The advent of cervical intervertebral disc replacement represents an exciting and new frontier in the treatment of myelopathy and discogenic pain. The goal of most disc arthroplasty designs is to attempt to approximate the normal spinal motion as much as possible. This survey article provides a general overview as to ...

A patent is a legal device that grants an inventor market exclusivity over a new invention or medication. Market exclusivity can mean tremendous economic rewards for the patent holder because it provides the inventor with a monopoly over the invention for the 20-year patent term. Obtaining a patent and retaining ...

In keeping with its mandate to provide the least burdensome means of product regulation, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of medical devices. The benefits of using standards in this manner include ...

We have developed the suspended-load backpack, which converts mechanical energy from the vertical movement of carried loads (weighing 20 to 38 kilograms) to electricity during normal walking [generating up to 7.4 watts, or a 300-fold increase over previous shoe devices (20 milliwatts)]. Unexpectedly, little extra metabolic energy (as compared to ...

Imiquimod, an imidazoquinoline amine, is an immune response modifier first FDA-approved for the treatment of external genital and perianal warts in 1997. Since its appearance on the market, its antiviral and antitumor properties have been used in the treatment of a variety of dermatologic conditions. In this review article, the ...

The pressurized metered-dose inhaler (pMDI) was introduced to deliver asthma medications in a convenient and reliable multi-dose presentation. The key components of the pMDI device (propellants, formulation, metering valve, and actuator) all play roles in the formation of the spray, and in determining drug delivery to the lungs. Hence the ...

By its very definition, efficacy's meanings remain fluid, their particularities contingent on context. The change seen as significant may occur on a symbolic level or through the removal of physical symptoms. It may address conditions of a social body. Some discussions differentiate between "healing" and "curing." Many of these meanings ...

This interim final rule conforms our regulations to section 302(a)(2)(E)(iv) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). This rule defines the term power mobility devices (PMDs) as power wheelchairs and power operated vehicles (POVs or scooters). It sets forth revised conditions for Medicare ...

The risk assessment of di(2-ethylhexyl) phthalate (DEHP) that migrated from polyvinyl chloride (PVC) medical devices is an important issue for hospitalized patients. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags was hydrolyzed by esterase to mono(2-ethylhexyl) ...

Elevated intracranial pressure (ICP) is a major factor associated with incidences of morbidity and mortality in patients with neurological disorders. The use of conventional methods for ICP monitoring is currently limited to patients with severe neurological conditions because of the methods' invasive nature. The authors have developed an ultrasonic device ...

Hydrophobins are self-assembling proteins of fungal origin. Their ability to self-assemble into an amphipathic membrane is of interest for many different applications, ranging from medical and technical coatings to the production of proteinaceous glue and cosmetics. Assembled hydrophobins can modify surface characteristics, thus controling the binding properties of the surface; ...

Partitioning of PCDD/F (polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofuran) congeners between gaseous and particulate phases and removal efficiencies of the existing air pollution control devices (APCDs) for PCDD/Fs at two large-scale municipal waste incinerators (MWIs) in Taiwan are evaluated via stack sampling and analysis. Two MWIs investigated are equipped with activated ...

FDA oversight of medical devices, including in vitro diagnostic devices (IVDs or laboratory tests), in the United States was a direct result of the passage of the Medical Device Amendments of 1976. This law introduced a series of general controls for medical devices including registration and listing, requirements for production ...

The current system of postmarketing surveillance of high-risk medical devices could be improved by taking advantage of the administrative billing data collected by the Centers for Medicare and Medicaid Services (CMS) to systematically monitor for adverse events that may signal device-related problems. In this paper we use the current concern ...

Circumcision is one of the commonest operations performed throughout the world for ritual, traditional or medical reasons. Self-circumcision may lead to disastrous complications. There have been reports of the complications following use of the constricting devices for improved sexual performance and for auto-erotic intentions, but cases of self-circumcision leading to ...

The biocompatibility of medical implants dictates the fate of almost all medical devices. It is well established that medical devices trigger a variety of adverse tissue responses, such as inflammation, fibrosis, infection and thrombosis. However, the mechanisms involved in biomaterial-mediated tissue responses remain largely unknown. The lack of such knowledge ...

The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals ...

This gallery of medical devices illustrates a multitude of common devices in the head, neck, spine, chest, and abdomen that are found in daily radiologic practice (orthopedic devices for the extremities and pelvis were illustrated in Part 1). All these medical devices have been more thoroughly discussed in the previous ...

In Germany, pharmaceutical trials and the testing of medical devices is regulated by statute. Any other kind of medical experimentation is handled according to the Declaration of Helsinki. Medical experimentation has to be reviewed by an ethics committee before the start and there has to be an elaborate research protocol, ...

Demand for development of new generation medical devices has led many governments to support medical-sector research. In the United Kingdom, the Medical Devices Faraday Partnership was created to establish a collaborative network that would enhance the transfer of good ideas into new products and processes. The services it offers medical ...

Vivian Ebsary was an inventor, designer and manufacturer of varied pieces of medical equipment, particularly those involving pumps. These included hypothermia machines and the heart-lung cardiopulmonary bypass machines used in Australian and New Zealand hospitals from the mid 1950s until well into the 1970s. Ebsary also designed and manufactured anaesthetic ...

Consolidation in the medical device industry has reduced the major players in each sector to three. While some laud the trend, saying one supplier can bundle products at a deep discount to hospitals, others say savings are often illusory. Cook Group President Kem Hawkins, left, sees the amalgamation as the ...

The evaluation of medical devices in the UK has been through many changes since the early hospital equipment assessments in the 1960s. The range of medical devices evaluated has increased and the evaluation reports published have changed, but the evaluation programme continues to be a respected service for the NHS ...

Hemostasis remains the major challenge in laparoscopic partial nephrectomy (LPN). The TissueLink Floating Ball (TissueLink Medical, Inc., Dover, NH), a high-density monopolar saline-cooled radiofrequency device, is an effective coagulation and dissection device to aid in LPN. Our porcine laboratory model and human clinical experience have shown the device capable of ...

Current technology introduces many new vascular and nonvascular devices to the medical field. With the assistance of these devices, patients can be offered many more diagnostic tests and therapeutic treatments that aid in the diagnosis and treatment of diseases. As with any new infusion technology, these devices can be associated ...

Porphyrins and fullerenes are spontaneously attracted to each other. This new supramolecular recognition element can be used to construct discrete host-guest complexes, as well as ordered arrays of interleaved porphyrins and fullerenes. The fullerene-porphyrin interaction underlies successful chromatographic separations of fullerenes, and there are promising applications in the areas of ...

When various companies are involved in the manufacture and export of medical devices to the United States (U.S.), it is not always easy to understand the reporting responsibilities under the U.S. Medical Device Reporting regulation. A new rule has been published to help companies better understand the requirements. This article ...

Heard of Section 731 of the Medicare Modernization Act? The provision, meant to clear up the generally murky and unwieldy Medicare reimbursement approval process, could quicken the national approval process for medical procedures and devices. The changes will create a more definable approach to OK'ing new technologies. "I like the ...

BACKGROUND: Flexible meniscus repair devices are designed to combine the benefits of rigid all-inside meniscus anchors with the biomechanical properties of sutures. HYPOTHESIS: Stiffness and pull-out strength of flexible all-inside suture anchors and conventional sutures under cyclic loading conditions will be comparable. STUDY DESIGN: Controlled laboratory study. METHODS: In 50 ...

Medical devices in the abdomen and pelvis are probably less frequently seen than those in the chest or extremities, but they are important and should be recognized. These devices can be grouped into a few major categories: intestinal tubes, genitourinary devices, postoperative apparatus, and a wide variety of odds and ...

PURPOSE: Stainless steel suture is high in tensile strength but is not widely used in flexor tendon repair because of difficulty with handling and knot tying. The purpose of this study was to examine the biomechanical characteristics of the single-strand multifilament stainless steel Teno Fix device (Ortheon Medical, Winter Park, ...

The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue ...

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they ...

Some of the recent advances in the field of biosensors for nucleic acid analysis in medical diagnostic applications are highlighted. Particular attention is paid in this review to the progress made in two key areas of development: (i) enhancements achieved in device selectivity, and (ii) enhancements achieved in device sensitivity.

It cannot be overemphasized that a piece of electrical equipment is not capable of replacing a vigilant, well-trained clinician. As monitoring devices become more sophisticated, the potential for artifact or misinterpretation increases. When applied appropriately, operated properly, and interpreted correctly, however, the monitors afford the patient the best possible outcome.

This study investigates the emissions of polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) from four electric arc furnaces (EAFs) and eight secondary aluminum smelters (secondary ALSs) in Taiwan. The mean PCDD/F International-Toxicity Equivalents (I-TEQ) concentrations in the stack gases of these EAFs and secondary ALSs are 0.28 ng I-TEQ/Nm3 (relative ...

Through the past decades, new medical devices have been introduced at an increasing pace at the urge primarily of manufacturers, clinicians, and patients. Whereas it is mandatory to assess and approve new pharmaceuticals before their widespread use is allowed, innovations in medical devices generally have not been subject to the ...

In this study, we show how medical devices used for patient care can be made safer if various cognitive factors involved in patient management are taken into consideration during the design phase. The objective of this paper is to describe a methodology for obtaining insights into patient safety features--derived from ...

The purposes of this study were to determine whether registered nurses are familiar with the Health Canada Medical Device Problem Report Form, and if so, how often they use it to report problems and concerns compared to how often they experience problems and concerns with medical devices. A survey was ...

This chapter describes a software process improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of ...

The URSafe project (IST-2001-33352) aims at creating a telemedicine care environment for the elderly and convalescent. The idea is to provide a portable device which monitors autonomously different biomedical signals and is able to send an alarm to a medical center if an abnormality is detected. In the initial version ...

The formulation of a Personal Area Network (PAN), consisting of a wireless infrastructure of medical sensors, attached to patient's body, and a supervising device carried by them, lays the path for continuous and real-time monitoring of vital signs without discomforting the person in question. This infrastructure enhances the context of ...

This work reports on a new and simple method to locate and track the medical robotic device based on the static magnetic field and Hall effort sensor array. In the design, we established a experimental platform based on the static magnetic field and Hall effect sensor array. The platform includes ...

The problem of medical devices and data integration in health care is discussed and a proposal for remote monitoring of patients based on recent developments in networking and data management is presented. In particular the paper discusses the benefits of the integration of personal medical devices into a Medical Information ...

Databases of medical devices were identified via complex search strategies to discover breadth and depth of coverage. The databases could be categorised into three types: Product, Business and Regulation. Evaluation of the databases uncovered several issues including: lack of continuity relating to the level of information provided; and little or ...

Hospitals and manufacturers are designing and deploying the IEEE 802.x wireless technologies in medical devices to promote patient mobility and flexible facility use. There is little information, however, on the reliability or ultimate safety of connecting multiple wireless life-critical medical devices from multiple vendors using commercial 802.11a, 802.11b, 802.11g or ...

Wearable medical devices can provide both continuous monitoring and ubiquitous treatment. Challenges in this area include the need for a low-power/power-saving design to extend battery life and to reduce the size of the battery itself. This is followed by size and weight restrictions to meet patient expectations of what is ...

This paper presents a photoplethysmography sensor based on a heart rate monitor for a portable MP3 player. Two major design issues are addressed: one is to acquire the sensor signal with a proper amplitude despite a wide range of variation and the other is to handle the noise contaminated signal ...

In certain cases, the evaluation and correct identification of resuscitative artifacts is critical to the correct diagnosis and determination of the cause and manner of death. Resuscitative artifacts can resemble homicidal or accidental injury and thus possibly be misinterpreted. Occasionally, new technologies and/or medical procedures will create original and/or distinctive ...

The current status and future directions of mechanical circulatory support devices (MCSDs) in Japan are reviewed. Currently used clinical MCSDs, both domestic and imported systems and continuous flow devices that are coming into the clinical arena are emphasized. Clinical MCSDs include the extracorporeal pulsatile Toyobo and Zeon systems and the ...