your sterilizer is not your father’s water heater · your sterilizer is not your father’s water...
TRANSCRIPT
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
WFHSS-SOBECC July 2010 3
Thomas K. “Chip” MooreThomas K. “Chip” Moore
Rochester, NYRochester, NY
Sterilization-Answer-Man.com Sterilization-Answer-Man.com
WFHSS-SOBECC July 2010 4
AORN JournalAORN JournalJuly 2009July 2009
CEU’sCEU’s
WFHSS-SOBECC July 2010 5
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.
WFHSS-SOBECC July 2010 6
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
WFHSS-SOBECC July 2010 7
Today’s SterilizersToday’s Sterilizers
WFHSS-SOBECC July 2010
Yesterday’s SterilizersYesterday’s Sterilizers
Circa 1890’s
Arnold
Steamer
WFHSS-SOBECC July 2010 9
Yesterday’s SterilizersYesterday’s SterilizersCirca 1950
Cylindrical Chamber
Manual Controls
No Recording Chart
Radial Arm Locking Door
WFHSS-SOBECC July 2010 10
Yesterday’s SterilizersYesterday’s Sterilizers
Circa 1950
Decontam Department
WFHSS-SOBECC July 2010 11
Yesterday’s SterilizersYesterday’s Sterilizers
Circa 1950
Processing Solutions
WFHSS-SOBECC July 2010 12
Yesterday’s SterilizersYesterday’s Sterilizers
Circa 1950
Gravity Flash Sterilization
WFHSS-SOBECC July 2010 13
Yesterday’s SterilizersYesterday’s Sterilizers
Circa 1950
Surgery
WFHSS-SOBECC July 2010 14
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
WFHSS-SOBECC July 2010 15
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
WFHSS-SOBECC July 2010 16
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
WFHSS-SOBECC July 2010 17
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
WFHSS-SOBECC July 2010 18
Mfg Guidance Document Mfg Guidance Document
WFHSS-SOBECC July 2010 19
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
WFHSS-SOBECC July 2010 20
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
WFHSS-SOBECC July 2010 21
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
WFHSS-SOBECC July 2010 22
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
WFHSS-SOBECC July 2010 23
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
WFHSS-SOBECC July 2010 24
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
WFHSS-SOBECC July 2010 25
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
WFHSS-SOBECC July 2010 26
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
WFHSS-SOBECC July 2010 27
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
WFHSS-SOBECC July 2010 28
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
WFHSS-SOBECC July 2010 29
Load/Chamber ValidationLoad/Chamber Validation
Courtesy of Getinge Sourcing LLC
WFHSS-SOBECC July 2010 30
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
WFHSS-SOBECC July 2010 31
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.
WFHSS-SOBECC July 2010 32
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.
WFHSS-SOBECC July 2010 33
Based on submitted labeling claims, the FDA issues a clearance to place the product into commercial distribution.
Source: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070657.pdf
WFHSS-SOBECC July 2010 34
Based on submitted labeling claims, the FDA issues a clearance to place the product into commercial distribution.
Source: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K092490.pdf
WFHSS-SOBECC July 2010 35
Based on submitted labeling claims, the FDA issues a clearance to place the product into commercial distribution.
Source: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K092490.pdf
WFHSS-SOBECC July 2010 36
AAMI ST79 Cycles- GravityAAMI ST79 Cycles- Gravity
Source: AAMI ST79, page 72
WFHSS-SOBECC July 2010 37
AAMI ST79 Cycles- Dynamic Air AAMI ST79 Cycles- Dynamic Air RemovalRemoval
Source: AAMI ST79, page 72
WFHSS-SOBECC July 2010 38
3 Min. Gravity Flash- Non Porous 3 Min. Gravity Flash- Non Porous Hard GoodsHard Goods
Pressure Temp
Time
WFHSS-SOBECC July 2010 39
10 Min Gravity Flash- Porous 10 Min Gravity Flash- Porous ItemsItems
Pressure Temp
Time
WFHSS-SOBECC July 2010 40
Pressure/VacuumPressure/VacuumWrapped GoodsWrapped Goods
Pressure Temp
Time
WFHSS-SOBECC July 2010 41
Steam Flush, Pressure Pulse Steam Flush, Pressure Pulse
WFHSS-SOBECC July 2010 42
Fractionated/SuperatmosphericFractionated/Superatmospheric
Pressure Temp
Time
European cycle for steam penetration (lumens/B-D Test)
WFHSS-SOBECC July 2010 43
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
WFHSS-SOBECC July 2010 45Source: http://www.wfhss.com/html/conf/assets/wfhss_workshop20071206_lecture03_03_en.pdf
WFHSS-SOBECC July 2010 46Source: http://www.wfhss.com/html/conf/assets/wfhss_workshop20071206_lecture03_03_en.pdf
WFHSS-SOBECC July 2010 47
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
WFHSS-SOBECC July 2010 48
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?
WFHSS-SOBECC July 2010 49
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?
WFHSS-SOBECC July 2010 50
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
WFHSS-SOBECC July 2010 51
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
WFHSS-SOBECC July 2010 52
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
WFHSS-SOBECC July 2010 53
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.
WFHSS-SOBECC July 2010 54
Time to Time to focus focus and take and take off with off with a a purposepurpose
WFHSS-SOBECC July 2010 55
Q and A?Q and A?
Thanks for the Opportunity