Table of Contents
FDA Consumer magazine
July-August 2000
by Carol Lewis
The popping sounds from the oxygen concentrator roused the elderly man from his sleep as fire engulfed his bed. With the help of his young granddaughter who was caring for him, the invalid managed to escape before two of the six high-pressure oxygen cylinders stored in a nearby closet exploded and burned the house down. The fire marshal investigation revealed that the oxygen concentrator malfunctioned, starting the blaze. Experts from the Food and Drug Administration, however, suspect that smoking also may have been a factor; both the man and his daughter, who lived with him, smoked cigarettes.
"My experience has been that smoking around oxygen may cause fires," says Duane Sylvia, a consumer safety officer in the Food and Drug Administration's Center for Drug Evaluation and Research. "Smoking anywhere near oxygen, even in the same room, can be extremely dangerous." FDA regulates medical gases, such as oxygen, as prescription drugs, and regulates the related delivery hardware, such as concentrators, tubing, and regulators, as medical devices.
Because of increasing reports about similar disasters involving medical gases, including some deaths, FDA is attempting to heighten both consumer and industry awareness about this specialty area of regulated products. Medical gases are the most frequently administered drugs in the United States, according to National Safety Technologies, Inc. The most commonly used include oxygen, nitrous oxide, carbon dioxide, medical air (which is used to provide a drug product to a patient), and nitrogen. These gases have a variety of medical uses, both in the home and in health-care facilities. For example, oxygen is usually administered at home to patients suffering from various respiratory conditions, such as emphysema. And surgeons use carbon dioxide to inflate the abdomen during laparoscopic surgery.
But in the last five years, FDA has received several reports of deaths and "near hits" (events in which the mistake of administering the wrong gas or contaminated gas was found in time to prevent injury), which have been traced to human error. For example, a patient died after receiving argon, a gas with a variety of industrial uses, instead of oxygen. Because maintenance personnel were not properly trained, argon was inadvertently dispensed in the hospital's main oxygen supply.
In addition, FDA has received 16 reports of aluminum regulators (valves that control the flow of a gas) burning or exploding when used with oxygen cylinders. FDA and The National Institute for Occupational Safety and Health believe that the aluminum in oxygen regulators was a major factor in both the ignition and severity of these fires, although experts say there could have been other contributing factors. Brass regulators are believed to be safer than aluminum for use with high-pressure oxygen. And even though oxygen doesn't burn, it supports combustion. A material, such as the metal in oxygen regulators or cylinders, that will not burn in air (which is only 21 percent oxygen) may burn in the presence of pure, high-pressure oxygen.
FDA's Sylvia also says that applying any lubricant, typically Vaseline or anything greasy, to medical gas apparatus in an attempt to make repairs can cause injuries and deaths. Most people don't know this, he says, since there is a natural tendency to apply some sort of oil to appliances or household equipment that are mechanically difficult to operate. But, in fact, where medical gases are concerned, this practice could be deadly. "It's extremely dangerous in the first place for companies to deliver cylinders or equipment without proper instructions and precautions," which would provide these warnings, he says, but there is no specific requirement for health-care companies to do so. "People shouldn't accept the apparatus without instructions, or use medical gases from a company that isn't registered with FDA and licensed by the state."
Christy Foreman, a biomedical engineer in FDA's Center for Devices and Radiological Health, emphasizes the importance of having all at-home medical gas equipment properly installed and regularly maintained by professionals. Pam Schweikert, a compliance officer in FDA's Office of Enforcement, agrees. Some patient manuals indicate that oxygen concentrators should be serviced every 9,000 hours, yet Schweikert says that just last year FDA issued a warning letter citing a firm for waiting as long as 30,000 hours before servicing a unit.
"Part of the problem is that the small operations [firms that provide medical gases], as well as many of the welding supply companies, haven't been brought up to industry standards," Sylvia says, "and we need to educate these companies about the many risks involved."
It's not easy to tell if a company has delivered the right gas, or if the oxygen cylinder is made with the safest material. Most people rely on the experts to assure that equipment delivered to their homes is in good working order. But there are actions consumers can take to protect themselves:
Carol Lewis is a staff writer for FDA Consumer.
For more information on medical gas safety, contact:
Compressed Gas Association
1725 Jefferson Davis Highway
Suite 1004
Arlington, VA 22202-4102
www.cganet.com
National Fire Protection Association
1 Batterymarch Park
Quincy, MA 02269-9101
www.nfpa.org
American Society for Testing and Materials
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959
www.astm.org
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Division of Safety Research
1-800-35-NIOSH (1-800-356-4674)
www.cdc.gov/niosh/firehome.html
--C.L.
Since medical gases are prescription drugs, and a responsibility of the FDA's Center for Drug Evaluation and Research, report any problems with the drug product to FDA's MedWatch program at 1-800-332-1088. Reports can be submitted by fax on 1-800-332-0178, by mail to MedWatch, Food and Drug Administration (HF-2), 5600 Fishers Lane, Rockville, MD 20852-9787, or through FDA's Website at www.fda.gov/medwatch/.
The Safe Medical Devices Act of 1990 requires hospitals and other user facilities to report deaths, serious illnesses, and injuries associated with the use of medical devices. Questions about mandatory reporting can be answered by the Division of Surveillance Systems, Reporting Systems Branch, by phone on 301-827-0361, or write to FDA, CDRH, MDR User Reporting (HFZ-531), PO Box 3002, Rockville, MD 20847-3002.
--C.L.
cylinder: metal container designed to hold compressed medical gases at a high pressure.
cryogenic vessel: metal container designed to hold liquefied compressed medical gases at extremely low temperatures.
compressed medical gas: any liquefied or vaporized gas alone or in combination with other gases.
concentrator: stand-alone unit that extracts oxygen from room air and delivers concentrated oxygen at a continuous flow rate.
regulator: mechanism that controls the flow of a medical gas.
--C.L.
Table of Contents | How to Subscribe | Back Issues | FDA Home Page
Questions concerning the editorial content of FDA Consumer should be directed to FDA's Office of Public Affairs.
(Hypertext created by tg 2000-JUN-13)