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Instrument Staining - Medical Devices

Corrosion? Surface residue? Water mark? Unknown discoloration? Oxidation issues? 

If you need to identify and prevent staining or discoloration on surgical and medical instruments then our experts can help.  Whether the discoloration is present after manufacturing (e.g. machining), post-processing (e.g. passivation or laser marking), re-processing via cleaning and sterilization, or use in the field, our state-of-the-art laboratories have a variety of different analytical techniques to quickly identify and characterize the stains.  Approaches can include combinations of techniques aimed at identifying, quantifying, and/or imaging elemental and molecular information within the discoloration and/or stain, such as:  

  • Surface science techniques, i.e. SEM, ToFSIMS, XPS, DSIMS, and EPMA
  • Direct chemical analysis approaches such as FTIR
  • Extraction and analytical chemistry techniques such as GC-MS, GC-FID, IC, ICP-OES, etc.

Our many years of expertise is then applied to identify the cause and recommend corrective and/or preventative actions. Quickly implementing such measures to prevent re-occurrence is paramount to manufacturing efficiency, patient safety and brand reputation.

Surface Science

Our surface science laboratories are run by world leading experts in their field.  We routinely carry out surface analysis to characterize instrument staining for manufacturers of medical devices, implants and instruments.  Common analysis techniques include:

Time of Flights Secondary Ion Mass Spectroscopy (ToFSIMS) is a qualitative technique that provides detailed molecular information of the outer surface of samples, in ppb sensitivity.  ToFSIMS is routinely used to fingerprint molecular species against suspected contaminants.

X-Ray Photoelectron Spectroscopy (XPS) provides fully quantified elemental and oxidation-state information (bonding environment) from the outer 3-8nm of the surface and is sensitive to 0.1At %.  All elements except H and He are detected.  XPS can be used to quantify the chemical difference on stained areas and unstained areas.

Scanning Electron Microscopy with Energy Dispersive X-Ray (SEM/EDX) is another technique that can be used.  This provides semi-quantitative, spatially resolved elemental analysis with rapid, high resolution imaging.

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Resources

  • White Paper

    Cleaning and Sterilization Validation of Reusable Medical Devices
    pdf (329 KB)

  • Data Sheet

    Medical Instrument Services
    pdf (300 KB)