Report Project No

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1 Report Project No Investigation of Clinical Reprocessed Shavers Client: Firma SMP GmbH Waldhörnlestrasse Tübingen 13.December 2001 Markwiesenstraße 55 D Reutlingen Tel Fax Bericht DAP P08F020 Rev 01 Reprocessing Study2 Seite 1 von 31

2 Table of Contents 1. DOCUMENT OVERVIEW 4 2. SUMMARY 5 3. INTRODUCTION 7 4. MATERIAL AND METHODS Scanning electron microscopy (SEM) Photoelectron spectroscopy (XPS) Samples 9 5. RESULTS TP 05 (Instrument No SHAV-05-00) Description of the specimens LM-analyses SEM-analyses TP 07 (Instrument No SHAV-07-00) Description of the specimens LM-analyses SEM-analyses XPS-analyses TP 14 (Instrument No SHAV-14-00) Description of the specimens LM-analyses SEM-analyses XPS-analyses TP 23 (Instrument No SHAV-23-00) Description of the specimens LM-analyses SEM-analyses XPS-analyses TP 24 (Instrument No SHAV-24-00) Description of the specimens LM-analyses SEM-analyses TP 26 (Instrument No SHAV-26-00) Description of the specimens LM-analyses SEM-analyses 31 Reprocessing Study2 Seite 2 von 31

3 Reprocessing Study2 Seite 3 von 31

4 1. Document Overview Client: Contact: Testing facility: Project No.: Title: Investigation of Clinical Reprocessed Shavers Firma SMP GmbH Waldhörnlestrasse Tübingen Mr. Klaus Roth an der Universität Tübingen Markwiesenstraße 55 D Reutlingen Telefon: (07121) Telefax: (07121) Internet: Investigation of Clinical Reprocessed Shavers Documentation: Material received on date: Test start: Test end: End Report date: Guidelines for the testing facility: EN ISO EN Archivation: Signatures: v:\...\56111_smp_ergebnisbericht.doc Methodes responsibility (MD017 SEM/EDX, MD024 XPS): Project Management: Dipl.-Phys. W. Fr. Dreher / Dr. R. Reichl Quality assurance: Dr. R. Reichl Dr. P. Beckmann DAP-PL The DAP GmbH has accreditied the under the No. DAP-PL according DIN EN ISO/IEC for the - methods MD014, 015, 017, 019, 024, 025 und 033. All investigations of the was fulfilled according internal quality assurance standards. Reprocessing Study2 Seite 4 von 31

5 2. Summary Investigation of Clinical Reprocessed Shavers 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 SHAV Investigations Sample Particles LM SEM XPS Detected elements (>1%) Oxidation layer Particles Oxidation layer Contamination Table 1: Results of LM investigations, SEM and XPS Particles Grooves SHAV Investigations Sample Smooth surface LM SEM XPS Detected elements (>1%) Copper layer Copper layer Particles No visible contamination Table 2: Results of LM investigations, SEM and XPS Fe Cr O C N Si Na P Cu SHAV Investigations Sample Contamination LM SEM XPS Detected elements (>1%) Contamination Polymer defects Contamination Contamination Particles Table 3: Results of LM investigations, SEM and XPS Contamination Particles Fe Cr O C N Si Na P Cu SHAV Reprocessing Study2 Seite 5 von 31

6 Investigations Sample LM SEM XPS Detected elements (>1%) Contamination Particles Material defects No visible contamination Table 4: Results of LM investigations, SEM and XPS Contamination Material defects Fe Cr O C N Si Na P Cu SHAV Investigations Sample Particles LM SEM XPS Detected elements (>1%) Particles Material defects No visible contamination Table 5: Results of LM investigations, SEM and XPS Particles Material defects SHAV Investigations Sample Scratches LM SEM XPS Detected elements (>1%) Particles Material defects No visible contamination Table 6: Results of LM investigations, SEM and XPS Particles Material defects Reprocessing Study2 Seite 6 von 31

7 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 Reprocessing Study2 Seite 7 von 31

8 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: 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: mbar Sensitivity: appr. 1 atom% Reprocessing Study2 Seite 8 von 31

9 4.3. Samples Instrument-No. Instrument Comments SHAV TP 05 Reprocessed and packaged SHAV TP 07 Reprocessed and packaged SHAV TP 14 Reprocessed and packaged SHAV TP 23 Reprocessed SHAV TP 24 Reprocessed SHAV TP 26 Reprocessed and packaged Table 7: Investigated devices, sorted by product code Reprocessing Study2 Seite 9 von 31

10 5. Results TP 05 (Instrument No SHAV-05-00) Description of the specimens Shav Outer tube, distal region Shav Inner tube, distal region Shav Inner tube, proximal region Shav-05-01/02/03 Reprocessing Study2 Seite 10 von 31

11 LM-analyses Fig. 1: SHAV View: Outer tube, distal, inner surface Numerous small particles Fig. 2: SHAV View: Inner tube, distal, inner surface Strong inhomogeneous oxidation (interference colours) Numerous small particles Fig. 3: Probe SHAV View: Inner tube, proximal, outer surface Strong inhomogeneous oxidation (interference colours) Contamination layers Reprocessing Study2 Seite 11 von 31

12 SEM-analyses Fig. 4: SHAV View: Part of LM-Fig.2 Numerous small particles Fig. 5: SHAV View: Part of SEM-Fig. 4 Numerous small particles Deepenings and grooves Reprocessing Study2 Seite 12 von 31

13 TP 07 (Instrument No SHAV-07-00) Description of the specimens Shav-07-01/02/ Shav Outer tube, distal region Shav Inner tube, distal region Shav Inner tube, proximal region Reprocessing Study2 Seite 13 von 31

14 LM-analyses Fig. 1: SHAV View: Outer tube, distal, inner surface Very smooth surface Fig. 2: SHAV View: inner tube, distal, inner surface Copper layer from opposite part. Fig. 3: SHAV View: Inner tube, proximal, inner surface Reprocessing Study2 Seite 14 von 31

15 SEM-analyses Fig. 4: SHAV View: Part of LM-Fig. 2 Particles and presumable copper layers Fig. 5: SHAV View: Part of SEM-Fig. 4 Particles and presumable copper layers Reprocessing Study2 Seite 15 von 31

16 XPS-analyses Specimen Specimen No. : Tube, inner surface IS, distal : SHAV 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 Shav Inner tube, IS, distal region Fe Cr O C N Si Na P Cu 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. Reprocessing Study2 Seite 16 von 31

17 TP 14 (Instrument No SHAV-14-00) Description of the specimens Shav-14-01/02/ Shav Outer tube, distal region Shav , polymer ring, distal region -02; Inner tube, distal region Shav Inner tube, proximal region Reprocessing Study2 Seite 17 von 31

18 LM-analyses Fig. 1: SHAV View: Outer tube, 20mm from tip, distal, inner surface Transparent layers on smooth surface Fig. 2: SHAV View: Outer tube, distal, inner surface Destroyed polymer surface and/or contamination Fig. 3: SHAV View: Outer tube, distal, inner surface Contamination layers Reprocessing Study2 Seite 18 von 31

19 Fig. 4: SHAV View: Outer tube, distal, outer surface Contamination layers Fig. 5: SHAV View: Outer tube, distal, inner surface Local contamination and single particles Reprocessing Study2 Seite 19 von 31

20 SEM-analyses Fig. 6: SHAV View: Part of LM-Fig. 3 Contamination layers and big particle Fig. 7: SHAV View: Part of SEM-Fig. 7 Contamination layers and big particle Reprocessing Study2 Seite 20 von 31

21 XPS-analyses Specimen Specimen No. : Tube, inner surface IS, distal : SHAV 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 Shav Inner tube, IS, distal region Fe Cr O C N Si Na P Cu <1 (0.4) <0, <0,1 <0,1 <0,1 Table 9: 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. Reprocessing Study2 Seite 21 von 31

22 TP 23 (Instrument No SHAV-23-00) Description of the specimens Shav Outer tube, distal region Shav Inner tube, distal region Shav Inner tube, proximal region Shav-23-01/02/03 Reprocessing Study2 Seite 22 von 31

23 LM-analyses Fig. 1: SHAV View: Outer tube, distal, inner surface Contamination on surface Fig. 2: SHAV View: Inner tube, distal, inner surface Numerous particles Layer, defects and fissures in the region of the weld seam Fig. 3: SHAV View: Inner tube, proximal, inner surface Reprocessing Study2 Seite 23 von 31

24 SEM-analyses Fig. 4: SHAV View: Part of LM-Fig. 2 Numerous small particles Layer, defects and fissures in the region of the weld seam Fig. 5: SHAV View: Part of LM-Fig. 4 Numerous small particles Layer, defects and fissures in the region of the weld seam Reprocessing Study2 Seite 24 von 31

25 XPS-analyses Specimen Specimen No. : Tube, inner surface IS, distal : SHAV 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 Shav Inner tube, IS, distal region Fe Cr O C N Si Na P Cu <0,1 <0,1 <0,1 Table 10: 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. Reprocessing Study2 Seite 25 von 31

26 TP 24 (Instrument No SHAV-24-00) Description of the specimens Shav Outer tube, distal region Shav Inner tube, distal region Shav Inner tube, proximal region Shav-24-01/02/03 Reprocessing Study2 Seite 26 von 31

27 LM-analyses Fig. 1: SHAV View: Outer tube, distal, inner surface Single particles Fig. 2: SHAV 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: SHAV View: Inner tube, proximal, inner surface Reprocessing Study2 Seite 27 von 31

28 SEM-analyses Fig. 4: SHAV View: Part of LM-Fig. 2 Small particles Layer, structure defects, holes Fig. 5: SHAV View: Part of SEM-Fig. 4 Small particles Layer, structure defects, holes Reprocessing Study2 Seite 28 von 31

29 TP 26 (Instrument No SHAV-26-00) Description of the specimens Shav-26-01/02/ Shav Outer tube, distal region Shav Inner tube, distal region Shav Inner tube, proximal region Reprocessing Study2 Seite 29 von 31

30 LM-analyses Fig. 1: SHAV View: Outer tube, distal, inner surface Scratches in radial direction Fig. 2: SHAV View: Inner tube, distal, inner surface Numerous particles Layer, defects and fissures in the region of the weld seam Fig. 3: SHAV View: Inner tube, proximal, inner surface Reprocessing Study2 Seite 30 von 31

31 SEM-analyses Fig. 4: SHAV 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: SHAV View: Part of SEM-Fig. 4 Numerous particles Layer, defects and fissures in the region of the weld seam. Surface with deepenings and grooves. Reprocessing Study2 Seite 31 von 31