An Overview of Regulatory Guidelines for Medical Gases

Abstract

Direct administration or supply of medical gases to patients is dangeous. Regulatory guidance requirements
of various regulatory agencies, the highest quality should be used in their manufacture and transfer. The
manufacturer of medical gases requires a license or regulatory approval to manufacture the gases; thus, they
must maintain the quality of the gases in accordance with standards or quality limitations established by the
drug regulatory authorities. Medicinal gases are manufactured, packed, and designed for patient administration
during anesthesia, therapy, or diagnostics. Oxygen, helium, carbon dioxide, nitrous oxide, medicinal air, and
nitrogen are officially recognized therapeutic gases. These gases are usually administered preoperatively,
intraoperatively, and postoperatively in surgical patients. This gas ignites supplied in an airtight, color-coded,
and properly labeled container as required by the relevant regulatory authorities in each country or through
the central line runs all over the hospital. Despite all the rules, they are reports on problems related to the
production and use of medical gases. In this study, we tried to give a brief overview of regulatory guidelines
for medical gases in India and USA.