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Today, the Association for the Advancement of Medical Instrumentation (AAMI) announces the release of an industry standard that clarifies the issue. Since the 2014 CMS Survey & Certification Group letter allowing certain AEM activities, accrediting bodies and healthcare technology management (HTM) professionals have debated over compliance.
The Association for the Advancement of Medical Instrumentation (AAMI) is an organization for advancing the development, and safe and effective use of medical technology founded in 1965 by Robert D. Hall Jr. and Robert J. Allen, President and Vice President respectively of Tech/Reps, Inc. (a medical Instrumentation marketing firm in Needham, Massachusetts).
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 ...
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
The current state of the science regarding endoscope reprocessing is not clear, and several issues remain unresolved. To confirm standard practices, additional research is needed, including an evaluation of the best ways to store endoscopes, the proper frequency of replacing accessories such as water bottles and connecting tubes, as well as the ...
Ultrasound endoscope: Used to perform endoscopic ultrasound (EUS) Video capsule: Used to perform video capsule enteroscopy: Endoscopy snare: Used to perform polypectomy and endoscopic foreign body removal: Band ligator: Used to perform variceal band ligation: Sengstaken–Blakemore tube: Used in the management of bleeding esophageal varices ...
The global income of third party SUD reprocessing companies are estimated to be “$1.054 billion.” [9] The reprocessing company, Innovative Health’s vice president of marketing and public affairs, Lars Thording states, “Some devices cannot be used more than once due to material degradation, technical limitations and patient safety.
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.