Baxter Struggles with Recall of Colleague Pump
The Chicago Trib runs a story today (reg req) about comments made by Baxter Chair and CEO Robert Parkinson to shareholders about efforts to resolve problems with their Colleague infusion pump.
company's annual meeting held at the Palmer House Hilton downtown,
Parkinson said Baxter awaits Food and Drug Administration approval of
the Deerfield-based medical products-maker's plan to fix and eventually
begin selling the pumps again. The company has been dogged by a federal
investigation into the pumps' problems.
The FDA in October
seized nearly 7,000 devices, mostly Colleague pumps, distributed from
two of Baxter's suburban facilities as part of an escalating probe of
the pumps, used primarily in hospitals to deliver medications to
patients intravenously.
A variety of issues, perhaps related to
hardware or software design, and other issues related to the Colleague
pump may be linked to seven deaths and 16 serious injuries, the company
and the FDA have said.
Baxter has not sold the pump since July of last year. The last full year of Colleague pumps generated about $170 million in sales. The Colleague has an installed base of over 200,000 pumps in the U.S., and another 40,000 mostly in Canada, Europe and Australia.
According to Baxter, “the primary issues the company is
addressing in regard to the pump are related to “design and usability”
as well as software and hardware issues involving the device's timing
mechanism.” A few months ago, there was an informal survey on the Biomed Listserv asking how many hospitals had Colleague pumps with the error code that caused the initial recall. While the result was a distinct minority that found the error code, I was surprise the problem was as wide spread as it was. Having been through my share of regulatory “situations” in the past, I don't expect to see Baxter selling pumps any time soon.
There are some great folks on the pump team at Baxter and I'm sure they're doing their best to do right by their customers and their patients. Pictured right is the Colleague integrated with a Philips patient monitor, shown as an advanced development project at AACN/NTI 2005.
Hillenbrand Reports Financials
Hillenbrand reports profits up, revenues down (slightly) for the second quarter. Earnings came in at $54.5 million, compared to $54 million for the same period last year.
The company also said its restructuring efforts, which the company
announced in September, are being executed as planned in the United
States and Europe.
Hillenbrand said it's on target to achieve its projected cost savings of $41 million this year from the restructuring.
The company's revenues fell 1 percent to $495.6 million.
According to new CEO, Peter Soderberg, restructuring progress should continue through the year.
Summit Data Communications to Support Cisco CCX
Chris Bolinger of Summit Data was kind enough to email me with some additional information on their embedded Wi-Fi radios (original post here).
Since most hospitals are Cisco shops, support for CCX (Cisco Compatible eXtensions) could have great appeal to IT departments. While Cisco has received credit for encouraging chip-set vendors to adopt all of the latest 802.11 standards, Cisco's CCX also includes some proprietary features. Specific CCX features include:
- Support for WPA (Wi-Fi Protected Access) and WPA2,
including a variety of EAP types; - WMM (Wi-Fi
Multimedia), a subset of 802.11e QoS (Quality of Service); - Fast roaming using the Cisco CCKM
(Cisco Centralized Key Management) protocol; - And RF management features
such as client RF scanning and reporting, as well as AP-specified
maximum client transmission power.
Some of these features (you know, the standards) will work with any industry standard access point (AP), while others work only with Cisco infrastructure. General purpose PC oriented NICs (network interface cards) support CCX, while application specific devices (ASDs as Summit calls them) have for the most part gone without.
To Cisco's credit, rather than using proprietary tech in place of standards, they have adopted industry standards and used proprietary tech to add capabilities that lie beyond what standards can provide. The relentless message to medical device vendors is that, “It's a general purpose computing world, baby.” The better they leverage the tools and capabilities of that world in their medical device systems, the better for everyone – the days of private networks, proprietary networks (WMTS), and dedicated VLANs are fading.
Pictured right is the Cisco Capatible logo that's earned through the CCX program for WLAN client devices.
Sensatex to Test Novel Sensor Technology
According to Health Data Management, Sensatex is looking for beta testers for its SmartShirt System.
Sensatex is using technology developed at the Georgia Institute of Technology to weave tiny conductive fibers into the cotton
fabric of a shirt to enable monitoring of physiological activity. Funded by DARPA for the 21st Century Land Warrior Program, the technology allows sensing, monitoring, and information processing devices to be networked together within a fabric.
The
conductive fiber collects data on a wearer's movement, heart rate and
respiration rate in real time. The shirt, minus the snap-on device, is
washable, according to the Bethesda, Md.-based vendor.
company envisions the shirt being used to remotely monitor home-based
patients, first responders, hazardous materials workers and soldiers.
It also can be used to monitor signs of fatigue in truck drivers and to
support athletic training.
Field testing is planned for later this year. Parties interested in testing the technology can send an e-mail to Robert Kalik, CEO at
Sensatex, at rkalik@sensetex.com.
Pictured right is an example of sensors distributed throughout a knit shirt.
Philips Launches Motiva in U.S.
Philips has announced the commercial launch of their remote monitoring system Motiva for the U.S. market (press release). The system is designed around the patient's home television, abut also requires a broadband connection and set to box.
Motiva supports daily vital signs monitoring for high-acuity
patients using wireless devices installed in the home. The current
product includes Bluetooth-enabled weight measurement, while future
Motiva releases are expected to incorporate blood pressure and glucose
measurement.
For every patient, Motiva monitors ongoing health status, usage
patterns and regularly queries patients about changes in their
knowledge, motivation and confidence levels — insights nurses can use
to adapt care plans and gauge impact on long-term behavior.
The requirement for a broadband connection will limit deployment to urban and suburban areas, and the set top box suggests an expensive installation. No mention was made about Philips distribution strategy.
Like weight loss and addiction treatment programs, there is probably
not one “best” approach to chronic disease management. In a comment to a past post,
David Williams noted that many of the chronically ill don't want to be
continuously reminded about their illness – making daily interaction
with your own reality TV show about your chronic disease less then
compelling. I would also expect this approach to be well accepted by
some patients; time will tell who they are and proportion of the
patient population they represent.
Pictured right is the Bluetooth enabled non-invasive blood pressure recorder.
