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INFECTION PREVENTION
c. They may be reprocessed, but only by entities that have complied with
FDA regulatory requirements.
d. both a and c
c. They may be reprocessed, but only by entities that have complied with
FDA regulatory requirements.
There has been much controversy in this area, and the CDC says
more studies are required to determine the extent of the risks and
benefits of reprocessing, then using, SUDs.1 However, FDA guidance
issued in 2000 allows the practice, so long as firms can reprocess
SUDs and document the process in such a way that they could meet
original manufacturing requirements.2
The FDA has increasingly required 510(k) regulatory submissions
and supplemental validation data,2 so any SUD reprocessing must be
outsourced to a third-party firm, if you choose that route. If you do, be
sure your third-party reprocessor complies with all FDA regulations
— for example, reprocessing only devices on the FDA-approved list
and devices for which it holds 510(k)s. It's also in your interest to
keep abreast of developments at www.fda.gov.
2. After sterilization, wrapped instrument packs are placed into storage. For
how long are the instruments inside these packs considered sterile?
a. The items remain sterile indefinitely.
b. The sterility depends on package integrity and storage conditions, or the
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O U T PAT I E N T S U R G E R Y M A G A Z I N E O N L I N E | N O V E M B E R 2012
