Search Results (331)

Product-quality complaints are usually handled as pharmaceutical quality-system events, yet defects in sterility, potency, identity, packaging, labelling, storage, distribution or delivery-device function may affect medication use, treatment continuity and patient outcomes. This structured narrative review examines product-quality complaints (PQCs) as a patient-safety interface linking pharmaceutical quality systems, pharmacovigilance, medication-error prevention, recall action and pharmacoepidemiology. Existing pharmacovigilance, quality-management and recall systems address different components of this pathway, but no integrated framework was identified in the sources reviewed that specifies how product-quality complaints should be linked to exposure evidence and patient outcomes. Sources were identified through targeted PubMed searches and purposive retrieval of official regulatory, pharmacovigilance and public-health documents up to 5 June 2026; the review was not registered and included no quantitative synthesis. The sources identified concentrate on regulatory architecture, sentinel contamination events and shortage-associated harms; routine complaints are studied comparatively little, and no source identified reported the complaint-to-defect-to-exposure-to-outcome cascade with a complaint-level denominator. We propose the term patient-relevant complaint status (PRCS) for a complaint warranting patient-safety triage because the reported defect could plausibly affect exposure, sterility, potency, identity, delivery, medication use or treatment continuity, together with a TRACE workflow, a six-level clinical-consequence classification and separately graded certainty for defect confirmation, patient exposure and outcome attribution. These tools are proposed, unvalidated and hypothesis-generating; they do not convert complaints into adverse reactions, recalls into causality or spontaneous reports into incidence. Their intended role is to structure patient-safety triage, batch-aware linkage, exposure reconstruction, clinical follow-up and proportionate mitigation while causal attribution remains incomplete; this role requires prospective validation before routine implementation. Full article

Physician-modified endografts (PMEGs) represent an important treatment option for urgent and semi-urgent complex abdominal aortic aneurysms (cAAAs). The Zenith Alpha Thoracic Endovascular Graft (Cook Medical, Bloomington, IN, USA) is a common choice for PMEGs due to its low strut interference, albeit at the cost of requiring removal of the proximal fixation barbs for resheathing—a process that remains technically challenging. The current article details a step-by-step approach on how to modify an Alpha thoracic endograft without requiring removal of the proximal barbs. The Zenith Alpha Thoracic Endovascular Graft is fully unsheathed on a sterile back-table and completely detached from the delivery system by removing the blue rotational handle. The grey positioner is removed from the introducer sheath. Next, a 0.018-inch guidewire is introduced distally through the inner positioner and retrieved via the exposed grey handle to function as a trigger wire. Following the creation and reinforcement of the fenestrations, circular diameter-reducing ties are constructed and secured using an insertion tool. The endograft is placed back on the delivery system and the guidewire is passed through the endograft fabric at the distal end and through the insertion tool, which is then removed. At the proximal end, the trigger wire is again passed through the endograft fabric, and both the proximal bare alignment stent and the distal end of the endograft are secured to the delivery system using 2-0 Prolene sutures (Ethicon Inc., Somerville, NJ, USA). The endograft is subsequently resheathed through the distal end of the introducer sheath using a tourniquet-assisted resheathing technique and a cut-off tip from an introducer sheath to guide the endograft’s passage through the valve. Using the current standardized modification protocol, a PMEG can be constructed using the Zenith Alpha Thoracic Endovascular Graft while preserving the active fixation barbs for the treatment of cAAAs. Full article

Background: Terminal sterilization is a regulatory requirement for most medical devices. However, conventional sterilization methods can compromise temperature-sensitive and biologically reactive components. This study evaluates the sterilization efficacy and preliminary material compatibility of a novel room-temperature sterilization modality using gaseous nitric oxide (NO). Methods: NO was delivered using standardized Sterile Solution^® (Sterile State Inc., Grand Rapids, MI, USA). To characterize microbial inactivation kinetics, the decimal reduction time (D-value) of commercial biological indicators (BIs), Bacillus atrophaeus Apex^® Discs, was determined in accordance with ISO 11138. BIs were exposed to NO at ambient temperature (18.9–22.0 °C). D-values were calculated using both the survivor curve method (Holcomb–Spearman–Karber) and the fraction-negative method (Stumbo–Murphy–Cochran). Material compatibility was evaluated across four primary medical device and packaging plastics, including polyethylene (PE), poly(ethylene terephthalate) (PET), polypropylene (PP), and polyvinyl chloride (PVC)), representing 70% of the industry market share. After exposure to NO sterilization cycles, mechanical and chemical properties were characterized using tensile testing (ASTM D882-18) and Fourier-transform infrared (FTIR) spectroscopy relative to unexposed controls. Results: The calculated D-values ranged from 1.31 (78.7 min) to 1.34 h (80.4 min) across both analytical methods, corresponding to an estimated 6-Log reduction in Bacillus atrophaeus BIs in approximately 8 h. Meanwhile, plastics exposed to the NO sterilization cycle showed no significant changes in mechanical or chemical properties. Conclusions: These findings demonstrate that NO sterilization achieves semi-Log-linear inactivation of a widely accepted BI and represents a promising alternative to conventional gaseous sterilization methods such as ethylene oxide (EtO). By achieving a reliable sterility assurance level under mild ambient conditions without adversely affecting the physicochemical properties of commonly used plastic materials, NO sterilization may offer a practical solution for thermosensitive and delicate medical devices. Full article

The global use of millions of small rodents annually in medical research creates a need for environmental enrichment that is both practical and sustainable. This study investigated the use of banana pseudostem, an agricultural residue, as a potential material for a laboratory-scale rodent enrichment prototype. A life cycle assessment (LCA) and life cycle costing (LCC) were conducted under a cradle-to-grave system boundary that included production, facility use, sterilization, freezer storage, transport, and infectious waste management. The prototype had a global warming potential (GWP) of 28.40 kg CO₂ eq per functional unit. The results showed that the production phase was the dominant contributor to the environmental impacts and costs. Heat pressing was identified as the main hotspot resulting from high electricity demand, while labor was the main cost contributor, as the manual production process at the laboratory scale was time-consuming. The scenario analysis revealed that modifying the press machine to press two pieces simultaneously reduced GWP by 37.54% and total life cycle cost by 29.11%. Full substitution of grid electricity with photovoltaic electricity for heat pressing reduced GWP by about 67.47%. Extending the replacement interval from 3 to 7 days showed the largest GWP reduction of 56.35%, although this option requires confirmation of animal welfare, hygiene, and structural durability. Although banana pseudostem is a renewable agricultural residue, the environmental impacts and costs of the prototype were mainly due to energy-intensive processing at the laboratory scale rather than the raw material. Further improvement in production efficiency and electricity sourcing is required to reduce impacts and increase the feasibility of the banana pseudostem enrichment prototype. Full article

Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening, chronic cutaneous inflammatory disease characterized by unpredictable, recurrent acute flares of painful sterile pustules on a widespread erythematous background. In addition to cutaneous manifestations, patients may experience fever, pruritus, pain, chills, and general malaise, which may be further complicated by secondary infection, sepsis, and organ failure, thus requiring urgent medical treatment and, in some cases, hospitalization. Prompt therapeutic management of the acute phase is crucial for severe cases, and proactive treatment to prevent flares should always be considered. However, early recognition of acute flares can be challenging due to the low frequency of the disease, the rapid onset of flares, the lack of hematological biomarkers and the absence of standardized diagnostic criteria. Moreover, despite the approval of new targeted therapies, there are still several unmet needs, as these treatments are highly expensive, not always readily available, and may have limited efficacy in patients with advanced or complicated disease. For these reasons, multidisciplinary round-table discussions and shared diagnostic and therapeutic algorithms involving dermatologists, who are responsible for diagnosing and treating GPP, and other medical specialists are desirable to facilitate prompt referral to dermatologists for accurate diagnosis and appropriate treatment. We report the updated literature discussed during a multidisciplinary meeting with the aim of providing practice recommendations for clinicians involved in GPP management. Full article

Background/Objectives. The use of antibiotic pastes in the Lesion Sterilization Tissue Repair (LSTR) technique has increased due to their ability to disinfect necrotic primary teeth without mechanical instrumentation. Tri-antibiotic mixtures (TAP) and Chloramphenicol-Tetracycline-Zinc Oxide (CTZ) paste remain the most common options, although their composition and dosing lack standardization. Evidence indicates that silver and zinc oxide nanoparticles enhance antimicrobial performance by disrupting biofilms and modulating inflammatory pathways, suggesting potential benefits when incorporated into intracanal medications. This study aimed to evaluate the antimicrobial activity of a chloramphenicol–tetracycline paste modified with silver nanoparticles (SNPs) and zinc oxide nanoparticles (ZnONPs) against wild Enterococcus faecalis, comparing its MIC, MBC, and inhibition zones with those of a commercial CTZ paste. Methods. SNPs and ZnONPs (1 × 10⁻² M) were synthesized and characterized using UV–Vis spectroscopy and dynamic light scattering (DLS). Two antibiotic pastes (1%) were formulated, including a nanoparticle-modified version with a 4% reduction in antibiotic content. Commercial CTZ paste was prepared according to the manufacturer’s instructions. Wild E. faecalis strains were isolated from necrotic primary teeth (N = 30). MIC, MBC, and inhibition zones were determined using microdilution and Kirby–Bauer assays. Results. AB Paste and Nanopaste showed larger inhibition zones (ZOI) than the other formulations (p < 0.001). MIC and MBC analyses showed no significant differences among antibiotic formulations and SNPs (p > 0.05). Conclusions. Both the nanoparticle-free antibiotic paste and the nanoparticle-modified paste demonstrated greater inhibitory activity than commercial pastes and Nanoparticles. Despite containing 4% less antibiotics, the Nanopaste showed equivalent efficacy, indicating that reducing the drug content does not compromise antimicrobial performance and that SNPs contribute to this effect. Full article

Background: Pericardial effusion has a broad differential diagnosis, whereas bacterial pericarditis is rare. Despite this, routine culturing of pericardial fluid is frequently performed, and its diagnostic yield remains uncertain. Methods: We conducted a retrospective study of all pericardial fluid cultures obtained at a tertiary medical center between January 2016 and May 2024. Cultures were classified as true positive if a recognized bacterial pathogen was isolated or if it was deemed clinically pathogenic by an infectious disease’s specialist at the medical record. Contaminants were defined according to CDC criteria. Clinical, laboratory, and imaging variables were analyzed using univariate testing and multivariable logistic regression. Results: Among 198 eligible pericardial fluid cultures, 8 (4%) yielded true bacterial pathogens, whereas 43 (23%) grew contaminants and 147 (73%) remained sterile. Thus, contaminant growth occurred more than five times as frequently as that of true pathogens. The most frequent pathogens were Staphylococcus aureus and Streptococcus species. No demographic features, presenting symptoms, or imaging findings were associated with culture positivity. In multivariable analysis, concurrent bacteremia (odds ratio [OR] 17.49; p = 0.002) and higher peripheral neutrophil percentage (OR 1.20; p = 0.012) independently predicted bacterial pericarditis. In models incorporating pericardial fluid cell counts, a lower mononuclear cell percentage was also independently associated with infection (OR 0.91; p = 0.03). Conclusions: Bacterial pericarditis is uncommon, and routine pericardial fluid cultures, of all pericardial fluid specimens, have a low diagnostic yield with substantial contamination. Laboratory markers, particularly bacteremia and neutrophilia, may help identify patients most likely to benefit from culture. A selective, laboratory-guided approach may improve diagnostic efficiency and reduce unnecessary testing. Full article

Trap–neuter–return (TNR) programs are the leading non-lethal approach to managing free-roaming cat populations. When cats are anesthetized for surgical sterilization, veterinarians have a brief opportunity to obtain blood samples for pre-surgical screening, infectious-disease surveillance, and contribution to population-level reference-interval research. Field conditions, however, make collecting good-quality blood samples difficult: cats are often dehydrated and stressed, the procedure is kept brief, and their medical history is unknown. This narrative review draws on the American Society for Veterinary Clinical Pathology (ASVCP) reference-interval guidelines, feline anesthesia and the blood-collection literature, and operational experience from Portuguese TNR programs to describe seven points in the sampling workflow at which technique most often fails: anesthetic depth verification, controlled aspiration speed, immediate EDTA-tube mixing, post-venipuncture hemostasis, hemolysis recognition, precise FIV/FeLV point-of-care test timing, and adherence to a maximum-attempts limit. Three recurrent failure modes—collapsed veins from excessive aspiration, clotted EDTA samples from inadequate mixing, and hematoma formation from insufficient hemostasis—account for the majority of poor samples observed in routine practice. The framework presented here is intended to support reproducible, welfare-compliant sample collection during TNR operations, giving veterinary teams a single, structured reference that supports both animal welfare and the diagnostic value of the samples they collect. Full article

Background: Efficient and safe instrument exchange remains an important challenge in robot-assisted laparoscopic surgery (RALS). Current workflows require human assistance, increasing staff workload and contamination risk. The modular design of the AdLap robotic laparoscopic instruments enables automated exchange of instrument shafts. This study presents the development and validation of the Instrument Carousel Exchange System (ICES). Methods: An automatic ICES was developed for the AdLap robotic surgery platform of the Delft University of Technology. The prototype was designed to hold six Shaft-Actuated Tip-Articulating (SATA) modular instrument shafts (SATA instrument line, SATA Medical, Amsterdam, The Netherlands) and focused on compactness, robustness, modularity, and rapid disassembly for cleaning and sterilization. System performance was evaluated using repeated autonomous instrument exchange cycles without user interaction. Reliability, alignment tolerance, safety, and exchange duration were assessed. Results: The ICES prototype was successfully designed, manufactured, and tested. Repeated functional testing demonstrated reliable autonomous instrument shaft exchange without human intervention. The system tolerated minor alignment deviations while maintaining stable and safe operation. The mean time for a complete instrument shaft exchange was 84 s (SD = 10 s). The modular architecture allowed straightforward disassembly and maintenance while preserving structural integrity and compact design. Conclusions: The developed ICES represents a substantial step toward fully automated modular instrument handling in RALS. Automated instrument exchange may reduce staff workload and minimize contamination risk during procedures. Future work will focus on improving automation speed, alignment efficiency, and autonomous reinsertion of the instrument shaft through the trocar to further enhance clinical applicability. Full article

Background/Objectives: Hydroxychloroquine is widely used in the treatment of autoimmune and dermatologic diseases; however, it may rarely induce severe cutaneous adverse reactions. Acute Generalized Exanthematous Pustulosis is an uncommon, acute pustular eruption most frequently associated with antibiotics. Hydroxychloroquine-induced AGEP remains relatively rare and diagnostically challenging due to its atypical and prolonged clinical course. Case presentation: We report the case of a 45-year-old woman with rheumatoid arthritis and a complex medical history who developed generalized urticarial and pustular dermatosis following re-exposure to hydroxychloroquine. Notably, the patient had experienced a similar cutaneous reaction after previous exposure to the same medication several years earlier. Ten days after completing a treatment course of hydroxychloroquine, she developed rapidly progressive pruritic erythematous and urticarial plaques that evolved into generalized annular lesions with peripheral scaling and grouped sterile pustules. Laboratory evaluation demonstrated leukocytosis, intermittent eosinophilia, and elevated IgE levels, while the infectious workup was negative. Histopathological examination revealed subcorneal pustules with neutrophilic infiltration, mild spongiosis, and scattered individual eosinophils, perivascular inflammatory infiltrates, findings consistent with AGEP. Retrospective assessment using the EuroSCAR scoring system classified the reaction as probable AGEP, while the Naranjo adverse drug reaction scale supported a probable causal relationship with hydroxychloroquine. Clinical improvement was achieved after withdrawal of the drug and treatment with systemic corticosteroids and supportive therapy. Conclusions: This case highlights the importance of recognizing atypical presentations compatible with hydroxychloroquine-induced probable AGEP and emphasizes the diagnostic value of a positive rechallenge as supportive evidence of drug causality. Early recognition and prompt discontinuation of the offending agent are essential to prevent severe complications and recurrence. Full article

Most airline passengers and crew assume that the air in the cabin is free from harmful or hazardous substances, as is mandated by airworthiness regulations. While fresh air entering the cabin is sterile (and if recirculated is usually efficiently filtered to remove microorganisms), if the fresh air is bled off the turbine compressors (as is the case in about 95% of airliners currently in service), it may be contaminated with traces of engine oil and ultrafine particles abraded from the turbine blades, and possibly traces of hydraulic fluid leaking from servo systems. Engine oil contains tricresyl phosphate (TCP) as an essential antiwear agent, but it is also a well-known neurotoxin, and it has been suggested that there may be no safe lower limit of exposure, not least because of considerable variation among individuals in sensitivity to tri-ortho-cresyl phosphate (ToCP) and other isomers with at least one ortho constituent. This paper reviews current knowledge about these hazards and discusses the medical and economic motivations for diminishing them. A calculation based on maintaining the life quality index shows that eliminating xenobiotic hazards in aircraft cabin air is likely to be affordable. Full article

Surface engineering strongly influences the performance, reliability, and safety of medical and biomedical devices, yet failures often originate at interfaces rather than in bulk materials alone. This review addresses the fragmented evidence base linking coating selection, interphase design, qualification testing, advanced characterization, and data-driven durability analysis. The objective is to provide an integrative, failure-mode-based framework for implants, reusable instruments, inhalation systems, diagnostics, wearables, and implantable electronics. A narrative synthesis of the peer-reviewed literature in coatings, biomaterials, electrochemistry, reliability, standards, and materials informatics was conducted, with qualitative tables used only when protocols were too heterogeneous for numerical pooling. The review compares physical vapor deposition (PVD), chemical and plasma-enhanced chemical vapor deposition (CVD/PECVD), atomic layer deposition (ALD), sol–gel/organically modified silica (ORMOSIL) hybrids, plasma polymers, parylene, bioactive or antimicrobial surfaces, and electronic encapsulation strategies. The main finding is that no universally superior coating exists; reliable performance depends on matching architecture and characterization to the dominant failure pathway, substrate compliance, geometry, sterilization or physiologic exposure, and the standards-constrained endpoint. The review further shows how electrochemical diagnostics, interfacial mechanics, multiphysics models, survival/reliability statistics, and carefully governed AI workflows can be combined to support service-life prediction and decision-oriented qualification. Full article

Introduction: Nasal colonization plays a pivotal role in Methicillin-resistant Staphylococcus aureus (MRSA) carriage and transmission, especially in healthcare settings. Asymptomatic carriers amongst healthcare workers (HCWs) may serve as an important source for inner-hospital transmission, besides personal increased risks of endogenous infections. Medical students are an often-overlooked part of medical staff which, while not typically included in statistics concerning HCWs, are associated with increased patient contact and exposure to healthcare-associated pathogens. This study aimed to assess MRSA carriage rate amongst clinical-year medical students in the largest Romanian medical university, in addition to identifying potential risk factors. Nonetheless, a methodological aim was incorporated, in order to evaluate the effect of nasal swab pre-moistening with sterile saline on MRSA retrieval rate. Materials and Methods: A cross-sectional study was conducted among clinical-year students from the ‘Carol Davila’ University of Medicine and Pharmacy in Bucharest, Romania. Participants completed a survey regarding potential risk factors and underwent nasal swab sampling, being randomly assigned to the two swab collection methods—dry swab or pre-moistened swab with sterile saline, randomization ensuring comparable baseline characteristics. Samples were inoculated on chromogenic MRSA agar media and incubated for 24–48 h at 35–37 °C. Isolates exhibiting characteristic growth further underwent coagulase testing, bacterial identification and methicillin resistance confirmation. Results: The study comprised 156 medical students, with an overall prevalence of asymptomatic MRSA nasal carriage of 5.76% (n = 9, 95% CI: 3.05–10.58%). No statistically significant associations were identified between MRSA carriage and hospital exposure. The prevalence of MRSA positive cultures was 5.00% (n = 4/80) among the conventional dry swab sampling subgroup, while the subgroup undergoing pre-moistened swab collection presented a 6.57% prevalence (n = 5/76), revealing no statistical significance (p = 0.74). Conclusions: Asymptomatic MRSA carriage among medical students in this cohort suggests the potential role of this population in intra-hospital transmission. In addition, pre-moistening the nasal swab for collection of the sample showed no statistically significant impact on MRSA recovery rates, correlating with existing literature on the topic. These findings further emphasize the need for strict adherence to infection prevention and control measures in hospitals. Full article

Background: In this study, we radiologically assessed potential increases in microvascularity, extracellular matrix-related changes, and tissue viscoelasticity following carboxytherapy for periorbital hyperpigmentation (POH). We also analyzed the correlation between radiological changes and clinical outcomes and explored implications for future outpatient selection, as well as the potential to predict treatment success based on radiological–clinical correlations. Materials and Methods: The present study included 78 patients (76 women and 2 men) aged over 18 years with Fitzpatrick skin types I–V and moderate-to-severe infraorbital dark circles who applied for treatment at the Dermatology Department in the Cosmetology Unit of Cerrahpaşa Medical Faculty Hospital. Each patient was given manual, pressure-controlled injections of sterile CO₂ into the upper and lower eyelids for 7 weeks, with one round of treatment per week. We conducted dermatoclinical and radiological evaluations, including measurements of epidermis–dermis thickness and SWE, musculus orbicularis oculi pars pretarsalis thickness, and cSMI vascular index percentage, as well as SOOF tissue SWE (measured in kPa). These analyses were performed on both lower eyelids before treatment and at 1 month and 6 months after treatment. Results: After treatment, VAS scores improved significantly. Grayscale ultrasonography showed significant increases in epidermis–dermis and orbicularis oculi thickness at 1 and 6 months (p < 0.05). SMI presented a significant increase in vascular index at both follow-ups (p < 0.05). SOOF SWE values increased significantly at 1 and 6 months, whereas epidermis–dermis SWE did not. Procedural pain was common, and 25 participants withdrew during the 7-week period due to discomfort. Injection depth was not confirmed by real-time imaging, and adverse events were not graded using a standardized classification system. Therefore, tolerability and procedural safety should be interpreted with caution. Conclusions: Carboxytherapy was associated with improvements in clinical outcomes and radiological parameters among patients who were able to tolerate the procedure, including increased microvascularity on SMI and changes suggestive of extracellular matrix-related alterations. These improvements were maintained at the 6-month follow-up, indicating temporal persistence of the observed findings. However, due to the absence of a control group, the results should be interpreted with caution, and further randomized controlled studies are required to confirm these findings and establish causality. Full article

Medical device manufacturing requires strict quality control, reliable traceability, and compliance with regulatory requirements. In many cases, inspection activities are still carried out manually and production information is recorded separately, which can result in inconsistent defect detection and limited visibility of manufacturing performance. This paper presents the development and industrial implementation of an integrated closed-loop quality control architecture for a sterile single-use medical device assembly line, addressing the lack of integration between inspection, traceability, and control systems in existing manufacturing approaches. In the proposed approach, we combine radio-frequency identification, machine vision inspection, programmable logic control, and centralized production monitoring. RFID tags store the status of each unit at individual stations so that defective products cannot proceed to downstream operations. Machine vision systems verify component presence, detect missing parts, and confirm color-specific assembly requirements during production. The architecture was tested through implementation on an assembly line and evaluated with comparative pilot studies against a traditional manual inspection process. The upgraded line achieved scrap cost reductions of 52.77% and 53.23% while also improving inspection consistency and production traceability. The results demonstrate that integrating machine vision inspection with RFID traceability can significantly improve quality control and manufacturing efficiency in regulated medical device production. Full article