THE FUTUTURE IS NOW INNOVATION IN DECONTAMINATION Niclas Gerdin, CSSD Project Design Specialist Sweden

Learning objectives Decontamination facility (CSSD)

Recommended Pressure difference & Goods Flow Highlight the Trends & Tendencies Identify the Needs to get an Innovative CSSD

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Basic Design Concept CSSD 3 Zones & 2 Barriers

Physical separation between zones 1:st barrier avoids cross-contamination of goods spread by staff 2:nd barrier avoids mixing up clean & sterile goods Good building design correct staff working routines avoid wrong human behavior

+10 Pa (UK)

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UK (HBN 13), FR, DK
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Basic Design Concept CSSD Goods Flow -Access from 2 or 3 Sides

Basic Functions:
WASH. DISINFECT. BARRIER

STAFF CHANGE

SPECIAL PREPERATION

SOILED RECEPTION

U-shaped workflow often solve the design

LINEN INSPECTION, FOLDING & PACKING

WASH & STAFF DISINFECTION CHANGE AREA

CONTROL & PACKING AREA

Container & Basket-flow

AUTOMATIC TROLLEY WASH CLEAN TROLLEY HOLD

MANUAL TROLLEY WASH

Goods flow:

CLEAN MATER. STORE

AIR LOCK

STERILIZER BARRIER

Trolley-Flow

ISSUE/DISPATCH

CLEAN CLEAN MATER. LINEN SUPPLY SUPPLY

STERILE STORE

STERILE STERILE DISPOSABLE DISPOSABLE SUPPLY STORE

Other room functions on request: Waste Holding Area, domestic Services room, Offices, Staff Rest
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Innovation in Decontamination

What are the Trends & Tendencies?

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Trends & Tendencies

Topics
Centralization: Disinfection rooms OR, local sterilization C.S.S.D. /Super C.S.S.D. Washer-Disinfectors: - House steam Electric Heated - External Internal drying More: Service Agreements Central Dosage Washer-Disinfectors Instrument containers (vs. paper) Cart Washer-Disinfectors Improved working environment & ergonomics Automation (W-D, Ster.) Traceability & Inventory Management Systems Less reusable dressing sets (surgeon & patient)
Super CSSD

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Trends & Tendencies Centralization

Today: Disinfection rooms at OR & partly local sterilization

CSSD Super CSSDs Out-sourcing In-sourcing

Super CSSD

Super CSSD/ Super centre/ Decontamination facility - big CSSD serving several hospitals Out-sourcing external provider, often placed outside the hospital In-sourcing external provider runs the CSSD at the hospital
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Centralization CSSD
Trend Centralization in hosp. to CSSD
CSSD
OUTPATIENT DEPT. WARDS SPECIAL CLINICS CENTRAL SURGICAL DEPTS

Background Demand: cost efficiency Centre of excellence OP nurse at OR (help surgeon, not using Washer-Disinfector) Traceability & Quality assurance demand (authorities) Connected OP-planning & traceability system Just in time Goods connected to W-D process

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Centralization CSSD
Consequence Big CSSDs More soiled goods Optimization of goods flow needed (close OP) Increased need for Automation Documentation systems solves Traceability & Quality assurance + Reduced investments (machines & maintenance) + Improved production quality
CSSD
OUTPATIENT DEPT. WARDS SPECIAL CLINICS CENTRAL SURGICAL DEPTS

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Centralization Super CSSD

Super CSSD

Centralization Super CSSD

Trend Centralization Super CSSD / Outsourcing (UK, NL, FR, CH, KW) Background Current CSSD:s: expensive upgrade (accreditation -medical devices directive 93/42/EEC) low usage (8h / 5,5 days) Economy of scale factory (cost/unit ) Outsource / insource (responsibility) Super CSSD

Possible if: many hospitals & short distance not traffic jam:

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I Niclas Gerdin I Decontamination & Sterilisation Conference, Abu Dhabi [Public]

Centralization Super CSSD

Consequence Very big CSSDs Longer opening hours (24/7) Need: Optimization of goods flow Short delivery times (penalty) Automation Traceability system (instruments) + Reduced investments (machines & maintenance) More instruments needed Dangerous goods (road) Super CSSD

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6 hospitals 12 million inst./year 4000m2

Trends & Tendencies Washer-Disinfectors - Heating

Trend House steam supply Electrically heated

Background Big Investment & Maintenance costs Energy loss during Steam Transport

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Trends & Tendencies Washer-Disinfectors - Heating

Consequences Longer processing time More W-D Automation ?

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Trends & Tendencies Washer-Disinfectors - Drying

Trend External Integrated Drying Background Avoid manual: Handling of Goods between W-D & Drying Cabinets Drying Dry goods reduces risk of: Recontamination Clean Goods Growth of Micro-Organisms

EN ISO 15883: Integrated drying in W-D shall be included when appropriate: Surgical Instruments etc. If not: Risk Analysis
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Trends & Tendencies Washer-Disinfectors - Drying

Consequences Longer processing time More W-D needed Automation ?

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Trends & Tendencies Service Agreement

Trend Service after machine failure Planned service with Service level agreement Service based on calendar schedule Service based on Equipment usage Machine repair without preparation Hands on machine as first action - Remote diagnostics to increase first time fix (Spare Parts..)

Background Focus on core business Want: Uptime / Availability Planned downtime in non-peak periods Demand on just in time delivery (penalties)

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Trends & Tendencies Service Agreement

Consequences More: Time to core Business Focus on value creation instead of Fixing Reliable Machines / increased Uptime Predictable costs (Budget)

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Trends & Tendencies Central Dosage Washer D. (Clean Management System)

Trend Manual change of detergents Automatic Central dosing device Outsourcing of Detergent handling Background Want: Focus on core Business Improved uptime Want to avoid: daily change of Detergent & less contact with Chemicals Heavy work (Ergonomics)
Movie

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Trends & Tendencies Central Dosage Washer D. (Clean Management System)

Consequences Centralize the detergents in separate Room Reduced workload with chemical for operator: Save time & better Ergonomics Less risk to spill & injuries Larger detergent Containers cheaper Outsourcing online monitoring of Detergent level (mail/sms)

Movie

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Trends & Tendencies Working Environment & Ergonomics

Trend Demand: improved working Environment

Background Avoid working injury Sick leave cost Heavy work Basement-workers Difficult to find qualified staff

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Trends & Tendencies Working Environment & Ergonomics

Consequences + Healthier staff save money + Ergonomic equipment + Moves up from basement daylight (window) + Increased status + Sound-absorbing actions: Sliding Windows (Washer-disinfector) Separate vacuum Pump (Sterilizer)
Height Adjustable Table H/A Loading trolley (sterilizer)

More attractive Work place

Innovation in Decontamination

How to get an Innovative CSSD

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How to get an Innovative CSSD Identify the Needs 1

Analyze current production statistics: no. processes/unit/day Plan for the future - growth?

Customer wished room functions: - Sterile disposable unpacking/store - Linen inspection, folding & packing - Staff rest - Office - Staff change

Sterile store at CSSD / user site? Investigate available locations Possible to make pit for cart washer / Floor loaded sterilizers?
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How to get an Innovative CSSD Identify the Needs 2

What systems is / will be used? Goods carrier DIN, ISO, SPRI, other Distribution Size, open / closed Disposable / reusable Anesthesia material? Need low temperature sterilization? Investigate Site Conditions & Intended Workflow CAD Drawing ?

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How to get an Innovative CSSD Make Demand Calculation & Evaluate the Result Number of: Operations / year (Hospital Beds) Working days/week Working hours/day Operation Rooms
Number of: daily produced baskets of Sterilized goods Washer-Disinfectors Sterilizers Number of Staff : Inspection & packing of instruments
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Inspection, folding & packing of Linen

How to get an Innovative CSSD Make Layout 1(2)

Sound Absorbing Barrier

Fly Manual

Side mounted Operator Panel

Automation Washer Disinfectors & Sterilizers

Fly Manual Traceability & Inventory Management System

Height Adjustable Tables & Trolleys Return Chamber with Sluice Function
2012-10-15 I Niclas Gerdin I Decontamination & Sterilisation Conference, Abu Dhabi [Public] Fly Auto Walk Manual Walk Auto

How to get an Innovative CSSD Make Layout 2(2)

Separate vacuum Pump (Sterilizers) Support functions: Offices & Staff Rest outside production Area

Washer Disinfectors with Integrated drying

Fly Manual

Sterilizer Service from unloading side (Sterile Store) Central Dosage (Detergent)
2012-10-15 I Niclas Gerdin I Decontamination & Sterilisation Conference, Abu Dhabi [Public] Fly Auto Walk Manual Walk Auto

How to get an Innovative CSSD

Washer Disinf. w. automation, Sound Absorbing Barrier, Return Chamber (sluice) Return Chamber w. Sluice function

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Sound Absorbing I Niclas Gerdin I Decontamination & Sterilisation Conference, Abu Dhabi [Public] barrier Folding doors

How to get an Innovative CSSD

Washer Disinfector with automation, Sound Absorbing Barrier Closed

Opened - Manual loading: fast track / Cleaning

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How to get an Innovative CSSD

Packing Area, Traceability & Inv. Man. System, Height adj. Trolleys / Tables

Height Adjustable Trolleys & Tables

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How to get an Innovative CSSD Packing Area: H/A Trolleys / Tables w. Electric Cables in flexible Tubes

Electric cables in flexible Tubes

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Height Adjustable Trolleys & Tables

How to get an Innovative CSSD

Sterilizers, Automatic Loaders, Side mounted Operator Panels
Separate vacuum-pump Low temperature sterilization

Automatic loaders Side mounted Operator Panels

2012-10-15 I Niclas Gerdin I Decontamination & Sterilisation Conference, Abu Dhabi [Public]

How to get an Innovative CSSD

Sterilizers, Automatic Unloaders, side mounted Operator Panels, Service Sterilizer
Sterilizer service from unloading side (Sterile Store)

Fly Auto

Walk Auto

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Innovation in Decontamination

Thanks for your attention

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Basic Design Concept CSSD - REFERENCES to page 3

Recommended Environmental Specific. & Design Options (UK, HBN 13)

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HBN 13: Sterile Services Department Page 36-37 (Table 1)

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Basic Design Concept CSSD - REFERENCES to page 3 Recommended Environmental Specific. & Design Options (UK, HBN 13)
HBN13: Sterile Services Department (UK) http://www.dh.gov.uk/en/index.htm (homepage, but no article available) 3.23 The IAP room is a Class 8 clean-room as defined in BS EN IOSO 14644. It should have a nominal 20 air changes per hour with a pressure differential of not less than 10 Pa between it and adjoining rooms. Pressure differential indicators, visible from outside the IAP room, should be provided to enable the pressure differential to be routinely monitored. Should this pressure differential fall below specified limits, an alarm system in the IAP room should indicate this (see also paragraph 6.49).

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Basic Design Concept CSSD - REFERENCES to page 3&4 Climate Conditions pressure difference & ISO Class (DK)

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Infection control in the health care sector Part 13: Requirements for reprocessing of sterilizable medical I Niclas Gerdin I Decontamination & Sterilisation Conference, Abu Dhabi [Public] equipment. Page 113

Basic Design Concept CSSD - REFERENCES to page 3 Climate Conditions pressure difference & ISO Class (DK, Danish only)
Infection control in the health care sector Part 13: Requriements for reprovessing of sterilizerable medical equipment (DK) 12 Kontrol, forbhandling, rengring og desinfektion af urent/brugt/nyt/renoveret produkt i genbehdlingsenhed (genbehandlingssted): (page 36) >((Wash & Disinfection Area)) 12.5d: Lokalet skal have et undertryck p 10 Pa i forhold til omgivelserne [75], [79] (page 37) 14 Kontrol, oplaegning, emballering og maerkning af rent produkt i genbehdlingsenhed (genbehandlingssted) (page 49) ->((Control & Packing Area)) 14.5j: Lokalet skal have et overtryck p 20 Pa i forhold til omgivelserne i overensstemmelse med kravene i DS 2451-9, 4.5.2.3.3. ofg DS 2451-5, 4.4.1. (page 50) 14.5e: Luftskiftet i lokalet skal vaere mindst 10 gange i timen i overensstemmelse med kravene i DS 2451-9. 4.5.2.3.1. (page 51) 14.5f: Leftens renhedsgrad skal overholde kravene til ISO klass 8 efter DS/EN ISO 14644-1:1999 [10] 15 Sterilisation og/eller kontrol og frigivelse af rent/sterilt produkt i genbehandlingenhed (genbehandlingssted) (page 59) ->((Unloading bay etc.)) NOTE 1 Kapitlet relaterar sig til lokaler, hvor lastning till autoklverne foretages, og hvar udlastning fra autoklvaer og nedkling af produktet foregr. Lokalet klassificeras som ISO klasse 8.. 15.5 i: Lokalet skal have et overtryck p 20 Pa i forhold til omgivelserne i overensstemmelse med kravene i DS 2451-9, 4.5.2.3.3 og SD 2451-5,4.4.1 ->((Unloading bay)) 15.5d: Luftskiftet i lokalet skal vaere mindst 10 gange i timen i overensstemmelse med kravene i DS 2451-9. 4.5.2.3.1. (page 51) 15.5e: Leftens renhedsgrad skal overholde kravene til ISO klass 8 efter DS/EN ISO 14644-1:1999 [10] 18 Opbevaring af rent/sterilt produkt i genbehandlingsenhed i sterilt lager (genbehandlingssted) (page 69) ->((Sterile Store)) 18.5a: Sframt detta lokale ogs indeholder nedklingszone fra autoklaver, klassificeras lokalet som ISO klass 8, og kravene till de fysiska rammer skal svare til kravene besrevet i 15.5. Sframt der ikke foretages nedkling af prodkuter i dette lokale gaelder flgende krav: [no demands on pressure difference!]
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Basic Design Concept CSSD - REFERENCES to page 3&4

Pressure levels must be distributed such that ISO Class 8 can be maintained wherever recommended (FR)

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Architecture and Sterilisation Premises. (Zentral Sterilisation Vol 16(3), issue no. 4, 2008). Page 204

Basic Design Concept CSSD - REFERENCES to page 3

Pressure levels must be distributed such that ISO Class 8 can be maintained wherever recommended (FR)

Architecture and Sterilisation Premises. (Zentral Sterilisation Vol 16(3):196-204, issue no. 4, 2008) (FR)
2.3 Control of aerobiocontamination: Pressure levels must be distributed such that ISO Class 8 can be maintained wherever recommended (Fig 3 and 4) Fig. 3: Distribution of pressure gradients Legend: ++: maximum positive pressure (30 pascals), + :positive pressure (15 pascals), - : atmospheric pressure (page 203-204) Based on Good Hospital Pharmacy Practices (1), the packaging zone must comply with ISO Class 8 during periods of inactivity. Furthermore, microbiological contamination must be monitored here during periods of activity and must be less than 200 cfu/m3. To protect a clean area against any contamination from neighbouring zones, static positive pressure must be maintained within these clean premises with respect to the adjoining zone. This positive pressure must be of a sufficiently high level and stable, with a minimum of 15 pascals in the desired direction (standard NF S 90-351). The positive pressure value prevailing in clean premises compared with less clean adjacent areas must not be less than 15 pascals. The different pressure levels within the CSSD shall be distributed as follows (Fig. 4): maximum positive pressure (30 pascal)in the instruments packaging zone and at the autoclave exit; positive pressure (15 pascals) in the laundry packaging zone, storage zone and sluice; atmospheric pressure in the zone used for incoming linen and linen sorting, cleaning zone, changing rooms and adjacent zones. If the MDs arrive in the CSSD without having been predisinfected (see 2.1.1.2 and 2.1.2.4), the zone allotted for receiving and sorting these contaminated MDs will be at negative pressure compared with the neighbouring zones. Distribution of the pressure gradients can be illustrated as shown in Fig. 3. The heat generated by the sterilisers shall be offset by thermal treatment of the air and compensation. (page 204)
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