validation of the cleaning and sterilization process used...
TRANSCRIPT
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Validation of the Cleaning and Sterilization Process
used for Medical Instruments
Dr. Michelle J. Alfa Ph.D., FCCMMedical Director Clinical Microbiology, DSM,
Winnipeg, Canada
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Overview:
n How to assess adequacy of instrument cleaning
n Process monitors for sterilization- steam
n What are the issues?
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Reprocessing of Medical Devices: Who is responsible for What??
n Manufacturers validate that an instrument can be reliably cleaned and sterilized/disinfected and is therefore re-usable.
n Users verify that cleaning/sterilization equipment is working and that in-hospital cleaning/sterilization protocols are consistently performed.
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Cleaning verification: Users
n Visually inspect the instruments after cleaning
n Monitor the automated washer
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Check Instruments after cleaning
n Visual inspection: good lighting, magnifying conditions- Do routinely for all surgical instruments- Not adequate alone: lumens, hinged areas etc.
n Take samples and test for residuals- protein, hemoglobin, carbohydrate- cutoff for acceptable cleaning??
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Taking Samples from Instruments
n Swab of surface
n Elute from instrument by immersion and sonication in sterile Reverse Osmosis water
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Rapid User Tests: SURFACE TESTING in-hospital cleaning assessment
n ProtTEST Check (unknown LD):Protein (MediSafe, UK)swab device àààà assess
n Protec Swab test (unknown LD):Protein or ATP (Biotrace) swab can be tested. (commercially available)
n Ninhydrin Swab test (2.5 µg/swab):Protein: ISO/CEN method evaluated for users;swab method (deBruin 2002)
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Study: Assess Surgical Instruments Before and After Cleaning to determine level of organic material
n Swab same area (1 cm2) on each instrument
n Elute swab
n Test fluid à protein, hemoglobin, carbohydrate and endotoxin
Quantitative test
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Plastic surgery instruments: patient-used [Avg of 5 patient procedures]
0
100
200
300
400
Ca
rbo
hyd
rate
ug
/cm
2
Before Cleaning After Cleaning
Carbohydrate on instrument
Curved forcep Fine needle driver
Curved Iris scissors
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Plastic surgery instruments: patient-used [Avg of 5 patient procedures]
0
5000
10000
15000
20000
25000
En
do
tox
in E
U/cm
2
Before Cleaning After Cleaning
Endotoxin on instrument
Curved forcep Fine needle driver
Curved Iris scissors
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Conclusions: Testing Instruments
n Level of Carbohydrate and Endotoxinincreased AFTER cleaning
n Level of Protein and Hemoglobin reduced after cleaning
n Likely due to final rinse water contaminated with biofilm [has high carbohydrate and endotoxin]
n Water used for final rinse needs to be monitored periodically.
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What are cutoffs for adequate cleaning??
n OPA method: 0.01 µg/device; (Verjat 1999)
n Ninhydrin method: 2.5 µg/swab; (deBruin 2002)
n Biuret method: 5.5 µg/cm2; (Kruger 1997)
n BCI method: 6.4 ug/cm2; (Alfa 2002)
Stainless Steel Surgical Instruments: Protein
Still controversial – No International Standard
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What Cleaning monitors for Washers are available (Surface vs Lumen)?
n TOSI:
n Browne’s Soil and washer monitor (dye)
Medisafe Lumen check: Laparoscopic device lumen Flexi check: Endoscope lumen
HealthMark USA, Medisafe, UK TOSI; Washer TOSI Lumchek
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Guidance documents: Cleaning of Surgical Instruments
n ISO15883-1: Washer-disinfectors –General requirements, terms and definitions and tests
n ISO15883-5: Test soils and methods for demonstrating cleaning efficacy
n AAMI TIR34:2007: Water for reprocessing of medical devices
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Monitors for Sterilization of Surgical Instruments
n Europe: Parametric release; [Based on standardized loading of sterilizer]
n North America: Biological and Chemical Indicators[Not able to ensure standardized loading of sterilizer]
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Steam Sterilization
n Gravity Displacement
n Dynamic Air-removal Steam sterilizere.g. Pre-vacuum steam sterilizer
Amsco/Steris Getinge
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Pre-Vac Steam Sterilization: Routine Hospital cycles
3 minutes4 minutesUnwrapped nonporous & porous items in a mixed load
3 minutes3 minutesUnwrapped nonporous items (e.g.instruments)
3 minutes4 minutesWrapped instruments
Exposure time at 135oC (275oF)
Exposure time at 132oC (270oF)
Dry Times not indicated, as these vary widely
AAMI ST79 Steam Sterilization Guidance document 2006
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Extended Steam Sterilization Cycle
n Instrument manufacturer recommended steam sterilization cycles that go beyond the times listed for routine hospital cycles
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Two main reasons for manufacturer recommended
Extended-Steam cycles
n Acetabular reamer system:- 18 mins PreVac at 132oC
n Orthopedic Set- 132oC for 40 mins
“Prion” related cycle:European instruments- alternatives may be given my manufacturer
Large mass/density of medical device or instrument set- steam penetration & heating issues
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Medical Device Reprocessing:User’s Responsibilities
n Provide Appropriate Process Monitoring for Steam sterilization cycles used.
n Both CI and BI have a role in process monitoring if parametric release is not used.
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Monitoring of Standard Pre-vac Steam sterilization cycles
n Biological Indicator (BI)- run 1/day (minimum 1/week) for every
steam cycle used that day- required for every load with implant(s)quarantine implant until results of BI known
n Chemical Indicator (CI)- Class I to VI (Canada)- external,internal and in PCD
BI: only used in Process Control Device (PCD)CI: used in PCD or in/on actual instrument package
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BI: Monitor Steam Cycle
n Spores
n Spores in self-contained BI
n Spores in BI in Process Challenge Device (PCD)
BI in PCD used for routine monitoring of steam and ETO cycles in Healthcare
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Chemical Indicators:
n Class 1: Process Indicators (changes color when exposed to steam)- differentiate processed vs unprocessed products. - use on the outside of ALL packages sterilized (e.g. autoclave tape).
n Class 2: Bowie-Dick- ONLY for pre-vacuum sterilizers to show adequate air removal
n Class 3: Single Parameter Indicator (e.g. temp, or steam, or ETO)- monitors single variable- place inside instrument package or in Process Challenge Device
n Class 4: Two or more critical variables (e.g. temp & sterilant)- monitors multiple variables- place inside instrument package or in Process Challenge Device
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Chemical Indicators:
n Class 5 & 6: “Integrators”: ALL critical variables for cycle(e.g. correct temp, & sterilant for specified period of time)
- tightly controlled must achieve success for ALL variables evaluate
- place inside instrument package or in Process Challenge Device
- Loads can be released based on these CIs(except implants which still need result of BI prior to release)
- Class 5 correlate with BI characteristics, - Class 6 “emulating” indicator correlate with stated values not necessarily with BI characteristics
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Why are BIs needed when CIsare more tightly controlled??
n Can chemicals or enzymes repair damage to regain function?
n Can microorganisms repair damage to regain function (e.g. Potential for infection)
NO
YES
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Extended Cycle Monitoring
n INAPPROPRIATE to use a BI (OR CI) in a test pack that has been validated for a standard hospital cycle (e.g. 4 min @ 135oC) to monitor an extended cycle (e.g. 18 min @ 132oc).
A self-contained BI in a “Test Pack” (i.e. PCD) is validated for a specific type of sterilization method and for a specific set of cycle parameters
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What can go wrong when manufacturer recommends extended steam cycle?
n Routine BI & CI in extended cycle:- not a proper challenge to ensure cycle parameters are adequate
n Standard steam cycle using appropriate routine BI:- inadequate sterilizationà instruments may not be sterile despite BI that passes
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What can Users do??
n Ask medical device manufacturer if extended cycles have been validated
n Limited user-testing to ensure steam penetration: - test BEFORE set is used for first time- place 3 BIs inside each layer of set- if any BIs fail; break set down into smaller tray sets and re-test
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Steam Sterilization: Multi-layer Surgical Sets
n If failure of any BIs: report to medical device manufacturer
n Break down set to smaller tray sets and re-test
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Issues that need Site specific attention:
n Ensure proper BIs and CIs used for steam cycles
n Ensure Device manufacturer cycle parameters (e.g. extended steam cycles) are followed unless written instructions otherwise
n Consolidate extended cycles to one sterilizer unit and ensure training and competency of staff
n May verify steam penetration using BI in tray-set as PCD
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What is being done to address this issue?
n Manufacturers working with AMMI and CSA to harmonize to ONLY two extended cycles (10 and 20 minutes suggested).
n All instruments and sets will be validated for existing routine steam cycles or for one of the two extended cycles
n Manufacturers to develop appropriate PCD for BI/CI monitoring of the two extended cycles(Note; there are CIs cleared for some extended steam cycles)
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SUMMARY
n BIs or CIs recommended for routine cycle monitoring when parametric release not used.
n Do NOT process devices/sets in routine cycles if extended cycles recommended by manufacturer
n Heavy, complex instrument sets à suggest limited pre-testing using instrument tray set as PCD until more appropriate ones available
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References:
n Alfa MJ et al A Survey of reprocessing methods, residual viable bioburden and soil levels in patient-ready ERCP duodenoscopes used in Canadian centers. Infect Control Hosp Epidemiol 2002;23:198-206.
n Moses FM, J Lee. Surveillance cultures to mnitor quality of gastrointestinal endoscope reprocessing Am J Gastroenterology 2003;98:77-81.
n Obee PC et al Real-time monitoring in managing the decontamination of flexible gastrointestinal endoscopes Am J Infect Control 2005;33:202-6.
n Pineau L et al Endoscope drying/storage cabinet: interest and efficacy. J Hosp Infect 2007;doi:10.1016/j.jhin.2007.10.012
n Sciortina CV, E L Xia, A Mozee Assessment of a novel approach to evaluate theoutcome of endoscope reprocessing. Infect Control and Hosp Epidemiol2004;25:284-290
n Orzechowski, ACP de Bruijn, C. Wassenaar Validation of a cleaning test for flexible endoscopes. Zentr Steril 2003;11:165-178
n Mehta AC et al American College of Chest physicians and American Association for Bronchology consensus Statement: Prevention of Flexible Bronchoscopy-associated infection. 2005;128;1742-1755
n Alfa M, C Landers, S Hadfield, C Hancock, L Jakeman, L Kingsbury,k P McCornick, D Trudeau User Alert: Problems with Process Monitors for Extended Steam Sterilization Cycles. Can J Infect Control Sept 2006