AirStrip OB Users Profiled
GE Healthcare introduced AirStrip OB, their wireless fetal monitoring surveillance product at HIMSS 2006 in San Diego. Here’s a story about the system and some early users in the San Antonio Express News. The 510(k) approved system transmits near real-time waveforms from GE fetal monitors for obstetrician’s to use in diagnosis and treatment decisions during labor. The system took 2 years to develop by software vendor MP4, and is sold by GE exclusively into the labor and delivery market.
The first facility in the country to install AirStrip was Fairview Hospital, part of the Cleveland Clinic in Ohio.
“Our chairman saw a demo and said, ‘We have to have it,’” said Terry McDaniel, system administrator for CentriCity Perinatal at Fairview.
It launched in September with 10 doctors. Through word of mouth, two or three more ask to be added each month, McDaniel said.
She said some of the doctors are heavy users of the new technology for everything from looking at readings that an on-site nurse may find troubling to viewing test results immediately.
AirStrip OB will be in eight hospitals and used by 191 doctors by February, and MP4 executives expect usage to grow quickly. It has just been approved by hospital giant HCA Corp. for installation in any of their 200 hospitals that want it.
And GE is marketing to the 1,500 hospitals around the country that already have GE labor and delivery monitoring equipment compatible with AirStrip.
It costs about $60,000 for a hospital to install the software that lets GE Healthcare’s obstetrics monitoring equipment in the hospital communicate with the doctors’ hand-held devices. Physicians then pay an annual subscription fee of $299.
Pictured right is fetal monitoring data being streamed to a Nokia smartphone via AirStrip at HIMSS 2006.
Philips Launches New Spot Check Vitial Signs Monitor – VS3
Targeting both acute care and alternate care markets, Philips introduced the SureSigns VS3 vital signs monitor today (press release). The new monitor builds on their new line of low acuity patient monitors, the VM 4, 6 and 8.
The SureSigns VS3 provides easy access to patient information
using innovative pop-up screens, fixed keys and icon-based menus. The
full-color, back-lit screen displays large, easy-to-read numerals that
are especially helpful when viewing from a distance or in low light
situations. The screen also provides clinicians with the choice of
viewing scrollable stored patient records and an optional Sp02
waveform. SureSigns VS3 measurements include non-invasive blood
pressure, pulse oximetry, pulse rate and temperature. With
programmable non-invasive blood pressure capabilities, users can
create up to five different programs to monitor non-invasive blood
pressure at particular intervals based on unit-specific protocols.
The SureSigns VS3's standard lithium ion battery and AC power cord
clip enhance battery operation and charging performance. Software
upgrades are remarkably quick and easy via the USB port and patient
data transfer is enabled with HL7 data output through an Ethernet
connection. In addition, an optional bar code scanner capable of
reading both one and two-dimensional bar codes makes patient ID entry
fast and accurate. The innovative design also makes the SureSigns VS3
monitor easy to support. Replacement parts are compatible with the
SureSigns VM monitors to help streamline parts inventory management
and repair.
The press release brags on the new 8.4″ color LCD, compared to the much smaller and purpose-built user interfaces found on spot vital signs monitors from, well, everyone else (GE Dynamap, Datascope Accutorr and Duo, Welch Allyn Spot, and Philips VS1). My guess is that Philips was tired of selling a vital signs monitor they OEM'd from someone else – the VS1 is from Colin. That plus the VS1 lacked network connectivity which was probably hurting competitively.
The VS3 sports an Ethernet port and has HL7 output from the device – another feature shared with the VM product line. Spot vital signs capture entails pushing the monitor from patient to patient several times a day to take readings. Given the inherently mobile nature of the task (compared to an ICU patient connected to a wall mounted patient monitor), it's disappointing there is no wireless capability on the VS3. Rolling the VS3 into a corner to recharge while you download data over a hardwired Ethernet connection will work, but will be a source of frustration for many customers. I can just imagine were staff grabs the pole mounted VS3 and takes off for their first reading, ripping the Ethernet cable and wall plate out of the wall (not to mention possibly damaging the VS3). The unit can store an impressive 400 readings in batch mode. And the onboard barcode reader is also pretty cool.
The features described imply a continuous spot monitoring use case, where a patient is hooked up “to monitor non-invasive blood
pressure at particular intervals based on unit-specific protocols.” Given this device's heritage and the continuous monitoring use case, I would expect the device to have local alarm annunciation. To capture this data into an electronic medical record would require an available Ethernet port in each patient room.
FDA Investigates Medtronic Concerto Wireless Capabilities
According to a story (subscription required) in the Wall Street Journal, a former Medtronic engineer has alleged that the wireless telemetry features of Medtronic's new Concerto cardiac device were not adequately tested.
The former employee, Christopher Fuller, was so concerned that he eventually quit in protest over how the company had done their testing and circumstances surrounding their release of the product.
senators from Minnesota. In one letter to Republican Sen. Norm Coleman,
Mr. Fuller wrote that the Concerto device's long-distance telemetry
“exhibited instabilities in testing” and that Medtronic “has chosen to
ignore the problem.”
Medtronic's response to the allegations was not encouraging.
band used by doctors to monitor patients with the Concerto “is
dedicated for these uses and we believe it's extremely stable. We have
had no adverse events reported due to the wireless telemetry features
of the devices.”
Regular readers of this site know that claims about “dedicated” frequencies have little impact on the actual operation of a device in the real world. Additionally, Fuller's concerns appear to have nothing to do with the radio frequency chosen for the product. By the way, Medtronic is using MICS (medical implant communications service) frequency specified and regulated by the FCC – more here.
from behaving properly” and can lead to “excessive” battery depletion
or can “burn up” other circuitry in the devices.
Wireless RF medical devices require an entire new realm of core competencies that is lacking in all vendors with little or no wireless experience (that's almost all of them). And the risks of situations like this one that's alleged (and we really don't know why Fuller quit or whether there are any risks with Concerto's wireless feature) is the reason the FDA developed their recent draft guidance on wireless medical devices. I'm sure a crew at Medtronic is pouring over that guidance document to ensure they have all their bases covered.
While this situation reminds some of Medtronic's “What's Inside” direct-to-consumer (DTC)advertising campaign, I'm reminded of Guidant's recent recall. I for one encourage Medtronic to come forth with some information besides, “we're using a dedicated frequency so nothing can go wrong.”
You can read more about Medtronic's introduction of the wireless Concerto here. Medtronic's also has a web page on wireless patient management.
Pictured right is Medtronic's gateway device for wireless home connectivity with the Concerto.
UPDATE: According to the St.Paul Pioneer Press, the FDA has completed their investigation of the allegations above and found nothing to indicate the devices are unsafe.
inspection of the manufacturing facility, a review of the data
previously evaluated in support of the marketing application, and a
review of available adverse event data,” she said. “To date, FDA has
found nothing that would have influenced its decision to approve this
device.”
This demonstrates that Medtronic followed their own product development processes, including proper design reviews and hazard analyses during the design phase – which is to be expected for a world class company like Medtronic. The only thing lef is for them to keep an eye on their CAPA (corrective and preventive actions) system to ensure that erratic hard to reproduce and track problems – like those alluded to by Fuller – don't start cropping up on their data.
Trends in Point-of-Care Alarm Notification
My story on point of care alarm notification was published in Patient Safety & Quality Healthcare magazine this month – my first story with references! Readers of this blog know alarm notification is a pet peeve of mine, and an unmet market requirement that most vendors to date have successfully avoided meeting. I got to interview some really knowledgeable folks for the story who provided great insights. Thanks to Jim Biondi, Charles Fox, William Hyman, and Brian McAlpine for your time and efforts on behalf of improved patient safety.
After describing alarm notification challenges and related patient safety issues at the point of care, the story dives into issues of both alarm delivery and the quality of alarms.
According to healthcare information technology veteran Charles Fox, “Using connectivity between medical devices and clinical information systems, we can be smart enough to let the clinician know what to focus on and what not to focus on; we need to help clinicians focus on the clinically significant data.” Alarms must be truly actionable to improve patient safety.
The integration required for this goes beyond a single parameter and its normal values and must evaluate parameters within the context of other parameters derived from other devices and data from information systems. This broader context results in patient-specific normal parameters that change over time. Traditional threshold alarm limits generate many false positive alarms of little clinical value. Adding decision support and specificity is critical to reducing false positive alarms.
Both Emergin‘s and Cardiopulmonary Corp‘s Bernoulli Enterprise systems are discussed as examples of how some vendors are pushing the alarm notification envelope. No vendor has a complete solution in this area yet, but these two companies – and a few others – are the pioneers. The big established medical device vendors have created a strategic niche market for vendors like Emergin and Cardiopulmonary by not delivering on alarm improvements. Other factors contributing to the lack of progress in alarms revolve around the structure of the medical device market, and vendor’s propensity for proprietary end-to-end solutions.
Most current systems are not real time. They collect data in real time, but don’t do anything with it until they’re asked for it. In a typical use case, data acquired from medical devices goes to a queue that waits for a clinician to validate the data before it’s pushed into the chart. The challenge is to move some part of the system from off-line to real time. This level of interoperable connectivity requires cooperation between vendors. But medical device vendors want to control the mechanisms and alerts associated with their devices to create end-to-end proprietary solutions. And healthcare IT vendors want to extend their products into point-of-care systems currently provided by device vendors. Getting direct competitors or even potential competitors to work together has been difficult. So far, only a few third parties like Cardiopulmonary and Emergin have been able to extract the necessary cooperation to realize truly innovative products.
Without pressure from the market, common business concerns will keep device and healthcare IT vendors from collaborating on solutions that could help solve persistent alarm notification problems.
Providers share at least some of the responsibility for the lack of progress in alarms.
Hyman observes that vendors meet market demands, and that providers must get more demanding with regard to patient and caregiver centric solutions for the point of care. Providers should identify gaps in current alarm notification systems and draft requirements for future purchases. “Unfortunately, not many hospitals have the resources to do this effectively,” says Hyman, “and tend to rely too much on rosey vendor characterizations.” This process can be done by individual providers, as a collaborative effort among providers, with a consultant, or with vendors.
Jim Biondi summarizes alarm trends with this observation:
“Alarm management is evolving into a clinical management tool,” says Biondi. As more patient data becomes available, the management of that data will support earlier clinical interventions, more effective alarms, and better patient outcomes. The real value in the digitalization of the hospital lies in better patient clinical management, safety, and triage.
The potential for change in the medical device industry alluded to the statement above boggles my mind. The traditional functions of bedside medical devices – acquiring physiological patient data, therapy delivery, surveillance and alarm notification – are mature and undifferentiated technologies. The future will be the device as a clinical management tool.
Be sure to read the whole thing. Pictured above is the cover of the current issue of Patient Safety & Quality Healthcare magazine – there’s also a pretty cool story in this issue on Global Care Quest and their clinical information system.
Smiths Medical "Smart Pump" Software Receives 510(k)
Smiths announced today that they received 510(k) clearance for their new medication safety software for
programming pain management infusion pumps (press release).
The CADD-Sentry Pro™™
Medication Safety Software reduces the risk of errors by enabling
medical professionals to enter standardized pain therapy protocols onto
a secure database on the hospital computer network and then download
them into a pump. Previously clinicians have had to program each pump
individually.
The software has two applications: the Administrator software which
enters, manages and stores therapy protocols in a secure database on the
hospital computer network and the Point of Care software which accesses
and downloads the protocols into a CADDPrizmm®
PCS II ambulatory infusion pump.
The Point of Care software incorporates additional safety features,
including bar code verification to ensure the patient receives the right
medication and another verification feature that ensures a second nurse
reviews the pump program before starting an infusion.
Smiths is the latest in a string of pump vendors who have followed the trail blazed by Alaris in 2001 – not much progress has been made by smart pump vendors since. Alaris is still the only infusion pump vendor with integrated connectivity and the ability to establish and display patient context (the patient's name and ID) on the device. All the other “smart” pumps currently have a WiFi radio module attached to the back of the pump that is plugged into the RS-232 port. All of the smart infusion pumps on the market have some serious limitations, and those limitations are in direct relation to how long they've been on the market.
Many of the infusion pump vendors will be at HIMSS next month – Cardinal, Hospira, Baxter, B Braun – and I'll be curious to see what progress they've made in meeting market requirements.
Pictured right is Smiths' CADD-Sentry Pro solution.
