Decontamination
Conclusion So, is it possible to reduce surgical site infections caused by decontamination? The answer is ‘yes’, if there is an active track and trace system in place to enable traceability through the reprocessing process to ensure IFU processes have been completed and identify training needs. Also, automated processes and thermal disinfection must be used to give the most effective cleaning with repeatability. Automated processes remove risks associated with human factors, while disinfection helps to protect decontamination staff when handling clean instruments. There needs to be good manufacturer-
provided professional education, especially where complex instruments are involved, so that decontamination staff are not guessing or having their own interpretation of IFU. It is possible to reduce surgical site infections caused by decontamination if manufacturers fully GLP validate their IFUs, design medical devices with reprocessing in mind, and make their IFUs clear, usable, and applicable for all regions where the devices are being used. Ultimately, hospitals, sterile services departments, decontamination societies, and medical device manufacturers all need to work together, with the right investment, and one common standard/ guideline to follow. CSJ
References 1. Wong, J., Ho, C., Scott, G., Machin, J. T., & Briggs, T. (2019), Getting It Right First Time: the national survey of surgical site infection rates in NHS trusts in England, Annals of the Royal College of Surgeons of England, 101(7), 463–471.
2. NHS Resolution. Claims Management.
https://resolution.nhs.uk/services/claims- management (Cited April 2019).
3. Dancer, S. J., Stewart, M., Coulombe, C., Gregori, A., & Virdi, M. (2012), Surgical site infections linked to contaminated surgical instruments’, Journal of Hospital Infection, 81(4), 231–238.
4. Whelan, J. (2023), Current issues in reprocessing of medical and surgical instruments, American Journal of Infection Control, 51(10), 1185–1188.
5. Saito, Y., Kobayashi, H., Uetera, Y., Yasuhara, H., Kajiura, T., & Okubo, T. (2014), Microbial
contamination of surgical instruments used for laparotomy, American Journal of Infection Control, 42(1), 43–47.
6. de Lissovoy, G., Fraeman, K., Hutchins, V., Murphy, D., Song, D., & Vaughn, B. B. (2009), Surgical site infection: incidence and impact on hospital utilization and treatment costs., American Journal of Infection Control,, 37(5), 387–397.
7. The Public Health Agency of Canada (2022), Infections liées aux instruments médicaux et aux interventions chirurgicales dans les hôpitaux de soins aigus du Canada de 2011 à 2020. Relevé des maladies transmissibles au Canada 2022, 48(7/8), pp. 357–72.
8. Mitchell, R., Taylor, G., Rudnick, W., Alexandre, S., Bush, K., Forrester, L., Frenette, C., Granfield, B., Gravel-Tropper, D., Happe, J., John, M., Lavallee, C., McGeer, A., Mertz, D., Pelude, L., Science, M., Simor, A., Smith, S., Suh, K. N., Vayalumkal, J., Wong, A., Amaratunga, K., & Canadian Nosocomial Infection Surveillance Program (2019), Trends in healthcare-associated infections in acute care hospitals in Canada: an analysis of repeated point-prevalence surveys, CMAJ : Canadian Medical Association Journal, Journal de l’Association Medicale Canadienne, 191(36), E981–E988.
9. ECRI (2023) About ECRI. Available at:
https://www.ecri.org/about/ (Accessed on 16/10/2023)
10. Expert Insights from Health Devices (2020) Top 10 Health Technology Hazards for 2020. Available at:
https://assets.ecri.org/PDF/ White-Papers-and-Reports/ECRI-Top-10- Technology-Hazards-2020-v2.pdf (Accessed on: 17/10/2023)
11. Lipscomb, I. P., Sihota, A. K., & Keevil, C. W. (2006), Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteinaceous deposits. Journal of Clinical Microbiology, 44(10), 3728–3733.
12. MAUDE - Manufacturer and User Facility Device Experience database (2023) U.S. Food and Drug Administration.
13. AAMI ST98:2022, Cleaning validation of health care products — Requirements for development and validation of a cleaning process for medical devices.
Reprocessing allows the safe reuse of instruments through following validated IFUs. Any deviations from the IFU can lead to the survival of microorganisms and therefore, increased risk of infection.
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www.clinicalservicesjournal.com I May 2024 About the author
Stuart is a decontamination expert and former decontamination manager at CMR surgical. With over 20 years of decontamination experience in both the public and private sectors, he has managed 24/7, 365 days SSD processing in excess of 5 million instruments, plus flexible endoscopes, in both the UK and overseas. Stuart previously managed reprocessing, biocompatibility plus decontamination for CMR Surgical for over three years.
14. Zentral Steril (2013), Guideline for validation of manual cleaning and manual chemical disinfection of medical devices’ Central Service Suppl.,21, pp.212-215.
About the author
Emile is the Head of reprocessing and biocompatibility at CMR Surgical. He is a pharmacist and holds a master’s degree in pharmaceutical technology and a PhD in nanotechnology for biomedical applications from the University of Paris-Saclay with more than 10 years’ experience in in the research and pre-clinical evaluation of biomaterials and medical devices. He is a former associate professor of materials and health in the College of Pharmacy of the University Paris-Saclay and an external expert at the French competent authority (ANSM) for biocompatibility and biological evaluation of medical devices.
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