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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.
Despite the medical advances of detection, diagnosis and treatment methods throughout the past 50 years, lung cancer causes more deaths than any other cancer in both men and women. [5] Currently, lung cancer is the most common form of cancer diagnosed in the United States and a major cause of death, accounting for 14% of all cancers.
The LUCAS device delivers high-quality compressions at a continuous rate, while up to a third of manual compressions can be incorrect. [9] In 2013, a 68-year-old male made a complete recovery, including no intellectual or neurological deficits, after an out-of-hospital cardiac arrest after 59 minutes of mechanical compressions on a LUCAS device.
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
An inspiratory impedance threshold device is a valve used in cardiopulmonary resuscitation (CPR) to decrease intrathoracic pressure and improve venous return to the heart. The valve is a part of a mask or other breathing device such as an endotracheal tube , and may open at high or low pressures (called "cracking pressures") [ citation needed ]
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).