Air Travelers Update: Label Issue Drags On

Air travelers 'hostile' as new required labels for respiratory equipment fail to materialize

by Quest Staff on July 15, 2009 - 5:27pm

Vent, CPAP and BiPAP users can expect to encounter ongoing obstacles if they plan to fly on commercial airlines in the near future.

Interviews with government and industry representatives show that the special labeling required for such equipment still has not been created, and no one – except the frustrated and angry travelers affected by the ruling – seems to consider it an urgent matter.

The problem

On May 13, the U.S. Department of Transportation (DOT) issued a rule requiring commercial airlines to allow passengers to use respiratory equipment during flight if the equipment bears a label saying it meets all safety requirements of the FAA (Federal Aviation Administration). The ruling affects all commercial planes with 19-seat capacity or greater.

Prior to the ruling, each airline decided independently whether or not to allow use of such equipment during flight. The DOT ruling was intended to give travelers greater assurance that they could use their equipment onboard by telling airlines they could not prohibit its use if it carried an approved label.

The catch: No such labels exist for ventilators and positive-air-pressure respiratory devices such as the BiPAP by Philips Respironics. Manufacturers have no definite plans to create the labels, saying the need is not great.

Meanwhile, the ruling seems to be having the opposite effect. Some airlines have cited it as a reason to refuse respiratory equipment operation during flight because the equipment lacks the “FAA OK” label. Some who flew with vents in the past have been literally turned back at the gate by airline personnel and told they could bring their equipment on board only if they didn’t use it.

Airlines still can choose to allow equipment use

The FAA’s Nancy Claussen, an aviation safety inspector and rulemaking coordinator, said the issue needs to be examined in light of its origins.

“This really shouldn’t be a case of, ‘if you don’t have a label, you can’t fly,’” she said. “Up until May 13, airlines could allow the use of respiratory devices pretty much as they wanted, as long as they determined, ideally through FAA guidance, that a device was safe. They could also disallow use of the device as they saw fit, if they decided it might not fit within the compliance guidelines.

“The significant point here is that the DOT ruling tells airlines they cannot prohibit use of the equipment if it bears a label. There is nothing that prohibits the airlines from allowing you to fly and use your equipment, label or no label, if they feel it is FAA-compliant.”

Nonetheless, Frontier Airlines’ regulations, for example, state, “These devices must bear a sticker indicating they are approved for use on aircraft and meet FAA requirements.”

Angry travelers have plenty to say

DOT acknowledged that feedback to its May 13 rule has been overwhelmingly negative, but said people are misguided in thinking they must have the label in order to fly.

The agency said it released the rule before a labeling protocol was created because there were other aspects of it, including provisions covering use of service animals on flights, which had immediate benefits.

Mike Spollen, a disability team leader in DOT’s Aviation Consumer Protection Division, said most responses to the ruling have been in the form of hostile e-mails.

“We’re trying to work through it,” he said, noting DOT is encouraging airlines to accept respiratory equipment if RTCA testing has been done on it by the manufacturer or a qualified testing agency.

Spirit Airlines’ regulations, typical of the 150 major airlines in the industry, advise potential passengers their respiratory gear can be considered FAA safety-compliant if it bears either a) a label that says “approved by the FAA” or b) a label saying the device is “RTCA/DO-160D Subpart 21 Compliant.”

RTCA is the Radio Technical Commission for Aeronautics, a federal advisory committee, and the standard cited pertains to acceptable levels of electromagnetic and radio frequency emissions from electronic equipment.

POCs are labeled, not others

The problem is that in most cases labels have not yet been created for the ventilators and positive-air-pressure respiratory devices most often used by people with neuromuscular diseases.

Currently, seven respiratory devices, made by six manufacturers, do meet FAA safety standards and have, or are authorized to have, the required labels. However, all of the devices are portable oxygen concentrators (POCs).

Evo Medical Solutions, which makes one of the approved POCS, also manufactures vents, but the company hasn’t sought to obtain FAA-approved labels for those items, according to Vanessa Saltmarsh, director of business services, who said she was somewhat familiar with the May 13 DOT rule.

“We haven’t done anything to acquire labels for our vents because we consider the use of that type of equipment to be infrequent,” she said. “Not having the labels hasn’t been a deterrent to sales, and we see POCs as being different. They’re needed full-time, including during travel.”

Valerie Cwik, MDA medical director and senior vice president of research, noted that people with weakened respiratory muscles from diseases such as ALS or Duchenne muscular dystrophy don’t require oxygen but may need intermittent or full-time pressurized ventilation to help them breathe.

Invacare is another company that has POC models approved for air travel and also makes other types of vents. Invacare spokesperson Lara Mahoney said they are well aware of the labels issue as it pertains to POCs, but, “for our other types of respiratory equipment, we’d have to run that through the FAA [approval] process, and at this time we don’t have plans to do that, primarily because vents are not part of our core oxygen business.”

Philips Respironics also manufactures one of the approved POCS as well as vents, BiPAPS and CPAPS. Mike Barsovich in the company’s marketing group said, “We knew what to do about POCs, but we were caught off-guard by the new vent provision. We’re talking about what we need to do.”

Although DOT published advance word in the Federal Register more than a year ago advising it intended to come out with a new rule pertaining to respiratory equipment, but major manufacturers say they were blindsided by it.

What should travelers do?

Claussen said the FAA is contemplating creating a rule that would identify a process whereby manufacturers would affix the labels to the FAA-approved equipment that they make. Airlines would be obliged to allow airborne operation of all such items.

When might the FAA embark on that process? “We don’t know,” Claussen said.

DOT’s Spollen said, “We [federal agencies] tend to do rulemaking at a glacial pace.”

Annie Kennedy, MDA vice president for advocacy, said the best course for advocates is to lobby Congress to light a fire under the FAA’s rulemaking process.

“This isn’t an issue that can be allowed to stagnate while being deliberated endlessly,” she said. “People with disabilities have the need to travel just like everyone else, and they can’t be denied the immediacy of air travel because of a technicality.”

For information and tools for lobbying elected officials, visit MDA’s advocacy page,

DOT offers a toll-free telephone number, (800) 778-4838, staffed Monday through Friday, 9 a.m. to 5 p.m., Eastern Time, especially for people with disabilities who have travel-related questions or complaints.

Meanwhile, Spollen advised respiratory equipment users who will be flying commercial airlines to call their carrier well in advance to advise of their specific travel plans and the make and model of their respiratory equipment.

Ask for the airline’s CRO (Complaint/Compliance Resolution Officer], he suggested, and have him or her determine if your equipment meets FAA requirements for compliance with RTCA standards.

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