ISO standard turns up heat on safety devices for oxygen

It may not have teeth in the United States yet, but a new amendment to the International Organization for Standardization (ISO) standard for oxygen concentrators still looms large for manufacturers here.

The amendment to ISO 8359, which requires that safety devices be added to oxygen concentrators and accessories to mitigate the acceleration of fires, has been approved by other countries and, therefore, affects manufacturers that do business overseas.

“The purpose behind the amendment is to try and help reduce some of the patient injury caused by smoking while on oxygen or from a fire in the area,” said Dave Polacsek, principle regulatory engineer at Invacare.

The amendment requires two safety devices: 1.) a “fire break,” such as a metal fitting or metal plate, at the outlet of the oxygen concentrator; and 2.) a “flow stop” device in the tubing (see related story below).

Company officials at Invacare and AirSep say their oxygen concentrators sold in Europe meet the amendment out-of-the-box or with a kit.

But just because the amendment wasn't approved by the American National Standards Institute (ANSI), the U.S. representative to the ISO, doesn't mean manufacturers can write off the amendment in this country. ISO is currently drafting an entirely new standard for oxygen concentrators that includes the basic requirements of the amendment, Polacsek says.

Oxygen concentrators sold in the United States by Invacare, for one, will comply with the amendment before the new standard is finalized, company officials say.

“We've made the decision to have a common product globally,” said Nancy Smoot, product development manager, respiratory care, at Invacare.

Because the requirements in the amendment don't prevent fires from happening in the first place, AirSep has also published white papers and created public service announcement ads to educate patients on the dangers of smoking while using oxygen.

“We have a turn off, take off and leave campaign that's similar to stop, drop and roll,” said Bob Jacobsen, vice president of sales and marketing for AirSep. “If patients are going to smoke, we want them to turn off their oxygen, take off their cannula and leave the room.”

Even though it looks like the amendment will stick, manufacturers still question whether the requirement for oxygen concentrators will do much to reduce rates of patient injury. Jacobsen cites a National Fire Protection Association study from 2008 that found burns on the face—where a patient wears a nasal cannula—account for 89% of all thermal burns.

“This requirement has been used in the U.K. since 2006, and their incidence of fire and injury has more than doubled what is talked about in the U.S.,” he said.