Articles on Law, Science, and Engineering

THE REAL USERS OF MEDICAL DEVICES[index]

There are no laws requiring medical device users to be licensed or even trained or tested. In the United States, a licensed physician may practice any type of medicine he chooses, irrespective of his training. He may also allow an untrained layman to perform medical tasks under his supervision. One can still find a general practitioner performing surgery while supervising a nurse's aide delivering anesthesia.

Even board certification is no guarantee of a competent user of an anesthesia machine. Certified anesthesiologists are never retested for competence in the rapidly changing field of anesthesia technology. When the standards for patient monitoring were being developed in the mid 1980's, a substantial group of anesthesiologists were opposed to the basic requirement that some type of patient monitoring be used.

Anesthesia machine manufacturers, as with most medical device manufacturers, have not attempted to restrict the sale or use of their machines to trained users. They have delegated the assessment of user skills to the medical profession. Physicians, however, treat medical devices like lawnmowers: they use them without training and sometimes stick their hands (or their patient's hand) into the blade. Faced with this user group, and the failure of anesthesia machine manufactures to attempt to control the use of their machines, the courts have rationally concluded that anesthesia machines are like lawnmowers rather than airplanes.

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