Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants.

BACKGROUND: The acquisition of reusable surgical instruments (RSIs) through loaner system is a worldwide phenomenon, particularly in orthopaedic surgeries. Loaner sets contain high-complex design RSIs, which are very difficult to clean, and also include single use implants, such as screws, that remain in the surgical tray and are subjected to multiple reprocessing until they are implanted. Inadequate cleaning of SI and various exposures of single-use implants to physical, chemical and biological agents can compromise their quality/safety and promote biofilm formation. The difficulty in cleaning is compounded in middle and low-income countries where automated cleaning infrastructure at sterilizing service units is often unavailable, and thus manual cleaning only is performed. Thus, we aimed to determine the condition of orthopaedic loaned sets when delivered to the hospital, assess the quality of complex-design RSIs reprocessed by manual cleaning, and evaluate the effect of multiple reprocessing on single-use implant (screw). METHODS: Flexible medullary reamers (FMRs), depth gauges and screws used for femur intramedullary nailing, in clinical use for >1 year, were obtained from three Brazilian loaner companies and assessed for residual ATP, protein, bacterial contamination, endotoxin and/or biofilm at delivery at the hospital, following cleaning and steam sterilisation. RESULTS: Before cleaning, blood was visible on a RSIs tray, and RSIs/screws were contaminated with high amounts of ATP, protein and bacteria. Visible soil was released during brushing of a FMR lumen and, following cleaning, the inner layer of 34/40 were visible soiled, and over 5/8 were protein test positive. Following sterilisation, biofilm and soil, including fragments appearing to be bone, were detected by scanning electron microscopy on RSIs/screws. A sterilised FMR revealed visible soil on the inner layer. Endotoxin tests were negative. CONCLUSION: The contaminated condition of loaned-complex-designed RSIs/screws upon arrival at the hospital and after reprocessing points to the insufficiency of manual reprocessing and management practices related to this instruments/implants. A multidisciplinary approach involving expert in design/manufacture, regulating, managing, reprocessing and surgeons is suggested to improve RSIs manufacture that enables complete decontamination and maintain the surgical patient safety.

Zero Tolerance in Medical Loaner Instrumentation and Implantables Quality Management in US / 中华医院感染学杂志

OBJECTIVE To introduce and discuss the quality management system of medical loaner instrumentation and implantables in the US.METHODS With US national standards and industry guidelines on loaner instrumentation and implantables,and the practical problems we encountered in China on this subject,we will discuss their quality management.RESULTS We should apply whole process quality management to loaner instrumentation and implantables.CONCLUSIONS Zero tolerance quality management in loaner instrumentation and implantables is crucial for medical safety.