definitions and Nomenclature Definitions and Nomenclature (cont’d)(cont’d)


Performed at home Performed at home

Absence of medical personnelAbsence of medical personnel

Frequency has reportedly ranged from Frequency has reportedly ranged from

5-7 nights a week 5-7 nights a week

Length is 6-10 hours per night Length is 6-10 hours per night



Blood flows (QB) 200-300 ml/min, Blood flows (QB) 200-300 ml/min,

Dialysate flows (QD) usually ~300 Dialysate flows (QD) usually ~300 ml/min, up to 800 ml/min*ml/min, up to 800 ml/min*

* * Pierratos, A. Pierratos, A. Nephrol Dial TransplantNephrol Dial Transplant 1999; 14:2835-2840 1999; 14:2835-2840


Human factorsHuman factors

Physician labelingPhysician labeling

Patient labelingPatient labeling

TrainingTraining


Human FactorsHuman Factors

the objective is to improve humanthe objective is to improve human

performanceperformance

reduce the burden on training and labeling reduce the burden on training and labeling

reduce the likelihood of use error and reduce the likelihood of use error and

patient injurypatient injury


Human FactorsHuman Factors

The objective is to improve humanThe objective is to improve human performanceperformance

Reduce the burden on training andReduce the burden on training and labeling labeling

Reduce the likelihood of use error and Reduce the likelihood of use error and patient injurypatient injury


Physician’s Instructions for UsePhysician’s Instructions for Use

The manual that accompanies a medical The manual that accompanies a medical device device

indications for use statement, indications for use statement, contraindications, contraindications, precautions and warnings. precautions and warnings.


Physician’s Instructions for UsePhysician’s Instructions for Use The manual that accompanies a medical

device indications for use statement, indications for use statement, contraindications, contraindications, precautions and warnings. precautions and warnings.

It should also include relevant data from It should also include relevant data from clinical studies and instructions for clinical studies and instructions for using and caring for the device.using and caring for the device.


Patient Instructions for Use Patient Instructions for Use

The manual that accompanies a medical The manual that accompanies a medical device device indications for use statement, indications for use statement, contraindications, contraindications, precautions and warnings. precautions and warnings.


Patient Instructions for Use Patient Instructions for Use The manual that accompanies a medical

device indications for use statement, indications for use statement, contraindications, contraindications, precautions and warnings. precautions and warnings.

It should also include relevant data from clinical studies and instructions for using and caring for the device.


Patient Instructions for Use Patient Instructions for Use

The manual that accompanies a medical device The manual that accompanies a medical device indications for use statement, indications for use statement, contraindications, contraindications, precautions and warnings. precautions and warnings.

It should also include relevant data from It should also include relevant data from clinical studies and instructions for using and clinical studies and instructions for using and caring for the device.caring for the device.

Written for a person with no medical trainingWritten for a person with no medical training.


Training

Teaching provided by the manufacturer

Medical expert to train the lay user

Lay user to successfully use the device

OverviewOverviewOverviewOverview








Nocturnal Home Nocturnal Home HemodialysisHemodialysisNocturnal Home Nocturnal Home HemodialysisHemodialysis

Device design and ComponentsDevice design and Components Human Factors IssuesHuman Factors Issues Water QualityWater Quality Use of a Partner and Remote MonitoringUse of a Partner and Remote Monitoring Vascular Access and Extracorporeal Circuit Vascular Access and Extracorporeal Circuit

ConnectionsConnections LabelingLabeling Lay-user TrainingLay-user Training

Nocturnal Home Hemodialysis Nocturnal Home Hemodialysis

Conventional Hemodialysis

Patient is passive Patient is passive recipient recipient

Nocturnal Home Nocturnal Home HemodialysisHemodialysis

Patient’s active rolePatient’s active roleGiver of treatmentGiver of treatmentPresumably asleepPresumably asleeptroubleshootingtroubleshooting

Nocturnal Home Nocturnal Home HemodialysisHemodialysis Nocturnal Home Nocturnal Home HemodialysisHemodialysis

Considerations for device designConsiderations for device design::

Redundancy Redundancy Additional safety alarms may become Additional safety alarms may become

necessary necessary LoudnessLoudness SensitivitySensitivity Ease of understanding and correctionEase of understanding and correction

User friendlyUser friendly


Consider the following additional safety featuresConsider the following additional safety features:

Safeguard to prevent blood access Safeguard to prevent blood access disconnections or air embolidisconnections or air emboli

Type of vascular accessType of vascular access Alarms to detect fluid leaksAlarms to detect fluid leaks Moisture detectorMoisture detector Software to include remote monitoringSoftware to include remote monitoring User-friendly instructionsUser-friendly instructions Displayed screen with menusDisplayed screen with menus


Human Factors IssuesHuman Factors Issues

User-friendlyUser-friendly Dispose of devices safely and Dispose of devices safely and

effectively with minimal dangerous effectively with minimal dangerous errorerror

Minimal dependance on labeling and Minimal dependance on labeling and trainingtraining


Water Quality concernsWater Quality concerns

Conventional hemodialysis: 360L/weekConventional hemodialysis: 360L/week Nocturnal Hemodialysis: Nocturnal Hemodialysis:

648L-1080L/week648L-1080L/week Types of water treatment systemsTypes of water treatment systems

Reverse osmosis (RO)Reverse osmosis (RO)Deionization (DI)Deionization (DI)CombinationCombination


Water Quality concernsWater Quality concerns

Standard water quality for hemodialysis vs. higher standards

Type of water treatment system Water source

Municipal water suppliersMunicipal water suppliers Well waterWell water


Issues on monitoringIssues on monitoring

Without a partner* In-center hemodialysis – constant

monitoring Home hemodialysis

* Raija, et.al. Experiences on Home Hemodialysis without an Raija, et.al. Experiences on Home Hemodialysis without an AssistantAssistant. Hemodialysis International. Hemodialysis International 2003; 7(1):73-104. 2003; 7(1):73-104.


Issues on monitoringIssues on monitoring

““Monitoring is essential for the initial 3 months Monitoring is essential for the initial 3 months

of nocturnal HD therapy until the HD team is of nocturnal HD therapy until the HD team is

convinced the patient is stable and convinced the patient is stable and

compliant.” compliant.”

* * The London Daily/Nocturnal Hemodialysis StudyThe London Daily/Nocturnal Hemodialysis Study. . AJKD,AJKD, 2003 2003


Vascular accessVascular access

Arteriovenous fistulaArteriovenous fistula

Synthetic graftSynthetic graft

Long-term cuffed catheterLong-term cuffed catheter



Arteriovenous fistulaArteriovenous fistula

Synthetic graftSynthetic graft

Long-term cuffed catheterLong-term cuffed catheter



Arteriovenous fistulaArteriovenous fistula** Synthetic graftSynthetic graft Long-term cuffed catheterLong-term cuffed catheter

* * Quintaliani, et. al., Survival of vascular access during daily Quintaliani, et. al., Survival of vascular access during daily and three times a week hemodialysis. and three times a week hemodialysis. Clin NephrolClin Nephrol 2000; 2000; 53:372-377.53:372-377.


Vascular access locationVascular access location Connection to the deviceConnection to the device Self cannulationSelf cannulation Locking devicesLocking devices Enuresis alarmsEnuresis alarms Moisture sensorsMoisture sensors Single vs dual needle techniqueSingle vs dual needle technique

Nocturnal Home HemodialysisNocturnal Home HemodialysisLabelingLabeling Operator’s Manual

WarningsWarnings Cautions and PrecautionsCautions and Precautions Device specificationsDevice specifications Instructions for maintenanceInstructions for maintenance Cleaning and DisinfectionCleaning and Disinfection

Patient Labeling Physician’s Labeling Additional risks


Additional risksAdditional risks

Inadvertent disconnections Blood loss from increased frequency of

treatments Potential increased rate of vascular access

infection Psychological effects


Lay user trainingLay user training Conduct safe and effective NHD Conduct safe and effective NHD

treatmentstreatments Length of training reported to be Length of training reported to be

approx 2-8 weeks* approx 2-8 weeks* φφ

** Agar, et. al., Agar, et. al., Hemodialysis InternationalHemodialysis International 2003; 7(4):278-289. 2003; 7(4):278-289.ΦΦ Leitch, et. al., Leitch, et. al., Am J Kidney DisAm J Kidney Dis 2003; 42(1):S56-60 2003; 42(1):S56-60..


Lay-user trainingLay-user training

Appropriate use of the hemodialysis Appropriate use of the hemodialysis devicedevice

Interpretation and use of safety Interpretation and use of safety features, accessories and features, accessories and hemodialysis treatment itselfhemodialysis treatment itself


Lay-user trainingLay-user training Water purification systemWater purification system Catheter lock boxesCatheter lock boxes Moisture sensorsMoisture sensors Monitoring deviceMonitoring device Vascular access connection Vascular access connection

techniquestechniques Test the adequacy of the trainingTest the adequacy of the training









Clinical StudiesClinical StudiesClinical StudiesClinical Studies

PurposePurpose

Patient selectionPatient selection

Study designStudy design


PurposePurpose

To demonstrate the safety and To demonstrate the safety and

effectiveness of the NHD devices effectiveness of the NHD devices

under actual use conditions.under actual use conditions.


FDA concernsFDA concerns:

OutcomesOutcomes Clearance ratesClearance rates FindingsFindings Adverse eventsAdverse events TrainingTraining


Reported patient selectionReported patient selection::

Agar , et. al., Nocturnal Hemodialysis in Australia. Agar , et. al., Nocturnal Hemodialysis in Australia. Hemodialysis InternationalHemodialysis International 2003; 7(4):278-289. 2003; 7(4):278-289.

Alloatti, et. al., Long Nocturnal Dialysis. Alloatti, et. al., Long Nocturnal Dialysis. Blood Purif Blood Purif 2002; 20:525-530.2002; 20:525-530.

Covic, et.al., Long-hours home haemodialysis – the Covic, et.al., Long-hours home haemodialysis – the best renal replacement therapy method? best renal replacement therapy method? Q J MedQ J Med 1999; 92:251-260.1999; 92:251-260.


FDA concernsFDA concerns::

Patient selection for trialPatient selection for trial Patient selection for marketingPatient selection for marketing Patient performs the entire treatment Patient performs the entire treatment Patient must wake up to attend the Patient must wake up to attend the

alarmsalarms


Patient selection criteriaPatient selection criteria::

Home environment Home environment Water supplyWater supplySewageSewageElectricityElectricitySpaceSpaceSocial interactionSocial interaction

• Patient's vascular access type and location Patient's vascular access type and location • Availability of a partnerAvailability of a partner• Patient's compliancePatient's compliance• Psychological well being Psychological well being


Study designStudy design:: Control groupControl group Sample sizeSample size Length of follow upLength of follow up Clinical endpointsClinical endpoints Evaluation of outcomesEvaluation of outcomes Target patient populationTarget patient population

Clinical StudiesClinical Studies

Other issues to be consideredOther issues to be considered::

Dialysate composition and additivesDialysate composition and additives Type of anticoagulationType of anticoagulation Choice of dialyzerChoice of dialyzer Type of monitoringType of monitoring Need of a partnerNeed of a partner Vascular accessVascular access ReuseReuse

ConclusionConclusionNocturnal Home Hemodialysis DevicesNocturnal Home Hemodialysis Devices Safety is a primary concern Increased demands on patient and

patient’s home/family should be assessed Treatment may only be available to a

selected population Design of the clinical studies to

demonstrate the safety and effectiveness of the device under actual use conditions should be discussed

ReferencesReferencesReferencesReferences1.1. United States Renal Data System (USRDS) United States Renal Data System (USRDS) www.usrds.org

2.2. Lockridge RS, Spencer M, Craft V, Pipkin M, Campbell D, Lockridge RS, Spencer M, Craft V, Pipkin M, Campbell D, McPhatter L, Albert J, Anderson H, Jennings F, and Barger T. McPhatter L, Albert J, Anderson H, Jennings F, and Barger T. Nocturnal Home Hemodialysis in North America. Nocturnal Home Hemodialysis in North America. Adv Ren Adv Ren Replace TherReplace Ther 2001; 8(4):250-256. 2001; 8(4):250-256.

3.3. Pierratos, A. Nocturnal home haemodialysis: an update on a 5-Pierratos, A. Nocturnal home haemodialysis: an update on a 5-year experience. year experience. Nephrol Dial TransplantNephrol Dial Transplant 1999; 14:2835-2840 1999; 14:2835-2840

4.4. Mehrabian S, Morgan D, Schlaeper C, Kortas C, and Lindsay Mehrabian S, Morgan D, Schlaeper C, Kortas C, and Lindsay RM. Equipment and water treatment considerations for the RM. Equipment and water treatment considerations for the provision of quotidian home hemodialysis. provision of quotidian home hemodialysis. Am J Kidney DisAm J Kidney Dis 2003; 42:S66-S70.2003; 42:S66-S70.

5.5. Raija M, Riitta MK, Meeri K, and Eero H. Experiences on Home Raija M, Riitta MK, Meeri K, and Eero H. Experiences on Home Hemodialysis without an AssistantHemodialysis without an Assistant. Hemodialysis International. Hemodialysis International 2003; 7(1):73-104.2003; 7(1):73-104.

ReferencesReferences6.6. Heidenheim AP, Leitch R, Kortas C and Lindsay RM. Heidenheim AP, Leitch R, Kortas C and Lindsay RM. Patient Patient

Monitoring in the London Daily/Nocturnal Hemodialysis Study. Monitoring in the London Daily/Nocturnal Hemodialysis Study. Am J Kidney DisAm J Kidney Dis 2003; 42:S61-S65. 2003; 42:S61-S65.

7.7. Quintaliani G, Buoncristiani U, Fagugli R, Kuluiranu H, Ciao G, Quintaliani G, Buoncristiani U, Fagugli R, Kuluiranu H, Ciao G, Rondini L, Lowenthal DT, and Reboldi G. Survival of vascular Rondini L, Lowenthal DT, and Reboldi G. Survival of vascular access during daily and three times a week hemodialysis. access during daily and three times a week hemodialysis. Clin Clin NephrolNephrol 2000; 53:372-377. 2000; 53:372-377.

8.8. Agar JWM, Somerville CA, Dwyer KM, Simmonds RE, Boddington Agar JWM, Somerville CA, Dwyer KM, Simmonds RE, Boddington JM, and Waldron CM. Nocturnal Hemodialysis in Australia. JM, and Waldron CM. Nocturnal Hemodialysis in Australia. Hemodialysis InternationalHemodialysis International 2003; 7(4):278-289. 2003; 7(4):278-289.

9.9. Leitch R, Ouwendyk M, Ferguson E, Clement L, Peters K, Leitch R, Ouwendyk M, Ferguson E, Clement L, Peters K, Heidenheim AP, and Lindsay RM. Nursing Issues Related to Heidenheim AP, and Lindsay RM. Nursing Issues Related to Patient Selection, Vascular Access, and Education in Quotidian Patient Selection, Vascular Access, and Education in Quotidian Hemodialysis. Hemodialysis. Am J Kidney DisAm J Kidney Dis 2003; 42(1):S56-60. 2003; 42(1):S56-60.

ReferencesReferencesReferencesReferences

10.10. Alloatti S, Molino A, Manes M, Bonfant G, and Pellu V. Long Alloatti S, Molino A, Manes M, Bonfant G, and Pellu V. Long Nocturnal Dialysis. Nocturnal Dialysis. Blood Purif Blood Purif 2002; 20:525-530.2002; 20:525-530.

11.11. Covic A, Goldsmith DJA, Venning MC, and Ackrill P. Long-Covic A, Goldsmith DJA, Venning MC, and Ackrill P. Long-hours home haemodialysis – the best renal replacement therapy hours home haemodialysis – the best renal replacement therapy method? method? Q J MedQ J Med 1999; 92:251-260. 1999; 92:251-260.

12.12. The following articles have not been cited in the above The following articles have not been cited in the above discussion of NHD, but may provide additional information. discussion of NHD, but may provide additional information. Copies of these may also be found in Appendix F.Copies of these may also be found in Appendix F.

13.13. Chan CT, Hanly P, Gabor J, Picton P, Pierratos A, and Floras JS. Chan CT, Hanly P, Gabor J, Picton P, Pierratos A, and Floras JS. Nocturnal Hemodialysis Lowers Heart Rate during Sleep and Nocturnal Hemodialysis Lowers Heart Rate during Sleep and Normalizes Its Parasympathetic and Sympathetic Modulation. Normalizes Its Parasympathetic and Sympathetic Modulation. Hemodialysis InternationalHemodialysis International 2003; 7(1):73-104. 2003; 7(1):73-104.

ReferencesReferencesReferencesReferences14.14. Faratro R and Chan CT. Nocturnal Hemodialysis Improves Faratro R and Chan CT. Nocturnal Hemodialysis Improves

Productivity of End-Stage Renal Failure Patients. Productivity of End-Stage Renal Failure Patients. Hemodialysis InternationalHemodialysis International, 2003; 7(1):73-104., 2003; 7(1):73-104.

15.15. Francoeur R and Digiambatista A. Technical Considerations Francoeur R and Digiambatista A. Technical Considerations for Short Daily Home Hemodialysis and Nocturnal Home for Short Daily Home Hemodialysis and Nocturnal Home Hemodialysis. Hemodialysis. Adv Ren Replace Ther Adv Ren Replace Ther 2001; 8(4):268-272.2001; 8(4):268-272.

16.16. Heidenheim AP, Muirhead N, Moist L, and Lindsay RM. Heidenheim AP, Muirhead N, Moist L, and Lindsay RM. Patient Quality of Life on Quotidian Hemodialysis. Patient Quality of Life on Quotidian Hemodialysis. Am J Am J Kidney DisKidney Dis 2003; 42:S36-S41. 2003; 42:S36-S41.

17.17. Kjellstrand CM and Ing T. Daily Hemodialysis: History and Kjellstrand CM and Ing T. Daily Hemodialysis: History and Revival of a Superior Dialysis Method. Revival of a Superior Dialysis Method. ASAIO JournalASAIO Journal 1998; 1998; 117-122.117-122.

ReferencesReferencesReferencesReferences18.18. Kjellstrand CM and Blagg CR. Differences in Dialysis Kjellstrand CM and Blagg CR. Differences in Dialysis

Practice are the Main Reasons for the High Mortality Rate in Practice are the Main Reasons for the High Mortality Rate in the United States compared to Japan. the United States compared to Japan. Hemodialysis Hemodialysis InternationalInternational 2003; 7(1):67-71. 2003; 7(1):67-71.

19.19. Kroeker A, Clark WF, Heidenheim AP, Kuenzig L, Leitch R, Kroeker A, Clark WF, Heidenheim AP, Kuenzig L, Leitch R, Meyette M, Muirhead N, Ryan H, Welch R, White S, and Meyette M, Muirhead N, Ryan H, Welch R, White S, and Lindsay RM. An Operating Cost Comparison Between Lindsay RM. An Operating Cost Comparison Between Conventional and Home Quotidian Hemodialysis. Conventional and Home Quotidian Hemodialysis. Am J Am J Kidney DisKidney Dis 2003; 42:S49-S55. 2003; 42:S49-S55.

20.20. Lindsay RM, Leitch R, Heidenheim AP, and Kortas C. Lindsay RM, Leitch R, Heidenheim AP, and Kortas C. The The London Daily/Nocturnal Hemodialysis Study – Study Design, London Daily/Nocturnal Hemodialysis Study – Study Design, Morbidity, and Mortality Results. Morbidity, and Mortality Results. Am J Kidney DisAm J Kidney Dis 2003; 2003; 42(1):S5-S12.42(1):S5-S12.

ReferencesReferencesReferencesReferences21.21. Lindsay RM, Alhejaili F, Nesrallah G, Leitch R, Clement L, Lindsay RM, Alhejaili F, Nesrallah G, Leitch R, Clement L,

Heidenheim AP, and Kortas C. Calcium and Phosphate Heidenheim AP, and Kortas C. Calcium and Phosphate Balance with Quotidian Hemodialysis. Balance with Quotidian Hemodialysis. Am J Kidney DisAm J Kidney Dis 2003; 42, S1:S24-29.2003; 42, S1:S24-29.

22.22. Nesrallah G, Suri R, Moist L, Kortas C, and Lindsay RM. Nesrallah G, Suri R, Moist L, Kortas C, and Lindsay RM. Volume Control and Blood Pressure Management in Patients Volume Control and Blood Pressure Management in Patients Undergoing Quotidian Hemodialysis. Undergoing Quotidian Hemodialysis. Am J Kidney DisAm J Kidney Dis 2003; 2003; 42:S13-17.42:S13-17.

23.23. Pierratos A. Daily nocturnal home hemodialysis. Pierratos A. Daily nocturnal home hemodialysis. Kidney Kidney InternationalInternational 2004; 65:1975-1986. 2004; 65:1975-1986.

24.24. Pierratos A. Quotidian Hemodialysis: Is it the Solution to the Pierratos A. Quotidian Hemodialysis: Is it the Solution to the Problem? Problem? Seminars in DialysisSeminars in Dialysis 2004; 17(2):77-78. 2004; 17(2):77-78.

ReferencesReferences

25.25. Radford MG, Shultman DS, Pasour AG, Cobb AM, and Radford MG, Shultman DS, Pasour AG, Cobb AM, and Chandler JT. An Incenter Nocturnal Hemodialysis Program Chandler JT. An Incenter Nocturnal Hemodialysis Program – Three Years Experience. – Three Years Experience. Hemodialysis InternationalHemodialysis International 2003; 2003; 7(1):73-104.7(1):73-104.

26.26. Rao M, Muirhead N, Klarenbach S, Moist L, and Lindsay RM. Rao M, Muirhead N, Klarenbach S, Moist L, and Lindsay RM. Management of Anemia with Quotidian Hemodialysis. Management of Anemia with Quotidian Hemodialysis. Am J Am J Kidney DisKidney Dis 2003; 42:S18-S23. 2003; 42:S18-S23.

27.27. Spanner E, Suri R, Heidenheim AP, and Lindsay RM. The Spanner E, Suri R, Heidenheim AP, and Lindsay RM. The Impact of Quotidian Hemodialysis on Nutrition. Impact of Quotidian Hemodialysis on Nutrition. Am J Am J Kidney DisKidney Dis 2003; 42(1):S30-S35. 2003; 42(1):S30-S35.


28.28. Suri R, Depner TA, Blake PG, Heidenheim AP, and Suri R, Depner TA, Blake PG, Heidenheim AP, and Lindsay RM. Adequacy of Quotidian Lindsay RM. Adequacy of Quotidian Hemodialysis. Hemodialysis. Am J Kidney DisAm J Kidney Dis 2003; 42:S42-S48. 2003; 42:S42-S48.

29.29. Van Biesen W, Veys N, Vanholder R, and Lameire Van Biesen W, Veys N, Vanholder R, and Lameire N. Effect of Long Nocturnal Dialysis on Nutritional N. Effect of Long Nocturnal Dialysis on Nutritional Status and Blood Pressure Control. Status and Blood Pressure Control. Hemodialysis Hemodialysis InternationalInternational, 2003; 7(1):73-104., 2003; 7(1):73-104.

30.30. Weick-Brady M. Medical Devices: Going Home. Weick-Brady M. Medical Devices: Going Home. FDLI UpdateFDLI Update 2003; September/October: 23-24, 29- 2003; September/October: 23-24, 29-30.30.


31.31. Weinger MB, Foreword to Weinger MB, Foreword to Designing Usability Designing Usability into Medical Productsinto Medical Products

32.32. Woods JD, Port FK, Stannard D, Blagg CR, and Woods JD, Port FK, Stannard D, Blagg CR, and Held PJ. Comparison of mortality with home Held PJ. Comparison of mortality with home hemodialysis and center hemodialysis: A hemodialysis and center hemodialysis: A national study. national study. Kidney InternationalKidney International, 1996; , 1996; 49:1464-1470.49:1464-1470.

33.33. Young BA, Hynes J, and McComb T. Home Young BA, Hynes J, and McComb T. Home Hemodialysis: Associations with Modality Hemodialysis: Associations with Modality Failure. Failure. Hemodialysis InternationalHemodialysis International, 2003; 7:73-, 2003; 7:73-104.104.

Documents

Gastroenterology and Renal Devices Branch Nocturnal Home Hemodialysis Draft Claudia C. Ruiz-Zacharek, M.D. Medical Officer / Nephrologist