What "Law" stops Respironics from talking to us?

[rested gal]

duplicate post deleted

[rested gal]

Ozij, have you seen this letter yourself or can you give us a URL where it is available to read?

I have no doubt she'll be delighted to show Respironics users the lettter in which the FDA demaned they keep the software away from patients.

I think ozij intended her post to be sarcastic...that there is no such letter from the FDA; thus, Ms Yurko wouldn't be able to produce one if asked. And if Ms Yurko, as manager of the Regulatory Affairs, doesn't have such a letter from the FDA... well.

[Slinky]

SnoreDog, are you SURE the FDA is made up mainly of doctors? Or have they become more like the HMOs w/non-medical personnel calling the shots after SOME doctors give their input?? Pardon my skepticism, please.

Seems to me that Wall Street and the bean counters are ruling every aspect of American life now, especially our government! No more wagging the government's tail, they've got a throat hold now and aren't about to let go!

[Slinky]

Thanks, RG. Guess I'm just a little thick yet this morning. Rough night last night. Some congestion and outta sight HIs tho the AIs were just 2.8. Waiting to hear from doctor: appointment or antibiotic script. *sigh*

[Guest]

If there is such a law Respironics can refuse to talk to you. If there isn't a law, Respironics can still refuse to talk to you. It's a slippery slope but they are already on top of the hill.
Even though spraying my nose with Flonase twice a day makes me feel better, The damn pharmacist will no give me enough to do it twice a day unless I bring another prescription in.

[ozij]

Sorry to hear about your bad night, Slinky. I hope the next one will be better.
Rested Gal was right, I was being sarcastic.... Had I found a letter I would of course have posted the link to it. All I found were various letters to Ms. Yurko, all having to deal with Respironics being given permission to sell their various machines.

I found nothing about selling the software.

Snoredog's is an interesting point, and falls in with something I found yesterday on Puritan Bennett's support site ("Solvit center")- they've created a FAQ site, and here's the piece of dialogue I did not like: (emphasis in the original)

http://solvitcenter.puritanbennett.com/afmmain.aspx

Last Update: February 27 2007, 12:31:25 PM
Question / Issue
Is there any way for patients to gain access to the recorded data stored within the GoodKnight 420 CPAP System ?


Answer / Solution

Puritan Bennett manufactures an application called Silverlining® 3 data management software that allows a physician or clinician to extract and then extrapolate the data stored in the GoodKnight® 420S CPAP device, 420E Auto-CPAP device, 425 and 425ST Bi-Level® Device. This software also allows the physician or clinician to download and view this data and make necessary adjustments to prescribed patient settings in these devices. It is for this reason the Silverlining software is not made available for patients as it would allow them to self-adjust their medical prescription.

Somebody out there in the US is clearly concerned about this "medical prescription" business. If only they had called it "self adjust the therapy" and not "self adjust the perscription" there would be no problem....

O.

[Slinky]

It seems to be a d*mn conspiracy on the part of the medical profession. Keep the patient in the dark ages so they don't recognize when we don't know what we're doing! Gads, I get so darned tired of that attitude!!!

[Guest]

LOL you can't get a 'prescription' for a piece of software...

[Slinky]

Ha ha! I can get a script for ANYTHING. All that is needed is a script pad, an illegible signature and a number. Doesn't mean I'll get what the script calls for but the script itself isn't all that difficult.

[dllfo]

Hi Snoredog,
"Just because you have a SV machine or your doctor wrote you a script for the software doesn't make it ok for you to call the manufacturer for advice."
I would agree with you except the software TOLD me to call that number.

And as was pointed out later, I DO have both manuals. No one else around here knows as much as I do (apparently). I asked for the names of any RTs or DMEs who have been trained in the Sacramento area and neither of us (me or the Respironics rep) know of even one. OK, partly my fault I got so sick and wanted Respironics. Many are already trained on the Resmed.

The lights will dim. You just have to wait awhile. I was on the phone with Respironics for some time this morning. If you ask them nicely, they will try to help ... UP TO A POINT. I would pile 3 handkerchiefs on the lights and go to sleep. Luckily, I can be asleep in a minute or two most nights. If I miss that window of opportunity, I seem to be up half the night.

PB sounds like a great company to work with, which of their models has the
Servo Ventilation feature???

"Encore Pro is not going to allow you to turn the LED's off anyway..." I don't remember implying Encore Pro would do that. I know better.

Surprisingly, the Respironics person agreed with several of my ideas and said they will submit them to the designers.

The only issue we haven't resolved is the alarms and other noise makers.
These machines are built to medical standards and have redundancy of systems within them. Put another way, if I cut a wire, or sucked the solder out of a board, the machine would probably quit. It has a diagnostic loop to check itself out.........pretty smart engineers, but they need to have a dozen of us check out the new machines. (Won't happen I guess

While brainstorming about the alarms, we decided I will try shoving the mask into my pillow so the air won't just sail through, setting of an alarm. I will see if that works.

For those who think Respironics doesn't care, you are wrong. You have to discern what it is that they do care about and approach them from that angle.
For example, read their charter with the FDA, always a loophole to pursue there. Or if Medicare & Tricare start receiving complaints that the machines are NOT solving the respiratory problems, P&B and Resmed would be very happy. Every corporation cares about something.

OceanPearl, you make an excellent point. Respironics does not have to talk to us, BUT THEY ARE RESPONSIBLE FOR TRAINING RTs AND DMEs aren't they?
IF they want us to use their products, and if they don't want to have to talk to us, they had better train people.

If I complained to Medicare, and it was well presented and documented, that Respironics put out this really good machine, but isn't training anyone on how to set it up and isn't allowing the users to call them...their liability would be off the charts. They aren't that dumb, or most of them are not. Even the employee who kept repeating he could not help me...I could tell he was frustrated as much as I was.

I TOLD RESPIRONICS THEY SHOULD COMPLY WITH THE DIRECTIVES TO TRAIN SUFFICIENT DME AND RT PERSONNEL SO I CAN CALL A DME OR AN RT.
Respironics could not name one person in my area I can call. NOW IT IS ON THEM TO TALK TO ME OR THE FDA. Don't tell me to talk to an RT if you have not trained any in my area. And we have well over two million people in the greater Sacramento area. (source: CSUS study)

If something happens and I cannot resolve it informally, I would not hesitate to file congressional complaints against the FDA for not enforcing the training side of the equation.

Don't underestimate the power we have when it is appropriately applied.

[dllfo]

Guest

Also Posted As:
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(SleepNapnia)
(thedean)

I HAVE THE PRESCRIPTION IN MY FILE. Apria has it also.

[ablong]

Good Work dllfo

You just pur a smile on my face


73's

Allen

[dllfo]

Thanks Ablong, good hearing from you. I am trying to work with Respironics on this new unit but as a corporate entity, they sometimes lose sight of the fact THEY have responsibilities to us. I reminded them.

If we can communicate with them and show them they have to train DMEs before we can use them, maybe they will be easier to deal with.

Corporations do not operate in a vacuum. They answer to their shareholders, their Board of Directors. the FDA, Medicare, Tricare and others.

[Vasily]

dllfo,

Where did you purchase the SV if I might ask, and why aren't you going back to them for advice on how to set it up?

I would say that whatever entity you bought the device from SHOULD have an individual trained on that device in order to sell it. I currently have 2 SV's and an AVAPS sitting in my office. I have been cleared to put the SV out on a patient, but that's only because the Respironics rep was here a week ago and gave me an inservice on it. Our policy is, NO Inservice, it does not go out on a patient. I believe EVERY company that sells these items should be held to that type of standard.

I did look around on the SV today and you are correct the lights do dim after a few minutes, ofcourse I use and M Series machine and the lights on it never bother me, so these didn't do much for me in a dark room either.

[ozij]

Very good post, dllfo - and please do not think I was implying you should try PB - who clearly does not have the machine you need, and I know it.

I mentioned being a happy user of PB as an indirect explanation of why I am not writing Ms. Yurko myself.

If I complained to Medicare, and it was well presented and documented, that Respironics put out this really good machine, but isn't training anyone on how to set it up and isn't allowing the users to call them...their liability would be off the charts. They aren't that dumb, or most of them are not. Even the employee who kept repeating he could not help me...I could tell he was frustrated as much as I was.

I TOLD RESPIRONICS THEY SHOULD COMPLY WITH THE DIRECTIVES TO TRAIN SUFFICIENT DME AND RT PERSONNEL SO I CAN CALL A DME OR AN RT.
Respironics could not name one person in my area I can call. NOW IT IS ON THEM TO TALK TO ME OR THE FDA. Don't tell me to talk to an RT if you have not trained any in my area. And we have well over two million people in the greater Sacramento area. (source: CSUS study)

If something happens and I cannot resolve it informally, I would not hesitate to file congressional complaints against the FDA for not enforcing the training side of the equation.

Don't underestimate the power we have when it is appropriately applied.

Excellent points.

For those who think Respironics doesn't care, you are wrong. You have to discern what it is that they do care about and approach them from that angle.
For example, read their charter with the FDA, always a loophole to pursue there. Or if Medicare & Tricare start receiving complaints that the machines are NOT solving the respiratory problems, P&B and Resmed would be very happy. Every corporation cares about something.

Once again, I fully agree with you. There is major difference between the corporation caring for itself (which is legitimate), and the leverage it gives us to help the corporation serve us better (and earn more money) and the kind of PR ploys used by representatives who explain their company "cares" about the patients, and then disappear - it was the latter I was being sarcastic about.

I am always impressed by the way you go about handling the people who give you less than optimal service - and have learned from it.

Please keep us up to date on Respironics' further responses e.g. if they ever let you know they now have a trained RT in you area.

Since you did get the machine you need (and I'm glad) clearly the liability of handing you this dangerous equipment with the double dangerous software is less than the liability of not giving you anything. I wish they had this as policy across the board.

O.

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