Active RFID from SecuriCode
Active RFID vendor SecuriCode was written up in Wireless Healthcare-News today. This U.K. based vendor includes health care as one of a number of vertical markets they go after. The following list of potential RFID applications shows they've done some homework. I have added the tag [software] to bullets below that would require tight integration with other software (beyond the RTLS positioning engine) to provide a reasonable workflow.
- Can identify and locate nurses, doctors and other skilled staff together with patients and medical equipment ensuring patient charters can easily be met and staff and emergency equipment are in the right place in life-threatening situations. [software - some positioning engines can manage associations like these, but another application would be required to integrate the information into workflow at the point of care]
- Will not compromise the safety of staff by alerting non-staff of their whereabouts and protects staff from loss or theft of identity.
- Offers ‘hands-free’ Access Control and non-intrusive operation. Staff go about their daily duties without having to overtly concern themselves about security. · Can prevent unauthorised use of equipment to ensure appropriately trained staff operate sophisticated equipment, view patient record systems or gain access to medical and drug supplies.
- Can automatically track patients or available beds and determine their location.
- Can act as a theft deterrent (by disabling equipment) and sound alarms if equipment is removed from the premises by unauthorised persons.
- Available with automatic time and attendance reporting which can update staff roster systems in real-time ensuring appropriate departments are staffed correctly and staff shortages can easily be identified. [software]
- Operates with exiting wired or wireless networks in-premises and will not track staff off-premises. Maintaining off duty employee privacy
- Could be used to automatically identify patients to doctors and specialists so that accurate medical records can be viewed. [software]
I've mentioned before (here) how RFID itself is not a product, and SecuriCode's list of health care related features bears this out. Asset tracking by itself, can deliver an attractive ROI, but it's dangerous to assume that an RFID system purchased for more generic purposes (asset tracking, theft deterrent, and access control) will also deliver equally good solutions that require tighter integration with other information systems.
SecuriCode's system is active, and operates in the 2.4 GHz band. The system requires dedicated readers that can be connected via Ethernet or WiFi. Tags can be read from as far away as 10 meters. The tags incorporate motion detection, battery monitoring, and the tag/reader communications protocol uses collision detection. Security features include encrypted data transmission, tag authentication, and automatically expire if lost or stolen. The tags don't continuously poll and can’t be monitored or cloned. Tags can optionally incorporate monitored inputs, alerts and anti-tamper alarms.
Increased Internet Use Bodes Well for Remote Monitoring
The Pew Internet and American Life Project reports that 73% of U.S. adults are Internet users, broadband connectivity lags at 42% of all adults. (Link to report here – pdf.)
The figures represent an increase from 66 percent, or 133 million
adults, in January 2005, according to the Pew Internet and American
Life Project.
In a report Wednesday, Pew noted that Internet use still varies with age and income. Eighty-eight percent of adults under 30 go online, compared with 32 percent for those age 65 and older. Only 53 percent of adults in households earning less than $30,000 a
year use the Internet, compared with 91 percent in households with
annual income exceeding $75,000.
While wireless Internet access from the home is one way to provide remote monitoring, for many applications I think wireless offers a better solution. Connectivity shouldn't be a major barrier to adoption, it should be invisible. Wired or wireless, Internet adoption trends are good news for remote monitoring.
Who Will Be Remote Monitoring's Early Adopters?
Health economist, Jane Sarasohn-Kahn notes today at iHealthBeat, the current turbulence in the remote patient monitoring in a review of Spyglass Consulting's new report (previous post here). Sarasohn-Kahn reports reimbursement, licensure, clinician resistance and lack of demonstrable
return on investment as the most formidable impediments to remote monitoring market adoption.
by ADT Tyco under a portfolio called, “Home Health Security.” [previous post here] This
monthly monitoring service offers a basic, two-way personal response
system and outfits the home with sensors and actuators that monitor the
resident's daily activities, including everything from using the toilet
to opening the refrigerator.
According to the product's Web
site, the activation fee is $199, and monthly monitoring costs $79.95.
While this cost clearly is not affordable for most seniors, there will
be a segment of people who might pay for this service themselves – or
could be subsidized by their children who might live sufficiently far
away from their aging parents to justify this monthly cost.
The lack of reimbursement for remote monitoring seems to be slowly giving way.
pay-for-performance programs in Medicare, which will begin to be
implemented by 2007. “A lot of organizations are investing to position
themselves for reimbursement,” according to Malkary.
The trial
of all trials to watch is being conducted by the Department of Veterans
Affairs, which is analyzing 6,000 patients using many modalities for
RPM. The VA is trying to figure out what works and at what the cost
benefit is. The VA's investment of $21 million has been significant.
The program is focusing on congestive heart failure, diabetes,
depression, hypertension and chronic obstructive pulmonary disease, and
it covers veterans residing in 30 states in order to take into account
for state licensure barriers. So far, the patients enrolled in the
program have shown a 30% reduction in hospitalizations and ED visits.
Sarasohn-Kahn also mentions a recent report published by Vodaphone that (not surprisingly) argues for adoption of mobile phones in health care. Sounds familiar – see this recent post.
in a younger population that is accustomed to using SMS in daily life.
This trial was particularly successful in demonstrating efficacy and
compliance in what is traditionally seen as a difficult-to-manage
patient population. Several trials in the UK found that the use of SMS
reminders reduced the number of missed physician appointments with
doctors by 26% to 39% and missed hospital appointments by 33% to 50%,
amounting to annual savings of about $457 million to $649 million.
In
reviewing the UK's positive experience with text messaging and health
care, we should remember that these savings would accrue to the UK's
National Health Service. The fragmentation of the U.S. health care
system is one of the unspoken – but formidable – barriers that have
prevented the universal adoption of telehealth since the inception of
the plain old telephone system.
So where will the early adopters of remote monitoring come from? Sarasohn-Kahn nails it with the following, “it might be the niche consumer end-user market – such as baby boomer
customers subsidizing their parents' independent living service – that
will be the early adopters of remote patient monitoring. After all, as
Tim Sanders' titled his book, Love is the Killer App.”
Could SAW RFID Tags Serve Health Care?
SAW stands for Surface Acoustic Wave technology that is used in a type of passive RFID tag that's been around since the 1970s. SAW tags use piezoelectric crystals with “reflectors” at predetermined intervals to represent a tag's data. The tags can be read from as far away as 20 meters, and can provide up to 2 foot positioning accuracy. Unlike some other tags, these can be read while mounted on metal and liquid containers. SAW tags are very small, can be read with very low power levels (<1 mWatt), and can withstand harsh environments (gamma radiation, high temperature). Oh, and they also transmit their temperature.
There were no SAW RFID tags that I saw at HIMSS 06. The biggest RFID take-away for me at HIMSS was that there is no “best” RFID system or technology; it's all about matching the application to the technology. The cool thing about the SAW tags pictured at right (from Sandia Labs) is their size and resistance to gamma radiation and high temperatures. According to the bug put in my ear by Brad Sokol, this technology is well suited to tracking surgical instruments and medical devices like consumables and implantable devices.
When imagining workflow automation through medical device connectivity, what about the autoclave as a medical device? The tracking system could track all the instruments (plus catheters, guide wires, and implantables) in a surgical suite – down to which one's are in the sterile field – ensure their sterilization, and even report their temperature. Sounds like just the thing ASP, 3M, Tuttnauer, Kimberly Clark, or Steris might want to do to differentiate or add value.
There's a new market study from IDTechEx, looking at SAW RFID tags here.
millimeter range. First- generation technologies did not meet open
standards for use by many service products. However, second-generation,
surface acoustic wave (SAW) tags are technically improved, lower in
cost, can store sufficient data, and operate at frequencies used by
conventional RFID chips. Chipless RFID can operate to more than a 10 m
range with 256 bits of data. Tags can be materials based or consist of
transistorless circuits. Transparent polymer transistor circuits are
now available from Philips, PolyIC, OrganicID, and Motorola, among
others.
Here's a technical paper from Sandia (pdf) for you RFID rocket scientists. And for us mere mortals, this paper (pdf) from vendor RFSAW, provides a nice general introduction to SAW-based tags.
Connectivity and Medical Device Regulatory Strategy
In talking with a fellow connectologist today, I realized that the
import of the Hospira/InnerWireless announcement is not apparent to
all.
Current medical device regulatory practice stipulates that when
major components of a regulated system are changed, the system must be
reverified – some might go so far as to revalidate, submit a letter to
file or submit a new 510(k), depending on the extent of the change.
Under the FDA's Quality System regulation (QSR), verification “means
confirmation by examination and provision of objective evidence that
specified requirements have been fulfilled,” i.e., testing against product specifications in the lab.
The QSR defines validation as, “confirmation by examination and
provision of objective evidence that the particular requirements for a
specific intended use can be consistently fulfilled,” i.e.,
demonstrating in an intended setting (customer site) that the system works as described in the 510(k) intended
use statement and all labeling (web site, brochures, presentations and
claims made by sales reps). Given that the verification testing
resources in most medical device vendors are usually the biggest
R&D bottleneck, this is a big deal.
To my knowledge, Hospira is the first medical device vendor to reverify
their MedNet system to run on InnerWireless' infrastructure.
InnerWireless, of course, wants many medical device vendors to be
able to use their Wireless Utility. And a medical device vendor who
wants to make a sale to a hospital that has InnerWireless installed
(and that number is growing) has to support that infrastructure if they
want to sell and install their product. Any hospital that invests in InnerWireless is probably a good prospect for a wireless connectivity solution, so I expect more device vendors to follow Hospira's lead.
This regulatory hurdle is an unanticipated expense in time and NRE (non
recurring engineering costs) for vendors – money they'd rather spend on
new product features.
The teaser on avoiding the revalidation effort at the end of the post refers to my belief that this burden could be avoided (or at least greatly reduced).
UPDATE: Harvey Knauss of Delphi Consulting Group made the following comment:
Submit a 510(k) for a Changed to an Existing Device.” Another quick
answer is if the Indications for Use have changed or extensive changes
in the design of the device then a new 510(k) is required. Adding
wireless will require that all safety testing be completed to Standards
that cover the whole system.
As Harvey knows, there are no easy answers. In my experience, getting a medical device vendor to change their regulatory approach (or to get a HIT vendor to accept FDA oversight for a product) can be a Sisyphean task. I agree, wirelessly enabling a medical device changes its intended use and requires a new 510(k) with full verification and validation. But the devices I'm referring to in this post are already wireless. The change to run on a distributed antenna system is equivalent to using a different make or model of access point – no change in transmitting frequency, technology or a removal/modification of features. Don't get me wrong, I'm not suggesting that you don't have to do anything, but if you put in place the right regulatory strategy you may be able to reduce your regulatory burden (the engineering work required to comply with regulations) significantly.
Here's an example where three widely divergent regulatory strategies – each with different impacts on R&D cost, time to market, and regulatory burden – are all executed within the law and approved by the FDA. In this example each medical device vendor wants to wirelessly enable their patient monitors and develop and sell a new central station product for surveillance and alarm notification. While this example focuses on the server required to implement a complete monitoring system, the principles can be applied to other connectivity situations.
- Vendor A determines that they must manufacture their server (i.e., configure, test and validate their own assembly of PC components into a complete server) in order to meet FDA regulations. They must design the computer, specify each component, assemble and test. Then as each component is changed or discontinued by the supplier, they must find a replacement, reverify and revalidate.
- Vendor B determines that they must select a specific server manufacturer and model to use in their system. Vendor B avoids the time and expense required to design, manufacture, and manage component obsolescence, but still has to verify and validate new models when their computer supplier decides to discontinue the product. Oh, and sales will have to explain to prospects why they're still selling an “obsolete” product, i.e., a product for which a newer model is available.
- Vendor C determines that due to the standardization of computers and the design of their system, they can simply specify minimum requirements for their server (e.g., 2 GHz Pentium, 512 MB memory, 120 GHz hard disk drive, Windows XP Professional etc.). There's still plenty of regulatory work in this scenario, but the ongoing effort is significantly reduced.
There are vendors who are currently selling systems using each of these approaches, all with 510(k) approval. The essence here is that the FDA QSR defines a process that can produce a safe and effective product through different means. Short answers must, by necessity, be easy answers as time requires that I make my response brief.
