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Checklist for Preparation of Visits by the Competent Inspection Authorities

Checklist in Preparation of Inspection of a Central Sterile Supply Department


No. Requirement y e s n o Reference to Remarks RKI Recommen ation

!eneral Is there a Central Sterile Supply Department (CSSD)?


Does this establishment have a quality management system? Has it been certified? Is decentralised processing carried out (additionally)?

If there is decentralised processing, in hich rooms! Disinfection (D)!


Cleaning (C)! "ac#ing (")! $y hom?

hich areas,

Sterilisation (S)! Ho ?
$y hom? Storage here?

Is processing also carried out for other areas or for third parties? If yes, for hom? (enclose description and agreement)

If yes, hich medical devices (%Ds)? &re there Infection Control "lans for all departments? 'hen dra n up? &re there Cleaning and Disinfection "lans for all departments, ith assigned competencies? Is the requisite protective gear available in all departments? ((loves, aprons, goggles, etc))
&re operating instructions for ha*ardous substances displayed? &re %Ds processed e+ternally?
'hich? $y hom? Has the processor been certified? &re surgical drapes being processed?

&re there additional rooms for handling surgical drapes, and

or#ing

areas for sorting, chec#ing and pac#ing laundry? ,aminated materials?

No. Requirement II Competence " Precon itions for Processin# " $rainin# in the CSSD Ho are competencies assigned for processing ithin the hospital? &re competencies assigned and documented for all processing steps (-%)? Is the CSSD manager . sterilisation manager a qualified /echnical Sterilisation &ssistant? Specialist Course 0, 1 or 2? Ho many employees are there in the CSSD? Ho many are qualified? 'hat is the qualification level of staff? Is there a /raining "lan for staff? &re all staff regularly briefed and is this documented? &re medical devices classified as per the 34I 3ecommendation? In the case of medical devices that may be reprocessed only for a limited number of times (as specified by the manufacturer in the operating manual), has it been set out in riting hether and ith hich method each %D, or as applicable product group (as app, the test models, criteria for forming product groups or choice of test models must be documented) may be reprocessed? Have critical processing steps been defined during ris# assessment? Have potential ha*ards been defined? Have ris# minimisation measures been defined? &re standard operating procedures and or# instructions available? Has proof been furnished of the suitability (product compatibility) and the effect5 iveness of the selected process on the basis of product.product5group5 specific tests and validation (as per Section 6 %"$etreib7, Sterilisation and automated cleaning and disinfection processes are validable) (manufacturer8s instructions)? &re Critical (roup C (as per 34I recommendations) %Ds processed? If yes, hich? Has the quality management system for Critical C %Ds been certified by a body accredited by the competent authority (pursuant to Section 19(0) %"()? If no, hich? Is processing conducted by a third party? If yes, is the establishment in possession of a quality management system . certificate ?

y e s

n o

Reference to Remarks RKI Recommen ation %.%

0)1)0)

0)1 0)0

III

Structural an $echnical &acilities 'as per RKI Recommen ation( Anne) *.*.%+( inclu in# ,ealth an Safety -easures

!eneral. ,ayout of premises? Is there an area ith a indo ?


,ength of transportation path ays and duration? &re there ventilation (air conditioning)systems?

7entilation system (that complies ith occupational safety regulations)?

- unclean area? - clean area (,&: ceiling of 0 m + 0);9 m above pac#ing station or terminal filter)? - Storage room?
Ho many computer terminals are there? Staff transfer areas (1 room)? &re the unclean and clean areas spatially separated? Is there a recreation room?

No. Requirement

y e s

Reference to n o Remarks RKI Recommen ation

Does the area before sterilisation ha/e. A+ 0nclean 1orkin# area 0) Is there a room for incoming materials? 1) Is there, if applicable, a separate recreation room? Is there an area for disinfecting and cleaning transport 2) containers? 6) Is there an area for disinfecting %Ds? ;) Is there an area for cleaning %Ds? <) &re there asher5disinfectors ('Ds) available? =) &re there different loading trolleys for the 'Ds? If yes, hich ? ) ) ) ) ) ) (please specify in 3emar#s column) >) Is.are the 'D(s) a 15door, load5through machine? If not, hat type of 'D? ?) Is there an ultrasound machine? 09) Is there a connection for demineralised ater? 00) Is there a pressurised ater pistol? 01) Is there a connection for medical compressed air? 02) Is there an area for servicing and maintenance tas#s? 06) &re there automatic dosing facilities for instrument disinfectants? 0;) &re there automatic dosing facilities for surface disinfectants? 0<) &re the dosing devices regularly serviced and inspected? @ Detergents, etc) ? 0=) &re there computers and scanners for recording and documenting or#ing procedural steps? 2+ Clean 1orkin# are 0) Is there a service room? 1) Is there an area for servicing, sorting and pac#ing? 2) Is there a connection for medical compressed air? Is there a or#station ith a magnifying glass or 6) microscope? &re there computers and scanners for recording and documenting ;) or#ing procedural steps as per assigned competencies? Is there suitable lighting @ spec) requirements (as per regulations <) for precision or#? Sterilisers3 area. Are the follo1in# a/ailable in the area after sterilisation. 0) Sterile supplies8 store 1) &rea or hatch for handing out materials 2) Staff changing rooms? 6) Staff transfer area bet een unclean and clean sides Is anaesthetic equipment also processed in the CSSD? If not, here? &re or#ing and all surfaces as ell as floors free of gaps, and easy to ash.disinfect? &re cables concealed or in closed channels? &re there separate e+hausts for equipment ith high thermal loads (e) g) vapour e+hausts)? Is there an Infection Control "lan (Cleaning and Disinfection

"lan)? IV Processin# % Processin# 0nuse -e ical De/ices (if there is questionable or definite contamination, process as used MDs) &re supplies unpac#ed to chec# technical.functional safety? &re medical devices repac#ed? 4.%

y e s No. Requirement

n o

Remarks

Reference to RKI Recommen ation

Is the sterilisation process as specified by the manufacturer being used? Ho is labelling done? Is processing documented? Is the release for use being documented? &re medical devices fully processed after their e+piry date? 4a+ Processin# 0se -e ical De/ices "reparation (pretreatment, collection, precleaning, if nec), dismantling, transport) &re coarse soils removed immediately after use (pretreatment ) (e) g) by iping surfaces, rinsing channels)? 'here? $y hom? 'hich? Ho ? Have the pretreatment agents and methods been tailored to the ensuing processing step (e) g)! avoidance of fi+ing procedures such as use of heat or aldehydes)? &re Aointed instruments stored in an opened state? &re supplies dry hen transported to the CSSD? If supplies are transported et, specify the disinfectant, concentration and e+posure time! Is protein fi+ation ruled out? 'ho prepares the solution? &re dosage aids available? Ho are %Ds transported to the CSSD? Ho is timely transport to the CSSD assured? &re contaminated %Ds transported to the CSSD in securely sealed containers? Ho often are supplies collected? Ho are arrangements for the ee#end? &re there suitable containers for transport and intermediate storage, as needed, to rule out chemical, mechanical and physical damage to %Ds (e) g) through #in#ing, crystallisation of residual liquids)? &re certain %Ds cleaned and disinfected at a decentralised location? $y If yes, ho ? 'here? hom? 'here are these %Ds sterilised, if necessary? If decentralised location, ho is responsible for release? 4b+ Cleanin# " Disinfection( Rinsin# an Dryin# 5 0sin# 0ltrasonic bath &re there ritten standard operating procedures for manual cleaning and disinfection procedures, listing agents.processes ith proven efficacy and

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suitability for respective %D? &re the manufacturer8s instructions available as per BC ISD 0=<<6 and they ta#en into account? Is protective gear available (gloves, aprons, goggles, etc)) /3$& 1;9? (/echnical 3egulations for Dperating Safety) 3egulations drafted by the statutory insurance accident companies (e) g)/3$& 1;9)? Have staff been briefed? Ha*ardous Substances 3egister? &re there immersion baths for manual cleaning and disinfection? 'hich detergent is used? Concentrati B+posure on! time! Ho often is the cleaning solution changed? 'hich disinfectant is used? Concentration! B+posure time!

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ZENTRALSTERILISATI ON 13. Jahrgang 2005

y e s No. Requirement

n o

Remarks

Reference to RKI Recommen ation

Has the disinfectant been approved by the (erman Society of Hygiene and %icrobiology (D(H%)? Is there an B+pert Dpinion attesting to virucidal activity? Is there an B+pert Dpinion attesting to virucidal activity against hepatitis $ virus (H$7)? Is protein fi+ation ruled out? :or ho long can the same disinfectant solution be used? Is the disinfectant solution rene ed daily? Is there a ater pistol for purging internal lumens? 'hat is the quality of the ater used to rinse disinfected instruments? &re %Ds dried ith non5linting cloths? &re there ritten standard operating procedures for automate cleaning and disinfection procedures, listing agents.processes ith proven efficacy and suitability for respective %D? &re the manufacturer8s instructions available as per BC ISD 0=<<6 and are they ta#en into account? Have the 'D processes been validated? Is there a validation protocol? 'ho conducted validation? 'ith hich programmes and reference loads? Have the respective tests for the 'Ds been specified and set out in riting (the test parameters are listed in the validation protocol ), e)g) b) daily routine tests c) batch5related routine tests d) %onitoring.testing of process parameters using measurement technology methods e) periodic tests of cleaning ith cleaning indicators? f) periodic tests of disinfection ith thermologgers? g) hich programmes are used for cleaning and disinfection? @ 7ario programme ith thermal disinfection? @ 7ario programme ith chemicothermal disinfection? @ :or hich %Ds? @ $(& programme (EBpidemic programmeF)? If others, hich? Do the detergents.disinfectants have access to all e+ternal and internal surfaces? (Aointed instruments opened, modular instruments dismantled, valves.coc#s opened) Is cleaning conducted, if possible, above pH 09 (pronounced efficacy in respect of dissolution of protein and fat residues, but can adversely affect materials)? &re %Ds amenable to thermal disinfection actually thermally disinfected?

0ltrasonic cleanin# Is an ultrasonic procedure used for processing? &re there ritten standard operating procedures for ultrasonic procedures, listing agents.processes ith proven efficacy and suitability for respective %D? &re the manufacturer8s instructions available as per BC ISD 0=<<6 and are they ta#en into account? Is cleaning conducted in the ultrasonic bath? Came of Concentrat detergent! ion Is cleaning and disinfection conducted in the ultrasonic bath? Came of detergent! Concentrat B+posure ion time Has the disinfectant been approved by the (erman Society of Hygiene and %icrobiology (D(H%)? &re the agents employed suitable for use in an ultrasonic bath? Is protein fi+ation ruled out?

Reference to No. Requirement Ho are the ultrasonic bath functional capabilities chec#ed? &re there standard operating procedures for daily start5up of ultrasonic equipment? Do the %Ds lend themselves to ultrasonic cleaning (caution! adhesive Aoinings, soft or air5filled %Ds)? Is the air removed from lumened %Ds?
Is the ultrasonic bath properly loaded and are all items immersed in the liquid (incorrect operation, e) g) spray shado ing)?

yes no

Remarks

RKI Recommen ation

'hat is the operating temperature of the ultrasonic bath? Is the ultrasonic bath rene ed if visibly contaminated or at least each or#ing day (avoidance of microbial gro th, impaired cleaning performance and of cross5contamination)? Disinfection Is disinfection conducted in the CSSD? Is it conducted manually or in the ultrasonic bath? Is it conducted in the 'D?
'ith D(H%5approved disinfectants) See manual and ultrasonic processing

'hich disinfection processes are used (s) ISD 0=<<6)? /hermal? 'hat temperatures are used for processing? &re there manufacturer8s instructions available for processing? Chemical? &re there manufacturer8s instructions available for processing? Chemothermal? 'hat temperatures are used for processing? &re there manufacturer8s instructions available for processing? &re the disinfection procedures used endo ed ith proven bactericidal efficacy?
&re the disinfection procedures used endo ed ith proven fungicidal efficacy?

&re the disinfection procedures used endo ed ith virucidal efficacy? (&$ spectrum of action)? Is there a D(H%5approved agent for manual disinfection? Came of the disinfectant? Concentration and e+posure time?
Has the disinfectant efficacy been certified for disinfection in asher5 disinfectors in an B+pert Dpinion issued by the manufacturer?

Came of the agent? Concentration and e+posure time? Have procedural measures been ta#en to ensure that precleaning does not cause fi+ation of residues on the %D (blood, secretions, tissue residues)?
Is the Dperating %anual observed, in particular the e+posure time?

Rinsin#( &inal Rinse an Dryin# Is formation of reaction products and residues due to intensive reversible flo during rinsing ruled out (effect a function of time, temperature and ater volume)?
Is suitably tested ater used for rinsing (at least, demineralised ater)?

Ho often is the ater quality chec#ed? Is medical compressed air used for drying? Is recontamination of disinfected %Ds ruled out? &re the dosing devices regularly serviced and inspected? ,ast time serviced!

No. Requirement %icrobiological testing! Is the 'D subAected to microbiological testing? If yes, hat is the outcome? %achin e! Date! 3esults! 4c+ Inspectin# Cleanliness an Inte#rity of Surfaces &re there standard operating procedures for inspecting cleanliness and integrity of surfaces? &re all parts of medical devices @ inspected for cleanliness and integrity (visually also for any residual contamination)? @ additional chemical or physical chec#? If the cleaning outcome cannot be assessed through visual inspection, e) g) long, narro lumens, hollo cavities, $ GC CriticalE %Ds, is a successful cleaning outcome assured by ta#ing procedural steps ? (e) g) by validated automated processes? &re test instruments and equipment available? 'hich, e) g) magnifying lamp? 4 + -aintenance an Repairs " Checkin# $echnical"&unctional Safety &re there standard operating procedures for maintenance and repairs? &re there standard operating procedures for chec#ing technical.functional safety? Is contamination ith dangerous substances (e) g) to+ic care agents) or particles (e) g) talc) ruled out (if necessary, chec# ith magnifying glass)? Have measures been ta#en to ensure that care agents do not compromise sterilisation results (e) g) medical hite oils, if necessary get name of care agent manufacturer)? Is there the necessary for functional tests (pipe equipment flo meters, compressed air, drive systems, etc)) ? &re the manufacturer8s instructions observed? Is technical.functional testing conducted before sterilisation? Is the scope and nature of the %D defined in standard operating procedures? Is protective gear available (gloves, aprons, goggles, etc)) /3$& 1;9? (/echnical 3egulations for Dperating Safety) $riefing ? Ha*ardous Substances 3egister?

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Remarks

Reference to RKI Recommen ation

4.4.4

4e+ Packin# 'mechanical protecti/e packa#in#( sterile packa#in#( if necessary repackin#+ &re there standard operating procedures for pac#ing? &re pac#ing procedures regularly validated as per ISD 00<9= "art

1? (I-, D- and "-) 'hat sterilisation processes are used? Steam sterilisation? BD sterilisation? :D sterilisation? "lasma sterilisation? Is suitable pac#aging used for steam? Is suitable pac#aging used for BD? Is suitable pac#aging used for :D? Is suitable pac#aging used for plasma? Is the pac#aging tailored to the sterilisation process to be sterile used (providing for sterilisation)?

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No. Requirement

y e s

Reference to no Remarks RKI Recommen ation

Does the pac#aging lend itself to preservation of the functional capabilities of the %D to be sterilised? (e) g) mechanical protection of delicate components) Does pac#ing ta#e account of respective needs? &re pac#ing lists used? Is the sterilisation date or batch number printed on the sterile pac#aging? Is the pac#aging tailored to the envisaged storage and transport (e) g) protection against mechanical stress and recontamination)? &re un rapped supplies sterilised (e)g) using Hflash8 sterilisation)? Is there a rotary sealing machine? Is the rotary sealing machine able to monitor the critical parameters (temperature and contact pressure) and interrupt the process in the event of any deviation from these? Is the sealing machine regularly inspected ((full service from manufacturer? Daily inspection of sealing seam (using elded seam and visual inspection using suitable test? Is the pac#er8s name recorded? 4f+ Sterilisatio 'hat type of sterilisation is used . number of sterilisers . Came! 0) Hot5air sterilisation (dry heat)! 1) Steam sterilisation (moist heat)! @ 026IC . ; minutes @ 026IC . 0> minutes @ 010IC .19 minutes 2) Bthylene o+ide gas sterilisation (if available, for more information see &nne+ 0)! 6) ,o temperature steam formaldehyde sterilisation ( ,/:S) ( if available, for more information see &nne+ 1)! ;) "lasma sterilisation Is a sterilisation process ith proven suitability and effectiveness for the %D being used (preferred process! thermal sterili*ation ith saturated steam 010IC or 026IC)? Have the processes been validated? Has the sterilant access to all e+ternal and internal surfaces? (valves.coc#s opened, lumens cleaned) Is the steam steriliser regularly serviced by authorised personnel as per BC ;;6? Date it as last serviced! Is the technical condition of sterile containers (single5use paper filter, filter cloths, valves for conveyance of steam and air, seals) regularly inspected? &re the requisite tests needed in various situations set out in riting (the parameters to be chec#ed can be consulted in the validation protocol), e) g) a) commissioning test (installation test) b) daily routine chec#s c) batch5related routine tests d) monitoring.testing of process parameters ith

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measurement technology methods e)periodic tests? f) test equipment? Is protective gear available (gloves, aprons, goggles, etc)) /3$& 1;9? (/echnical 3egulations for Dperating Safety) Is the &ccident "revention 3egulation (J77 /3$& 1;9) available? $riefing? Ha*ardous Substances 3egister?

y e s No. Requirement

n o

Remarks

Reference to RKI Recommen ation

!as sterilisation( le#ally re#ulate by the ,a6ar ous Substances ''!ef Re#ulation StofV supplemente by $echn. Re#ulations for ,a6ar ous Substances '$R!S ;%>+( Anne) %. 'penetratin# isinfection( temperature *; 5 ;7 @C( humi ity appro). 87 A+ Has approval been granted by the competent authority (/rade Supervisory Inspectorate)? Is the sterilisation process fully automated (since 0??; only fully automated BD sterilisers may be operated in hospitals)? &re sufficient qualified staff available (proof of qualifications)? &re there operating instructions for staff? &ccident "revention 3egulation (J77) Documented briefing? Does documented briefing ta#e placeannually? Have measures been ta#en to rule out danger to the environment by e+haust gas generated during operation of e+haust air cleaning systems (catalytic combustion of e+haust gas) 'ashing out BD in a 0@ ; K H1SD6 solution (gas et5 ashing procedures)! Is there measurement equipment for detecting BD in the ambient air and in the sterile supplies? Is the steriliser serviced as per /3(S ;02 at least once annually? $y hom? Is there a list of the %Ds to be sterilised? &re there ritten manufacturer8s instructions giving information on BD sterilisation? Anne) 4. Bo1C$emperature SteamC&ormal ehy e Sterilisation 'B$&S+ Ne#ati/e Has approval been granted by the competent authority (/rade Supervisory Inspectorate)? Is the sterilisation process fully automated (since 0??; only fully automated formaldehyde sterilisers may be operated in hospitals) &re sufficient qualified staff available (proof of qualifications)? &re there operating instructions for staff? Does documented briefing ta#e place annually? Have measures been ta#en to rule out danger to the environment by e+haust gas generated during operation of e+haust air cleaning systems (not validable)? Desorption of formaldehyde by repeatedly rinsing ith steam! Is there measurement equipment for detecting :D in the ambient air and in the sterile supplies? Is the steriliser serviced as per /3(S ;02 at least once annually? Is there a list of the medical devices to be sterilised? &re there ritten manufacturer8s instructions giving information on :D sterilisation?

of 7%"%7(%89:( Section ?thylene o)i e #as

%; <!assin#=(
sterilisati on

CPressure Processes at :7 5D7 @C

Anne) >. B$P Sterilisation 'Plasma Sterilisation+. Is the pretreated item rinsed ith demineralised ater? %anually? 'hich %Ds are processed ith this procedure? Is suitable pac#aging material used? 4#+ Babellin# &re the requirements for labelling as per the 34I recommendations observed? Is the %Ds itself clearly and permanently labelled? %D designation affi+ed to %D, pac#aging, if not readily visible? /ime and type of sterilisation process used (batch designation, sterilisation date)? B+piry date, up till hich safe use is demonstrably possible? &re there safety and arning notices (e) g) FCritical CE %D group, manufacturer8s name and, if applicable, batch and serial numbers)? 4.4.;

No. Requirement If processed by third party, are the name.address of processor clearly visible? If a limited number of reprocessing cycles has been imposed by the manufacturer, are the number of times and type of reprocessing already conducted clearly sho n?

y e s

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Remarks

Reference to RKI Recommen ation

V Documentation " Ser/icin# " Release for 0se &re the persons authorised to release supplies named in riting (level of qualification)? 'hat is the qualification level of these persons? Is there a standard operating procedure specifying ho the decision for release is ta#en, is this documented? Is there a standard operating procedure specifying procedures in the event of deviation from correct process sequence? Is there an agreement bet een the process parameters obtained during processing and those specified in the validation protocol? &re routine tests conducted and documented? Daily @ for sterilisation (e) g) $o ie L Dic# test)! $atch5related routine tests and batch documentation (e)g) chemical indicators, process indicators such as pressure, temperature and time)! "eriodic semi5annually microbiological tests or after 699 batches (biological indicators)! Is the pac#aging inspected for integrity and dryness? Is the labelling inspected? &re the measured values recorded for the process parameters during processing documented? "rogramme control (&c#no ledgement signal)! /emperature5time recorded as diagram! /emperature5time recorded as printout of process data! If the release decision documented hile giving the name of the person responsible for release as ell as the batch? Is there a record that the processing procedure used as conducted as per the standard operating procedures, hile observing the parameters set out in the validation protocol? Have the individual steps been recorded and archived (Section ? M1N) %edical Devices Dperating Drdinance (%" $etreib7)O are data also saved on data storage media? VI $ransport an Stora#e Has a storage period been set out in riting for sterile supplies? &re processed supplies left to cool do n for the specified time before being

4.4.: un 4.4.D

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transported? Have measures been ta#en to ensure that the properties of processed %Ds are not adversely affected by transport and storage? &re the instructions of the %D and pac#ing materials8 manufacturer observed (cool, dar#, protected against dust, dry, free of vermin, adequate distance from floor. all? &re there mechanisms to ensure containers are securely closed and sho any tampering seals, adhesive strips)? &re the e+piry dates of supplies chec#ed on time? $y hom? VII Processin# -Ds in the Bi#ht of /CED" CED &re the respective recommendations implemented? &re there standard operating procedures for handling potential vCPD@contaminated %Ds? &re there standard operating procedures as regards ho long an %D must be preserved until a diagnosis is made? &re staff familiar ith the contents of the 34I 3ecommendation for vCPD.CPD?