Secondary Medication Administration and IV Smart Pump Setup.

ABSTRACT: Secondary infusion by large-volume IV smart pump is used extensively in the acute care setting for one-time or intermittent administration of medications such as antibiotics, electrolyte replacements, and some oncology drugs. Consistent and accurate delivery of secondary medications requires a full understanding of the system and setup requirements. Unfortunately, it is not uncommon for nurses to find a secondary medication only partially administered when their programming should have resulted in a complete infusion. This article discusses the technical requirements that every nurse should know when administering secondary medications using an IV smart pump.

Implantation Time Has No Effect on the Morphology and Extent of Previously Reported "Degradation" of Prolene Pelvic Mesh.

OBJECTIVES: Prolene polypropylene ("Prolene") meshes demonstrate no in vivo degradation, yet some claim degradation continues until no more Prolene polypropylene can be oxidized. We studied whether implantation time affects the morphology/extent of previously reported as cracking/degradation of completely cleaned Prolene explants. METHODS: Urogynecological explants (248 patients) were collected. After excluding non-Prolene/unknown meshes and those without known implantation times, completely cleaned explants (n = 205; 0.2-14.4 years implantation) were analyzed with light microscopy, scanning electron microscopy, and Fourier transform infrared spectroscopy. Based on implant times and storage (fixative or dry), representative specimens were randomly selected for comparison. Controls were unused ("exemplar") TVT specimens with and without intentional oxidation via ultraviolet light exposure. RESULTS: Prolene explants included 31 dry (18 TVT; 7 Prolift; 4 Gynemesh; 2 others) and 174 wet (87 TVT; 47 Prolift; 10 Gynemesh; 30 others) specimens. Specimens had similar morphologies before cleaning. Progressive cleaning removed tissue and cracked tissue-related material exposing smooth, unoxidized, and nondegraded fibers, with no visible gradient-type/ductile damage. Fourier transform infrared spectroscopy of the explants confirmed progressive loss of proteins. Cleaning intentionally oxidized exemplars did not remove oxidized carbonyl frequencies and showed deep cracks and gross fiber rupture/embrittlement, unlike the explants and nonoxidized exemplars. CONCLUSIONS: If in vivo Prolene degradation exists, there should be wide-ranging crack morphology and nonuniform crack penetration, as well as more cracking, degradation, and physical breakage for implants of longer implantation times, but this was not the case. There is no morphologic or spectral/chemical evidence of Prolene mesh degradation after up to 14.4 years in vivo.

Heuristic evaluation and simulated use testing of infusion pumps to inform pump selection.

BACKGROUND: Poorly designed infusion pumps can lead to user errors and adverse incidents. Therefore, assessments of their usability and performance that can inform managerial decisions about the selection of appropriate medical devices are essential. OBJECTIVE: This study aimed to identify design deficiencies and evaluate the usability and performance of four infusion pump models and thus inform decisions about infusion pump selection. METHODS: Four evaluators evaluated the interface designs of the pumps according to a series of design principles in a heuristic evaluation in order to identify pump design deficiencies. Additionally, 60 registered nurses participated in simulated use testing to perform a series of tasks using the pumps in order to examine the pump performances. Outcome measures included task completion time, frequency of deviations, frequency of requests for assistance, and nurses' perceptions. RESULTS: Design issues identified included system status visibility, information access, and error prevention. The results of simulated use testing favored some pumps over others, depending on which outcome measures were considered. CONCLUSIONS: Heuristic evaluations and simulated use testing can provide information about the basic usability of medical devices and related operational issues. However, practitioners should select appropriate evaluation principles, testing tasks, and outcome measures based on the tested medical devices and contexts.

An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh.

Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event. Results: There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown. Conclusions: The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.

Perfil dos pacientes pediátricos submetidos a implantes de dispositivos cardíacos eletrônicos implantáveis em hospital público do Rio de Janeiro: revisão de 57 procedimentos sequenciais / Profile of pediatric patients submitted to implantable electronic cardiac devices in a public hospital in Rio de Janeiro: review of 57 sequential procedures

Introdução: A população pediátrica corresponde a menos de 1% dos implantes de marcapasso e possui desafios peculiares. Este estudo tem o objetivo de revelar o perfil dos pacientes pediátricos submetidos a cirurgias de dispositivos cardíacos eletrônicos implantáveis e taxas de complicação. Método: Estudo observacional retrospectivo de análise de prontuários de pacientes com até 18 anos de idade, submetidos a cirurgias de dispositivos cardíacos eletrônicos implantáveis entre 2009 e 2014 no Instituto Nacional de Cardiologia, sobre variáveis clínicas e cirúrgicas e complicações. Resultados: Entre 2009 e 2014, 51 pacientes foram submetidos a 57 cirurgias, dos quais 60,8% eram do sexo feminino. A média de idade foi de 8,32 anos. Cardiopatia congênita foi encontrada em 60,8% dos pacientes e cirurgia cardíaca prévia, em 76,4%. As principais indicações para dispositivos cardíacos eletrônicos implantáveis foram bloqueio atrioventricular total pós-operatório (40,4%) e bloqueio atrioventricular total congênito (31,6%). Dentre as cirurgias realizadas, destacam-se implante de marcapasso bicameral (38,6%) e implante de marcapasso monocameral ventricular (28,1%). Em 44 cirurgias de implantes, 72,7% foram endocárdicos. Ocorreram 3 complicações (5,3%). Conclusão: Na população pediátrica sujeita a implante de dispositivos cardíacos eletrônicos implantáveis, a escolha do sistema de estimulação cardíaca, a técnica de implante, a programação e o acompanhamento devem ser criteriosos. As taxas de complicação foram baixas. A melhor compreensão dessa população pode auxiliar na definição de diretrizes para seu tratamento

Background: The pediatric population represents less than 1% of all pacemaker implants and has unique challenges. This study is aimed at identifying the profile of pediatric patients undergoing surgical procedures for implantable electronic cardiac devices and complication rates. Method: This was a retrospective observational analysis of medical records of patients up to 18 years of age, submitted to implantable electronic cardiac devices between 2009-2014 at the National Institute of Cardiology on the clinical and surgical variables and complications. Results: Between 2009 and 2014, 51 patients underwent 57 surgeries, of which 60.8% were female. Mean age was 8.32 years. Congenital heart disease was found in 60.8% of the patients and 76.4% had had a previous heart surgery. The main indications for implantable electronic cardiac devices implantation were: postoperative complete heart block (40.4%), and congenital complete heart block (31.6%). The surgeries included dual chamber pacemakers (38.6%), and ventricular single chamber pacemaker (28.1%). Out of 44 surgical implants, 72.7% were endocardial. There were 3 complications (5.3%). Conclusion: In the pediatric population subject to implantable electronic cardiac device implantation, the choice of the cardiac pacing system,the implantation technique, planning and follow-up must be carefully made. Complication rates were low. A better understanding of this population can help define treatment guidelines

National Endoscopy Quality Improvement Program Remains Suboptimal in Korea.

BACKGROUND/AIMS: We evaluated the characteristics of the National Cancer Screening Program (NCSP) and opinions regarding the National Endoscopy Quality Improvement Program (NEQIP). METHODS: We surveyed physicians performing esophagogastroduodenoscopy and/or colonoscopy screenings as part of the NCSP via e-mail between July and August in 2015. The 32-item survey instrument included endoscopic capacity, sedation, and reprocessing of endoscopes as well as opinions regarding the NEQIP. RESULTS: A total of 507 respondents were analyzed after the exclusion of 40 incomplete answers. Under the current capacity of the NCSP, the typical waiting time for screening endoscopy was less than 4 weeks in more than 90% of endoscopy units. Performance of endoscopy reprocessing was suboptimal, with 28% of respondents using unapproved disinfectants or not knowing the main ingredient of their disinfectants and 15% to 17% of respondents not following reprocessing protocols. Agreement with the NEQIP was optimal, because only 5.7% of respondents did not agree with NEQIP; however, familiarity with the NEQIP was suboptimal, because only 37.3% of respondents were familiar with the NEQIP criteria. CONCLUSIONS: The NEQIP remains suboptimal in Korea. Given the suboptimal performance of endoscopy reprocessing and low familiarity with the NEQIP, improved quality in endoscopy reprocessing and better understanding of the NEQIP should be emphasized in Korea.

Are Wearables Safe? We Carry Our Smart Devices with Us Everywhere--Even to Bed--But Have We Been Sleeping with the Enemy, or are Cautionary Tales Overinflated?

Sometime over the last few years, wearable electronics have become the norm. Whether it's a cell phone attached to a holster at the hip, a smart watch on the wrist, or sensors on and sometimes woven into clothing, these technologies are part of everyday life. Along with this trend, many of the devices are also now collecting and transmitting health information. That is certainly convenient, but the question with any kind of health care device, including wearable medical technology, has always been and continues to be: is it safe?

A Novel Method to Detect an Oxygenator Defect Prior to Cardiopulmonary Bypass Initiation.

Cardiopulmonary bypass (CPB) is a common practice in our era. The medical technology used for cardiac surgery goes through rigorous testing to ensure its safety. Unfortunately, it is not fail proof. Oxygenator failures are a rare occurrence but may lead to catastrophic events. We present a case where the preparation for initiating CPB was complicated by an oxygenator defect. After thorough examination, the oxygenator was found leaking from the gas exhaust port suggesting a disruption in continuity of the fibers. This was found by the vigilance of the perfusionist and a creative method to quickly assess the integrity of the oxygenation device. We describe a simple technique to help diagnose an oxygenator leak.

Obstacles to Studying Emerging Technologies.

Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.

Making healthcare safer by understanding, designing and buying better IT.

When nobody or nothing notices an error, it may turn into patient harm. We show that medical devices ignore many errors, and therefore do not adequately support patient safety. In addition to causing preventable patient harm, errors are often reported ignoring potential flaws in medical device design, and front line staff may therefore be inappropriately blamed. We present some suggestions to improve reporting and the procurement of hospital equipment.

Catheter for Cleaning Surgical Optics During Surgical Procedures: A Possible Solution for Residue Buildup and Fogging in Video Surgery.

Currently, there is a tendency to perform surgical procedures via laparoscopic or thoracoscopic access. However, even with the impressive technological advancement in surgical materials, such as improvement in quality of monitors, light sources, and optical fibers, surgeons have to face simple problems that can greatly hinder surgery by video. One is the formation of "fog" or residue buildup on the lens, causing decreased visibility. Intracavitary techniques for cleaning surgical optics and preventing fog formation have been described; however, some of these techniques employ the use of expensive and complex devices designed solely for this purpose. Moreover, these techniques allow the cleaning of surgical optics when they becomes dirty, which does not prevent the accumulation of residue in the optics. To solve this problem we have designed a device that allows cleaning the optics with no surgical stops and prevents the fogging and residue accumulation. The objective of this study is to evaluate through experimental testing the effectiveness of a simple device that prevents the accumulation of residue and fogging of optics used in surgical procedures performed through thoracoscopic or laparoscopic access. Ex-vivo experiments were performed simulating the conditions of residue presence in surgical optics during a video surgery. The experiment consists in immersing the optics and catheter set connected to the IV line with crystalloid solution in three types of materials: blood, blood plus fat solution, and 200 mL of distilled water and 1 vial of methylene blue. The optics coupled to the device were immersed in 200 mL of each type of residue, repeating each immersion 10 times for each distinct residue for both thirty and zero degrees optics, totaling 420 experiments. A success rate of 98.1% was observed after the experiments, in these cases the device was able to clean and prevent the residue accumulation in the optics.

Perceived usefulness of a usability issues reporting form to help understand "usability-induced use-errors": a preliminary study.

The Medical Device regulation requires manufacturers to anticipate and prevent risks of use errors of their medical device. However, manufacturers experience difficulties to understand the concept of "usability-induced use-errors". Based on a "usability framework" aiming at describing the relationship between usability design principles, usability flaws, usage problems, and outcomes, a usability evaluation reporting form had been designed to support understanding the use-error concept. This paper reports the preliminary evaluation of the perceived usefulness of this form. Results show that manufacturers found helpful the presentation of the results of a usability evaluation through this form for it supports the understanding of the usability origins and the consequences of use-errors. Even if the use of this reporting form should be made easier as usability experts experience difficulties to fill it, it seems a promising way to clearly present "usability-induced use-errors" to manufacturers.

Membrane oxygenator heat exchanger failure detected by unique blood gas findings.

Failure of components integrated into the cardiopulmonary bypass circuit, although rare, can bring about catastrophic results. One of these components is the heat exchanger of the membrane oxygenator. In this compartment, unsterile water from the heater cooler device is separated from the sterile blood by stainless steel, aluminum, or by polyurethane. These areas are glued or welded to keep the two compartments separate, maintaining sterility of the blood. Although quality control testing is performed by the manufacturer at the factory level, transport presents the real possibility for damage. Because of this, each manufacturer has included in the instructions for use a testing procedure for testing the integrity of the heat exchanger component. Water is circulated through the heat exchanger before priming and a visible check is made of the oxygenator bundle to check for leaks. If none are apparent, then priming of the oxygenator is performed. In this particular case, this procedure was not useful in detecting communication between the water and blood chambers of the oxygenator.

Clinical evaluation of a new technique to monitor return electrode skin temperature during radiofrequency ablation.

PURPOSE: Return electrode burns occur occasionally in cardiac radiofrequency ablation and more frequently in tumor radiofrequency ablation. A return electrode incorporating a thermochromic liquid crystal (TLC) layer, which changes color with temperature, has been shown in sheep studies to accurately indicate underlying skin temperature. We aimed to validate the accuracy of TLC-coated return electrodes in indicating skin temperature in the clinical setting of cardiac radiofrequency ablation. METHODS AND RESULTS: The top layer of a standard return electrode was replaced with TLC. Fluoro-optic thermometer (FOT) probes were laid on the skin side of the return electrode, which was then placed on the left lateral mid-thigh of 18 patients (mean age = 61 ± 12 years, 12 men) undergoing cardiac radiofrequency ablation. Return electrode photographs were taken when FOT temperature exceeded 35 °C. TLC color changes, observed in 11 patients, were converted to temperature and compared with FOT temperature. TLC temperature correlated well with FOT temperature (Pearson's coefficient = 0.97 ± 0.03). Bland-Altman analysis showed good agreement (mean temperature difference = -0.04 ± 0.08 °C, upper limit of agreement = 0.11 ± 0.005 °C, lower limit of agreement = -0.19 ± 0.005 °C). The maximum FOT temperature recorded was 39.6 °C. There was no thermal injury at the return electrode site on any patients, when assessed immediately after and the day following the procedure. CONCLUSION: TLC-coated return electrodes accurately indicate underlying skin temperature in cardiac radiofrequency ablation and may help prevent burns. This technology might be essential in high energy radiofrequency ablation.

[The algorithms for the tuning of the speech processors of cochlear implants].

The tuning of the speech processors of cochlear implants implies the measurement of the threshold perception levels and the achievement of the maximally comfortable level of loudness in each auditory channel. The authors present a detailed description of the approach to the optimal tuning including the sequence of procedures and manipulations for this purpose, from the first tuning to the achievement of the desired result. This algorithm summarizes the worldwide and the authors' own experience based on the original investigations that have been carried in the Sankt-Peterburg Research Institute of Otorhinolaryngology and Speech during more than 15 years.

Especificações mínimas aceitáveis de um analisador de desfibriladores e cardioversores / Minimum acceptable specifications for a defibrillator and cardioverter analyzer

Esta pesquisa objetiva recomendar especificações que os analisadores de desfibriladores e cardioversores devam apresentar, tais como: erro máximo de medição, resolução, condições de operação e recursos desejáveis. As recomendações apresentadas baseiam-se nos quesitos demandados para a realização dos ensaios previstos pelas normas NBR IEC  60601-2-4:2005 e ANSI/AAMI  DF80:2003. Uma avaliação das especificações fornecidas de quatro analisadores importados (Fluke  QED6, Fluke Impulse  7000, MTK-Biomed  Delta 3000  MKII e NETECH Delta  3000) e dois analisadores nacionais (Transmai  JM-01 e Ourox  JAU-100) também foi realizada, tendo encontrado diversas falhas de especificações em todos os analisadores. Estas falhas vão desde o não fornecimento de dados a condições aquém das desejáveis para um analisador de desfibriladores e cardioversores. Os problemas mais graves encontrados estão relacionados à não apresentação de especificações tais como precisão, exatidão de medição, erro máximo de medição ou outra informação que por sua vez auxiliaria na determinação do intervalo de abrangência para a medida, como a de energia pelo analisador Transmai  JM-01, algo inaceitável para um instrumento de medição, incertezas elevadas e condições de operação aquém das necessárias para a realização dos ensaios determinados pelas normas NBR IEC  60601-2-4:2005 e ANSI/AAMI  DF80:2003.

This study aims to recommend specifications for defibrillator and cardioverter analyzers, such as maximum permissible measurement error, resolution, operating conditions and desirable features. The recommendations are based on the test requirements from the ABNT  NBR IEC  60601-2-4:2005 and ANSI/AAMI  DF80:2003 standards. An evaluation of the specifications provided by four imported analyzers (Fluke QED 6, Fluke Impulse  7000, MTK-Biomed  Delta 3000  MKII and NETECH Delta  3000) and two Brazilian analyzers (Transmai  JM-01 and Ourox  JAU-110) has also been performed, and several problems were found with specifications of those analyzers. These problems range from unsupplied data to less than desirable conditions for a defibrillator and cardioverter analyzer. The most serious problems encountered are related to the lack of specifications such as precision, accuracy, maximum permissible measurement error or other specifications that would help determine the coverage interval of the measure, an unacceptable  mistake for a measurement instrument. Other problems were related to measurement error and operating conditions not complying with the requirements of the ABNT  NBR IEC  60601-2-4:2005 and the ANSI/AAMI  DF80:2003 standards.

EOS 2D/3D X-ray imaging system: a systematic review and economic evaluation.

BACKGROUND: EOS is a biplane X-ray imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris, France). It uses slot-scanning technology to produce a high-quality image with less irradiation than standard imaging techniques. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of EOS two-dimensional (2D)/three-dimensional (3D) X-ray imaging system for the evaluation and monitoring of scoliosis and other relevant orthopaedic conditions. DATA SOURCES: For the systematic review of EOS, electronic databases (MEDLINE, Allied and Complementary Medicine Database, BIOSIS Previews, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, Health Management Information Consortium, Inspec, ISI Science Citation Index and PASCAL), clinical trials registries and the manufacturer's website were searched from 1993 to November 2010. REVIEW METHODS: A systematic review of studies comparing EOS with standard X-ray [film, computed radiography (CR) or digital radiography] in any orthopaedic condition was performed. A narrative synthesis was undertaken. A decision-analytic model was developed to assess the cost-effectiveness of EOS in the relevant indications compared with standard X-ray and incorporated the clinical effectiveness of EOS and the adverse effects of radiation. The model incorporated a lifetime horizon to estimate outcomes in terms of quality-adjusted life-years (QALYs) and costs from the perspective of the NHS. RESULTS: Three studies met the inclusion criteria for the review. Two studies compared EOS with film X-ray and one study compared EOS with CR. The three included studies were small and of limited quality. One study used an earlier version of the technology, the Charpak system. Both studies comparing EOS with film X-ray found image quality to be comparable or better with EOS overall. Radiation dose was considerably lower with EOS: ratio of means for posteroanterior spine was 5.2 (13.1 for the study using the Charpak system); ratio of means for the lateral spine was 6.2 (15.1 for the study using the Charpak system). The study comparing EOS with CR found image quality to be comparable or better with EOS. Radiation dose was considerably lower with EOS than CR; ratio of means for the centre of the back was 5.9 and for the proximal lateral point 8.8. The lowest ratio of means was at the nape of the neck, which was 2.9. No other outcomes were assessed in the included studies, such as implications for patient management from the nature and quality of the image. Patient throughput is the major determinant of the cost-effectiveness of EOS. The average cost per procedure of EOS decreases with utilisation. Using estimates of patient throughput at national level from Hospital Episode Statistics data suggests that EOS is not cost-effective for the indications considered. Throughput in the region of 15,100 to 26,500 (corresponding to a workload of 60 to 106 patient appointments per working day) for EOS compared with a throughput of only 7530 for CR (30 patient appointments per working day) is needed to achieve an incremental cost-effectiveness ratio of £30,000 per QALY. EOS can be shown to be cost-effective only when compared with CR if the utilisation for EOS is about double the utilisation of CR. LIMITATIONS: The main limitation of the systematic review of the clinical effectiveness of EOS was the limited number and quality of the data available. In particular, there were no studies assessing the potential health benefits arising from the quality and nature of the image, over and above those associated with reduced radiation exposure. Uncertainty in the model inputs was not fully explored owing to a lack of reporting of standard deviations or confidence intervals in the published literature for most of the parameters. As a result, uncertainty in the cost-effectiveness results was not presented. CONCLUSIONS: Radiation dose is considerably lower with EOS than standard X-ray, whereas image quality remains comparable or better with EOS. However, the long-term health benefits from reduced radiation exposure with EOS are very small and there was a lack of data on other potential patient health benefits. The implications of any changes in the quality and nature of the EOS image compared with standard X-ray, for patient health outcomes, needs to be assessed. Given the higher cost of an EOS machine, utilisation is the major determinant of cost-effectiveness. Estimates of patient throughput at national level suggest that EOS is not cost-effective. FUNDING: The National Institute for Health Research Health Technology Assessment programme.