Disturbing Respironics changes

lgelb

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This info is adapted from the Apnea Board, though I verified it elsewhere.

Context: After the recall that we have covered earlier (unstable foam), which has its own issues on top of issues, Philips released the DreamStation 2 CPAP line, which are unaffected by recall and so are intended to replace the recalled machines. The CPAP market is their largest consumer market, so it makes sense that they started there.

The problem: in some of the new models, they took this opportunity to move all the clinical settings (even the heated tube setting for humidification in some cases) out of menus accessible to patients. So for those machines, to make any change, it appears necessary to enter an incorrect PIN eight times to bring up a factory reset option, which wipes everything and forces the user to start over, entering each setting from scratch. Do you think a CALS would have that kind of time when a PALS is choking?

Settings and data went into a proprietary, licensed data management system called Care Orchestrator (CO), that is not available to the public. xPAP mfrs have long had different proprietary software options, but not to hold settings hostage to this new extent.

The notion that the company could extend these policies to new Trilogy and other BiPAP models, as those come on line, is quite chilling. I would like to believe that Respironics would not endanger BiPAP users, but delaying IPAP access for even some CPAP users (who would have to know about the factory reset option to even get into the menu!) could cost lungs and lives, and I'm shocked they went that far against Safety 101. If you know a CPAP user, I would certainly warn them against any Respironics product at this stage. I'm always happy to suggest alternatives. For existing Trilogy users, you should be good in terms of settings access, but of course, should stay alert for signs of deteriorating foam, whether "original" or "replaced."

No doubt, plans for next-gen Trilogies and other BiPAPs are in the works. So I encourage you to write/tweet/call Respironics (the FDA doesn't really have a design say for "next gen" approvals with a predicate device) and state unequivocally that P/CALS, along with every other user, should have full and immediate access to all xPAP machine data and all settings. I would hope (though not expect) that the ALSA and MDA, along with clinical groups, might consider a proactive stand as well.

Best,
Laurie
 

KimT

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Thanks, Laurie. Fred's c-pap was recalled. Nobody advised him. I found it by accident while researching new pulmonary doctors. He now has a new doctor and a new machine.

This is good information and so important. I hope this thread stays open with updates. I'll be calling Respironics this week.
 
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