Medical gases (e.g., oxygen, carbon dioxide, helium, nitrogen, nitrous oxide, medical air, and combinations of these) are drugs regulated by section
201(g) of the Federal Food, Drug, and Cosmetic Act. The United States Pharmacopeia (USP) sets standards for all medical gases,
including those that address quality, strength, purity, packaging, labeling, and identification. The proper handling of medical
gases has been called into question during the past several years because of incidents resulting in patient harm and even
death that have been documented by the US Food and Drug Administration, by the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), and by USP through its Medication Errors Reporting Program. In most cases, the deaths and injuries
occurred to patients who were thought to be receiving medical-grade oxygen but instead were receiving a different gas (e.g., nitrogen or argon) that had been mistakenly connected to the oxygen supply system.
In April 2001, FDA issued a Public Health Advisory addressing the reports from hospitals and nursing homes concerning deaths
and injuries to patients resulting from medical gas errors (1). In the advisory, FDA pointed out that incorrect gases were
administered to patients who should have received oxygen. The advisory also described recurring errors caused by a lack of
training of personnel who connected gas to the systems and who failed to carefully examine the labels on the gas containers.
In response, FDA made several recommendations to help prevent future errors:
- In hospitals and other patient-care facilities, medical-grade products should be stored separately from industrial-grade products.
- All personnel who handle medical gases should be trained to recognize various types of medical gas labels and should be trained
to examine labels carefully.
- Personnel should understand how containers are connected to oxygen supply systems and be instructed about the serious consequences
of changing or forcing connections.
- Facilities should emphasize repeatedly that the fittings on medical gas containers should not be changed under any circumstances.
- Once a cryogenic container is connected to an oxygen supply system and before the product is introduced into an air-supply
system, a knowledgeable person should ensure that the correct container has been connected properly.
In 2001, the USP Medication Errors Reporting Program received a report from a community hospital indicating that mislabeled
gas cylinders were delivered to the hospital. According to the report, four yellow air tanks with air tank fittings (valves)
were delivered from the supplier and were mislabeled as nitrogen. An alert respiratory therapist recognized the distinctive
air-tank fittings and alerted the appropriate personnel, thus preventing these mislabeled products from reaching patients.
As a result of this error and others reported to FDA, USP posted an article on its Web site alerting practitioners about the
possibility of medical gas mix-ups and cited the FDA Public Health Advisory (2).