HIMA'S PROPOSED INFUSION PUMP ALTERNATIVE TRACKING SYSTEM
This article was originally published in The Gray Sheet
Executive SummaryHIMA'S PROPOSED INFUSION PUMP ALTERNATIVE TRACKING SYSTEM is inadequate "to ensure effective tracking," FDA states in an Aug. 1 letter denying a Health Industry Manufacturers Association petition for variance from device tracking requirements for electromechanical parenteral infusion pumps. "To ensure effective tracking systems, it is critical for manufacturers to keep track of devices throughout the distribution chain, not just to the first consignee and then later to the multiple distributor as HIMA proposes," FDA says.
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