Park Ridge, Ill.–Responding to a decision by the Food and Drug Administration (FDA) to approve a new machine that allows healthcare providers who are not anesthesia experts to give the powerful drug propofol to patients undergoing colonoscopies and other gastrointestinal procedures, the American Association of Nurse Anesthetists (AANA) stated that the safest option for any patient receiving propofol is still the hands-on care provided by Certified Registered Nurse Anesthetists (CRNAs) and physician anesthesiologists.
The pre-market approval of Johnson & Johnson’s Sedasys™ machine for administering propofol (Diprivan™) was announced on May 6 after three years of denial by the agency.
“Propofol is an effective anesthetic drug for colonoscopies and endoscopies because it is short acting and patients typically wake up quickly and feeling alert,” said Janice Izlar, CRNA, DNAP, president of the 45,000 member AANA. “However, propofol is also a very powerful drug in that any patient receiving it can slip from a mildly sedated state into a state of general anesthesia requiring assistance with breathing. That’s why it is always best for propofol to be administered by a qualified anesthesia professional. Since a machine is not able to prevent or manage loss of consciousness, we have serious concerns.”
A 2004 joint position statement of the AANA and the American Society of Anesthesiologists (ASA) concurs, saying, “Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures.”
Even the FDA-approved labeling on propofol warns that the drug should only be provided by persons qualified in general anesthesia, because the drug’s effects cannot be reversed.
According to Johnson & Johnson, facilities where the Sedasys is used should have an anesthesia professional immediately available for assistance or consultation, a vague requirement that generally limits the machine’s utility and cost-effectiveness. Johnson & Johnson also stresses the need for the propofol provider to be trained in dealing with the drug’s cardiorespiratory effects—abilities that CRNAs and anesthesiologists master during years of advanced education and clinical training.
“CRNAs are master’s prepared anesthesia experts educated and trained in the administration of general anesthesia and pain management,” said Izlar. “Numerous studies have demonstrated the cost effectiveness and high quality of CRNA care when personally provided to an individual patient. Substituting a machine for a dedicated anesthesia expert involves unknown costs and risks.”
Johnson & Johnson plans to conduct two studies to monitor use of the Sedasys machine in actual clinical practice after a limited rollout in 2014.