Optimizing the surgical instrument tray to immediately increase efficiency and lower costs in the operating room.

BACKGROUND: Surgical trays are often poorly configured and can be ongoing sources of frustration and excess costs. We conducted an observational study to determine if the use of a customized mathematical inventory optimization model would result in a greater reduction in the number of instruments on a surgical tray than a clinician review of the tray. METHODS: Utilization of instruments on the major orthopedic tray at a large academic hospital was documented over 80 procedures. Processes in the medical device reprocessing department and operating room were observed to comprehensively quantify all associated costs. Results of the observations were applied to a customized mathematical model to determine the ideal tray configuration. For comparison, a clinician review was also performed. RESULTS: The mathematical model alone produced an ideal tray size of 47 instruments, a reduction of 41 instruments from the original size of 88 instruments (47% reduction). This represented $34 440 in annual savings. In contrast, the clinician review alone suggested an ideal tray size of 67 instruments (23% reduction), representing $17 640 in annual savings. When clinicians were provided with the additional information from the model, they reduced the tray size to 51 instruments (42% reduction), producing $31 870 in savings. The mathematical model yielded an additional 22% instrument reduction and $14 230 in savings compared with clinician review alone. CONCLUSION: Our mathematical model is generalizable and can be applied to all specialties and hospitals to determine optimal tray configuration. As such, the financial implications are broad; at our institution, application to all surgical trays would result in $205 000 of savings annually. Surgeons and managers looking to streamline surgical trays should consider this evidence-based approach.

The spectrum of skin diseases seen in a Jamaican tertiary academic medical center.

BACKGROUND: The diversity of skin diseases seen in a dermatology clinic varies with the composition of the population. OBJECTIVE: The aim was to document the spectrum of cutaneous disorders seen and the variation with sex, age, and seasons. METHODS: This was a retrospective study on new patients attending an academic dermatology clinic in Jamaica during 2018. Disease frequencies and prevalence by sex, seasons, and age group were recorded. RESULTS: There were 547 new patients with 329 females (60%) and 218 males (40%). The mean age was 36.8 years, ranging from 2 weeks old to 103 years old. The largest number of patients were in the third decade (20-29 years) (n = 139). More patients presented in the dry season and in spring and summer. The most common diagnoses were: seborrheic dermatitis (n = 65, 11.9%), acne (n = 56, 10.2%), and contact dermatitis (n = 38, 6.9%). The most common disease groups were dermatitis (n = 161, 29.4%), infections (n = 130, 23.8%), and inflammatory disorders (n = 129, 23.6%). LIMITATIONS: The generalizability of our findings may be limited, and selection bias may play a role in patients choosing to attend an academic dermatology clinic. CONCLUSIONS: Skin diseases varied with age, sex, and season with seborrheic dermatitis being most common.

Using Return on Investment Operational and Monte Carlo Modeling Techniques to Predict Financial Performance in a Tertiary Care Outpatient Clinic.

INTRODUCTION: The vast majority of health care quality improvement studies provide inadequate financial analysis to accurately predict a return on investment. We hypothesized that using return on invested capital operational mapping combined with a Monte Carlo simulation financial model could accurately predict institutional costs and operational metrics within an outpatient urology clinic. METHODS: A process map of a typical outpatient clinic visit was developed, and time studies were performed by following a sample of patients while considering all operational and financial variables that contributed to patient care. this process map was adapted into a return on invested capital-tree for financial modeling. Stochastic modeling using Monte Carlo simulation was performed to estimate financial metrics based on these operational and financial inputs for both the 2017-2018 and 2018-2019 fiscal years. These were then compared to the actual performance measures of those fiscal years. RESULTS: Combined return on invested capital-Monte Carlo simulation modeling generated financial and operational estimates that characterized the clinic's performance based on multivariable inputs. Most financial estimates for 2017-2018 differed by <4.31% from the actual financial values from that year. In predicting financial performance for 2018-2019, most of the estimated values were <7.67% different from their actual financial statement line items. CONCLUSIONS: As a proof of concept, this study demonstrated that a combined return on invested capital-operational mapping and Monte Carlo simulation modeling can predict key financial metrics in a tertiary care clinic. As such, common business tools can be useful in a health care setting when clinicians are evaluating how investments in quality improvement will influence their financial and operational performance.

Green Synthesized BSA-Coated Selenium Nanoparticles Inhibit Bacterial Growth While Promoting Mammalian Cell Growth.

BACKGROUND: Selenium is an essential trace element that is critical for many biological processes. Selenium nanoparticles (SeNPs) have shown more promise than other forms of selenium due to their low cytotoxicity and high bioavailability. METHODS: In this work, a one-step method was demonstrated for fabricating bovine serum albumin (BSA) stabilized SeNPs using ascorbic acid as the reductant. Human dermal fibroblasts were used to assess mammalian cytotoxicity, and Staphylococcus aureus and Escherichia coli were used to assess antibacterial performance. RESULTS: These SeNPs demonstrated increased fibroblast growth and reduced Staphylococcus aureus growth with a fibroblast IC50 value (>681 µg/mL) 1 order of magnitude higher than that for bacteria at day 1. CONCLUSION: This study demonstrated the promise of this synthesis process in achieving controllable selenium nanoparticle sizes without the use of strong basic solvents for improved antibacterial properties.

Modulating cell culture oxidative stress reduces protein glycation and acidic charge variant formation.

Controlling acidic charge variants is critical for an industrial bioprocess due to the potential impact on therapeutic efficacy and safety. Achieving a consistent charge variant profile at manufacturing scale remains challenging and may require substantial resources to investigate effective control strategies. This is partially due to incomplete understanding of the underlying causes for charge variant formation during the cell culture process. To address this gap, we examined the effects of four process input factors (temperature, iron concentration, feed media age, and antioxidant (rosmarinic acid) concentration) on charge variant profile. These factors were found to affect the charge profile by modulating the cell culture oxidative state. Process conditions with higher acidic peaks corresponded to elevated supernatant peroxide concentration, intracellular reactive oxygen species (ROS) levels, or both. Changes in glycation level were the primary cause of the charge heterogeneity, and for the first time, supernatant peroxide was found to positively correlate with glycation levels. Based on these findings, a novel mathematical model was developed to demonstrate that the rate of acidic species formation was exponentially proportional to the concentrations of supernatant peroxide and protein product. This work provides critical insights into charge variant formation during the cell culture process and highlights the importance of modulating of cell culture oxidative stress for charge variant control.

Selenium Nanoparticle Protection of Fibroblast Stress: Activation of ATF4 and Bcl-xL Expression.

BACKGROUND: In recent years, selenium nanostructures have been researched due to their antibacterial properties, low toxicity to mammalian cells, and high biological efficacy. However, the clinical implementation of the use of selenium has received mixed results, and there is much work needed to improve the understanding of the biological mechanisms involved in the observed cellular responses. MATERIALS AND METHODS: In this work, an investigation into the mechanistic pathways of selenium nanoparticles (SeNPs) in biological systems was conducted by studying the changes in gene expression of ATF4, Bcl-xL, BAD2, HSP70, and SOD2 in non-cancerous human dermal fibroblasts (HDF) under oxidative stress, nutrient deprivation stress, and no treatment (control) conditions. RESULTS: This study revealed that SeNP incubation led to reduced internal reactive oxygen species (ROS) generation for all conditions tested, thus, providing a protective environment for HDF. At the stress conditions, the expression of ATF4 and Bcl-xL increased for cells treated with SeNP incubation, leading to attenuation of the cells under stress. These results also hint at reductive stress causing a detrimental impact to cell proliferation under routine cell passaging conditions. CONCLUSION: In summary, this study highlights some possible mechanistic pathways implicated in the action of SeNPs that warrant further investigation (specifically, reducing stress conditions for HDF) and continues to support the promise of SeNPs in a wide range of medical applications.

Industrial bioprocessing perspectives on managing therapeutic protein charge variant profiles.

Controlling the charge profile of therapeutic protein is a critical challenge in the current quality-by-design (QbD) paradigm, throughout all phases of biologics process development (PD): cell line development, upstream cell culture, recovery process, downstream purification, and analytical characterization. Charge variant profiles may influence efficacy and/or lead to unintended side-effects. Thus, maintaining a consistent charge profile is of tremendous importance, and increasingly, researchers have focused efforts toward developing strategies to mitigate variability during cell culture and to improve separation and detection of charge variants. Current understanding of factors affecting charge variant formation during manufacturing remains inadequate, and sometimes, even substantial commitment of resources may still not fully achieve the desired or consistent profiles. As such, this review attempts to provide a comprehensive resource for the biologics community by summarizing the impact of charge variants and CQA management, analytical methods for charge variant detection, as well as strategies in downstream and upstream PD for controlling charge variant profiles.

Addition of Selenium Nanoparticles to Electrospun Silk Scaffold Improves the Mammalian Cell Activity While Reducing Bacterial Growth.

Silk possesses many beneficial wound healing properties, and electrospun scaffolds are especially applicable for skin applications, due to their smaller interstices and higher surface areas. However, purified silk promotes microbial growth. Selenium nanoparticles have shown excellent antibacterial properties and are a novel antimicrobial chemistry. Here, electrospun silk scaffolds were doped with selenium nanoparticles to impart antibacterial properties to the silk scaffolds. Results showed significantly improved bacterial inhibition and mild improvement in human dermal fibroblast metabolic activity. These results suggest that the addition of selenium nanoparticles to electrospun silk is a promising approach to improve wound healing with reduced infection, without relying on antibiotics.

Antimicrobial performance of mesoporous titania thin films: role of pore size, hydrophobicity, and antibiotic release.

Implant-associated infections are undesirable complications that might arise after implant surgery. If the infection is not prevented, it can lead to tremendous cost, trauma, and even life threatening conditions for the patient. Development of an implant coating loaded with antimicrobial substances would be an effective way to improve the success rate of implants. In this study, the in vitro efficacy of mesoporous titania thin films used as a novel antimicrobial release coating was evaluated. Mesoporous titania thin films with pore diameters of 4, 6, and 7 nm were synthesized using the evaporation-induced self-assembly method. The films were characterized and loaded with antimicrobial agents, including vancomycin, gentamicin, and daptomycin. Staphylococcus aureus and Pseudomonas aeruginosa were used to evaluate their effectiveness toward inhibiting bacterial colonization. Drug loading and delivery were studied using a quartz crystal microbalance with dissipation monitoring, which showed successful loading and release of the antibiotics from the surfaces. Results from counting bacterial colony-forming units showed reduced bacterial adhesion on the drug-loaded films. Interestingly, the presence of the pores alone had a desired effect on bacterial colonization, which can be attributed to the documented nanotopographical effect. In summary, this study provides significant promise for the use of mesoporous titania thin films for reducing implant infections.

Antibacterial Nanostructured Polyhydroxybutyrate Membranes for Guided Bone Regeneration.

The principle of guided bone regeneration (GBR) in orthopedic, cranio-maxillofacial and dental tissue engineering applications is to create a secluded space for the treatment of large bone defects while excluding fibrous connective tissue formation at the defect area. In dental surgeries, a GBR membrane is placed near the dental implant in post-extraction sockets to grow new bone at the implant site, along with inhibiting infection due to the microbial nature of the mouth flora. Poly[(R)-3-hydroxybutyric acid] (PHB) is a natural polyester synthesized by a wide variety of microorganisms which has been proposed for various biomedical applications. In this study, to improve the performance of PHB as a GBR, a NaOH based alkaline treatment was designed to create nanofeatured PHB membranes. The newly fabricated nanofeatured PHB membranes were investigated for GBR applications. The results showed that a quick, simple, and inexpensive sodium hydroxide treatment modified the nanostructured surface morphology and chemistry of the PHB membranes by inducing hydrolysis of the ester bonds in the PHB backbone creating carboxylic surface functional groups, which increased the hydrophilicity of the PHB surfaces. Cytocompatibility studies showed increased proliferation of human osteoblasts (bone forming cells) on the NaOH treated PHB membranes compared to the untreated ones. Importantly, in vitro bacterial studies with Staphylococcus aureus (S. aureus) indicated that the NaOH-treated PHB surfaces inhibited S. aureus growth more than 60% after 48 hours of culture compared to the untreated PHB membrane. Thus, this study, for the first time, showed that nanofeatured PHB membranes modified with a NaOH treatment may be a useful anti-bacterial, osteoconductive GBR membrane for numerous orthopedic, cranio-maxillofacial and dental tissue engineering applications.

Sapropterin Dihydrochloride Mixed With Common Foods and Beverages.

Sapropterin dihydrochloride is used to lower blood phenylalanine levels in tetrahydrobiopterin-responsive phenylketonuria in conjunction with a phenylalanine-restricted diet. This study investigated the solubility and stability of sapropterin tablets and a sapropterin powder formulation when mixed in selected beverages and foods. Solubility was partial for the tablets and complete for the powder. The stability testing showed that 93% or more of active sapropterin dihydrochloride is present at 1 hour after either tablets or powders are mixed with certain foods and beverages. Mixing sapropterin powder with foods and beverages might facilitate its administration in patients who have difficulty swallowing the drug according to prescribing information.

Nanostructured anti-bacterial poly-lactic-co-glycolic acid films for skin tissue engineering applications.

Major issues faced with the use of today's skin grafts are infection, scar tissue formation, insufficient keratinocyte (or skin producing cells) proliferation and high production costs. To overcome these limitations, we propose here for the first time, a nanofeatured poly(lactide-co-glycolide) (PLGA) membrane as a next generation antibacterial skin graft material. An alkaline surface treatment method was used to create random nanofeatures on PLGA membranes where sodium hydroxide (NaOH) concentration and exposure times were altered to control surface morphology. Most significantly, and without the use of antibiotics, results showed a decrease in Staphylococcus aureus (a dangerous pathogen infecting skin grafts) growth for up to ∼40% after 2 days of culture on nanofeatured PLGA membranes compared to untreated controls. Results also showed that while bacteria growth was stunted, mammalian cell growth was not. Specifically, cell culture results showed an increase in human epidermal keratinocyte density, while the density of scar tissue forming human dermal fibroblasts, did not change on nanofeatured PLGA surfaces compared to the untreated controls after 3 days of culture. These findings indicate that the alkaline treatment of PLGA membranes is a promising quick and effective manner to limit scar tissue formation and bacterial invasion while increasing skin cell proliferation for improving numerous wound-healing applications.