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

roving the safety, quality, and cost-effectiveness of patient care.)

As a result, FDA's actions could adversely affect patient safety. Says Dr. Melissa Langhan (Assistant Professor of Pediatrics, Emergency Medicine, at Yale School of Medicine):

"While I'm sure the FDA is doing what it thinks is in the best interest of the patient, a ban on this product could severely affect patients in a negative direction.  There is mounting evidence for this device in the detection of respiratory events prior to current standards, acting as an early warning system for healthcare providers.  There have been numerous accounts of patient deaths that could have been averted with this monitoring device – why put more patients at risk?"

Trevor Lewis, a medical device regulations expert, with substantial FDA experience, suggests a more balanced approach, "Any medical device denied market access cannot fulfill its intended purpose and will be likely to leave some patients at increased risk. The best way forward here means to me a regulatory system that is effective and cost effective, always has the patients' best interests at heart and everyone aims for the highest ethical, moral and technical standards possible within reasonable budgets."

About Physician-Patient Alliance for Health & Safety

Physician-Patient Alliance for Health & Safety (PPAHS) is an advocacy group devoted to improving patient health and safety. PPAHS is composed of physicians, patients, individuals, and organizations. Our website is http://ppahs.wordpress.com/

PPAHS is currently developing a caregiver safety checklist targeted towards patient-controlled analgesia and sedation. For expert commentary on this checklist initiative and how it may help to prevent "dead in bed" syndrome with pati
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SOURCE Physician-Patient Alliance for Health & Safety
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