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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 ...
cite journal}}: CS1 maint: multiple names: authors list : Auvard's speculum: Alfred Auvard: Gynaecology: vaginal speculum [4] Luer taper, Luer lock: Hermann Wülfing Luer: General use: Fitting to ensure leak-free connection in medical fluid administration systems [5] Penrose drain: Charles Bingham Penrose: Surgery
Single-use medical devices include any medical equipment, instrument or apparatus having the ability to only be used once in a hospital or clinic and then disposed. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [ 1 ]
The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. [88] [89] [90] Most AI/ML devices focus upon radiology. As of 2020, there was no specific regulatory pathway for AI/ML ...
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
BioXensor had not received regulatory approval as of June 2023. Haifa, Israel-based company HAGAR completed a study of its GWave non-invasive CGM, reporting high accuracy. This sensor uses radiofrequency waves to measure glucose levels in the blood. [64] The device had not received regulatory approval anywhere as of August 2023.
It was the first FDA approved nasally administered, ready-to-use medication used to reverse the effects of an opioid overdose. [14] Narcan does not require any assembly, medical training, or needle injection. [15] In 2016, Aptar entered into an agreement with Becton Dickinson & Company to develop new self-injection devices. [16] [17]