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The "A" in AAMI is for Ambitious
As I mentioned in last week's Healthmarket Digest, the agenda for AAMI Sterilization Standards meetings promised discussion of big issues. That, for sure, was the case. Most notable are three new initiatives: Standardized IFU's, Human Factors Engineering Principles in IFU's and Flexible Endoscope Reprocessing.
Writing the Cookbook for Cleaning IFU's
As part of their FDA submission, device manufacturers must include validated instructions for use (IFU's) for device reprocessing. This includes instructions for cleaning as well as terminal sterilization (or high-level disinfection). While there are standard cycles for sterilization, there really are not for cleaning. Of course, given the great diversity of surgical instruments in materials, design and function, cleaning will never be as uniform as sterilization. It is the consensus of the AAMI Workgroup 12, however, that it is possible to develop some standardized processes that similar devices could be validated to. A standard "recipe" for cleaning could greatly assist device manufacturers in developing their instructions, and also greatly assist CSSD's in implementing those instructions effectively.
The Human Touch
A growing science in the last few decades, human factors engineering, will come to IFU's for device reprocessing. The basic goal of human factors engineering is to reduce mistakes by engineering out the sources of error that come from the inherent limitations of human beings. A simple example is font size: rather than print instructions with 6pt type, human factors engineering would specify that a larger, minimum-size type face. For humans that have weakening vision (like me) this is a natural benefit, helping us do our jobs better. The new workgroup taking up this challenge will develop principles and guidelines for IFU's to insure a high degree of usability (i.e., illustrations, demonstration videos, etc.).
Focus on Scopes
Any perusal of trade press will confirm what those "on the ground" already know - the use and uses of flexible endoscopes is increasing every day. These marvels of modern technology, however, pose a serious challenge to effective cleaning. Various groups, formal and informal, have developed recommended practices for proper reprocessing. But the challenge remains to develop a "best practices" document that merges the best of what is and can be done when it comes to flexible endoscope reprocessing. The new AAMI workgroup will bring together the best in the industry to share their expertise and knowledge in a Technical Information Resource (TIR) document that will summarize those best practices.
Ralph Basile Healthmark Industries
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Tip of the Week
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The FDA has asked for comment on a proposed survey of healthcare providers regarding the most effective device labeling. To learn more about commenting, visit here: click here
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