Challenges in the medical-gas business

摘要

Medical-gas manufacturers and suppliers to-day are facing new financial and regulatory challenges. Various forces, including stricter testing policies, higher operating costs, changes in medical-gas standards, and various new FDA, LISP, and DOT requirements, make the medical-gas business an increasingly challenging arena in which to participate. To be successful, medical-gas manufacturers should be aware of the potential impact of these factors on their businesses. In May 2003, the U.S. Food and Drug Administration (FDA) issued a draft guidance document entitled "Guidance for Industry - Current Good Manufacturing Practice for Medical Gases." This document represents the FDA's first step toward updating its formal written guidance for medical gases since 1989, and reports the FDA's latest thinking on medical gases. It expands upon the regulation's historic scope in both traditional ways and through introduction of new areas such as bulk medical-gas systems at healthcare facilities.