Search results
Results from the WOW.Com Content Network
an act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. ISO standards about medical devices and procedures provide examples of use errors, which are attributed to human factors, include slips, lapses and mistakes. Practically, this means that they are attributed ...
The complementary process that involves increase in quantities of cellular components is called upregulation. [ 1 ] An example of downregulation is the cellular decrease in the expression of a specific receptor in response to its increased activation by a molecule, such as a hormone or neurotransmitter , which reduces the cell's sensitivity to ...
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 ...
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
A design failure modes and effects analysis, DFMEA, is a structured qualitative analysis of a system, subsystem, device design to identify potential failure modes and their effects on correct operation. The concept and practice of performing a DFMEA, has been around in some form since the 1960s.
Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. [1] Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation.
This page was last edited on 17 January 2009, at 23:24 (UTC).; Text is available under the Creative Commons Attribution-ShareAlike 4.0 License; additional terms may apply.
Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...