ISO Criteria Research Articles

Using sound pressure level and vibration velocity method to determine sound reduction index of lightweight partitions

Nowadays, lightweight building structures are widely used by the construction industry as a more natural and cost-effective method. The purpose of this study is to compare between sound pressure level and vibration velocity method for sound reduction index determination for single- and double-leaf gypsum board partitions. The sound pressure level method was carried out according to the requirements of ISO 140-3:1997, and the vibration velocity method (V) was carried out according to some criteria of ISO 10848-1:2006. Regarding double-leaf partitions, measurements were carried out with the leaves separated by 5- and 10-cm air gaps. The effect of cavity filling with absorbing materials was studied experimentally. The space between the leaves was filled with Rockwool and polyurethane to illustrate the effect of cavity absorption on the sound reduction index behavior. It was found that there is good agreement between the two methods. Also, cavity filling with a 10-cm absorbing material such as Rockwool increases the sound reduction index at the critical frequency by 7 dB using sound pressure method and 4 dB using vibration velocity method.

Accuracy of Glucose Meter Among Adults in a Semi-urban Area in Kathmandu, Nepal

Glucose meters are gaining popularity in monitoring of blood glucose at household levels and in health care set-ups due to their portability, affordability and convenience of use over the laboratory based reference methods. Still they are not free of limitations. Operator's technique, extreme temperatures, humidity, patients' medication, hematocrit values can affect the reliability of glucose meter results. Hence, the accuracy of glucose meter has been the topic of concern since years. Therefore, present study aims to evaluate the analytical and clinical accuracy of glucose meter using International Organization for Standardization 15197 guideline. A community based descriptive cross-sectional study was conducted in Kapan, Kathmandu, Nepal in April 2018. Glucose levels were measured using glucose meter and reference laboratory method simultaneously among 203 adults ≥20 years, after an overnight fasting and two hours of ingestion of 75 grams glucose. Modified Bland-Altman plots were created by incorporating ISO 15197 guidelines to check the analytical accuracy and Park error grid was used to evaluate the clinical accuracy of the device. Modified Bland-Altman plots showed>95% of the test results were beyond the acceptable analytical criteria of ISO 15197:2003 and 2013. Park Error Grid-Analysis showed 99% of the data within zones A and B of the consensus error grid. Glucose meter readings were within clinically acceptable parameters despite discrepancies on analytical merit. Possible sources of interferences must be avoided during the measurement to minimize the disparities and the values should be interpreted with caution.

Characterization of environmental labels beyond the criteria of ISO 14020 series

ISO 14020 series of standards provide guidance for establishing ecolabels and a classification based on three label types, I, II, and III. They also determine the consideration of product’s life cycle and application of the life cycle assessment (LCA) in ecolabeling. Still, the large number and variety of existing ecolabels has led to consumer confusion in the recent years. The objective of this paper is to propose a characterization scheme for ecolabels and to provide recommendations for the enhancement of existing ecolabel classification, questioning the current sufficiency of ISO. To reach the objective, we first create a sample of ecolabels covering forest and paper products as an example, to narrow down the enormous number of existing ecolabels (over 460 as of August 2018). Second, we analyze their content, purpose, and awarding criteria through a desk research. In parallel, scientific publication, reports, and standards are also analyzed. Third, based on the obtained information, we define a list of ecolabel characterization attributes and their options and observe tendencies in ecolabel development. Ultimately, based on the outcomes of the proposed characterization scheme, we give recommendations for enhancement. Ultimately, we compare a sample of 45 ecolabels against 18 attributes of the proposed characterization scheme, including, among others, their ISO typology, life cycle perspective, awarding format, covered environmental aspects, and scope. Regarding type I or type III label, ISO seems to be explicit and their requirements are well respected, including how LCA is to be applied. However, approximately 60% of the explored ecolabels in our sample did not declare any ISO typology, whereas none assigned a type II classification. These “undefined” ecolabels, as we call them, apply different awarding formats and criteria in combination and hybrid forms that are not recognized and described by ISO or any other observed classification approach. Misuse of the term “LCA” is also perceived in such “undefined” initiatives. We conclude that the current ISO standards on ecolabels belittle the consequences that the increased number of undefined ecolabels brings. We provide a list of recommendations for the enhancement of the current ISO classification in seven topics, namely, awarding format, aspects diversity, operation scope, verification, reconsideration of the usability of ISO 14021, new ISO classification, and transparency. Limitations of the study and outlook conclude the work.

The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria

Self-monitoring of blood glucose is recommended to monitor glycaemic levels for the prevention and treatment of diabetes mellitus.The accuracy of blood glucose monitoring systems (BGMS) directly affects the health of the patients. In this study, we evaluated the accuracy of four different blood glucose monitoring systems, including Gold-Accu Meter, Nova StatStrip Xpress® Glucose Hospital Meter, Freestyle Optium Neo H® and Accu-Chek Performa according to ISO15197:2003 and ISO15197:2013 criteria. We found that four brands of BGMS (eight BGMS) all met the minimum requirements for system accuracy performance of ISO 15197:2003 and the accuracy criteria of ISO 15197:2013. All results of BGMS lie within zones A and B of the Consensus Error Grid (CEG). In conclusion, all BGMS met the accuracy criteria of ISO 15197:2003 and the accuracy criteria of ISO 15197:2013.

Validation of the Welch Allyn Home blood pressure monitor with professional SureBP algorithm with a special feature of accuracy during involuntary (tremor) patient movement.

BackgroundCurrent blood pressure (BP) measurement guidelines recommend certain patient requirements, especially keeping still for 5 min. Some patients cannot comply. My colleagues and I have reported accurate performance of the Welch Allyn SureBP algorithm for BP estimates during voluntary patient motion. No validation studies for involuntary patient movement (tremor) BP readings have been reported. This paper reports the validation of the Welch Allyn Home BP monitor, the 1700 Series, which contains that same SureBP algorithm, and the results of tremor testing as well. This device has multiple clinical advantages.Patients and methodsEighty-five patients (49 females) were studied using the ANSI/AAMI/ISO 81060-2, 2013 requirements. Three sizes of cuffs were included. The tremor experiments used a simulator programmed to frequency and amplitude of oscillometric impulses typically seen in patients with diseases causing tremors. This is the first protocol developed for this clinical scenario. The device uses an inflation-based algorithm, reducing discomfort and cycle times.ResultsThe mean±SD for the device minus manual readings per ISO Criterion 1 were −2.93±6.64 mmHg for systolic BP and −2.453±5.48 mmHg for diastolic BP. The tremor testing was performed at low, normal, and high BP simulations. The device recorded a BP value for every cycle tested. The errors (device minus manual BP estimates) were quite low.ConclusionThe Welch Allyn Home BP monitor is accurate in the presence of involuntary patient motion (tremor). Clinicians can have a high level of confidence in the use of a self-measurement device, which operates using the same algorithm as contained in the ‘professional grade’ family of devices.

Should we assume accuracy of point of care glucose meters? an observation from a tertiary health care centre

Background: Self-monitoring of blood glucose is important in the management of patients with diabetes mellitus in the community as well as in the hospital. It has been used for calculation of insulin doses of individuals with dysglycaemia and monitoring of glucose control. Errors in the measurement of the blood glucose can lead poor management of a patient. There is therefore the need to ensure standardization of these meters in order to achieve accuracy and precision. Objectives: To evaluate the precision and accuracy of four glucose meters commonly used for self-monitoring of blood glucose (SMBG) in a tertiary health care Centre compared to the reference laboratory method. Materials and Methods: We analyzed blood glucose samples of 55 diabetic patients who came to diabetes clinic using 4 different glucose meters (Accucheck active, Novo max extra, One touch Ultra 2 and On call plus (accoson)). Capillary and Venous blood samples were taken simultaneously from each patient for analysis using four blood glucose meters and laboratory reference method respectively. The laboratory value was used as a tool for comparison. The accuracy and precision were evaluated by the ISO and ADA criteria. The results obtained were analysed using Bland Altman graphs, correlation coefficients, scatter plots and Clarke's error grid analysis. Results: We observed good correlation between two glucose meters (Accucheck TM and Novomax TM ) and laboratory analyzed values. Among the glucose meters Accucheck TM , Novomax TM , One touch Ultra TM and On call plus TM , the correlation coefficient was 0.97, 0.96, 0.88 and 0.69 respectively. The degree of agreement of the laboratory method and the Accucheck TM , Novomax TM , One touch ultra TM and On call plus TM glucose meters was 89.09, 80.00, 76.20 and 71.32% respectively. Accucheck and Novomax TM were within ±20% accuracy (14.5% and 16.1%). Conclusion: There is a need for adequate and appropriate evaluation of all glucose meters in our setting before that we deploy them for use. None of glucose meters met the ISO target. Only one glucose meter (Accucheck TM ) met the ADA guideline for accuracy. Keywords: Accuracy; glucose meters; diabetes mellitus; self-monitoring of blood glucose

The design of additively manufactured lattices to increase the functionality of medical implants

The rise of antibiotic resistant bacterial species is driving the requirement for medical devices that minimise infection risks. Antimicrobial functionality may be achieved by modifying the implant design to incorporate a reservoir that locally releases a therapeutic. For this approach to be successful it is critical that mechanical functionality of the implant is maintained. This study explores the opportunity to exploit the design flexibilities possible using additive manufacturing to develop porous lattices that maximise the volume available for drug loading while maintaining load-bearing capacity of a hip implant.Eight unit cell types were initially investigated and a volume fraction of 30% was identified as the lowest level at which all lattices met the design criteria in ISO 13314. Finite element analysis (FEA) identified three lattice types that exhibited significantly lower displacement (10-fold) compared with other designs; Schwartz primitive, Schwartz primitive pinched and cylinder grid. These lattices were additively manufactured in Ti-6Al-4V using selective laser melting. Each design exceeded the minimum strength requirements for orthopaedic hip implants according to ISO 7206-4. The Schwartz primitive (Pinched) lattice geometry, with 10% volume fill and a cubic unit cell period of 10, allowed the greatest void volume of all lattice designs whilst meeting the fatigue requirements for use in an orthopaedic implant (ISO 7206-4). This paper demonstrates an example of how additive manufacture may be exploited to add additional functionality to medical implants.

Performance of the Flash Glucose Monitoring System during exercise in youth with Type 1 diabetes

AimMetabolic changes during exercise may affect the accuracy of glucose sensors impacting on Type 1 diabetes (T1D) management. The present study aimed at assessing the performance of the Flash Glucose Monitoring system (isCGM) during exercise and in free-living condition in youth with T1D. MethodsSeventeen youth (53% male), aged 13.7 ± 3.8 years, with T1D for 5.4 ± 3.8 years, HbA1c 7.4 ± 1.0% (57 ± 11 mmol/mol), were enrolled. Paired isCGM, plasma (PG) and capillary (CG) glucose values (total of 136) were collected during an interval exercise (45 min at 55% VO2max load with 20 s sprints at 80% VO2max every 10 min). Paired isCGM and CG (total of 832) were collected during free-living condition. ResultsDuring exercise, isCGM absolute relative difference (ARDs) means/medians were 12.5/9.4% versus PG and 15.4/10.8% versus CG. During rest, ARDs means/medians were 16.6/12.0%. The Consensus Error Grid analysis showed 98.4% of readings during exercise and 97.24% during rest in zones A + B. Percentage of readings meeting the ISO criteria for CG levels <5.55 mmol/L was 62.5% during exercise, 53.4% during rest; for CG levels ≥5.55 mmol/L was 64.0% during exercise, 60.4% during rest. ConclusionsisCGM demonstrated similar clinical safety and performance during exercise and in everyday life; further studies are needed to confirm its accuracy during exercise.

Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study.

BackgroundClareon® is a new hydrophobic acrylic optic biomaterial designed for enhanced clarity and greater resistance to glistening. The present study evaluated the effectiveness and safety of a three-piece hydrophobic, monofocal intraocular lens (IOL) Model MA60NM, made of this new optic material.MethodsIn this prospective, multicenter, open-label study, eligible patients aged ≥60 years, underwent a unilateral implantation with IOL Model MA60NM following phacoemulsification. Patients were followed-up for up to 3 years after implantation. Visual outcome and serious adverse events (SAEs, cumulative and persistent) were compared to ISO grid rates (BS EN ISO 11979-7:2006). The primary effectiveness variable was Best Spectacle-Corrected Visual Acuity (BSCVA) at 1-year postoperative follow-up. In addition, posterior capsular opacification (PCO) was assessed qualitatively and graded by slit lamp exam on a 5-point scale at all visits.ResultsOverall, 179 and 138 patients completed the 1-year and 3-year postoperative follow-up, respectively. The BSCVA outcomes were better with IOL Model MA60NM than the ISO grid rates with 95.5% of patients at 1 year and 94.2% of patients at 3 years having achieved a BSCVA of 20/40 or better vs 92.5% in ISO grid. The incidence of cumulative or persistent SAEs was lower after Model MA60NM implantation than the ISO grid reference. The incidence of clinically significant PCO was 1.1% at the 1-year and 2.2% at the 3-year visit. Posterior capsulotomy rate was 1.1% at 1 year and 1.4% at 3 years.ConclusionThe three-piece hydrophobic, monofocal IOL Model MA60NM was effective for the visual correction of aphakia and successfully met all the safety parameters as defined by the ISO criteria. PCO and posterior capsulotomy rates were low over the 3-year follow-up period. This study provides evidence and supports the long-term safety and effectiveness of the new optic biomaterial Clareon®.

Empirical Study of Room Acoustic Conditions and Neurophysiologic Strain in Staff Working in Special Open-Plan Bank Offices

Noise in open-plan offices induces psychological stress and fatigue in staff. Focusing on workstations and noise exposure, this study investigated acoustic conditions in special open-plan offices and their relationship with neurophysiologic strain. Twenty banks and 104 participants were randomly selected. Acoustic properties of banks and workstation partitions were assessed using the ISO criteria and speech transmission index (STI). Equivalent noise level (LAeq) of the staff was measured in three 30-min intervals, and skin conductance level (SCL) and respiratory rate (RR) of staff were assessed in three 5-min intervals at the beginning, in the middle, and at the end of the work hours. The intelligibility of speech between staff workstations (SW) was better than that between staff and clients (SC however, with increasing STI between SW and with decreasing STI between S&C, the staff strain increased. With increasing noise exposure, psychological stress of the staff increased too. Because of the acoustic condition and partitions used in the banks, the acoustic comfort of staff was not desirable. Since many other banks use such partitions, any improvement in partitions between workstations can enhance acoustic comfort in the banks.

Evaluation of gravimetric sampler bias, effect on measured concentration, and proposal for the use of harmonised performance based dust sampler for exposure assessment

The last three years has brought about alarming news of re-identification of coal worker’s pneumoconiosis (CWP) or ‘black lung’ in Australia after reporting nearly being absent for over five decades. While, the CWP statistics in South Africa (SA) are unverifiable, but certainly CWP has not been eliminated. These events have re-kindled the need for better understanding of the dust monitoring, performance of sampling devices, and compliance determination. Over the last half century, gravimetric sampling has been the fundamental means for dust exposure monitoring using recognised respirable size-selective standards. In both South Africa and Australia, the gravimetric sampling technique in coal mines has been followed since 1988 and 1983 respectively using samplers of original Higgins-Dewell (HD) type design. This paper provides the evaluation results of currently used South African and Australian gravimetric samplers compared against the original UK SIMPEDS ‘true reference’ sampler. The results consistently suggested that the South African and Australian cyclones do not conform to the required size selective curve or even the ‘true’ reference sampler. The results show that the currently used SA and Australian samplers showed a D50 sampling bias as high as 59% and 47% respectively against the size-selective curve. Similarly, under the controlled laboratory coal dust test conditions measuring the same coal mine dust level in a chamber, the South African, Australian and UK standard SIMPEDS sampler were 7.87, 9.79 and 6.71 mg/m3 respectively, which aligned with the sampling bias. The differences can in part be attributed to the ‘un-auditable’ inherent design and manufacturing quality, or unverifiable data on size-selective sampling curve. This finding has significant implications towards exposure data collected over the last 25 years and their subsequent use in the arrival of the dose-response curves. Therefore, it is strongly recommended that the harmonised use of ‘true reference’ SIMPEDS cyclone that meets the ISO (1995) criteria uniformly across the industry would benefit the exposure assessment and compliance determination.

Review of criteria for determining HFM minimum test duration

The actual thermal behaviour of façades is important to identify suitable energy-saving measures and increase the energy performance of existing buildings. However, the accuracy of in situ measurements of façades’ U-values varies widely, mostly due to inadequate test durations. The aim of this paper was to evaluate the minimum duration of in situ experimental campaigns to measure the thermal transmittance of existing buildings’ façades using the heat flow meter method, and to analyse the thermal performance of the façade during the test. Minimum test duration was determined according to data quality criteria, variability of results criteria, and standardized criteria for different ranges of theoretical thermal transmittance and for the same range of average temperature difference. Then, the minimum test duration results were compared. The findings show that ISO criteria are more sensitive and provide more accurate results, requiring a longer test duration. However, when certification is not required, the duration of the test could be reduced by applying data quality and variability of results criteria. The minimum duration of experimental campaigns depends on the theoretical thermal transmittance and the stability of climatic conditions. Moreover, results are more accurate when the dynamic method is used.

Comparison of the pharmacodynamics of protamine zinc insulin and insulin degludec and validation of the continuous glucose monitoring system iPro2 in healthy cats

With the aim to improve current therapeutic and monitoring options for diabetic cats, the present study compared pharmacodynamic parameters of protamine zinc insulin (PZI) and insulin degludec and validated the continuous glucose monitoring system (CGMS) iPro2 with Sof-sensor and Enlite-sensor focusing on the low glycemic range.Three doses (0.1, 0.2 and 0.3IU/kg) of the two insulin preparations and the CGMS iPro2 with two different sensors were tested in six healthy cats. After each insulin administration, onset of action, time to glucose nadir and duration of action were calculated by measuring glucose concentrations with a portable blood glucose meter (PBGM). After sensor placement, paired PBGM and sensor glucose measurements were done and analytical and clinical accuracy were calculated according to the ISO 15197:2013 criteria.Onset of action, time to glucose nadir and glucose nadir were similar for both insulin formulations. Duration of action of insulin degludec was significantly longer than those of PZI at 0.1IU/kg (P=0.043) and 0.2IU/kg (P=0.043). Overall, 166/191 (87%) Sof-sensor measurements and 106/121 (88%) Enlite-sensor measurements met ISO criteria for analytical accuracy, and all sensor measurements fulfilled ISO criteria for clinical accuracy.Insulin degludec was well tolerated in healthy cats and showed longer duration of action than PZI. Further studies on the use of insulin degludec in diabetic cats might be recommended. Both sensors had good clinical accuracy, when used with the CGMS iPro2, but the analytical accuracy was below the minimum set by ISO 15197:2013.

Cutting velocity accuracy as a criterion for comparing robot trajectories and manual movements for medical industry

Industrial robots perform technological operations, such as spot and arc welding, machining and laser cutting along different trajectories within their performance characteristics. The evaluation of these characteristics is carried out according to the criteria of the standard ISO 9283. The criteria of this standard are applicable in industrial manufacturing, but not in the medical industry, as they are not developed in the framework of medical tasks. Therefore, it is necessary to evaluate according to criteria built on different principles. In this article, the question of comparative evaluation of trajectories from program movements of a robot and manual movements of a surgeon, arising during the development of robotic medical complexes using industrial robots, is considered. A comparative evaluation is required to prove the expediency of automating medical operations in maxillofacial surgery. This study focuses on the estimation of velocity accuracy of a medical instrument. To obtain the velocity of the medical instrument, coordinates of the trajectory points from the program movements of the robot KUKA LWR4+ and trajectories from the manual movements of a professional surgeon have been measured. The measurement was carried out using a coordinate measuring machine, the laser tracker Leica LTD800. The accuracy estimation was carried out by two criteria: the criterion set out in the ISO 9283 standard, and the developed alternative criterion, the description of which is presented in this article. A quantitative comparative evaluation of the trajectories of a robot and a surgeon was obtained.

Fingers vibration transmission performance of vibration reducing gloves

Vibration attenuation performance of vibration reducing (VR) gloves is, invariably, measured at the palm using the method described in ISO 10819 (2013). The standardized method, however, does not address the glove performance in terms of fingers vibration, which is substantially different from that of the palm. An investigation was conducted to enhance the understanding of fingers vibration transmission properties of 4 different types of VR gloves (air, gel, hybrid and leather) using 4 male subjects in the laboratory. Three different finger adapters, each containing a miniature three-axis accelerometer, were designed and assessed for measurements of vibration responses at the fingers of the gloved hand. Vibration responses of the VR gloves were measured at the middle phalanges of the index and middle fingers using two Velcro finger adapters under the standardized vibration spectra and the spectra of 3 different hand tools, namely a road breaker, a nutrunner and an orbital sander. Vibration transmissibility of the gloves was also measured at the palm using the standardized palm adapter. The frequency response functions (FRF) obtained for the fingers of the gloved hand were used to estimate vibration transmission performances of the gloves at the index and middle fingers. The results show that only the air and hybrid VR gloves provide some attenuation of vibration transmitted to the index finger compared to the bare hand, while nearly all the gloves amplify vibration of the middle finger. The vibration attenuation was evident at the palm for the air and hybrid gloves above 40 Hz. The gel and leather gloves revealed nearly unity transmissibility in most of the frequency range. Only the hybrid glove passed the criteria of ISO 10819 (2013) to be designated as an anti-vibration (AV) glove, although it amplified vibration transmitted to the middle finger, particularly in the H-frequency range (200–1250 Hz). Fairly good agreements (−11%–13%) were obtained between the measured and estimated fingers vibration responses for all the gloves using the FRF method under the vibration spectra of the selected tools.Relevance to industry:Vibration is transmitted to the hand-arm system of operators using power tools and occupational exposure to hand transmitted vibration (HTV) arising from hand-held power tools has been related to an array of disorders. Vibration reducing (VR) gloves are viewed as one of the simple methods to protect workers from hand-arm vibration syndrome (HAVS). The international standard on the assessment of VR gloves addresses only the transmission of vibration to the palm, even though the vibration responses of fingers are substantially different. This study explored both the palm and fingers vibration transmissibility characteristics of VR gloves and proposed a method for assessing the vibration reduction performance of the glove under vibration spectra of different tools. The results of the study are thus considered to provide guidance towards enhanced screening criteria for AV gloves, and for selection of gloves for different tools.

ANALISIS KANDUNGAN BORAKS DAN Escherichia coli PADA JAJANAN BAKSO SAPI YANG DIPERDAGANGKAN DI KOTA BANJARBARU

This study aims to determine how the content of borax and Escherichia coli on meatballs snacks and the factors that affect the food security of meatballs snacks by using Easy Method of Borax Test and Method of Most Probable Number (MPN) for Escherichia coli bacteria contamination. This research was conducted in Banjarbaru on 5 village s , and sampling technique used is stratified sampling. The results of the study showed that from 32 samples taken from five village location, it was not identified any borax based on PERMENKES No. 033 of 2012, while for the examination of Escherichia coli , there are 14 samples of meatballs (43.75%) which were eligible, and 18 samples of meatballs (56.25%) which contain Escherichia coli ranges from 3.6 to 62 CFU /g or not meeting the criteria of ISO 7388: 2009. The f actor that might not trigger the addition of borax is that the traders have a good knowledge and attitude toward borax which regarded a s a toxic substance and can be harmful to health. Factors that cause microbial contamination of Escherichia coli on meatballs snacks is the lack of food hygiene and sanitation in the food processing, cooked food storage, transport, serving , sanitation facilities, and personnel handlers compared with the good supply of foodstuffs and food ingredients storage.

Enzymes Enhance Biofilm Removal Efficiency of Cleaners.

Efficient removal of biofilms from medical devices is a big challenge in health care to avoid hospital-acquired infections, especially from delicate devices like flexible endoscopes, which cannot be reprocessed using harsh chemicals or high temperatures. Therefore, milder solutions such as enzymatic cleaners have to be used, which need to be carefully developed to ensure efficacious performance. In vitro biofilm in a 96-well-plate system was used to select and optimize the formulation of novel enzymatic cleaners. Removal of the biofilm was quantified by crystal violet staining, while the disinfecting properties were evaluated by a BacTiter-Glo assay. The biofilm removal efficacy of the selected cleaner was further tested by using European standard (EN) for endoscope cleaning EN ISO 15883, and removal of artificial blood soil was investigated by treating TOSI (Test Object Surgical Instrument) cleaning indicators. Using the process described here, a novel enzymatic endoscope cleaner was developed, which removed 95% of Staphylococcus aureus and 90% of Pseudomonas aeruginosa biofilms in the 96-well plate system. With a >99% reduction of CFU and a >90% reduction of extracellular polymeric substances, this cleaner enabled subsequent complete disinfection and fulfilled acceptance criteria of EN ISO 15883. Furthermore, it efficiently removed blood soil and significantly outperformed comparable commercial products. The cleaning performance was stable even after storage of the cleaner for 6 months. It was demonstrated that incorporation of appropriate enzymes into the cleaner enhanced performance significantly.

Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013

Objective For patients with diabetes, regular self-monitoring of blood glucose (SMBG) is essential to ensure adequate glycemic control. Therefore, accurate and reliable blood glucose measurements with SMBG systems are necessary. The international standard ISO 15197 describes requirements for SMBG systems, such as limits within which 95% of glucose results have to fall to reach acceptable system accuracy. The 2013 version of this standard sets higher demands, especially regarding system accuracy, than the currently still valid edition. ISO 15197 can be applied by manufacturers to receive a CE mark for their system.Research design and methods This study was an accuracy evaluation following ISO 15197:2013 section 6.3 of two recently updated SMBG systems (Contour* and Contour TS; Bayer Consumer Care AG, Basel, Switzerland) with an improved algorithm to investigate whether the systems fulfill the requirements of the new standard. For this purpose, capillary blood samples of approximately 100 participants were measured with three test strip lots of both systems and deviations from glucose values obtained with a hexokinase-based comparison method (Cobas Integra† 400 plus; Roche Instrument Center, Rotkreuz, Switzerland) were determined. Percentages of values within the acceptance criteria of ISO 15197:2013 were calculated. This study was registered at clinicaltrials.gov (NCT02358408).Main outcome Both updated systems fulfilled the system accuracy requirements of ISO 15197:2013 as 98.5% to 100% of the results were within the stipulated limits. Furthermore, all results were within the clinically non-critical zones A and B of the consensus error grid for type 1 diabetes.Conclusions The technical improvement of the systems ensured compliance with ISO 15197 in the hands of healthcare professionals even in its more stringent 2013 version. Alternative presentation of system accuracy results in radar plots provides additional information with certain advantages. In addition, the surveillance error grid offers a modern tool to assess a system’s clinical performance.

Numerical and clinical precision of continuous glucose monitoring in Colombian patients treated with insulin infusion pump with automated suspension in hypoglycemia

Abstract Objectives Insulin pump therapy associated with continuous glucose monitoring has shown a positive clinical impact on diabetes control and reduction of hypoglycemia episodes. There are descriptions of the performance of this device in other populations, but its precision and accuracy in Colombia and Latin America are unknown, especially in the routine outpatient setting. Methods Data from 33 type 1 and type 2 diabetes patients with sensor-augmented pump therapy with threshold suspend automation, MiniMed Paradigm® Veo™ (Medtronic, Northridge, California), managed at Hospital Universitario San Ignacio (Bogota, Colombia) and receiving outpatient treatment, were analyzed. Simultaneous data from continuous glucose monitoring and capillary blood glucose were compared, and their precision and accuracy were calculating with different methods, including Clarke error grid. Results Analyses included 2262 continuous glucose monitoring-reference paired glucose values. A mean absolute relative difference of 20.1% was found for all measurements, with a value higher than 23% for glucose levels ≤75 mg/dL. Global compliance with the ISO criteria was 64.9%. It was higher for values >75 mg/dl (68.3%, 1308 of 1916 readings), than for those ≤75 mg/dl (49.4%, 171 of 346 readings). Clinical accuracy, as assessed by the Clarke error grid, showed that 91.77% of data were within the A and B zones (75.6% in hypoglycemia). Conclusions A good numerical accuracy was found for continuous glucose monitoring in normo and hyperglycemia situations, with low precision in hypoglycemia. The clinical accuracy of the device was adequate, with no significant safety concerns for patients.

IAEA INTERCOMPARISON EXERCISES OF THYROID MEASUREMENT: PERFORMANCE OF LATIN AMERICAN AND CARIBBEAN LABORATORIES

(131)I is widely used in Latin America and Caribbean Region in the field of nuclear medicine and has been recognised as one of the main sources of potential intake of radionuclides by the staff. The In Vivo Monitoring laboratory of the Institute for Radiation Protection and Dosimetry (IRD-CNEN-Brazil) organised three intercomparison exercises (2005, 2009 and 2013) in the scope of IAEA technical cooperation projects RLA9049 and RLA9066 aimed to disseminate and harmonise the technique for measuring (131)I in the human thyroid. The number of participants in Latin America increased from 9 to 20 institutions from 7 and 13 countries, respectively, over the last 10 y. The participants have improved significantly their ability on the in vivo measurement technique. In the 2013 round all laboratories which reported results presented performances in an acceptable range according to the ISO criteria indicating the benefit of such exercises in the region.