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The dose rate at one meter from the source was 4.56 grays per hour (456 rad·h −1). While the serial number of the device was unknown, hindering the ability to verify its identity, the device was thought to have been made in the U.S. at Oak Ridge National Laboratory as a radiation source for radiation therapy at the Goiânia hospital. [1]
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Each Holter system has hardware (called monitor or recorder) for recording the signal, and software for review and analysis of the record. There may be a "patient button" on the front that the patient can press at specific instants such as feeling/being sick, going to bed, taking pills, marking an event of symptoms which is then documented in the symptoms diary, etc.; this records a mark that ...
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]
A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed. Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. The facilities must also report ...
Some of the passed fragments of a 1-cm calcium oxalate stone that was smashed using lithotripsy. The most common use of extracorporeal shockwave therapy (ESWT) is for lithotripsy to treat kidney stones [3] (urinary calculosis) and biliary calculi (stones in the gallbladder or in the liver) using an acoustic pulse.
The halo device itself was invented in the 1960s by doctors working at the Rancho Los Amigos hospital. [7] [8] [9] Their work was published in a paper entitled "The Halo: A Spinal Skeletal Traction Fixation Device." [10] The clinician Pierre Stagnara utilized the device to develop Halo-Gravity traction. [11] [12] [13]