Infusion Pumps to Consider for Use with Hyperbaric Chambers
February 17, 2016 | Evaluations & Guidance
In a March 5, 2014, Important Infusion Pump Discontinuation Notice, Hospira announced that it would be discontinuing the manufacture, sale, leasing, service, and support of the Plum A+ hyperbaric infusion pump after June 30, 2014. This was the only pump with FDA clearance for providing infusions to patients in hyperbaric chambers. Since the pump's dedicated infusion sets were also discontinued, some facilities have reportedly continued to use the pump off-label for hyperbaric infusions with Hospira's standard sets manufactured for the Plum A+ and Plum 360 pumps, which are marketed for conventional hospital infusions.
The market for hyperbaric-compatible infusion pumps is very small, and these pumps have a life expectancy of more than 10 years. Therefore, pump manufacturers cannot justify the regulatory burden and support costs to continue providing them. As a result, there are currently no large-volume or syringe infusion pumps that have FDA clearance for use with hyperbaric chambers. FDA considers clinical chambers to be class II medical devices.
This article describes hyperbaric chambers, explores the issues associated with delivering IV medication to patients receiving therapy in these chambers, and identifies infusion pump models that might be used.
Hyperbaric oxygen (HBO2) chambers are pressure chambers constructed specifically for exposing individuals to pressures greater than 1 atmosphere (14.7 pounds per square inch absolute psia) while they breathe near-100% medical-grade oxygen (O2). Clinical HBO2 is defined by the Undersea and Hyperbaric Medical Society (UHMS) as an intervention in which a patient breathes medical-grade oxygen while at pressures greater than 1.4 atmospheres absolute (ATA). HBO2 is indicated for disorders such as decompression sickness, arterial gas...