CardioNet Arrhythmia Detector Receives 510k

CardioNet

CardioNet appears to be moving beyond high tech holter monitoring and into ambulatory cardiac monitoring. The new device has be ability to do arrhythmia detection in the sensor (rather than the PDA-like monitor) and transmitting alarms to CardioNet's Monitoring Center that provides 24×7 analysis of alarms and related cardiac rhythms.

The last two pages of the FDA approval document (pdf file) list 8 outpatient cardiac monitoring indications for use. The document also describes, “[d]ata from the device may be used by another device to analyze, measure or report QT interval.” This sounds like export to an ECG cart.

Pictured right is the old CardioNet device, shot at the Healthcare Unbound conference this past summer.

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Boston Scientific Brags on GE EMR Integration

Zoom-Latitude-programmer

Last month (November) Boston Scientific announced FDA approval of LATITUDE 2.0 Patient Management software with “remote data integration capabilities.”

LATITUDE Patient Management is the first and only remote monitoring
system to provide clinicians with direct device data integration
capability into GE's Centricity Electronic Medical Record (EMR). The
enhanced version of the LATITUDE website also provides increased
efficiencies to clinicians through streamlined system navigation,
increased alert flexibility, faster printing and fine-tuned automatic
scheduling.

Everything that generates patient data needs to integrate with an EMR, and ICDs are no exception. The fact that Boston Scientific is the first is not that big a deal; I expect their competitors to quickly follow suit. The interesting questions here revolve around how they've implemented their connectivity, especially their business processes around connectivity and the resulting costs.

Since a lot of pacemaker programmers, software and services are given away to hospitals and physicians – the classic “give away the razor to sell the blades” – the costs to develop and maintain EMR integration is a cost that comes right off the bottom line. Because EMR integration is one of those things that either works or it doesn't, there is no competitive advantage in usability or some other qualitative performance characteristic. Given how fragmented the EMR market is, and there are hundreds of EMR vendors, the ICD vendor with the most efficient and low cost connectivity strategy will be the winner here.

Pictured right is the Zoom Latitude wireless programmer.

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Bar Code vs. RFID Smack Down

Aztec-barcode

Health Data Management has an article on the use of bar codes and RFID for patient identification, meds admin, blood transfusions, collecting lab specimens, etc. Passive RFID performs better than bar codes – easier to read – but the significant price differential between even 2D bar codes and passive RFID tags will stymie RFID adoption for now.

At
this point in the race, RFID's superior functionality-no line of sight
required-is often being trumped by the convenience and lower cost of
bar code systems, experts say.

Passive RFID tags often cost $1 or more each, and the handheld
readers are more expensive than comparable handheld bar code readers.

Bar codes also are already affixed by manufacturers and suppliers to items such as medications and blood bags.

Patient tracking is mentioned as an application for passive RFID. Sure, you could use passive RFID tags with readers positioned at strategic choke-points, like the entrance to labor and delivery. Such a deployment would only be good for things like infant abduction and patient elopement. Passive RFID cannot provide true tracking (as defined in this post).

The issues that have plagued bar codes still exist, but good planning and execution can greatly minimize problems. Use two-dimensional bar codes, and make sure they're oriented for maximum readability. The use of permanent ink in bar code printers, and quality materials on which the bar codes are printed also improve readability. Expect to replace bar codes, especially on patients with a greater than average length of stay.

Some hospitals confuse patient identification workflows (around the applications mentioned above) and active RFID. And then there's this canard:

The
vendor's Real Time Location System uses tags that emit RF signals that
can be tracked by Wi-Fi networks. A big selling point for the system
was that the hospital didn't have to install RF antennas but could use
its existing Wi-Fi network, also from Symbol.

Regular readers of this blog know better. Pictured right is an Aztec 2D barcode.

UPDATE: HIT veteran Charles Fox adds some pithy observations on RFID versus barcode in the comments below, including this:

“…the major obstacle [with RFID] I see is tag ambiguity. It's still too easy for RFID tags on
two closely positioned patients to be confused. This situation occurs frequently
in venues such as PACU and ED.”
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