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Lumen claims of the STERRAD 100NX Sterilizer: Testing...

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Lumen claims of the STERRAD 100NX Sterilizer: Testing performance limits of this technology Magda Diab-Elschahawi, Alexander Blacky , Walter Koller Clinical Institute of Hospital Hygiene Medical University of Vienna
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Page 1: Lumen claims of the STERRAD 100NX Sterilizer: Testing ...novo.sobecc.org.br/programacao/congresso/material_congresso_5_2… · STERRAD 100NX™ Sterilizer can adequately process 0.7mm

Lumen claims of the STERRAD 100NX

Sterilizer: Testing performance limits of

this technology

Magda Diab-Elschahawi, Alexander Blacky, Walter Koller

Clinical Institute of Hospital Hygiene

Medical University of Vienna

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STERRAD100NX™ Sterilizer

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STERRAD 100NX Full Cycles

• Standard Cycle – 47 minutes

Sterilization of most surgical instruments including Inox

lumened devices

AND

• Flex Cycle – 42 minutes

Sterilization of flexible endoscopes only

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Study Background

• A main drawback in the past has been the reliable sterilization of devices featuring long narrow lumens.

• According to the manufacturers information the STERRAD100NX™ Sterilizer can adequately process 0.7mm X 500mm Inox lumened devices.

• We placed inoculated carriers at the midpoint position of lumens, which were then submitted to half-cyclesterilizing conditions in the STERRAD100NX™ Sterilizer.

• In order to simulate insufficient cleaning of instruments or crystalline residues we added organic and inorganic challenges respectively to our inoculated carriers.

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Aim of the study

• The aim of this study was to qualify the performance of the STERRAD100NX™ Sterilizer under different experimental settings* representing worst case conditions.

• Protocol:

1. Stainless steel lumens of 0.7mm x 500mm

2. Wrapping (1 X)

3. Flex Scope conditions

4. Organic and inorganic burdens

* These conditions do not correspond to the manufacturer’s instructions for use

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Test Conditions

Manufacturer’s IFU University Worst Case

Test Condition

Lumen Claim 0.7 mm X 500 mm Inox 0.7 mm X 500 mm Inox*

Instrument Condition Must be clean and dry Contaminated with

inorganic and organic

material

Load Arrangement Arranged pouches on

edge

Pouches stacked on top

of each other

Sterilization Cycle STANDARD FLEX

* 0.7 mm X 500 mm Inox are validated for sterilization only in the

STERRAD 100NX STANDARD cycle. Do not process these

devices in the FLEX cycle.

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Rationale for Worst Case

Conditions

• Cleaning process not validated >> sub-standard washing or rinsing– Simulated by use of inorganic and organic soils

• Human Error >>Improper loading– Simulated by stacking pouched lumens on top of each

other

• Human Error >> selecting the wrong cycle for the devices to be processed– Simulated by use of FLEX cycle for sterilization of a

rigid lumen

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Test load

Test load upper shelf Test load lower shelf

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Manfacturer’s Recommendation

Place pouches on edge

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Experimental setting

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BI (condition) Mean spore count/ml SD Final titer (mean)

unchallenged 5,08E+00 ± 2,81 5,08E+05

300ppm 1,23E+01 ± 4,01 1,23E+06

600ppm 1,77E+01 ± 4,63 1,77E+06

1200ppm 1,37E+01 ± 2,77 1,37E+06

5%FBS 1,88E+01 ± 4,07 1,88E+06

Titer verification

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condition position number 1 2 3 4 5 6 7 8 9 10

untreated cycle 2 nG G nG nG G G nG nG nG nG

cycle 3 nG G nG nG nG nG nG G nG nG

cycle 4 nG G nG nG nG nG nG nG nG nG

negative (%) 100% 0% 100% 100% 66% 66% 100% 66% 100% 100%

300ppm cycle 2 G G G G G G G G G G

cycle 3 G G G G G G G G G G

cycle 4 G G G G G G G G G G

negative (%) 0% 0% 0% 0% 0% 0% 0% 0% 0% 0%

600ppm cycle 2 G nG nG G nG nG G G nG nG

cycle 3 G G G G G G G G G G

cycle 4 G G G G G G G G G G

negative (%) 0% 33% 33% 0% 33% 33% 0% 0% 33% 33%

1200ppm cycle 2 G G G G G G nG G G G

cycle 3 G G G G G G G G G G

cycle 4 G G G G G G G G G G

negative (%) 0% 0% 0% 0% 0% 0% 33% 0% 0% 0%

5% FBS cycle 2 G G G G G G G G G G

cycle 3 G G nG G nG G G G G G

cycle 4 nG G G nG G G G G G G

negative (%) 33% 0% 33% 33% 33% 0% 0% 0% 0% 0%

Qualitative Results

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Quanitative results

wires

0,00

1,00

2,00

3,00

4,00

5,00

6,00

7,00

1 2 3 4 5 6 7 8 9 10

position numbers

log

redu

ctio

n/w

ire

untreated

300ppm

600ppm

1200ppm

5%FBS

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Besides the protocol:

0,00

1,00

2,00

3,00

4,00

5,00

6,00

7,00

1 2 3 4 5 6 7 8 9 10

log

re

du

cti

on

/BI

position numbers

untreated

untreated HS

Untreated wires: Heatshock vs. non Heatshock

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Discussion

• The titer determination of the inoculated wires in unchallenged condition provided by ASP showed a titer of only 5.08 x 105.

• As our quantitative results showed that CFU counts of unchallenged wires found after sterilization were below detection limit, the actual log reduction rate can only be stated as ≥ 5.71.

• Though one can assume, that a SAL of 10-6 could be achieved, a positive verification would have required a higher inoculation of the BI’s.

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• We also cannot rule out that an effect known as

inoculum effect would not influence the test results had

we had a higher initial test inoculum.

• The inoculum effect refers to a decrease of the effect of

a microbicide associated with a higher inoculum as

described for antibiotics and certain disinfectants.

• The increase in bio-burden going along with an

increasing inoculum size would decrease the amount of

available sterilant per bacterial cell. Hence in our case

H2O2 might fail to kill all test-organisms, thus resulting in

inadequate sterilization especially in situations with

heavy contamination and insufficient previous cleaning.

Discussion

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• Inoculum effects must be considered relevant in all

situations where biocides are not abundant in relation to

microbial inocula.

Discussion

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Recommendations regarding the

STERRAD100NX™

• strictly adhere to the manufacturer’s

recommendations specified in their user guide

• correct cycle (Standard or Flex Scope) and

• permitted dimensions for the processing of

medical devices with lumens in the STERRAD

100NX Sterilizer.

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• Nelson DB. Infection control during gastrointestinal endoscopy. J Lab Clin Med 2003 Mar; 141(3):159-67.

• Babb JR, Bradley CR. Endoscope decontamination: where do we go from here? J Hosp Infect 1995 Jun; 30 Suppl: 543-51.

• Ishino Y, Ido K, Sugano K. Contamination with hepatitis B virus DNA in gastrointestinal endoscope channels: risk of infection on

reuse after on-site cleaning. Endoscopy 2005 Jun; 37(6):548-51.

• Kyi MS, Holton J, Ridgway GL. Assessment of the efficacy of a low temperature hydrogen peroxide gas plasma sterilization

system. J Hosp Infect 1995; 31:275-284.

• Rutala WA, Gergen MF, Weber DJ. Comparative evaluation of the sporicidal activity of new low-temperature sterilization

technologies: ethylene oxide, 2 plasma sterilization systems, and liquid peracetic acid. Am J Infect Control 1998 Aug;

26(4):393-8.

• Berube R, Oxborrow GS, Gastaud JW. Sterility testing: Validation of sterilization processes and sporicide testing. In: Block SS,

Ed. Disinfection, Sterilization and Preservation, 5th edn. Lippincott Williams & Wilkins 2001; 1367-1368.

• Anonymous. EN ISO 14937. Sterilization of health care products. General requirements for characterization of sterilizing agent

and the development, validation and routine control of a sterilization process. Berlin: Beuth; 2000.

• Koller W and Lessky E. Microbiological test results and observations with an H2O2 plasma sterilizer. Zentr Steril 1996; 4:79-

87.

• Pflug IJ. Microbiology and Engineering of Sterilization processes, 10th edn. Minneapolis, MN, USA: University of Minnesota

Environmental Sterilization Laboratory 1999.

• Okpara J. Requirements fort the testing of sterilisation processes with Bacillus spores. Zentr Steril 1998; 6(2):96-112.

• Smith DF. Technical information. The Sterrad 100NX Sterilization System. ASP, Johnson and Johnson company.

• Chan-Myers H, McAlister D, Antonoplos P. Natural bioburden levels detected on rigid lumened medical devices before and

after cleaning. Am J Infect Control 1997 Dec; 25(6):471-6.

• Alfa MJ, Olson N, Al-Fadhaly A. Cleaning efficacy of medical device washers in North American healthcare facilities. J Hosp

Infect 2010 Feb; 74(2):168-177. Epub 2009 Aug 27.

• Chu NS, Favero M. The microbial flora of the gastrointestinal tract and the cleaning of flexible endoscopes. Gastrointest

Endosc Clin N Am 2000 Apr; 10(2):233-44.

• Diab-Elschahawi M, Fürnkranz U, Blacky A, Koller W. Re-evaluation of current A0 value recommendations for thermal

disinfection of reusable human waste containers based on new experimental data. J Hosp Infect 2010 May; 75(1):62-5.

• Deutsche Gesellschaft für Krankenhaushygiene: Mitteilung des Vorstandes der DGKH zum aktuellen Erkenntnisstand der

Validierung des Sterrad/E-Plasma-Sterilisationsverfahrens mit den sich ergebenden Schlußfolgerungen für die Praxis. Hyg

Med 1995; 20:52-53.

• Li RC and Ma HH. Parametrization of inoculum effect via mathematical modeling: aminoglycosides against Staphylococcus

aures and Escherichia coli. J Chemother 1998 Jun; 10(3):203-7.

• Koller W, Wewalka G and Rotter M. Special features in the evaluation of aldehyde-free surface and instrument disinfectants.

Hyg Med 1995; 20:8-18.

• Okpara-Hofmann J, Knoll M, Dürr M, Schmitt B, Borneff-Lipp M. Comparison of low-temperature hydrogen peroxide plasma

sterilization for endoscopes using various Sterrad™ models. J Hosp Infect 2005; 59:280-285.

• ASP, Johnson & Johnson: STERRAD® 100NX™ - Users Guide Ref:99970_01 February 2008.

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Thank you for your attention!


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