Biofilme em parafusos ortopédicos prontos para uso adquiridos por meio de sistema de consiganação/comodato / Biopelícula en tornillos ortopédicos listos para uso adquiridos por medio del sistema de consignación/comodato / Biofilm on patient-ready orthopaedic screws acquired through the loaner system

Resumo Objetivo Avaliar a integridade da superfície e as condições microbiológicas de parafusos prontos para uso em bandejas ortopédicas após múltiplos processamentos. Métodos Após o processamento completo, as bandejas utilizadas em cirurgias de pequenos fragmentos, fornecidas por meio de sistema de consignação/comodato em um hospital brasileiro, foram selecionadas aleatoriamente durante quatro meses. Os parafusos mais utilizados (números 14, 16 e 18 - Grupo 1) e menos utilizados (números 10 e 38 - Grupo 2), portanto, os mais e menos expostos a agentes biológicos, químicos e físicos, foram aleatoriamente removidos e submetidos a inspeção visual (n=126), seguido de cultura bacteriana (n=6 parafusos/bandeja, 9 bandejas), teste de proteínas (n=6 parafusos/bandeja, 9 bandejas) e Microscopia Eletrônica de Varredura (MEV) (n=2 parafusos/bandeja, 9 bandejas). As culturas positivas foram submetidas a métodos automatizados de identificação bacteriana e suscetibilidade antimicrobiana. Resultados Foram detectadas ranhuras em 8,7% dos parafusos, predominantemente no Grupo 2 (8/11). Proteína residual foi detectada em 96,3%, e não houve diferença estatisticamente significativa na quantidade de proteína entre os grupos (P=0,07). Crescimento bacteriano foi identificado em 3/54 parafusos. Danos na superfície e presença de sujidade foram visualizados em todos os parafusos submetidos a MEV. Formação de biofilmes extensos foi detectada em oito parafusos, três do Grupo 1 e cinco do Grupo 2. Conclusão Recuperação de bactérias viáveis, acúmulo de biofilme e danos na superfície foram detectados nos parafusos prontos para uso. Os parafusos costumam permanecer nas bandejas cirúrgicas e serem submetidos a múltiplos processamento, sendo expostos a contaminação e danos repetidas vezes. Esses achados apontam para a necessidade de discutir e repensar a forma como esses implantes de uso único são atualmente disponibilizados para cirurgias.

Resumen Objetivo Evaluar la integridad de la superficie y las condiciones microbiológicas de tornillos listos para uso en bandejas ortopédicas después de múltiples procesamientos. Métodos Después del procesamiento completo, fueron seleccionadas aleatoriamente durante cuatro meses las bandejas utilizadas en cirugías de pequeños fragmentos, proporcionadas mediante el sistema de consignación/comodato en un hospital brasileño. Los tornillos más utilizados (números 14, 16 y 18 - Grupo 1) y menos utilizados (números 10 y 38 - Grupo 2), por lo tanto, los más y menos expuestos a agentes biológicos, químicos y físicos, fueron quitados aleatoriamente y sometidos a inspección visual (n=126), seguido de cultivo bacteriano (n=6 tornillos/bandeja, 9 bandejas), prueba de proteínas (n=6 tornillos/bandeja, 9 bandejas) y microscopía electrónica de barrido (MEB) (n=2 tornillos/bandeja, 9 bandejas). Los cultivos positivos fueron sometidos a métodos automatizados de identificación bacteriana y susceptibilidad antimicrobiana. Resultados Se detectaron ranuras en el 8,7 % de los tornillos, predominantemente en el Grupo 2 (8/11). Se detectó proteína residual en el 96,3 % y no se encontró diferencia estadísticamente significativa en la cantidad de proteína entre los grupos (P=0,07). En 3/54 tornillos se identificó crecimiento bacteriano. Se visualizaron daños en la superficie y presencia de suciedad en todos los tornillos sometidos a MEB. En ocho tornillos se detectó la formación de biopelículas, tres del Grupo 1 y cinco del Grupo 2. Conclusión Se detectó recuperación de bacterias viables, acumulación de biopelícula y daños en la superficie en los tornillos listos para uso. Los tornillos suelen permanecer en las bandejas quirúrgicas y son sometidos a múltiples procesamientos, donde están expuestos a contaminación y daños repetidas veces. Estos descubrimientos señalan la necesidad de discutir y repensar la forma como estos implantes de uso único se ponen a disposición para cirugía actualmente.

Abstract Objective Assess the surface integrity and microbiological conditions of patient-ready screws in orthopaedic trays that had been multiply reprocessed. Methods After full reprocessing, clinical trays used for small fragment surgery provided through a loaner system to a Brazilian hospital were randomly selected during four months. The most (numbers 14, 16 and 18 - Group 1) and least (numbers 10 and 38 - Group 2) frequently implanted screws, therefore, the ones estimated to be the most and least exposed to biological, chemical and physical agents, were randomly removed and subjected to visual inspection (n=126), followed by bacterial culture (n=6 screws/tray, 9 trays), protein test (n=6 screws/tray, 9 trays) and Scanning Electron Microscopy (SEM) (n=2 screws/tray, 9 trays). Positive cultures were subjected to automated bacterial identification and antimicrobial susceptibility tests. Results Grooves were detected on 8.7% screws, predominantly in Group 2 (8/11). Residual protein was detected on 96,3%, and there was no statistically significant difference in the amount of protein between the groups (P=0.07). Bacterial growth was identified in 3/54 screws. Surface damage and soil were visualized on all screws subjected to SEM. Extensive biofilms were detected on eight screws, three from Group 1 and five from Group 2. Conclusion Recovery of bacteria, biofilm accumulation and surface damage were detected on patient-ready screws. Screws frequently remain in surgical trays for multiple reprocessing; thus they are repeatedly exposed to contamination and damage. These findings point to the need to discuss and review the way these single-use implants are currently made available for surgeries.

Reprocessing of loaned surgical instruments/implants in Australia and Brazil: A survey of those at the coalface.

BACKGROUND: Acquisition of surgical instruments (SI) and implants by loaner system is a worldwide practice. Although quality of device reprocessing has been reported to be lower in low and middle-income countries compared with higher income countries, few investigations have been conducted on the management and reprocessing of loaned devices. Thus, in this study we evaluate the practices of management and reprocessing of loaner SI and non-sterile implants (NSI) in a high (Australia) and a middle-income (Brazil) country. METHODS: Cross-sectional surveys (hardcopy or online form) was self-administered by sterilising service unit's personnel of Brazilian and Australian hospitals. Only those units that sourced orthopaedic surgical instruments and non-sterile loaned implants from independent companies were eligible. RESULTS: A total of 65 questionnaires from Australia and 168 from Brazil were analysed. Quality indicators regarding structure and work process for the management and reprocessing of loaned SI and NSI was of a higher standard in Australia than in Brazil. However, failures were detected in both countries, for instance delivery delays and improper point-of-use pre-cleaning practices. CONCLUSION: There are key challenges inherent of the multifaceted reusable medical devices loaner system in both countries, such as communication failures, implementation of non-recommended practices, reprocessing of NSI, and other related to structure and process quality indicators, that must be faced. Initial and ongoing education and training should be provided and should embrace the themes of technical proficiency, effective communication and teamwork, and should include all personnel involved in this process, even loaner company staff.

Evaluation of stainless steel surgical instruments subjected to multiple use/processing.

BACKGROUND: To determine the effect of multiple use and processing cycles on instrument quality over the life of stainless steel, complex designed clinical surgical instruments. METHODS: Steam sterilised surgical instruments due to be discarded from Australian hospitals, because of loss of functionality, were assessed for contaminating protein and bacteria using the bicinchoninic acid protein assay and microbial culture, respectively. Biofilm presence and instrument damage were visually confirmed by scanning electron microscopy (SEM). Instruments were categorised into hinged/serrated, screw, cannulated, flexible, and irregular surfaced (but not hinged) according to their design. RESULTS: Protein contamination ranged from 24 µg on the new screw to 3,756,046 µg contaminating a discarded forceps. The more complex the instrument design the higher the protein contamination. All samples were culture negative, however, biofilm was visually confirmed on 4/8 instruments tested using SEM. SEM also detected soil, holes or black stains on all the instruments. CONCLUSION: "Ready to use" surgical instruments that underwent multiple uses and processing cycles were contaminated with high amounts of protein, and microscopy revealed the presence of soil, structural damage, black stains and biofilm. While less affected new but multiply processed screws also showed soil and biofilm contamination. These findings highlight the need for further research into determining what is the "life" of stainless steel instruments and development of standard criteria for evaluating when to "retire" an instrument.

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.

Alcohol fixation of bacteria to surgical instruments increases cleaning difficulty and may contribute to sterilization inefficacy.

BACKGROUND: Alcohol is frequently inappropriately used on surgical instruments to reduce bacterial contamination, but fixes protein to stainless steel. Here we compare the effect of air drying, prolonged soaking in water, and alcohol treatment on cleaning difficulty of contaminated forceps. METHODS: Haltsted-mosquito forceps were contaminated with only Staphylococcus aureus. Instruments were air-dried for 10 (control), 75, or 240 minutes, soaked in water, or air dried then treated with ethanol or isopropanol for 10 seconds. All instruments were prewashed for 15 minutes. Forceps contaminated with blood and S aureus or Pseudomonas aeruginosa were dried and then sprayed or wiped with ethanol, and prewashed. Bacterial viability and soiling were determined by standard plate culture and crystal violet staining, respectively. RESULTS: Soaking or spraying instruments with alcohol significantly reduced viable bacterial numbers, but significantly increased soil attached to forceps, as did air drying. Wiping instruments with alcohol had little effect on bacterial viability, but increased cleaning difficulty. Soaking in water for 75 or 240 minutes increased cleaning difficulty perhaps due to bacterial attachment to forceps. CONCLUSIONS: Treating contaminated instruments with alcohol, allowing them to dry, or allowing them to soak in water for prolonged periods increases cleaning difficulty and should be discouraged.