Equipment standards: history, litigation, and advice.
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The authors present a concise history of the development of national and international standards for surgical equipment. Standards-writing organizations, surgical and other specialty societies, universities, test houses, and the U.S. government have influenced this process, which is now manifested in complex interactions between national and international standards-writing organizations, and in CE (Conformite Europeene) marks being placed on surgical equipment in the United States and elsewhere. The history of litigation in standards development is also reviewed. Recommendations to maximize patient safety and to help ensure successful, cost-effective defense in litigation for surgeons who use equipment and may suffer its malfunctions are given. Overall, the complicated oversight of surgical equipment standards and the approval process appears to be contributing to the improving and outstanding results of U.S. surgery reported by the U.S. government. (+info)
Cranionavigator combining a high-speed drill and a navigation system for skull base surgery--technical note.
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Drilling of the skull base bone without damaging the important inside structures and with the correct orientation is very difficult even with the help of the anatomical landmarks. Monitoring of the location and direction of the drill tip and indications of the removed part of the bone during the drilling procedure enhances safety and achieves less invasive neurosurgery. We have developed a novel cranionavigator by combining a high-speed drill with a neurosurgical navigation system. To reduce the positional error to less than 1.5 mm, the position sensor (magnetic field sensor) must be attached 5 cm from the metallic fan portion of the drill and the sensor kept at least 10 cm away from the operating microscope. Simulation studies with the cranionavigator using two dried skulls and three cadaver heads were performed before clinical application. Clinically, this surgical instrument was used in four patients with the skull base tumor. The cranionavigator helped to safely drill the skull base bone in a shorter time by dynamic and real-time display of the precise operating site and extent of bone drilling on the preoperative computed tomography scans or magnetic resonance images. The cranionavigator is a very helpful instrument for skull base surgery in the hands of neurosurgeons with extensive expertise and anatomical knowledge. (+info)
Prevention of skin and soft tissue entrapment in tibial segment transportation.
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We report of a ten year old patient with soft tissue damage and bone defect of the tibia as a sequel of osteomyelitis. After excision and stabilization with an Ilizarov fixateur segment transportation was started. In order to avoid skin and soft tissue entrapment in the docking region, we used a metal cage as a space provider, which was shortened as segment transportation progressed. To our knowledge this simple method has not been described so far. (+info)
Preparing to perform an awake fiberoptic intubation.
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Fiberoptically guided tracheal intubation represents one of the most important advances in airway management to occur in the past thirty years. Perhaps its most important role is in management of the anticipated difficult airway. This is a situation in which the dangers of encountering the life-threatening "can't intubate, can't ventilate" situation can be avoided by placement of an endotracheal tube while the patient is awake. Although skill at the procedure of endoscopy is obviously necessary in this setting, these authors hold that success or failure of the technique frequently depends on the adequacy of preparation. These measures include 1) pre-operative assessment of the patient; 2) careful explanation of what lies in store; 3) "setting the stage"; 4) preparing the equipment to be used; and 5) preparing the patient (antisialogue, sedation, application of topical anesthesia to the upper airway). If these preparatory measures are carried out meticulously, the likelihood of performing a successful and comfortable awake fiberoptic tracheal intubation is greatly increased. (+info)
Efficacy of navigation in skull base surgery using composite computer graphics of magnetic resonance and computed tomography images.
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The efficacy of a neurosurgical navigation system using three-dimensional composite computer graphics (CGs) of magnetic resonance (MR) and computed tomography (CT) images was evaluated in skull base surgery. Three-point transformation was used for integration of MR and CT images. MR and CT image data were obtained with three skin markers placed on the patient's scalp. Volume-rendering manipulations of the data produced three-dimensional CGs of the scalp, brain, and lesions from the MR images, and the scalp and skull from the CT. Composite CGs of the scalp, skull, brain, and lesion were created by registering the three markers on the three-dimensional rendered scalp images obtained from MR imaging and CT in the system. This system was used for 14 patients with skull base lesions. Three-point transformation using three-dimensional CGs was easily performed for multimodal registration. Simulation of surgical procedures on composite CGs aided in comprehension of the skull base anatomy and selection of the optimal approaches. Intraoperative navigation aided in determination of actual spatial position in the skull base and the optimal trajectory to the tumor during surgical procedures. (+info)
Medicare program; additional supplier standards. Health Care Financing Administration (HCFA), HHS. Final rule with comment period.
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This final rule establishes additional standards for an entity to qualify as a Medicare supplier for purposes of submitting claims and receiving payment for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). These regulations will ensure that suppliers of DMEPOS are qualified to provide the appropriate health care services and will help safeguard the Medicare program and its beneficiaries from any instances of fraudulent or abusive billing practices. (+info)
Surgical instruments and dressings: an information service.
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A regional information service on surgical equipment, instruments, and dressings is proposed that would be staffed by information scientists. It would appreciably reduce the time spent on administration and make the buying of equipment more efficient. Such a service could be extended to all health service staff. (+info)
URobotics--Urology Robotics at Johns Hopkins.
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URobotics (Urology Robotics) is a program of the Urology Department at the Johns Hopkins Medical Institutions dedicated to the development of new technology for urologic surgery (http://urology.jhu.edu/ urobotics). The program is unique in that it is the only academic engineering program exclusively applied to urology. The program combines efforts and expertise from the medical and engineering fields through a close partnership of clinical and technical personnel. Since its creation in 1996, the URobotics lab has created several devices, instruments, and robotic systems, several of which have been successfully used in the operating room. This article reviews the technology developed in our laboratory and its surgical applications, and highlights our future directions. (+info)