Sometimes the dividing line between regulation and flexibility can be unclear. Somewhere in the middle of the life cycle for new innovations, there exists a period of time when innovation slows and a crystallization of […]
“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 […]
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 […]
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 […]
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 […]
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. […]
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. […]
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, […]
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 […]
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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