Premier Claims Safety Improvements with Medical Device Unique IDs
Premier Safety Institute sent out the September issue of their (usually) excellent Safety Share newsletter today. Here was the lead item (emphasis in original):
A major move to improve the safety of medical devices – On September 21, Congress approved a law requiring the Food and Drug Administration (FDA) to put into place a unique medical device identification system.
Pshaw! The newsletter went on to report that Premier surveyed 1,000 hospitals in an effort to claim a safety benefit from implementing such a system. Let’s look at this survey (you can download your very own copy here.)
(Identification industry proponents refer to these unique identifiers for medical devices using the acronym “UID.”)
The first red flag is Table 1, listing the job types of survey respondents. It seems that biomedical or clinical engineers didn’t respond to the survey. As the one department in hospitals responsible for patient safety and medical devices, this group should be identified. Instead we’re left to guess if “clinical support” or “Facility/environment” somehow includes biomeds.
Table 2 includes the survey questions. Of note here is question 2, “Do you have a system or database, beyond the individual patient record, to track or record medical devices that are implanted in a patient?” Only 46% of respondents said yes. Question 3 asks how patient care equipment (i.e., medical devices like infusion pumps or patient monitors) is labeled: 65% handwritten or text, 28% bar code, and 2% RFID.
The fact that most hospitals don’t log implanted devices, beyond the patient chart, is embarrassing. How do these hospitals get accredited? Because biomeds tend to be so obsessive about documenting patient care devices, question 3 is worded differently. The end result is the same, regardless how the device is identified, biomeds do a good job of documenting and tracking devices – recalled or otherwise.
Question 4 asks how recalled devices are located: 42% manually review patient records (implants?), 58% and 40% review manual and electronic logs respectively (patient care devices?).
To this point, we have interesting data on sloppy recording of implanted devices. There is no data that shows problems with identifying or locating patient care devices. Nor is there anything in the survey that indicates that a UID would improve patient safety – implanted devices that are not logged are a problem whether they have the current “unique identifier” known as a serial number, or a UID.
Question 6 shifts gears asking, “to what degree do you believe that having a unique device identifier system would enhance patient safety by improving your current process for recording device information and tracking recalls?” This question conflates the numbering scheme with an improved process when in fact they are separate issues.
According to what Premier has to offer, the safety claim of a UID is bogus. Patient safety improvements are all dependent on improved hospital operations, and not on the numbering scheme used to identify medical devices.
Perhaps some supply chain expert can tell us why a UID would perhaps lower health care costs. While less compelling and sexy than improving patient safety, lowering costs is at least believable.
Pictured right is a typical asset tag. Tags like this, combined with medical devices’ current unique identifiers, can support all the patient safety improvements attributed to UID.
Networking Medical Devices Ignored by Medical Automation
Dana Blankenhorn, ZDNet Healthcare writer and blogger became an honorary Connectologist today with his short story on medical device connectivity. Dana lead with a consumer electronics comparison of plug and play printers that operate with personal computers.
can easily install, which will allow ready communication between it and
your PC. You expect it to deal with files created by your PC, and you
expect your PC to deal with its files, too.
It took years for this to become routine, and replicating this ease-of-use is one of the great challenges open source still faces.
In the medical device market, however, this work has not even begun. In fact it has barely been imagined.
Ah, but it has been imagined – in mind numbing detail – by the feverish minds found reading this site. Dana refers to previous blog post on this site to make his point about the complexities and challenges of medical device connectivity.
He forthrightly states, “This is nothing less than a scandal. Common standards and interfaces
are needed to change this. The PC industry has lots of standards to
choose from, which interoperate. The medical market needs the same
thing.”
Pending FDA Legislation Mandates Unique IDs for Medical Devices
The bill to mandate unique IDs for medical devices is expected to be signed into law as a part of a Food and Drug
Administration bill currently making its way to President Bush's desk. I've not read the bill, but this is what supporters contend:
Modernization Act portion of the FDA Amendments Act of 2007, would
enable universal tracking and easier location of products in the case
of a recall, say supporters of the provision. It would also allow
hospitals to better compare products in specific categories.
Since all medical devices (except things like, you know, tongue depressors) already require unique serial numbers, and furthermore all medical device vendors are required to maintain a device history file for each medical device, I don't see how this legislation will improve tracking or recall of devices. And enabling hospitals to “better compare products in specific categories” seems like fantasy.
for some manufacturers. “One of the complications the FDA will have to
face is that medical devices include everything from Band-Aids to very
complicated implantable devices,” said Joe Pleasant, chairman of the
Coalition for Healthcare eStandards–an advocacy organization that has
worked with the FDA on the issue. “I think what the agency may try to
do is say requirements will be different depending on the class of the
device.”
The potential benefits that I've heard suggested from this are all dependent on the creation of an industry wide numbering scheme ($$), electronic systems for vendors to track products and issue/manage recalls ($$$), and similar systems for each medical device user so that device usage can be tracked and reconciled with vendor data ($$$$$).
Now these are laudable goals, but somebody – I mean besides those who envision profitable new business models out of all this – should evaluate how realistic all of this is and what any return on investment might be. Oh wait, the FDA's already done this.
Devices for Diabetics Improve
Business Week has an interesting story about recent advances in glucose meters and insulin delivery systems for diabetics. Many of the devices in the story aim to improve usability in various ways to improve patient compliance and outcomes. Proper control of blood glucose levels has a tremendous impact on a diabetic's health, quality of life and susceptibility to complications.
The market for glucose management has not escaped medical device vendors or entrepreneurs:
The audience for diabetes-management tools is large–and growing. The Centers for Disease Control & Prevention estimates that there are 20.8 million American diabetics, about 7% of
the U.S. population. According to the International Diabetes
Federation's latest statistics, nearly 194 million adults around the
world are diabetic; by 2025, according to estimates, this figure will
reach 333 million. Palo Alto (Calif.) research and consulting firm Frost & Sullivan estimates that the U.S. market for traditional diabetes monitoring
(blood testing equipment and strips that diabetics use to measure their
glucose levels) tallied $3.53 billion last year, up 12% from 2005.
“In the last several years, we've seen low double-digit growth,”
says Mona Patel, director of Frost & Sullivan's medical research
department. “Yes, there will be a saturation factor, but the number of
diabetics keeps increasing–even among children.” So, Patel says, the
market for pediatric devices will grow, too.
The market is slowly growing, but the real opportunity is the poor design of conventional products made for diabetics. They are hard to use, make funny noises, inconvenient, have a medical device look that makes patients look and feel “sick”, have poor battery life, and can be big and clunky.
Blogger Amy Tendrich posted an open letter to Steve Jobs on her blog Diabetes Mine, challenging Apple to bring the same design excellence they bring to consumer electronics to devices for diabetics. The Business Week story describes a design created in response to Tendrich's plea, and touches on a number of other products. (Surprisingly, no mention of DexCom's continuous glucose monitoring system.)
The (glacial) transformation taking place in diabetic devices highlights a structural problem in the medical device industry. Due to barriers to market entry, established vendors feel little pressure to create the equivalent of an iPod for diabetics. Some vendors like Medtronic have created innovative systems like the MiniMed insulin pump with real time glucose monitoring. But in order not to cannibalize sales from their conventional products line, they price the new solution at a significant premium. (Medtronic has taken a similar approach to their relatively new wireless ICDs, charging a $6,000 premium for the wireless models over products that still use induction wands that must be placed over the pacemaker. I know cardiologists that refuse to implant the wireless models because they feel it is unfair to burden the patient/payor for such a high premium.)
Payors only reimburse for technology that has a clear return on investment. They won't reimburse for a fancy (read “expensive”) MiniMed pump for a patient whose condition does not require continuous monitoring and administration of insulin. Sure payors will pay more for a product with better outcomes (i.e., lower costs to the payor resulting from a healthier patient). But proving those improved outcomes – and lower costs of care – is an expensive and time consuming proposition.
It appears that Medtronic – and vendors who pursue a similar strategy – are stuck with a small subsection of the diabetic market, unless they're willing to reduce the price of the MiniMed where patients are willing to pay the difference over what their payor will reimburse for a conventional glucose management system.
The poor comparison between conventional glucose management products and consumer electronics has not been lost on medical device entrepreneurs. Vendors like Medicom, DexCom, Health Pia, and Insulet (pictured right) are bringing better designs and technology to market. These new players will need more of a consumer electronics product strategy, rather than Medtronic's strategy for the MiniMed, if they are to succeed.
More here in a iHealthBeat story about a recent FDA continuous glucose monitoring approval for children that highlights cost and potential savings in reduced health care costs.
of their blood sugar through the devices, although other studies have
found minimal impact. Irl Hirsch of the University of Washington said
the discrepancy can be attributed to a lack of effort from diabetics,
not the sensor technology.
The glucose sensors can cost up to
$1,000, with at least $350 in monthly fees for supplies. Although some
insurers pay for them, many refuse to reimburse patients for the
devices until there is more proof that they improve health, the AP/Star reports.
UPDATE: Reader Bernard Farrell has an excellent point in the comments:
present. They don't adequately cover treatments for chronic diseases, and then
later they pay for the outcomes of poor management. There is an argument that
better designed devices will lead to better medical outcomes AND lower support
costs for the device makers. As far as I'm concerned good device design is a
win-win-win situation for patients, device makers, AND insurance companies.
Unfortunately it feels mostly like I'm shouting into the wind about this.
There are two problems I think. The first is demonstrating the hard dollar savings from well designed devices. This naturally falls on the device vendor, and is neither a quick or inexpensive task. The other problem is the tendency of device vendors to want to get a significant premium for their better designed product. A major price increase requires justification before payors will reimburse for a new “class” of device. If a vendor introduced a better designed device (with some additional features) at a slight premium, patients might be willing to pay the difference themselves – think the iPod.
Perhaps what's needed is more of a consumer electronics mindset applied to these kinds of products, rather than the conventional medical device paradigm.
More Physician Disintermediation
On of the changes roiling health care is the disintermediation of primary care physicians. The advent and continued growth of retail clinics and concierge medicine are examples of a new business model chipping away at physician's traditional business. This New York Times story describes a company called Inn-House Doctor.
A new kind of medical practice is flourishing nationwide that offers
to go to where the patients are – whether a home, an office or a hotel – to treat ailments as diverse as a sprained ankle or a bad case of bronchitis. Some services may even wheel in a mobile X-ray machine or an ultrasound machine, depending on the ailment, or perhaps pull out kits to test for strep throat or to draw blood. They may dole out medication on the spot or arrange for pharmacies to deliver prescriptions.
“When
you call, you can speak to a doctor in five minutes, and that doctor
can be there with you within the hour. Where else do you get that kind
of delivery?” said Walter Krause, founder of Inn-House Doctor. The
company says it has 40 physicians on call in Boston, Chicago, Dallas,
Houston, Las Vegas, Phoenix, Philadelphia and Washington; some of the
doctors are in private practice or work in hospitals, and they make house calls during their time off.
This firm charges $250 to $450 per appointment, compared to $80 for a typical office appointment. So what's the problem driving these new services? In some markets where there is a shortage of primary care physicians, patients can wait weeks for an appointment. The office experience itself can be marginal when you get all of 10 minutes with your physician, some times after a lengthy wait to be seen.
Conventional practitioners complain that such interlopers interrupt and fragment the delivery of care to a patient. In reality the office-bound primary care physician with their paper charts and network of specialists they refer to typically don't offer any better coordination of care across a patient's physicians.
The enabler for many of these new services is health care IT. Improving access, convenience, and better coordination of care requires things like open scheduling systems (where patients or referring physicians can book appointments), e-prescribing, EMRs and PHRs. All of this must provide some level of interoperability so that appropriate information can be easily shared with the patient and among providers.
UPDATE: iHealthBeat reports on a radio story about an NYC physician, Jay Parkinson, “who founded a solo practice that treats young, healthy uninsured patients over e-mail, instant message or video chat.” You can check his cool web site here.
If there were more practices like Parkinson's, you could make a case for getting less expensive catastrophic health insurance and paying everything else out of pocket.
