[MCOH-EH] a lesson in procedures

william hyman wahyman at gmail.com
Wed Oct 10 14:46:12 PDT 2018

A recent FDA Warning Letter to a device manufacturer has lessons on the
possible difference between procedures and reality.The findings included:
- touching contaminated surfaces with gloved hands and then returning to
the supposedly protected activity
- using tap water for sterile surface cleaning
- rapid movements in sterile areas when the procedure requires slow and
deliberate movement (to control air disturbance)

The question then is how much monitoring is there of what is actually
happening as opposed to what is supposed to be happening?.
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