Texas Instruments Closes Chipcon Acquisition
Not one to be left out of the wireless sensor market, Texas Instruments has completed their acquisition of low power RF wireless transceiver company Chipcon. (Press release)
The Chipcon product line strengthens
TI’s position in ZigBee, a global standard for wireless monitoring and
control applications. Chipcon was the first company to launch a 2.4 GHz
IEEE 802.15.4 compliant and ZigBee-ready RF transceiver. The company
also introduced the world's first true System-on-Chip ZigBee-compliant
solution and recently added location estimation capability to this
product. Chipcon is the first company to offer three ZigBee-compliant
development platforms and provides a true one-stop-shop solution
including RF transceivers, the industry-leading Z-StackTM ZigBee
protocol software, development tools and proven reference designs.
Chipcon also offers a broad range of
proprietary low-power and high-performance CMOS RF-ICs for a large
number of wireless applications in the 300 to 1000 MHz and 2.4 GHz ISM
frequency bands. This product portfolio includes transceivers as well
as true System-on-Chip solutions. Unlike competing System-on-Chip
solutions, these products deliver everything the designer needs in a
single die without requiring off-chip memory and enable shorter
time-to-market, lower cost and smaller end products, due to the high
integration level.
FDA
I stumbled across this PowerPoint presentation the other day. John Murray at the FDA put together this presentation that spells out expectations regarding patching off the shelf (OTS) software used in medical devices. If you want to know the real story, check it out. The term guidance is in quotes because this is an informal communications, rather than a formal guidance document.
You can read previous posts on this issue here, here, and here.
Another Hospital Offers Patients Free Wi-Fi
The Richardson Regional Medical Center now provides free Wi-Fi Internet access to patients and visitors throughout the hospital. What started as a WLAN to support paperless charting became a broader deployment.
Today, the entire hospital is on a Wi-Fi system. The system
includes waiting rooms, patient rooms and associated medical office
buildings. Access is also available to clinical personnel and for
business functions.
The clinical and business operations are completely separate from
patient access so that no one can tap into the hospital's confidential
records, [CIO Ronald] Franquiz said. “We definitely have total control to make sure
that our business network and hospital network are not affected at
all.”
The system also facilitates attending physicians who want to access their own EMR in their practice from within the hospital. Pretty cool.
Secondary vs. Primary Alarm Notification – An Artificial Distinction?
Last month when I was at the FDA’s Twinbrook offices, I had a chance to talk with some FDA officials involved in software compliance. We talked about secondary alarm notification systems and how they fit the FDA’s regulatory framework. It was a very interesting conversation. With a finite budget and human resources, the FDA has a whole laundry list of issues that do not reach the threshold of proactive enforcement; secondary alarm notification has yet to reach that threshold. If (or when) a situation arises that breaches this threshold they will enforce the regulations.
According to the FDA folks I talked to, the 21 CFR regulation does not make (nor allow for) a distinction between “primary” and “secondary” alarm notification. Any system “labeled” as a means for alarm notification is a medical device per the regulation. The term “secondary alarm notification” appears to be a term of art created by industry, rather than a regulatory distinction.
In the 1990s Philips and VitalCom (acquired by Data Critical, acquired by GE) brought to market nurse-carried alarm notification using wireless pagers. These pagers displayed both alarm text and a sample waveform. Paging systems are not a closed loop system and adverse events resulted when alarms were never received on the pager. The FDA’s involvement in these reported events resulted in a change in product labeling and creation of the term “secondary alarm notification” by vendors. Over the last few years, several vendors have shown nurse-carried alarm notification devices using closed loop WLAN systems, based mostly on PDAs. With the exception of Baxter’s PDA for their smart pumps and Cardiopulmonary Corp’s products, no other vendor has yet to offer a released product of this type that is covered by a 510(k) with an intended use that includes alarm notification.
One might reasonably ask, “If the buyer knows the distinction between primary and secondary alarm notification, what’s the harm?” First off, there are hundreds of secondary alarm notification systems installed in hospitals; secondary alarm notification market penetration is probably just over 10 percent. Based on the capabilities of some of these installed systems, or how they are used, one could reasonably question their safety. (You can find another answer here.) With increased pressure on hospitals to improve patient safety the need for alarm notification that extends beyond the bedside device or central station grows. Market demand for improved alarm notification also exists because higher acuity patients are being cared for outside traditional critical care areas where the endemic nursing shortage sometimes stretches nurse to patient ratios. These more acute patients are frequently under more aggressive therapies (delivered by infusion pumps and ventilators) necessitating greater surveillance (telemetry or multi parameter patient monitors). The impact of these changes on alarm responses has not gone unnoticed. These “secondary” alarm notification systems can offer many advantages over traditional central stations or local device-based alarms.
If improved alarm notification was simple and straight forward, they would be included in vendor’s 510(k) intended use statements and this would be a non-issue – but it neither simple nor straight forward. Medical device vendors must reach beyond their embedded systems business models and venture into the land of general purpose computing systems. Health care IT vendors must do the opposite, and consider crossing the regulatory hurdle mandated by 21 CFR. And of course hospitals want solutions that will fit into their IT environment, and caregivers are not interested in carrying more than one alarm notification device.
Vendors need to consider new approaches to improved alarm notification that truly meet market requirements (even the ones they’d rather not meet). For years, vendors have relied on the high level of care provided in operating rooms and critical care units to ensure the safety of local alarms. (If the efforts of CIMIT’s Operating Room of the Future are any indication, improvements are needed in those areas as well.) As more patients are treated and monitored in more general care areas, the need for improved alarm notification will continue to grow. Patient safety and alarm notification could be an inflection point resulting in major changes to the medical device market with new players grabbing major market share, and some vendors seeing their products becoming commoditized.
Can hospitals buy these types of systems without assuming undue risk associated with “off label” use? The short answer is yes. What is needed is a needs assessment, vendor selection, and implementation process that ensures the purchase of a system that can be used safely in your environment. Hospitals following a documented process that assures patient safety should be reasonably protected in the event of a sentinel event that involves a secondary alarm notification system. If your hospital has a secondary alarm notification system in use, an audit of the system’s capabilities and how it is being utilized should be done. Of course, it is only in using regulated medical devices in accordance with the device’s intended use that a hospital’s liability risk will be at the absolute minimum.
Meet the Bloggers at HIMSS
Just a reminder that a group of bloggers are going to be getting together one evening at HIMSS. This is our chance (and yours) to get to know the folks
we've been reading, quoting and linking to our blogs.
We're
meeting Sunday evening after the HIMSS opening reception at
8:30 pm at an Irish bar Hennessey's Gaslamp, a few blocks from the convention
center. You can get directions (via a Google map) here. Since we eschewed sponsorship, everyone will be responsible for their own food and drinks.
You can see who's attending by clicking here, and you can add yourself to the list here.
