90-335!82!04 Reinigungsgutachten MarSeal En

8/4/2019 90-335!82!04 Reinigungsgutachten MarSeal En

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Fon: ++49 (0) 70 71 / 857 893-100

Fax: ++49 (0) 70 71 / 857 893 100Email [email protected]

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SMP GmbH Service fr Medizinprodukte

Hechingerstrasse 262 72072 Tbingen


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Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80-630-09 page 2 from 10Publications or copies are only allowed of the complete report.

ein Projekt des in Kooperation mit

7DEOHRIFRQWHQWV1. Overview:................................................................................................................ 3

2. Objective of investigation ........................................................................................ 4

3. Conclusion .............................................................................................................. 4

4. Material and methods ............................................................................................. 54.1 Preparation of the test soil................................................................................. 54.2 Contamination ................................................................................................... 54.3 Cleaning............................................................................................................ 64.4 Second Measurement with the Gamma camera ............................................... 74.5 Devices and reagents........................................................................................ 74.6 Instruments under investigation......................................................................... 7

5. Results.................................................................................................................... 8

5.1 Run 1 (29/08) .................................................................................................... 85.2 Run 2 (34/08) .................................................................................................. 105.3 Run 3 (39/08) .................................................................................................. 12

7. Appendix: Logger data.......................................................................................... 15


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2EMHFWLYHRILQYHVWLJDWLRQThe objective of this experiment is, to evaluate the cleaning behavior of the bipolarmarseal and marseal handle with the radionuclide method.

The radionuclide method (RNM) is a non-destructive test procedure, which allows theinvestigation of the cleaning behavior of tubular instruments and instruments withhidden corners. After artificial contamination and cleaning of the inner surfaces of theinstrument as well as of the outside, residues can be made visible with the help ofgamma radiation. The basic idea is to label the test soil prior to the contamination ofthe instrument. The exact distribution of the contamination can be checked anddocumented before and after cleaning. For labeling macro albumins (known from thelung perfusion scintigraphy) with radioactive 99m Technetium (Tc-99m) are used andmixed with fresh coagulable blood.5 counts/sec (Zr-value in tables of run 1 3; see chapter 5) is the threshold value forexcellent cleaning results. Values above 5 counts/sec can be tolerable, when a risk

analysis is performed, which takes into consideration the amount of contaminationand location before and after the cleaning process, the size of the device and theway how it is been used.

&RQFOXVLRQThe investigation shows that the handle and the tube of the bipolar MIC instrumentmarSeal can be successfully cleaned. The DYHUDJH of the detected contamination is 5 count/s. The instruments placed forceps upside show a slightly increase of

contamination after cleaning.Test result in SMP investigation No:11107011407 show, that a coagulation ofcontaminated tissue after HF current impact does not cause a fixation of coagulated

blood on the instrument.&OHDQLQJVWHSVFor the cleaning procedure the instrument is dismantled.

0DQXDOO\SUHFOHDQLQJ

Put the instruments in an ultrasonic bath for 5 minutes with 0,5%neodischer Mediclean Forte (Dr. Weigert) at 40C

All parts of the instruments are flushed with a water jet pistol with cold tapwater for at least 10 sec. (3,8 bar static water pressure)

Scrub thoroughly using a soft brush

Cleaning of forceps and hinge with special KLS Martin tool

5HSURFHVVLQJLQDZDVKHUGLVLQIHFWRUConnecting the instruments to the MIC-rack of the washer disinfectorThe instruments are cleaned with the following program (Vario TD, only thecleaning steps are performed):

2 min pre-washing with cold water

emptying

5 min washing with 0,5 % neodischer Mediclean Forte (Dr. Weigert)by 55C

emptying


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3 min neutralizing with warm water (>40C)

emptying 2 min intermediate rinsing with warm water (>40C) emptying

0DWHULDODQGPHWKRGV

3UHSDUDWLRQRIWKHWHVWVRLOA flask Pulmocis is labelled by 400 MBq Technetium99m and filled up to the volume

of 5 mL with 0,9% sodiumchloride solution. Heparinized sheep blood andprotaminsulfat is added.

Mixing ratio of the test soil ingredients:

9 mL heparinized sheep blood (Acila GMN)

100 MBq Technetium99m (~ 0,9 mL) 150 L Protaminsulfat

&RQWDPLQDWLRQ

5 devices are marked with different colors.Contamination is performed in plastic cup filled with the test-soil (1). The instrumentsare submerged into the test-soil up to the hinge of the forceps (2). In this position theforceps are affected 3 times.After the contamination, the tubes are placed in a basket: 4 of the five tubes withforceps down, one tube with forceps up to simulate the worst case. In this position itis possible for the test soil to get inside the tube.Additional the part of this tube, which is connected with the handle, is contaminated

by touching with contaminated gloves. In the next step this tube is assembled withthe handle to transfer the contamination inside the handle.After 5 minutes coagulation is insisted, the instruments dried for 1 hour at roomtemperature. Then the emission of the gamma quanta and the distribution on andinside the instruments are measured by a gamma camera.

Figure 1: Example of the contamination procedure

2

1


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&OHDQLQJThe cleaning process starts 60 minutes after the contamination of the instruments.

&OHDQLQJVWHSV

For the cleaning procedure the instrument is dismantled.0DQXDOO\SUHFOHDQLQJ

Put the instruments in an ultrasonic bath for 5 minutes with 0,5%neodischer Mediclean Forte (Dr. Weigert) at 40C

All parts of the instruments are flushed with a water jet pistol with cold tapwater for at least 10 sec. (3,8 bar static water pressure)

Scrub thoroughly using a soft brush

Cleaning of forceps and hinge with special KLS Martin tool

5HSURFHVVLQJLQDZDVKHUGLVLQIHFWRUConnecting the instruments to the MIC-rack of the washer disinfector

The instruments are cleaned with the following program (Vario TD, only thecleaning steps are performed):

2 min pre-washing with cold water

emptying

5 min washing with 0,5 % neodischer Mediclean Forte (Dr. Weigert)by 55C

emptying

3 min neutralizing with warm water (>40C)

emptying

2 min intermediate rinsing with warm water (>40C)

emptying


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6HFRQG0HDVXUHPHQWZLWKWKH*DPPDFDPHUDAfter cleaning, the instruments are measured again using the gamma camera.Regions of interest (ROI) are defined to allow subsequent determination of exactareas of residual contamination in the individual instruments. The results aredocumented and residual contamination is determined on the basis of the remaining

activity. Only the Zr value given in the table is used for the evaluation of the residualcontamination. The other values are data recorded by the camera, or which arerecorded during the test and which serve only as a basis for the calculation of the Zrvalue.Zr: counts/sec with correction of time-dependent gamma decay of metastabletechnetium 99 (half-life 6,01 h)

'HYLFHVDQGUHDJHQWV- washer disinfector (Miele)

- MIC rack (E 450)- gamma camera (Gaede GMS 586)- Curiementor-E (Semens)- Ultrasonic bath Sonorex (Bandein)- magnetic stirrer- neodischer Mediclean Forte (Dr. Weigert)- Syringe- Beaker- heparinised sheep blood Lot: 18477 (Acila GMN)- Pulmocis (CIS bio international)

- Protaminsulfat (Acila GMN)- Technetium99m

- gloves (Satin plus, Safe skin)- Data logger for temperature and pressure Ebi -125A-PT (Ebro)

,QVWUXPHQWVXQGHULQYHVWLJDWLRQFor the investigation five instruments are used.

Figure 2 bipolar marseal Ref: 80-630-02 370 mmmarseal handle Ref: 80-630-09

HandleInner shaft

marseal Instrument


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5HVXOWV

5XQInstruments have been washed with a procedure described under 4.3.

! " # % & ' ( 0 2 4 7 2 !

A B

C D E G 4 H P Q 2 R T G U V H

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A

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d b C 4 d

A B

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A B

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B

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A u v

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B u y

t G U b

2 5 4 H G t

2

A

V b

B B

G $ Q s T

H G H

B

G t

H G H

B

d

8150 264 1,4 0 150 H G H

B

b

6608 264 1,4 0 150 H G H

B y B

t

2860 299 1,4 0 150 H G H

B

V

B B

T

v

7848 299 1,4 0 150 H G H

B v

U

7487 299 1,4 0 150 U H d

B

U H d

B

d

3001 3174 1,4 5 150 U H d

B

y B

t

3973 3243 1,4 5 150 U H d

B

b

2841 3243 1,4 5 150 U H d

B

V

B B

T

v 2001 3243 1,4 5 150 U H d

B

v

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465 3174 1,4 5 150 2 5 4 H G t

2

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B B

G $ Q s T

H G H

B

G t

H G H

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d

84 210 1,4 128 150 G U H

103 1251 1,4 128 150 H G H

B

b

195 189 1,4 128 150 G U H

83 1251 1,4 128 150 H G H

B y B

t

109 210 1,4 128 150 G U H

89 1251 1,4 128 150 H G H

B

V

B B

T

v 162 210 1,4 128 150 G U H

96 1251 1,4 128 150 H G H

B v

U

266 189 1,4 128 150

G U H

131 1251 1,4 128 150

U H d

B

d

339 3174 1,4 132 150 U H d

B

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303 3243 1,4 132 150 U H d

B

b

280 3243 1,4 132 150 U H d

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B B

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v 303 3243 1,4 132 150 U H d

B

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251 3243 1,4 132 150

4

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H T j k q q l

after contamination

after pre-cleaning


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m n o

after cleaning

{

73 230 1,4 172 150 |} ~

109 1341 1,4 172 150

104 230 1,4 172 150 |} ~

95 1341 1,4 172 150

104 230 1,4 172 150 |

} ~

90 1341 1,4 172 150

150 230 1,4 172 150 } ~

115 1341 1,4 172 150 ~ }

246 230 1,4 172 150 } ~

134 1341 1,4 172 150 |

}

~ { {

310 3174 1,4 176 150 ~ {

271 3243 1,4 176 150

~ {

242 3243 1,4 176 150 |

~ {

237 3243 1,4 176 150 |

~ { ~ }

230 3243 1,4 176 150 |

1RWRI5XQInstrument white to simulate the worst case. In this position it is possible for the testsoil to get inside the tube.(see chapter 4.2)


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P

7610 288 1,4 0 150

3120 288 1,4 0 150

2689 299 1,4 0 150

3624 276 1,4 0 150

3831 299 1,4 0 150

3709 3519 1,4 4 150

3374 3519 1,4 4 150

3544 3640 1,4 4 150

6999 3712 1,4 4 150

3919 3519 1,4 4 150

386 160 1,4 108 150

86 1071 1,4 108 150

235 144 1,4 108 150

87 952 1,4 108 150

96 160 1,4 108 150

84 1071 1,4 108 150

210 144 1,4 108 150

61 952 1,4 108 150

97 144 1,4 108 150

75 952 1,4 108 150

242 3519 1,4 112 150

261 3519 1,4 112 150

388 3640 1,4 112 150

466 3712 1,4 112 150

332 3519 1,4 112 150

after contamination

after pre-cleaning


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after cleaning

123 198 1,4 121 150

89 1170 1,4 121 150

107 198 1,4 121 150

91 1053 1,4 121 150

49 198 1,4 121 150

84 1170 1,4 121 150

123 198 1,4 121 150

83 1053 1,4 121 150

56 176 1,4 121 150

101 1053 1,4 121 150

220 3519 1,4 125 150

277 3519 1,4 125 150

321 3640 1,4 125 150

332 3712 1,4 125 150

274 3519 1,4 125 150

1RWRI5XQInstrument red to simulate the worst case. In this position it is possible for the test soilto get inside the tube.(see chapter 4.2)


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P

6073 288 1,4 0 150

7065 312 1,4 0 150

6441 288 1,4 0 150

4347 288 1,4 0 150

6290 312 1,4 0 150

7149 3082 1,4 5 150

4705 3128 1,4 5 150

3845 3082 1,4 5 150

2999 3082 1,4 5 150

4538 3128 1,4 5 150

307 180 1,4 86 150

61 882 1,4 86 150

391 180 1,4 86 150

87 882 1,4 86 150

311 200 1,4 86 150

63 882 1,4 86 150

346 180 1,4 86 150

67 882 1,4 86 150

90 200 1,4 86 150

71 882 1,4 86 150

314 3082 1,4 96 150

286 3128 1,4 96 150

283 3082 1,4 96 150

275 3082 1,4 96 150

516 3082 1,4 96 150

after contamination

after pre-cleaning


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after cleaning

291 180 1,4 131 150

61 882 1,4 131 150

223 180 1,4 131 150

68 882 1,4 131 150

239 200 1,4 131 150

47 882 1,4 131 150

275 180 1,4 131 150

50 882 1,4 131 150

83 180 1,4 131 150

75 882 1,4 131 150

285 3082 1,4 135 150

267 3128 1,4 135 150

261 3082 1,4 135 150

274 3082 1,4 135 150

314 3082 1,4 135 150

1RWRI5XQInstrument yellow to simulate the worst case. In this position it is possible for the testsoil to get inside the tube.(see chapter 4.2)


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6. References:

Draft Standard Test Method for Validation of cleaning cycles forreusable medical devices with lumens and hidden surfaces. This

test method is under the jurisdiction of ASTM Committee F04Medical and Surgical Devices and is the direct responsibility ofSubcommittee F04.35 GI Endoscopes.

TIR 30 TIR 30 A compendium of processes, materials, test methods,acceptance criteria for cleaning reusable medical devices

ISO 17664 Publication date:2004-03 Sterilization of medical devices - Information tobe provided by the manufacturer for the processing of resterilizablemedical devices

EN ISO 15883-1:2006 Publication date:2006, Washer/-disinfectors - Part 1: Generalrequirements, terms and definitions and tests; German version EN ISO15883-1:2006

EN ISO 15883-2:2006 Publication date:2006 Washer/-disinfectors - Part 2: Requirements andtests for washer/disinfectors employing thermal disinfection for surgicalinstruments, anaesthetic equipment, bowls, dishes receivers, utensils,glassware, etc. (ISO 15883-2:2006); German version EN ISO 15883-2:2006


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Fig.3: Pressure and temperature logger diagram


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04.08 90-335-82-04 Printed in Germany Copyright by Gebrder Martin GmbH & Co. KG Alle Rechte vorbehalten Technische nderungen vorbehaltenWe reserve the right to make alterations Cambios tcnicos reservados Sous rserve de modifications techniques Ci riserviamo il diritto di modifiche tecniche

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Postfach 60 D-78501 Tuttlingen/Germany

Tel. +49 7461 706-0 Fax +49 7461 706-193

[email protected] www.klsmartin.com

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90-335!82!04 Reinigungsgutachten MarSeal En

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