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| Validation and Verification |
It's AAMI document review and preparation time again. The
Association for the Advancement of Medical Instrumentation (AAMI) is the group
that is recognized for setting the voluntary standards for all healthcare
facilities and medical device manufactures, when it comes to "best practices"
in surgical instrument reprocessing. One of the symbiotic definitions that
comes up often in these documents are validation versus verification.
Most simply stated, healthcare facilities (the users of
medical devices) verify that they are complying with the validated instructions
provided by the medical device manufacturer (MDM). The FDA places the burden
upon the MDM to document that the methods they recommend to the user of a
device have undergone rigorous scientific testing to demonstrate that the
method (i.e., sterilization) will achieve the expected result in a healthcare
facility.
The user of the device, needs to verify that they are 1)
following the instructions provided by the MDM and 2) are achieving the
expected results (i.e., instruments exposed to sterilization conditions).
Having said this, sometimes healthcare facilities need to do more - they need
to validate a process. This occurs when, for example, a facility plays the role
of the MDM - for instance designing a unique set of instruments in a
container, or utilizing a device in a way not described by a MDM in their
validated instructions.
Validation and Verification, 2 very important sides of the
same coin - making sure things are done right.
Sincerely,
Ralph J. Basile
Vice President of Marketing
Healthmark Industries Company, Inc.
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| Tip of the Week |
Medical facilities need to
verify their process. When it comes to cleaning this is now possible. One area
of concern is stains on instruments. Stains come in all sizes, shapes
and intensity. Sometimes a stain can appear
quite benign, or not be easily detected by the human eye.
Light colored
spotting literally can come from water droplets, residuals of mineral
deposits with the water(like sodium) drying onto the
surface of the
instrument. If this is happening after your
cleaning process, look at your
final rinse water and have it tested. This is
one way to help verify your
cleaning process and understand the source of the
stain.
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| News Headlines |
Medtech Industry Experiences Delayed Reaction to Recession...
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| Thank You for Your Continued Interest! |
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Sincerely,
Alex Kirk
Healthmark Industries Company, Inc.
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