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FDA MEDWATCH ALERTS

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

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FDA Medwatch Alert 10-20-14

October 16, 2014

FDA MedWatch - LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

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FDA MedWatch LifeCare Flexible Intravenous Solutions by Hospira Inc

October 13, 2014

FDA MedWatch - CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure

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FDA MedWatch CareFusion EnVe and ReVel Ventilators

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Recommended Scope of Practice of Nurse Anesthetists and Anesthesiologist Assistants

Because nurse anesthetists and anesthesiologist assistants are not trained to make medical judgments, virtually all states require direct physician participation in care provided by these anesthesia providers. State statutes and regulations specify the requirements for medical direction or supervision of nurse anesthetists by a physician or dentist legally authorized to deliver anesthesia services. State statutes and regulations that license anesthesiologist assistants, or permit them to practice pursuant to delegated anesthesiologist authority, require direct anesthesiologist participation in the care provided by them.

State regulations generally require either direct and immediate supervision of nurse anesthetists and other allied healthcare providers by a qualified physician or the existence of a protocol/collaboration arrangement with such a physician. State regulations dealing with anesthesiologist assistants all require that they be directed or supervised by an anesthesiologist.

The following principles related to nurse anesthetist/anesthesiologist assistant scope of practice are supported by ASA:

In many situations, anesthesia care is rendered through use of an anesthesia care team in which an anesthesiologist concurrently medically directs two, three or four nurse anesthetists and/or anesthesiologist assistants in the performance of the technical aspects of anesthesia care. Anesthesiologists engaged in medical direction are responsible for the preanesthetic medical evaluation of the patient, prescription and implementation of the anesthesia plan, personal participation in the most demanding procedures of the plan (including induction and emergence), following the course of anesthesia administration at frequent intervals, remaining physically available for the immediate treatment of emergencies and providing indicated postanesthesia care.

In some institutions, nurse anesthetist performance is supervised by the operating practitioner, who assumes responsibility for satisfying the requirement found in most state health codes and federal Medicare regulations that nurse anesthetists be supervised by a physician. The operating practitioner rarely, if ever, is able to assume all of the supervision involved in medical direction. The operating practitioner’s supervision of nurse anesthetist activities, therefore, involves a lesser application of physician judgment or skills for anesthesia care and thus involves greater reliance on the training and capabilities of the individual nurse anesthetist.

A qualified nurse anesthetist is a licensed registered nurse who has satisfactorily completed an accredited nurse anesthesia training program and who has been credentialed by the institution on recommendation of the anesthesiology staff or, in the absence of an anesthesiologist, by the active medical staff. Credentialing of nurse anesthetists should take into account whether the nurse anesthetist will provide care under medical direction by an anesthesiologist or under supervision by the operating practitioner.

A qualified anesthesiologist assistant is an allied healthcare provider who has satisfactorily completed an anesthesiologist assistant program granting a Master’s degree, has been certified by the National Commission for Certification of Anesthesiologist Assistants (NCCAA) and has been credentialed by the institution.

Subject to the foregoing limitations, a nurse anesthetist or an anesthesiologist assistant may, under medical direction by an anesthesiologist, or in the case of a nurse anesthetist, under supervision of an operating practitioner who has assumed responsibility for the performance of anesthesia care (collectively, the “responsible physician”):

  • Provide non-medical assessment of the patient’s health status as it relates to the relative risks involved with anesthetic management of the patient during performance of the operative procedure;
  • Based on the health status of the patient, determine, in consultation with the responsible physician, and administer the appropriate anesthesia plan (i.e., selection and administration of anesthetic agents, airway management, monitoring and recording of vital signs, support of life functions, use of mechanical support devices and management of fluid, electrolyte and blood component balance);
  • Recognize and, in consultation with the responsible physician, take appropriate corrective action to counteract problems that may develop during implementation of the anesthesia plan;
  • Provide necessary, normal postanesthesia nonmedical care in consultation with the responsible physician; and
  • Provide such other services as may be determined by the responsible physician.

Nurse anesthetists and anesthesiologist assistants should not be credentialed to perform procedures that involve medical diagnostic assessment, indications, contraindications and treatment in response to complications that require the application of medical skill and judgment. ASA’s position on participation by non-physicians in regional anesthesia and invasive monitoring procedures is respectively set forth in its “Statement on Regional Anesthesia” and its “Practice Guidelines for Pulmonary Artery Catheterization,” which can be found on the ASA website under “Clinical Information.”

For further information, please contact Ronald Szabat, ASA Executive Vice President & General Counsel, or Lisa Percy, ASA State Legislative and Regulatory Issues Manager, at (202) 289-2222.

March 2009