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Physician-Patient Alliance for Health & Safety: Can There Be Too Much FDA Oversight?
Date:1/19/2012

ng process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products ..."

So, with these resource and strategic planning issues that need solving, did the FDA fulfill its oversight role when it banned the importation of capnograph products into the US?

The ability of capnographs to measure the concentration of carbon dioxide that a person breathes out in exhaled air is an essential device for maintaining patient safety. Not only are capnographs the standard of care in hospital operating rooms, but capnographs are increasingly being used outside the operating room.

Explains David Watson (Vice President at ECRI):

"One instance where the use of capnographs outside the operating room benefits patient safety is patient-controlled analgesia (PCA). In 2011, ECRI listed the need to monitor for oversedation during use of PCA infusion pumps as one of the top ten health technology hazards. In that report, PCA therapy and the need for effective monitoring using capnography and/or pulse oximetry in order to detect respiratory depression monitored by continuous oximetry and capnography was described. Again, in 2012, ECRI has named infusion pumps as one of the top health technology hazards."

(ECRI Institute is an independent, nonprofit organization that researches the best approaches to imp
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SOURCE Physician-Patient Alliance for Health & Safety
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