Development Of Operating Procedures Research Articles

A Smart Web Aid for Preventing Diabetes in Rural China: Preliminary Findings and Lessons

BackgroundIncreasing cases of diabetes, a general lack of routinely operational prevention, and a long history of separating disease prevention and treatment call for immediate engagement of frontier clinicians. This applies especially to village doctors who work in rural China where the majority of the nation’s vast population lives.ObjectiveThis study aims to develop and test an online Smart Web Aid for Preventing Type 2 Diabetes (SWAP-DM2) capable of addressing major barriers to applying proven interventions and integrating diabetes prevention into routine medical care.MethodsDevelopment of SWAP-DM2 used evolutionary prototyping. The design of the initial system was followed by refinement cycles featuring dynamic interaction between development of practical and effective standardized operation procedures (SOPs) for diabetes prevention and Web-based assistance for implementing the SOPs. The resulting SOPs incorporated proven diabetes prevention practices in a synergetic way. SWAP-DM2 provided support to village doctors ranging from simple educational webpages and record maintenance to relatively sophisticated risk scoring and personalized counseling. Evaluation of SWAP-DM2 used data collected at baseline and 6-month follow-up assessment: (1) audio recordings of service encounters; (2) structured exit surveys of patients’ knowledge, self-efficacy, and satisfaction; (3) measurement of fasting glucose, body mass index, and blood pressure; and (4) qualitative interviews with doctors and patients. Data analysis included (1) descriptive statistics of patients who received SWAP-DM2–assisted prevention and those newly diagnosed with prediabetes and diabetes; (2) comparison of the variables assessed between baseline and follow-up assessment; and (3) narratives of qualitative data.ResultsThe 17 participating village doctors identified 2219 patients with elevated diabetes risk. Of these, 84.85% (1885/2219) consented to a fasting glucose test with 1022 new prediabetes and 113 new diabetes diagnoses made within 6 months. The prediabetic patients showed substantial improvement from baseline to 6-month follow-up in vegetable intake (17.0%, 43/253 vs 88.7%, 205/231), calorie intake (1.6%, 4/253 vs 71.4%, 165/231), leisure-time exercises (6.3%, 16/253 vs 21.2%, 49/231), body weight (mean 62.12 kg, SD 9.85 vs mean 58.33 kg, SD 9.18), and body mass index (mean 24.80 kg/m2, SD 3.21 vs mean 23.36 kg/m2, SD 2.95). The prediabetic patients showed improvement in self-efficacy for modifying diet (mean 5.31, SD 2.81 vs mean 8.53, SD 2.25), increasing physical activities (mean 4.52, SD 3.35 vs mean 8.06, SD 2.38), engaging relatives (mean 3.93, SD 3.54 vs mean 6.93, SD 2.67), and knowledge about diabetes and risks of an imbalanced diet and inadequate physical activity. Most participating doctors and patients viewed SWAP-DM2 as useful and effective.ConclusionsSWAP-DM2 is helpful to village doctors, acceptable to patients, and effective in modifying immediate determinants of diabetes at least in the short term, and may provide a useful solution to the general lack of participation in diabetes prevention by frontier clinicians in rural China.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 66772711; http://www.controlled-trials.com/ISRCTN66772711 (Archived by WebCite at http://www.webcitation.org/6OMkAqyEy).

Development of Best Practice Standard Operating Procedures for Prevention of Fireground Injuries

Fireground operations account for a large percentage of firefighter injuries, and injury rates vary widely among fire departments. Differences in safety and health management approaches including standard operating procedures (SOPs) for fireground operations may help explain the variation in injury rates. The purpose of this study was to identify SOP best practices in order to provide a mechanism to improve firefighter safety and health. As part of a larger study comparing fire department injury rates internationally, a panel with fire service representatives from four continents was convened to develop best practice fireground SOPs. The panel members focused on four tasks or operations with relatively high injury rates: handling charged hose; forcible entry; use of ground ladders; and overhaul, reviewed injury data and identified approaches for reducing these injuries. General agreement was reached on the need for a risk management approach to identify high risk activities and corrective actions. Within SOPs, addition of an awareness column describing specific hazards and corrective actions was also recommended. Probationary period training and incorporation of national data into the continuing review and revision of these documents were also considered best practices. Hazards and action points were also identified to guide SOP development for the selected fireground tasks and operations. The international panel identified specific safety and health management approaches associated with SOP development, which, if effectively implemented, would be expected to reduce fireground injuries.

Laser Safety Program At Woods Hole Oceanographic Institution

Implementing a laser safety program at the Woods Hole Oceanographic Institution (WHOI) presents many challenges and opportunities for improving safety performance. Getting all laser users to take ownership of safety and comply with all laser safety requirements are key ingredients of a successful laser safety program. WHOI's laser safety program includes the following elements: registration of high power lasers, hazard analysis of laser facilities, proper design of laser facilities, selection of hazard controls, laser safe operating procedures, laser safety training for all laser users, and routine inspections of laser facilities. Laser owners are required to sign the high power laser registration form and agree to comply with all applicable requirements. All laser users are required to sign the laser safe operating procedure that applies to their facility and follow the requirements. Laser users are included in the development of laser safe operating procedures, design of their facilities, review of hazard analysis calculations for their lasers, and in the selection of hazard controls. Laser safety training for new laser users includes a tour of established laser facilities, review of laser safe operating procedure, and a review of basic laser safety information. By engaging the laser users in all elements of the laser safety program, ownership of laser safety at the user level is more easily established and compliance with safety requirements is significantly improved. New laser owners and users are mentored by experienced laser users and are given an opportunity to observe the implementation of laser safety procedures at established laser facilities before operating their own high power lasers. Increased compliance with safety requirements has been demonstrated with fewer non-compliance items noted during annual laser safety inspections, more participation in initial and annual refresher training, and more requests from higher power laser users for assistance with selection and implementation of exposure controls. New laser users are referred to the LSO by the laser owners for initial laser safety training rather than the LSO discovering untrained laser users during laser facility inspections.

Operational and Environmental Assessment of Electric Taxi Based on Fast-Time Simulation

Economic pressure and increasing environmental awareness stimulate the development of new taxi operation technologies and procedures. One of the most promising developments is the use of electrically powered landing gear for medium-size aircraft in civil aviation. If the prerequisite that the weight of the new equipment and the weight of the saved fuel be approximately balanced is met, operational as well as economic and environmental benefits can be achieved. This paper describes a method of assessing these benefits by means of a fast-time simulation model and presents the findings for two airports. The first, Frankfurt am Main Airport, is one of the major European hub airports. Because of the higher share of heavy aircraft, which are assumed not to be equipped with an electric taxi system, the relative benefit of almost 20% fuel savings is lower than at the second airport in the study, Berlin Brandenburg Willy Brandt Airport, which is still under construction and estimated to open in 2014 at the earliest. Because the share of medium-size aircraft is expected to be higher, relative fuel savings of more than 36% can be achieved there. Besides these economic and environmental impacts, operational benefits can also be observed as the aircraft can back out from their parking stands autonomously. With this maneuver, the time-consuming coupling and decoupling of a pushback vehicle can be eliminated.

Human Factors Implications for Standard Operating Procedure Development and Usability in Reprocessing Safety

The development of standard operating procedures (SOPs) in endoscope reprocessing is an oftneglected task with vital implications. At present, there is little to no organizational standardization o...

Establishment of pure NOTES procedure using a conventional flexible endoscope: review of six cases of gastric gastrointestinal stromal tumors

An increasing number of reports have recently been published on hybrid natural orifice transluminal endoscopic surgery (NOTES). These reports do not address how to complete an operation with a flexible endoscope alone (pure NOTES), but rather how to combine use of an endoscope and a laparoscope. Surgical procedures using flexible and rigid endoscopes have been developed using different processes and concepts. Recognizing this conceptual difference, we conducted a study to address how to establish a pure NOTES procedure. Six patients with gastric gastrointestinal stromal tumors (GISTs) underwent hybrid NOTES. Each case was retrospectively reviewed to determine the appropriateness of the treatment and the usefulness of the endoscopic submucosal dissection (ESD) method, double-scope method, spaced perforation method, duodenal balloon occlusion method, and loop clip technique. The development of operative procedures that take advantage of the characteristics of flexible endoscopes, even with conventional flexible endoscopic devices and conventional endoscopes alone, may contribute to the realization of pure NOTES.

Evaluation of Methods for Measuring Particulate Matter Emissions from Gas Turbines

The project SAMPLE evaluated methods for measuring particle properties in the exhaust of aircraft engines with respect to the development of standardized operation procedures for particulate matter measurement in aviation industry. Filter-based off-line mass methods included gravimetry and chemical analysis of carbonaceous species by combustion methods. Online mass methods were based on light absorption measurement or used size distribution measurements obtained from an electrical mobility analyzer approach. Number concentrations were determined using different condensation particle counters (CPC). Total mass from filter-based methods balanced gravimetric mass within 8% error. Carbonaceous matter accounted for 70% of gravimetric mass while the remaining 30% were attributed to hydrated sulfate and noncarbonaceous organic matter fractions. Online methods were closely correlated over the entire range of emission levels studied in the tests. Elemental carbon from combustion methods and black carbon from optical methods deviated by maximum 5% with respect to mass for low to medium emission levels, whereas for high emission levels a systematic deviation between online methods and filter based methods was found which is attributed to sampling effects. CPC based instruments proved highly reproducible for number concentration measurements with a maximum interinstrument standard deviation of 7.5%.

Smelt spout corrosion in a recovery boiler

Severe corrosion led to an in-service failure of one of the six spouts on a recovery boiler at Cenibra. The failure resulted in a large amount of cooling water entering the boiler and contacting smelt around the spout opening, but fortunately no smelt-water explosion occurred. An extensive investigation was conducted to determine the causes of the spout failure. The failure was caused by insufficient cooling water flow to the smelt spout, which, in turn, was caused by a sequence of events that occurred after a general blackout of an electrical energy system at the mill. The experience has led to the development and placement of operating and maintenance procedures that ensure adequate cooling water flows to smelt spouts to prevent future failures.

Global Mortality Attributable to Aircraft Cruise Emissions

Aircraft emissions impact human health though degradation of air quality. The majority of previous analyses of air quality impacts from aviation have considered only landing and takeoff emissions. We show that aircraft cruise emissions impact human health over a hemispheric scale and provide the first estimate of premature mortalities attributable to aircraft emissions globally. We estimate ∼8000 premature mortalities per year are attributable to aircraft cruise emissions. This represents ∼80% of the total impact of aviation (where the total includes the effects of landing and takeoff emissions), and ∼1% of air quality-related premature mortalities from all sources. However, we note that the impact of landing and takeoff emissions is likely to be under-resolved. Secondary H(2)SO(4)-HNO(3)-NH(3) aerosols are found to dominate mortality impacts. Due to the altitude and region of the atmosphere at which aircraft emissions are deposited, the extent of transboundary air pollution is particularly strong. For example, we describe how strong zonal westerly winds aloft, the mean meridional circulation around 30-60°N, interaction of aircraft-attributable aerosol precursors with background ammonia, and high population densities in combination give rise to an estimated ∼3500 premature mortalities per year in China and India combined, despite their relatively small current share of aircraft emissions. Subsidence of aviation-attributable aerosol and aerosol precursors occurs predominantly around the dry subtropical ridge, which results in reduced wet removal of aviation-attributable aerosol. It is also found that aircraft NO(x) emissions serve to increase oxidation of nonaviation SO(2), thereby further increasing the air quality impacts of aviation. We recommend that cruise emissions be explicitly considered in the development of policies, technologies and operational procedures designed to mitigate the air quality impacts of air transportation.

MO-B-203-03: Clinical Implementation of Robotic Systems for Brachytherapy

Image‐guidance is one of the main aspects of brachytherapy for accuracy and consistency of seed implantation. Modalities such as ultrasonography (U/S), computed tomography(CT), and magnetic resonance(MR) have been integrated with the robots for performing the clinical procedures. Therefore, proper calibration and appropriate testing of the integrated system are critical for achieving the desired treatment, safety and clinical outcome. However, satisfactory acceptance testing simply assures that the robotic system satisfies all agreed‐upon specifications between the vendor and the buyer. The process of commissioning a robot for clinical use should include verification of dosimetric planning system and testing of its accuracy, development of operational procedures, and training of all concerned with the operation of the robotic system. Before introducing any new robotic system in clinical environment, the robustness and reliability of the system should be evaluated. In additional to the traditional tests for brachytherapy, several additional items must be tested before commissioning the robotic system and should be periodically evaluated following a quality assurance program. Due to the complexity and constraints of the clinical environment where the clinician is an expert with high abilities to detect, analyze and react to unwanted critical situations, the clinician and the robot have to work together in a collaborative synergistic way. Interaction between the robot and the patient is extremely important because of the nature of tasks intended to be performed by a brachytherapyrobot. Since the brachytherapyrobotic systems carry a surgical tool (needle) and radioactive seeds and come in contact with the patient as well as close proximity to the clinical staffs, the robots have to be at least partly cleanable, sterilizeable (needle and seed passage), robust, reliable and safe. Safety, accuracy, user‐friendliness and reliability (SAUR) are the critical criteria that need to be satisfied for any robotic system to be introduced in clinical practice. Learning Objectives: 1. Review the imaging modalities used for robot‐assisted seed implantation 2. Understand the brachytherapyrobotic system calibration 3. Understand the commissioning and QA procedures and issues 4. Understand the safety and reliability issues for introducing robotic systems in the clinic

Quality assurance in non-interventional studies.

Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres. Before start of statistical analysis a statistical analysis plan (SAP) should be created. The use of standardized tables and figures is highly recommended. The basis of the report writing should be the STROBE-statement “Strengthening the Reporting of Observational studies in Epidemiology Initiative” containing a checklist of 22 points to be covered in the report. The development of own standard operating procedures (SOP) describing the processes during planning, conduct and evaluation of a non-interventional study as well as the quality management and the regular training of all involved people is also highly recommended. All accompanying measures to improve or to keep the quality of the NIS should not violate the concept of non-intervention.

Quality and Safety Models and Optimization as Part of Computer‐Integrated Manufacturing

This article is part of a collection entitled “Models for Safety, Quality and Competitiveness of the Food Processing Sector,” published in Comprehensive Reviews in Food Science and Food Safety. It has been peer‐reviewed and was written as a follow‐up of a pre‐IFT workshop, partially funded by the USDA NRI grant 2005‐35503‐16208.ABSTRACT: Mathematical models are the basis of modern process engineering methods. Mathematical optimization is at the kernel of systematic and efficient tools for (1) experimental design, model development, and identification, (2) development of optimal operating procedures, and (3) implementation of those procedures by means of model‐predictive controllers. Here, we review and discuss how these model‐based optimization techniques can be used at the core of computer‐integrated manufacturing systems for the food industry. These systems will be able to bring the operation of food processing plants closer to the best possible product quality and safety, at a reduced cost and with minimal environmental impact.

Stakeholder representation in international environmental standardisation - Joint Communiqué by ANEC, ECOS, and the Pacific Institute

International standardisation in the field of the environment has long been considered an important tool in contributing to sustainable production and sustainable development policies at the global level. This has in particular been the aim of the ISO 14000 series of standards on environmental management, developed by ISO Technical Committee (hereinafter referred to as ‘TC’) 207 on Environmental Management. To help ensure that the International Standards developed by ISO enjoy a degree of credibility and legitimacy, the ISO Strategic Plan lists as one of its key objectives the need to ensure that interested and affected stakeholders are adequately involved in ISO’s work and processes. The importance of ensuring the participation of public interest groups is also echoed in the ISO Code of Ethics. Despite the noble objectives of openness and transparency, consumer and environmental NGOs have long wrangled with the issue of business dominance and the marginalisation of public interests in standardisation. To help improve this imbalance in the particular case of ISO TC 207, a mixed group of NGO representatives and the TC leadership – the so-called NGO-CAG Task Force – was tasked in 2003 with developing a pair of operating procedures to improve the balance of stakeholder participation in the work of the TC. This paper reflects the long process of development of operational procedures for balanced stakeholder involvement in ISO TC 207 on Environmental Management, and highlights the need for a change in the way environmental standards, supporting broader public policies, are developed.

That's classified

The basic characteristic of oil and petrochemical industry processes is the use of flammable substances at high pressures and flows. Despite the strict requirements enforced to build process equipment that will be used in these industries, the high risk of accidents involving explosions and fires draws the attention of researchers because of the number of victims, material losses, and environmental damages. Locations where an explosive atmosphere may be formed are called "classified areas." Once these areas are identified, the technical specifications for electrical and electronic equipment and the development of specific operational procedures to ensure safety at work in these areas can be written and enforced.

Full-Height Thermal-Hydraulic Scaling Analysis of Pb-Bi-Cooled Fast Reactor PEACER

A liquid-metal–cooled fast reactor Proliferation-resistant Environment-friendly Accident-tolerant Continuable-energy Economical Reactor (PEACER) is being developed at Seoul National University with metallic-type U-Pu-Th fuel and lead-bismuth (Pb-Bi) coolant, employing the steam-generating Rankine cycle without an intermediate loop. The natural circulation potential is a key ingredient of the liquid-metal reactor design. PEACER is designed as a loop system, which increases the natural circulation capacity and reduces the maintenance cost. This work is concerned with design of a large-scale test loop Heavy Eutectic Loop Integrated Operation System (HELIOS) to simulate thermal-hydraulic behavior of Pb-Bi in the PEACER system following a single-phase one-dimensional flow loop model. The full-height loop is being constructed for Pb-Bi natural-circulation testing and operating procedure development. Electrically heated rods are used in the heating section, and a water-cooling method is adopted in the cooling section. HELIOS has the same elevation difference between thermal centers of the heat source and heat sink but reduced piping diameters.

Pediatric liver transplantation

Liver transplantation has become the accepted standard of care in the treatment of a child with a failing liver. Advances in the management of critical care and immunosuppression along with the development of innovative operative procedures have improved outcome such that 5-year survival rates of 80% to 90% are expected following liver transplantation. Organ allocation schemes have evolved in an effort to better stratify recipient risk thereby more appropriately distributing deceased donor grafts. A persistent shortage of appropriate donors continues to contribute to patient mortality. The consequences of long-term immunosuppression have become increasingly apparent such that health care providers need to be aware of the side effects of chronic immunosuppression. New strategies need to be defined to minimize the need of continuous immunosuppression. The continued success of pediatric liver transplantation will require multi-disciplinary health care teams comprised of general pediatricians, pediatric hepatologists, transplant surgeons, and transplant coordinators who focus on the complex needs of the transplant recipient.

Optimization and Control of Industrial Microbial Cultivation Processes

AbstractCompared to the immense achievements in fundamental molecular biological sciences, the improvements in the fermentation and downstream processing technologies used in industry have been less spectacular over the last decade. Hence, there is a misbalance between new cellular systems and production technologies, resulting in a decreasing annual rate of approved production processes. In its PAT initiative the U.S. Food and Drug Administration identifies the potential for continuous improvement and makes concrete suggestions how this can be achieved. Here, some of these suggestions were applied to recombinant protein production with Escherichia coli and Pichia pastoris cultures. Concretely, the development of process operational procedures is discussed that allow a more tight supervision of the processes and the automatic control in cases where processes deviate from their set‐point profiles.

Tensile engagement of the peri-ankle ligaments in stance phase.

Development of reconstructive operative procedures to restore normal ankle kinematics after injury requires an understanding of the biomechanics of the ankle during gait. The contribution of the peri-ankle ligaments to ankle motion control is not yet well understood. Knowledge of the tensile engagement of the peri-ankle ligaments during stance phase is necessary to achieve physiologic motion patterns. Eleven fresh-frozen cadaver ankles were subjected to a dynamic loading sequence simulating the stance phase of normal level gait. Simultaneously, ligament strain was continuously monitored in the anterior talofibular, calcaneofibular, and posterior talofibular ligaments, as well as in the anterior, middle, and posterior superficial deltoid ligaments. Eight of these specimens underwent further quasi-static range-of-motion testing, where ligament tension recruitment was assessed at 30 degrees plantarflexion and 30 degrees dorsiflexion. In the dynamic loading tests, none of the ligaments monitored showed a reproducible strain pattern indicating a role in ankle stabilization. However, in the extended range-of-motion tests, most ligaments were taut in plantarflexion or dorsiflexion. A consistent combination of individual ligament strain patterns that principally control ankle motion was not identified; none of the ligaments studied were reproducibly recruited to be a primary stabilizing structure. The peri-ankle ligaments are likely to be secondary restraining structures that serve to resist motion to avoid extreme positions. Stance phase ankle motion appears to be primarily controlled by articular congruity, not by peri-ankle ligament tension.

Clopidogrel before urgent coronary artery bypass graft

Comment Development of new operative procedures has caused a resurgence in the surgical treatment of atrial fibrillation. Like the Cox maze procedure, these new operations generally include isolation of the pulmonary veins and excision of the left atrial appendage. Exposure of these structures, particularly in a large left atrium, is challenging. A series of new atrial retractor blades (Kapp Surgical Inc, Cleveland, Ohio) provides exposure of the posterior left atrium and pulmonary vein orifices. These blades, which are malleable and universally adjustable, attach to a standard mitral valve retractor. This system provides excellent and consistent exposure of the posterior left atrium and pulmonary veins without the need for surgical assistance, facilitating operations for atrial fibrillation.

Topographical analysis of lymphatic pathways from the meso- and hypopharynx based on minute cadaveric dissections: possible application to neck dissection in pharyngeal cancer surgery.

To facilitate the development of new operative procedures for pharyngeal cancer, it is important to understand the precise location of the lymph nodes and their pathways. Minute dissection of 22 neck-halves (11 adult cadavers) was undertaken to determine the location and topographical relationships of the lymphatics of the pharynx. Four groups of lymph nodes on the drainage pathways from the meso- and hypopharynx to the internal jugular nodes were classified according to their topographical relationships to the carotid arteries: lateral pharyngeal, superior thyroid, lateral retropharyngeal and medial retropharyngeal nodes. Lymphatics from the mesopharynx passed laterally to lateral pharyngeal or jugulodigastric nodes or slightly upward to lateral retropharyngeal nodes. Lymphatic drainage from the hypopharynx was multidirectional with the pathways being classified as follows: ascending pathway to the lateral pharyngeal and lateral retropharyngeal nodes, lateral pathway to the internal jugular chain, and descending pathway connecting to the uppermost vessels ascending from the recurrent laryngeal nerve chain. In addition, a contralateral pathway was found originating from the hypopharynx extending to the contralateral internal jugular chain. These findings provide valuable information for comparison with CT and MRI studies, as well as with clinicopathological data, to clarify the precise mode of metastasis in head and neck cancers. These results are also applicable to neck dissection in meso- and hypopharyngeal cancers.