umc g - vadea january 22nd, 1997 target: end in 1998 essential hospital-organisations participate...

University Medical Center Groningen / Folie 1

Brunner HaustechnikBrunner HaustechnikBrunner Haustechnik AG, CH-8304 Wallisellen-ZürichAG, CH-8304 Wallisellen-ZürichAG, CH-8304 Wallisellen-Zürich

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Current Current Current Current hospital guidelines inhospital guidelines inhospital guidelines inhospital guidelines inSwitzerland and in GermanySwitzerland and in GermanySwitzerland and in GermanySwitzerland and in Germany

Arnold Brunner, dipl. HLKS-Ing. SIAArnold Brunner, dipl. HLKS-Ing. SIAArnold Brunner, dipl. HLKS-Ing. SIAArnold Brunner, dipl. HLKS-Ing. SIA

VDI 2167-1: Building services in hospitals - Heating,ventilation and air-conditioning

SWKI 99-3: Heating, ventilation and air-conditioningin hospitals

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Guideline for the Guideline for the Guideline for the Guideline for the design,design,design,design, construction, construction, construction, construction,operation and monitoring of ventilationoperation and monitoring of ventilationoperation and monitoring of ventilationoperation and monitoring of ventilationand airconditioning systems in hospitalsand airconditioning systems in hospitalsand airconditioning systems in hospitalsand airconditioning systems in hospitals

◆ SKI-Guideline Band 35 (1987)◆ Three hygiene room-classes◆ Class I 10 CFU/m3

◆ Class II 200 CFU/m3 Class IIb 50 CFU/m3

◆ Class III 500 CFU/m3



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HVAC guideline 1987HVAC guideline 1987HVAC guideline 1987HVAC guideline 1987 Low turbulence displacement air flow

Low turbulence displacement air flow with zonesegregation

Dilution air flow, no zone segregation



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Development of the standard OP-Room:Development of the standard OP-Room:Development of the standard OP-Room:Development of the standard OP-Room:"small" ULF with 2000 - 3000 m"small" ULF with 2000 - 3000 m"small" ULF with 2000 - 3000 m"small" ULF with 2000 - 3000 m3333/h/h/h/h

ULF: Unilateral flow (Laminar air flow)



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Revision of the Swiss Revision of the Swiss Revision of the Swiss Revision of the Swiss hospital hospital hospital hospital guidelineguidelineguidelineguideline

◆ Start January 22nd, 1997◆ Target: End in 1998◆ essential Hospital-organisations participate

▲ Hospital hygiene▲ Technical and maintenance service▲ Building services engineering

◆ 1st draft with official consultation January 2001◆ final draft December 2002 (2nd official consultation)



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The revision of the DIN 1946-4The revision of the DIN 1946-4The revision of the DIN 1946-4The revision of the DIN 1946-4

◆ Revision of the guidelineDIN 1946-4 "Ventilation and air conditioning.Part 4: Ventilation in hospitals" of 1999was classified as unsatisfactory

◆ Alternatives are published



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RKI requirements RKI requirements RKI requirements RKI requirements for surgeryfor surgeryfor surgeryfor surgery

◆ Unidirectional airflow ventilation is essential foraseptic interventions with high risk of infection.

◆ The size of the ceiling panel has to conform tothe type of surgical intervention.As a rule, the operating table and the instrumenttables shall be protected.

◆ A room class I (DIN1946-4) shall be installed onlyin the operating room.



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Hygiene und Medizin 2002Hygiene und Medizin 2002Hygiene und Medizin 2002Hygiene und Medizin 2002



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Conventions of theConventions of theConventions of theConventions of the German Society forGerman Society forGerman Society forGerman Society forHospital Hygiene (et all.)Hospital Hygiene (et all.)Hospital Hygiene (et all.)Hospital Hygiene (et all.)◆ Protection range with a size of 2.8 x 2.8 m

required (containing OP and instrument tables)◆ unidirectional airflow◆ Total size: 3.2 x 3.2 m with aprons 5 - 50 cm◆ Filter class H 14◆ degree of primary turbulence < 5%◆ corridors for sterile goods supply shall be

operated with positive pressure at all times



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FKT home page December 2002FKT home page December 2002FKT home page December 2002FKT home page December 2002



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Table of contentsTable of contentsTable of contentsTable of contents

1st Scope2nd Terms, organizations and definitions3rd General4th Classification of rooms5th Measurement method6th Determination of the protective effect7th Analysis8th Planning



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Table of contentsTable of contentsTable of contentsTable of contents

9th Realisation10th System qualification11th Acceptance12th Operation13th Requalification and optimisation - Bibliography. - Annex (Examples HVAC concepts)



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Scope of VDI 2167Scope of VDI 2167Scope of VDI 2167Scope of VDI 2167

◆ hospital buildings in general◆ ambulant clinics◆ physicians’ premises with rooms for surgery◆ facilities for internal and external sterilisation

services◆ centralised sterilisation units◆ .....



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Medicine production/pharmaciesMedicine production/pharmaciesMedicine production/pharmaciesMedicine production/pharmacies

◆ In contrast to the SWKI 99-3 the VDI 2167 doesn'tdeal with HVAC systems for pharmaceuticalproduction and pharmacies

◆ Regional authorities are in charge of supervision.HVAC systems for pharmaceutical production shallbe designed to meet the specifications of the relevantprovisions, e.g.

▲ cGMP Good Manufacturing Practice regulations for pharmaceutical products



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Centralised sterilisationCentralised sterilisationCentralised sterilisationCentralised sterilisation

◆ Centralised sterilisation must be subdivided into:cleaning room, packing room and sterile goodsstoreroom

◆ Decontamination- and (additional) cleaning machinesbetween cleaning area and packing area

◆ Pass-through autoclaves between packing area andsterile goods storeroom

◆ Outgassing is required for material sterilised by gas-eous media. These materials must be stored separately.



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ClassificationClassificationClassificationClassification of Operating rooms andof Operating rooms andof Operating rooms andof Operating rooms andother rooms for surgical interventionsother rooms for surgical interventionsother rooms for surgical interventionsother rooms for surgical interventionsbased on the risk of the infectionbased on the risk of the infectionbased on the risk of the infectionbased on the risk of the infection

◆ General consideration◆ Operating rooms and other rooms for surgical

interventions◆ Other rooms with increased hygienic-requirements◆ Other hygienically relevant rooms



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Other hygienically relevant roomsOther hygienically relevant roomsOther hygienically relevant roomsOther hygienically relevant rooms

◆ Patient’s room◆ Emergency ward◆ Recovery, observation room◆ Delivery, Labour room,

Room for caesarean sections◆ Waiting rooms



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Waiting roomsWaiting roomsWaiting roomsWaiting rooms

◆ The danger of transmitting unidentifiedpathogen makes it necessary to provideefficiently ventilated waiting rooms (exhaust-airrate in excess of 75 m3/(h· P).

◆ Separate waiting rooms must be available forpatients undergoing immunological suppression



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Basic requirements for rooms withBasic requirements for rooms withBasic requirements for rooms withBasic requirements for rooms withincreased hygienic demandsincreased hygienic demandsincreased hygienic demandsincreased hygienic demands

◆ Requires increased outdoor-air flow rate> 100 m3 / (h · P)

◆ Terminal filter F9◆ Non-unilateral flow may be accepted

(turbulent ventilation)



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Rooms with increased hyg.-requirementsRooms with increased hyg.-requirementsRooms with increased hyg.-requirementsRooms with increased hyg.-requirements

◆ Sterile-goods storage / sterile corridor◆ Angiographie, heart catheter laboratory, surgical

Angiographie where minor interventions serve toimplant foreign material

◆ minor surgery, dermatology, wound care◆ Rooms for transplant recipients after surgery◆ Intensive care unit including neonatology◆ Endoscopic diagnosis



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Isolating roomIsolating roomIsolating roomIsolating room

◆ Closed space

◆ Supply-air rate per room of 500 m3/h or◆ Air-exchange rate of 12 vol/h◆ Maintained at negative pressure◆ Exhaust air shall be HEPA-filtered before entering

the exhaust-air network (terminal high-efficiencyparticulate air filter, class H13)



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Isolating roomIsolating roomIsolating roomIsolating room

gemeinsame Zuluft gemeinsame Abluft

LW = 12-fach

F9

ev. flexibel

Korridor (bei Normalzimmer) Patientenzimmer Dusche / WC / AusgussSchleuse (bei ordentlichem Isolierzimmer)

AC = 12/h

Joint supply air Joint exhaust

flexible ev.

Corridor (in case of normal room) Patient's room Shower / WC / SinkAirlock (in case of normal isolation room)

H13

50 m /h3

100 m /h3

150 m /h3



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Operating rooms and other rooms forOperating rooms and other rooms forOperating rooms and other rooms forOperating rooms and other rooms forsurgical interventionssurgical interventionssurgical interventionssurgical interventions

◆ Outdoorair flow volume of 800 to 1000 m3/h◆ for outdoorair three-stage filtering is required◆ work checked terminal H13-filters◆ ULF supply-air diffuser (unilateral-flow diffuser )◆ Minimum size for the ULF diffuser 9.0 m2

◆ surrounding apron down to the height of thedoors (up to approx. 2,1m above floor level)



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Basic requirements on Basic requirements on Basic requirements on Basic requirements on ULF-diffuserULF-diffuserULF-diffuserULF-diffuser

◆ Min. mean supply-air velocity: 0,24 m/s◆ Minimum supply-air velocity: 0,20 m/s◆ Sound pressure level at nominal air flow rate

at 1,75 m above floor : 48 dB (A)◆ supply-air temperature 18 -24 ° C (arbitrary)◆ Local deviation from Tmean: 1.0 K◆ Comfort parameters as per VDI 2083-5



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Project Project Project Project performance performance performance performance specificationsspecificationsspecificationsspecifications

◆ Project definition, Intended use description◆ Project organisation and quality management

(QM-Masterplan)◆ Testing concept (system qualification)◆ Energy control and measurement concept◆ Fire protection concept (fire compartments,

escape routes, smoke extraction, evacuation)◆ Time schedule, cost estimate



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Project Project Project Project performance performance performance performance specificationsspecificationsspecificationsspecifications

◆ Room definitions (room data sheet) listing at least:▲ hygiene classification▲ protective-overpressure concept▲ electrical safety classification▲ room-climate requirements

(temperature, humidity, sound pressure level)▲ materials to be used (walls, floor, ceilings, etc.)▲ operational facilities, equipments (internal loads)



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Project Project Project Project performance performance performance performance specifications IIspecifications IIspecifications IIspecifications II

◆ Prepared by the orderer / customerin cooperation with experts

◆ The target definition phase will be concludedwhen the performance specification of theproject is approved by all parties involved intarget definition.

◆ This serves as a basis for planning.



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parties involved in the projectparties involved in the projectparties involved in the projectparties involved in the project

◆ Investor (authorities, hospital management, etc.)◆ Users (surgeons, anaesthetists, nursing service, etc.)◆ Hospital hygiene (hospital-hygiene experts, cleaning pers.)◆ Purchase departement (OP equipment, medium supply

system, IT equipment etc.)◆ Maintenance staff (technical service, external maintenance

service, energy suppliers, etc.)◆ Planner (architects, building services engineering, ...)◆ Consultant (organizational and financial consultants, ...)◆ Further parties involved in the project



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Integral OP acceptance tests (qualification)Integral OP acceptance tests (qualification)Integral OP acceptance tests (qualification)Integral OP acceptance tests (qualification)

Two Two Two Two acceptance testsacceptance testsacceptance testsacceptance tests::::

Technical acceptance testTechnical acceptance testTechnical acceptance testTechnical acceptance testperformance parameter of theHVAC system

Hygienic acceptance testHygienic acceptance testHygienic acceptance testHygienic acceptance testsufficient protective effect againstload entry from outside

sufficient protective effect againstload entry from inside


Technical acceptance testTechnical acceptance testTechnical acceptance testTechnical acceptance testperformance parameter of theHVAC system




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OP-Room OP-Room OP-Room OP-Room acceptance testacceptance testacceptance testacceptance test (outer load entry)(outer load entry)(outer load entry)(outer load entry)

M3

M1

OP-Tisch 200x60

OP-Lampe

OP-Tisch

M2

M11 M12 M13

M01 M02 M03



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OP-Room OP-Room OP-Room OP-Room acceptance testacceptance testacceptance testacceptance test (inner load entry)(inner load entry)(inner load entry)(inner load entry)

M3

M1

OP-Tisch 200x60

OP-Lampe

OP-Tisch

M2

M11 M12 M13

M01 M02 M03



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Reference loadReference loadReference loadReference load

◆ reference particle concentration CRef = 106 P/ft3

(room background, ULF field surroundings)

◆ Protection degree 10-5 is correctly traceablecx / cRef = 10 / 106 = 10-5

◆ aerosol flow is emitted at the specified locations,the emission having low momentum and beingisothermal



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Reference load IIReference load IIReference load IIReference load II

◆ QRef = CRef • ARef • vRef

◆ QRef = 106 • 10 • 0,3 • 35,3 • 60 = 6,3 • 109

P/min = P/ft³ • m² • m/s • ft³/m³ • s/min

(ULF diffuser: 3,15 • 3,15 m²; 0,3 m/s)



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◆ measured values:measured values:measured values:measured values: particle concentration cx at ahygienically relevant measuring point X in thearea to be protected

◆ definition

◆ example: cx = 950 P/ft³: SGX = 3,0

Local Local Local Local protection class protection class protection class protection class SGSGSGSGxxxx

−=

Ref

XX c

c logSG cRef : 106 P/ft³



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Result: Protection effect of the OP-RoomResult: Protection effect of the OP-RoomResult: Protection effect of the OP-RoomResult: Protection effect of the OP-Room

◆ The smallest numerical value of the localprotection classes is used to characterise theactual protective effect of the operating room

◆ Usual range of values: SG = 1 ... 5

◆ The result integrates all influences of the clean air(ULF) diffuser, medical devices and anaestheticequipment, i.e. heat-load, convection, turbulences,...



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Test structureTest structureTest structureTest structure



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Test structure IITest structure IITest structure IITest structure II



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◆ Technical acceptance:

▲ Planner, manufacturer and supplier

◆ Hygienic acceptance:

▲ The measuring technician collect the readings

▲ the hospital-hygiene expert in charge makes thehygienic interpretation and determines theprotective measures or use restrictions

ResponsibilitiesResponsibilitiesResponsibilitiesResponsibilities



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hospital-hygiene hospital-hygiene hospital-hygiene hospital-hygiene conclusionconclusionconclusionconclusion

◆ State-of-the-art operating roomsState-of-the-art operating roomsState-of-the-art operating roomsState-of-the-art operating rooms

▲ Minimum requirement: protection effect 4

◆ Existing Existing Existing Existing operating roomsoperating roomsoperating roomsoperating rooms

▲ Higher protection effect values are to be preferred:(4 is better than 3 is better than 2)

▲ Protection effect =/<1 is unacceptable anddemands renovation!



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Microbiological tests in the OP-RoomMicrobiological tests in the OP-RoomMicrobiological tests in the OP-RoomMicrobiological tests in the OP-Room

◆ The decision on the need for microbiological /hygienic checks during operation is made by thehospital-hygiene expert in charge.

◆ Airborne-germ counts in the empty operatingroom are not required in any case.



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Hygiene requirements on HVAC-PlantsHygiene requirements on HVAC-PlantsHygiene requirements on HVAC-PlantsHygiene requirements on HVAC-Plants

◆ In addition to hospital-specific requirements,the HVAC systems must also fulfil the“common” requirements.

◆ Furthermore, observe VDI 6022 „Hygienicstandards for ventilation and air-conditioningsystems – Offices and assembly rooms” and itsrequirements.



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◆ The VDI 2167-1 contains for the first time detailson the technical and hygienic qualification ofoperating rooms

◆ The results of predefined test methods lead toclear quality characteristics which can be usedto deduce specific design elements.

◆ Verifiability of each design element allows toachieve constant & reproducible quality levels

Summary and look-outSummary and look-outSummary and look-outSummary and look-out



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◆ The target is a European guideline

◆ The first steps for the CEN guideline are made:RESOLUTION 304 taken by CEN/TC 156 on 2004-11-04CEN/TC 156, Ventilation for buildings, agrees to createthe following new Working Group:WG 13 – Ventilation in Hospitals.

◆ Research and development in the laboratoryoperating room at the HTA School ofEngineering + Architecture in Lucerne

Summary and look-out IISummary and look-out IISummary and look-out IISummary and look-out II



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Laboratory OPLaboratory OPLaboratory OPLaboratory OP



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Laboratory OP IILaboratory OP IILaboratory OP IILaboratory OP II



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Conclusion on hospital hygieneConclusion on hospital hygieneConclusion on hospital hygieneConclusion on hospital hygiene

◆ Applies to all operating theatres: Applies to all operating theatres: Applies to all operating theatres: Applies to all operating theatres:

Without a catalogue of flanking measuresWithout a catalogue of flanking measuresWithout a catalogue of flanking measuresWithout a catalogue of flanking measuresand the application of due operationaland the application of due operationaland the application of due operationaland the application of due operationaldiscipline the best clean air technologydiscipline the best clean air technologydiscipline the best clean air technologydiscipline the best clean air technologycan only be seen as an 'alibi exercise'.can only be seen as an 'alibi exercise'.can only be seen as an 'alibi exercise'.can only be seen as an 'alibi exercise'.



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umc g - vadea january 22nd, 1997 target: end in 1998 essential hospital-organisations participate...

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