Foundations of medical oxygen systems 2023（英文）行业资料

FOUNDATIONSOFMEDICALOXYGENSYSTEMS

17FEBRUARY2023

Foundationsof

systems

medicaloxygen

1

oxygensystems

Foundationsofmedical

17FEBRUARY2023

WHO/2019-nCoV/Clinical/Oxygen/2023.1

©WorldHealthOrganization2023

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Coverandsectionsmarkers1–4AdobeStock/Elroi,Alla,dizfoto1973,peuceta,НиколайАмосеев,andcurrahee_shutter.Page67:WHO/GabreezProduction,Page73:WHO/IsmailTaxta.Figures1.16,2.8,2.11,2.34,2.36,2.35,2.36,2.37and3.5,WHO/L.AlejandraVelez;Figures2.9and2.10WHO/StefanAdriaensens;Figures2.12and2.13WHO/FlorestanBoualame;Figure2.33WHO/HuguesGaertner;Figure3.2WHO/AlexY.Sokemawu.

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FOUNDATIONSOFMEDICALOXYGENSYSTEMS

Contents

Acknowledgementsv

Abbreviationsvii

Introduction

1

Structure

1

Method2

1.Oxygenhistory,ecosystemandrelatedsystems3

1.1Anessentialmedicine5

1.2Historyofmedicaloxygen5

1.3Oxygentherapyandrespiratorysupport:keyconcepts7

1.4Elementsoftheoxygenecosystem8

1.5Oxygensystems8

1.6Oxygenproduction,storageanddistribution10

1.7Deliveryequipmentanddevices14

1.8Patientmonitoring18

1.9Conditioning,regulationandtestingdevices18

2.Healthfacilityoxygensystems19

2.1Onsiteproductiontechnologies:PSA,VSAandVPSA21

2.2TechnicalrequirementsforPSAoxygengeneratorplants22

2.3SizingandconfiguringofPSAoxygengeneratorplants26

2.4PSAsystemcosts29

2.5Cylinderfillingstation:boostercompressorandfillingramp30

2.6Distributionramp31

2.7Pneumaticchangeoversystem:automatic/manual31

2.8High-pressuregascylinders33

2.9Medicalgaspipelinesystems39

2.10Onsiteliquidoxygenstorage42

3.Operationalizationofoxygensystems45

3.1Estimationofoxygendemand47

3.2Calculationmethodsforestimatingoxygendemand48

3.3Tipsforrationaluseofoxygen49

3.4Systemimplementation,operationandmaintenance50

3.5Structuralandelectricalrequirementsforonsiteoxygensystems51

3.6Safetyandmitigationmeasures56

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FOUNDATIONSOFMEDICALOXYGENSYSTEMS

4.Offsiteoxygenproduction61

4.1Valuechainofliquidoxygen63

4.2Liquidoxygenavailability64

5.Toolsandresources67

5.1WHOclinicaltreatmentguidelines69

5.2WHOEmergencyResponseFramework70

5.3WHOCOVID-19EssentialSuppliesForecastingTool(ESFT)70

5.4MedicalEquipmentforCOVID-19CaseManagementInventoryTool70

5.5WHOGlobalClinicalPlatformforCOVID-1970

5.6WHOtechnicalconsultationonoxygenaccessscale-upforCOVID-1970

5.7O2CoV2study71

5.8Externalresources71

Glossary75

References78

Additionalresources80

Annexes

WebannexA.Technicalconsiderationsfortheprocurementofoxygengeneratorplants

/iris/bitstream/handle/10665/366134/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-A-

2023.1-eng.pdf

WebannexB.Siteevaluationforoxygengeneratorplants

/iris/bitstream/handle/10665/366135/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-B-

2023.1-eng.pdf

WebannexC.Sitereadinessforoxygengeneratorplants

/iris/bitstream/handle/10665/366136/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-C-

2023.1-eng.pdf

WebannexD.Commissioningreportforoxygengeneratorplants

/iris/bitstream/handle/10665/366137/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-D-

2023.1-eng.pdf

WebannexE.Oxygensupplier’smapping

/iris/bitstream/handle/10665/366138/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-E-

2023.1-eng.pdf

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FOUNDATIONSOFMEDICALOXYGENSYSTEMS

Acknowledgements

TheWorldHealthOrganization(WHO)wouldliketogivespecialthankstotheHealthCareReadinessDepartment,ClinicalManagementTeam,ledbyDrJanetDiaz,forcoordinationoftheOxygenAccessScaleUpInitiative;andthetechnicalteamwhichdevelopedthecontent,coordinatedbyLauraAlejandraVelez,withthecollaborationofHuguesGaertnerforthedocument,andFlorestanBoualame,EdgardoDiazandIngridLarafortheannexes.

WHOwouldalsoliketothankallcollaboratorswhocontributedcontentandexpertreview,fromthefollowingdepartments,regionalandcountryofficesandentities.

AccesstoMedicinesandHealthProductsDivision:SteveEstevãoCordeiro(NormsandStandardsforPharmaceuticals);BenediktHuttner(ModelListsofEssentialMedicines);HerbertSchmidt(NormsandStandardsforPharmaceuticals);AdrianaVelazquez(MedicalDevices).

HealthEmergenciesProgramme(WHE):SylviaBertagnolio(Head,ControlandResponseStrategiesUnit);VanessaCramond(ClinicalManagementandOperationsUnit);MicheleDiMarco(OperationsSupportandLogistics);ConstanceMcDonough-Thayer(OperationsSupportandLogistics);JiaHe(ClinicalManagementandOperationsUnit);MartaLadoCastro-Rial(ClinicalManagementandOperationsUnit);MaheshMadyagol(OperationsSupportandLogistics);PryankaRelan(EmergencyMedicalTeams);JamieRylance(ClinicalManagementandOperationsUnit);AnaSilenzi(OperationsSupportandLogistics).

Biomedicalandoxygenfocalpointsatregionalandcountrylevel:AtalawoeKossiviKumedjro,MarthaMulerwa(WHORegionalOfficeforAfrica);EdgardoDiaz,ClaudioMeirovich,DmytroOsin,UlianRotari(WHORegionalOfficeforEurope).

WHOwouldliketothankthefollowingexternalreviewersfrompartnerorganizationsfortheirsupportinthepreparationofthisdocument:BeverlyBradley,MansiDalal,FlorinGheorghe,KatherineKirsch,IngridLara,HelenPetach,HabtamuSeyoumTolla(UnitedNationsChildren’sFund[UNICEF]);MarthaGartley(ClintonHealthAccessInitiative[CHAI]);NoahHudelson(BuildHealthInternational);AntoineMaillard(AllianceforInternationalMedicalAction[ALIMA]);JimStunkel(AssistInternational).

DevelopedwithfundingsupportofUnitaid.

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FOUNDATIONSOFMEDICAL

OXYGENSYSTEMS

vii

FOUNDATIONSOFMEDICALOXYGENSYSTEMS

Abbreviations

AFNOR

AGA

ALIMA

ASME

ASU

AVR

BPAP

BP

BS

CGE

CHAI

COA

CPAP

DIN

DISS

DOT

EBC

ESFT

EurPh

FiO

2

FSC

GB

GDP

GMP

GOX

HFNC

HFNO

HHHF

HTM

HVAC

ICU

IPC

ISO

JIS

kPa

KPI

LCC

L/min

AssociationFrançaisedeNormalisation

AmericanGasAssociation

AllianceforInternationalMedicalAction

AmericanSocietyofMechanicalEngineers

airseparationunit

automaticvoltageregulator

bilevelpositiveairwaypressure

BritishPharmacopoeia

BritishStandard

CompressedGasAssociation(USA)

ClintonHealthAccessInitiative

certificateofanalysis

continuouspositiveairwaypressure

DeutscheIndustrialNorms

DiameterIndexSafetySystem

DepartmentofTransport(USA)

EveryBreathCountsCoalition(public-privatepartnership)

EssentialSuppliesForecastingTool(WHO)

EuropeanPharmacopoeia

fractionofinspiredoxygen

FreeSalesCertificate

GuoBiao(nationalstandards,People’sRepublicofChina)

gooddistributionpractices

goodmanufacturingpractices

gaseousoxygen

high-flownasalcannula

high-flownasaloxygen

heatedhumidifiedhighflow

HealthTechnicalMemorandum(NHS)

heating,ventilation,airconditioning

intensivecareunit

infectionpreventionandcontrol

InternationalOrganizationforStandardization

JapaneseInstituteofStandards

kilopascal(unitofpressure,metric)(SI)

keyperformanceindicator

lifecyclecost

litresperminute

viii

FOUNDATIONSOFMEDICALOXYGENSYSTEMS

LMIC

LOX

MGPS

NFPA

NHS

NIV

Nm3/hr

NTP

OEM

OSPT

O

2

PIC/S

PMP

PPE

PPM

PSA

PSI

PSIG

QA

QC

RPV

SaO

2

SARI

SI

SLA

Sm3/hr

SPD

SpO2

STP

TCO

TPED

UNDSS

UNICEF

USP

VIE

VPSA

VSA

VSD

WFSA

WHO

%v/v

low-andmiddle-incomecountries

liquidoxygen

medicalgaspipelinesystem

NationalFireProtectionAssociation(USA)

NationalHealthService(UnitedKingdom)

Non-InvasiveVentilators

normalcubicmetresperhour

normaltemperatureandpressure

originalequipmentmanufacturing

OxygenSystemPlanningTool(UNICEF)

oxygen(molecule)

PharmaceuticalInspectionCo-operationScheme

preventivemaintenanceprogramme

personalprotectiveequipment

plannedpreventivemaintenance

pressureswingadsorption

poundspersquareinch(unitofpressure,imperial)

PSIgauge

qualityassurance

qualitycontrol

residualpressurevalve

arterialoxygensaturation

severeacuterespiratoryinfection

InternationalSystemofUnits

servicelevelagreement

standardcubicmetresperhour

surgeprotectiondevice

peripheralcapillaryoxygensaturation

standardtemperatureandpressure

totalcostofownership

TransportablePressureEquipmentDirective(EuropeanUnion)

UnitedNationsDepartmentforSafetyandSecurity

UnitedNationsChildren’sFund

UnitedStatesPharmacopoeia

vacuum-insulatedevaporator

vacuumpressureswingadsorption

vacuumswingadsorption

variablespeeddrive

WorldFederationofSocietiesofAnaesthesiologists

WorldHealthOrganization

percentagevolumepervolume

1

FOUNDATIONSOFMEDICALOXYGENSYSTEMS

Introduction

Oxygen–anelementpresentintheatmosphere–isthesecondlargestcomponentafternitrogen,comprising20.8%ofairbyvolume.Itisthemostcommonmedicinalgasusedinhealthfacilities.

Medicaloxygenislifesavingandanessentialmedicineusedtoensuresafesurgical,emergencyandcriticalcareservices.ItisusedatalllevelsofthehealthcaresystemandiscrucialforthetreatmentofCOVID-19andotherlife-threateningconditionssuchasseverepneumonia,severemalaria,sepsiscausedbyawidevarietyofpathogens,traumaandcomplicationsofpregnancyorbirth.Unlikemanymedicines,ithasnosubstitute.Althoughmuchworkhasbeenundertakenintheoxygenecosystemovertheyears,especiallyinrelationtoitsclinicaluse,accessandavailabilityremainlimitedinmanycountries.TheCOVID-19pandemichashighlightedthisgap.Onlycollaborativeactioncantrulyscaleupaccesstoandavailabilityofmedicaloxygen.

Foundationsofmedicaloxygensystemshas

beencompiledtocapturedefinitions,technicalrequirements,toolsandresourcesrelatedtomedicaloxygensystemsbasedoninformationavailableasofJanuary2023.Thepurposeofthiseffortistomakerelevantandpracticalmaterialaccessiblefornationalauthorities,policy-makers,donors,implementingpartners,practitioners,biomedicalengineersandanyoneinterestedinmedicaloxygensystems.

ThisdocumentreferenceskeyWHOproducts,whicharetheresultofmultidisciplinaryeffortsrelatedtomedicaloxygen;itssafeuseandqualitysystem’simplementation.Amajorgapregardingmedicaloxygensystemsconcernspubliclyavailabletechnicalguidance(1),andthisdocumentfocusesonprovidingdefinitionsrelatedtomedicaloxygensystemsandthetechnicalandengineeringaspectsrequiringcontextualizedassessment,implementationandoperation.Relevantexternalresourcesareoutlined,acknowledgingtherecentenhancedglobalcollaborationmadetoclosetheidentifiedgapswhichhavestartedtobeaddressedsincethebeginningoftheCOVID-19pandemic.

Structure

Thedocumenthasfivemainsections:

1.Oxygenhistory,ecosystemandrelatedsystems:

Thissectionprovidesdefinitions,givesahistoryoftheuseofmedicaloxygen,outlinestheoxygenecosystemanddescribesthedifferentcomponentsofoxygensystems.

2.Healthfacilityoxygensystems:Thissectionpresentsanoverviewoftheonsitetechnologiesfortheproduction,distributionandstorageofmedicaloxygen.

3.Operationalizationofoxygensystems:Keyoperationaltopicsandmainconcernsrelatedtothedesign,implementationanduseofoxygensystemsarecoveredinthissection.

4.Offsiteoxygenproduction:Thissectionprovidesabriefappraisalofgeneraltopicsrelatedtothevaluechainofoffsiteliquidoxygen(LOX)production.

5.Toolsandresources:HerevariousWHOpracticaltools,studiesandplatformsareoutlinedandlinkstoexternalrelevantresources,allrelatedtooxygenecosystem.

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FOUNDATIONSOFMEDICALOXYGENSYSTEMS

19-oxygen-emergency-impacting-more-than-half

-a-million-

people-in-low--and-middle-income-countries-every-day-as-

demand-surges

Method

ThecontentsofthisintroductiondocumentweredevelopedbyWHOcollaboratorsfromtheHealthCareReadinessDepartment,undertheClinicalPillarledbyJanetDiaz,andwrittenbyLauraAlejandraVelezwithfurthercontributionsfromHuguesGaertner.ThedocumentisbasedoninformationavailableasofSeptember2022,andreferstoavailableWHOguidelinesandguidance,andongoingworkrelatedtooxygenacrossanumberofWHOunits.TheWHOtechnicaltoolscontainedintheannexesweredevelopedtogetherwithconsultantsFlorestanBoualame,EdgardoDiazandIngridLara.ThesetoolshavebeentestedviacountryandregionalsupportincollaborationwithWHObiomedicalengineersandoxygenfocalpoints.AppropriateWHOconfidentialityundertakingsweresignedandsubmittedbyallindividualconsultants.

ThisdocumentcontainslinkstomultidisciplinaryWHOoxygen-relatedresources,suchasnormativeproducts,clinicalguidelines,platforms,dashboards,calculatorsandotherpublications.RelevantexternalresourcesproducedbyrecognizedpartnersbelongingtotheOxygenTaskForceareoutlined.Theentitieswereconsultedtoapproveinclusionoftheexternalresources.WHOisnotresponsibleforthedevelopmentoruseofthosetoolsandsimplyreferstothemasavailableresources.

ThedraftdocumentwassentforreviewtoselectedinternationallyrecognizedentitieswithtechnicalexpertiseofthesubjectmatterandwhicharepartoftheOxygenTaskForce.Thecontentwasreviewedforreadability,technicalaccuracyandusability.

Note:FurtherinformationabouttheOxygenTaskForcecanbe

foundat:

/news/item/25-02-2021-covid-

ConfidentialityandDeclarationsofInterest

TheselectionofinternalWHOparticipantswasbasedontheirinvolvementinoxygen-relatedwork.Theselectionofentities,whichparticipatedintheexternalreview,wasbasedontheirtechnicalexpertiseofthesubjectmatter.Eachentityappointedrepresentativestoundertakecontentreview.ThenecessarymeasurestoavoidconflictsofinterestandtofollowtheFrameworkofEngagementwithNon-StateActorsruleswereassessedbytheWHOtechnicalunitinconsultationwiththelegalunit,andnoconflictswereidentified.AppropriateWHOconfidentialityundertakingsweresignedandsubmittedbyallindividualconsultantsoftheparticipatingentities.

Anoteonpressureunits

ThisdocumentreferstounitsderivedfromtheInternationalSystemofUnits(SI).Therefore,referencestopressureareexpressedinpascal(Pa).However,theunitsmostcommonlyusedbymanufacturersarebarorpoundspersquareinch(psi).Tofacilitateunderstanding,pressurevaluesareexpressedinkPawithbarandpsiconversionsprovidedinthepresentdocument.AdditionalconversionequivalencesareshowninTable1.

Table1.Pressureunitvalueequivalents

kg/cm2

atm

bar

psi

(libra/pulg2)

kPa

mmhg

1kg/cm2

0.968

0.980

14.2

98

736

1atm

1.033

1.013

14.7

101.3

760

1bar

1.020

0.987

14.5

100

750

1psi(libra/pulg2)

0.070

0.068

0.069

6.894

51.7

1kPa

0.010

0.010

0.010

0.145

7.50

1000mmhg

1.360

1.316

1.333

19.33

133.3

FOUNDATIONSOFM