Systematic Review of Black Spots Found on Reprocessed Reusable Medical Devices

Gerald Chan 1, John Pereira 2, Victoria D’Abrera 3

St John Of God Murdoch Hospital, Murdoch, WA, Australia

Fiona Stanley Hospital (Serco), Murdoch, WA, Australia

St John of God Pathology, Osborne Park, WA, Australia


Introduction: The reprocessing of reusable medical devices (RMDs) plays a significant role in the prevention and control of surgical site related infections. Compliance with the Australian Standards in the cleaning, disinfecting and sterilisation of RMDs is paramount in ensuring high quality patient care.

Between 2010 and 2012, black spots were detected on reprocessed RMDs as well as in washer disinfector chambers in a central sterilization services department (CSSD) at our hospital.

– determine the nature of the black spots as microbial or inorganic;
– identify the potential source(s) of the black spots;
– review surgical site infection (SSI) surveillance for any correlation.

Method: A systematic review was undertaken to identify potential intrinsic/extrinsic sources for the black spot contaminants seen on reprocessed RMDs. The black spots were analysed under pyrolysis, Fourier Transform Infrared Spectroscopy (FTIR), gas chromatography, and mass spectroscopy. Any black material in the reprocessing chain was also analysed. A review of the water supply system to the CSSD was undertaken. SSI surveillance trends were closely monitored and reviewed for potential peaks in infections.

Results: Analysis revealed the black spots were comprised of styrene/methyl methacrylate co-polymer and identified in pre-mixed bone cement compound. There was no correlation with SSI rates.

Conclusion: A significant rise in orthopaedic joint arthroplasty numbers saw an increase in the use of bone cement compounds. The fine dust from these pre-mixed bone cement compounds contributed to the formation of black spots seen in reprocessed RMDs.

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