Assessment of Channelizing Device Effectiveness on High Speed/High Volume Roadways, 2007

Part 6 of the Manual on Uniform Traffic Control Devices (MUTCD) describes several types of channelizing devices that can be used to warn road users and guide them through work zones; these devices include cones, tubular markers, vertical panels, drums, barricades, and temporary raised islands. On higher speed/volume roadways, drums and/or vertical panels have been popular choices in many states, due to their formidable appearance and the enhanced visibility they provide when compared to standard cones. However, due to their larger size, drums also require more effort and storage space to transport, deploy and retrieve. Recent editions of the MUTCD have introduced new devices for channelizing; specifically of interest for this study is a taller (>36 inches) but thinner cone. While this new device does not offer a comparable target value to that of drums, the new devices are significantly larger than standard cones and they offer improved stability as well. In addition, these devices are more easily deployed and stored than drums and they cost less. Further, for applications previously using both drums and tall cones, the use of tall cones only provides the ability for delivery and setup by a single vehicle. An investigation of the effectiveness of the new channelizing devices provides a reference for states to use in selecting appropriate traffic control for high speed, high volume applications, especially for short term or limited duration exposures. This study includes a synthesis of common practices by state DOTs, as well as daytime and nighttime field observations of driver reactions using video detection equipment. The results of this study are promising for the day and night performance of the new tall cones, comparing favorably to the performance of drums when used for channelizing in tapers. The evaluation showed no statistical difference in merge distance and location, shy distance, or operating speed in either daytime or nighttime conditions. The study should provide a valuable resource for state DOTs to utilize in selecting the most effective channelizing device for use on high speed/high volume roadways where timely merging by drivers is critical to safety and mobility.

Electronic control device exposure: a review of morbidity and mortality.

The use of electronic control devices has expanded worldwide during the last few years, the most widely used model being the Taser. However, the scientific knowledge about electronic control devices remains limited. We reviewed the medical literature to examine the potential implications of electronic devices in terms of morbidity and mortality, and to identify and evaluate all the existing experimental human studies. A single exposure of an electronic control device on healthy individuals can be assumed to be generally safe, according to 23 prospective human experimental studies and numerous volunteer exposures. In case series, however, electronic control devices could have deleterious effects when used in the field, in particular if persons receive multiple exposures, are intoxicated, show signs of "excited delirium," or present with medical comorbidities. As the use of electronic control devices continues to increase, the controversy about its safety, notably in potentially high-risk individuals, is still a matter of debate. The complications of electronic control device exposure are numerous but often recognizable, usually resulting from barbed dart injuries or from falls. Persons exposed to electronic control devices should therefore be fully examined, and traumatic lesions must be ruled out.

Vacuum-assisted closure device for the management of infected postpneumonectomy chest cavities.

BACKGROUND: Infected postpneumonectomy chest cavities may be related to chronic postpneumonectomy empyema or arise in rare situations of necrotizing pneumonia with complete lung destruction where pneumonectomy and pleural debridement are required. We evaluated the safety and efficacy of an intrathoracic vacuum-assisted closure device (VAC) for the treatment of infected postpneumonectomy chest cavities. METHOD: A retrospective single institution review of all patients with infected postpneumonectomy chest cavities treated by VAC between 2005 and 2013. Patients underwent surgical debridement of the thoracic cavity, muscle flap closure of the bronchial stump when a fistula was present, and repeated intrathoracic VAC dressings until granulation tissue covered the entire chest cavity. After this, the cavity was obliterated by a Clagett procedure and closed. RESULTS: Twenty-one patients (14 men and 7 women) underwent VAC treatment of their infected postpneumonectomy chest cavity. Twelve patients presented with a chronic postpneumonectomy empyema (10 of them with a bronchopleural fistula) and 9 patients with an empyema occurring in the context of necrotizing pneumonia treated by pneumonectomy. In-hospital mortality was 23%. The median duration of VAC therapy was 23 days (range, 4-61 days) and the median number of VAC changes per patient was 6 (range, 2-14 days). Infection control and successful chest cavity closure was achieved in all surviving patients. One adverse VAC treatment-related event was identified (5%). CONCLUSIONS: The intrathoracic VAC application is a safe and efficient treatment of infected postpneumonectomy chest cavities and allows the preservation of chest wall integrity.

Percutaneous Endovascular Salvage Techniques for Implanted Venous Access Device Dysfunction.

PURPOSE: Implanted venous access devices (IVADs) are often used in patients who require long-term intravenous drug administration. The most common causes of device dysfunction include occlusion by fibrin sheath and/or catheter adherence to the vessel wall. We present percutaneous endovascular salvage techniques to restore function in occluded catheters. The aim of this study was to evaluate the feasibility, safety, and efficacy of these techniques. METHODS AND MATERIALS: Through a femoral or brachial venous access, a snare is used to remove fibrin sheath around the IVAD catheter tip. If device dysfunction is caused by catheter adherences to the vessel wall, a new "mechanical adhesiolysis" maneuver was performed. IVAD salvage procedures performed between 2005 and 2013 were analyzed. Data included clinical background, catheter tip position, success rate, recurrence, and rate of complication. RESULTS: Eighty-eight salvage procedures were performed in 80 patients, mostly women (52.5 %), with a mean age of 54 years. Only a minority (17.5 %) of evaluated catheters were located at an optimal position (i.e., cavoatrial junction ±1 cm). Mechanical adhesiolysis or other additional maneuvers were used in 21 cases (24 %). Overall technical success rate was 93.2 %. Malposition and/or vessel wall adherences were the main cause of technical failure. No complications were noted. CONCLUSION: These IVAD salvage techniques are safe and efficient. When a catheter is adherent to the vessel wall, mechanical adhesiolysis maneuvers allow catheter mobilization and a greater success rate with no additional risk. In patients who still require long-term use of their IVAD, these procedures can be performed safely to avoid catheter replacement.

Apical closure device for transapical valve procedures?.

OBJECTIVES: Transapical transcatheter valve procedures are performed through a left minithoracotomy and require apical sutures to seal the apical access site. The use of large-calibre devices compromises any attempt to fully perform the procedure with a thoracoscopic approach or percutaneously. We report our preliminary experience in animals with a new sutureless self-expandable apical occluder, engineered to perform transapical access site closure in a minimally invasive setting with large-size introducer sheaths. METHODS: The apical occluder with extendable waist was implanted in six young pigs during an acute animal study. Under general anaesthesia, animals (mean weight: 62 ± 8 kg) received full heparinization (heparin: 100 UI/kg; activated clotting time above 250 s). Through a median sternotomy, a 21-Fr Certitude? introducer sheath (outer diameter: 25 Fr) was placed over the wire into the cardiac apex. The delivery catheter carrying the constrained apical plug was inserted into the sheath and deployed under fluoroscopic control, whereas the Certitude? was retrieved. After protamine infusion, we observed and recorded the 1-h bleeding with standard haemodynamic parameters. Animals were sacrificed, and hearts analysed. RESULTS: Six apical closure devices were successfully introduced and deployed in six pig hearts through large-size apical sheaths at first attempt. In all animals, the plugs guaranteed immediate apical sealing and traces of blood were collected in the pericardium during the 1-h observational period (mean of 16 ± 3.4 ml of blood loss per animal). Haemodynamic parameters remained stable during the entire study period and no plug dislodgement was detected with normal systemic blood pressure (mean arterial mean blood pressure: 65 ± 7 mmHg). Post-mortem analysis confirmed the full deployment and good fixation of all plugs, without macroscopic damages to the surrounding myocardium. CONCLUSIONS: This sutureless self-expandable apical occluder is a simple device capable of sealing large-size apical access sites (20-35 Fr) in an acute animal study. This approach is a step further towards less invasive transapical valve procedures in the clinical setting, and further animal tests will be performed to confirm the long-term efficacy and safety of this device.

Compliance of crane electrics with electrical safety standards and codes

Master’s thesis focuses on the questions of crane electrics compliance with electrical safety standards. Overview and short comparison of the world’s effective standards in the field is made in order to understand their demands. Basic concepts of a proper electrical circuit design are presented. Characteristics, construction and operation principles of overcurrent protective devices are studied in details. Electrics of the basic crane is designed according to the assumed customer’s demands, compliance with the requirements of the standards is checked. Solutions to achieve better compliance in some issues are proposed. Accent is made on the National Electrical Code (NEC) and standards by Underwriters Laboratories (UL) latests demands. Requirements of the International Electrotechnical Commission (IEC) are also taken into account.

Packaging concept development for an assortment of medical device products

Diplomityön tavoitteena oli kehittää Wipak Oy:n valmistamille sterilointipakkauksille tulevaisuuden pakkauskonsepti. Sterilointipakkaukset luokitellaan lääkelaitedirektiivin mukaan lisätarvikkeiksi luokan 1 lääkelaitteille, ja tämä näkökulma oli vahvasti mukana konseptin kehityksessä. Lähtökohtana pakkauskonseptin suunnittelulle oli tuotteiden arvoketjussa, eli pakata tuotteet siten että pakkausten avulla voidaan tuottaa lisäarvoa arvoketjun toimijoille. Tavoitteena oli parantaa pakkausten viestintää, toimivuutta/tehokkuutta toimitusketjussa sekä vahvistaa brändin imagoa myynti- ja kuljetuspakkauksen avulla. Lääkinnälliset laitteet ja tarvikkeet ovat lainsäädännön ja normien avulla tarkasti säädeltyjä. Näiden normien vaatimukset asettavat perusteet myynti- ja kuljetuspakkausten kehittämiselle. Tämän lisäksi suunnittelussa on huomioitu asiakkaiden toiveet ja kehitystarpeet. Kirjallisuusosuudessa on keskitytty lääkinnällisten laitteiden pakkausyksiköiden toimintoihin sekä niiden kehitysnäkymiin. Pääpaino on ollut pakkausmerkintöjen ja jäljitettävyyden kehittämisellä, koska tietojen automaattisen tunnistuksen hyödyntäminen lääkintälaitteiden pakkausten arvoketjussa on kasvava trendi. Manuaalisesti tehtävät tuotevirtojen kirjaukset ketjun eri toimijoiden osalta lisäävät riskejä jäljitettävyyden kannalta ja aiheuttavat lisätyötä ja – kustannuksia ketjun kaikille osapuolille. Ehdotus uudesta pakkauskonseptista on kehitetty näiden tietojen pohjalta. Ehdotuksessa on huomioitu lainsäädännöstä ja ketjun toimijoilta tulevat tarpeet, sekä alan tulevaisuuden kehitysnäkymät. Ehdotetun pakkauskonseptin avulla saadaan lisättyä myynti- ja kuljetuspakkausten tehokkuutta, parannettua jäljitettävyyttä ja helpotettu arvoketjun alavirran toimijoiden työtä lisäämällä erillinen sisäpakkaus myyntiyksikön sisälle. Työssä on lisäksi selvitetty pakkauskonseptin kustannusvaikutukset tuotteiden hintaan. Lopussa on ehdotettu jatkotoimenpiteet suunnitelman implementoimisesta käytäntöön.

Fault-finding device

El projecte es va fer al KHLim a Diepenbeek. Es tractava de dissenyar un nou dispositiu de localització d'avaries del relè del motor, per tal de de substituir el que ja hi havia, per raons de seguretat

Operational safety: Development of electronic system for dynamic balance evaluation of farm tractors

The present study aimed at the development and evaluation of a low cost electronic device in order to provide safety for farm tractor users. The major accident occurrence in agricultural surroundings is from farm tractor side bending. Therefore, this sensor was designed to detect and alert about it. The results were satisfying. © 2013 Taylor & Francis Group.

Inicial nasal mucosa detachment using piezoelectric device in the Le Fort I osteotomy: A technical note

In maxillary Le Fort I type osteotomy the detachment of the nasal mucosa should be done carefully. Piezoelectric surgery contributed much to increase the safety of osteotomies, despite the initial advantage of minimizing the risk of injury in nervous tissue, mainly in bilateral sagittal split osteotomy; we use the piezoelectric device for the initial detachment of the nasal mucosa in the maxillary osteotomy.

Computer-assisted femoral head-neck osteochondroplasty using a surgical milling device an in vitro accuracy study

Surgical navigation might increase the safety of osteochondroplasty procedures in patients with femoroacetabular impingement. Feasibility and accuracy of navigation of a surgical reaming device were assessed. Three-dimensional models of 18 identical sawbone femora and 5 cadaver hips were created. Custom software was used to plan and perform repeated computer-assisted osteochondroplasty procedures using a navigated burr. Postoperative 3-dimensional models were created and compared with the preoperative models. A Bland-Altmann analysis assessing α angle and offset ratio accuracy showed even distribution along the zero line with narrow confidence intervals. No differences in α angle and offset ratio accuracy (P = 0.486 and P = 0.2) were detected between both observers. Planning and conduction of navigated osteochondroplasty using a surgical reaming device is feasible and accurate.

Experimental contamination assessment of a novel closed ultravitrification device

To evaluate the safety of a new ultravitrification closed device.

Technical Feasibility and Application of Mechanical Thrombectomy with the Solitaire FR Revascularization Device in Acute Basilar Artery Occlusion

Acute BAO is a devastating neurological condition associated with a poor clinical outcome and a high mortality rate. Recanalization has been identified as a major prognostic factor for good outcome in BAO. Mechanical thrombectomy using retrievable stents is an emerging treatment option for acute stroke. First clinical trials using stent retrievers have shown promising high recanalization rates. However, these studies mainly included large artery occlusions in the anterior circulation with only a few or single cases of BAO. Therefore, the purpose of this study was to evaluate technical feasibility, safety, and efficacy of mechanical thrombectomy using retrievable stent in the treatment of acute BAO.

Safety of Active Implantable Devices during MRI Examinations: A Finite Element Analysis of an Implantable Pump

The goal of this study was to propose a general numerical analysis methodology to evaluate the magnetic resonance imaging (MRI)-safety of active implants. Numerical models based on the finite element (FE) technique were used to estimate if the normal operation of an active device was altered during MRI imaging. An active implanted pump was chosen to illustrate the method. A set of controlled experiments were proposed and performed to validate the numerical model. The calculated induced voltages in the important electronic components of the device showed dependence with the MRI field strength. For the MRI radiofrequency fields, significant induced voltages of up to 20 V were calculated for a 0.3T field-strength MRI. For the 1.5 and 3.0T MRIs, the calculated voltages were insignificant. On the other hand, induced voltages up to 11 V were calculated in the critical electronic components for the 3.0T MRI due to the gradient fields. Values obtained in this work reflect to the worst case situation which is virtually impossible to achieve in normal scanning situations. Since the calculated voltages may be removed by appropriate protection circuits, no critical problems affecting the normal operation of the pump were identified. This study showed that the proposed methodology helps the identification of the possible incompatibilities between active implants and MR imaging, and can be used to aid the design of critical electronic systems to ensure MRI-safety

Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome

OBJECTIVES: We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California). BACKGROUND: Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. METHODS: Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age > or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support. RESULTS: A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%. CONCLUSIONS: Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.