The issue of a U.S. Food and Drug Administration moratorium on the use of the pulmonary artery catheter.

OBJECTIVE: To review the literature addressing the issue of a U.S. Food and Drug Administration (FDA) moratorium on use of the pulmonary artery catheter (PAC). DATA SOURCE: Pertinent English language articles dealing with medical devices including the PAC were retrieved from 1976 through 1996. STUDY SELECTION: Articles were chosen if issues related to medical devices were studied or reviewed. DATA EXTRACTION: From the articles selected, information about the 1976 Medical Device Amendment and the PAC was obtained. DATA SYNTHESIS: In 1976, the Medical Device Amendment gave the FDA power over medical devices. The pulmonary artery catheter is considered a class II device and was on the market before passage of the 1976 Act. Class II devices require general and specific controls to reasonably assure safety and effectiveness. A reasonable assurance of safety occurs when the probable benefits to health from the use of the device outweigh any probable risks. If a monitor measures an established and well-understood variable and the intended use claim is limited to the measurement of that variable, then the effectiveness consists of determining device safety and performance defined as the measurement of agreement with a recognized reference method. Deaths and serious injuries secondary to pulmonary artery catheterization are extremely rare despite more than 25 years of use. Pulmonary artery catheter manufacturer's indications for use are measurements such as hemodynamic pressures, thermodilution cardiac output, continuous cardiac output, mixed venous oxygen saturation, and blood sampling; intended uses have not included claims of clinical benefit. Evidence exists that pulmonary artery catheterization provides agreement with established measurements including pressure and cardiac output. Evidence also exists that pulmonary artery catheter derived data are unobtainable clinically, that the derived data helps in therapy changes and may lead to more appropriate therapy. The evidence demonstrates an absence of unreasonable risk of injury from pulmonary artery catheterization and provision of important clinical results. Therefore, pulmonary artery catheterization meets FDA requirements for safety and effectiveness. CONCLUSION: An FDA moratorium on the use of the PAC is not indicated.