AAMI Asks FDA to Clarify Standards Expectations
The Association for the Advancement of Medical Instrumentation (AAMI) reports that it has sought clarity on what considerations Food and Drug Administration (FDA) review staff would like the association and similar organizations to take into account during the standards development and revision processes.
The association made the request in written comments to draft guidance the agency issued in May on the appropriate use of voluntary consensus standards in premarket submissions. The draft guidance builds upon a document released in 2007, adding information on how applicants have used standards inappropriately in their premarket submissions.
In its comments, which generally welcomed the FDA’s revision, AAMI said that it would be helpful “to know more about ‘how’ standards are used incorrectly or inappropriately, so that AAMI can produce tools (e.g., checklists or guides) that make it easier for industry to know what they are doing incorrectly.”
To read further from AAMI, CLICK HERE.
Source: AAMI
Unmasking Vaccine Myths: Dr Marschall Runge on Measles, Misinformation, and Public Health Solutions
May 29th 2025As measles cases climb across the US, discredited myths continue to undercut public trust in vaccines. In an exclusive interview with Infection Control Today, Michigan Medicine’s Marschall Runge, PhD, confronts misinformation head-on and explores how clinicians can counter it with science, empathy, and community engagement.
Silent Saboteurs: Managing Endotoxins for Sepsis-Free Sterilization
Invisible yet deadly, endotoxins evade traditional sterilization methods, posing significant risks during routine surgeries. Understanding and addressing their threat is critical for patient safety.
Endoscopes and Lumened Instruments: New Studies Highlight Persistent Contamination Risks
May 7th 2025Two new studies reveal troubling contamination in both new endoscopes and cleaned lumened surgical instruments, challenging the reliability of current reprocessing practices and manufacturer guidelines.
From the Derby to the Decontam Room: Leadership Lessons for Sterile Processing
April 27th 2025Elizabeth (Betty) Casey, MSN, RN, CNOR, CRCST, CHL, is the SVP of Operations and Chief Nursing Officer at Surgical Solutions in Overland, Kansas. This SPD leader reframes preparation, unpredictability, and teamwork by comparing surgical services to the Kentucky Derby to reenergize sterile processing professionals and inspire systemic change.
