Resp Care
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The Suggested Guidelines for Respiratory Therapy Home Care that are published here are just that--suggested guidelines. This document is the fourth draft on the topic as prepared by the Professional Standards Committee of the American Association for Respiratory Therapy. ⋯ Even then the final document must be approved by the AART's Board of Directors, Board of Medical Advisors, and House of Delegates. Comments on these suggested guidelines, and suggestions for changes or additions to them, should be mailed to George A West RRT, Respiratory Care Department, COX-3, Massachusetts General Hospital, Boston MA 02114.
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The Medical Device Amendments of 1976 were intended to protect the public from unsafe and ineffective medical devices. The Food and Drug Administration (FDA) has general authority from this law to regulate medical devices but now must establish specific regulations to do so. In this process all devices are being classified in Class I (general controls), Class II (performance standards), or Class III (premarket approval). ⋯ The Medical Device Amendments also provide for release of safety and effectiveness data to the public, for tracing of devices in the field in case of recalls or problems, and for assistance to small manufacturers in complying with the law. The Medical Device Amendments should help to improve medical devices, but official regulations cannot accomplish everything. Users must also do their part by employing preventive maintenance and applying devices knowledgeably and safely.