Oversight of VA Pacemaker Policy: Hearing Before the Committee on Veterans' Affairs, United States Senate, Ninety-sixth Congress, Second Session, Wednesday, April 23, 1980 |
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ALAN CRANSTON appropriate April 23 audit battery beats per minute cardiac pacemaker prostheses cardiologist Central Office Clinic of America clinical surveillance Committee on Veterans cost effective Department of Medicine determine Director Drug Administration electrocardiogram electronic established evaluation explanted Food and Drug guidelines heart hospital in-house individual Inspector General's lithium batteries makers malfunction Marketing Center medical centers Medicine and Surgery Medtronic mercury-zinc Model Number monitoring of pacemaker monitoring services months notified November 13 Pacemaker Diagnostic Clinic pacemaker follow-up pacemaker implants pacemaker inventories pacemaker monitoring pacemaker patients pacemaker program pacemaker purchases pacemaker recalls pacemaker registry pacemaker surveillance pacemaker system pacer pacing system Parsonnet performance personnel physician problems procedures Prosthetics pulse question received recommendations records responsibility RUBIN Senator STONE specific staff Supply Service telephone surveillance telephonic monitoring testing tion transtelephonic units VA Medical Center VA's VAMC Veterans Administration warranty
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Page 3 - II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Page 24 - This action shall include both examination of the reasons for the procurement being noncompetitive and steps to foster competitive conditions for subsequent procurements, particularly as to the availability of complete and accurate data, reasonableness of delivery requirements, and possible breakout of components for competitive procurements.
Page 24 - ... procurements. This action should include both examination of the reasons for the procurement being noncompetitive and steps to foster competitive conditions for subsequent procurements, particularly as to the availability of complete and accurate data, reasonableness of delivery...
Page 105 - All implanted and life-supporting devices will require FDA approval for safety and effectiveness before they can be marketed unless FDA determines that premarket approval is not necessary. Premarket approval can be required for other devices if general controls or a performance standard are insufficient to assure their safety and effectiveness.
Page 112 - The Health Services Research, Health Statistics, and Health Care Technology Act of 1978.
Page 3 - I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Page 89 - Panels of the Bureau of Medical Devices of the Food and Drug Administration (FDA) have developed guidelines for design of clinical trials and for statistical treatment and format for reporting results.
Page 190 - NOTE TO READER The Inter-Society Commission for Heart Disease Resources was created through a contract with the Regional Medical Programs Service to help fulfill the requirements of Section 907 of Public Law 89-239 which established regional medical programs in 1965. Its purpose has been to develop guidelines for optimal medical resources for the prevention and treatment of cardiovascular diseases. The Commission's reports have been published serially in CIRCULATION, the official journal of the American...
Page 19 - Because of the needs of the National Naval Medical Center and the Walter Reed Army Medical Center...