Your Sterilizer is not your Father’s Water Heater · Your Sterilizer is not your Father’s Water...

WFHSS-SOBECC July 2010 1

Your Sterilizer is not your Your Sterilizer is not your Father’s Water HeaterFather’s Water Heater

““It’s a Class II Medical It’s a Class II Medical Device”Device”

WFHSS-SOBECC July 2010

你好

Bonjourこんにちは

Ciao Hello

Hola

HalloOlá

здравствуйте

안녕하세요


Thomas K. “Chip” MooreThomas K. “Chip” Moore

Rochester, NYRochester, NY

Sterilization-Answer-Man.com Sterilization-Answer-Man.com


AORN JournalAORN JournalJuly 2009July 2009

CEU’sCEU’s


Seminar ObjectivesSeminar Objectives Understand the load challenges as defined in Understand the load challenges as defined in

AAMI/ANSI ST8, the sterilizer Mfg guidance AAMI/ANSI ST8, the sterilizer Mfg guidance

document, to include 16 towel pack, metal document, to include 16 towel pack, metal

weight, Bowie-Dick Test and air leaks.weight, Bowie-Dick Test and air leaks.

Cycle types for gravity and vacuum defined Cycle types for gravity and vacuum defined

and performance explained for US and and performance explained for US and

Europe.Europe.


Water Heater vs SterilizerWater Heater vs Sterilizer Similar AttributesSimilar Attributes

Maintains temperatureMaintains temperature Built to National Safety Built to National Safety

StandardsStandards Different LeagueDifferent League

Not a commodityNot a commodity Regulated Class II deviceRegulated Class II device Meets AAMI Performance Meets AAMI Performance

StandardsStandards


Today’s SterilizersToday’s Sterilizers

WFHSS-SOBECC July 2010

Yesterday’s SterilizersYesterday’s Sterilizers

Circa 1890’s

Arnold

Steamer


Yesterday’s SterilizersYesterday’s SterilizersCirca 1950

Cylindrical Chamber

Manual Controls

No Recording Chart

Radial Arm Locking Door



Circa 1950

Decontam Department



Circa 1950

Processing Solutions



Circa 1950

Gravity Flash Sterilization



Circa 1950

Surgery


ASMEASME American Society of American Society of

Mechanical EngineersMechanical Engineers Recognized by States for Recognized by States for

pressure vessel pressure vessel constructionconstruction

Safety standards (rated Safety standards (rated for 2.5 times normal for 2.5 times normal operating pressure)operating pressure)

Serial # Controlled by Serial # Controlled by the National Boardthe National Board


Door ClosureDoor Closure CompressionCompression

Radial Arm LockingRadial Arm Locking Clam shell lockingClam shell locking Gasket LifeGasket Life

Active GasketActive Gasket Steam pressure to seal, vacuum Steam pressure to seal, vacuum

to unsealto unseal Gasket LifeGasket Life

Manual vs. PowerManual vs. Power Hinged, vertical or horizontal Hinged, vertical or horizontal

slideslide Single Door vs Double Door Single Door vs Double Door

Pass throughPass through

Design CriteriaDesign Criteria Inherently safeInherently safe Maintained per Mfg Maintained per Mfg

instructionsinstructions


Chamber DesignChamber Design MaterialMaterial

NiCladNiClad Thin coat of nickel over Thin coat of nickel over

carbon steelcarbon steel StainlessStainless

316L316L Interior FinishInterior Finish

polished polished or sand blastedor sand blasted

Full Jacket and semi JacketedFull Jacket and semi Jacketed Stress corrosion Stress corrosion

Weld RepairsWeld Repairs

ShapesShapes


Regulated IndustryRegulated IndustryCode of Federal RegulationsCode of Federal RegulationsTitle 21, Volume 8Title 21, Volume 8CITE: 21CFR880.6880CITE: 21CFR880.6880Revised as of April 1, 2009Revised as of April 1, 2009PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICESPART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICESSubpart G--General Hospital and Subpart G--General Hospital and Personal Use Miscellaneous Devices Personal Use Miscellaneous Devices Sec. 880.6880 Steam sterilizer.Sec. 880.6880 Steam sterilizer.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=880.6880

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=880


Mfg Guidance Document Mfg Guidance Document


AAMI ST8-2008 RequirementsAAMI ST8-2008 Requirements 4.1 Labeling4.1 Labeling

Safety, manuals, identification, UL61010-1 & IES61010-2-040Safety, manuals, identification, UL61010-1 & IES61010-2-040 4.2 Design, construction, components & accessories4.2 Design, construction, components & accessories

Pressure vessel, electrical components, Corrosion resistant, Pressure vessel, electrical components, Corrosion resistant, Load Accessories, air filterLoad Accessories, air filter

4.3 Sterilizer safety4.3 Sterilizer safety Interlock, thermal hazardsInterlock, thermal hazards

4.4 Process monitoring and control devices4.4 Process monitoring and control devices Monitor, record and control time, temperature & pressure.Monitor, record and control time, temperature & pressure.

4.5 BI performance4.5 BI performance


ST8-2008 Test ReqmtsST8-2008 Test Reqmts 5.5.2 BI performance 5.5.2 BI performance

w/ fabric PCDw/ fabric PCD 5.5.4 BI performance 5.5.4 BI performance

w/ wrapped nonporous w/ wrapped nonporous instruments PCDinstruments PCD

5.5.5 BI performance 5.5.5 BI performance for Flash, unwrapped & for Flash, unwrapped & single wrapped single wrapped nonporous instrumentsnonporous instruments

5.6. B-D Test5.6. B-D Test Air Leak Rate TestAir Leak Rate Test

16 towel Pack (US Gold Std)16 towel Pack (US Gold Std) 181 kg/m181 kg/m33/11.3 lbs/ft/11.3 lbs/ft33

At least 25 lbs (11.3 kg)At least 25 lbs (11.3 kg)

At least 25 lbs. (11.3 kg)At least 25 lbs. (11.3 kg)

Folded towels or PCDFolded towels or PCD Vacuum SterilizersVacuum Sterilizers


ST8-2008 Fabric Pack/PCDST8-2008 Fabric Pack/PCDAcceptance CriteriaAcceptance Criteria For Vac cycle, 1 pack; full load for GravityFor Vac cycle, 1 pack; full load for Gravity 3 cycles at 1/2 recommended exposure3 cycles at 1/2 recommended exposure 1010-6-6 Kill Kill Moisture retention- no more than 3% weight gainMoisture retention- no more than 3% weight gain

Source: AAMI/ANSI ST8-2008, page 12


ST8-2008 Wrapped InstrumentST8-2008 Wrapped Instrument Tray + Metal Instruments at least 11.3 kg/25 lbsTray + Metal Instruments at least 11.3 kg/25 lbs Lumened devices 3 mm x 400 mm may be consideredLumened devices 3 mm x 400 mm may be considered Wrapped in 140 tread count muslin/ 2 ply & launderedWrapped in 140 tread count muslin/ 2 ply & laundered 3 cycles at 1/2 recommended exposure, full load & single tray3 cycles at 1/2 recommended exposure, full load & single tray 1010-6-6 Kill at 1/2 the recommended exposure time Kill at 1/2 the recommended exposure time Moisture retention- no more than 20% weight gain, no wet spotsMoisture retention- no more than 20% weight gain, no wet spots

Source: AAMI/ANSI ST8, page 15


ST8-2008 Flash for nonporous ST8-2008 Flash for nonporous Items OnlyItems Only

ST8-2008 no longer ST8-2008 no longer requires validation of the requires validation of the 10 minute Flash cycle for 10 minute Flash cycle for porous itemsporous items

ST8-2008 does provide ST8-2008 does provide testing for the traditional 3 testing for the traditional 3 minute unwrapped minute unwrapped Gravity, nonporous load Gravity, nonporous load and for Dynamic Air and for Dynamic Air Removal for FlashRemoval for Flash


ST8-2008 Flash for nonporous ST8-2008 Flash for nonporous Items Items

Gravity CyclesGravity Cycles Wire mesh tray for min Wire mesh tray for min

load and max, full loadload and max, full load 11.3 kg/25 lbs weight11.3 kg/25 lbs weight 1010-6-6 Kill at 1/2 the Kill at 1/2 the

recommended exposure recommended exposure timetime

Dynamic Air RemovalDynamic Air Removal Wire mesh tray for min Wire mesh tray for min

load and max, full loadload and max, full load 11.3 kg/25 lbs weight11.3 kg/25 lbs weight 1010-6-6 Kill at 1/2 the Kill at 1/2 the

recommended exposure recommended exposure timetime


B-D Air Removal TestB-D Air Removal Test 100% freshly laundered 100% freshly laundered

cotton towels, @ Rh of cotton towels, @ Rh of 35%-60%35%-60%

Folded to 9.8”x11.8”x Folded to 9.8”x11.8”x 9.8 to 11” high 9.8 to 11” high (250x300x250 cm +/-20cm)(250x300x250 cm +/-20cm)

Weight 8.8 lbs/4 kg Weight 8.8 lbs/4 kg (+/- (+/- 5%)5%)

134134oo C (273 C (273o o F) for 3.5 F) for 3.5 minmin

Source: AAMI/ANSI ST8-2008, page 18


B-D Test RequirementB-D Test Requirement Requirement started in ST8-Requirement started in ST8-

20012001 Temperature over shoot to Temperature over shoot to

be designed out.be designed out. Only 10 seconds allowed Only 10 seconds allowed

after exposure phase starts.after exposure phase starts. Slow heat up desired, Slow heat up desired,

improves steam penetration.improves steam penetration.

Source: AAMI/ANSI ST8, page 20


Air Leak Rate TestAir Leak Rate Test Measures the rate Measures the rate

pressures rises once a pressures rises once a deep vacuum is achieved.deep vacuum is achieved.

50 mmHg or 0.97 psia50 mmHg or 0.97 psia Acceptance Criteria is 1 Acceptance Criteria is 1

mmHg or 0.019 psia a mmHg or 0.019 psia a minute over a timed minute over a timed period (15 minutes).period (15 minutes).

Performed Manually or Performed Manually or AutomaticAutomatic

Dart TestDart Test


ST8-2008 Test MatrixST8-2008 Test MatrixRequirementsEmpty Chamber profile x # of Chambers sizes x 3BI/16 Towel Packs-Gravity Full Load x # of Chambers sizes x 3BI/16 Towel Packs-Vac 1 Pk x # of Chambers sizes x 3BI/16 Towel Packs-Vac Full Load x # of Chambers sizes x 3BI/Wrapped Gravity 25 lbs Instrument 1 Tray x # of Chambers sizes x 3BI/Wrapped Gravity 25 lbs Instrument Full Load x # of Chambers sizes x 3BI/Wrapped Vac 25 lbs Instrument 1 Tray x # of Chambers sizes x 3BI/Wrapped Vac 25 lbs Instrument Full Load x # of Chambers sizes x 3BI/ Single wrapped Gravity 25 lbs Instrument 1 Tray x # of Chambers sizes x 3BI/ Single Wrapped Gravity 25 lbs Instrument Full Load x # of Chambers sizes x 3BI/ Single Wrapped Vac 25 lbs Instrument 1 Tray x # of Chambers sizes x 3BI/ Single Wrapped Vac 25 lbs Instrument Full Load x # of Chambers sizes x 3BI/ Unwrapped Gravity 25 lbs Instrument 1 Tray x # of Chambers sizes x 3BI/ Unwrapped Gravity 25 lbs Instrument Full Load x # of Chambers sizes x 3BI/ Unwrapped Vac 25 lbs Instrument 1 Tray x # of Chambers sizes x 3BI/ Unwrapped Vac 25 lbs Instrument Full Load x # of Chambers sizes x 3


Load/Chamber ValidationLoad/Chamber Validation

Courtesy of Getinge Sourcing LLC


FDA 510k ClearanceFDA 510k Clearance No commercial distribution until clearanceNo commercial distribution until clearance

No orders, no talking about features, no advertisingNo orders, no talking about features, no advertising All labeling based on cleared claims that the All labeling based on cleared claims that the

device is safe and effectivedevice is safe and effective Design changes means a new 510k submissionDesign changes means a new 510k submission Verbal communication is considered labelingVerbal communication is considered labeling AbtoxAbtox


Source: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090339.pdf

Based on submitted labeling claims, the FDA issues a clearance to place the product into commercial distribution.

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090339.pdf









http://www.accessdata.fda.gov/cdrh_docs/pdf7/K.pdf









AAMI ST79 Cycles- GravityAAMI ST79 Cycles- Gravity

Source: AAMI ST79, page 72


AAMI ST79 Cycles- Dynamic Air AAMI ST79 Cycles- Dynamic Air RemovalRemoval

Source: AAMI ST79, page 72


3 Min. Gravity Flash- Non Porous 3 Min. Gravity Flash- Non Porous Hard GoodsHard Goods

Pressure Temp

Time


10 Min Gravity Flash- Porous 10 Min Gravity Flash- Porous ItemsItems

Pressure Temp

Time


Pressure/VacuumPressure/VacuumWrapped GoodsWrapped Goods

Pressure Temp

Time


Steam Flush, Pressure Pulse Steam Flush, Pressure Pulse


Fractionated/SuperatmosphericFractionated/Superatmospheric

Pressure Temp

Time

European cycle for steam penetration (lumens/B-D Test)


US Cycles vs. EuropeanUS Cycles vs. European Different challenges per StandardsDifferent challenges per Standards

B-D test- European 2x heavierB-D test- European 2x heavier Lumens- nothing defined yet in the USLumens- nothing defined yet in the US

Load Validation by the UserLoad Validation by the User Our Regulated IndustryOur Regulated Industry

User follow instructions for safe and effective User follow instructions for safe and effective applicationapplication

WFHSS-SOBECC July 2010 44Source: http://www.wfhss.com/html/conf/assets/wfhss_workshop20071206_lecture03_03_en.pdf

http://www.wfhss.com/html/conf/assets/wfhss_workshop20071206_lecture03_03_en.pdf





Steam CyclesSteam Cycles

1950’s 1960’s 1970’s 1980’s 1990’s 2000’s

Gravity

Displacement Hi Vac

Single /Deep w. Vac Pump

B-D Test

Pre-Vac

Multi sub-

Atmospheric

Pulsing

Heavy Linen Loads Heavy Metal/Lumins/Plastic

Pressure/vacuum pulses w/ water ejectors

Pressure/vacuum pulses w/ water ejectors & Vac Pumps


Impact on YouImpact on You IFU’s by European Device MfgIFU’s by European Device Mfg What is your load mix?What is your load mix?

Lot’s of metal & lumen items (steam Lot’s of metal & lumen items (steam contact/drying)?contact/drying)?

Lot’s of plastic trays/inserts (hard to dry)?Lot’s of plastic trays/inserts (hard to dry)? Lot’s of textile packs (dense yet easy to dry)?Lot’s of textile packs (dense yet easy to dry)?

Would you consider LOAD VALIDATION?Would you consider LOAD VALIDATION?


The FutureThe Future AAMI Action for Hollow DeviceAAMI Action for Hollow Device

Per the PCD WG Co-ChairsPer the PCD WG Co-Chairs Test device per ISO 11140-6 (helix)Test device per ISO 11140-6 (helix) Round Robin testingRound Robin testing Results reported to AAMI in late 2010Results reported to AAMI in late 2010 2011 Standard?2011 Standard? ST8 revision?ST8 revision?


Flash Sterilization Can be GoodFlash Sterilization Can be Good No evidence of infection/ Steam is forgivingNo evidence of infection/ Steam is forgiving Not goodNot good

Insufficient instrumentationInsufficient instrumentation Quick wash at the scrub sinkQuick wash at the scrub sink Open TraysOpen Trays

One Cleaning standardOne Cleaning standard 2009 JCAHO/CMS Notice2009 JCAHO/CMS Notice

The process (cleaning/Mfg Instructions/Delivery)The process (cleaning/Mfg Instructions/Delivery) Facility/Policies Designed for FlashFacility/Policies Designed for Flash

Mini CS in Surgery/DD Pass ThroughMini CS in Surgery/DD Pass Through Vacuum cycles for Trays/ContainersVacuum cycles for Trays/Containers


Recommended PracticeRecommended Practice 25 lb Instrument sets (less is best)25 lb Instrument sets (less is best) Multi-layer Plastic Sets are ProblematicMulti-layer Plastic Sets are Problematic 20-30 minute Dry Time20-30 minute Dry Time ““Pre Bake/Post bake time” Pre Bake/Post bake time” Cracking the Door or Wide Open (Is Post Bake a Sacred Cracking the Door or Wide Open (Is Post Bake a Sacred

Cow?)Cow?) Loading TechniquesLoading Techniques Load “Cool Down Time” after the cycleLoad “Cool Down Time” after the cycle Three Sets of Loading Equipment per SterilizerThree Sets of Loading Equipment per Sterilizer

(1) In the sterilizer (2) Preparing the next load (3) Cooling down(1) In the sterilizer (2) Preparing the next load (3) Cooling down Reduce weight per tray & don’t over loadReduce weight per tray & don’t over load


Sterilizer PerformanceSterilizer Performance Follow recommended preventative maintenanceFollow recommended preventative maintenance In House Maintenance or Contracted (pay for In House Maintenance or Contracted (pay for

up time or pay for down time)up time or pay for down time) Verify utilities to Mfg Spec (pressure/flow)Verify utilities to Mfg Spec (pressure/flow)

WaterWater SteamSteam ElectricityElectricity DrainDrain


SummarySummary Understand the load challenges as defined in Understand the load challenges as defined in

AAMI/ANSI ST8, the sterilizer Mfg guidance document, AAMI/ANSI ST8, the sterilizer Mfg guidance document,

to include 16 towel pack, metal weight, Bowie-Dick to include 16 towel pack, metal weight, Bowie-Dick

Test and air leaks.Test and air leaks.

Cycle types for gravity and vacuum defined and Cycle types for gravity and vacuum defined and

performance explained for US and Europe.performance explained for US and Europe.

How users can verify steam cycle performance at their How users can verify steam cycle performance at their

own facility using devices inside their steam sterilizer.own facility using devices inside their steam sterilizer.


Time to Time to focus focus and take and take off with off with a a purposepurpose


Q and A?Q and A?

Thanks for the Opportunity

Your Sterilizer is not your Father’s Water Heater · Your Sterilizer is not your Father’s Water...

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