From the Federal Register for 04/21/2010

[howkim]

As a part of my job, I monitor health-related Federal Register notices. There was a pre-publication alert today that I thought might be of interest to this group. I will try to remember to post the permanent URL tomorrow after the official publication.

Docket No. FDA-2010-N-0202, ORA 201014. Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device Technology Migrating Into the Home; Public Workshop; Request for Comments. Meeting on May 24, 2010 Comments due June 30, 2010 http://edocket.access.gpo.gov/2010/pdf/2010-9287.pdf

ETA: The URL is updated.

[xyz]

"The purpose of the workshop is to solicit information from healthcare providers, ... patients, and caregivers, on the challenges surrounding medical device technology in the home environment."

I am not a fan of government over-regulation, but in the case of DMEs they could start with regulating and fining DMEs that lie to patients.

One of the greatest challenges that new OSA patients face is being told something by their DME that isn't true at all.

The stories that I read here on cpaptalk.com cause me to shake my head.
There is a huge amount of abuse going on.
And it's all to increase the profits for the DMEs.
At the customer's expense, both financially and in terms of their health.

"No, you can't have that auto machine without paying us extra for it."
"No, you can't get that mask for six months."

ad infinitum

[Kate P]

Thank you!

I know someone who is a sleep/pulmonary physician (MD) and definitely wants to comment. Can you tell me how to monitor those health-related Federal Register notices-is there a special way to monitor only the health related ones, and perhaps have them sent to my email? Are there services that do that?

I work for an activist Physician, & it is more fun than it was working for non-activist ones. He works for patients rights and can't stand games played by DME suppliers (among others)!

Plus I am a CPAP user. My local DME supplier wanted $1100 and two appointments to supply me with a Puritan Bennett Good Knight machine. I got mine at CPAP dot com for $294. The hours and service is better and all the info on the site is great. NEVER believe the things that DME suppliers tell you-ALWAYS check online first!

[howkim]

Can you tell me how to monitor those health-related Federal Register notices-is there a special way to monitor only the health related ones, and perhaps have them sent to my email? Are there services that do that?

Hi, Kate,

The FDA website has its own Federal Register section about publications related to it. You can find it at http://www.accessdata.fda.gov/scripts/o ... /index.cfm . There are quite a few other newsletters available, some free some subscription.

[howkim]

There are a couple of other things from the FDA. A press release at http://www.fda.gov/NewsEvents/Newsroom/ ... 209138.htm and a white paper at http://www.fda.gov/downloads/MedicalDev ... 209056.pdf.

I posted this information as I believe that this kind of meeting represents an opportunity for we who use these "complex" home use devices to tell the FDA what we think of the regulations and how they affect us.

[DreamDiver]

There are a couple of other things from the FDA. A press release at http://www.fda.gov/NewsEvents/Newsroom/ ... 209138.htm and a white paper at http://www.fda.gov/downloads/MedicalDev ... 209056.pdf.

I posted this information as I believe that this kind of meeting represents an opportunity for we who use these "complex" home use devices to tell the FDA what we think of the regulations and how they affect us.

howkim,
Typically, when there is a 'request for comments', along with a number of documents to read, there is also a place on line where the public can comment in a form. In this case, there seems to be a place where you can register to actually go to the conference and vocally express yourself as well. This link provides information on how to participate on several different levels with different deadlines for the various levels of participation. I certainly would like to put together some choice comments myself.

[howkim]

Typically, when there is a 'request for comments', along with a number of documents to read, there is also a place on line where the public can comment in a form. In this case, there seems to be a place where you can register to actually go to the conference and vocally express yourself as well. This link provides information on how to participate on several different levels with different deadlines for the various levels of participation. I certainly would like to put together some choice comments myself.

That is certainly true for Advisory Committee meetings, too. Also, the Advisory Committees are supposed to have consumer representation of some sort in the membership of the Committee. This is apparently a "workshop" (whatever that means). It's still a way of allowing consumer voices to be heard in the regulatory process.

I always enjoy reading comments, especially the consumer comments, to the varying Public Dockets that the FDA initiates. While it's kind of tricky to figure out, http://www.regulations.gov allows one to read them. (Hint: If you have a Federal Register item that requests comments, there will be a Docket Number included. Use that Number at regulations.gov to see all the comments filed to that particular Docket.) I believe that the website also has instructions for how to file comments to the varying Dockets.