Standards: Overview and Up-date 2014 - deconidi.ie · Sterilization of Health Care Products. 20 ... sterilizing agent and the development, validation and routine control of a sterilization

© 3M 2007. All Rights Reserved. Note: all information dated September 2013

Brian Kirk 3M UK

Standards: Overview and Up-date 2014

Klaus Hahnen, 3M, Germany

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© 3M 2007. All Rights Reserved. Note: all information dated September 2013!

Purpose of the Presentation

Provide a brief introduction to standards, standardization bodies and how standards are generatedIntroduce the current sterilization and associated standards including:

the processing standardsthe equipment standardsthe product standards

Update on current situation with key standardsThe UK perspective

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How do we measure Length ?

The ellThe footThe span…

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A Problem occurs,

Humans are not standardised!Egypt:

• royal ell: 0,52• minor ell: 0,45

Persia: 0,533 or 0,548Greece: 0,46Germany: 0,53 to 0,896Bavaria: 0,833Switzerland: 0,498 – 0,61Italy: 0,54Vatican: 0,75Poland: 0,596…

(Local) Measures of length, volume, … were placed in public at market places to minimise disputes.

What the “ell” ?

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© 3M 2007. All Rights Reserved. Note: all information dated September 2013!© 3M 2007. All

What is this?

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A standard-metre (mètre-étalon) located at 36, rue de Vaugirard in Paris

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The Metre – the modern standard of lengthdefined by the French Academy of Sciences as the length between two marks on a platinum-iridium bar in 1799representing one ten-millionth of the distance from the Equator to the North Pole along the Paris Meridian.In 1983, the metre was redefined as the distance travelled by light in free space in 1⁄299,792,458 of a second.

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What are standards?

written documents agreed by consensus of all parties involvedapproved by a recognized regulating bodya specification for a given device or a process designed to achieve a desired end point

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Why do we need them?

To ensure that what we want is what we gete.g. purchasing specification

To avoid cross border barriers to tradeTo enable a universal approach to achieving a given objective

e.g. a sterile product

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Standardisation of Outcomese.g. of a sterilization process

Multi-use products• circular manufacturing process

• mostly used in health care setting

OutcomeThe same:

a sterile product!

Single-use products• linear manufacturing processes

• mostly used in industry

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The relationship of standards& guidance to legislation

EU Directives

eg MDD

UK LegislationEg Med Dev Regulation

Harmonised European Standardseg EN 285, EN ISO 17665

Annex ZA

Health and Social Care ActNICECQCMHRANotified BodiesHealthWatch

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Legal Frameworks – EU, NationalEuropean Directives (ED’s);

Pan European frameworks for locally implemented legislation in member states produced by the European Commission and ratified by the European Parliament.

National LegislationLaws or regulations enacted by national governments and parliaments implementing into local statutes ED’s

Harmonised European Standards (EN’s).Standards developed within CEN which allow an presumption of compliance to the essential requirements of European Directives and hence compliance with national legislation.EN’s contain an annex ZA which describes which clause allows compliance to which EREN’s have to be implemented as local British Standards (BS) unchanged

Professional and Governmental Guidance (“Cook Books”)Documents produced by professional institutes or government departments which provide detailed guidance on how to achieve current best practice standards reflecting state of art.They should be framed so as to allow compliance to national legislation, regulatory requirement and standards compliance.

Best practiceA written document describing a process or practice based on consensus amongst a group of experts or professionals available to those who practice their art; defensible in law.

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Medical Device Directive

Current MDD has “sterilizers” as accessories to MD. Cannot have an accessory to an accessory so support equipment not regarded as MD. Not CE marked eg Bowie and Dick Test Packs

Except in France

New MDD will make sterilizers Medical Devices in their own right which means a number of “accessories” will also become a MD and require CE marking.Bowie and Dick Test Packs MD ?

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National Standards Organisations

Belgium: nbnFrance: AFNORGermany: DINNetherlands: NEN United Kingdom: BSIUSA: ANSI / AAMI

Scotland – SSI ?

Committees populated by experts from academia, industry, regulatory bodies and user groups.

All developed nations have a national standards body

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http://www.sis.se//Default.aspx

http://www.ianor.org/

http://www.bsigroup.com/

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Regional Standards Organisations

CEN Management CentreAvenue Marnix 17B-1000 BrusselsBelgiumTel: + 32 2 550 08 11Fax: + 32 2 550 08 19www.cen.eu

Committees populated by delegates nominated from each EU countries’ standards body.

http://upload.wikimedia.org/wikipedia/de/6/6b/Logo_CEN_klein-dreisprachig.png

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Technical Committees

CEN/TC 102 Sterilizers for medical purposesSecretariat DIN / Ms A. MüllerChairman K. Hahnen

CEN/TC 204 Sterilization of medical devicesSecretariat BSI / Ms M. Di Carlo Chairman Dr. E. V. Hoxey

Each with several working groups (e.g. large steam sterilizers, indicators, washer/disinfectors, …)

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International Standards Organisations

International Organization for Standardization (ISO)1, ch. de la Voie-Creuse, Case postale 56CH-1211 Geneva 20SwitzerlandTelephone +41 22 749 01 11Fax +41 22 733 34 30www.iso.org

Committees populated by delegates nominated from participating countries’ standards body.

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WG 1 Industrial ethylene oxide sterilizationWG 2 Radiation sterilizationWG 3 Moist heat sterilizationWG 4 Biological indicatorsWG 5 TerminologyWG 6 Chemical indicatorsWG 7 PackagingWG 8 Microbiological methods WG 9 Aseptic processingWG 10 Liquid chemical sterilization WG 11 General criteria for sterilization processesWG 12 Information for reprocessing of re-sterilizable devicesWG 13 Washer-disinfectors

ISO Technical Committee 198 Sterilization of Health Care Products

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Points to NoteStandards are voluntary BUT compliance to standards identifies a clear path to regulatory compliance (see Article 5 of MDD).

ISO standards can be:adopted as national standards,coexist with existing national standards,be subject to local variations (national deviations).

CEN standards for EU member states have to be:adopted as national standards,adopted unchanged,any conflicting local standards must be withdrawn.

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Medical Device Directive – Article 5

Article 5 states that products complying with a harmonised EN are presumed to meet the Essential Requirements of the MDD

annex ZA of the particular standard.

Harmonised EN’s are important because they offer a clear route to conformity to MDDs & CE marking of product.

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The Vienna Agreement

An agreement made between CEN and ISO to ensure harmonisation of standards published by the two organisations.

When standards are reviewed under the terms of the agreement, one of the organisations take the lead and revise both sets of standards in a single committee. Once finished the resulting document will go out for “parallel voting” which means member bodies in EU will vote for the standard as both an EN and ISO and then adopt said standard as an EN.

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The Life Cycle of a Standards

NWIP

CD

CD(V)

DIS

FDIS

EN -ISO -STD

Proposed by a national standards body eg BSI

Based on NWIP, often developed by convenor. !st draft for discussion by wg

First draft finalised by wg and sent to national bodies for comment

Arises from resolution of comments on CD(V). Once complete sent out for more detailed scrutiny by Nat. Bodies

Arises from resolution of comments on DIS. Once ready wg recommends document to go to FDIS

The published standardArises from FDIS with yes or no vote and editorial comments ONLY.

Revision cycle every 5 yearsStd may be reconfirmed or whole process begins again.

© 3M 2007. All Rights Reserved. Note: all information dated September 2013

Standards

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EN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices For terminally sterilized MD’s to be designated “STERILE”, the theoretical probability of there being a viable micro-organism present shall be = < 1 x 10 -6

What do we mean by “Sterile” ?

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Now ;SAL = 1 in =< 10 -6

ProposedSAL = 1 in =< 10 -x

X = a value dependent on the intended use of the productEg 3 for non critical products so labelling may become;

What do we mean by Sterile

STERILE -3

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EN ISO 14937:2009Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

“Mother” of Process Standards

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ISO 14937 - SectionsQUALITY SYSTEM – ISO 13485

STERILE PRODUCTMAINTENANCE

PRODUCT RELEASE

ROUTINE CONTROL

VALIDATION

PROCESS DEFN

PRODUCT DEFN

EQUIPMENT SPEC

STERILIZING AGENT Agent defn, microbial effectiveness, material compatibility, safety & environment

Equipment specificationProduct specification, Packaging materials, Product quality prior to sterilization

Development, Biological safety, Process residuals, Product compatibility, re-sterilization

IQ, OQ, PQ, Review and approval

Product presentation, Process monitoring, Record generationRecord Review, Indicator Tests, Product disposition, Corrective actionProduct Quality prior to Sterilization, Calibration, Maintenance, Re-qualification.)

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Current Processing Standards

They all have a common formatfollowing that used in ISO 14937

The all use consistent definitionsusing those defined in ISO TS 11139

They all have common quality system elementsbased on reference to ISO 13485

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Sterilization Processes used in Health CareProcess Standards:

Sterilization Processes

Physical Chemical

Mechanical Removal(Filtration)

Hot Cold

Moist Heat(Steam)

Dry Heat

UV Light

Ionising radiation

Gamma

e- Beam

Oxidising Agents Alkylating Agents

H2O2Vapour

H2O2 Vapour(with Plasma)

H2O2 Vapour(with Ozone)

Chlorine Dioxide

Per Acetic Acid Vap (with Plasma)

Ethylene Oxide

LTS withFormaldehyde

Glutaraldehyde

Ozone Gas

BS EN ISO 17665

ISO 20857

BS EN ISO 11137 BS EN ISO 14937

BS EN ISO 11135

ISO 25424

UK HTM 2010 Covers:

•Moist Heat

•Dry Heat

•EO

•LTSF

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Sterilization Processes used in Health CareEquipment Standards:

Sterilization Processes

Physical Chemical

Mechanical Removal(Filtration)

Hot Cold

Moist Heat(Steam)

Dry Heat

UV Light

Ionising radiation

Gamma

e- Beam

Oxidising Agents Alkylating Agents

H2O2Vapour

H2O2 Vapour(with Plasma)

H2O2 Vapour(with Ozone)

Chlorine Dioxide

Per Acetic Acid Vap (with Plasma)

Ethylene Oxide

LTS withFormaldehyde

Glutaraldehyde

Ozone Gas

BS EN 285

BS EN 13060

BS EN ISO 1422

BS EN 14180

UK HTM 2010 + MES Covers:

•Moist Heat

•Dry Heat

•EO

•LTSF

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SPECIFICS

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Requirements for the development, validation & routine control of sterilization processes for Medical Devices –Moist Heat

• a single standard for all moist heat processes used in Pharmaceutical, Medical Device & Health Care

ISO 17665-1

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Current StatusEN ISO 17665-1 and 2:2006

PUBLISHEDImportant for EU countries:EN 554 withdrawn since August 2009;Guidance published:

ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat --Part 2: Guidance on the application of ISO 17665-1

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ISO 17665 – Scope

Specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.

Moist heat sterilization processes covered by this standard include but are not limited to:

a) saturated steam venting systemsb) saturated steam active air removal systemsc) air steam mixturesd) water spraye) water immersion

Gravity sterilizersPre-vacuum sterilizers

Industrial (Pharmaceutical)

Ensure to use the correct, applicable part for your processes!

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Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

ISO/TS 17665-3:2013

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ISO 17665-3Sterilization of Healthcare products – Moist HeatGuidance on the designation of a medical device to a product family and processing category;

The ability of a sterilization process to sterilize a re-usable MD depends on;

Physical designMaterialFunctional characteristicsSterile barrier system used to maintain sterility

Sterilizers supplied with pre set cycles usually designed to process the challenge loads specified in BS EN 285

type and works testing

Modifications may be required for complex devices/loads

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Describes product attributes to consider when assigning a product to a product family;Design;

How complex is the instrument, how easy is it to displace air with steam, how easy is it to raise the device to sterilization temp.

Material;Metals heat up quicker than plastics (thermal conductivity), mixtures of materials produce a complex picture.

Weight;Heavy devices will require more steam to raise to sterilization temp.

Sterile Barrier System (packaging)Single wrapped items present less challenge than multiple wrapped. Container systems are different to flexible packaging.

ISO 17665-3

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Elements from 17665-3

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Performance QualificationExamples

E3 – medium to low complexity, suction tip most challenging

E7+ - very complex set, heavy (10kg) with complex lumened devices

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Germany pushing to have 17665-1 & 2 put into revisionProposal to have a new work item to develop a global standard for moist heat sterilizers.

Sponsored by UK under guidance of Keith Oates

Part of an attempt to combine and harmonise requirements for moist heat sterilization

BS EN 285 large steam sterilizers and 13060 – small steam sterilizers have different requirements !!!

Initial draft will address common elementsMeasurement systems, Safety, Noise, EMC,

Will be resisted by some countries particularly Germany.

BS EN ISO 17665 – Moist Heat

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Current Status

EN 285:2006 Sterilization -Steam sterilizers - Large sterilizersPUBLISHED2 amendments:

A1:2008 replacing former “rubber load test” by new PTFE test deviceA2:2009 to align document with modified MDD (Medical Device Directive)

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Enactment of Machinery Directive meant “Sterilizers” regarded as “Machines” so needed to complyBS EN 285 put into revision two years agoAbout ten meetings later prEN published including new requirements for MD compliance250 comments received (key);

Definition of independent monitoring and control (system integration)France proposed to increase NCG limit to >45% v/vGermany proposed to delete the BDTGermany proposed to make Air Detectors redundent.

BS EN 285 - Revision

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EN285:2006 + A1:2008

Committee regarded the hollow rubber tube test device (“rubber load test”) as outdated and decided there was a need for a new “Hollow Load Test”A round-robin test was conducted to identify a suitable test device design Outcome: publish an amendment to EN285 to replace rubber load test with a device from EN867-5

Important: this test is not a replacement for the steam penetration test (aka: Bowie Dick Test)!

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EN285:2006 + A1:2008 Hollow Load PCD

A tube with a capsule at one end for placement of an indicator.

Wall Thickness: 0.5 +/- 0.025mmInternal Diameter: 2.0 +/- 0.1 mmLength: 1500 +/- 15 mmCapsule Mass: 10.0 +/- 0.1gFree Capsule Volume: 6 +/- 1%of total internal volumeMaterial: PTFE

Please note: the suitability of this design is currently questioned – see other presentations.

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Current BI & CI Standards

EN ISO 11138 – Biological Indicators

EN ISO 11140 – Chemical Indicators

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BI’s – Current status:

EN ISO 11138:2006ALL PARTS PUBLISHED

Part 1 General requirementsPart 2 BI’s for EOPart 3 BI’s for Moist HeatPart 4 BI’s for Dry HeatPart 5 BI’s for LTSFPart 6 BI’s for H2O2

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Biological Indicator for Vapour Phase H2O2(Sterrad, V-Pro)Draft document in process of developmentDo we need a standard for validation and routine control of equipment and processes ?

An International standard for determining Reduced Incubation Time (RIT) for BI’s.

Current standard incubation time 7 daysSelf contained BI’s typically 24 to 48 hours (FDA method)New Rapid methods – 0.5 to 10 hours

BI’s Current Status

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EN ISO 14161:2009

Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results

ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.ISO 14161:2009 applies to biological indicators for which International Standards exist.

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CI’s – Current Status

EN ISO 11140-1General requirementsand classes 1, 3, 4, 5, 6Revised FDIS

ISO 11140-2 Replaced by ISO 18472

EN ISO 11140-3 to 5 “BDT” standardsPublished about to be revised

Note: part 5 not accepted by EU/CEN!

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CI typesType 1 – Process Indicators

Used to show exposure to a process. No information about the success or failure of the process

Type 2 – Specific Test Indicators (e.g. BDT)Type 3 – Single variable indicators

Respond to a single variable in the process e.g. temperatureType 4 – Multivariable Indicators

Respond to two or more variables in the processType 5 – Integrating Indicators

Respond in a way which mimics the response of a BI if used in the same process

Type 6 – Emulating IndicatorsRespond to all defined critical variables of the process at levels associated with acceptable sterilizing conditions e.g. 134°C for 5 minutes

Important: classification is non-hierarchical!

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ISO 18472:2006Sterilization of health care products -- Biological and chemical indicators -- Test equipment

Please note: standard hospital sterilizers are not suitable for “testing” indicators!

Test Equipment for CI & BI

BIER / CIER at 3 Laboratory, Neuss, Germany

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EN 867-5

Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

defines a specific porous PCDdefines a specific hollow PCDdefines test conditions

valid standardcurrently under revision, will probably re-emerge as EN ISO 11140-6

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Original work item “ to revise and update EN 867-5”Scope creep – scope described uses in other equipmentQuestions raised about content of early drafts

No justification for significant changes to requirements and test methods.

Significant questions raised about the performance of the hollow reference device.Round Robin Tests carried out

EN 867-5 and ISO 11140-6 A disaster Movie in the making

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ISO 11140-6 Round Robin

Collated Test results for CI’s and BI’s from3M Eu, 3M USA, gKe, VP, Steritek

ISO TC 198 WG 6 - November 2013

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EN285:2006 + A1:2008 & EN 13060Hollow Load PCD

A tube with a capsule at one end for placement of an indicator.

Wall Thickness: 0.5 +/- 0.025mmInternal Diameter: 2.0 +/- 0.1 mmLength: 1500 +/- 15 mmCapsule Mass: 10.0 +/- 0.1gFree Capsule Volume: 6 +/- 1%of total internal volumeMaterial: PTFE

Please note: the suitability of this design is currently questioned – see other presentations.

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Test CycleST1-4 (342 litre) and ST3-RM (11 litre)

Time

Pressure

4 pulses : CP vac = 300, 320, 350, 370, 400 mbar3 pulses : CP steam = 950mbarCome-up : CP = 3100 mbarTarget ΔP/Δt: 400mbar/min

CP Steam

CP vac

CP Come-up

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3M Eu Chemical Indicator – Colour DevelopmentB1 – 400mbar/min - ST3-RM – 11 litre chamber

0% 50% 100%

393639373938393939403946394739483949

300-950mbar

0% 50% 100%

395239543956395839623964400740084009401040114019402040214022402440254026402740284029

320-950mbar

0% 50% 100%

3950395339553957396139633965396739683969397039714002

350-950mbar

0% 50% 100%

398739883989399139923993399439953996399739983999

400-950mbar

165 ml Air115ml Air 281 ml Air

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P mB 220 240 260 280 300 320 340 360 380 400 Key - Pass/Fail in %, (number of tests) all from small chamber data

3M USA

P/F100/0

(9)3M Europe

P/F100/0(21)

P/F31/69(13)

P/F0/100(12)

P/F100/0

(3)

P/F100/0

(3)

P/F100/0

(3)

P/F0/100

(6)

P/F0/100

(3)

P/F100/0

(3)

P/F100/0

(3)

P/F100/0

(3)

P/F0/100

(3)

P/F0/100

(3)

P/F0/100

(3)

P/F0/100

(3)gKe

VPP/F

100/0(1)

P/F100/0

(1)

P/F67/33

(3)

P/F33/67

(3)

P/F0/100

(2)

ISO 11140-6 Round Robin CI Collated Results All – Aug 2012

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Biological Indicator ResultsThe picture shows the BI test piece used.

1.5 m long PTFE tube, 2mmID, 0.5 mm wall.Metal spigot 3cm long with 106 G stearothermophilus spores

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175 200 220 240 260 280 300 320 340 360 PmBKey - Pass/Fail in %, (number of tests) all from small chamber data

3M USA

NG/G100/0

(9)3M

Europe

NG/G80/20

(5)

NG/G100/0

(6)

NG/G50/50

(6)

VPNG/G100/0

(9)

ISO 11140-6 Round Robin BI Collated Results All – Oct 2013

NG/G66/33

(5)

NG/G100/0

(9)

NG/G100/0

(9)

NG/G100/0

(9)

NG/G80/20(15)

NG/G100/0

(3)

NG/G100/0

(9)

NG/G100/0

(9)

NG/G100/0

(9)

NG/G100/0

(9)

NG/G78/22

(9)

NG/G56/44

(9)

NG/G12/88

(6)Steritek

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150 200 250 300 350 400 450 500 550 600 PmBKey – No growth – green /BI growth – red from small chamber data

3M USA

3M Europe

VP

ISO 11140-6 Round Robin BI Collated Results All – Nov 2013

Steritek

Gke

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Current Status

Committee has decided to remove Hollow Reference device from latest Committee Draft WATCH THIS SPACE

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Cleaning and Disinfection Processesused in Health Carefor re usable medical devices and other equipmentBS EN ISO 15883 – Washer-disinfectors –Scope: Specifies the performance requirements and methods of testing WD’s for use in medical, laboratory, veterinary, dental and pharma.

Part 1 – Gen Reqs, terms and definitions and testsPart 2 – Req and tests for thermal WD’s for surgical instruments, anaesthetic equipment, etcPart 3 – Req and tests for thermal WD’s for bed pansPart 4 – Req and tests for chemical WD’s for thermolabile endoscopesPart 5 – test soils and methods for demonstrating cleaning efficacyPart 6 – Reqs and tests for thermal WD’s for non invasive, non critical MD’s and HC equipment

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ISO 15883 Washer DisinfectorsCurrent TC198 / WG13 activity

Part 1: General requirements, terms and definitions and tests• Systematic review now triggered as 5 years since last review.• 16 June deadline for voting by countries.

Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

• Systematic review just completed and now will be released as Committee Draft for wider input.

• Following stages will be DIS and FDIS. Expected to be complete by end 2015.

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ISO 15883 Washer DisinfectorsCurrent TC198 / WG13 activity

Part 5 : Test soils and methods for demonstrating cleaning efficacy.• Collaborative study to identify protocol for assessing test soil

performance continues• Beginning to review content of new draft

Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and health care equipment.

• New part under CEN lead (TC 102/WG 8)

• The DIS is now circulated and voting closes on 27 July.

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Current Status

Test soils in question – scientific basis ?Method to assess resistance of soils to removalAlternative markers

TOC, Haemoglobin, Carbohydrate, ATP, taK,

Definition of “Clean”6.3 microgram50 Microg (Nigel Tomlinson, IDSc Conf 2013)

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How effective are current cleaning methods using AWD’s

After Use:Tissue load after use – estimated at 1 to 60mg or more tissue

After cleaning and sterilizing120 cleaned instruments analysed from 5 NHS hospitals.

Tissue Load After cleaning 0.2 to 0.7mg protein• Baxter et al, (2006), J Hosp Inf, 63(3), 439-434

206 cleaned and sterilized instrument packs analysed for residual protein17% contaminated with between 3ug and 45mg of protein

• Murdoch et al, (2006), J Hosp Inf, 63(3), 432-438

23 instruments monitored for contamination using EDIC/EP microscopyAll instruments showed contamination, 56% gross (21 ug protein)

• Lipscombe et al, (2006), J Hosp Inf, 62, 141-148

Prion Infective dose:10 000 molecules, 0.6 x10-15 g (femtog) is one infective unit.

• Barron et al (2007),J Biol Chemistry, 49, 35878-86

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Detection of CleanCurrent

Ninhydrin test (Very insensitive to protein – Perret)Biuret test (Sensitive to about 3 microg)OPA (Ortho phthallic dialdehyde) test (Very sens.)

ProposedATP Bioluminescence (Test for generic soil – good indicator)Total Organic Carbon (TOC) (Picks up all organic debris)Haemoglobin (Just tests for blood)Carbohydrate. (Just tests for sugars)

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The End