gu advisory panel meeting gu advisory panel meeting nocturnal home hemodialysis carolyn y. neuland,...

GU Advisory Panel GU Advisory Panel MeetingMeeting GU Advisory Panel GU Advisory Panel MeetingMeeting

Nocturnal Home Nocturnal Home HemodialysisHemodialysis

Carolyn Y. Neuland, Ph.D.Carolyn Y. Neuland, Ph.D.

Chief, Gastroenterology and Renal Devices Branch

Division of Reproductive, Abdominal and Radiological Devices

Office of Device Evaluation

Center for Devices and Radiological Health

June 8, 2005

2

OverviewOverviewOverviewOverview

IntroductionIntroduction Panel Update Panel Update Regulation of Hemodialysis DevicesRegulation of Hemodialysis Devices Guidance Documents for HemodialysisGuidance Documents for Hemodialysis Definition of Nocturnal Home Definition of Nocturnal Home

HemodialysisHemodialysis Meeting Objectives Meeting Objectives

3

Linda CarrLinda Carr Consumer Safety TechnicianConsumer Safety Technician

Jeffrey Cooper, D.V.M.Jeffrey Cooper, D.V.M. Veterinarian / Panel Exec. Sec.Veterinarian / Panel Exec. Sec.

Linda Dart, M.S.Linda Dart, M.S. BiochemistBiochemist

Gema Gonzalez, M.S.Gema Gonzalez, M.S. Biomedical EngineerBiomedical Engineer

Irada Isayeva, Ph.D.Irada Isayeva, Ph.D. Polymer Chemist Polymer Chemist

Kristina Lauritsen, Ph.D.Kristina Lauritsen, Ph.D. Tumor Biologist Tumor Biologist

Barbara McCool, M.S.R.N.Barbara McCool, M.S.R.N. Nurse ConsultantNurse Consultant

Joshua Nipper, M.E.Joshua Nipper, M.E. Biomedical EngineerBiomedical Engineer

Kathleen OlveyKathleen Olvey BiologistBiologist

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

Rebecca StephensonRebecca Stephenson Chemical EngineerChemical Engineer

Kellie StraughnKellie Straughn Clerk TypistClerk Typist

Richard WilliamsRichard Williams Mechanical Engineer Mechanical Engineer

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Panel UpdatePanel UpdatePanel UpdatePanel Update

5

P020006P020006 - Enteryx Procedure - Enteryx Procedure KitKitBoston Scientific CorporationBoston Scientific Corporation


Description/Indication Description/Indication – solution injected into the LES – solution injected into the LES for the treatment of GERD in patients who are for the treatment of GERD in patients who are responsive to pharmacologic therapy responsive to pharmacologic therapy

Panel Meeting DatePanel Meeting Date – January 17, 2003 – January 17, 2003

GU Panel RecommendationGU Panel Recommendation – Approval with Conditions – Approval with Conditions

Modified physician labelingModified physician labeling

Modified patient labelingModified patient labeling

Post market study with 36 months follow-up from the Post market study with 36 months follow-up from the last injectionlast injection

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Current StatusCurrent Status – PMA approved – PMA approved April 22, 2003April 22, 2003

Post-approval Study Post-approval Study

3 year post-implantation follow-up3 year post-implantation follow-up

Medical Device Reporting (MDR)Medical Device Reporting (MDR)



7



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Regulation of Hemodialysis Regulation of Hemodialysis DevicesDevicesRegulation of Hemodialysis Regulation of Hemodialysis DevicesDevices

Class II Medical DevicesClass II Medical Devices Risk Based classificationRisk Based classification Moderate level of risk Moderate level of risk Requirement for Requirement for General ControlsGeneral Controls and and

Special ControlsSpecial Controls to ensure safety and to ensure safety and effectivenesseffectiveness

510(k) - Premarket Notification510(k) - Premarket Notification There are currently no devices cleared by There are currently no devices cleared by

FDA for Nocturnal Home HemodialysisFDA for Nocturnal Home Hemodialysis

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Regulation Regulation ofof Hemodialysis Hemodialysis DevicesDevicesRegulation Regulation ofof Hemodialysis Hemodialysis DevicesDevices

Establishes Establishes substantial equivalencesubstantial equivalence (SE)(SE) to a legally marketed predicate to a legally marketed predicate devicedevice

As safe and as effective as predicate As safe and as effective as predicate devicedevice

Performance data:Performance data:Bench studies Bench studies Clinical studies (especially for Home Systems)Clinical studies (especially for Home Systems)

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Dialysis DevicesDialysis DevicesDialysis DevicesDialysis Devices

Most are regulated as Class II devicesMost are regulated as Class II devices Primary classification regulations used:Primary classification regulations used:

§876.5820 – Hemodialysis systems and §876.5820 – Hemodialysis systems and accessories accessories

- Conventional DialyzersConventional Dialyzers- Reuse of Conventional DialyzersReuse of Conventional Dialyzers- Dialysis Delivery Systems and Tubing SetsDialysis Delivery Systems and Tubing Sets- HemodialysatesHemodialysates

§876.5860 – High permeability hemodialysis §876.5860 – High permeability hemodialysis systems systems

- High Flux DialyzersHigh Flux Dialyzers- Reuse of High Flux DialyzersReuse of High Flux Dialyzers- Dialysis Systems with Ultrafiltration ControllerDialysis Systems with Ultrafiltration Controller

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Dialysis DevicesDialysis DevicesDialysis DevicesDialysis Devices

§876. 5600§876. 5600 - Sorbent regenerated dialysate - Sorbent regenerated dialysate delivery system for delivery system for

hemodialysishemodialysis

§876. 5665§876. 5665 - Water purification system for - Water purification system for

hemodialysishemodialysis

§876. 5540§876. 5540 - Blood access device and accessories - Blood access device and accessories- Class III for implanted cathetersClass III for implanted catheters

§876.5630§876.5630 - Peritoneal dialysis system and - Peritoneal dialysis system and accessories accessories

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Guidance Documents for Guidance Documents for Hemodialysis DevicesHemodialysis DevicesGuidance Documents for Guidance Documents for Hemodialysis DevicesHemodialysis Devices

Guidance for the Content of Premarket Notifications Guidance for the Content of Premarket Notifications for Conventional and High Permeability for Conventional and High Permeability Hemodialyzers – 1998Hemodialyzers – 1998

Guidance for the Content of Premarket Notifications Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems – 1998for Hemodialysis Delivery Systems – 1998

Guidance for Hemodialyzer Reuse Labeling – 1995Guidance for Hemodialyzer Reuse Labeling – 1995

Guidance for the Content of Premarket Notifications Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for for Water Purification Components and Systems for Hemodialysis – 1997Hemodialysis – 1997

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Guidance DocumentGuidance DocumentGuidance DocumentGuidance Document

“ “Guidance documents are documents Guidance documents are documents prepared for FDA staff, prepared for FDA staff, applicants/sponsors, and the public applicants/sponsors, and the public that describe the agency’s that describe the agency’s interpretation of or policy on a interpretation of or policy on a regulatory issue” regulatory issue”

21 CFR §10.115 21 CFR §10.115

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Definition of Nocturnal Home Definition of Nocturnal Home HemodialysisHemodialysisDefinition of Nocturnal Home Definition of Nocturnal Home HemodialysisHemodialysis

Nocturnal Home Hemodialysis (NHD) is a Nocturnal Home Hemodialysis (NHD) is a

type of hemodialysis performed in the home type of hemodialysis performed in the home

by the patient, while the patient is asleep by the patient, while the patient is asleep

((typically at nighttypically at night), over a 6-10 hour period, ), over a 6-10 hour period,

using slower flow rates for blood and using slower flow rates for blood and

dialysate, and a treatment frequency of 5 to 7 dialysate, and a treatment frequency of 5 to 7

days per week. days per week.

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Nocturnal Home Nocturnal Home HemodialysisHemodialysisObjectives of MeetingObjectives of Meeting

Nocturnal Home Nocturnal Home HemodialysisHemodialysisObjectives of MeetingObjectives of Meeting

To discuss and provide recommendations on the To discuss and provide recommendations on the clinical and scientific issues associated with clinical and scientific issues associated with hemodialysis device design, labeling, and hemodialysis device design, labeling, and training for Nocturnal Home Hemodialysistraining for Nocturnal Home Hemodialysis

To discuss and provide recommendations on To discuss and provide recommendations on clinical trial design to study Nocturnal Home clinical trial design to study Nocturnal Home HemodialysisHemodialysis

To obtain scientific feedback which can be used To obtain scientific feedback which can be used to help in device evaluation decisions and may to help in device evaluation decisions and may lead to the future development of a guidance lead to the future development of a guidance document for Nocturnal Home Hemodialysisdocument for Nocturnal Home Hemodialysis

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Nocturnal Home Nocturnal Home HemodialysisHemodialysisNocturnal Home Nocturnal Home HemodialysisHemodialysis

Overview of Conventional Overview of Conventional

Hemodialysis SystemHemodialysis System

Joshua Nipper – Biomedical EngineerJoshua Nipper – Biomedical EngineerGastroenterology and Renal Devices BranchGastroenterology and Renal Devices Branch

Overview of Conventional Overview of Conventional Hemodialysis Delivery Hemodialysis Delivery

DevicesDevices

Overview of Conventional Overview of Conventional Hemodialysis Delivery Hemodialysis Delivery

DevicesDevices

Joshua C. Nipper, M.E.Joshua C. Nipper, M.E.

Biomedical Engineer

Gastroenterology and Renal Devices Branch




June 8, 2005

18


Conventional Hemodialysis (HD) SystemsConventional Hemodialysis (HD) SystemsA “standard” deviceA “standard” deviceMonitored parametersMonitored parametersAlarmsAlarms

Accessory DevicesAccessory DevicesWater treatment systemsWater treatment systemsHemodialysis blood tubingHemodialysis blood tubingRemote monitoring systemsRemote monitoring systemsBlood access devicesBlood access devices

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DisclaimerDisclaimerDisclaimerDisclaimer

Any examples in this presentation are not Any examples in this presentation are not intended as an endorsement or criticism intended as an endorsement or criticism of any specific technology, device or of any specific technology, device or companycompany

No devices are currently cleared for No devices are currently cleared for nocturnalnocturnal home hemodialysis home hemodialysis

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Hemodialysis Delivery Hemodialysis Delivery SystemsSystemsHemodialysis Delivery Hemodialysis Delivery SystemsSystems

Classified under two different sections of the Classified under two different sections of the Code of Federal Regulations (CFR):Code of Federal Regulations (CFR):21 CFR §876.5820 for a low permeability system21 CFR §876.5820 for a low permeability system21 CFR §876.5860 for a high permeability system 21 CFR §876.5860 for a high permeability system

(ultrafiltration controller)(ultrafiltration controller)

Suggestions for the content of a 510(k) Suggestions for the content of a 510(k) submission found in the FDA guidance submission found in the FDA guidance document: “Guidance for the Content of document: “Guidance for the Content of Premarket Notifications for Hemodialysis Premarket Notifications for Hemodialysis Delivery System”Delivery System”

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Air Detector

Blood Leak Detector

PT

PT = Pressure Transducer

PT

Venous clamp

Anticoagulant

Blood from Patient

Blood return to Patient

Dialysate In

Dialysate / UF Out (green / yellow)

Informational Display

A “Standard” HD Delivery SystemA “Standard” HD Delivery System

PT

Mixing System

Conductivity Meter

Water, Acid Concentrate, Bicarbonate

Concentrate In

Pre-mixed or sorbent

regenerated dialysate

Saline

Drip Chamber

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Solute Transfer & Solute Transfer & UltrafiltrationUltrafiltrationSolute Transfer & Solute Transfer & UltrafiltrationUltrafiltration

C blood > C Dialysate

P blood ≈ P Dialysate

C blood > C Dialysate

P blood > P Dialysate

Blood Dialysate

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Monitored HD Monitored HD ParametersParametersMonitored HD Monitored HD ParametersParameters

Blood and dialysate flow rates (pump speed)Blood and dialysate flow rates (pump speed) PressurePressure

ArterialArterialVenousVenousDialysateDialysateWaste / Dialysate OutWaste / Dialysate OutTransmembrane Pressure (TMP)Transmembrane Pressure (TMP)

Patient fluid removed (UF) Patient fluid removed (UF) TemperatureTemperature

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HD AlarmsHD AlarmsHD AlarmsHD Alarms

Typically come in two varieties:Typically come in two varieties:

CAUTION

WARNING

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Standard HD AlarmsStandard HD AlarmsStandard HD AlarmsStandard HD Alarms

TemperatureTemperature Blood leakBlood leak Flow ratesFlow rates PressurePressure

ArterialArterialVenousVenousTransmembrane Transmembrane

Pressure (TMP)Pressure (TMP)DialysateDialysateWaste / Dialysate OutWaste / Dialysate Out

Excessive UFExcessive UF Air embolismAir embolism Conductivity / pHConductivity / pH Water qualityWater quality System alarmsSystem alarms Vascular access Vascular access

disconnection – disconnection – venous pressure?venous pressure?

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Accessory DevicesAccessory DevicesAccessory DevicesAccessory Devices

Water Treatment SystemsWater Treatment Systems

HD Blood TubingHD Blood Tubing

Remote Monitoring SystemsRemote Monitoring Systems

Blood Access DevicesBlood Access Devices

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Water Treatment Water Treatment SystemsSystemsWater Treatment Water Treatment SystemsSystems

Classified under 21 CFR §876.5665Classified under 21 CFR §876.5665 Guidance for The Content of Premarket Guidance for The Content of Premarket

Notifications for Water Purification Notifications for Water Purification Components and Systems for HemodialysisComponents and Systems for Hemodialysis

Converts potable water to purified water Converts potable water to purified water meeting the requirements of the Association meeting the requirements of the Association for the Advancement for Medical for the Advancement for Medical Instrumentation (AAMI) RD:62 standardInstrumentation (AAMI) RD:62 standard

Can be designed for multiple patients, or Can be designed for multiple patients, or can be single patientcan be single patient

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Water Treatment Water Treatment SystemsSystemsWater Treatment Water Treatment SystemsSystems

Reverse Osmosis

DeionizationCarbon Filters

Worker / Polisher

Water Out

Data Out

Water In

Ultrafilter

Pre-treatment

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Blood TubingBlood TubingBlood TubingBlood Tubing

Serves as basic conduit for bloodServes as basic conduit for blood Contains a “blood pump” segmentContains a “blood pump” segment Can have multiple connection pointsCan have multiple connection points

Patient access (arterial & venous)Patient access (arterial & venous)Pressure transducers with transducer protectorsPressure transducers with transducer protectorsAir detectorsAir detectorsRoller / peristaltic blood pumpRoller / peristaltic blood pump

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Blood TubingBlood TubingBlood TubingBlood Tubing

Can be “cassette” based, which Can be “cassette” based, which limits the number of user limits the number of user connections neededconnections needed

Kinked tubing can cause hemolysis, Kinked tubing can cause hemolysis, which can lead to deathwhich can lead to death

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Remote Monitoring Remote Monitoring SystemsSystemsRemote Monitoring Remote Monitoring SystemsSystems

Can be used for data transmissionCan be used for data transmission Connect HD machine to Internet via Connect HD machine to Internet via

modem or broadband connectionmodem or broadband connection Can transmit real time alarms, and/or Can transmit real time alarms, and/or

completed treatment datacompleted treatment data FDA labels current systems are FDA labels current systems are

contraindicated as the sole method of contraindicated as the sole method of monitoring a patient during hemodialysismonitoring a patient during hemodialysis

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Blood Access DevicesBlood Access DevicesBlood Access DevicesBlood Access Devices

Long-term, cuffed HD CathetersLong-term, cuffed HD CathetersSingle or double lumenSingle or double lumenContain luer locks meeting ISO standards for Contain luer locks meeting ISO standards for

connection to blood tubingconnection to blood tubing Arterio-Venous (AV) GraftsArterio-Venous (AV) Grafts

Implanted prosthesis designed to bypass sections Implanted prosthesis designed to bypass sections of native vesselsof native vessels

AV FistulasAV FistulasSurgical procedure, not a device regulated by FDASurgical procedure, not a device regulated by FDAFistula needles are medical devices, and contain Fistula needles are medical devices, and contain

the same luer locks as cathetersthe same luer locks as catheters


Michael Mendelson, D.D.S., M.S.Michael Mendelson, D.D.S., M.S.Biomedical Engineer, Director Health Biomedical Engineer, Director Health

Promotion OfficerPromotion Officer

Human Factors Science and Engineering BranchHuman Factors Science and Engineering Branch

Michael Mendelson, D.D.S., M.S.Michael Mendelson, D.D.S., M.S.

Biomedical Engineer, Director Health Promotion Officer

Human Factors Science and Engineering Branch

Division of Device User Programs

Office of Communication, Education, and Radiation Control


June 8, 2005

Human Factors and Human Factors and Nocturnal Home Nocturnal Home

HemodialysisHemodialysis

Human Factors and Human Factors and Nocturnal Home Nocturnal Home

HemodialysisHemodialysis

35

TopicsTopicsTopicsTopics

Introduction to human factors (HF)Introduction to human factors (HF) Magnitude of medical error-caused Magnitude of medical error-caused

adverse incidentsadverse incidents HF methodsHF methods Nocturnal Home Hemodialysis (NHD) Nocturnal Home Hemodialysis (NHD)

challenges and observationschallenges and observations Human Factors Branch Human Factors Branch

recommendations for premarket recommendations for premarket submissionssubmissions

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General Definition of Human General Definition of Human FactorsFactors General Definition of Human General Definition of Human FactorsFactors

Human Factors discovers and applies Human Factors discovers and applies information about information about human behaviorhuman behavior, abilities, , abilities, limitationslimitations, and other characteristics to the , and other characteristics to the design of tools, machines, systems, tasks, jobs design of tools, machines, systems, tasks, jobs and environments for productive, safe, and environments for productive, safe, comfortable, and effective comfortable, and effective humanhuman use. use. **

-- Alphonse Chapanis, 1985-- Alphonse Chapanis, 1985

*Sanders & McCormick, Human Factors in Engineering*Sanders & McCormick, Human Factors in Engineering

and Design., McGraw-Hill, Inc., 1987; p 5 and Design., McGraw-Hill, Inc., 1987; p 5

37

General Definition of ErrorGeneral Definition of ErrorGeneral Definition of ErrorGeneral Definition of Error

Human error is an inappropriate or Human error is an inappropriate or undesirable human decision or behavior undesirable human decision or behavior that reduces, or has the potential for that reduces, or has the potential for reducing, effectiveness, safety, or system reducing, effectiveness, safety, or system performance.performance.**

**Sanders & McCormick, Human Factors in Engineering Sanders & McCormick, Human Factors in Engineering

and Design., McGraw-Hill, Inc., 1987; p 607and Design., McGraw-Hill, Inc., 1987; p 607

38

Magnitude of the Problem of Medical Magnitude of the Problem of Medical ErrorErrorMagnitude of the Problem of Medical Magnitude of the Problem of Medical ErrorError

Errors during hospital treatment result in 120,000 Errors during hospital treatment result in 120,000 deaths each year – roughly equivalent to deaths each year – roughly equivalent to a jumbo a jumbo jet’s crashing each dayjet’s crashing each day. . (Leape, Harvard School of (Leape, Harvard School of Public Health)Public Health)

At least 44,000 people,and perhaps as many as At least 44,000 people,and perhaps as many as 98,000 people,die in hospitals each year as a result 98,000 people,die in hospitals each year as a result of medical errors that could have been preventedof medical errors that could have been prevented……((To Err is Human: Building a Safer Health SystemTo Err is Human: Building a Safer Health System; ; Institute of Medicine / National Academy of Sciences, Institute of Medicine / National Academy of Sciences, 1999)1999)

Photo courtesy of BoeingPhoto courtesy of Boeing

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Design of Hemodialysis Systems Design of Hemodialysis Systems Requires Human Factors Requires Human Factors Engineering ProcessEngineering Process

Design of Hemodialysis Systems Design of Hemodialysis Systems Requires Human Factors Requires Human Factors Engineering ProcessEngineering Process

The Quality System Regulation: HF implied inThe Quality System Regulation: HF implied inDesign Controls Section (21 CFR 820.30)Design Controls Section (21 CFR 820.30)ManufacturerManufacturer

Must address the intended useMust address the intended use

Must address the Must address the needs of the user and patientneeds of the user and patient

Shall include Shall include testing under actual or simulated use testing under actual or simulated use

conditionsconditions

HF required at HF required at Input phaseInput phase (design needs), (design needs), Output phase Output phase

(compare user needs <===> device design), and (compare user needs <===> device design), and

Validation Phase Validation Phase (realistic “use” study)(realistic “use” study)

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Safe & Safe & effective effective

Unsafe orUnsafe orineffectiveineffective(Use Error)(Use Error)

Use EnvironmentUse Environment• Light, NoiseLight, Noise• DistractionDistraction• Motion/VibrationMotion/Vibration

Device UserDevice User• KnowledgeKnowledge• AbilitiesAbilities• ExpectationsExpectations• LimitationsLimitations

DeviceDevice• Operational Operational requirements, procedures requirements, procedures• Device complexityDevice complexity• Specific user interface characteristicsSpecific user interface characteristics

UsUsee

DeviceUse

Human Factors Human Factors ConsiderationsConsiderationsHuman Factors Human Factors ConsiderationsConsiderations

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Increased Patient Safety Increased Patient Safety through USABILITY of the through USABILITY of the Use InterfaceUse Interface

Increased Patient Safety Increased Patient Safety through USABILITY of the through USABILITY of the Use InterfaceUse Interface Intuitive operationIntuitive operation Clear displaysClear displays Safe and simple-to-use controlsSafe and simple-to-use controls Positive and safe connectionsPositive and safe connections Effective alarmsEffective alarms Clear and effective labelingClear and effective labeling Safe and simple installation, repair, Safe and simple installation, repair,

maintenance, and disposalmaintenance, and disposal

42

Two Key Human Factors Two Key Human Factors MessagesMessages Two Key Human Factors Two Key Human Factors MessagesMessages

A poorly designed device use interface A poorly designed device use interface can needlessly permit and even induce can needlessly permit and even induce errorerror

Warnings and instructions in the Warnings and instructions in the operating manual (and even on the operating manual (and even on the device) may help but they device) may help but they can notcan not OVERCOME a flawed designOVERCOME a flawed design

43

Important Principles of Good Important Principles of Good Design*Design* Important Principles of Good Important Principles of Good Design*Design*

Make things visibleMake things visible Communicate clearlyCommunicate clearly Provide correct and natural mappingsProvide correct and natural mappings Don’t be arbitrary, be consistentDon’t be arbitrary, be consistent Simplify tasksSimplify tasks Use appropriate constraintsUse appropriate constraints Design for errorDesign for error

*modified from *modified from The Design of Everyday ThingsThe Design of Everyday Things, Donald Norman, Donald Norman

44

Make Things Visible: Make Things Visible: This PCA pump fails.This PCA pump fails.Make Things Visible: Make Things Visible: This PCA pump fails.This PCA pump fails.

Obradovich and Woods (1996)

45

Obradovich and Woods (1996)

46


Make things visibleMake things visible Communicate clearly: e.g., mode / system Communicate clearly: e.g., mode / system

statusstatus Provide correct and natural mappingsProvide correct and natural mappings Don’t be arbitrary, be consistentDon’t be arbitrary, be consistent Simplify tasksSimplify tasks Use appropriate constraintsUse appropriate constraints Design for errorDesign for error


47


Make things visibleMake things visible Communicate clearlyCommunicate clearly Provide correct and natural mappings: Provide correct and natural mappings:

“What is this switch for?”“What is this switch for?” Don’t be arbitrary, be consistentDon’t be arbitrary, be consistent Simplify tasksSimplify tasks Use appropriate constraintsUse appropriate constraints Design for errorDesign for error


48


Make things visibleMake things visible Communicate clearlyCommunicate clearly Provide correct and natural mappingsProvide correct and natural mappings Don’t be arbitrary, be consistent: Don’t be arbitrary, be consistent: e.g., valve conventionse.g., valve conventions Simplify tasksSimplify tasks Use appropriate constraintsUse appropriate constraints Design for errorDesign for error


49


Make things visibleMake things visible Communicate clearlyCommunicate clearly Provide correct and natural mappingsProvide correct and natural mappings Don’t be arbitrary, be consistentDon’t be arbitrary, be consistent Simplify tasks: e.g., reduce Simplify tasks: e.g., reduce programming stepsprogramming steps Use appropriate constraintsUse appropriate constraints Design for errorDesign for error

**modified from modified from The Design of Everyday ThingsThe Design of Everyday Things, Donald Norman, Donald Norman

50

SAFESAFE

Lead Wires with ProtectedLead Wires with ProtectedPins and Correct ConnectionsPins and Correct Connections

UNSAFEUNSAFE

Lead Wires with UnprotectedLead Wires with UnprotectedPins and Incorrect ConnectionsPins and Incorrect Connections

Protected Pins

Protected Pins

ElectrodeLead Wires

PatientCable

PowerCord

Monitor

Use only lead wires that have protected pins. Protected pins can not accidentally be plugged into power cords or electrical outlets.

From Patient

UnprotectedPins

From Patient

UnprotectedPins

Power Cord orExtension Cord

Use Appropriate ConstraintsUse Appropriate Constraints

FDA, Dec. 28, 1993FDA, Dec. 28, 1993

51


Make things visibleMake things visible Communicate clearlyCommunicate clearly Provide correct and natural mappingsProvide correct and natural mappings Don’t be arbitrary, be consistentDon’t be arbitrary, be consistent Simplify tasksSimplify tasks Use appropriate constraintsUse appropriate constraints Design for error: e.g., require Design for error: e.g., require

confirmation of critical actionsconfirmation of critical actions


52

Human Factors: Critical in NHDHuman Factors: Critical in NHDHuman Factors: Critical in NHDHuman Factors: Critical in NHD

UsersUsers Lack of on-site staff Lack of on-site staff

and suppliesand supplies Variable level of Variable level of

education education Medically Medically

compromised: vision, compromised: vision, touch, memory touch, memory

Language and cultural Language and cultural diversitydiversity

Healthy-patient Healthy-patient selection responsible selection responsible for home safety level*for home safety level*

EnvironmentEnvironment Family responsibilities, Family responsibilities,

children, petschildren, pets StressStress Physical (placement, Physical (placement,

voltage/grounding, voltage/grounding, temperature, humidity, temperature, humidity, dust, water quality)dust, water quality)

**D’Amico&Bazzi, D’Amico&Bazzi, Home HemodialysisHome Hemodialysis, in , in Replaplacement of Renal Function by Replaplacement of Renal Function by Dialysis, 1989, page 694Dialysis, 1989, page 694

53

Clinical Incidents: Potential Clinical Incidents: Potential Nocturnal Home Issues? Nocturnal Home Issues? Clinical Incidents: Potential Clinical Incidents: Potential Nocturnal Home Issues? Nocturnal Home Issues?

Hazards always exist:Hazards always exist: For 3 fault codes which indicate need for manual For 3 fault codes which indicate need for manual

adjustment of transmembrane pressure (TMP) => adjustment of transmembrane pressure (TMP) => not actually controllable. Recall. Solution: not actually controllable. Recall. Solution: labelinglabeling**

If unit plugged into receptacle without ground fault If unit plugged into receptacle without ground fault circuit interrupter (GFCI) – with certain other circuit interrupter (GFCI) – with certain other conditions => overheating. Recall. Solution: conditions => overheating. Recall. Solution: labelinglabeling**

*ECRI Healthcare Product Comparison System, *ECRI Healthcare Product Comparison System,

Sept. 2004; p 10 (HDA A5092, A5624)Sept. 2004; p 10 (HDA A5092, A5624)

54

NHD User NeedsNHD User NeedsNHD User NeedsNHD User Needs

Simplify setup: minimize requirements for Simplify setup: minimize requirements for strict hygiene where possible.strict hygiene where possible.

Minimize burden on training. Consider Minimize burden on training. Consider periodic retraining.periodic retraining.

Minimize dependence on bulky labeling. Use:Minimize dependence on bulky labeling. Use: On-screen help/voice prompts On-screen help/voice prompts

(“Wizards”)(“Wizards”) Quick Guides (laminated cards, “cheat Quick Guides (laminated cards, “cheat

sheets”)sheets”)

55

NHD User Needs (continued)NHD User Needs (continued)NHD User Needs (continued)NHD User Needs (continued)

Monitor supplies and preparation of Monitor supplies and preparation of prescribed dialysateprescribed dialysate

Ensure simple set up operation, and Ensure simple set up operation, and adjustmentadjustment

Ensure safety of consumablesEnsure safety of consumables Need for priming blood lines, knowing Need for priming blood lines, knowing

symptoms of air embolism, how to respond symptoms of air embolism, how to respond

56


Potential interrupted treatment: Ability to detect Potential interrupted treatment: Ability to detect

and respond?and respond?

Allow flexible installation – various viewing Allow flexible installation – various viewing

anglesangles

Allow for physical impairment (ESRD co-Allow for physical impairment (ESRD co-

morbidities)morbidities)

Consider touch screen and no cryptic error codesConsider touch screen and no cryptic error codes

57


Consider “progressive disclosure” of Consider “progressive disclosure” of information– for range of user abilities and information– for range of user abilities and wants.wants.

Facilitate detection of bleeding: enuresis Facilitate detection of bleeding: enuresis pads, moisture detectors, effective needle pads, moisture detectors, effective needle dislodgement alarm (single needle?).dislodgement alarm (single needle?).

Patient abilities may be lowest at start of Patient abilities may be lowest at start of session.session.

58


Consider tricky power-interruption Consider tricky power-interruption scenarios (error-codes, default settings)scenarios (error-codes, default settings)

Design in virtual “guardrails”Design in virtual “guardrails”

Allow for compromised nocturnal Allow for compromised nocturnal response to alarmsresponse to alarms

59

Human Factors Engineering Human Factors Engineering Process (HFE)Process (HFE)Human Factors Engineering Human Factors Engineering Process (HFE)Process (HFE)

Start integrating HFE at concept phase (beginning of Start integrating HFE at concept phase (beginning of design)design)User needs designed inUser needs designed inEarly HF design changes fast , economical, and effectiveEarly HF design changes fast , economical, and effectiveFewer “slapped-on” warnings and bulky manualsFewer “slapped-on” warnings and bulky manualsUser acceptance and product life increasedUser acceptance and product life increased

Usability (HF) study at Validation phase demonstrates: Usability (HF) study at Validation phase demonstrates: low low risk of dangerous use errorrisk of dangerous use error where and when device is used where and when device is used by by typical userstypical users (usually a simulation). (usually a simulation).

Clinical trials demonstrate: Clinical trials demonstrate: safety and effectivenesssafety and effectiveness where where and when used and when used exactly as directed.exactly as directed.

60

Human Factors Human Factors Recommendations/ConclusioRecommendations/Conclusionn

Human Factors Human Factors Recommendations/ConclusioRecommendations/Conclusionn

AssumeAssume significant patient/user and significant patient/user and environmental compromises.environmental compromises.

MinimizeMinimize burden on training and paper burden on training and paper instructions.instructions.

Ensure Ensure comprehensivecomprehensive patient/user support patient/user support from manufacturer or value-added retailer.from manufacturer or value-added retailer.

Encourage Encourage postmarketpostmarket feedback from users. feedback from users. DesignDesign to protect user/patient from error. to protect user/patient from error.


Claudia C. Ruiz-Zacharek, M.D.Claudia C. Ruiz-Zacharek, M.D.Medical Officer / NephrologistMedical Officer / Nephrologist

Gastroenterology and Renal Devices Gastroenterology and Renal Devices BranchBranch


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

Medical Officer / Nephrologist

Gastroenterology and Renal Devices Branch




June 8, 2005

63

Nocturnal Home Hemodialysis Nocturnal Home Hemodialysis DevicesDevicesNocturnal Home Hemodialysis Nocturnal Home Hemodialysis DevicesDevices

Optimal device design for actual use Optimal device design for actual use conditionsconditions

Adequate labeling to minimize errorAdequate labeling to minimize error Appropriate training for successful Appropriate training for successful

treatments treatments Risk analysis to minimize unforeseen Risk analysis to minimize unforeseen

problemsproblems Clinical study design to demonstrate Clinical study design to demonstrate

safety and effectivenesssafety and effectiveness

64


1.1. Background InformationBackground Information

2.2. Nocturnal Home HemodialysisNocturnal Home Hemodialysis

3.3. Clinical StudiesClinical Studies

65





66

Background InformationBackground InformationBackground InformationBackground Information

DemographicsDemographics Review of the literatureReview of the literature Definitions and nomenclatureDefinitions and nomenclature

67

Background InformationBackground InformationBackground InformationBackground Information

Conventional HemodialysisConventional Hemodialysis Typically in-center, 4 hours, 3 X weekTypically in-center, 4 hours, 3 X week Medical personnelMedical personnel Patient has a passive role during Patient has a passive role during

treatmenttreatment

Nocturnal Home HemodialysisNocturnal Home Hemodialysis Performed at home, typically at night, Performed at home, typically at night,

and while the patient sleepsand while the patient sleeps Absence of medical personnelAbsence of medical personnel Patient is the performer of the Patient is the performer of the

treatmenttreatment

68

Definitions and Definitions and NomenclatureNomenclatureDefinitions and Definitions and NomenclatureNomenclature

Nocturnal Hemodialysis (NHD)Nocturnal Hemodialysis (NHD)Nightly Hemodialysis Nightly Hemodialysis Nocturnal Home Hemodialysis Nocturnal Home Hemodialysis Long nocturnal hemodialysisLong nocturnal hemodialysisSlow nocturnal hemodialysisSlow nocturnal hemodialysis

In-center nocturnal hemodialysis In-center nocturnal hemodialysis

Daily hemodialysisDaily hemodialysis

69


Nocturnal Home HemodialysisNocturnal Home Hemodialysis

Performed at home by patientPerformed at home by patient

Absence of medical personnelAbsence of medical personnel

Frequency has reportedly Frequency has reportedly

ranged from 5-7 nights a week ranged from 5-7 nights a week

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

70


Nocturnal Home HemodialysisNocturnal Home Hemodialysis

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

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

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

71

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

Data from the United States Data from the United States Renal Data System Renal Data System (USRDS)(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., Lockridge, et al., Adv Ren Replace TherAdv Ren Replace Ther 2001; 8(4):250- 2001; 8(4):250-256.256.

72

Population ComparisonPopulation ComparisonPopulation ComparisonPopulation Comparison

Lockridge et al.Lockridge et al.

Diabetic nephropathy* 14%Diabetic nephropathy* 14%

Hypertension 18%Hypertension 18%

Glomerulonephropathy 11%Glomerulonephropathy 11%

Polycystic Kidney 9%Polycystic Kidney 9%

** Lockridge, et al., Lockridge, et al., Adv Ren Replace TherAdv Ren Replace Ther 2001 2001

US Demographics (USRDS)

Diabetic nephropathy 45%Diabetic nephropathy 45%

Hypertension 28%Hypertension 28%

Glomerulonephropathy 8%Glomerulonephropathy 8%

Polycystic Kidney 2.3%Polycystic Kidney 2.3%

73

Background Information – Background Information – Review of the LiteratureReview of the LiteratureBackground Information – Background Information – Review of the LiteratureReview of the Literature

Study Design # Patients

London Daily/NocturnalDialysis Study, 2003

Prospective,observational

23 (total),22 matched

controls

Van Biesen, 2003 Retrospective 12

Alloati, 2002 Prospective 18

Chan, 2003 Case control 9

Agar, 2003 Prospective 16

Pierratos, 1999 Prospective 37

74

Background Information – Background Information – Review of the Literature Review of the Literature Background Information – Background Information – Review of the Literature Review of the Literature

Study Blood pressure

Calcium -Phosphorus

Anemia

London Daily/Nocturnal Dialysis Study, 2003

Improved Improved control

No significant improvement

Alloati, 2002 Improved Improved control


Chan, 2003 Improved

Agar, 2003 Improved Improved control

Increased epoetin & iron

Pierratos,1999 Improved Improved control


75

Background Information – Background Information – Review of the LiteratureReview of the LiteratureBackground Information – Background Information – Review of the LiteratureReview of the Literature

Study Reported Outcome

London Daily/Nocturnal Dialysis Study, 2003

Improved controlreduction of number and severity of dialysis symptoms

Van Biesen, 2003 Improved serum albumin

Agar, 2003 •No fluid or dietary restrictions•Improved sleep patterns

Pierratos, 1999 Reduction of sleep apnea

76





77


Device Design and ComponentsDevice Design and Components Human Factors IssuesHuman Factors Issues Water QualityWater Quality Use of a Partner and Remote Use of a Partner and Remote

MonitoringMonitoring Vascular Access and Extracorporeal Vascular Access and Extracorporeal

Circuit ConnectionsCircuit Connections LabelingLabeling Lay-User TrainingLay-User Training

78


Conventional Conventional HemodialysisHemodialysis

Patient is passive Patient is passive recipientrecipient

Troubleshooting by Troubleshooting by medical personnelmedical personnel


Patient’s active rolePatient’s active rolePresumably asleepPresumably asleepNeed to troubleshootNeed to troubleshoot

79


Human Factors IssuesHuman Factors Issues

User- friendlyUser- friendly Use device successfully while Use device successfully while

minimizing use errorminimizing use error Minimal dependance on labeling Minimal dependance on labeling

and trainingand training

80

Nocturnal Home Nocturnal Home HemodialysisHemodialysis Nocturnal Home Nocturnal Home HemodialysisHemodialysis

Considerations for device designConsiderations for device design::

Redundancy Redundancy Adequacy of alarmsAdequacy of alarms

LoudnessLoudness SensitivitySensitivity Ease of understanding and correctionEase of understanding and correction

Additional safety alarmsAdditional safety alarms

81


Water Quality concernsWater Quality concerns

Conventional Hemodialysis: Conventional Hemodialysis: 360 L/week360 L/week

Nocturnal Hemodialysis:Nocturnal Hemodialysis:648 L-1080 L/week648 L-1080 L/week

Standard water quality for Standard water quality for hemodialysis vs higher standardshemodialysis vs higher standardsTotal viable microbial count <200 CFU/mLEndotoxin concentration < 2 EU/mL

82


Water Quality concernsWater Quality concerns

Types of water treatment systemsTypes of water treatment systemsReverse osmosis (RO)Reverse osmosis (RO)Deionization (DI)Deionization (DI)CombinationCombination

Water sourceWater source Municipal water suppliersMunicipal water suppliers Well waterWell water

83


MonitoringMonitoring

Without a partner*Without a partner* 59 patients, prospective study59 patients, prospective study

In-center hemodialysis – constant In-center hemodialysis – constant monitoringmonitoring

Home hemodialysisHome 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.

84


MonitoringMonitoring

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

months of nocturnal HD therapy until months of nocturnal HD therapy until

the HD team is convinced the patient the HD team is convinced the patient

is stable and compliant.” is stable and compliant.”

* * The London Daily/Nocturnal Hemodialysis StudyThe London Daily/Nocturnal Hemodialysis Study. . AJKD,AJKD, 20032003

85


Vascular accessVascular access

Long-term cuffed catheterLong-term cuffed catheter

Synthetic graftSynthetic graft

Arteriovenous fistulaArteriovenous fistula

86


Vascular accessVascular access

Long-term cuffed catheter Long-term cuffed catheter Synthetic graft Synthetic graft Arteriovenous fistulaArteriovenous fistula

Observational study; 24 patients in daily Observational study; 24 patients in daily dialysis; follow up 3.6 years*dialysis; follow up 3.6 years*

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

87


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

88


LabelingLabeling Operator’s ManualOperator’s Manual

WarningsWarnings PrecautionsPrecautions Device specificationsDevice specifications Instructions for maintenanceInstructions for maintenance Cleaning and disinfectionCleaning and disinfection

89

LabelingLabelingLabelingLabeling

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

medical device medical device It should also include relevant data It should also include relevant data

from clinical studies and instructions from clinical studies and instructions for using and caring for the devicefor using and caring for the device

90

LabelingLabelingLabelingLabeling

Patient’s Instructions for UsePatient’s Instructions for Use The manual that accompanies a medical The manual that accompanies a medical

device device It should also include relevant data from It should also include relevant data from

clinical studies and instructions for using clinical studies and instructions for using and caring for the deviceand caring for the device

Written for a person with no medical Written for a person with no medical trainingtraining

91


TrainingTraining

Teaching provided by the Teaching provided by the

manufacturermanufacturer

Medical expert to train the lay userMedical expert to train the lay user

Lay user to successfully use the Lay user to successfully use the

devicedevice

92


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..

93


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

Test to confirm the adequacy of the Test to confirm the adequacy of the trainingtraining

94


Risk AnalysisRisk Analysis

Inadvertent disconnectionsInadvertent disconnections Blood loss from increased Blood loss from increased

frequency of treatmentsfrequency of treatments Potential increased rate of Potential increased rate of

vascular access infection vascular access infection Psychological effectsPsychological effects

95





96

Clinical StudiesClinical StudiesClinical StudiesClinical Studies

PurposePurpose

Patient selectionPatient selection

Study designStudy design

97


PurposePurpose

To demonstrate the safety and To demonstrate the safety and effectiveness of the NHD devices effectiveness of the NHD devices under actual use conditionsunder actual use conditions

Not intended to evaluate the long term Not intended to evaluate the long term morbidity and mortality of NHD as a morbidity and mortality of NHD as a therapeutic modality compared to therapeutic modality compared to conventional hemodialysisconventional hemodialysis

98


FDA concernsFDA concerns::

Patient selection for trialPatient selection for trial Patient selection for marketingPatient selection for marketing Patient performs the entire Patient performs the entire

treatment treatment Patient must wake up to attend the Patient must wake up to attend the

alarms alarms

99


Reported patient selectionReported patient selection::

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

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

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

100



Agar, et al., Nocturnal Hemodialysis in Agar, et al., Nocturnal Hemodialysis in Australia. Hemodialysis International 2003; Australia. Hemodialysis International 2003; 7(4):278-289.7(4):278-289. 16 patients, prospective16 patients, prospective Clinically stable > 3 mo in HDClinically stable > 3 mo in HD Psychologically soundPsychologically sound Technically adeptTechnically adept Stable and supportive homeStable and supportive home CompliantCompliant

101



Alloatti, et al., Long Nocturnal Dialysis. Alloatti, et al., Long Nocturnal Dialysis. Blood Purif 2002; 20:525-530.Blood Purif 2002; 20:525-530. 18 patients, nonrandomized, prospective18 patients, nonrandomized, prospective Glomerulonephritis (7)Glomerulonephritis (7) Tubulointerstitial (4)Tubulointerstitial (4) Nephroangiosclerosis (3)Nephroangiosclerosis (3) Diabetic nephropathy (1)Diabetic nephropathy (1) Vasculitis (1)Vasculitis (1) Other (2)Other (2)

102



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 Med 1999; 92:251-260.Q J Med 1999; 92:251-260. 286 UK patients; retrospective, observational 286 UK patients; retrospective, observational

studystudy Initially excluded older and frailer patientsInitially excluded older and frailer patients Excluded patients with diabetes, cardiac failure, Excluded patients with diabetes, cardiac failure,

and multiple myelomaand multiple myeloma Currently 33% diabetic patientsCurrently 33% diabetic patients

103


Patient selection criteriaPatient selection criteria::

Availability of a partnerAvailability of a partner Patient's compliancePatient's compliance Psychological well beingPsychological well being Home environment (Medicare) Home environment (Medicare)

Water supplyWater supplySewageSewageElectricityElectricitySpaceSpaceSocial interactionSocial interaction

104


Study design discussionStudy design discussion::

Clinical endpointsClinical endpointsEffectivenessEffectivenessSafety / Adverse EventsSafety / Adverse Events

Control groupControl groupRandomized vs patient as own controlRandomized vs patient as own control

Length of follow-upLength of follow-up Sample sizeSample size

105


Treatment related issues to be consideredTreatment related issues to be considered::

Dialysate composition and additivesDialysate composition and additives Administration of anticoagulationAdministration of anticoagulation Choice of dialyzerChoice of dialyzer Type of monitoringType of monitoring Vascular accessVascular access Dialyzer reuseDialyzer reuse

106

ConclusionsConclusionsConclusionsConclusions Nocturnal Home Hemodialysis DevicesNocturnal Home Hemodialysis Devices

Optimal device design for actual use Optimal device design for actual use conditionsconditions

Adequate labeling to minimize errorAdequate labeling to minimize error Appropriate training for successful Appropriate training for successful

treatments treatments Risk analysis to minimize unforeseen Risk analysis to minimize unforeseen

problemsproblems Clinical study design to demonstrate Clinical study design to demonstrate

safety and effectivenesssafety and effectiveness

107

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. Adv Ren Nocturnal Home Hemodialysis in North America. Adv Ren Replace Ther 2001; 8(4):250-256.Replace Ther 2001; 8(4):250-256.

3.3. Pierratos, A. Nocturnal home haemodialysis: an update on a Pierratos, A. Nocturnal home haemodialysis: an update on a 5-year experience. Nephrol Dial Transplant 1999; 14:2835-5-year experience. Nephrol Dial Transplant 1999; 14:2835-28402840

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. Am J Kidney Dis provision of quotidian home hemodialysis. Am J Kidney Dis 2003; 42:S66-S70.2003; 42:S66-S70.

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

108

ReferencesReferencesReferencesReferences

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

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

8.8. Agar JWM, Somerville CA, Dwyer KM, Simmonds RE, Agar JWM, Somerville CA, Dwyer KM, Simmonds RE, Boddington JM, and Waldron CM. Nocturnal Hemodialysis Boddington JM, and Waldron CM. Nocturnal Hemodialysis in Australia. Hemodialysis International 2003; 7(4):278-289.in Australia. Hemodialysis International 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 Patient Selection, Vascular Access, and Education in Quotidian Hemodialysis. Am J Kidney Dis 2003; 42(1):S56-Quotidian Hemodialysis. Am J Kidney Dis 2003; 42(1):S56-60.60.

109


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. Blood Purif 2002; 20:525-530.Nocturnal Dialysis. Blood Purif 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 hours home haemodialysis – the best renal replacement therapy method? Q J Med 1999; 92:251-260.therapy method? Q J Med 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 Chan CT, Hanly P, Gabor J, Picton P, Pierratos A, and Floras JS. Nocturnal Hemodialysis Lowers Heart Rate during Sleep JS. Nocturnal Hemodialysis Lowers Heart Rate during Sleep and Normalizes Its Parasympathetic and Sympathetic and Normalizes Its Parasympathetic and Sympathetic Modulation. Hemodialysis International 2003; 7(1):73-104.Modulation. Hemodialysis International 2003; 7(1):73-104.

110


14.14. 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 International, 2003; 7(1):73-104.Hemodialysis International, 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. Adv Ren Replace Ther 2001; 8(4):268-272.Hemodialysis. Adv Ren Replace Ther 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. Am J Patient Quality of Life on Quotidian Hemodialysis. Am J Kidney Dis 2003; 42:S36-S41.Kidney Dis 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. ASAIO Journal 1998; Revival of a Superior Dialysis Method. ASAIO Journal 1998; 117-122.117-122.

18.18. 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. Hemodialysis the United States compared to Japan. Hemodialysis International 2003; 7(1):67-71.International 2003; 7(1):67-71.

111


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. Am J Conventional and Home Quotidian Hemodialysis. Am J Kidney Dis 2003; 42:S49-S55.Kidney Dis 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. Am J Kidney Dis 2003; Morbidity, and Mortality Results. Am J Kidney Dis 2003; 42(1):S5-S12.42(1):S5-S12.

21.21. 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. Am J Kidney Dis 2003; Balance with Quotidian Hemodialysis. Am J Kidney Dis 2003; 42, S1:S24-29.42, 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. Am J Kidney Dis 2003; Undergoing Quotidian Hemodialysis. Am J Kidney Dis 2003; 42:S13-17.42:S13-17.

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

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

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. Hemodialysis International – Three Years Experience. Hemodialysis International 2003; 7(1):73-104.2003; 7(1):73-104.

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

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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. Am J Impact of Quotidian Hemodialysis on Nutrition. Am J Kidney Dis 2003; 42(1):S30-S35.Kidney Dis 2003; 42(1):S30-S35.

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

29.29. Van Biesen W, Veys N, Vanholder R, and Lameire N. Effect Van Biesen W, Veys N, Vanholder R, and Lameire N. Effect of Long Nocturnal Dialysis on Nutritional Status and Blood of Long Nocturnal Dialysis on Nutritional Status and Blood Pressure Control. Hemodialysis International, 2003; Pressure Control. Hemodialysis International, 2003; 7(1):73-104.7(1):73-104.

30.30. Weick-Brady M. Medical Devices: Going Home. FDLI Weick-Brady M. Medical Devices: Going Home. FDLI Update 2003; September/October: 23-24, 29-30.Update 2003; September/October: 23-24, 29-30.

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31.31. Weinger MB, Foreword to Designing Usability into Medical Weinger MB, Foreword to Designing Usability into Medical ProductsProducts

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

33.33. Young BA, Hynes J, and McComb T. Home Hemodialysis: Young BA, Hynes J, and McComb T. Home Hemodialysis: Associations with Modality Failure. Hemodialysis Associations with Modality Failure. Hemodialysis International, 2003; 7:73-104.International, 2003; 7:73-104.

gu advisory panel meeting gu advisory panel meeting nocturnal home hemodialysis carolyn y. neuland,...

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