The Cost of Guideline Adherence: A Multicenter Analysis of the Financial Implications of Adopting the US Multi-Society Task Force Polypectomy Guidelines.

GOAL: The goal of this study was to determine the financial impact of adopting the US Multi-Society Task Force (USMSTF) polypectomy guidelines on physician reimbursement and disposable equipment costs for gastroenterologists in the academic medical center and community practice settings. BACKGROUND: In 2020, USMSTF guidelines on polypectomy were introduced with a strong recommendation for cold snare rather than cold forceps technique for removing diminutive and small polyps. Polypectomy with snare technique reimburses physicians at a higher rate compared with cold forceps and also requires different disposable equipment. The financial implications of adopting these guidelines is unknown. MATERIALS AND METHODS: Patients that underwent screening colonoscopy where polypectomy was performed at an academic medical center (Loma Linda University Medical Center) and community practice medical center (Ascension Providence Hospital) between July 2018 and July 2019 were identified. The polypectomy technique performed during each procedure was determined (forceps alone, snare alone, forceps plus snare) along with the number and size of polyps as well as disposable equipment. Actual and projected provider reimbursement and disposable equipment costs were determined based on applying the new polypectomy guidelines. RESULTS: A total of 1167 patients underwent colonoscopy with polypectomy. Adhering to new guidelines would increase estimated physician reimbursement by 5.6% and 12.5% at academic and community practice sites, respectively. The mean increase in physician reimbursement per procedure was significantly higher at community practice compared with the academic setting ($29.50 vs. $14.13, P <0.00001). The mean increase in disposable equipment cost per procedure was significantly higher at the community practice setting ($6.11 vs. $1.97, P <0.00001). CONCLUSION: Adopting new polypectomy guidelines will increase physician reimbursement and equipment costs when colonoscopy with polypectomy is performed.

Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom. Final order.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to "single-use internal condom," a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for "female condom," a preamendments class III device (product code OBY), by renaming the device "multiple-use female condom," to distinguish it from the "single-use internal condom." This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device.

[Objective and subjective requirement of aids and appliances in patients with neurogenic lower urinary tract dysfunction : Multicenter study to determinate the daily necessity of urological aids and appliances]. / Objektiver und subjektiver Hilfsmittelbedarf bei Patienten mit neurogenen Harnblasenfunktionsstörungen : Multicenterstudie zur Ermittlung des täglichen Bedarfs an urologischen Hilfsmitteln.

BACKGROUND: The provision of urological appliances for patients with neurogenic lower urinary tract dysfunction (NLUTD) is essential. Hitherto existing standard guidelines for the estimation of monthly material requirements are based solely on estimates. OBJECTIVE: The goal of this work was to define the objective and subsequently subjective requirements for urological appliances on a scientifically validated basis. MATERIALS AND METHODS: Data concerning bladder management and daily consumption of urological appliances for patients with NLUTD were collected through a standardized survey at six different centers in Germany during the period of October to December 2014 and statistically evaluated. RESULTS: In all, 767 patient records were analyzed: 543 men and 221 woman (N/A = 3). The daily disposable catheter consumption of 577 patients who exclusively used intermittent catheterization was 5.13. Patients who used other means of bladder emptying (n = 31) in addition to catheterization consumed on average 3.17 catheters. The margin of deviation was larger for children. Of the 608 patients with intermittent catheterization, 94 (15.5 %) required additional paddings as absorbent aids (on average 2.29 paddings per day), 34 patients (5.6 %) additionally used pants (2.55 per day) and 46 patients (7.6 %) utilized condom catheters (3.81 per day) between catheterization. Among all surveyed patients, 126 (16.4 %) used paddings (5.03 per day) and 51 patients (6.6 %) pants (3.03 per day). Of all male respondents 82 (15.1 %) used condom catheters (2.80 urinary sheaths per day). CONCLUSION: Applying twice the standard deviation of the mean as a measure of assessing the objective requirement of urological appliances and aids for adult patients with NLUTD allows the following daily thresholds to be defined: 1-9 disposable catheters, 0-7 urinary sheaths, 1-9 paddings and 0-7 pants. These thresholds can serve as a basis for estimating the subjective need. They allow for a scientifically validated benchmark for an economically feasible and patient-tailored supply with urological aids and appliances. Individually required appliances and aids have to be recognized. Verifiable quality standards need to be developed.

[Selection of disposable personal protective equipment for work with samples containing highly pathogenic microorganisms]. / Dobór jednorazowych srodków ochrony osobistej do pracy z materialem zawierajacym wysoce niebezpieczne patogeny.

Emerging microbiological threats, such as SARS, Ebola, MERS-CoV, anthrax, cause necessity of considering how effectively protect laboratory workers against dangerous pathogens which might be present in clinical samples. The article presents requirements for personal protective equipment (PPE) in microbiological laboratories and examples of selection and application of disposable PPE.

In vitro power profiles of daily disposable contact lenses.

PURPOSE: To evaluate and compare the distribution of refractive power within the optic zone of different soft contact lenses and to investigate the effect of lens decentration on the power profiles. METHODS: The Nimo TR1504 instrument was used to measure the optical power across different aperture diameters (from 1.5mm to 5.5mm in steps of 0.5mm) of four daily disposable contact lenses: DAILIES TOTAL1, Proclear 1-Day, SofLens daily disposable and 1-DAY ACUVUE MOIST. Measurements were performed using a wet cell. Power data were evaluated when contact lenses were in its centered position and after inducing different amounts of lens decentration (from 0.2mm to 1.0mm in steps of 0.2mm). RESULTS: All contact lenses showed an increase - more negative - in lens power with distance from the lens center. The amount of change varied depending on the lens. It was about 10% of lens power for DAILIES TOTAL1 (-0.29diopters (D)), SofLens daily disposable (-0.36D), and Proclear 1-Day (-0.32D) whereas 1-DAY ACUVUE MOIST showed a percentage variation of 3.3% (-0.10D). After inducing a lens decentration up to 1mm, the power curves were shifted in the negative direction. However, the change obtained in lens power compared with well-centered position was always lower than a quarter of diopter both for all the lenses and aperture diameters. CONCLUSIONS: Our results showed a variation of the refractive power from the lens center, becoming more negative toward the periphery, with a negligible effect of the decentration for all disposable contact lenses studied.

[Classification of disposable medical plastics and search for alternatives without polyvinyl chloride in the Hospital Virgen de las Nieves (Granada, Spain)]. / Clasificación de materiales plásticos sanitarios desechables y búsqueda de alternativas sin policloruro de vinilo en el Hospital Virgen de las Nieves.

OBJECTIVES: To identify and classify disposable hospital products containing polyvinyl chloride (PVC), including the search and evaluation of cost-effective sustainable alternative products free of PVC. METHODS: A descriptive observational analysis was performed, after classifying the latest research in major databases, and disposable products that could contain PVC. These were divided into 5 groups: cannulas, catheters, tubes, bags, and equipment, purchased in the period 2008-2009, differentiating between the technical and economic assessment of the materials. RESULTS: In the analysis of the composition of 492 articles selected, 234 (47.5%) contained PVC, and 19.4% were considered PVC-free alternatives, with only 11.3% of these being economically viable. CONCLUSIONS: This study highlights the advantages of the classification of PVC products, by showing that safe and efficient alternatives exist for some product lines that are consistent with patient safety and quality in the work by doctors.

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

Actual and estimated costs of disposable materials used during surgical procedures.

It is difficult to estimate precisely the costs of disposable materials used during surgical operations. To evaluate the actual costs of disposable materials, we calculated the actual costs of disposable materials used in 59 operations by taking account of costs of all disposable materials used for each operation. The costs of the disposable materials varied significantly from operation to operation (US$ 38-4230 per operation), and the median [25-percentile and 75-percentile] of the sum total of disposable material costs of a single operation was found to be US$ 686 [205 and 993]. Multiple regression analysis with a stepwise regression method showed that costs of disposable materials significantly correlated only with operation time (p<0.001). Based on the results, we propose a simple method for estimating costs of disposable materials by measuring operation time, and we found that the method gives reliable results. Since costs of disposable materials used during surgical operations are considerable, precise estimation of the costs is essential for hospital cost accounting. Our method should be useful for planning hospital administration strategies.

Engineered structures for use in disposable incontinence products.

The background and evolution of absorbent disposable hygiene products is discussed. The current technology used to produce disposable hygiene products such as baby diapers, feminine hygiene products and adult incontinence management products is shown to have a number of manufacturing and in-use problems. Alternative technologies, such as multilayer composite webs offer the opportunity to achieve better product weight control, and therefore better control over the other related properties, reduced raw material waste and improved functional characteristics. There are still problems to be resolved when using such composite materials, but the potential of these new technologies has now been established.

Effects of disposable or interchangeable positive end-expiratory pressure valves on work of breathing during the application of continuous positive airway pressure.

OBJECTIVE: To determine which of a series of disposable or interchangeable positive end-expiratory pressure (PEEP) devices functions with the least imposition of inspiratory and expiratory work during continuous positive airway pressure. DESIGN: Prospective laboratory evaluation performed on a lung model. SETTING: Research laboratory at a university medical center. INTERVENTIONS: A spontaneously breathing lung model, created from a training test lung and a volume ventilator, were used to simulate a patient spontaneously breathing at a tidal volume of 0.4 L, peak inspiratory flow of 40 L/min, an inspiration/expiration ratio of 1:2, and a respiratory rate of 20 breaths/min. Ten PEEP valves attached to a continuous high-flow system were evaluated. MEASUREMENTS AND MAIN RESULTS: All of the PEEP valves studied imposed high levels of both inspiratory and expiratory work of breathing. The BE-171 and BE-142 valves (Instrumentation Industries) imposed the least amount of inspiratory work. In general, imposed inspiratory work accounted for approximately 70% to 80% of total imposed work of breathing. CONCLUSIONS: All of the disposable/interchangeable PEEP valves that were studied imposed a considerable amount of both inspiratory and expiratory work, even when the continuous flow provided exceeded the peak inspiratory flow demands of the lung model. The primary reason for the high imposed work levels is the high gas-flow resistance of all of the valves studied.

Analysis of serum elements and the contaminations from devices used for serum preparation by inductively coupled plasma mass spectrometry.

Two different samples of serum were prepared from a blood specimen by using two types of serum-separation tubes. Each serum sample was diluted by 100 times with deionized and sub-boiling distilled water. Thirty-six elements in the serum and exudate, from devices used for the serum preparation, were determined by inductively coupled plasma mass spectrometry (ICP-MS). From the comparison of elemental concentrations in two groups of 11 serum samples, it was found that the exudate from serum-separation tubes, as well as from disposable stainless steel needles, had serious effects on the elemental concentrations in the serum. Means for the concentrations of Li, Co, Ga, Cd, Sn, Sb, Ba, La, and Ce in the two serum groups were statistically different from each other. The concentrations of Cr, Mn, Fe, and Mo in both groups were apparently higher than those reported in the literature, suggesting contamination from the disposable stainless steel needle and spectral interferences due to molecular species produced in the argon plasma.