Oxygen therapy device risks warrant continued prescription labeling -- FDA petition response.
This article was originally published in The Gray Sheet
Executive Summary
OXYGEN THERAPY EQUIPMENT RECALLS, ADVERSE EVENTS WARRANT Rx LABELING, FDA says in a Sept. 15 denial of petitions filed in 1991 by the California Association of Medical Product Suppliers (CAMPS) and the New England Medical Equipment Dealers. One reason that the equipment should not be exempt from prescription requirements, FDA says, is that agency records show that oxygen therapy devices have been associated with "eight recalls (five Class II and three Class III) and two Safety Alerts." In addition, FDA found 58 adverse event reports consisting of "8 deaths, 10 serious injuries and 40 malfunctions."