EMR Connectivity for Medical Devices Is a Mess


Yours truly was quoted in a HealthLeaders technology story about, you guessed it, medical device connectivity.

Information technology consultant Tim Gee has a nontechnical description of the current state of connecting medical devices to clinical information systems: “It’s a mess.” Not that direct data capture from medical devices is impossible; some hospitals have been exporting data from devices into clinical information systems for years. But as Gee and other experts point out, the effort can be so confounding that many hospitals don’t even try. Even in highly automated inpatient settings, a common method of data capture from the plethora of monitors, pumps and ventilators is good old pen and paper. Someone, often a nurse, writes down the value and either logs it on paper or re-enters the data online.

The writer, Gary Baldwin, must have caught me on a bad day, it seems I couldn’t say anything nice about anyone.

Trinity exemplifies the industry’s challenge in capturing data directly from medical devices. The health system maintains more than 2,000 physiologic monitors and 9,750 IV pumps, says Kini, adding that the equipment comes from at least five different manufacturers. In this scenario, the key problem, Gee contends, is the absence of industry standards for how data is formatted and exported from the devices. Even devices from the same manufacturer may vary, he says. “Unless a device has the identical model number, the protocol may change,” he says. “To the medical device vendor, their product is the center of the universe. The idea of connectivity is one that vendors have to be pushed kicking and screaming into by their customers.”Hospitals have been willing accomplices up to now, Gee acknowledges. “Most hospital IT departments don’t think about data capture from devices,” he says. “They suffer from the same perspective vendors have. The IT department figures nurses will just type in the data.”

Gary also interviews Julian Goldman, who lends his more soothing perspective to the challenges of connectivity.

Be sure to read the whole thing.

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Defibrillator News


Boston Scientific got some press on their remote monitoring capability.

The LATITUDE patient management system is able to detect clinical
events between a patient's scheduled follow-up visits and then send the
clinical event data directly to the physician.

Over the course of 106,000 monitoring months, and out of a
15,000-patient population with an average follow-up of seven months,
the system detected 948 patients with at least one event of sustained
atrial arrhythmia for more than 24 hours.

This feature has been released for some time, but new data is always an excuse for a press release.

St Jude Medical has received FDA clearance for their wireless ICDs and CRTs. This capability replaces induction wands for programming and receiving data from the implanted devices. Unlike the remote monitoring capability provided by Biotronik and Boston Sci (above), the St Jude feature does not provide remote monitoring between follow ups.

And a while back, Medtronic announced FDA clearance for the first implantable cardiac devices available with Medtronic's
proprietary Conexus Wireless Telemetry, developed using the Medical
Implant Communications Service (MICS, 402-405 MHz). The Medtronic remote monitoring function is limited to transmissions between implanted device and a home based receiver. This contrasts with Biotronik's remote monitoring that uses a mobile phone like gateway devices that can communicate over a wireless carrier network or POTS (plain old telephone system).

Pictured right is the Biotronik wireless remote monitoring gateway, the CardioMessenger.

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Medtronic Delays Sale of Physio-Control


Blaming “market turmoil,” Medtronic announced that the delay of their planned spin-off of Physio-Control. Here's their explanation:

The market for these devices — and more sophisticated versions used by
emergency responders and in hospitals — has been in turmoil since
market leader Medtronic Inc. suspended shipments of its products in
January because of quality issues at its Redmond, Wash., plant.

In reality, the external defibrillator market has in fact been going great guns:

Cardiac Science Corp., of Bothell, Wash., said domestic sales of
AEDs shot up 83 percent in the second-quarter, compared with the same
quarter last year.

Over the past year, its stock rose 28 percent.

Medical Corp., of Chelmsford, Mass., said sales in its North American
pre-hospital market, which includes defibrillators for public places,
increased 43 percent in the third fiscal quarter. But its stock has
performed erratically — up sharply after Physio-Control announced it
was suspending product shipments, but losing steam in recent months.

A more likely reason to delay the sale is that Medtronic won't get a fair value for Physio-Control until they're off ship hold.

In related news, Welch Allyn announced a recall on their AED 20.

Pictured right is the LifePak AED.

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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.

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