Report Project No. 56111 - Smith & Nephew - Corporate · 56111-SHAV-05-00 26 00 TP 05 Reprocessed and packaged ... LM-analyses Fig. 1: 56111-SHAV-05-01 View: Outer tube, distal, inner

NMI Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen

Markwiesenstraße 55 D-72770 Reutlingen Tel. 0 71 21 5 15 30 - 0 Fax 0 71 21 5 15 30 - 16

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Bericht DAP P08F020 Rev 01 Reprocessing Study2 Seite 1 von 31

Report Project No. 56111

Investigation of Clinical Reprocessed Shavers

Client:

Firma SMP GmbH Waldhörnlestrasse 22 72072 Tübingen

13.December 2001




Reprocessing Study2 Seite 2 von 31

Table of Contents

1. DOCUMENT OVERVIEW 4

2. SUMMARY 5

3. INTRODUCTION 7

4. MATERIAL AND METHODS 7

4.1. Scanning electron microscopy (SEM) 8

4.2. Photoelectron spectroscopy (XPS) 8

4.3. Samples 9

5. RESULTS 10

5.1. 26 00 TP 05 (Instrument No. 56111-SHAV-05-00) 10 5.1.1. Description of the specimens 10 5.1.2. LM-analyses 11 5.1.3. SEM-analyses 12

5.2. 26 00 TP 07 (Instrument No. 56111-SHAV-07-00) 13 5.2.1. Description of the specimens 13 5.2.2. LM-analyses 14 5.2.3. SEM-analyses 15 5.2.4. XPS-analyses 16













1. Document Overview

Client: Firma SMP GmbH Waldhörnlestrasse 22 72072 Tübingen

Contact: Mr. Klaus Roth

Testing facility: NMI Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen Markwiesenstraße 55 D-72770 Reutlingen Telefon: (07121) 51530-11 Telefax: (07121) 51530-16 Internet: http://www.nmi.de

NMI Project No.: 56111

Title: Investigation of Clinical Reprocessed Shavers

Documentation: Material received on date: 26.09.2001 Test start: 04.11.2001 Test end: 12.12.2001 End Report date:13.12.2001

Guidelines for the testing facility: EN ISO 14630 EN 12006-3

Archivation: v:\...\56111_SMP_Ergebnisbericht.doc

Signatures:

Methodes responsibility (MD017 SEM/EDX, MD024 XPS):

Dipl.-Phys. W. Fr. Dreher / Dr. R. Reichl Project Management:

Dr. R. Reichl Quality assurance:

Dr. P. Beckmann

DAP-PL-3420.00

The DAP GmbH has accreditied the NMI under the No. DAP-PL-3420.00 according DIN EN ISO/IEC 17025 for the NMI- methods MD014, 015, 017, 019, 024, 025 und 033. All investigations of the NMI was fulfilled according internal quality assurance standards.

http://www.nmi.de/





2. Summary

6 reprocessed shavers have been investigated with light microscopy (LM), scanning electron microscopy (SEM) and 3 of them with X-ray photoelectron spectroscopy (XPS). The investigation yieleded that due to the high number of revolutions of the inner tube the bearing regions are highly loaded showing strong inhomogeneous oxidation layers often combined with material defects and particles. Furthermore contamination was observed on some instruments. 56111-SHAV-05-00

Investigations Sample

LM SEM XPS Detected elements (>1%)

05-01

Particles

05-02

Oxidation layer Particles

Particles Grooves

05-03

Oxidation layer Contamination

Table 1: Results of LM investigations, SEM and XPS 56111-SHAV-07-00



07-01

Smooth surface

07-02

Copper layer Copper layer Particles

Fe Cr O C N Si Na P Cu 1 2 28 54 2 2 4 1 6

07-03

No visible contamination




14-01

Contamination

14-02-01

Contamination Polymer defects

Contamination Particles

Fe Cr O C N Si Na P Cu 17 77 1 5

14-02-02

Contamination

14-03

Contamination Particles








23-01

Contamination

23-02

Particles Material defects

Contamination Material defects

Fe Cr O C N Si Na P Cu 4 1 23 68 1 3

23-03





24-01

Particles

24-02



24-03





26-01

Scratches

26-02



26-03


Table 6: Results of LM investigations, SEM and XPS





3. Introduction

The study presented here examines the potential problems and risks of reprocessed instruments due to possible contamination and damage after clinical use and reprocessing. Contamination and damage have been to be located and analyzed visual and with surface- and microstructural analytical methods like light microscopy (LM), scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS). 4. Material and Methods

The testing of the devices includes 1) Visual inspection and documentation of the device and package (if existing) without opening sterile

barrier 2) Visual inspection and documentation of device after removal from package (if existing) 3) Dividing devices into portions (specimens) 4) Investigation of special specimens by Light microscopy (LM) 5) Investigation of special specimens by Scanning electron microscopy (SEM) 6) Investigation of one specimen by Photoelectron spectroscopy (XPS), if necessary





4.1. Scanning electron microscopy (SEM)

Using a scanning electron microscope the structure and topochemistry of a surface can be investigated. Scanning the surface with an electron beam the intensity of the generated secondary electrons determines the brightness of the pixel. This intensity is affected both by the orientation of the surface to the detector and the electronic work function of the secondary electrons and therefore the chemical composition of the investigated surface. Device: Cambridge S 90 Acceleration voltage: 10 / 25 kV Sputtering: Gold Observation angle: 45°

4.2. Photoelectron spectroscopy (XPS)

Monoenergetic soft X-rays produced in a X-ray source penetrate the surface of a solid and interact with the atoms in the surface region by the photoelectric effect. The emitted electrons provide quantitative data about the elemental composition of the surface in question and of the oxidation state of the identified elements. So the chemical composition and the chemical binding states of the identified elements can be determined. Apart from hydrogen and helium all elements are detectable. Due to the kinetic energy of the detected electrons in the range of 50 eV up to 1500 eV the technique has an information depth of only a few atomic layers. XPS is therefore very sensitive to parts of an atomic monolayer like invisible surface contamination. Device: VG ESCALAB 200 Irradiation: MgKα Diameter of area of measurement: ∅ 1 mm Depth of information: 1-10 nm Residual gas pressure: 10-10 mbar Sensitivity: appr. 1 atom%





4.3. Samples

Instrument-No. Instrument

Comments

56111-SHAV-05-00 26 00 TP 05 Reprocessed and packaged



56111-SHAV-23-00 26 00 TP 23 Reprocessed

56111-SHAV-24-00 26 00 TP 24 Reprocessed


Table 7: Investigated devices, sorted by product code





5. Results

5.1. 26 00 TP 05 (Instrument No. 56111-SHAV-05-00)

5.1.1. Description of the specimens

56111-Shav-05-01/02/03

56111-Shav-05-01 Outer tube, distal region

56111-Shav-05-02 Inner tube, distal region

56111-Shav-05-03 Inner tube, proximal region

0302

01





5.1.2. LM-analyses

Fig. 1: 56111-SHAV-05-01

View: Outer tube, distal, inner surface Numerous small particles

Fig. 2: 56111-SHAV-05-02

View: Inner tube, distal, inner surface Strong inhomogeneous oxidation (interference colours) Numerous small particles

Fig. 3: Probe 56111-SHAV-05-03

View: Inner tube, proximal, outer surface Strong inhomogeneous oxidation (interference colours) Contamination layers





5.1.3. SEM-analyses

Fig. 4: 56111-SHAV-05-02

View: Part of LM-Fig.2 Numerous small particles

Fig. 5: 56111-SHAV-05-02

View: Part of SEM-Fig. 4 Numerous small particles Deepenings and grooves







56111-Shav-07-01/02/03




02 03

01





5.2.2. LM-analyses

Fig. 1: 56111-SHAV-07-01

View: Outer tube, distal, inner surface Very smooth surface

Fig. 2: 56111-SHAV-07-02

View: inner tube, distal, inner surface Copper layer from opposite part.

Fig. 3: 56111-SHAV-07-03

View: Inner tube, proximal, inner surface





5.2.3. SEM-analyses

Fig. 4: 56111-SHAV-07-02

View: Part of LM-Fig. 2 Particles and presumable copper layers

Fig. 5: 56111-SHAV-07-02

View: Part of SEM-Fig. 4 Particles and presumable copper layers





5.2.4. XPS-analyses

Specimen : Tube, inner surface IS, distal Specimen No. : 56111-SHAV-07-02 For quantification of the elements a homogeneous distribution of the elements was assumed. Hydrogen was not taken into account. The calculated concentrations of elements at the surface of the specimen are listed in the following table.

conc. [at%*] Sample

Fe Cr O C N Si Na P Cu

56111-Shav-07-02 Inner tube, IS, distal region

1 2 28 54 2 2 4 1 6

Table 8: Quantification of detected elements at the surface of the specimen

100%-calculation, homogeneous distribution and without consideration of hydrogen and helium. Detection range: All elements without H and He Detection limit: < 1 at% Information depth: 2-7 nm Accuracy of quantitative analysis: <± 30% from measured value without standard

<± 5% from measured value with standard The investigations of the element concentrations yield normal contamination concentrations corresponding to standard surfaces. Note the copper layer comming from the opposite copper part.







56111-Shav-14-01/02/03


56111-Shav-14-02- -01, polymer ring, distal region -02; Inner tube, distal region


02 03

01





5.3.2. LM-analyses

Fig. 1: 56111-SHAV-14-01

View: Outer tube, 20mm from tip, distal, inner surface Transparent layers on smooth surface

Fig. 2: 56111-SHAV-14-02-01

View: Outer tube, distal, inner surface Destroyed polymer surface and/or contamination

Fig. 3: 56111-SHAV-14-02-02

View: Outer tube, distal, inner surface Contamination layers





Fig. 4: 56111-SHAV-14-02-02

View: Outer tube, distal, outer surface Contamination layers

Fig. 5: 56111-SHAV-14-03

View: Outer tube, distal, inner surface Local contamination and single particles





5.3.3. SEM-analyses

Fig. 6: 56111-SHAV-14-02-02

View: Part of LM-Fig. 3 Contamination layers and big particle

Fig. 7: 56111-SHAV-14-02-02

View: Part of SEM-Fig. 7 Contamination layers and big particle





5.3.4. XPS-analyses


Conc. [at%*] Sample


56111-Shav-14-02-02 Inner tube, IS, distal region

<1 (0.4)

<0,1 17 77 1 5 <0,1 <0,1 <0,1



<± 5% from measured value with standard The investigations of the element concentrations yield normal contamination concentrations corresponding to standard surfaces.







56111-Shav-23-01/02/03




02 03

01





5.4.2. LM-analyses

Fig. 1: 56111-SHAV-23-01

View: Outer tube, distal, inner surface Contamination on surface

Fig. 2: 56111-SHAV-23-02

View: Inner tube, distal, inner surface Numerous particles Layer, defects and fissures in the region of the weld seam

Fig. 3: 56111-SHAV-23-03






5.4.3. SEM-analyses

Fig. 4: 56111-SHAV-23-02

View: Part of LM-Fig. 2 Numerous small particles Layer, defects and fissures in the region of the weld seam

Fig. 5: 56111-SHAV-23-02

View: Part of LM-Fig. 4 Numerous small particles Layer, defects and fissures in the region of the weld seam





5.4.4. XPS-analyses


Conc. [at%*] Sample


56111-Shav-23-02 Inner tube, IS, distal region

4 1 23 68 1 3 <0,1 <0,1 <0,1



<± 5% from measured value with standard The investigations of the element concentrations yield normal contamination concentrations corresponding to standard surfaces.







56111-Shav-24-01/02/03




02 03

01





5.5.2. LM-analyses

Fig. 1: 56111-SHAV-24-01

View: Outer tube, distal, inner surface Single particles

Fig. 2: 56111-SHAV-24-02

View: Inner tube, distal, inner surface Numerous particles especially in the round tip

Layer, defects and fissures in the region of the weld seam Rough surface structure with local big deepenings(SEM-Fig.4+5)

Fig. 3: 56111-SHAV-24-03






5.5.3. SEM-analyses

Fig. 4: 56111-SHAV-24-02

View: Part of LM-Fig. 2 Small particles Layer, structure defects, holes

Fig. 5: 56111-SHAV-24-02

View: Part of SEM-Fig. 4 Small particles Layer, structure defects, holes







56111-Shav-26-01/02/03




02 03

01





5.6.2. LM-analyses

Fig. 1: 56111-SHAV-26-01

View: Outer tube, distal, inner surface Scratches in radial direction

Fig. 2: 56111-SHAV-26-02

View: Inner tube, distal, inner surface Numerous particles

Layer, defects and fissures in the region of the weld seam

Fig. 3: 56111-SHAV-26-03






5.6.3. SEM-analyses

Fig. 4: 56111-SHAV-26-02

View: Part of LM-Fig. 2 Numerous particles Layer, defects and fissures in the region of the weld seam. Surface with deepenings and grooves.

Fig. 5: 56111-SHAV-26-02

View: Part of SEM-Fig. 4 Numerous particles Layer, defects and fissures in the region of the weld seam. Surface with deepenings and grooves.

Documents

Report Project No. 56111 - Smith & Nephew - Corporate · 56111-SHAV-05-00 26 00 TP 05 Reprocessed and packaged ... LM-analyses Fig. 1: 56111-SHAV-05-01 View: Outer tube, distal, inner