You Heard It First

With this in-flight audio, passengers may know if an aluminum shower is approaching.have to tip my hat to United Airlines. Its exclusive “From the Cockpit” audio channel is the greatest thing to hit domestic air travel since the honey-roasted peanut.

“From the Cockpit” allows passengers to don earphones and listen to their captain chat with the en-route air traffic controllers responsible for pushing tin though North America’s crowded airspace.

There’s a surprising amount of chatter. Pilots are constantly discussing weather and turbulence conditions, comparing notes and changing altitudes to give the paying passengers a smoother ride.

The exchanges between air and ground were professional, and not always perfect. Controllers and flight crews got a little confused sometimes, but they sorted things out. Overall, this unique display of openness left me very impressed. I walked off the plane with renewed appreciation for the work of airline pilots and air traffic controllers.

On the other hand, with this in-flight audio, passengers may know if an aluminum shower is approaching — air traffic control slang for a midair collision — so it took some guts for United to put “From the Cockpit” on the air. United — and its flight crews — must have realized they could not censor what passengers would be hearing. They went ahead and installed the system anyway.

It’s too bad everyone doesn’t have the same “right stuff.”

In many ways, the U.S. Food and Drug administration has made great strides in opening its processes to ordinary citizens. Yet the FDA is considering a private firm with a history of secrecy to regulate the aftermarket service industry. As we’ve reported previously, the deal will be worth millions to whatever company gets the nod. Since all the work to draft the program is tightly controlled by staff members of the Association for the Advancement of Medical Instrumentation, they will likely get the award.

Why is the FDA considering this? With no evidence of service-related problems? Bureaucratic inertia. Service industry regulation is a pilot project for an internal agency effort to create “Leveraging” — a delightfully Dilbert-esque word that means “move the mountain of work off the desk” according to the project Web site, www.fda.gov/oc/leveraging/default.htm.

The motivation for “leveraging” is fraught with contradiction. “As you know, more than ever before, we are being asked to do so much with precious few resources to get all our jobs done,” wrote FDA commissioner Jane Henney in an “all-hands” 

e-mail dated Jan. 7. “However, our collaborations should not be driven merely by objectives of resource savings or economies of work, but rather by the need to constantly search for ways to increase our ability to protect and promote the public health.”

It has been claimed the AAMI proposal to privatize remanufacturer and servicer regulation was a team effort, and that several organizations will be able to compete for the lucrative role of “registrar,” but privately, members of these other organizations concede they can’t win and are afraid to speak publicly because they fear AAMI retaliation. As one association officer put it, “AAMI puts FDA staff on its committees and boards, how can you compete with that?”

The “Guiding principles for leveraging at FDA” stipulate that a leveraged regulatory effort should not create “the occurrence or the appearance of a conflict of interest, or be seen as a means to avoid or off-load work and responsibilities or merely as a response to an inadequate budget.” But the plan to privately regulate healthcare technology service violates all of these.

The “guiding principles” also say offloading efforts must retain “an open and credible process,” yet AAMI is anything but open. In fact, the association refused press access to sessions at its recent annual meeting and denied 24×7 access to a presentation on this topic.

Our industry is in trouble if this program is adopted, but if the negotiations between AAMI and the FDA remain under wraps, and if “leveraging” is the chosen course of the FDA commissioner, how can we avoid an aluminum shower?