Home Use of Medical Devices Challenges FDA
Medical Devices Today has a good post on potential safety and effectiveness issues surrounding medical devices where home use by patients is outside the scope if intended use. “Although manufacturers need FDA approval to market a device
over-the-counter directly to a patient or specifically for home use,
there are few restrictions on whether a physician can send a patient
home with a device that is not specifically labeled for use in the home.”
One of the biggest issues revolves around older devices that have been replaced and become hand-me-downs for home health. Concerns include:
- Neither devices or directions for use not designed for patient use
- Hand-me-down devices frequently missing directions for use
- Patient purchased devices, e.g., after the reimbursed rental period, end up getting “recycled” through eBay – with no safeguards for proper maintenance, operation or directions for use
- Proper distribution channel safeguards to ensure safety and effectiveness when sold retail or through other resellers
Besides contemplating new regulations or legislation, the FDA is making the following responses:
Meanwhile, in the next six months FDA hopes to invite manufacturers
to participate in its new online labeling repository for home-use
devices. The voluntary repository, which will initially focus on
infusion pumps, will give consumers access to the most up-to-date
instructions for specific models.
The agency is also preparing to launch a sub-network of its MedSun
adverse event reporting program called HomeNet. Participating home
health agencies will be encouraged to report to FDA adverse events,
including close-calls, related to devices used in the home setting.
Be sure to read the whole thing. Pictured right is a Baxter Syndeo pump – perhaps something that might be used in the home?
Biomed Listserv Is Moving
Mike Kauffman’s labor of love, the Biomed Listserv has moved. Once hosted by AOL, Mike’s snapped up an Internet domain (www.bmetsonline.org) and is adding some new features to extend the email listserv.
If you’re already subscribed to the Biomed Listserv, Mike has already moved all the subscribers to the new system (thanks Mike!). If you want to subscribe, click here. Be sure to check out the FAQ first. Starting January, 2008 Mike will be charging list subscribers a modest annual fee – well worth the investment.
UPDATE: The Biomed Listserv is now called Biomedtalk, and is sponsored and administrated by the ECRI Institute. Here’s a description of the transition from Mike Kauffman to the ECRI Institute from a press release:
ounded in 1997 by Mike Kauffman, assistant director of facilities for the Reading Hospital and Medical Center in Reading, PA, Biomedtalk became an active forum for discussion across all members of the biomedical and clinical engineering profession.
The listserv now has over 1,700 members, having attracted over 100 new members since March 1, 2010, when ECRI Institute took the reins and discontinued the membership fee.
See FAQ number two on this web page on ECRI’s site to learn how to subscribe to the listserv. There’s a searchable archive too, but you have to register (here’s how).
Networking Medical Devices Ignored by Medical Automation
Dana Blankenhorn, ZDNet Healthcare writer and blogger became an honorary Connectologist today with his short story on medical device connectivity. Dana lead with a consumer electronics comparison of plug and play printers that operate with personal computers.
can easily install, which will allow ready communication between it and
your PC. You expect it to deal with files created by your PC, and you
expect your PC to deal with its files, too.
It took years for this to become routine, and replicating this ease-of-use is one of the great challenges open source still faces.
In the medical device market, however, this work has not even begun. In fact it has barely been imagined.
Ah, but it has been imagined – in mind numbing detail – by the feverish minds found reading this site. Dana refers to previous blog post on this site to make his point about the complexities and challenges of medical device connectivity.
He forthrightly states, “This is nothing less than a scandal. Common standards and interfaces
are needed to change this. The PC industry has lots of standards to
choose from, which interoperate. The medical market needs the same
thing.”
Pending FDA Legislation Mandates Unique IDs for Medical Devices
The bill to mandate unique IDs for medical devices is expected to be signed into law as a part of a Food and Drug
Administration bill currently making its way to President Bush's desk. I've not read the bill, but this is what supporters contend:
Modernization Act portion of the FDA Amendments Act of 2007, would
enable universal tracking and easier location of products in the case
of a recall, say supporters of the provision. It would also allow
hospitals to better compare products in specific categories.
Since all medical devices (except things like, you know, tongue depressors) already require unique serial numbers, and furthermore all medical device vendors are required to maintain a device history file for each medical device, I don't see how this legislation will improve tracking or recall of devices. And enabling hospitals to “better compare products in specific categories” seems like fantasy.
for some manufacturers. “One of the complications the FDA will have to
face is that medical devices include everything from Band-Aids to very
complicated implantable devices,” said Joe Pleasant, chairman of the
Coalition for Healthcare eStandards–an advocacy organization that has
worked with the FDA on the issue. “I think what the agency may try to
do is say requirements will be different depending on the class of the
device.”
The potential benefits that I've heard suggested from this are all dependent on the creation of an industry wide numbering scheme ($$), electronic systems for vendors to track products and issue/manage recalls ($$$), and similar systems for each medical device user so that device usage can be tracked and reconciled with vendor data ($$$$$).
Now these are laudable goals, but somebody – I mean besides those who envision profitable new business models out of all this – should evaluate how realistic all of this is and what any return on investment might be. Oh wait, the FDA's already done this.
Verizon Announces Move from CDMA/EV-DO to GSM-based LTE
Since before I did health care wireless data at AT&T Wireless in the naughties, there were rumors that Verizon would eventually abandon CDMA for a wireless telephony standard that was compatible with their joint venture partner Vodaphone's GSM-based network in Europe. Well it's finally happening.
Currently AT&T and T-Mobile (along with Europe) are running a GSM-based network that includes GPRS, EDGE, and UMTS (which includes HSPDA). Confused yet? Each acronym in the preceding alphabet soup provides faster wireless data speeds, increasing from GPRS to HSPDA. Sprint and Verizon have used CDMA-based networks, with the fastest data service called EV-DO.
Partisans from the two GSM/CDMA camps argue vociferously as to which technology provides the best quality and speed. The performance difference between the two is close enough not to matter to us mere mortals.
Many of these different designations in network performance represent software updates or minor hardware upgrades. Some jumps to the next level of OTA (that's “over the air”) performance require a forklift upgrade – i.e., swapping out cell tower radio hardware for totally new equipment. Forklift upgrades are kept to a minimum, because each time a carrier has to replace all their cell tower hardware they have an opportunity to switch vendors.
Vodaphone was recently making noises about pulling out of their half of the U.S. Verizon Wireless joint venture – which would have required Verizon to pony up billions to buy them out or risk being saddled by an unknown new partner. Instead, Verizon decided to placate Vodaphone and agree to merge technologies in the near term – 3 or 4 years. I'm not sure if this jump is coincident to a forklift upgrade after EV-DO, or increased pressure from Vodaphone – perhaps a reader can enlighten us.
The new technology is called LTE and will provide 100 mb/sec download speeds. With the adoption of this new standard, wireless carriers will be running pure TCP/IP networks over the wireless link for the first time.
What does this mean for health care? If you're planning to embed a cellular radio into a medical device, in the next 3 or 4 years you will probably want to use an LTE radio. In addition to supporting both European and U.S. market, the LTE radio will run on 3 carriers networks, increasing the chance your end user will find a carrier that provides decent coverage.
Don't worry about Qualcomm in all this. They hold patents a-plenty in the LTE sphere (which is based on W-CDMA). This will actually improve Qualcomm's value proposition. Before with the cellular market divided between Sprint/Verizon and Cingular/T-Mobile there just wasn't enough critical mass on the carrier side to drive adoption. Now with the two biggest carriers on the same technology base, Healthcare Unbound mobile phone based applications could really take off.
Although Verizon's announcement put a fly in the ointment of Qualcomm's MVNO project, LifeComm.
AAHSA Annual Meeting Courts Bloggers
I was cleaning out the inbox this afternoon. An email promoting the upcoming AAHSA conference sported a big bile-colored text box with the following:
Calling All
Bloggers
Help create the future of aging services by sharing your
Annual Meeting experience through your blog. Write about your thoughts,
perspectives and share what you learned at AAHSA's annual meeting.
Bring your own laptop and we'll even provide wireless Internet
access if you'll blog during the conference.
Send us the URL for
your blog and we will reference it in our communications about the meeting as
well. What better way to get others engaged and talking about the importance of
what we do?
Contact Lauren
Shaham to let us know where to find you in the blogosphere.
I don't plan on attending, but it is nice to see associations and producers recognize the value that bloggers can bring to their events.
