Search Results (9)

In cemented endoprosthetics, closed prepacked mixing systems represent the most advanced generation of cementing technology. (1) Background: The purpose of the present study is to evaluate four approved prepacked systems—Palacos^® R+G pro, SmartMix™ Cemvac GHV, Optipac^® Refobacin and Cemex^® System Genta—with a focus on practical handling and intraoperative hygiene. (2) Method: The systems were evaluated according to established standard test methods for bone cements (ISO 5833), including dough time, setting time, additional mechanical tests and the level of system closure. (3) Results: The results show that all systems are safe to use and meet the general requirements, but there are relevant differences in terms of intraoperative hygiene. The Palacos R+G pro system shows significantly shorter doughing and setting times, which helps to minimize wound exposure during surgery and thus significantly reduces the overall operating time and the risk of bacterial contamination. Two of the systems cannot be classified as completely closed “pre-packaged systems.” In two cases, the system must be temporarily opened before mixing to insert the mixing element, which may result in a temporary but clinically relevant impairment of sterility and a corresponding potential risk of contamination. (4) Conclusion: From a hygienic point of view, systems that remain completely closed throughout the entire preparation process can offer advantages in terms of infection prevention. This was the case for all systems tested. Short handling times, reduced exposure of the surgical site and a shorter overall duration of the procedure could further improve intraoperative safety and reduce the risk of contamination. In terms of intraoperative hygiene, the Palacos R+G pro system achieved the best results compared to the three other systems tested due to its rapid readiness for use and comparatively short setting time (according to ISO 5833). Cemex System Genta performed worst in this respect due to its late doughing time and setting time. Full article

Biofilms, structured communities of microorganisms encased in an extracellular matrix, are a major cause of persistent infections, particularly when formed on medical devices. This study investigated the kinetics of biofilm formation by Escherichia coli and Pseudomonas aeruginosa, two clinically significant pathogens, on two medical-grade polymers: polyether ether ketone (PEEK) and polyamide 12 (PA12). Using a modified crystal violet staining method and spectrophotometric quantification, we evaluated biofilm development over time on polymer granules and catheter segments composed of these materials. Results revealed that PEEK surfaces supported significantly more biofilm formation than PA12, with peak accumulation observed at 24 h for both pathogens. Conversely, PA12 demonstrated reduced bacterial adhesion and lower biofilm biomass, suggesting surface characteristics less conducive to microbial colonization. Additionally, the study validated a reproducible protocol for assessing biofilm formation, providing a foundation for evaluating anti-biofilm strategies. While the assays were performed under static in vitro conditions, the findings highlight the importance of material selection and early prevention strategies in the design of infection-resistant medical devices. This work contributes to the understanding of how surface properties affect microbial adhesion and underscores the critical need for innovative surface modifications or coatings to mitigate biofilm-related healthcare risks. Full article

Background: This study examines the role of the built environment in mitigating risk in healthcare facilities, with a particular focus on how the design of hospital infrastructures can influence and improve the safety of patients, staff, and visitors. Methods: A two-phase mixed-methods approach was adopted. First, a scoping literature review was conducted to identify design-based strategies targeting five categories of risk: healthcare-associated infections (HAIs), indoor air quality (IAQ), safety, falls, and emergency resilience. Based on this review, a structured questionnaire was developed and administered to a sample of hospital facilities in Northern Italy to assess the implementation of the strategies emerged. Results: The literature review identifies recurring specific design solutions and strategies that have proven effective in mitigating risks in healthcare infrastructures in the following dimensions: infection mitigation, indoor air quality, falls reduction, safety, emergency preparedness. At the same time, survey data from (n = 9) hospitals indicate a significant implementation gap. Key shortcomings included a lack of spatial flexibility, limited environmental monitoring (especially for IAQ and acoustic conditions), and underutilization of antibacterial surfaces. Antibacterial flooring and wall finishes were absent in (n = 4/9) and (n = 6/9) of the facilities, respectively. IAQ monitoring was mostly confined to surgical areas, with (n = 0/9) facility reporting comprehensive building-wide monitoring. Only two (n = 2) facilities reported adaptable spaces suitable for emergency conversion and accessible green areas. Conclusions: This study provides a comprehensive overview of risk mitigation strategies in hospital design. The results reveal critical gaps in implementation, particularly in spatial flexibility, environmental monitoring, and antimicrobial surfaces. Future research should focus on developing adaptable design models that are context-sensitive, scalable, and capable of enhancing healthcare resilience in response to emerging global health threats. Full article

Environmental monitoring (EM) is the cornerstone for the assurance of sterility during aseptic manufacturing. In this study, the EM quality aspects in the radiopharmaceutical cleanrooms of the University Medical Center Groningen (UMCG), The Netherlands, were evaluated. Hereto, data obtained from EM over the period 2010–2022 were analyzed. The data were sorted according to the Good Manufacturing Practice (GMP) classification of the respective premises with their corresponding limits, and frequencies of excursions were determined per location. The frequency of conducted measurements gradually increased between the start and end of the assessed period. There was a trend of increased action limit excursions observed between 2010–2022. We found that EM in grade A areas appeared to be significantly less compliant with GMP specifications than the combined data from all sampled premises at the facility (p < 0.00001; two-sided Fisher’s exact test). A trend was found for reduced action limit excursions for passive air sampling and particle counting, suggesting improved GMP compliance over time for this specific type of EM. The contamination recovery rate (CRR) found for cleanroom conditions, around 10%, was considered sufficient. From this comprehensive data analysis, we learn that, in order to be fully compliant with the requirements set in the recent revision of EU (European Union)-GMP Annex 1 ‘Manufacture of sterile medicinal products’ (in force as of 25 August 2023), strategies to further improve product protection are justified. For example, improved cleaning and disinfection procedures, more efficient working methods as well as optimization of the conditions under which aseptic manufacturing is performed are to be considered. Full article

In light of the close contact between patient and clinician during ophthalmic examinations and the multiple opportunities for pathogen transmission, we identified and evaluated potential pathogen transmission routes through high-touch surfaces in an outpatient ophthalmology clinic. A circuit simulation was performed to replicate a patient’s journey through an ophthalmology clinic with various stations. Fluorescent oil and powder were applied to the hands of Simulated Patient A who went through the circuit. Routine disinfection of surfaces in the slit lamp environment and hand hygiene by the ophthalmologist were conducted prior to Simulated Patient B going through the same circuit with untagged hands. Ultraviolet black light was used to identify fluorescent marker contamination after Simulated Patient B completed the circuit. Fluorescent marker contamination was found on the hands of all the simulated patients and staff, various items of the simulated patients, multiple equipment surfaces—particularly the ophthalmologist’s working table and slit lamp environment—and miscellaneous objects like appointment cards and files. Fluorescent marker contamination on Simulated Patient B’s untagged hands despite proper hand hygiene being performed prior suggests suboptimal surface disinfection following Simulated Patient A’s circuit. Through this pilot study, we recognised the key role that ophthalmic high-touch surfaces play in fomite transmission and that thorough disinfection of high-touch surfaces is essential on top of proper hand hygiene. With the contact sequences delineated in this pilot study, specific cues for hand hygiene and surface disinfection may be implemented at suitable intervals during contact with high-touch surfaces. Environmental decontamination adjuncts could also be considered to reinforce surface disinfection. Full article

The German health authorities’ guidelines for medical devices in 2012 highlighted the importance of cleaning ultrasound probes, emphasizing their validation and reliability. In addition to automated and validated options, alternative manual methods such as wipe disinfection have gained traction due to their independence from additional hardware. The study examines the effectiveness of a manual cleaning process using wipes, addressing concerns raised by the Robert Koch Institute regarding the lack of validation for wipe disinfection of semi-critical devices. The EQUINOS colored wipe disinfection kit identified wetting gaps in all cleanings across four probes tested. The results indicate significant challenges in ensuring complete surface wetting, particularly in complex device parts such as clip-on areas and fixtures for additional biopsy attachments, suggesting that manual methods alone may not adequately mitigate the risk of infection transmission (p value < 0.0001). The study concludes that while manual disinfection methods are a commonly used alternative to automated reprocessing, there is a critical need for enhanced training and potentially the development of more effective manual disinfection techniques or colored wipes to ensure patient safety and compliance with healthcare hygiene standards. Full article

Healthcare-associated infections (HAIs) are considered to be one of the biggest health problems as they continue to be an important cause of morbidity and mortality worldwide. They cannot be completely prevented, but their incidence can be significantly limited. Preventive action is the most important measure in this case. Due to the frequent interaction between healthcare professionals and patients, the crucial importance of hand hygiene is therefore emphasised. Adherence to good disinfection and hand washing practices remains around 40%, which can be improved by using a variety of nudge tools to promote desired hygienic behaviour. We conducted an open observation of employees and visitors with participation. The aim of this study was to determine the actual status of hand disinfection in a selected healthcare facility amongst doctors, registered nurses, medical technicians, cleaners, and visitors or parents of children; then, we selected and introduced three nudge tools of desired hygiene behaviour and analysed their effectiveness; finally, we provided suggestions for the use of nudge tools of desired hygiene behaviour with the aim of influencing doctors, registered nurses, medical technicians, cleaners, and visitors or parents of children so that they disinfect their hands properly. The actual state of hand disinfection was determined on the basis of observation without introducing any changes; then, we separately introduced three nudge tools, posters with an inscription and picture, the scent of citrus, and flashing lights. The obtained results were analysed with the help of the SpeedyAudit Lite application, and the effectiveness of each nudge tool and the adequacy of hand disinfection by categories of people were compared. In general, posters with a picture and an inscription contributed the most to more consistent disinfection of employees’ hands, while the scent of citrus and flashing lights contributed slightly less. Full article

Hospital-acquired infections are a significant concern in healthcare settings, leading to patient safety risks, increased morbidity and mortality, and financial burdens. Hand hygiene is crucial in preventing the spread of bacteria in hospitals and communities. Manual hand sanitizer dispensers can harbor presumptive pathogenic bacteria and act as fomites for bacterial transmission. This study aimed to assess the microbial contamination of manual hand sanitizer dispensers in a hospital setting and to study their antibiotic resistance profiles. Samples were collected using sterile cotton swabs and then inoculated into brain heart infusion broth. Subsequent subcultures were performed on both blood and MacConkey agar. The isolates were then identified using the Bruker MALDI Biotyper (Bruker Daltonik, Bremen, Germany) to the species level. Sampling was conducted in various wards and in the hospital and the University areas on dispenser levers and nozzle areas. The results showed that all samples yielded one or more bacterial species. Bacterial isolates identified belonged to species commonly found on the skin microflora and some Gram-negative enteric bacilli. Higher colonization was observed on the dispenser lever. Among Gram⁺ microorganisms, most bacterial species were shown to be sensitive to β-lactams, with the exception of Staphylococcus spp., resistant to AMP (Ampicillin) and Penicillin. However, no Methicillin resistant isolates were detected. Gram⁻ microorganisms such as Pseudomonas luteola were shown to be sensitive to all tested antibiotics, while Pantoea agglomerans was shown to be resistant to AMC (amoxicillin–clavulanic acid). Rifampicin tested only against Bacilli showed resistance. Based on the findings, it is recommended to implement systematic cleaning and proper maintenance of manual dispenser areas or to use automated dispensers to reduce hand contact and minimize microbial contamination. Monitoring the presence of microorganisms in hand sanitizing gels and dispensers is an essential infection control strategy. Full article

Contamination of water use points in health establishments is a frequent and concerning problem. Maintenance and disinfection of water systems can be inefficient. Sterilizing filters are commonly used at selected taps. We report diagnostic and corrective approaches that have succeeded in making a contaminated health facility sustainably compatible with its activity without restriction in taps use. The zones contaminated with pseudomonas as well as those, along the water networks, at risk of biofilm development were identified. Corrective measures on the network and various types of decontamination were carried out. At the end of this work, the bacterial load in the water significantly decreased and 219 out of 223 controls were negative for P. aeruginosa over 3 years of follow-up. Four positive results were linked to three taps not used for care which were satisfactorily treated locally. Errors at the design and setup phases of health facilities may result in resistant bacterial contamination. P. aeruginosa contamination of newly built healthcare facilities is an underreported problem. Guidelines on design, disinfection, and monitoring procedures of water networks of healthcare facilities should be adapted consequently and would certainly improve the offered care limiting patients’ risk and avoid many unwanted financial situations for the providers. Full article