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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 ...
A multi-million-dollar company formed by two corporations merging in 2005; Vanguard Medical Concepts and Alliance Medical Corporation. Ascent has facilities in two locations where the reprocessing of medical devices is done, Phoenix, Arizona and Lakeland in Florida. It is transported and delivered across various states in North America ...
The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization and other actions on medical devices, equipment and consumables; for subsequent ...
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).
Autoclave tape is only a marker that steam and heat have activated the dye. The marker on the tape does not indicate complete sterility. A more difficult challenge device, named the Bowie-Dick device after its inventors, is also used to verify a full cycle. This contains a full sheet of chemical indicator placed in the center of a stack of paper.
Medisafe International is a United Kingdom-based company that develops and manufactures products in the field of surgical instrument reprocessing. In 1985, Medisafe introduced the Sonic Irrigation technology to the medical device market. [1]
This strong market position generates substantial cash flows that support shareholder returns. Turning to the specifics, the pharmaceutical giant offers investors a 4.3% dividend yield backed by a ...
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...