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March 3, 2000
Dr. David W. Feigal Jr., Director, Center for Devices and Radiological Health, Food and Drug Administration sent a letter to the Coalition of Respiratory Care Manufacturers on February 2, 2000 stating:
We recognize that from switching from aluminum to brass [regulators] may pose a weight problem for some patients. It seems clear that the decision as to whether to choose a brass or aluminum regulator for any individual patient is a risk-benefit decision that must be made by the physician and patient, taking into account the patient's condition and balancing the advantages of the lighter weight of the aluminum product against the possibility that it might post a somewhat greater risk of explosion or fire.
This statement comes after a series of meetings that the Coalition of Respiratory Care Manufacturers conducted with both Dr. Feigal and his staff over the past year in reference to the February 1999 FDA and NIOSH Public Health Advisory: Explosions and Fires in Aluminum Oxygen Regulators. In the Advisory, the FDA recommended replacing aluminum with brass regulators. In one of its meetings with the FDA, the Coalition along with representatives from the three physician groups with direct interest in pulmonary medicine (National Association for Medical Direction of Respiratory Care, American College of Chest Physicians and the American Thoracic Society) made the case that patients who use oxygen in the home care setting need aluminum for ambulation, that the benefits aluminun regulator provided for patients outweighed the risks, and that the majority of fires were in the emergency rather than in the home care environment.
Although the FDA's position on oxygen regulators is unchanged from what is stated in their February 1999 joint Public Health Advisory with NIOSH, the FDA also has recognized in its letter to the Coalition key points the Coalition stressed in its meetings with FDA staff. These include:
The FDA intends to publish a Question and Answer section regarding this updated information following the February 1999 Public Health Advisory on their website.
The Coalition is now working with the ASTM, FDA, NIOSH and NASA to develop a credible performance standard, using an ignition test, to assure safer performance of oxygen regulators, regardless of their material composition.