Proposed advertising for portable oxygen administrator The Commission rendered an advisory opinion as to the…

No. 126. Proposed advertising for portable oxygen administrator The Commission rendered an advisory opinion as to the legality of certain proposed advertising for a portable oxygen administrator designed for individual use.

The advertising would represent that there are many emergencies that can for an immediate supply of oxygen, such as sudden heart attacks , coronary occlusions, respiratory defects , gas and smoke poisoning, drowning, electric shock, asthmatic seizures, and more. Providing oxygen the instant it is needed can, according to the advertising, make the difference between prolonging life and losing it or between complete and partial recovery. When needed oxygen must be supplied within 5 to 8 minutes to prevent brain damage. Until recently, if an emergcncy oxygen deficiency occurred, one had to wait for professionaJ medical assistance and there was no way of knowing how long that would take. Now one can have a low cost portable administrator so simple to operate that anyone can administer it, even to themselves. While the literature would caution in some places that an heart and respiratory conditions are not alike and thus the need for oxygen may vary widely in its application so that your doctor win have to be your guide, it would also add that the advertiser knows of no emergency situation where oxygen can do harm and it may save a life under many circumstances.

The opinion pointed out that the matter presented a diffcult problem to treat under the advisory opinion procedure , for the Commission has not conducted its own tests of this particular unit and hence is not in a position to comment upon every question raised by the advertising. Hence, its opinion has to be based upon such general medical knowledge as is available and be directed at the main themes of this advertising rather than at specific details. Based upon what is known of the capabilities of similar devices the Commission advised that it could not place its stamp of approvall1pon advertising which holds this device out to the general public as suitable for use and capable of saving lives under a1l conditions specified without its having been recommended for use by a doctor familiar with the patient and without the individual for \vhorn it has been prescribed, or his family, having been given instructions for its use. This is particularly true when it is considered that in some cases of asthma and emphysema there is a danger in the administration of oxygen without a doctor s prescription and instruction because an over supply in these conditions can actually cause the patient to stop breathing. The opinion further added that aside from the question of danger in this specific situation of use and the general fire hazard when oxygen is improperly used or stored, the scientific evidence available indicates that without a positive-pressure apparatus, this device will accomplish little morc than will mouth-to-mouth resus- ADVISORY OPINION DIGESTS 1735 citation in situations where emergency oxygen is indicated. In fact, the emergency resuscitator attachment appears to require mouth-to-mouth techniques in conjunction with the device and the evidence indicates this would only increase the oxygen a patient would receive by an insignificant amount. Positive pressure, which can only be administered by trained personnel without grave danger to the patient, is indicated for use when a patient is not breathing. If the patient is breathing he wil usuaUy inhale suffcient oxygen from the air by himself until medical help can be obtained. The fault of this advertising, as the Commission views it, is that while beneficial results can be achieved by the skiUed administration of the proper amounts of oxygen when that treatment is indicated, it is deceptive to hold out to the unskiled person that he can by himself properly diagnose the patient' s condition and administer oxygen in the required amounts and in the proper manner through use of this device so as to achieve the results claimed in the advertising. (File No. 673 7088, released May 26, 1967.