Physio-Control Reaches Agreement with FDA on Monitors

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12lead_sm.jpgFor a lot of EMS providers out there, at least at the ALS level, Physio Control is the manufacturer of the monitors they use to read patient heart rhythms.  Recently, however, they have been unable to support their customer base because of a voluntary stop order they issued over a year ago in accordance with the wishes of the FDA.  The problem surrounds issues with some of their manufacturing process and quality control paperwork they are supposed to keep regarding adverse effects and other trackable items.

Read the article here.

This has kept many agencies from upgrading their machines to Bi-Phasic defibrillation standards.  It has caused a lot of issues for a lot of EMS companies out there.  I hope that this signals the end of the is problem and that organizations can get back on track with their upgrades and purchases.

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