Verified Reprocessing of Medical Devices - CLEANICAL® · 2000 Foundation of SMP GmbH Tuebingen – Examination, Validation, Investigation Associate and CEO Klaus Roth 2001 Foundation

Verified Reprocessing ofMedical Devices

FORUM workshop CLEANICAL®

Chirurgie-Instrumenten-Arbeitsgruppe Berlin

Dr. med. Dipl.-Ing. Thomas W. Fengler

Kilkenny, Eire 7th of March 2013

Where surgery started... and itwas „manually“

Meanwhile we haveimage guided minimallyinvasive surgery -Innovation with newtechniques and devices

Where we started…

Chirurgie-Instrumenten-AG (Surgical Work Group) Berlin

Chronologie der Chirurgie-Instrumenten-AG (CLEANICAL ®) Berlin1993 Foundation of Surgical Work Group Chirurgie-Instrumenten-AG (CLEANICAL®) at Hospital Moabit

Berlin, Chairman Dr. Med. Dipl.-Ing. Thomas W. Fengler, Member of German Society of Surgery, German Society of Visceral Surgery, European Association of Endoscopic Surgery (E.A.E.S.), German Society of Reprocessing of Medical Devices (DGSV e.V.), German Society for Hospital Hygiene (DGKH), Technical Director Antje Hartwig (until 2010 Helmut Pahlke 30.9.10)

1994 Quality of Instruments for Laparoscopyretro-/prospective clinical studies concerning medical devices at the hospital Moabit Berlin

1998 Projects with manufacturers of medical devices for surgery (KARL STORZ Endoscopes, Miele PROFESSIONAL, ebro, Schuelke) in regard of hygienic performance(design, funktionality, cleanability, remnants, debris, process-control)

1999 Organisation of the 1rst clinical multicenter study on remnants/contaminants after mechanicalcleaning before thermal disinfection for different instrument design in 6 different hospitals (CSSD)1rst international FORUM medical devices & processes, congress center MEDICA Duesseldorf

2000 Foundation of SMP GmbH Tuebingen – Examination, Validation, InvestigationAssociate and CEO Klaus Roth

2001 Foundation of ZEHNACKER CLEANICAL® GmbH Associate and CEO Th. W. Fengler2002 3rd international FORUM medical devices & processes in Berlin 2005 Business Support International: FORUM-Tour Argentina, Armenia, Brazil, China, Chile,

Georgia, Eire, Mexico, Norway, Russia2007 Foundation of 2 Companies: CMP (process validation) und CLEANICAL® GmbH (consultancy and

coaching of operators in the clinical field – medical devices & processes) 2010 Member editorial board CENTRAL SERVICE and Aufbereitung in der PRAXIS (Th. W. Fengler)2011 Member scientific board aseptica (A. Hartwig)2012 Letter series „International FORUM Medical Devices & Processes“ (Vol. 16-19)

First prospective clinical study on cleaning efficiency during clinical reprocessing

Poder limpiar significa poder volver a usar

La comprobación de trazos de proteínas en nuestro estudioclínico multicéntrico1999-2001* nos mostró que 1-2 de cada 3 productos médicos estudiados contenían proteínas solubles.

6 CEYES, 6 instrumentos diferentes, 6 muestras de cadadiseño – examinando la solución filtrada con 3 métodosdistintos

* Fengler Th, Pahlke H, Michels W et al.:¿Están libres de proteínas los instrumentos quirúrgicosreprocesados? Resultados de un estudio clínico multicéntricode la contaminación restante (MRSA). Zentralsterilisation 9 (1): 20-32 (2001)

… meanwhile we know that cleanabilityand design of the medical device areconnected. It is established knowledgefor officials and in regulatory affairs (e.g. TIR 30, USA)

What are we going to do today?1. Introduction2. CLEANICAL® Investigation & Application3. What is (re)processing?4. Legal framework: European Medical Device Directive (MDD 93/42), national law,

expert guidelines, recommendations, standards e.g. 16775, 17664, 11607, SOP5. Verification leads to validation:

definition of parameters: countable and non-countable events6. Practices of process validation: definition, considered processes,

difference to device validation for marketing a medical device, market survey, check lists)

7. Examples of typically validated processes:washer disinfector, sterilizer, sterile barrier systems to ensure a moisture-freesterilized product for use/storage

8. Packaging – sterile barrier systems:solid containments, wrapped „soft“ units,comparison of efficiency of different materials, results

9. Check list for sterile barrier system10.Questions & answers

Environment and hygiene in the operating theatre :The Medical Device is just a part of it!

13

Why „(oh so…) correct“ Reprocessing?

The risks of reprocessing are considered to be „fully manageable“. Correctnessis the basic requirement in order to rule out at least one source of infection!

Incidence of nosocomial infections remains unclear, since they are difficult to trace back. They probably concern several patients per year, resulting then in fatalities; some of which (allegedly: 20-30%) could be prevented.

„The hygiene - and sterilisation risk has to be kept to the inevitable residual risk, according to the state of science and technology.“ (from a verdict of German Federal Supreme Court [BGH])

From a legal point of view, (re)processing is a task „of a higher degree“. Thisimplies an obligation for the staff, to be guided by the current state of scienceand technology at all times and further their education „to the limits of what canreasonably be expected“ (quotations from relevant verdicts).

Operational Practice Quality Management

Practice of Reprocessing

Reprocessing – a production of sterilized unitsMany manual steps included in the process:

Is it a quality cycle then?What does (re-)processing of medical devices imply:

traceability

sterilize

waste use

stock

clean & disinfect dry

inspect waste

sterilize

wrap & label

rawmaterial

Operational Practices:

VerifyValidated

Adequate separatedspaces/rooms for practicaland administrative dutiesExisting technicalinfrastructure(devices, solutions, installations)Qualified staff (profession, training on the job)Appropriate medicaldevices withAdministering medicaldevices (quantity, quality, availability, maintenance, storage)

Some preconditions of successfull (re-)processing

Directly after the end of the operation a dry positioning fortransport is executed.

Contaminated MD in closed transport containments withoutany solution

Advantges:Lower weight of the loadLess waste of disinfection solutionNo danger from the disinfectantLess fixation of potentially infective bioburdenMitarbeiterschutz

Preparation for transport (dry)

Order and structure

Washer disinfector offer mechanical support

Washer disinfector can possibly rinse inner lumina of medical devices with a defined pressure …

Mechanized reprocessing does not „automatically“ lead to clean results

Correctly placed MD in specifically constructed load carrierswith sufficient pressure of (tap or fully desalinated?) water

Limpieza automatizada y estandardizadacon máquinas de limpieza y desinfección (RDG)

I am loaded?Beware of this load!

CEN ISO 15 883 Part 1-7

Load carriers to be specified(a proposal of ours for standardization next)

Validated cleaning should be(come more) reproducible

Correct cleaning dries the load ...

Cleaning is more than washing

Bathing - washing - cleaningResults depend on temperature, time and daily constitution

Parámetros del lavado (Círculo de Sinner)

Químico Temperatura

Agua

Mecánico Tiempo

Manual cleaning happens subsequently – one after the other!

¿Cuantos lavabos tiene?

Cleaning is the main precondition for sterility

How do we reach this goal?How do we preserve thecleaned and disinfectedmedical device?

Efficient loads?

Validation of the cleaning step supported by data logger

Monitoring ofwater pressure

Cleaning process control supported by data logger

Sterilization process control with data logger

Validation is documentation. Documentation is knowledge in case of …

Appropriate means?

Just doing it!

What are we going to do?1. Introduction2. CLEANICAL® Investigation & Application3. What is (re)processing?4. Legal framework: European Medical Device Directive (MDD 93/42), national law,







Legal framework: European Medical Device Directive (MDD 93/42)

The actual directive might become a regulation that is introduced directly as a legal instrument in all countries of the European Union in 2015-17 (earliest) without national transposition (after passing this European parliament – beforeelections in 2014)

Mandatory unique device identification (at least for class III)Accessories only have to „assist“ instead of „enable“ a medical device to be

used (intended use)Informations should be provided on the device itself if practicable„Qualified person“ is introduced (e.g. for notified bodies)Placing products in the marketPost-market follow up / market surveillanceControls in the manufacturer´s place are becoming a new tool of

surveillance (unannounced audits by notified bodies and their subsidiaries)

Law for medical devices / Directive for MDSocial lawKRINKO „Requirements for the hygiene in processing medical products“DIN EN 285 Large sterilizers / EN 13060 Small sterilizers (< 60 liters)EN ISO 17665 Validation of sterilization processesISO EN 11140-4 Routine control (Bowie Dick Test)Recommendation of DGKH for the validation and routine control of sterilization processes with saturated steam for medical productsEN ISO 15883 part 1-7 Routine control and validation of washer disinfectorsEN 868 part 2-10, DIN EN ISO 11607 part 1 – 2 (DIN 58953 part 1-9) Guidelines of DGKH, DGSV and A-K-I for the validation and routinecontrol of washer disinfectors

Regulatory Affairs – the German perspective

National laws – Legislation (e.g. Germany)

– Richtlinie 90/385/EWG des Rates vom 20. Juni 1990 über implantierbare medizinische Geräte– Richtlinie 93/42/EWG des Rates vom 14.6.1993 über Medizinprodukte– Richtlinie 2007/47/EG DES EUROPÄISCHEN PARLAMENTS UND DES RATES vom 5. September 2007 zur Änderung der Richtlinien 90/385/EWG des Rates zur Angleichung der Rechtsvorschriften der Mitgliedstaaten über aktive implantierbare medizinische Geräte und 93/42/EWG des Rates über Medizinprodukte sowie der Richtlinie 98/8/EG über das Inverkehrbringen von Biozid-Produkten– Gesetz über Medizinprodukte (Medizinproduktegesetz/MPG)– Verordnung über Medizinprodukte (MPV)– Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizinprodukte-Betreiberverordnung, MPBetreibV)

National laws - Legislation

Arbeits- und Umweltschutz: – Biostoffverordnung– ArbMedVV– Chemikaliengesetz– Gefahrstoffverordnung– Strahlenschutzverordnung– Abfallgesetz– TRBA 250

– TRGS ( 300, 401, 440, 513, 525, 555; 900, 905)

Expert guidelines, recommendations- Guidelines might become more complexe to the clinical user as standardsthemselves (ISO/DTS 16775)- Recommendations sometimes are more legislation as it looks like (KRINKO 2012)

ISO/DTS 16775© ISO 2012 – All rights reservedContentsForewordIntroduction1 Scope (p1)2 Terms and definitions (p1)3 Guidance for health care facilities (p2)3.1 Test methods (p2)3.2 Guidance for conformance to ISO 11607-1 (p2)3.2.1 General guidance for materials, preformed sterile barrier systems and sterile barrier systems (p2)3.2.2 Design and development guidance for packaging systems(ISO 11607-1:2006, 6.1 and 6.2) (p3)3.2.3 Packaging system performance testing (ISO 11607-1:2006, 5.3, 5.4, 5.5, 6.3) (p9)3.2.4 Sterile barrier system stability evaluation (shelf life) (ISO 11607-1:2006, 6.4) (p10)3.2.5 Documentation (p10)3.3 Guidance on conformance to ISO 11607-2, "Validation requirements forforming, sealing and assembly processes" (p10)

ISO/DTS 16775 … more contents:3.3.1 General (p10)3.3.2 Method of validation (p11)3.4 Quality system (p19)4 Guidance for industry (p20)4.1 General guidance (p20)4.1.1 Quality systems (p20)4.1.2 Test methods (p20)4.1.3Sampling (p20)4.2 Design inputs (p21)4.3 Selection and evaluation of materials (p21)4.3.1 Guidance on sterilization requirements (ISO 11607-1:2006, 5.1.6e) + 5.3) (p21)4.3.2 Guidance on safety requirements (ISO 11607-1:2006, 5.1.5 and 5.1.6) (p21)4.3.3 Guidance on barrier requirements (ISO 11607-1:2006, 5.1.4 and 5.1.6) (p21)4.3.4 Guidance on visibility and appearance requirements (p21)4.3.5 Guidance on physical property requirements (ISO 11607-1:2006, 5.1.6 c), 5.1.7 e) + 6.3.2) (p21)4.3.6 Guidance on heat sealability requirements [ISO 11607-1:2006, 5.1.6 d) and 5.1.8 c)] ................. 224.3.7 Guidance on processing requirements (ISO 11607-1:2006, 5.1.2 to 5.1.9) .................................... 224.3.8 Guidance on printing requirements (ISO 11607-1:2006, 5.4) .......................................................... 224 3 9 Guidance on cleanliness and particulate requirements [ISO 11607-1:2006

Packaging for terminally sterilized medical devices — Guidanceon the application of ISO 11607-1 and ISO 11607-2

1 ScopeThis document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, therequirements of ISO 11607-1 and/or ISO 11607-2. This document does not includerequirements to be used as basis of regulatory inspection or certificationassessment activities. This guidance can be used to better understand the requirementsof ISO 11607-1 and/or ISO 11607-2 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 11607-1 and/or ISO 11607-2. It is not required to utilize this document to demonstrate compliance with theInternational Standards.This document provides guidelines for evaluation, selection and use of packagingmaterials, preformed sterile barrier systems, sterile barrier systems and packagingsystems. It also provides guidance on validation requirements for forming, sealing and assembly processes. This document provides information for health care facilities (seeclause 3) and for the medical devices industry (see clause 4). This document does notprovide guidance for applications of packaging materials and systems after theiropening. In the use of packaging for other purposes such as a "sterile field" or transportof contaminated items, other regulatory standards will apply.

Standards e.g. 16775, 17664, 11607, 14971








Apropos:Validation is verification of

specified „predestined“ values?Or just a lot of paper?

Validation is verification of specified „predestined“ values

Countable events:Defining parameters in the labDefining values for those parameters in the labMeasuring parameters in the clinical environment

Not countable events:

Quality Management with

standard operating procedures

(SOP)

Documentation

Validiation of processesfollowing guideline of theDGKH, DGSVe.V., AKI forvalidation (PQ), performancerequalification and routinecontrol

Maschinelle Reinigung / Desinfektion

Alcaline cleaning following RKI:ph-Wert 10 bis 12,5recommended 11-11,5

Thermal disinfection with 80 to 93°C

Risk analysis as part of the quality management

Uncritical medical devices (MD)Semi-critical MD group ASemi-critical MD group BCritical MD group ACritical MD group BCritical MD grouo C








Maschinelle Reinigung/ DesinfektionVors

pülung

Reini

gungNeu

tralis

atio

nZw

isch

enspül

ungDesi

nfektio

n

Trock

nung

A0- Wert 3000 heißt 90°C – 5 Min. > bei kritischenMP u. thermoresistente Viren (unbehüllte)visuelle Überprüfung des Reinigungserfolges

Freigabe RDG- Prozess

alle angelieferten MP sind einem kompletten Aufbereitungsprozess zu unterziehenHerstellerangaben (HA) beachtenProzessparameter einhaltenEinwirkzeiten, Dosierungen einhaltenMP mit Gelenke öffnenZerlegbare MP zur Aufbereitung gem. HA zerlegenGeeignete Hilfsmittel verwendenAlle Geräte vor in Betriebnahme SichtprüfungBeladung der Geräte gem. ihrer validierten ProzesseLückenlose, nachvollziehbare, gerichtsfeste Dokumentation

Zusammenfassung

Sufficient rinsing with desalinated waterDrying with fluff „free“ clothAir (medical, pressure)Medical devices packaged free of remanentsUsed / corroded / deformed, porous or otherwisedamaged medical devices sorted outMedical devices for repair have to be reprocessedcompletelyIf not possible – appropriate warningMaintenance of medical devicesStandard operating procedures (SOP)Description in the working place / of processes

Validated cleaning in conclusion

THE BOWIE AND DICK AUTOCLAVETAPE TEST*

AT a recent symposium1 one of us (J. H. B.) described a standard package for testing high-vacuum sterilisers. There was also a reference to a simpler form of the test developed by Mr. J. Dick in which thermocouples were replaced by heat-sensitive indicator tape. This test has since proved so convenient and so reliable that we con- sider that it should be more widely known. There is urgent need to check the performance of new sterilisers.2 The test we now describe should be within the capabilities of any hospital and should permitinformation to be quickly collected over a wide area.

TEST AS ORIGINALLY DESCRIBED29 huckaback towels were washed and folded into four along their length and then doubled across to give

------------------------------------* A report to the Medical Research Council Working Party on Steam Pressure Sterilisers.

1. Recent Developments in the Sterilization of Surgical Materials: Report of a Symposium organised by the PharmaceuticalSociety of Great Britain and Smith & Nephew Research Ltd. London, 1961.

2. See Lancet, 1962, i, 628.

If the air cannot be ejected, the steam cannot penetrate the medical device.

Requirement for sufficient steam penetration is the air ejection and steamquality.

Therefore, the air ejection test / steam penetration test are done.

BD was developed by Mr. Bowie / Mr. Dick in the UK in 1961.

Origin and Idea of the BD Test

.

Medical Devices –Product „Families“ regarding Reprocessing Properties

considering Permeability (to Steam or Water)

.

1. Massive goods (surgical instruments, e.g. hammer)

Free access of steam to all surfaces

Factors are steam quality and dimensions

2. Porous goods (Surgical covers, wound covers, pad)

Factors are air ejection as well as steam quality.

Overdry cellulose fibers can re-hydrate (overheating)

3. Hollow „containers“(surgical instruments, e.g. minimal invasive surgical instruments)

Factors are air ejection as well as steam quality

Problematic are: tubes, joints, threads etc.

Medical Devices –Product „Families“ regarding Reprocessing Properties

considering Permeability (to Steam or Water)








What does Processing of Medical Devices imply?

traceability

sterilize

waste use

stock

clean & disinfect dry

inspect waste

sterilize

wrap & label

rawmaterial

What is validation?Repeatable verification for the fact, that a process permanently reachesthe required predetermined results.

Where must validation takeplace?Positive results of a process can notbe reached by a simple measurement, but are considered as an essential part of the qualitymanagement.

Considering the Term „Validation“ … once more

A validation includes the installation qualification(IQ), the operational qualification (OQ) and theperformance qualification (PQ).

A validation is a definite argument for the fact, thatprocedures, process steps and entire processes withtheir specific equipment, materials and devices orsystems lead to the expected results - in the form of a spot check.

The results are summarized and annotated in a validation report. This is the basis for the formulationand realization of propositions with regard to processoptimization. Or it just reassures the correctness of the existing process.

Validation reported

Routine Monitoring:

Periodically realized verifications to check, if theoperating performance of the washer disinfectoror sterilizer will be within the defined limits, whichwere defined during the validation.

The number of times the routine monitoring has to take place depends on the instrument and theprocess. The operator carries responsibility forthe frequency of the routine monitoring.

Definition Routine Monitoring

Validations must only be carried out by persons, who are familiar with the task and qualified- by virtue of their training and their practical activities in the field of cleaning, disinfection and sterilization, - by virtue of their knowledge of the pertinent laws, standards and directives have the required expertise.

Persons entrusted with validations must have at their disposal the necessary measurement technology and chemico-technical facilities at hand (e.g. laboratory, microbiological testing, process challenging devices (PCD), medical device simulators)

Who can perform Validations?

What is the required Expertise?

EN ISO 15883-1:General requirements, definitions and tests

EN ISO 15883-2:Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, hollowware, utensils, glasware, etc.

EN ISO 15883-4:Requirements and tests for washer-disinfectors employing chemical disinfections for thermo-labile endoscopes (ISO/DIS 15883-4:2003)

Washer Disinfector Processes according to EN ISO 15883

1. Washer Disinfector2. Load3. Resources4. Process Chemicals5. Design of Instruments6. Trays

Influences on Cleaning and Disinfection Processes

Influences to Cleaning and Disinfection Processes

1. Washer Disinfector

Cleaning programDisinfection programRinsing waterCarriersSpray arms

2. Loading

Position of instruments in the trayConcave/convex effects for retention of rinse waterClosed connections for rinsingHollow instrumentsUmbrella effect


3. Working materialsWater qualityWater pressureOperating meansPower supplyContainersBasketsTrays


4. Process Chemicals

Cleaning agentDisinfection agentNeutralising agentRinse agent

Concentration of the agents


5. Design of Instruments

„Permeability“ of the inner lumen

Materials and coatingsJoints, HingesHollows, CavitiesShaftsSurface properties


6. Loading trays

Trays or basket or container

Rotating armsInstrument holdersSpraying nozzles


The term A0 for a moist heat disinfection process (thermal disinfection), denotes the lethality effect expressed in terms of the equivalent time in seconds at a temperature of 80°C as delivered by the process to the medical device with reference to microorganisms possessing a z-Value of 10:

A0 : is the A-Value when z equals 10 °C t : exposure time to moist heat above 65°CT : temperature of the loadz : z-value is a measurement of the temperature relationship to the microbial destruction in the process(Basically, the z-value corresponds to the number of degrees which causes a 10-fold variation of the sterilization rate.)

The A0-Concept for thermal disinfection

tA ZT

Δ∑ ⋅

−

=

)80(0 10

A0-Value 60 (300) bedpan washer

A0-Value 600 noncritical medical device

A0 -Value 3000 critical medical device

The Robert Koch-Institute recommends a thermal disinfection with a A0 -value of at least 3000 for all critical medical devices

Minimum A0-Values

Table: Progression of time-temperature-ratio

The manufacturer of washerdisinfectors has to be informed bythe manufacturer of chemicalsabout the following aspects :

All requirements for a safehandling

Data concerning the highestacceptable residual concentration on the products

Verification procedures, whichare used for the determinationof process residues

25

30

35

40

45

50

55

60

65

Tem

pera

tur

[°C

]

-100

0

100

200

300

400

500

600

700

800

Leitwert [µS/cm

]

Washing-Up of all Process ChemicalsProof by µS Measurement

Validation/Routine Monitoring in Washer Disinfectors

Routine Monitoring of the Cleaning Step - Validation Report

Software - for programming and evaluating of thermo-loggers, appropriate for chargecontrol and routine control

- for the validation of washer-disinfectorsaccording to DIN EN 15883 and of steamsterilisers according to DIN EN 554 and ISO 17665

Evaluation software

.

1. An effective steam sterilizer process requires the sterilization chamberand the sterilized product to be free from air.

2. The steam must be free from not condensable gases (NCG); the steamcan then condensate and deactivate the microorganisms.

3. Remaining air or NCG act as insulation and prevent sterilization.

4. Bad air ejection as well as bad steam quality cannot be compensatedby extended exposure times.

Quality of Steam SterilizersRequirements

• Indicator treatedTestbedingungen erfüllt: Vollständige Verfärbung der Indikatorfarbe vonrot-violett nach grün.Keine unzulässige Rest-Luft vorhanden, Dampfdurchdringung erfolgtegleich-mäßig. Der Sterilisator ist funktionstauglich. •Behandelter Indikator

Testbedingungen nicht erfüllt: Kein vollständiger Farbumschlag der Indikatorfarbe vonrot-violett nach grün.Durch Rest-Luft im Zentrum des Testpaketes bzw. nicht ausreichende Dampfeinwirkungkeine komplette Verfärbung nach grün.Rot-violette Aufhellung im Zentrum des Testbogens. Überprüfung der Testbedingungen und Wiederholung des Bowie-Dic

Water

Overheatedsteam

2 3 Bar

134°C

121°C

The indicator shows changes -What do they mean?Stupid – it´s thermodynamics!

Indication of sufficient temperature, time?, steam penetration of the indicator

Insufficient air removal,subsequent partial steam penetration

„Burned“ indicator, no proof of airremoval nor steam penetration

No change of indicator

Pressure 3.04 bar

Temperature 134 °C (-0 °C / + 1.5 °C)

Bowie Dick Test according to ISO 17665, DIN EN 285, DIN EN 13060

Maximum time 3.5 minutes

Minimum time 3 minutes

Humidity

Most important: Daily control of the steam sterilizer

Daily routine control in steam sterilizers

1. Multichannel temperature- and pressuremonitoring with external NiCrNi probes

Recording devices are outside of the washingdisinfector or the sterilizer

2. Temperature- and pressure recording data loggeris within the sterilizer or washer disinfector

Remember … previous Measurement Methods

Measuring Principle „3 in 1“

New Program definitions

Software DPCD Professional and EBI 15 for DPCD

Result “Passed”


Result “Failed”


Steam Sterilization ProcessesDIN EN 285: Large steam sterilisers

DIN EN 554 / EN ISO 17665 (NEW)Sterilisation of medical products, validation and routine controlfor sterilisers with damp heat

Recommended by DGKH for validation and routine control of sterilisation processes with saturated steam for medical products

DIN EN 13060: Small steam sterilisers

DIN V 58929Guideline for the use of small steam sterilisers in public healthcareValidation and routine control of sterilisation processes

EN ISO 11140-4 Routine control of steam sterilisersAlternative Bowie Dick Tests

Difference between EN 554 and ISO 17665

DIN EN 554

Sterilization of medical productsValidation and routine control for sterilizers with damp heat (steam)

Application:The European standard determines the requirements for development, validation, process regulation and sterilization monitoring of medicalproducts using damp heat.

EN ISO 17665 (new)

Application:ISO 17665 provides the requirements for development, validation and guidance of the application of a sterilization process for medical productsfor manufacturers and operators of sterilizers.


DIN EN 554

Specifies the relevant process parameters(e.g. compensation time, temperature band)

EN ISO 17665 (NEW) Point 8

„The sterilization process including the process parameters and corresponding limit values are to be defined“

Qualitative requirement without numeric values.


DIN EN 554

EN 554 requires a separate inspection for each loading form.

EN ISO 17665 (NEW) 9.4.3 ff.

It must be verified that:

„the test loading of the sterilizer includes products that are processedroutinely and that are either part of a product family that is related to a sterilization process, or represent product families which constitute thehighest level of difficulty for the sterilization process..“

Specific Characteristics ISO 17665

Product families

Groups and sub-groups of products that have similar features and thathave similar requirements for the sterilization process.(e.g. dimensions, material, lumen, model, form, packing)

Performance Qualification (PQ) 9.4.3

„ (…)e) the loading configuration corresponds to 6.1.1 j) and is most difficult to sterilize; f) The size and/or dimensions of the loading correspond to 6.1.1 k).“

Specific Characteristics ISO 17665ISO 17665 is kept very open.

ISO 17665 does not require compliance of the temperature band or theplateau time. It must be proven that the required F0 value is reached undersaturated steam anytime.

According to ISO 17665, you can also validate processes of oldersterilizers that do not comply to the guidelines according to EN 285, EN 13060.

An annual validation cannot be justified precisely; however, typically an annual requalification is necessary (ISO 17665-2 Section 12.4). Thefrequency depends on the risk evaluation as well as on the stability of theprocess.

Conclusion:The requirements for the performance of the validation have become morestrict. A high level of special knowledge is required, in order to perform a validation of sterilization processes properly.

Requirements for the measuring technology according to EN 285 / ISO 17665

Temperature measuring probes made of platinum resistors, Pt class A as per IEC 60751 or thermal elements, class 1 as per IEC 60584-2, Diameter of the temperature probe ∅ less than 2 mmTemperature measuring range 0 to 150°CMeasuring rate ≤ 2.5 sResolution 0.1 KAccuracy temperature probe: minimum 0.5 KAccuracy temperature recording unit ± 0.25 K Calibration of temperature measuring system, before and after validation(DIN EN 554 Section 4.6.5)Calibration of temperature measuring system according to themanufacturer instructions. Calibrated temperature must be within thesterilization temperature (DIN EN 285 Section 26.4.9).

Requirements for the measuring technology according to EN 285 / ISO 17665

Temperature compensated pressure measuring probeMeasuring rate ≤1 sMeasuring range pressure measuring unit: 0 to 4 bar (0 to 400 kPa)Resolution: 0.04 bar (4 kPa)Accuracy pressure recording unit: ± 0.5 % of measuring range, if the environment temperature is (20 ± 3°C)The device must have a valid certificate.Calibration according to manufacturer instructions,Traceable to a national norm, e.g. DKD (DIN EN 285 Section 26.5)

Validated cleaning and disinfection processesCorrect loadingCorrect program selectionComplete dryingMaintenance and care of instrumentsValidated wrapping (packaging stage)Maintained sterilizersCorrect loadingCorrect program selectionValidated sterilization processRoutine monitoring of the processes (documentation)

Important Preconditions for the Sterilization

water

overheated steam

2 3 bar

134°C

121°C

Theoretical Saturated Steam Temperature

Bowie Dick Test according to ISO 11140-4:

Temperature 134°C (-0 °C / +1,5 °C)Time 3,5 minutesPressure 3,04 barSaturated Steam

Daily Routine Monitoring in Steam Sterilizers

More Safety during the Routine Monitoring of the SteamSterilizer:

Electronic Bowie Dick Test ISO 11140-4Checking of the parameters temperature/pressure/timeParameters: 134°C for 3,5 minutes according to DIN EN 285 (PCD)

Vacuum test according to DIN EN 285Calculation of the theoretic steam temperatureEarly error detectionCalculation of lethality value F0

Data recording with software Winlog.medFast demonstration of problems of different causes of defectwith description for trouble shooting

Electronics Bowie Dick Test and Routine Monitoring PCD

VALIDATION

Validation according to DIN EN 554 / EN ISO 17665

Commissioning:

• Installation qualification (IQ)

• Operation qualification (OQ)

Performance qualification (PQ):

• Thermometric measurements

• Microbiological tests

The verification includes:1. Verification of vacuum2. Verification of empty load3. Verification for steam penetration (Bowie Dick Test)4. Verification for performance of sterilizers during partial loading5. Verification for performance of sterilizers during full loading6. Verification for drying performance

Performance Qualification according to EN DIN 554/ISO 17665

Performance Qualification (PQ) is defined as the process of obtaining and documenting evidence that the equipment as comissioned will produce an acceptable product when operated according to process specification.The performance test must be realized with standardized loadingaccording to EN 285.

Preparation for the Validation of Sterilization Processes

Buildup of „standardized“ loads:Selection of medical devices for reprocessing (e.g.) sterilization(instruments, MIC, orthopedics) Packaging(container, paper, fleece, foil and other wrapping)Weight of loads before and after sterilization(heavy instruments, container or basket loading, single items)Reference loading (product families)(Buildup, weighing)

Important: Documentation and photograph of all sample loadings

Sight check of the sterilizerCalibration (depending on themeasuring system)Vacuum testEmpty load testBowie Dick testPerformance test of sterilizers

during partial and full loadingVerification for dryingperformance

Performing the Validation

Positioning of Sensors by Mapping

Programming of Data Loggers

Evaluation of the Validation

Validation Report according to EN 554/ISO 17665

Interpretation of thermal Measurement

sterilizationtemperature

sterilizationtemperatureband

overheat

equilibrationtime holding time

plateau period

1 2 3 4

1 = free space2 = active discharge3 = fastest4 = slowest

What kind of measures have to be taken when results do not meet the specifications?

• Check if loading is correct

• Check position of probes

• Recalibrate measuring system

• Adjustment of standard loads

• Alternative medical instrumentation (material, construction)• Call service technician for re-adjustment of process parameters

(e.g. pressure of chamber, timing of steam), but: Before validation takes place, the technician should have done the necessary maintenance work already!

VALIDATION

Validation according to DIN EN 554 / EN ISO 17665

Commissioning:

• Installation qualification (IQ)

• Operation qualification (OQ)

Performance qualification (PQ):

• Thermometric measurements

• Microbiological tests

Validation is essential and requires verification of parameters thatare predefined.

The specifications of validation must reflect the actual state of science and technology.

The dataloggers are essential tools in the optimization, control and error diagnostics of the processes in washer-disinfectors as well as in steam sterilisers.

Validation is more than this anyway (e.g. standard operatingprocedures (SOP) for manual steps).

Conclusion





7. Examples of 3 typically validated processes:washer disinfector, sterilizer, sterile barrier systems to ensure a moisture-freesterilized product for use/storage



Container-VerpackungVorteile:- Formbeständig- Sicher für Transport und Lagerung

Nachteile:- Hohes Gewicht- Wartung- pflegeintensiv

Verpacken der Medizinprodukte

Container-Verpackung

Containergrößen sind genormtz.B. 30 x 15 x 60 cm; 30 x 15 x 30 cm

1 Sterilisiergut- Einheit?

1 StE- DIN Norm = 300 x 600 x 300mm

1 StE = 10 kg


Container-VerpackungContainer haben für den Medienaustausch Ventil-oder Filtersysteme

Einmalfilter sind vor jeder Sterilisation zu erneuern

Baumwollfilter sind für den mehrfachen Gebrauch, müssen regelmäßig kontrolliert und erneuert werden

Sogenannte Dauerfilter (Teflon) sind gemäßHerstellerangeben einzusetzen


Container-VerpackungEinmalfilter


Container-VerpackungBaumwollfilter


Container-VerpackungDauerfilterfilter


Weichverpackung

Vorteile:- flexibel, anpassungsfähig- geringes Gewicht- geeignete Innenverpackung kann als sterile

Unterlage eingesetzt werden


Weichverpackung

Nachteile:- evtl. schwierigere Trocknung im Sterilisator- ggf. Transportprobleme- höhere Abfallentsorgung


Normgerechte DIN 58953-7 Falttechnik muss eingehalten werden

Eine Zweifachverpackung entsteht durch zweimaliges einpacken und nicht durch das einmalige Einpacken mit 2 Bögen

Die Innenverpackung ist zur sterilen Entnahme im OP vorgesehen


Verpacken der Medizinprodukte DIN 58953-7

Verpacken der Medizinprodukte DIN 58953-7

Folien/ Papierverpackung(Klarsichtverpackung)

Geeignet z.B. für Einzelinstrumente und kleine Sets

Geeignet für Dampf- und Gassterilisation(Indikatoren)

Zellulosefreie für Plasmasterilisation


Beim Befüllen auf Peelrichtung achtenNur ¾ befüllenca. 3 cm Platz zur Siegelnaht


Siegelnaht 6mm breit ohne Lufteinschlüsse und Falten (Test?)

Folienverpackung mit Falte nicht immer geeignet, nicht zu empfehlen

Beschriftung außerhalb der Füllzone mit geeignetem Stift (kein Kugelschreiber)


Sterilisation aufrecht im Korb

Folie an Folie; Papier an Papier

Der Medienaustausch erfolgt nur durch das Papier

Nicht zu eng – eine flache Hand muss zwischen die Verpackungen passen


Lagerung von Medizinprodukten

Egal ob einfach oder zweifach verpackt!

Ungeschützte Lagerung –zum alsbaldigen Gebrauch

Geschützte Lagerung –6 Monate, jedoch nicht länger als das Verfallsdatum

Lagerverpackung –5 Jahre, sofern keine andere Verfallsfrist vomHersteller festgelegt

Achtung Nachweispflicht!

Anforderung an die Lagerung von Medizinprodukten

Die Umgebung muss trocken sein

Die Art der Lagerung beeinflusst die Lagerfähigkeit

Die geschlossene Lagerung (Schränke) erhöht die Lagerungszeit

Die Temperatur sollte 20°C bis 25°C betragen

Instrumentenpflege

1. Inspección visual táctil2.Mantenimiento3.Pruebas de funcionamiento

Mejorando ....

Artistas de empaque

Empaquetado moderno en cestas

Unidad esteril:6 UTE¡Demasiadopeso!

4 ó 5 UTE¿Productividadmedible?

Calidad y cantidad en el proceso de esterilización





7. Examples of 3 typically validated processes:washer disinfector, sterilizer, sterile barrier systems to ensure a moisture-freesterilized product for use/storage



Documents

Verified Reprocessing of Medical Devices - CLEANICAL® · 2000 Foundation of SMP GmbH Tuebingen – Examination, Validation, Investigation Associate and CEO Klaus Roth 2001 Foundation