Journal articles on the topic 'Medical instruments and apparatus Standards'

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1

Jette, L. P., and N. G. Lambert. "Evaluation of Two Hot Water Washer Disinfectors for Medical Instruments." Infection Control & Hospital Epidemiology 9, no. 5 (May 1988): 194–99. http://dx.doi.org/10.1086/645832.

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AbstractTwo models of hot water washer disinfectors (Decomat 128 and Hospital A, Euroclean Canada Inc; Ontario, Canada) were evaluated by two methods for their efficacy in disinfecting anesthesia equipment. In the first method, three different microbial suspensions were each sealed into 30 capillary tubes. In the second method, corrugated anesthesia tubes were rinsed with suspensions of each of two bacterial strains. The tubes then underwent a standard cycle in the hot water washer disinfectors and were subsequently tested for growth of microorganisms. All experiments were repeated three times, and the temperature was registered in all cases. In the capillary test, growth was rarely detected (13/540 tubes) and the inactivation factor for both apparatus was > 5 log,,. In the rinse test, no growth was detected. The mean temperature for 15 disinfection cycles was 84.2 ± 0.8°C for Decomat 128 and 88.9 ± 0.5% for Hospital A. However, for Decomat 128 we observed a variation of 3°C from one disinfection cycle to another and a progressive reduction of 2.2°C over a series of five consecutive complete cycles. Both methods gave reproducible results. Under our experimental conditions, both hot water washer disinfectors proved to be efficacious for the disinfection of reusable anesthesia equipment.
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Lando, Hands, Sukri Palutturi, Amran Razak, Darmaw ansyah, Saifuddin Sirajuddin, and Muhammad Kardi. "Analysis of Determinants of the Logistics Management System of Medical Devices at the Wamena Regional General Hospital, Jayawijaya Regency." NeuroQuantology 20, no. 5 (May 2, 2022): 141–49. http://dx.doi.org/10.14704/nq.2022.20.5.nq22157.

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Functions and Roles of hospitals in addition to medical treatment also meet the requirements of location, buildings, infrastructure, and human resources, hospitals must also meet the requirements of pharmacy and equipment. Medical Devices are instruments, apparatus, machines and/or implants that do not contain drugs that are used to prevent, diagnose, cure and relieve disease, treat sick people, restore health in humans, and/or form structures and improve body functions. The purpose of this study was to determine the logistics management system for medical devices at the Wamena Regional General Hospital. This type of research is qualitative descriptive with in-depth interviews and document review involving 8 informants. The results of this study indicate that planning is made based on annual and routine meetings, procurement is based on unit needs, budgeting is based on RAB and APBD, no logistics warehouse storage, distribution is often long and late so users wait, standard maintenance and categorizes good and damaged goods, elimination carried out on unused goods due to damage, monitoring and evaluation are effective because the final part of the logistics management process is to maintain grade, quality and quantity.
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Manita, Aakash Deep, Vikram, Avtar C. Rana, and Prabodh C. Sharma. "Regulation and Clinical Investigation of Medical Device in the European Union." Applied Clinical Research, Clinical Trials and Regulatory Affairs 6, no. 3 (November 13, 2019): 163–81. http://dx.doi.org/10.2174/2213476x06666190821095407.

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Background:: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective:: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion:: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.
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Giarrizzo-Wilson, Sharon. "Collaborative instrumentation standards; fire protection standards; sterilizers; medical gas fittings; borrowing instruments." AORN Journal 82, no. 4 (October 2005): 673–78. http://dx.doi.org/10.1016/s0001-2092(06)60039-2.

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5

Vorogushin, V. A., T. V. Kustov, G. N. Pakharkov, and Z. M. Yuldashev. "Implementation of Professional Standards in Use of Medical Instruments." Biomedical Engineering 48, no. 2 (July 2014): 97–99. http://dx.doi.org/10.1007/s10527-014-9429-y.

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6

Баурина and Svetlana Baurina. "Standardization and Quality of Medical Equipment and Apparatus." Economics of the Firm 3, no. 2 (June 17, 2014): 8–12. http://dx.doi.org/10.12737/5989.

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Trends in medical-technical industry of Russia are discussed. Provided are brief characteristics of quality indicators and review of requirements for medical devices and equipment. The author describes basic standards, governing regulatory requirements for medical equipment maintenance support and quality management systems for medical equipment and apparatus production.
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7

Zhang, Jin Liang. "Usage and Maintenance of Medical Apparatus and Instruments of Human Factors Research." Applied Mechanics and Materials 651-653 (September 2014): 1691–94. http://dx.doi.org/10.4028/www.scientific.net/amm.651-653.1691.

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Medical equipment maintenance and use of personnel, is crucial. Used properly and rational division of engineering and technical personnel, strict management, to train engineering technical personnel with professional spirit, all-round for clinical medical services; To strengthen the training of equipment use of personnel, highlight the preventive maintenance and maximize or prolonged trouble-free of medical instrument equipment, ensure the effective operation of the clinical diagnosis and treatment work.
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8

Levin, Sergey F. "The measurement problem of calibration of measuring instrument under specified conditions." Izmeritel`naya Tekhnika, no. 4 (2021): 9–15. http://dx.doi.org/10.32446/0368-1025it.2021-4-9-15.

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The problem of calibration of measuring instruments for given conditions based on the correction function is considered as a measurement problem of structural-parametric identification of the calibration diagram. It is shown, that the correction function allows at the first stage to obtain a ratio for correcting the readings, and at the second stage to obtain a corrected measurement result, it is necessary to identify the probability distribution of possible deviations from it. An example of solving the measurement problem of calibration for given conditions is given. Negative aspects of the practice of calibration of measuring instruments are noted: carrying out calibration under normal conditions according to the methods of verification of measuring instruments; presentation of calibration results by tables of joint readings of measuring instruments and standards; the presence in the calculations of the calibration diagram of significant restrictions on the mathematical apparatus of the «Guidelines for the expression of measurement uncertainty», specified by ISO/IEC 31010:2019 “Risk management – Risk assessment techniques”.
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9

Genuth, Sara Schechner. "Book Review: Nineteenth-Century Apparatus: Pike's Illustrated Catalogue of Scientific & Medical Instruments." Journal for the History of Astronomy 18, no. 2 (May 1987): 140–41. http://dx.doi.org/10.1177/002182868701800215.

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10

Van Lente, Eric, and Martin Power. "Standardising assessment instruments and care planning in Ireland." Quality in Ageing and Older Adults 15, no. 1 (March 4, 2014): 46–60. http://dx.doi.org/10.1108/qaoa-01-2013-0002.

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Purpose – Scoping of instruments in use for assessment of needs and the practices that surround care planning in residential care for older people in Ireland, in the wake of the introduction of national standards. The paper discusses these issues. Design/methodology/approach – Survey of care providers using an online/postal questionnaire, developed from the domains of need outlined in the standards. Findings – There is wide variation in the use of standardised instruments for assessment. Within some domains, standardised instruments enjoy near universal usage. However, within other domains, standardised instruments are often absent, external professional input and/or guidelines dominate and/or instruments have been adapted in-house. Practices surrounding care planning are largely homogeneous and the preserve of medical professionals. Research limitations/implications – This research was confined to the Republic of Ireland, limiting generalisation. The self-selecting nature of participants must also be considered. Further research could include, examining how, over time, the standards are shaping care practice, particularly in relation to interdisciplinary working and person-centred care. Practical implications – The non-prescriptive nature of the standards presents a challenge to care providers in selecting appropriate standardised instruments for assessment. In addition, medical dominance of care planning limits the extent to which care plans can enhance the provision of interdisciplinary and person-centred care. Originality/value – This paper contributes to a growing literature on standardisation of assessment and care planning, provides a reference point for comparison with other nations and, in an Irish context, addresses an area that has received little attention to-date. As such, it is of interest to practitioners, care providers and regulators.
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11

RAMLI, MUHAMMAD, OKKY AFRIWAN, and BUDIARTO BUDIARTO. "KEBERHASILAN IMPLEMENTASI PERATURAN PEMERINTAH NOMOR 71 TAHUN 2010 TENTANG STANDAR AKUNTANSI PEMERINTAHAN BERBASIS AKRUAL." GANEC SWARA 14, no. 1 (March 6, 2020): 406. http://dx.doi.org/10.35327/gara.v14i1.114.

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This study aims to determine the factors that play a role in the successful implementation of Government Regulation Number 71 of 2010 concerning Accrual Based Government Accounting Standards. This type of research is a quantitative research with a regression analysis method to the factors of regulation, HR, commitment, supporting tools, and relevant training which are thought to influence the successful implementation of Government Regulation No.71 of 2010 concerning Accrual Based Government Accounting Standards. The research population is the regional financial manager in 33 Regional Apparatus Organizations/Regional Apparatus Work Units within the Mataram City Government, namely the Head of the OPD/SKPD and/or Financial Administration Officials, Treasurers and Planning Staff. The research sample is selected by using the purposive sampling method with 91 respondents out of 99 respondents who are given questionnaires. The results showed that partially the quality of human resources and training have a significant relationship, while regulations, commitments, and supporting instruments do not have a significant relationship to the success of the local government in implementing PP71/2010. And based on simultaneous analysis shows that there is an influence of the relationship between regulations, human resources, commitments, supporting tools, and training on the success of local governments in the implementation of PP71/2010.
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12

Taylor, Paul J., and Rosalie A. Bouska. "Automated serum chloride analysis using the Apple computer." Journal of Automatic Chemistry 10, no. 1 (1988): 10–14. http://dx.doi.org/10.1155/s1463924688000057.

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Analysis of standards and reference sera indicate the method is rapid, accurate and precise. Application of this apparatus as a teaching aidfor electronics to chemistry and medical students is also described.
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13

Morriss, Richard K., and Alison J. Wearden. "Screening instruments for psychiatric morbidity in chronic fatigue syndrome." Journal of the Royal Society of Medicine 91, no. 7 (July 1998): 365–68. http://dx.doi.org/10.1177/014107689809100706.

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Physicians require a screening instrument to detect psychiatric disorders in patients with chronic fatigue syndrome (CFS). Different threshold scores on the Hospital Anxiety and Depression scale (HAD) and the mental health scale of the Medical Outcome Survey (MOS) were compared with two gold standards for the presence or absence of psychiatric disorder, standard diagnostic criteria (DSM-III-R) and a threshold score for the number of psychiatric symptoms at a standardized psychiatric interview (Revised Clinical Interview Schedule total cut-off score of 11/12). They were compared by use of validating coefficients and receiver operating characteristics in 136 consecutive CFS medical outpatients. The HAD scale at cut-off of 9/10 was a valid and efficient screening instrument for anxiety and depression by comparison with both gold standards. The MOS mental health scale at its recommended cut-off score of 67/68 yielded too many false-positives to be recommended as a psychiatric screening instrument in CFS patients.
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14

Yang, Yan-Qiu, and Shuo-Yang Zhao. "Application of Pulsating Vacuum Cleaning Technology to Medical Devices Cleaning." Journal of Biomaterials and Tissue Engineering 12, no. 5 (May 1, 2022): 984–88. http://dx.doi.org/10.1166/jbt.2022.2979.

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This study aims to solve existing problems in cleaning medical devices, such as the cumbersome loading of minimally invasive surgical instruments, the incomplete cleaning of instruments with complex structures, and the low cleaning efficiency of ordinary instruments. A pulsating vacuum cleaning machine was combined with ultrasonic cleaning and boiling cleaning technology to clean various complex medical devices through a pressure pulsating process (i.e., repetitive pump-out and pumpin until the cleaning results meet the cleaning standards for medical devices). The cleaning results of spay washing, ultrasound cleaning and pulsating vacuum cleaning were compared among four groups of medical devices, including silica gel hoses, chamber instruments, whole box of minimally invasive instruments and surgical instruments. The amount of protein residues was tested using the spectrophotometric method. The testing results revealed that the loading capacity of a pulsating vacuum cleaning machine is 3–4 times as much as that of an ordinary spray cleaning machine, without manual placement and connection operation required, which reduced the workload of pretreatment. The protein residue after cleaning meets the requirements of the YY/T0734 standard for the cleaning effect of medical devices. Pulsating vacuum cleaning technology has an overall better loading capacity, when compared to spay washing and ultrasound cleaning, and this can make up for the shortcomings of commonly used cleaning machines, such as the low cleaning efficiency and unsatisfactory cleaning results of medical devices with complex structures.
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15

Turner, M. J., and S. Culbert. "Apparatus to measure the step and frequency responses of gas analysis instruments (respiratory gas analysis)." Physiological Measurement 14, no. 3 (August 1, 1993): 317–26. http://dx.doi.org/10.1088/0967-3334/14/3/010.

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16

Neeley, W. E., K. O'Classen, and M. Gruber. "Determination of serum aspartate aminotransferase with pyridoxal 5'-phosphate in the Technicon SMAC and Du Pont aca compared and correlated with the IFCC recommended method." Clinical Chemistry 31, no. 1 (January 1, 1985): 139–42. http://dx.doi.org/10.1093/clinchem/31.1.139.

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Abstract Inexpensive improvements in continuous-flow analytical apparatus can eliminate some perplexing inconsistencies and limitations in the use of the Technicon SMAC instrument for measuring the activity in serum of aspartate aminotransferase (EC 2.6.1.1) in the presence of pyridoxal 5'-phosphate. In addition, a calibration procedure based on values for this enzyme obtained by a modified IFCC method can be used to calibrate both the Technicon SMAC and the Du Pont aca instruments to produce excellent correlation between the two.
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Schaffer, R., G. N. Bowers, and R. S. Melville. "History of NIST's contributions to development of standard reference materials and reference and definitive methods for clinical chemistry." Clinical Chemistry 41, no. 9 (September 1, 1995): 1306–12. http://dx.doi.org/10.1093/clinchem/41.9.1306.

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Abstract The issuance of cholesterol as a Standard Reference Material (SRM) in 1967 started the National Institute of Standards and Technology (NIST; then named the National Bureau of Standards) on a major effort to help clinical laboratories establish and improve the quality of measurements they make. NIST now issues three kinds of SRMs for that purpose: analyte samples of certified purity as primary standards, serum samples having certified analyte concentrations as accuracy controls, and materials certified for calibrating instruments. In working with clinical laboratory scientists to establish Reference Methods (RMs) for measuring the analytes, NIST developed Definitive Methods (DMs) to use for evaluating RM accuracy and then used the DMs for assigning analyte values to its SRMs. The development of SRMs and DMs is discussed.
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Kwan, Yu Heng, Kelly Png, Jie Kie Phang, Ying Ying Leung, Hendra Goh, Yi Seah, Julian Thumboo, A/P Swee Cheng Ng, Warren Fong, and Desiree Lie. "A Systematic Review of the Quality and Utility of Observer-Based Instruments for Assessing Medical Professionalism." Journal of Graduate Medical Education 10, no. 6 (December 1, 2018): 629–38. http://dx.doi.org/10.4300/jgme-d-18-00086.1.

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ABSTRACT Background Professionalism, which encompasses behavioral, ethical, and related domains, is a core competency of medical practice. While observer-based instruments to assess medical professionalism are available, information on their psychometric properties and utility is limited. Objective We systematically reviewed the psychometric properties and utility of existing observer-based instruments for assessing professionalism in medical trainees. Methods After selecting eligible studies, we employed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria to score study methodological quality. We identified eligible instruments and performed quality assessment of psychometric properties for each selected instrument. We scored the utility of each instrument based on the ability to distinguish performance levels over time, availability of objective scoring criteria, validity evidence in medical students and residents, and instrument length. Results Ten instruments from 16 studies met criteria for consideration, with studies having acceptable methodological quality. Psychometric properties were variably assessed. Among 10 instruments, the Education Outcomes Service (EOS) group questionnaire and Professionalism Mini-Evaluation Exercise (P-MEX) possessed the best psychometric properties, with the P-MEX scoring higher on utility than the EOS group questionnaire. Conclusions We identified 2 instruments with best psychometric properties, with 1 also showing acceptable utility for assessing professionalism in trainees. The P-MEX may be an option for program directors to adopt as an observer-based instrument for formative assessment of medical professionalism. Further studies of the 2 instruments to aggregate additional validity evidence is recommended, particularly in the domain of content validity before they are used in specific cultural settings and in summative assessments.
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Rosenkoetter, Ulrike, and Robyn L. Tate. "Assessing Features of Psychometric Assessment Instruments: A Comparison of the COSMIN Checklist with Other Critical Appraisal Tools." Brain Impairment 19, no. 1 (December 7, 2017): 103–18. http://dx.doi.org/10.1017/brimp.2017.29.

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The past 20 years have seen the development of instruments designed to specify standards and evaluate the adequacy of published studies with respect to the quality of study design, the quality of findings, as well as the quality of their reporting. In the field of psychometrics, the first minimum set of standards for the review of psychometric instruments was published in 1996 by the Scientific Advisory Committee of the Medical Outcomes Trust. Since then, a number of tools have been developed with similar aims. The present paper reviews basic psychometric properties (reliability, validity and responsiveness), compares six tools developed for the critical appraisal of psychometric studies and provides a worked example of using the COSMIN checklist, Terwee-m statistical quality criteria, and the levels of evidence synthesis using the method of Schellingerhout and colleagues (2012). This paper will aid users and reviewers of questionnaires in the quality appraisal and selection of appropriate instruments by presenting available assessment tools, their characteristics and utility.
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Asfiati, Asfiati. "Authentic Assessment Implementation Subjects Islamic Education Curriculum 2013 In SMA 1 Hutabargot Mandailing Natal." FITRAH:Jurnal Kajian Ilmu-ilmu Keislaman 6, no. 1 (June 29, 2020): 19–30. http://dx.doi.org/10.24952/fitrah.v6i1.2486.

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Implementation of authentic assessment is motivated emergence of KTSP curriculum changes into the curriculum of 2013. Curriculum 2013 seeks to enhance authentic assessment standards. Emphasis on the authentic assessment of learning outcomes. This study aims to determine the implementation of authentic assessment on the Curriculum 2013 in public senior high school/SMA Negeri 1 Hutabargot Mandailing Natal district . The research method is descriptive qualitative. Subjects were teacher of Islamic education in public senior high school/SMA Negeri 1 Hutabargot counties Christmas Apparatus Mandailings Civil State (ASN). Data collected through observation, interviews, and documentation. The results showed the implementation of authentic assessment on the Curriculum 2013 in accordance with the technique, instruments and processes. Attitude assessment techniques is observed using a check list. Ratings knowledge using verbal and written tests. Skills assessment using tests, a list of scale
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Marcia King, Brink, Sebranek Joseph G., C. Anthony, P. Coleman, B. Cottingham, R. Culmo, R. Curtis, et al. "Combustion Method for Determination of Crude Protein in Meat and Meat Products: Collaborative Study." Journal of AOAC INTERNATIONAL 76, no. 4 (July 1, 1993): 787–93. http://dx.doi.org/10.1093/jaoac/76.4.787.

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Abstract Twelve laboratories participated in a collaborative study to compare a combustion method with the AOAC mercury catalyst Kjeldahl method (928.08) for the determination of crude protein in meat and meat products. Three different combustion instruments were used; consequently, the combustion method for this study is written in generic terms describing the principle, the apparatus specifications, and the performance requirements needed. Fifteen sample pairs were used for the study; each pair consisted of the same commercial meat product from each of 2 different manufacturers. Protein content of all samples ranged from about 10 to 20%. In addition, nicotinic acid and lysine monohydrochloride were used as standards to assess combustion equipment performance. All laboratories and all instruments performed the combustion method satisfactorily on the basis of results for the standards. For the meat samples, repeatability standard deviations (sr) ranged from 0.11 to 0.40 for the Kjeldahl method and from 0.12 to 0.41 for the combustion method; the repeatability relative standard deviations (RSDr) ranged from 0.82 to 2.41% and from 0.60 to 2.23% for the Kjeldahl and combustion methods, respectively. Reproducibility standard deviations (SR) ranged from 0.20 to 0.49 for the Kjeldahl method and from 0.18 to 0.46 for the combustion method, whereas the reproducibility relative standard deviations (RSDR) ranged from 1.59 to 2.84% for the Kjeldahl method and from 1.32 to 3.35% for the combustion method. Overall grand means were 15.59% protein for the Kjeldahl method and 15.75% protein for the combustion method. The combustion method was adopted first action by AOAC International.
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Wohlleber, Kerstin, Patrick Heger, Pascal Probst, Christoph Engel, Markus K. Diener, and André L. Mihaljevic. "Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies." Quality of Life Research 30, no. 9 (July 20, 2021): 2429–66. http://dx.doi.org/10.1007/s11136-021-02810-8.

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Abstract Purpose Patient-reported outcomes including health-related quality of life (HRQoL) are important oncological outcome measures. The validation of HRQoL instruments for patients with hepatocellular and cholangiocellular carcinoma is lacking. Furthermore, studies comparing different treatment options in respect to HRQoL are sparse. The objective of the systematic review and meta-analysis was, therefore, to identify all available HRQoL tools regarding primary liver cancer, to assess the methodological quality of these HRQoL instruments and to compare surgical, interventional and medical treatments with regard to HRQoL. Methods A systematic literature search was conducted in MEDLINE, the Cochrane library, PsycINFO, CINAHL and EMBASE. The methodological quality of all identified HRQoL instruments was performed according to the COnsensus-based Standards for the selection of health status Measurements INstruments (COSMIN) standard. Consequently, the quality of reporting of HRQoL data was assessed. Finally, wherever possible HRQoL data were extracted and quantitative analyses were performed. Results A total of 124 studies using 29 different HRQoL instruments were identified. After the methodological assessment, only 10 instruments fulfilled the psychometric criteria and could be included in subsequent analyses. However, quality of reporting of HRQoL data was insufficient, precluding meta-analyses for 9 instruments. Conclusion Using a standardized methodological assessment, specific HRQoL instruments are recommended for use in patients with hepatocellular and cholangiocellular carcinoma. HRQoL data of patients undergoing treatment of primary liver cancers are sparse and reporting falls short of published standards. Meaningful comparison of established treatment options with regard to HRQoL was impossible indicating the need for future research.
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Lepekhina, N. G. "Application of closed aspiration system for sanitation of the tracheobronchial tree under the conditions of artificial lung ventilation personnel management." Medsestra (Nurse), no. 12 (December 3, 2022): 7–16. http://dx.doi.org/10.33920/med-05-2212-01.

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Currently, the risk of HCAI is reduced due to innovative technologies, the use of modern antiseptics, disposable instruments, and strict adherence by medical staff to the sanitary and anti- epidemic regime. The introduction of nursing standards, strict adherence to the implementation of medical procedures technologies can improve the quality of medical care for ICU patients, increase the efficiency of care for patients with an infectious profile.
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Jang, Hansol, U.-Ryeong Chung, Jeong-Hyun Moon, Seong-Kyeong Choi, Won-Suk Sung, Min-Seop Hwang, Seung-Deok Lee, Kyung-Ho Kim, Jong-Hwa Yoon, and Eun-Jung Kim. "A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus." Journal of Korean Medicine 43, no. 3 (September 1, 2022): 150–63. http://dx.doi.org/10.13048/jkm.22037.

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Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity.Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was draftedResults: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety.Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.
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Fushimi, R. "Considerations in Cleaning of Reusable Surgical Instruments and Apparatus(<Review>Washing, Disinfectant Agent and Medical Devices)." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 77, no. 5 (May 1, 2007): 311–15. http://dx.doi.org/10.4286/ikakikaigaku.77.5_311.

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Truzyan, Nune, Zaruhi Grigoryan, Lusine Musheghyan, Byron Crape, and Varduhi Petrosyan. "Quality of Inpatient Tuberculosis Health Care in High-Burden Resource-Limited Settings: Protocol for a Comprehensive Mixed Methods Assessment Study." JMIR Research Protocols 9, no. 1 (January 7, 2020): e13903. http://dx.doi.org/10.2196/13903.

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Background The quality of care for tuberculosis (TB) is deficient in high-burden countries and urgently needs improvement. However, comprehensively identifying the required improvements is challenging. Providing high-quality TB care is an important step toward improving patients’ quality of life and decreasing TB morbidity and mortality. Effective tools for assessing the quality of TB services using international standards and guidelines can identify existing gaps in services and inform improvements to ensure high-quality inpatient TB services. Objective This study aimed to develop evaluation instruments for defining the quality of provision of TB services. Methods To assess quality of services in the largest TB hospital in Armenia, we developed instruments based on the Joint Commission International Accreditation Standards for Hospitals, International Standards for TB Care, TB Laboratories Bio-Safety Standards, and the World Health Organization framework for conducting TB program reviews. A mixed methods approach was utilized, triangulating quantitative (checklists) and qualitative (in-depth interviews) results. A scoring system and strengths, weaknesses, opportunities, and treats analysis was applied to detail results for each of the 122 standards assessed. A scaling approach was used to present overall performances of inpatient services for eight patient-centered functions and five organization management functions. Results Overall, 40 in-depth interviews and 91 checklists (21 observations, 16 policy papers, 20 staff qualification documents, and 34 medical records) were developed, utilized, and analyzed to explore practices of health care professionals, assess inpatient treatment experience of patients and their family members, evaluate facility environmental conditions, and define the degree of compliance to standards. Conclusions The effective comprehensive evaluation instruments and methods developed in this study for quality of inpatient TB services support the implementation of similar effective assessments in other countries. It may also become a platform to develop similar approaches for assessing ambulatory TB services in resource-limited countries. International Registered Report Identifier (IRRID) DERR1-10.2196/13903
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Alhamd, M. W., Aqeel Maryoosh Jary, Sadeq Naeem Atiyah, and Nazar Ali Abbood. "Improve X-ray images using quality assurance tests." Journal of Physics: Conference Series 2114, no. 1 (December 1, 2021): 012034. http://dx.doi.org/10.1088/1742-6596/2114/1/012034.

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Abstract In this research, entrance surface doses of patients which are resulted from a classical radiograph in most widespread tests (Chest, skull, abdomen, limbs, …) have been measured with selected instruments in (Specialized surgeries hospital) and one of the private clinic in Baghdad, the instruments are of various origins and different make date. A group of patients (10 patients) for each test and according the average of the resulted doses. Comparison of the patient’s doses, in this research, has been close with the reliable International standards and it has been found that radiological doses are bigger than reference doses ranging (132–1.79) in most of the appliance and the range doses to one whenever the instrument is new and the radiographer has good experience, this increase relates to several functions discussed in the research in detail For the importance of the quality assurance of x-ray instruments, three tests have been performed by three of the instruments only, and these tests are : Beam Alignment test : The Beam Alignment was measured and the x-ray radiograph was found symmetrical round the two axes of the instruments (A, B) but it is about 3 ° away from the vertical axis of the instrument (C). Optical and Radiation Field Congruence Test: The light field coincides with the radiative field in a and b and their mismatch in c. Focal Spot Size Test: The radiation focus area was measured by the star tool and what appeared is that the focus of the x-ray instrument (C) is smaller than the international standards on the contrary of the focus area of the x-ray instrument (E) which is identical with the international standards. From these results reached is that the instruments (A, B) have passed quality assurance tests and they are suitable for work in the present, but the instrument (C) has not passed most of the quality assurance tests, so this instrument should not be used for medical tests This in research is considered the first one for these instruments to evaluate their doses or measure a quality assurance.
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Lenters-Westra, Erna, and Robbert J. Slingerland. "Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria." Clinical Chemistry 60, no. 8 (August 1, 2014): 1062–72. http://dx.doi.org/10.1373/clinchem.2014.224311.

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Abstract BACKGROUND In 2009, we investigated the conformance of 8 hemoglobin A1c (Hb A1c) point-of-care (POC) instruments. Since then, instruments have improved and new devices are available on the market. In this second study, we evaluated the performance of DCA Vantage, Afinion, InnovaStar, Quo-Lab, Quo-Test, Cobas B101, and B-analyst Hb A1c POC instruments. METHODS Clinical and Laboratory Standards Institute protocols EP-5 and EP-9 were applied to investigate imprecision, accuracy, and bias. We assessed bias using the mean of 3 certified secondary reference measurement procedures (SRMPs). Assay conformance with the National Glycohemoglobin Standardization Program (NGSP) certification criteria was also evaluated. Interference of common Hb variants was investigated for methods that could work with hemolysed material. RESULTS The total CVs for all instruments, except for the DCA Vantage at a high Hb A1c value, were ≤3.1% in SI units and ≤2.1% in Diabetes Control and Complications Trial (DCCT) units. Afinion, DCA Vantage, B-analyst, and Cobas B101 instruments passed the NGSP criteria with 2 different reagent lot numbers. Quo-Test, Quo-Lab, and InnovaStar instruments had a negative bias compared to the mean of the 3 SRMPs and failed NGSP criteria. Most of the common Hb variants did not interfere with the investigated instruments, except Hb AE for the Cobas B101. CONCLUSIONS Afinion, DCA Vantage, Cobas B101, and B-analyst instruments met the generally accepted performance criteria for Hb A1c. Quo-Test, Quo-Lab, and InnovaStar met the criteria for precision but not for bias. Proficiency testing should be mandated for users of Hb A1c POC assays to ensure quality.
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Bukve, Tone, Sverre Sandberg, Wenche S. Vie, Una Sølvik, Nina G. Christensen, and Anne Stavelin. "Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing." Clinical Chemistry 65, no. 6 (June 1, 2019): 791–97. http://dx.doi.org/10.1373/clinchem.2018.300202.

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Abstract BACKGROUND The optimal situation in external quality assessment (EQA) is to use commutable materials. No previous study has examined the commutability of a whole-blood material for point-of-care (POC) testing. The aim of this study was to determine the commutability of the Norwegian Quality Improvement of Laboratory Examinations (Noklus) organization's “in-house” whole-blood EQA material for C-reactive protein (CRP), glucose, and hemoglobin for frequently used POC instruments in Norway and to determine the possibility of using a common target value for each analyte. METHODS The study was performed according to the Clinical and Laboratory Standards Institute guidelines. The EQA material was pooled stabilized EDTA venous whole-blood containing different concentrations of the analytes. The EQA material and native routine patient samples were analyzed using 17 POC and 3 hospital instruments. The commutability was assessed using Deming regression analysis with 95% prediction intervals for each instrument comparison. RESULTS The EQA material was commutable for all CRP and hemoglobin POC instruments, whereas for glucose the material was commutable for all POC instruments at the lowest concentration analyzed [126.0 mg/dL (7.0 mmol/L)] and for 3 POC instruments at all of the concentrations analyzed. CONCLUSIONS Noklus EQA participants using CRP and hemoglobin POC instruments now receive results that are compared with a reference target value, whereas the results for participants using glucose POC instruments are still compared with method-specific target values. Systematic deviations from a reference target value for the commutable glucose POC instruments can be calculated, and this additional information can now be offered to these participants and to the manufacturers.
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Auty, B. "The DHSS Evaluation Programme for Infusion Control Instruments." Engineering in Medicine 15, no. 4 (October 1986): 175–83. http://dx.doi.org/10.1243/emed_jour_1986_015_049_02.

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The DHSS commissioned the Bath Institute of Medical Engineering (BIME) to carry out a comparative evaluation of instruments for the control of intravenous infusions. This project commenced six years ago. To date, six reports have been published in the DHSS‘ Health Equipment Information series and more are in preparation. Some three dozen different instruments have been assessed. The programme proceeds in three independent phases: technical, clinical, and safety testing. The technical phase includes performance testing in the laboratory, assessment of ease of operation and assessment of design and production techniques used, ease of servicing, and reliability. The clinical evaluation is designed to check the capability of the instrumentation under actual ward usage and questionnaires are completed by medical staff. Safety testing to BS 5724 Part 1 is undertaken at the British Standards Test House at Hemel Hempstead. There are four different types of instrument for infusion control: gravity controllers, drip-rate pumps, volumetric pumps, and syringe pumps. Each type has different performance characteristics to cater for specific applications. During the course of the evaluation, much has been learnt and many different aspects of performance have been studied, including drop size variations, air embolism, delivery pressure, and alarm response times.
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Voskou, Panagiota, Athanasios Douzenis, Alexandra Economou, and Sokratis G. Papageorgiou. "Testamentary Capacity Assessment: Legal, Medical, and Neuropsychological Issues." Journal of Geriatric Psychiatry and Neurology 31, no. 1 (December 18, 2017): 3–12. http://dx.doi.org/10.1177/0891988717746508.

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Introduction: The increase in the aging population and the number of patients with dementia led to the research in older adults’ capacity assessment over the last 3 decades. Many cases of contested wills occur due to lack of testamentary capacity (TC), especially in cases of dementia. Aim: Purpose of the present study was to overview the legal, medical, and neuropsychological aspects of TC as well as the instruments used for TC assessment. Findings: The testator/testatrix with intact TC has realistic perception of his or her property value, lack of psychopathology affecting contact with reality, and intact intention of how and to whom he or she will dispose his or her assets. It is frequent for the health practitioners to serve as “gold standards assessors” by examining an individual’s ability to make a valid will and giving evidence to the court to support or not a will contest. The TC assessment is a complex process of clinical and legal practice requiring usually a variety of methods, that is, interviews, evaluation of clinical records, and administration of neuropsychological instruments. Conclusion: The evaluation of TC is a multidimensional process that integrates both the legal and medical field, requiring a collaborative approach to its definition and assessment.
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Kost, Gerald J. "Preventing Medical Errors in Point-of-Care Testing." Archives of Pathology & Laboratory Medicine 125, no. 10 (October 1, 2001): 1307–15. http://dx.doi.org/10.5858/2001-125-1307-pmeipo.

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Abstract Objective.—To prevent medical errors, improve user performance, and enhance the quality, safety, and connectivity (bidirectional communication) of point-of-care testing. Participants.—Group A included 37 multidisciplinary experts in point-of-care testing programs in critical care and other hospital disciplines. Group B included 175 professional point-of-care managers, specialists, clinicians, and researchers. The total number of participants equaled 212. Evidence.—This study followed a systems approach. Expert specifications for prevention of medical errors were incorporated into the designs of security, validation, performance, and emergency systems. Additional safeguards need to be implemented through instrument software options and point-of-care coordinators. Connectivity will be facilitated by standards that eliminate deficiencies in instrument communication and device compatibility. Assessment of control features on handheld, portable, and transportable point-of-care instruments shows that current error reduction features lag behind needs. Consensus Process.—Step 1: United States national survey and collation of group A expert requirements for security, validation, and performance. Step 2: Design of parallel systems for these functions. Step 3: Written critique and improvement of the error-prevention systems during 4 successive presentations to group B participants over 9 months until system designs stabilized into final consensus form. Conclusions.—The consensus process produced 6 conclusions for preventing medical errors in point-of-care testing: (1) adopt operator certification and validation in point-of-care testing programs; (2) implement security, validation, performance, and emergency systems on existing and new devices; (3) require flexible, user-defined error-prevention system options on instruments as a prerequisite to federal licensing of new diagnostic tests and devices; (4) integrate connectivity standards for bidirectional information exchange; (5) preserve fast therapeutic turnaround time of point-of-care test results; and (6) monitor invalid use, operator competence, quality compliance, and other performance improvement indices to reduce errors, thereby focusing on patient outcomes. (Arch Pathol Lab Med. 2001;1307–1315)
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Bradshaw, John Thomas, Tanya Knaide, Alex Rogers, and Richard Curtis. "Multichannel Verification System (MVS): A Dual-Dye Ratiometric Photometry System for Performance Verification of Multichannel Liquid Delivery Devices." JALA: Journal of the Association for Laboratory Automation 10, no. 1 (February 2005): 35–42. http://dx.doi.org/10.1016/j.jala.2004.08.012.

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Artel has developed the Multichannel Verification System (MVS), a photometric method for verifying the performance of automated multichannel liquid delivery equipment. 1 On the basis of Artel's patented Dual-Dye Ratiometric Photometry method, the MVS determines both the accuracy and precision of each individual channel of a multichannel liquid delivery device. The MVS verifies aqueous volumes of 2–200 μL, produces results that are traceable to national standards, and can be applied to a wide range of instruments. It is important that the MVS is a robust system that is convenient to use in the laboratory environment so that the volumetric performance of automated liquid-handling equipment can be verified frequently without causing unnecessary delay in use of the instruments for their intended applications.
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Adriansyah, Mohamad Vikri, and Auliffi Ermian Challen. "Analysis of the Application of Statements of Financial Accounting Standards Number 71 concerning Financial Instruments (Case Study at Ltd Bank BRI (Persero) Plc in 2020)." Operations Research: International Conference Series 3, no. 2 (June 5, 2022): 52–66. http://dx.doi.org/10.47194/orics.v3i2.132.

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Statements of Financial Accounting Standards are commonly called PSAK in Indonesian terms. PSAK No. 71, which is the adoption of International Financial Reporting Standards (IFRS) 9, has officially come into force effective as of 1 January 2020 as Indonesia's new Financial Accounting Standards are commonly called SAK in Indonesian terms. PSAK No. 71 changed several rules related to financial instruments. This emerged as a response to the failure of corporations, especially the financial sector, which could not see signals from the market regarding uncollected bills from the start. This study aims to determine the application of PSAK No. 71 Financial Instruments in the financial sector, especially in the banking industry. The subject in this study is Ltd Bank BRI (Persero) Plc because Ltd Bank BRI (Persero) Plc is the Bank with the largest total assets and the Bank with the highest credit distribution value in Indonesia in 2020. The object in this study is the financial statements of Ltd Bank BRI (Persero) Plc ending as of December 31, 2020. This research type of research is descriptive qualitative with a case study approach. The results showed that Ltd Bank BRI (Persero) Plc had implemented all the regulations contained in PSAK No. 71 for the financial statements ended December 31, 2020, and the impact of implementation can be seen from the total value of Allowance for Impairment Losses are commonly called CKPN in Indonesian terms which increased by 29.07% at the beginning of its implementation.
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Heeg, Peter, Klaus Roth, Rudolf Reichl, C. Philip Cogdill, and Walter W. Bond. "Decontaminated Single-Use Devices: An Oxymoron That May Be Placing Patients at Risk for Cross-Contamination." Infection Control & Hospital Epidemiology 22, no. 9 (September 2001): 542–49. http://dx.doi.org/10.1086/501949.

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AbstractObjective:To determine whether reprocessed single-use devices would meet regulatory standards for sterility and meet the same materials standards as a new device.Design:The study included single-use and reusable biopsy forceps and papillotomes and a reusable stone retrieval basket. The suitability of these devices for cleaning and disinfection or sterilization was examined.Methods:Testing of cleanability was conducted on devices contaminated with technetium 99-radiolabeled human blood. Instruments were cleaned using hospital recommended practices for manual cleaning. Gamma counts per second were determined before and after cleaning to localize contaminants, which were additionally visualized using light and scanning electron microscopy. X-ray phc-toelectron spectroscopy was used to quantify contamination elements on the materials tested. Residual bioburden testing on instruments contaminated with microorganisms suspended in coagulable sheep blood was carried out to establish the efficacy of disinfection and sterilization.Results:All devices remained contaminated after cleaning, but single-use devices and the stone basket tended to be more heavily contaminated than reusable forceps and papillotomes. Cleaning procedures facilitated distribution of contaminants further into the lumens of the disposable forceps. Decreased concentrations of silicon and increased concentrations of carbon and nitrogen suggested that layers of silicon lubricant had been removed and contaminants were organic material. Reusable devices were effectively disinfected, but single-use devices were not Sterilization could not eliminate the challenge microorganisms completely.Conclusions:None of the reprocessed single-use instruments were effectively cleaned, disinfected, or sterilized. This condition may provide an opportunity for the viability of non-resistant or nosocomial organisms and viruses. Additionally, reprocessing procedures may result in material destruction of fragile devices. Cost-saving initiatives that have inspired reprocessing of single-use devices, despite the absence of data establishing the efficacy of decontamination and the durability of materials throughout reprocessing, should be pushed into the background.
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Varghese, Abu P., J. Prasad, and K. S. Jacob. "Mild cognitive impairment and dementia in older patients attending a general hospital in south India: DSM-5 standards and correlates." International Psychogeriatrics 31, no. 1 (May 25, 2018): 133–38. http://dx.doi.org/10.1017/s1041610218000625.

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ABSTRACTBackground and Aims:The changes in DSM-5 diagnostic criteria for dementia (Major neurocognitive disorder (NCD)) and mild cognitive impairment (mild NCD) mandate a re-evaluation of screening instruments. This study attempted to validate screening instruments, identify optimum threshold, and describe their indices of efficacy.Method:Consecutive people above the age of 65 years attending the outpatient department of a general hospital were recruited. They were assessed using the Mini-Mental State Examination and the Vellore Screening Instruments for Dementia and were evaluated against the DSM-5 standard. Bivariate and multivariate statistics were obtained. Receiver-operating-characteristic curves were drawn, optimum thresholds obtained, sensitivity, specificity, and predictive values calculated.Results:One hundred and thirty four older people were recruited. The majority were women, married, with low levels of education, not employed, living with family, and had medical co-morbidity. A minority satisfied DSM-5 criteria for major (1.5%) and mild NCD (36.5%). The factors associated with NCD were older age, fewer years of education, and lower socio-economic status. MMSE, VSID patient, and VSID informant scores were significantly associated with NCD. The indices of efficacy for the MMSE and VSID patient version were modest for identifying Mild NCD. However, their performance in identifying major NCD was better. Nevertheless, optimal thresholds for recognition differed markedly from their originally recommended cut-offs.Conclusions:The DSM-5 standards, with new and different cognitive domains, mandate a revaluation and recalibration of existing screening instruments. Ideally, new screening instruments, which match the cognitive domains and DSM-5 standard should be developed.
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Widodo, Haris, Nursalam Nursalam, and Erna Dwi Wahyuni. "Analysis of Implementation of Perioperative Care Instrument Based on Standards of Nursing Diagnosis, Intervention and Outcomes in Indonesia." Jurnal Ners 15, no. 1Sp (July 7, 2020): 57–62. http://dx.doi.org/10.20473/jn.v15i1sp.18911.

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Introduction: Perioperative nursing care has been widely applied in either various hospitals or other healthcare facilities. The purpose of this study was to analyze the implementation of a perioperative care instrument based on the Indonesian Nursing Diagnosis Standards (SDKI, the Indonesian Nursing Intervention Standards (SIKI), and the Indonesian Nursing Outcome Standards (SLKI) in the operating room in a Teaching hospital, East Java.Methods: This research design was a descriptive study. The study population was the perioperative nursing care instrument in the medical records of patients with fracture cases. The research sample consisted of 106 medical records with total sampling. The dependent variable of this study was the implementation of the perioperative nursing care instrument based on SDKI, SLKI, and SIKI. Data were collected using observation sheets and analyzed using descriptive analysis.Results: Applying the diagnosis of nursing care according to the standard the risk of infection is (27.36%), acute pain (20.75%), and the risk of injury (2.83%). The application of nursing outcomes according to standards is the infection rate (27.36%), pain level (20.75%) and fluid balance (2.83%).Conclusion: The nursing interventions, implementation, and evaluation of nursing are not according to the Indonesian Nursing Intervention standards (SIKI). The application of perioperative nursing care instruments, which includes titles, diagnoses, and outcomes, is partly following SDKI and SLKI standards. Nursing interventions, implementation, and evaluation of nursing are not according to standards.
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Hagedorn, Dave. "Infection Risk Mitigation for Biofeedback Providers." Biofeedback 42, no. 3 (November 1, 2014): 93–95. http://dx.doi.org/10.5298/1081-5937-42.3.06.

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Biofeedback providers necessarily make contact with patients or clients using sterile and nonsterile instruments and sensors. Many biofeedback providers lack the aseptic technique training that is common to licensed medical providers. This review familiarizes biofeedback providers with the essential principles and procedures of infection risk mitigation by touching on routes of disease transmission, disinfection, sanitization, and Spaulding classification. Basic suggestions for infection risk mitigation standards of practice are offered.
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Tolstanov, K. O., A. G. Krut, I. A. Dmitrenko, and V. V. Gorachuk. "Problems of regulating the quality of medical care in Ukraine and the main directions of their solution." Medicni perspektivi 27, no. 1 (March 30, 2022): 166–73. http://dx.doi.org/10.26641/2307-0404.2022.1.254468.

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Improving the quality of health care remains problem of the day for world health systems. Recognized quality management tools are used in Ukraine. However, a series of studies indicate the need for their improvement.. The aim of this work was to determine the features of the application of international instruments for regulating the quality of medical care and to substantiate the conceptual directions of their improvement in Ukraine. Materials and methods of research used: systemic approach; comparative analysis; bibliosemantic; conceptual modeling; scientific literature sources, including systematic reviews from the PubMed database; domestic legal documents. Main results: unlike international practices, professional activity of doctors is not licensed in Ukraine. The economic activity of health care institutions and individuals-entrepreneurs engaged in medical practice is subject to licensing. Аccreditation standards have not been revised since 2013. Domestic adaptation of clinical guidelines has been suspended for several years. Certification of quality management systems is administratively related to accreditation. All quality management tools are strictly regulated by the Ministry of Health, without the involvement of local governments, public patient organizations and health professionals. Conceptual directions of improvement of tools of quality regulation are offered: adoption of the law on professional licensing of doctors; creation of an independent accreditation agency; updating the content of accreditation standards, supplementing them with patient safety standards in accordance with international criteria; creation of methodological support for accreditation and certification; training of accreditation inspectors; introduction of tracer methodology in order to verify compliance with accreditation standards; resumption of adaptation of international clinical guidelines at the health sector.
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De, B. K., B. A. Karr, S. Ghosn, and B. E. Copeland. "Problems and practical considerations in assessing accuracy with NIST SRM 909a: report of defective vials." Clinical Chemistry 42, no. 11 (November 1, 1996): 1832–37. http://dx.doi.org/10.1093/clinchem/42.11.1832.

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Abstract During an experimental period of 12 months in 1992-1993, while we were comparing the effectiveness of monthly vs quarterly use of the National Institute for Standards and Technology Standard Reference Material (NIST SRM) 909a as an accuracy material for the projected 30-year Fernald Medical Monitoring Program, we encountered three random defective vials with a glucose recovery of less than 30% of the NIST-assigned value. Analysis with five different multichannel instruments confirmed the original finding. Concomitant glucose recovery from adjacent vials was 97%-104%, as determined by using the same instruments, reagents, calibrators, and quality-control criteria on the same days. Recoveries of uric acid and cholesterol were also low (53-75% and 75-80%, respectively) in the three defective vials. Other analytes were unaffected. Studies to identify the cause of the defective vials were carried out with microbiological, electron microscopic, and biochemical techniques. When used for accuracy studies, each vial of NIST SRM 909a should have a concomitant check for glucose recovery to detect whether the vial is defective.
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Langley, Paul C. "Rasch Measurement and Patient Reported Value Claims: A Primer for Hemophilia." INNOVATIONS in pharmacy 13, no. 4 (December 16, 2022): 16. http://dx.doi.org/10.24926/iip.v13i4.5111.

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This commentary proposes that Rasch Measurement Theory (RMT) is an innovative method for assessments of patient-centric therapy response in hemophilia A and B, as they are in other disease states or target patient populations. RMT is a necessary and sufficient approach to moving from ordinal observations to interval measurement, which has arithmetic properties. This applies across the board in hemophilia and other disease states for clinical value claims, patient centric or subjective value claims as well as those for anticipated drug utilization and other medical care resources. The purpose of this commentary is to point out limitations regarding current methods for making claims regarding hemophilia response and to propose a new start in hemophilia studies to identify core claims that meet required measurement standards. This applies to both the development of new patient reported outcome instruments as well as the evaluation of existing instruments, with a focus on polytomous instruments and their sub-domains, to evaluate their possible application as measures that approximate RMT requirements.
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Suprihartini, Baiq Endang, Nur Radiah, and Muhammad Wahyu Hidayat. "Evaluasi penerapan standar pelayanan kefarmasian di Puskesmas." Sasambo Journal of Pharmacy 3, no. 1 (April 28, 2022): 1–5. http://dx.doi.org/10.29303/sjp.v3i1.128.

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Pharmacy services is a direct service and obligation to the patients regarding the pharmacy substances with the aim to increase the public health services in the field of pharmacy. The purpose of this study is to evaluate the implementation of pharmaceutical standard at the primary health services Puskesmas. This study is conducted in descriptive research, data collection using a cross sectional survey approach. The instruments in this study was a questionnaire sourced from the Regulation of the Minister of Health No. 74 of 2016 concerning pharmaceutical service standards in Puskesmas. Respondents in this study were pharmacists at the Pagesangan Puskesmas. The management activities reach 100% of drug and medical consumables, 93.75% of equipment and supporting facilities, 100% of human resources. These results indicate that the evaluation of the implementation of pharmaceutical service standards at the Puskesmas based on pharmaceutical service indicators has been carried out well at the Pagesangan Puskesmas with an average value of 96.77%. The implementation of pharmaceutical service standards at the Pagesangan Puskesmas has met all the indicators of pharmaceutical service standards at the Puskesmas.
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Wu, Mao Sheng, Xi Meng Wu, and Wen Juan Liu. "Application of the Serial Port in Experiment Teaching and Development of Embedded Products." Advanced Materials Research 271-273 (July 2011): 1884–89. http://dx.doi.org/10.4028/www.scientific.net/amr.271-273.1884.

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Because of its advantages of small size, light weight, powerful etc., the single chip microcomputer(sometimes called “SCM”, ”microcontroller”, or ”MCU”) has a very wide range of applications in information appliances, instruments and meter, industrial control, medical apparatus and communication systems. The serial port is one of the most important resources in the microcontroller and has a very important role in the embedded application system. Some application skills of the serial port in experimental teaching and development of embedded products are discussed in this paper, such as the serial port application in program debugging during experiment teaching, multiple serial port expansion technology and implementation method of USB interface during development of embedded application system.
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Trusova, A. V., and S. G. Klimanova. "Reporting randomized trials of psychological and psychosocial interventions: consort-spi 2018." V.M. BEKHTEREV REVIEW OF PSYCHIATRY AND MEDICAL PSYCHOLOGY, no. 3 (October 11, 2020): 41–49. http://dx.doi.org/10.31363/2313-7053-2020-3-41-49.

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Randomized controlled trial (RCT) is a “gold standard” evidence-based approach to the assessment of psychological and psychosocial interventions; the results of RCT provide an opportunity to give a scientifically grounded decision about the effectiveness and the applicability of intervention. The current biopsychosocial approach requires the necessity of having precise, comprehensive, and transparent reports about conducting RCT in medicine, as well as psychological and psychosocial interventions, including psychotherapy. The unified standards for reporting RCT’s results were developed by the CONSORT group (CONsolidated Standards Of Reporting Trials, the latest edition in 2010). They are currently considered a guide for presenting results in leading medical journals in the world. The expansion of CONSORT, which described the standards for presenting the results of psychological and psychosocial intervention CONSORTSPI was developed in 2018. The article presents the history of developing the standards, their scientific and methodological principles, the brief content, and the main instruments used (check-list and block-scheme). It is important to consider the guidelines of CONSORT-SPI 2018 and follow them in order for the scientific community to assess the quality, the applicability of different contexts, as well as replicability of psychological and psychosocial interventions studies.
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Lipchak, D. A., A. A. Dushkina, and A. A. Chupov. "External humidifier for ventilator: PID control based on the Ziegler-Nichols method." Ural Radio Engineering Journal 4, no. 4 (2020): 376–96. http://dx.doi.org/10.15826/urej.2020.4.4.002.

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Due to the ubiquitous spread of SARS-CoV-2 coronavirus infection, the demand for anaesthesia and respiratory devices has significantly increased since the beginning of 2020. In particular, artificial ventilation devices, inhalation anaesthesia devices, or oxygen inhalers. The respiratory support devices must include special medical devices designed to heat and increase the moisture content of the respiratory mixture supplied to the patient from the respiratory therapy apparatus. These medical devices are known to as humidifiers. The production of a humidifier for breathing mixtures “TEVLAR” – “UOMZ” according to TU 32.50.21-121-07539541-2018 with accessories was organized jn the territory of Joint Stock Company “Production Association “Urals Optical & Mechanical Plant” named after Mr. E. S. Yalamov”. The electronic measuring instruments unit of the device has been modified within the framework of the project for the modernization of the humidifier of breathing mixtures “TEVLAR” – “UOMZ”. In particular, in order to increase the accuracy of thermal stability of the heating element when heating the breathing mixtures to the target temperature, the software of the electronic measuring instruments unit was modernized by the Medical Devices Design Bureau, namely, the stable PID controller was implemented and tuned. Thus, this article provides an overview of the methods for tuning the PID controller, justifies the choice of PID tuning by the Ziegler-Nichols method and also provides the experimental results to confirm device operation stability.
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FENTON, LAURA, and BRIAN SALTER. "Competition and compromise in negotiating the new governance of medical performance: the clinical governance and revalidation policies in the UK." Health Economics, Policy and Law 4, no. 3 (July 2009): 283–303. http://dx.doi.org/10.1017/s1744133109005027.

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AbstractThis article explores the development of two policies for the governance of medical performance in the UK: the Department of Health's (DH) clinical governance policy and the medical profession's revalidation policy. After discussing the institutional context in which each of these policies emerged, we examine how and why they were constructed. While the clinical governance policy was in large part a swift reaction to high-profile cases of medical misconduct in the late 1990s, revalidation was the profession's response to the politicisation of its self-regulatory apparatus. The profession took notably longer than the DH to piece together its policy as a result of internal disagreements about the role clinical standards should play in the evaluation of a doctor's fitness to practice. Following the Fifth Report of the Shipman Inquiry in late 2004, the government stepped in and eventually introduced legislation that modifies the profession's policy. With clinical governance, the state – via arms-length regulatory organisations – has entered the clinic in new ways, strengthening hierarchy-based forms of governance in the governance of medical performance. However, the success of hierarchical forms of governance is likely to be restricted by the lack of a clear system of sanctioning and the state's reliance on a lengthy chain of command in the National Health Service for the implementation of clinical standards.
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Aslam, Zeeshan, Hafiz Muhammad Hamza Farooq, Mahwish Ghayour, Hajra Hashmi, Raja Altaf Ahmed Khan, and Ahmad Mumtaz Banday. "A Research Study on use and Importance of the Diagnostic Radiology Reference Values." Pakistan Journal of Medical and Health Sciences 16, no. 8 (August 30, 2022): 799–800. http://dx.doi.org/10.53350/pjmhs22168799.

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Aim: References values (RVs) remain being utilized for the radiation quantities from specific bits of radiography apparatus to doses from comparable equipment evaluated in nationwide reviews. RVs optional through American Connection of Physicists in Medicine were established from General Assessment of X-ray trends review, which was conducted by government radiation defense services through understanding and also encouragement of United States Food and Drug Government, Symposium of Radioactivity Control Program Executives, and also American College of Radiology. The RVs used by the American Association of Physicists in Medicine approximate 90th percentile of questionnaire results. As a result, hardware that exceeds the RVs uses higher radiation doses than 90% of apparatus in studies. Radioactive quantities for precise projects should be monitored yearly using standardized ghosts, as suggested through USA College of Radiology. Whenever RVs remain reached, medical physicist must examine source too, in collaboration through radiologist in charge, evaluate if such dosages are warranted or even if the imaging equipment must be adjusted to decrease individual radiation quantities. RVs remain important instruments for likening individual radiation exposures across the UK and giving details concerning radiography performance and reliability. Keywords: Diagnostic radiology, Reference Values, Importance, impacts.
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48

Sazonova, N. V., E. V. Shiryaeva, D. S. Leonchuk, and N. M. Kluyshin. "ECONOMIC ANALYSIS OF TREATMENT OF THE PATIENTS WITH CHRONIC POSTTRAUMATIC OSTEOMYELITIS OF THE SHOULDER BY THE METHOD OF TRANSOSSEOUS OSTEOSYNTHESIS BY ILIZAROV’S APPARATUS." Grekov's Bulletin of Surgery 175, no. 3 (June 28, 2016): 94–99. http://dx.doi.org/10.24884/0042-4625-2016-175-3-94-99.

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An analysis of the terms of hospitalization, cost of treatment was made. There were matched the real medical costs of treatment of the patients with chronic posttraumatic osteomyelitis of the shoulder using the method of transosseous osteosynthesis with application of Ilizarov’s apparatus and medical costs according to the medical standards of treatment for patients with osteomyelitis. It was shown that actual expenses on drug therapy and expendable materials on one patients were approximately three times higher, than planned expenses according to standard. The presence of different microflora was revealed throughout the bacteriological research of suppurative focus in 25(96%) patients. There was detected an excess of actual expenses on one patient with given nosology compared with standard of financial expenditure from the funds for high-technology medical care from 6 % (average case) to 58% (Bassilus pynocyaneus). The excess of actual expenses from the funds of local program of obligatory medical insurance achieved from 48% (average patient) to 100% (Bassilus pynocyaneus case).
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49

Milojevic, Milanko, Sinisa Avramovic, Bratislav Kostic, Jelena Sotirovic, and Aleksandar Peric. "Endoscopic dacryocystorhinostomy." Vojnosanitetski pregled 67, no. 6 (2010): 463–67. http://dx.doi.org/10.2298/vsp1006463m.

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Background/Aim. Intensive epiphora (lacrimal apparatus disease) can make difficult daily routine and cause ocular refraction disturbances. In most cases ethiology is unknown, rarely occurs after nose surgical procedures, face fractures, in Wegener granulomatosis, sarcoidosis and malignancies. The aim of this study was to evaluate efficacy of endonasal endoscopic surgical procedure with the conventional surgical instruments in treatment of nasolacrimal obstructions. Methods. This retrospective study included 12 female patients with endonasal endoscopic surgical procedure from Otorhinological and Ophtalmological Departments of Military Medical Academy, Belgrade from September 2007 to April 2009. Preoperative nasal endoscopy was performed in order to reveal concomitant pathological conditions and anatomic anomalies which could make surgical procedure impossible. Computerized tomography was performed only in suspect nose diseases. Surgical endonasal endoscopic procedure was performed by otorhinolaryngologist and ophtalmologist in all patients. The patients had regular controls from 2 to 20 months. Results. A total of 12 female patients, age 34-83 years, were included in our study. Epiphora was a dominant symptom in all patients. In two patients deviation of nasal septum was found, and in other one conha bulosa at the same side as chronic dacryocystitis. All patients were subjected to endonasal dacryocystorhinostomy (DCR) by endoscopic surgical technique using conventional instruments. Concomitantly with DCR septoplastics in two patients and lateral lamictetomy in one patient were performed. There were no complications intraoperatively as well as in the immediate postoperative course. In two patients the need for reoperation occurred. Conclusion. Endoscopic DCR is minimally invasive and efficacious procedure for nasolacrymal obstructions performed by otorhinolaryngologist and ophtalmologist. Postoperative recovery is very fast.
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50

Ohmichi, H. "Safety Management on Hospital Instruments in Standards of Japan Council for Quality Health Care(The 4th Medical Devices Safety Measures Society)." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 75, no. 11 (November 1, 2005): 802–8. http://dx.doi.org/10.4286/ikakikaigaku.75.11_802.

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