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Standards

Mary Logan: We Need Science, not Scapegoats, in Sterility Assurance Debate

  • by AAMI
  • Posted on March 24, 2015November 2, 2018
  • Medical Device Industry

“How clean is clean enough?” has resurfaced as a pressing question in medical device reprocessing because of national media coverage of superbug outbreaks involving contaminated duodenoscopes. While the intense media interest is new, the issue […]

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Eamonn Hoxey: How Can We Prepare Standards More Effectively?

  • by AAMI
  • Posted on December 19, 2014December 19, 2014
  • Medical Device Industry

This year, I have been participating in the revision of three standards of differing size, scope, and extent of use: ISO 9001, the generic standard for quality management systems to which over one million companies […]

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Lisa Simone and Daniel Rubery: A Tower of Babel with Medical Device Software Failures

  • by AAMI
  • Posted on October 10, 2014October 10, 2014
  • Healthcare IT

Another set of health information is compromised, another medical device unexpectedly reboots, another set of patient data results is mixed up, another device fails to perform as intended. News stories bring us reports of medical […]

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William Hyman: Beep, Beep

  • by AAMI
  • Posted on April 21, 2014November 2, 2018
  • Healthcare IT

There was an interesting thread recently on the listserv for the National Patient Safety Foundation on whether medication barcode readers should beep (or make some other noise) when read. Such systems are typically part of […]

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Jennifer Moyer: Five Tricks to Help You ‘Set Standards’

  • by AAMI
  • Posted on April 8, 2014
  • Standards

As a healthcare technology professional, you can play a major role in creating the AAMI standards that pertain to a growing list of medical devices and equipment. Here’s how: 1. Select your area of expertise. […]

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Dave Osborn: Standards Live Forever

  • by AAMI
  • Posted on October 8, 2013October 8, 2013
  • Standards

The distance between the rails of U.S. standard gauge railroads is 4 feet 8 ½ inches. This distance is a rather strange number. For you metric fans, the equivalent 1.4351 meters is an even stranger number. […]

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John G. Abbott: Standards Travel—Junket or Jetlag?

  • by AAMI
  • Posted on September 11, 2013September 18, 2013
  • Regulations

As those who have worked in standards development know, one of the most difficult facets of participation in standards meetings has nothing to do with the actual process of negotiating consensus and writing text.  Rather, […]

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Leighton Hansel: Despite Criticism, U.S. Regulation of Medical Devices Is a Success

  • by AAMI
  • Posted on May 28, 2013May 28, 2013
  • Regulations

In recent years, the FDA’s premarket notification process has been challenged as an ineffective tool for assuring that safe and effective devices enter the marketplace. That criticism, however, is too broad and fails to recognize […]

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Scott A. Colburn: Conference Focuses on International Standards, Regulations

  • by AAMI
  • Posted on March 21, 2013March 21, 2013
  • Standards

Gathering in Herndon, VA, AAMI and the U.S. Food and Drug Administration kicked off their 23rd  conference on medical device standards and regulation. This year, attendees have the opportunity to hear from key leaders such […]

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Dave Osborn: Sounding the Alarm at Standards Week

  • by AAMI
  • Posted on December 7, 2012November 2, 2018
  • Patient Safety

The new AAMI Alarms Committee met during Standards Week in Daytona. This committee was formed following the AAMI/FDA Alarms Summit. The energy created by the summit has propelled the committee forward, working both in the […]

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