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Electromagnetic interference can cause hospital devices to malfunction, McGill group warns.

Electromagnetic interference (EMI) from sources such as television transmitters, police radios and cellular phones can cause medical monitors and other hospital devices to malfunction, says the principal investigator of a McGill biomedical engineering group set up in 1989 to study, predict and prevent such problems. The impact of equipment malfunction can range from mere inconvenience to serious problems. The research group advises physicians and other health care professionals to learn how to spot problems related to EMI and electromagnetic compatibility.

Electromagnetic Fields↗

Multicenter German reference data base for peripheral quantitative computer tomography.

The wide spread use of bone densitometers in Germany and other European countries has required the establishment of a validated reference population data base. A semianthropomorphic forearm cross-calibration phantom (EFP), developed during a concerted research action of the European Union's programme in Biomedical Engineering (COMAC-BME), was used to cross-calibrate the peripheral quantitative computer tomography (pQCT) devices at four German centers participating in the multicenter study. In total, 723 women and 208 men were included in the normal data base. No significant regional differences were found between the data of the different centers. In addition to the manufacturers calibration standard, proper calibration of the pQCT devices could be monitored during collection of the normal female and male data base. As a merit of the COMAC-BME study the measurements obtained with all pQCT devices thus ensured an uniform reference data base for distal radius measurements in Germany.

Adult↗

[Tissue reaction to implanted polyurethane designed for parts of the artificial heart].

Experiments on producing polyurethane membranes which could be used for elements of an artificial heart have been carried out in Poland for several years. In the Institute of Biocybernetics and Biomedical Engineering PAN in Warsaw two kinds of polyurethanes with symbols PU 47 and PU 90 have been worked out. They differ in physicochemical properties and they were subjected to investigations of tissue reaction in the Institute of Experimental Surgery and of Biomaterials Investigations of the Medical Academy in Wrocław. The investigations were carried out on 70 rats of the Wistar breed and on 30 rabbits of the New Zealand breed. Polyurethane circles were implanted into subcutaneous tissue, to peritoneal cavity and into muscles of the back in rats; polyurethane oars were implanted into muscles of the back along the backbone of the rabbits. Sections of the animals were carried out 3, 7, 14, 28, 90 and 180 days after the surgery taking 5 animals in each term. Macroscopic and microscopic as well as physicomechanical investigations were carried out. The carried out experimental investigations of the both kinds of polyurethanes showed good tolerance of the animals' organisms on the implanted material. Summing up, we can say that the tested polyurethane foils with symbols PU 47 and PU 90 satisfy the basic requirements made on the materials designed for temporal contact with a living organism.

Abdominal Muscles↗

[Optimization of production diagrams in automated control systems for medical technology industries].

An algorhythm for drawing up optimal production schedule graphs covering a shop floor (production area) over a planned period of output, based on the criterion of minimizing the total time for the workpiece treatment that may be applicable in the APCS of biomedical engineering industry, is set forth. In this connection the notions of a critical workpiece, critical equipment and of a conflicting situation are introduced, and the LRT rule, that plays a dominant role in combination with those of the SIO and MIN idle time, is applied. A relation intended to settle the conflicting situation in compiling the optimal schedule graphs is adduced and its solution for computerized programming is given.

Electronic Data Processing↗

Laser system for measuring small changes in plasma tracer concentrations.

The authors developed a laser-diode system that can be used for on-line optical concentration measurements in physiologic systems. Previous optical systems applied to whole blood have been hampered by artifacts introduced by red blood cells (RBCs). The system introduced here uses a commercially available filter cartridge to separate RBCs from plasma before plasma concentration measurements are made at a single wavelength. The filtering characteristics of the Cellco filter cartridge (#4007-10, German-town, MD) were adequate for use in the on-line measurement system. The response time of the filter cartridge was less than 40 seconds, and the sieving characteristics of the filter for macromolecules were excellent, with filtrate-to-plasma albumin ratios of 0.98 +/- 0.11 for studies in sheep and 0.94 +/- 0.15 for studies in dogs. The 635-nm laser diode system developed was shown to be more sensitive than the spectrophotometer used in previous studies (Klaesner et al., Annals of Biomedical Engineering, 1994; 22, 660-73). The new system was used to measure the product of filtration coefficient (Kfc) and reflection coefficient for albumin (delta f) in an isolated canine lung preparation. The delta fKfc values [mL/(cmH2O.min.100 g dry lung weight)] measured with the laser diode system (0.33 +/- 0.22) compared favorably with the delta fKfc obtained using a spectrophotometer (0.27 +/- 0.20) and with the Kfc obtained using the blood-corrected gravimetric method (0.32 +/- 0.23). Thus, this new optical system was shown to accurately measure plasma concentration changes in whole blood for physiologic levels of Kfc. The same system can be used with different optical tracers and different source wavelengths to make optical plasma concentration measurements for other physiologic applications.

Analysis of Variance↗

A statistical approach to the quantitative comparison of pulsatile flow in vitro data of prosthetic heart valve testing.

BACKGROUND AND AIMS OF THE STUDY: In vitro evaluation and animal testing are fundamental steps in the assessment of prosthetic heart valves before their use in clinical practice. Valve testing under pulsatile conditions is the best in vitro simulation of cardiac valve function, and the ensuing results should support the surgeon's decision concerning the time of valve replacement. However, limits in hydraulic reproduction of cardiac function and differences in protocol implementation of in vitro testing lead to difficulties in obtaining reliable and comparable results. Debate among researchers and standardizing bodies about discrepancies in results becomes critical in light of the European CE certification of implantable medical devices. An interlaboratory environment has been created at the Biomedical Engineering unit of the Istituto Superiore di Sanita in Rome, which uses differing test apparatus to evaluate prosthetic heart valves in vitro, in order to define significant measurement parameters and procedures that produce comparative data. METHODS: Two prosthetic valves-a tilting disc and a bileaflet valve-each sized 29 mm, were tested in the aortic position on two different pulse duplicators (PDs), namely the Dynatek MP1 and a system developed at the University of Sheffield. The common protocol adopted was the FDA Interlaboratory Comparison Testing Protocol. Original software was used to manage all test phases, thus minimizing operator-dependent variability in both systems and imposing strict control of experimental conditions. Statistical analysis performed on the data followed two approaches: (i) separate fitting of the two regression equations of pressure drop-flow rate relationship obtained for each valve on both PDs, and (ii) application of a multiple regression model, to fit a single regression equation of pressure drop-flow rate relationship, using data obtained from both PDs for each valve. In addition, an additional independent (dummy) variable was introduced. RESULTS AND CONCLUSIONS: Using this approach, the valve parameter range was obtained and, by imposing strict control of the experimental set-up, the coincidence of the two valve power laws, estimated by each of the two PDs, was studied.

Heart Valve Prosthesis↗

Evaluation of domiciliary long-term oxygen therapy with oxygen concentrators.

Domiciliary long-term oxygen therapy (LTOT) is usually supplied by means of oxygen concentrators (OCs). Various factors that determine the efficacy of such a treatment were evaluated. Sixty-three patients, arbitrarily selected from lists of health care providers, were visited at home by a biomedical engineer and a pulmonary function technician. The evaluation consisted of: i) responses to a directed questionnaire, ii) assessment of the OC output characteristics, and iii) measurement of the patient's oxygen saturation (SaO2) at rest with and without oxygen supplement. Only 33% of patients received oxygen treatment for the recommended 12-24 hours/day and 5% of patients waited the recommended 10 minutes of OC warm-up before connection. Filters were cleaned weekly by only 30% of patients and the concentrator was serviced 3-4 times a year in 25% of cases. The OC was thought to be unduly noisy by 24% of patients and connecting tubing of less than 6 meters was fitted to 90% of OCs, thereby limiting patient mobility. Most of the OCs did not yield the recommended oxygen concentration and the flow rate meters on them tended to underread. Therefore, only 22% of patients received the prescribed oxygen supplement. Whilst breathing room air, a substantial proportion of patients had an SaO2 >90%. Improvements are clearly required in terms of medical indications for LTOT, patient education and supervision, supply and maintenance of concentrators and related equipment.

Home Care Services↗

19 mm sized bileaflet valve prostheses' flow field investigated by bidimensional laser Doppler anemometry (part I: velocity profiles).

The investigation of the flow field downstream of a cardiac valve prosthesis is a well established task. In particular turbulence generation is of interest if damage to blood constituents is to be assessed. Several prosthetic valve flow studies are available in literature but they generally concern large-sized prostheses. The FDA draft guidance requires the study of the maximum Reynolds number conditions for a cardiac valve model to assess the worst case in turbulence by choosing both the minimum valve diameter and a high cardiac output value as protocol set up. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, the Laboratory of Biomedical Engineering is currently conducting an in-depth study of turbulence generated downstream of bileaflet cardiac valves. Four models of 19 mm sized bileaflet valve prostheses, namely St Jude Medical HP Edwards Tekna, Sorin Bicarbon, and CarboMedics, were studied in aortic position. The prostheses were selected for the nominal annulus diameter reported by the manufacturers without any assessment of the valve sizing method. The hemodynamic function was investigated using a bidimensional LDA system. Results concern velocity profiles during the peak flow systolic phase, at high cardiac output regime, highlighting the different flow field features downstream of the four small-sized cardiac valves.

Aortic Valve↗

19 mm sized bileaflet valve prostheses' flow field investigated by bidimensional laser Doppler anemometry (part II: maximum turbulent shear stresses)

The investigation of the flow field generated by cardiac valve prostheses is a necessary task to gain knowledge on the possible relationship between turbulence-derived stresses and the hemolytic and thrombogenic complications in patients after valve replacement. The study of turbulence flows downstream of cardiac prostheses, in literature, especially concerns large-sized prostheses with a variable flow regime from very low up to 6 L/min. The Food and Drug Administration draft guidance requires the study of the minimum prosthetic size at a high cardiac output to reach the maximum Reynolds number conditions. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, an in-depth study of turbulence generated downstream of bileaflet cardiac valves is currently under way at the Laboratory of Biomedical Engineering of the Istituto Superiore di Sanita. Four models of 19 mm bileaflet valve prostheses were used: St Jude Medical HP, Edwards Tekna, Sorin Bicarbon, and CarboMedics. The prostheses were selected for the nominal Tissue Annulus Diameter as reported by manufacturers without any assessment of valve sizing method, and were mounted in aortic position. The aortic geometry was scaled for 19 mm prostheses using angiographic data. The turbulence-derived shear stresses were investigated very close to the valve (0.35 D0), using a bidimensional Laser Doppler anemometry system and applying the Principal Stress Analysis. Results concern typical turbulence quantities during a 50 ms window at peak flow in the systolic phase. Conclusions are drawn regarding the turbulence associated to valve design features, as well as the possible damage to blood constituents.

Aortic Valve↗

Kinematic characterization of wheelchair propulsion.

Rehabilitation scientists and biomedical engineers have been investigating wheelchair propulsion biomechanics in order to prevent musculoskeletal injuries. Several studies have investigated wheelchair propulsion biomechanics; however, few have examined wheelchair propulsion stroke patterns. The purpose of this study was to characterize wheelchair propulsion stroke patterns by investigating joint accelerations, joint range of motions, wheelchair propulsion phases, and stroke efficiency. Seven experienced wheelchair users (5 males, 2 females) were filmed using a three-camera motion analysis system. Each subject pushed a standard wheelchair fitted with a force-sensing pushrim (SMARTWheel) at two speeds (1.3 and 2.2 m/s). The elbow angle was analyzed in the sagittal plane, while the shoulder joint was analyzed in the sagittal and frontal planes. Three distinctly different stroke patterns: semi-circular (SC), single looping-over-propulsion (SLOP), and double looping-over-propulsion (DLOP), were identified from the kinematic analysis. Through our analysis of these patterns, we hypothesized that SC was more biomechanically efficient than the other stroke patterns. Future studies using a larger number of subjects and strokes may reveal more significant distinctions in efficiency measures between stroke patterns.

Biomechanical Phenomena↗

Synthesis and surface engineering of iron oxide nanoparticles for biomedical applications.

Superparamagnetic iron oxide nanoparticles (SPION) with appropriate surface chemistry have been widely used experimentally for numerous in vivo applications such as magnetic resonance imaging contrast enhancement, tissue repair, immunoassay, detoxification of biological fluids, hyperthermia, drug delivery and in cell separation, etc. All these biomedical and bioengineering applications require that these nanoparticles have high magnetization values and size smaller than 100 nm with overall narrow particle size distribution, so that the particles have uniform physical and chemical properties. In addition, these applications need special surface coating of the magnetic particles, which has to be not only non-toxic and biocompatible but also allow a targetable delivery with particle localization in a specific area. To this end, most work in this field has been done in improving the biocompatibility of the materials, but only a few scientific investigations and developments have been carried out in improving the quality of magnetic particles, their size distribution, their shape and surface in addition to characterizing them to get a protocol for the quality control of these particles. Nature of surface coatings and their subsequent geometric arrangement on the nanoparticles determine not only the overall size of the colloid but also play a significant role in biokinetics and biodistribution of nanoparticles in the body. The types of specific coating, or derivatization, for these nanoparticles depend on the end application and should be chosen by keeping a particular application in mind, whether it be aimed at inflammation response or anti-cancer agents. Magnetic nanoparticles can bind to drugs, proteins, enzymes, antibodies, or nucleotides and can be directed to an organ, tissue, or tumour using an external magnetic field or can be heated in alternating magnetic fields for use in hyperthermia. This review discusses the synthetic chemistry, fluid stabilization and surface modification of superparamagnetic iron oxide nanoparticles, as well as their use for above biomedical applications.

Animals↗