Due to increasing integration and reliability of modern medical devices, based on the situation of China, the new framework for medical equipment management must be explored. The new system involves not only in-house and manufacturer, but also the third parties. Compared with the original concept, the 6-year-long exploration of the ...

The newly developed pump is a magnetically levitated centrifugal blood pump in which active and passive magnetic bearings are integrated to construct a durable ventricular assist device. The developed maglev centrifugal pump consists of an active magnetic bearing, a passive magnetic bearing, a levitated impeller, and a motor stator. The ...

The use of styrenic block copolymers has undergone a renaissance as a biomaterial and drug delivery matrix. The early promise posed by the physical and biological properties of these block copolymers for implantable medical devices was not met. However, there has been an increased understanding of the role of microphase ...

Recent advances in mobile computing technologies have made electronic medical records(EMRs) on handheld devices an attractive possibility.However, data entry paradigms popular on desktop machines do not translate well to mobile devices 1,2. Based on a review of the literature on mobile device usability 1-4,we built a prototype user interface for ...

Safe use of medical devices is a comprehensive concept with its technical integration. It includes not only its procedural operations but also its vigilance to patient status, correct installation of device, proper user's education and training, appropriate device maintenance, user facility compatibility, and acceptable interference from environment. Consequently, in technology ...

Older adults and people with physical disabilities can get Medicare coverage for mobility devices, like wheelchairs, walkers, and scooters, which are necessary for use in their homes. However they cannot get coverage for mobility devices that are solely for functioning outside their home. Since the institution of Medicare's coverage standards ...

Two days before the first ascent of Mt. Everest in 1953, Tom Bourdillon and Charles Evans climbed to within 90 m of the summit at unprecedented speeds. By breathing pure oxygen from a closed circuit, the pair were able to obtain an enormous physiological advantage. Unfortunately, due to a malfunction ...

This paper briefly reports on preparations and applications of two kind multipurpose medical piezoelectrical ultrasonic transducer materials, high-performance medical ultrasonic diagnosis transducers and medical ultrasonic therapy transducers in present work, then, some problems of the piezoelectric materials and devices used for the ultrasonic medicine which need further researches are pointed ...

Neuromuscular incapacitation (NMI) devices discharge a pulsed dose of electrical energy to cause muscle contraction and pain. Field data suggest electrical NMI devices present an extremely low risk of injury. One risk of delivering electricity to a human is the induction of ventricular fibrillation (VF). We hypothesized that inducing VF ...

A method of ranking devices for replacement has been successfully trialled at Flinders Medical Centre (FMC). Software developed by Flinders Biomedical Engineering (see www.fbe.org.au) has been distributed to a network of device managers throughout FMC for the entry of easily determined parameters which relate to the likelihood of a device ...

Two factors are driving a new wave of medical products. The first is the use of technology to make products "intelligent"--that is, build them not only to measure a particular parameter, like blood glucose, but to help patients and caregivers manage conditions. This allows the users of these products focus ...

Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of ...

By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device ...

The Food and Drug Administration (FDA) is classifying newborn screening test systems for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Newborn Screening ...

The National Institute of Standards and Technology (NIST) polyethylene-encapsulated 226Ra/222Rn emanation (PERE) standards (old SRM 4968 and new SRMs 4971, 4972, and 4973) provide precise radon emanation rate, certified to a high degree of accuracy (approximately to 2%). Two new SRM 4973 standards containing totally 1036 Bq (0.028 microCi) of ...

Companies preparing United States (US) premarket submissions should be aware of a US policy that may save them time and money. This policy allows the grouping or "bundling" of multiple devices or multiple indications for use in a single submission. This article discusses this policy and a US guidance document ...

Two devices that facilitate the use of the Minnesota tube (C. R. Bard, Covington, GA) are described in this article. One device is the Lopez enteral valve (ICU Medical, San Clemente, CA), a three-way stopcock-like device that facilitates inflation of the gastric balloon with air, as measured by a 60-mL ...

Case report of an unusual use of AMS 800 (American Medical Systems, Inc., Minnetonka, Minnesota) artificial urinary sphincter cuff in a female patient affected by neurogenic urinary incontinence. To describe this rare surgical solution. Department of Urology in Italy. A 43-year-old woman affected by flaccid paraplegia, acontractile bladder and incompetent ...

BACKGROUND: The true public health burden of adverse events associated with medical devices is unknown. The purpose of this study, therefore, was to produce the first-ever national estimates of medical device-associated adverse events resulting in emergency department (ED) visits. METHODS: From July 1999 through June 2000, reports of 10,395 medical ...

A new Canadian standard (CAN/CSA/Z264.1-02:2002) has been published with the purpose of helping to ensure the safety, efficacy and functionality of spacers and/or holding chambers. They are prescribed for use by spontaneously breathing patients for the treatment of various respiratory diseases where medication is delivered to the lungs using pressurized-metered ...

"No one has advanced a just and logical reason why reward for service to the public should be extended to the inventor of a mechanical toy and denied to the genius whose patience, foresight, and effort have given a valuable new [discovery] to mankind" (Katopis CJ. Patents v patents: policy ...

Inadequate subject enrollment represents a significant obstacle during a medical device clinical investigation. It can lead to costly delays and jeopardise the success of an entire device development project. This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met.

Inner ear medical therapy has been gaining increasing popularity during the last 2 decades. Despite the increased use of this therapy,basic questions regarding this type of treatment have not been answered. The authors have used a variety of sustained-release devices in the laboratory to begin to answer some of these ...

The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan." The agency is taking this ...

A new automatic device for recording the host-seeking behavior of mosquitoes was designed using photoelectric sensors. The host-seeking rhythms of several species of mosquitoes were recorded under laboratory conditions. Use of CO2, in addition to heating and black color to activate mosquito flight, proved to be important for evaluation of ...

OBJECTIVES: We assessed the clinical utility of hand-carried cardiac ultrasound (HCU) devices to assist physicians in the diagnosis of cardiovascular disease. MATERIALS AND METHODS: We reviewed 42 articles published from 1978 to 2004. RESULTS: The capability and simplicity of the HCU device assist physicians in the diagnosis of cardiovascular disease ...

Dystonia is a movement disorder characterized by involuntary muscular contractions that generate twisting and repetitive movements and/or abnormal postures. It can affect a few muscle groups (focal dystonia) or spread to most muscles in the body (generalized dystonia). While botulinum toxin injections can be successfully used to treat focal dystonias, ...

In the aftermath of a genocidal civil war, the Government of Cambodia is left with major deficiencies in its healthcare system. This article recounts a military medical mission to Cambodia; the authors describe the objectives of the mission and provide a summary of the lessons learned. Specific areas of concern ...

OBJECTIVE: To conduct a systematic review of studies on clinically relevant digital mobile phone electromagnetic interference with medical equipment. DATA SOURCES: MEDLINE and SUMSEARCH were searched for the period 1966-2004. The Cochrane Library and Database of Abstracts of Reviews of Effects were also searched for systematic reviews. STUDY SELECTION: Studies ...

Spirotox is a short-term acute toxicity test with a large ciliated protozoan Spirostomum ambiguum. The test was created in the Department of Environmental Health Sciences, Medical University of Warsaw, Poland, during the early 1990s. It was presented for the first time during the 6th International Symposium on Toxicity Assessment, in ...

OBJECTIVE: To define the possible effects of gastric electrical stimulation (GES) for gastroparesis on pancreatic function, we performed 2 related human studies. METHODS: Fecal elastase values were compared in 2 patient groups: (1) GES devices ON and (2) GES devices OFF and (2) in 3 control groups: (1) no response ...

This study compared the efficacy and costs of the most used approaches for percutaneous closure of large patent ductus arteriosus, that is, multiple coils and the Amplatzer duct occluder (ADO) device. From April 2000 to September 2003, 47 patients underwent closure of large, symptomatic patent ductus arteriosus (diameter 4.6 +/- ...

Clinicians caring for cardiac device patients with implanted pacemakers or cardioverter defibrillators (ICDs) are frequently asked questions by their patients concerning electromagnetic interference (EMI) sources and the devices. EMI may be radiated or conducted and may be present in many different forms including (but not limited to) radiofrequency waves, microwaves, ...

A new technique using a marking needle (Accura; Medical Device Technologies, Gainesville, FL) placed under ultrasonographic guidance preoperatively in a calcific deposit in the rotator cuff of the shoulder is described. When standard subacromial bursoscopy is performed, the needle is visualized in the bursa and followed to its position in ...

BACKGROUND: In Europe, several filler devices are currently on the market for use in aesthetic dermatology and some of them cause severe, permanent, adverse reactions. Since 1996 a non-animal stabilized hyaluronic acid (NASHA) from Q-Medical, Sweden, has been introduced and is becoming a leading product in aesthetic dermatology. Hyaluronic acid ...

Parts 18 and 19 of ISO 10993, Biological Evaluation of Medical Devices, currently in draft, are receiving even more emphasis as they become an integral part of the biological safety evaluation of biomaterials and medical devices. An important step in this process is the characterisation of the material and identification ...

Carbadox cannot be used in food-producing animals within the European Union following the adoption of Commission Regulation EC 2788/98/EC. Monitoring of the longest remaining residue--quinoxaline-2-car-boxylic acid (QCA)--is the most effective way of enforcing the prohibition on its use. The study was under taken to determine if QCA could be passed ...

In this study we developed a model lung to compare the effectiveness of ventilation using four different cricothyrotomy devices. The Ravussin 13G cannula (VBM Medical), the Quicktrach cannula 4 mm ID (VBM Medical), the Melker cannula 6 mm ID (Cook) and a cuffed tracheal tube 6 mm ID were used ...

A range of factors needs to be considered when choosing a microporous membrane for a medical device application. In addition to the composition and performance characteristics of the membrane, engineers should also evaluate potential suppliers for their quality systems, support capabilities, general financial strength and commitment to manufacturing the product. ...

Detergent-disinfecting agents (dD) are used daily for cleaning reused medical devices. We have devised a simple method to test dD detergent activity (DA) using an E. coli 54127 biofilm prepared in haemolysis glass tubes, which are cleaned with test dD, according to supplier's recommendations. Crystal violet 0.05% is used to ...

OBJECTIVE: To assess the spread of automated external defibrillators and their use by non-medical first responders in Finland. METHODS: A structured survey was mailed to all voluntary and ordinary fire brigades in Finland. The questions were related to the purchase, experience of use and anticipated benefits from the devices. RESULTS: ...

The Food and Drug Administration (FDA) is classifying the Immunomagnetic Circulating Cancer Cell Selection and Enumeration System device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration ...

An editorial just published in Naturel draws attention to a profound issue concerned with the risks associated with the introduction of new technologies into medical practice. The risks are derived from the way in which genes are delivered, and central to the solutions to these problems may be some innovative ...

Far too many medical device companies are failing to reap the benefits of an effective risk management programme. Thus, patients, users and the companies themselves are continuing to suffer the consequences of device problems that could have been identified and resolved before products are placed on the market. This article ...

Xenogeneic extracellular matrix (ECM) can be harvested and configured to function as a bioscaffold for tissue and organ reconstruction. The mechanical properties of the ECM vary depending upon the tissue from which it is harvested. Likewise, the manufacturing steps required to develop ECMs into medical grade devices will affect the ...

An experienced intensivist performed an emergency endotracheal intubation on a 72-year-old woman without difficulty. The vocal cords were visualized during the intubation. An esophageal detector device was used to confirm correct airway placement. After aspiration of the device, it was impossible to easily ventilate the patient. The endotracheal tube was ...

In France, endoscope maintenance regulations present some particularities in terms of the definitions and texts referring to the disinfection and sterilization of medical devices, with respect to the prion risk. The main measures specified are a double cleaning prior to disinfection, with some stipulations concerning the procedure itself, such as ...

OBJECTIVE: To verify the accuracy of a new hand-held metabolic rate measuring device (MedGem) in quantifying postprandial energy expenditure (PP EE). MedGem measurements were compared to measurements obtained with a conventional indirect calorimeter (Delta-Trac). RESEARCH METHODS AND PROCEDURES: The resting metabolic rate of 15 healthy subjects was measured for 20 ...

Biomaterials have played an enormous role in the success of medical devices and drug delivery systems. We discuss here new challenges and directions in biomaterials research. These include synthetic replacements for biological tissues, designing materials for specific medical applications, and materials for new applications such as diagnostics and array technologies.

A lost intrauterine device (IUD) is an uncommon event. Recently, a new levonorgestrel-releasing intrauterine system was introduced. In view of several cases of an unusual diagnostic discrepancy in the location of a lost levonorgestrel-releasing IUD in our department, we sought to determine if the extrauterine location of lost levonorgestrel-releasing IUDs ...