Got a call from Puritan-Bennett

A customer service person from Puritan-Bennett called me about an hour ago in answer to an Email I sent to the company.

His first question was whether I was a health care professional. He said that there are certain limits to what they can discuss with patients as opposed to professionals or DME's. He said that he was quite surprised to find out that I was not a DME because my questions were so specific and precise. I told him about cpaptalk.com and he said that he scans the posts on the talk lines just about every day and is impressed with the level of knowledge being exchanged. But he said that the FDA has placed limits on what information they can disseminate to patients because in the past people have damaged their health by making changes to the settings without realizing what they were doing.

Boy! I sure hope I didn't get my DME in trouble! He said that the FDA does not allow providers to give clinical manuals to patients.

He also said that PB does not have a machine on the market that is called a "425e". The "e" machine is a 420.

He also said that PB does not have a machine with C-flex, mainly because their machines are sensitive enough that the flex feature is not needed. He said that PB machines can sense the change from inspiration to expiration within 6/100ths of a second and so the change in pressure settings does not need to be "covered up" with a different intermediate pressure setting. (That part didn't make a whole lot of sense, but that's sort of what he said.)

But on the positive side, he said that the new BiPAP with S/T should be fully compatible with SL 3.6 and be able to give all the clinical data that the 425 does not (but they are also working on improving that problem).

Great report, Judy!! (Judith?)

When he got into the C-flex bit, I think he was deliberately ignoring the concept of what it does in a straight cpap and in an autopap. Sounds like he bounced way over into bi-level territory... marketing yadda-yadda to avoid the issue. heheh.

The reason that whole part didn't make a lot of sense was because apples and oranges were getting mixed together.

PB is probably getting a bit annoyed hearing about people enjoying C-Flex especially after Respironics added it to their REMstar autopap. Probably PB is even more defensive about that kind of discussion now that ResMed is coming out with their own version of exhalation relief in a cpap, too.

Good job getting him to talk to you at all, Judy!

ahujudybear wrote:....he said that the FDA has placed limits on what information they can disseminate to patients because in the past people have damaged their health by making changes to the settings without realizing what they were doing.

Boy! I sure hope I didn't get my DME in trouble! He said that the FDA does not allow providers to give clinical manuals to patients....

Ya, better to keep patients operating in the dark and tell them nothing...hmmm what's that old mushroom joke?

I think these FDA lines are bull crap...

-JB, who did you write to?

This "FDA won't let us" business sure sounds fishy. Unless, maybe their claims lawyer's initials are "FDA"?

O.

This is rich!
I just did a search for CPAP in fda.gov, and this it what I found, in the FDA Enforcement Report section: (my emphasis).



PRODUCT Patient Guide Companionr 318 Nasal CPAP
System, used for the treatment of obstructive
sleep apnea:
(a) Companionr 318 Nasal CPAP Home Care
Assembly, Catalog No. 126800-00
(b) Companionr 318 Nasal CPAP Home Care
Assembly without the Hourmeter, Catalog No.
126804-00. Recall #Z-972/973-6.
CODE Lot numbers: (a) 512141D, 512142D, 512191B,
601021D, 601111D, 601291D, 602121D,602271D,
603041D, and 603131D;
(b) 512111B, 512181B, 512271B, 602051B,
601081B, and 601231B.
MANUFACTURER Lithographics, Overland Park, Kansas (patient
guide).
RECALLED BY Nellcor Puritan Bennett Corporation, Lenexa,
Kansas, by letters dated May 23 or 24, 1996.
Firm-initiated field correction ongoing
DISTRIBUTION Nationwide, Canada.
QUANTITY 2,247 manuals were distributed.
REASON Some of the patient guides had sections
omitted.

http://www.puritanbennett.com/about/CONTACTUS.ASPX

This page gives several ways to contact them. I have done this before, but this was the first time they answered by telephone!

Re: FDA - I can believe him. Remember the big flap about Respironics and Iron Lungs? The FDA wouldn't let Respironics (or anyone else) use Emerson's schematics to reproduce the parts on a large scale because they did not have the "verification papers" delineating the tests performed on various material formulae to see which would be the most durable. (And this would take years of testing to replicate)

Re: Flex - I believe that too. From my experience the Puritan-Bennett machines are far more sensitive to insp/exp changes than the others. There is no way that I can use a Sullivan (?)(The flat one with the built-in handle across the front?). Respironics (is that Resmed now?) older model was much better, but not responsive enough for my muscle strength. The PB was and is wonderfully easy to breathe with. It has more sensitivity settings than other BiPAPs. He explained it as a reversal of the blower when the settings change to soften the shift in pressure. That plus the fast response time (set at .01 seconds on my machine) for giving you a breath make PB machines much smoother in operation than the others, IMHO... at least for the BiPAPs.

This guy said that there were some people who were able to change their settings, thinking that if a setting of 8 is good, then 16 must be twice as good... and ended up in the hospital and sued the manufacturing company.

He said it's like Rx medicine. You get what the Dr. orders and use it as directed. (But I told him that I was self-adjusting my diabetes Rx because I was taking too strong a dose and found myself having to eat more than I wanted to, just to keep up with the RX! I have 5mg, 2.5mg and 1.25mg tablets, and with my Dr's blessing and direction, have been testing various combinations and letting him know each time I change it. He (the guy from PB) thought that was very strange. <LOL> I'm down from 5mgx2/d to 1.25Mg AM and 2.5mg PM.)

I asked him some specific questions about the read-outs, but he couldn't answer because I was not a clinician.

But as frustrating as it was, we had a nice long conversation.