Medical Implant Issues: Part 1, A True Story

When I started this article, I thought I could place it into a single posting.  However, having written just the first section, noted it's length and how much more there was to write.  Thus, I decided to turn this into a serialized publication just as I am doing with HE-75.  Thus, here is Part 1 ...
 

Part 1: Background Story

Before I dive into the technical details of this issue, I want to tell a true story from my own experience.  It involves a friend of mine.  (I need to be vague regarding the person's identity including gender and how I came to know this person.  As you read this, you'll understand.) 

My friend was incredibly intelligent (e. g., the best applied statistician I have ever known) and physically attractive, and diagnosed as a paranoid schizophrenic.  In the early 1990's, my friend underwent back surgery.  To my amazement, my friend claimed that the surgeon had placed a "chip," small processor into the person's spinal cord.  My friend said that the chip could be activated by people with controls that looked like garage door openers.  When activated, the chip would cause my friend to have a sudden, overwhelming desire to have sexual relations with the person who had activated the chip.  My friend called this chip a "tutu."

At the time I had been part of the cutting-edge technology community to know that such a chip was absurd.  And I told my friend that this chip did not exist. My information was not well received by my friend who was convinced of the reality of this chip.

I tell this story because at the time my friend informed me of the "tutu," the idea of embedding a chip in a human being and activate it using wireless means was patently absurd.  Embedding programmable chips with wireless communications less than a decade and a half later is no longer considered absurd, but real.  And for some people, frightening with religious overtones.  Consider what the Georgia state legislature just passed and you'll understand what I mean.  Here's a link to that article: Georgia Senate Makes "Mark of the Beast Illegal."


The reaction from the Georgia Senate makes my paranoid-schizophrenic friend's story seem plausible.  Interestingly enough and I did not realize it at the time (but I do now), that was my introduction to wireless, medical remote programming.  As I said, my friend was extremely intelligent and as it turned out more creative and prescient than I realized at the time.  Turns out that today a device embedded in the spinal cord with the ability to trigger sexual experience is real.  And the ability to embed microprocessors and controls in people with the capability of wireless communication and medical management is also real.


I tell you that story not to make light of people's stories and fears, but as a "sideways" introduction to the technical topic of dealing with multiple, embedded medical monitoring and remote programming systems.  And to suggest that people may have real fears and concerns regarding the capabilities that technologists like myself often overlook.  In this series I discuss real and imagined fears as well as the technical problems with multiple, implanted devices.




Part 2: Multiple, Implanted Wireless Communicating Devices

Books sold by Amazon that might be of interest in this series

New Frontiers in Medical Device Technology

MEMS and Nanotechnology-Based Sensors and Devices for Communications, Medical and Aerospace Applications
 

Remote Monitoring Demonstration System for Diabetes & COPD Available

I want to share the article and it's link to the the demonstration system.  Here are a few quotes from the article.

Health Revolution Sciences Inc. has launched a new Website demonstrating its remote health care monitoring capabilities for perspective patients and care givers.

Called ForVida, the software application represents a sea change in health care technology. 

The software allows physicians and patients to watch streaming cardiac telemetry or reference steadily growing actionable patient EKG and heart rate histories.

The system apparently uses a communication model similar to one I have described in an earlier article.  (http://medicalremoteprogramming.blogspot.com/2009/10/communication-model-for-medical-devices.html)  I do not know what data integrity and security measures they have taken.
 
The article can be found at:
http://www.healthrevolutionsciences.com/2010/04/forvida-demo-up-and-running/

Remote Monitoring and Preventing Unnecessary ICD Shocks

In 2009 there was an interesting editorial written by Joseph E. Marine from Johns Hopkins University School of Medicine, published in the journal, Europace (European Society of Cardiology).  The title of the editorial was "Remote monitoring for prevention of inappropriate implantable cardioverter
defibrillator shocks: is there no place like home?"  The entire article can be found at the following location: http://www.europace.oxfordjournals.org/content/11/4/409.full.pdf
  
For those of you unfamiliar with ICD's (implantable cardioverter
defibrillator), the ICD delivers a relatively high-voltage shock to the heart when conditions indicate that the heart may be about to go ventricle fibrillation (a rapid irregular heartbeat that will likely lead to death) or that the heart ceases beating.  The latter condition is easily detected, however, determining the former condition is more difficult.  Because the conditions are not always clear, ICD (and a companion system, the CRT-D) too frequently deliver shocks unnecessarily. (I have discussed issues related to detection in other articles in the blog.  Here are the links to those discussions:  http://medicalremoteprogramming.blogspot.com/2009/11/remote-monitoring-sensitivity-and.html, http://medicalremoteprogramming.blogspot.com/2009/11/remote-monitoring-update-to-sensitivity.html
http://medicalremoteprogramming.blogspot.com/2009/11/remote-monitoring-predictability.html)  Another reason that an ICD might deliver unnecessary shocks would be because of sensor lead failure or near failure. 


Joseph Marine examined the value of remote monitoring to the prevention of unnecessary shocks.  He concluded that remote monitoring was particularly suited to providing early detection of failing sensor leads.  However, ...

[f]inally, most inappropriate ICD shocks are not caused by
lead failure, but rather by supraventricular arrhythmias, and this
study does not provide any evidence that home monitoring
reduces risk of inappropriate shocks from this cause.

In other words, remote monitoring could not aid with improving the false positive rate - the delivery of unnecessary shocks.

To those who have not been involved with ICDs, it may seem that the delivery of an unnecessary may not be so bad given the alternative, that a failure to deliver a shock will likely lead to the patient's death.  And there are many cardiologists who will argue the case for a "hair-trigger" system - acceptance of false positives, but no acceptance of false negative: that is a failure to deliver a shock when conditions warrant.

However, unnecessary shocks will do damage over time.  Furthermore, those patients who have received a shock describe it as feeling like "... a mule kicked" them in the chest.  I know of situations where patients who a received shocks eventually have the ICD removed. 

So, I want to make the case to the medical device industry that remote monitoring may be the key to solving the false positive problem.  In that the data that remote monitoring systems collect and transmit may lead to better detection and discrimination.  In addition with reference to my article on prediction, remote monitoring may enable physicians to tune ICDs based on specific predecessor events that could enable remotely adjusting the parameters on the ICD to allow better targeting.


I'm not an expert in this area.  However, I know enough about indicator conditions in other areas that can be used to adjust systems and improve their accuracy.

Market Research Report Available: Remote & Wireless Patient Monitoring Markets

A new market research report has just been made available that discusses the market and investment potential of remote and wireless monitoring of patients.  I do not endorse this study or suggest it's purchase.  I am making it's existence known.

Here's a list of some of disorders covered by the study:

• Asthma
• COPD
• CHF
• CHD 
• Diabetes 

Here are a few quotes from the press release:

Patient monitoring systems are emerging in response to increased healthcare needs of an aging population, new wireless technologies, better video and monitoring technologies, decreasing healthcare resources, an emphasis on reducing hospital days, and proven cost-effectiveness.

Of these new high-tech patient monitoring systems, nearly all focus on some form of wireless or remote patient monitoring. ...

...  the following companies are profiled in detail in this report:

• Abbott Laboratories, Inc
• Aerotel Medical Systems
• GE Healthcare
• Honeywell HomMed LLC
• Intel Corporation
• Philips Medical Systems
• Roche Diagnostics Corporation

Here's the link to the press release and links to purchasing this study: http://www.marketresearch.com/product/display.asp?productid=2645944&g=1

 

Article: Investments in Real Time Medical Monitoring

This is an article targeted to the investment community regarding investment in real time medical monitoring.  I do not endorse anything in this article.  However I do find it interesting.  I do not know the track record of this publication.  Nevertheless, here a link to the article: http://www.onemedplace.com/blog/archives/4878

Article: Initiation of a Telemonitoring Study of Heart Failure, COPD and Diabetes Patients

A study will be performed by researchers from Case Western Reserve University and Cleveland State University with patients suffering from heart failure, diabetes and COPD.  The objective of the study will be to determine how effective remote monitoring is with maintaining the health of these patients and with keeping them out of the hospital.

Here's a link to a report on this study: http://www.physorg.com/news190634143.html 

Additional Resources

COPD 

 The Complete Guide to Understanding and Living with COPD: From A COPDer's Perspective 

COPD For Dummies 

Diabetes

Diabetes For Dummies (For Dummies (Health & Fitness)) 

Tell Me What to Eat If I Have Diabetes: Nutrition You Can Live With 

The Official Pocket Guide to Diabetic Exchanges 

Heart Failure

The Cleveland Clinic Guide to Heart Failure (Cleveland Clinic Guides)


Manual of Heart Failure Management

Medtronic Remote Monitoring Study: CONNECT

At the American College of Cardiology 59th annual conference George H. Crossley, MD presented evidence that cardiac patient from remote monitoring (one scheduled in-office visit per year with remote monitoring) verses standard in-office care (four in-office visits per year) cuts the time between the time a cardiac or device related event occurs and when a treatment decision is made.

The title of the study: "The clinical evaluation of the remote notification to reduce time to clinical decision (CONNECT) Trial: The value of remote monitoring."

I present a summary of the method and the results of the study gleaned from the slides presented by Dr. Crossley at the conference.

Hypothesis

Tested hypothesis: Remote monitoring with automatic clinician notifications reduces the time from a cardiac or device event to a clinical decision.

Additionally investigated were rates utilization of the health care system including hospitalization and between treatment groups.

Method

Study participants:  1997 newly implanted CRT-D and DR-ICD patients from 136 US centers were randomly assigned to one of two groups. The first group had 1014 patients assigned to the remotely monitored group and the second had 983 patients assigned to the standard in-office care group. The patients were reasonably well matched for age and gender characteristics.  (A procedure similar to the Biotronik TRUST studies.)

The patients were followed for 12 months.  (On first reading, I found the the time relatively short in that I would not expect enough differentiating events would occur during that time.  However, on further reading, I believe my first impression was incorrect.)

Findings

Time from Event to Clinical Decision

The median time (used nonparametric inferential statistics for the analysis) from the cardiac or device event to clinical decision was 4.6 days in the remote group and 22 days in the in office group. This difference was significant.  The remote group involved 172 patient while the in-office group involved 145 patients.

The cardiac/device events included:

• Atrial Tachycardia/Fibrillation (AT/AF) for 12 hours or more
• Fast Ventricular rate. Of at least 120 beats per minute during at least a 6 hour AT/AFT event
• At least two shocks delivered in an episode
• Lead impedance out of range
• All therapies in a specific zone were exhausted for an episode
• Ventricular Fibrillation detection/therapy off
• Low battery

Total number of events Remote group: 575 and In-office group: 391.  The slides show the breakdowns.

Office Visits

The number of office visits per patient reported are shown below.

                        Scheduled     Unscheduled      All office

Remote group:     1.68              2.24              3.92

In-office group:    4.33              1.94              6.27

The TRUST studies showed a slight increase of more unscheduled visits for the remote group. However, given the nature of the study and that remotely monitored patients would receive only one in-office visit per year, it's remarkable how similar the numbers between the two groups are.

Utilization of the Health Care System

Number of incidents where patients used the health care system show virtually no difference, hospitalization or emergency room. 

However, a remarkable difference was the significant difference in length of stay when there was a hospitalization. The remote group had a mean hospital stay of 3.3 days while the in-office group was 4.0 days with an estimated savings per hospitalization of $1659.

Conclusion

The CONNECT and (Biotronik) TRUST studies show clear benefits from a number of standpoints for remote monitoring.  In addition, the CONNECT study showed clear cost and hospital resource utilization benefits from remote monitoring in that hospitalized patients had shorter stays indicating that they were in better shape than patients in the in-office group when admitted to the hospital.  Quick responses seem to lead to better outcomes as well as cost reductions.

Here is the link to Medtronic's press release of the study: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1268659150410&lang=en_US

Here is another link to an article on the study that includes a link to Dr. Crossley's slides: http://www.cmio.net/index.php?option=com_articles&view=article&id=21235:acc-remote-monitoring-shortens-event-response-time-reduces-hospital-costs

Additional resources

Reimbursement for Remote Patient Monitoring in the United States- Regulatory Antennae Picking Up Demand Signals 

Remote ICD monitoring speeds diagnosis of arrhythmias.(CARDIOVASCULAR MEDICINE)(implantable cardioverter defibrillators)(Report): An article from: Internal Medicine News

Reader Article: Controlling Glucose Level to Prevent Diabetes

 Here's something I have been wishing for ... a guest article authored by one of my readers.  If you have something that you would want me to publish in this blog, by all means, please send it and if I think it has technical merit and seems appropriate, I shall publish it.  


This article is written by Kristina Ridley who writes for the diabetes blood glucose  blog. (http://www.diabetesmeters.org/)This is her personal hobby-blog that focuses on healthy eating and tips to measure blood glucose levels at home to help people understand early diabetes symptoms.  

This article may have bearing on remote monitoring technology for diabetes in the what people consume has likely impact on glucose and insulin levels.  I know that heart failure patients (whom I understand are often diabetic) can remotely report to caregivers their weight, blood pressures, etc.  I would seem reasonable that diabetics could report their food and fluids intake for remote monitoring by their caregivers. 

I am particularly interested in Kristina's last section, "Too Much Control."  My experience in cardiac rhythm management suggest close monitoring and control are strong positives.  I hope that Kristina or someone else could write a rejoinder to this section.


Here is Kristina's unedited article:

Here’s a Quick Way to Control Glucose Level to Prevent Diabetes

 

Our pancreas is affected by diabetes – specifically, Type 2.Our body contains glucose found in the blood stream, which it gets from the sugar in food. Our body uses the glucose, but only when it goes into our blood cells and the insulin released by our pancreas converts it. Insulin production and utilization is difficult for someone who lives with Type 2 diabetes. There is a lot of glucose in the body, but your cells cannot locate them.

The American Diabetes Association has become very important when it comes to gathering critical information about this medical condition. With approximately 23.6 million citizens living with diabetes, America is an extremely unhealthy country. Over 90% of all patients with diabetes have Type 2.Most diabetics tend to be overweight and have relatives with the same condition. Too much glucose can cause serious, irreparable damage to internal organs and to the overall nervous system.

Diabetes and Your Life

If you have Type 2 diabetes, you need to live in a healthy manner. Living healthy and engaging in healthy practices will affect you tremendously. Two common examples of healthy routines include exercising and consuming healthy foods. Making sure that your glucose levels stay in the recommended range translates into being able to avoid complications in your health. A finger prick test is a common and reliable way to monitor your body’s blood glucose levels. 

 

This test, according to physicians, is sufficient enough for glucose monitoring like the HbA1c test. The amount of glycated hemoglobin in your blood is determined by this HbA1c test, aside from it alerting you if you reach a high glucose level. Results of these A1c tests show that people with diabetes are at a seven percent level. The CDC reports that if one maintains their a1c levels at seven percent, they could reduce the possibility of risks as high up as forty percent.

Too Much Control 

Recently, there have been medical studies that seem to indicate that maintaining A1c levels below 7% may be a bad idea after all. One of these studies, conducted at the Lancet and Swedish Medical Center in Seattle, has found that people who have median levels may be at a far greater risk of death, especially for those taking insulin. However, other tests have indicated that A1c levels of 7 percent is still perfectly healthy. Matt Davies, An accredited Endocrinologist, has stated that maintaining a 7% A1c level is healthy according to recent studies, but that physicians should always take the individual patient's history into account prior to planning treatment.

 

Kristina provides diabetic recipes in here blog.  In addition, I have provided a link to Amazon that will initiate a search for diabetic cookbooks.

Search Amazon.com for diabetic cookbook

Why the Moniker "RemoteProgrammerGuru?"

For those who have wondered ... there is a story behind why I use the moniker, "RemoteProgrammerGuru."  Any identity that has as part of the name, "guru" could be considered more than a little ostentations.  Here's the definition as provided by Wikipedia:http://en.wikipedia.org/wiki/Guru.

The definition describes someone with "supreme knowledge."  Fortunately for me, the term in India is synomous with "teacher."  For me, the "term" teacher was more appropriate and the role of a teacher came as a surprise.

I was part of a project where remote programming was the technical centerpiece of a proposed solution.  Frankly, I was new to remote programming for medical devices ... as are most.  However, I have a rich telecommunications background including expertise in wireless communications.  (I was the principal investigator on two federally funded telecommunications research grants.)  I know the technologies and I know how things work. 

As it turned out, I knew more about telecommunications than my colleagues who had been working in remote programming for longer than I ... much more.  And I started teaching them, about communications and about remote programming and necessary processes to insure communication integrity.  In effect, I became a "guru," a teacher.

Finally, since remote programming when designed and implimented correctly, involves sophisticated monitoring, I decided to incorporate the term "remote programmer" to represent someone who informs people about remote monitoring and programming.  Thus the moniker, "RemoteProgrammerGuru" was created.

Article: Wireless Remote Monitoring Prevents Complications of Chronic Diseases

An interesting article about the benefits of remote monitoring in the care of patients with chronic diseases from the Press of Atlantic City, 8 March 2010.  Here's the link to the article:  http://www.pressofatlanticcity.com/life/monday_health/article_1333e585-e3a6-5ba8-a411-75530f6b63cf.html

Quotes from the article:

Improving management

By early 2012, Americans will use about 15 million wireless health-monitoring devices, according to a forecast from ABI Research, which tracks mobile-technology trends. The mobile health market is projected to more than triple to $9.6 billion in 2012 from $2.7 billion in 2007, according to study from Kalorama Information Inc

[T]he first pilot project in the nation to assess whether the use of remote digital devices with data sent over the Internet to a doctor's office improved management of multiple chronic diseases - diabetes, heart disease and high blood pressure, also known as hypertension. 

Diabetics and hypertensive patients increased the number of days between appointments by 71 percent and 26 percent respectively ...
"One of the great promises of wireless (health) is making it a part of the patient's daily life, not an interruption to what they're doing every day," ...

From personal experience I believe the last sentence I quoted is among the most important in the article.  The entire process should be so smooth, so automated, so uncomplicated and unintrusive that the patient's life is uninterrupted and that the data is seamlessly collected and sent to the patient's caregiver.

Two other items to note.  The first is a brief discussion of the sensors connected to the patient's body.  They mention band-aid size electrodes.  I am not sure if these are the "digital plaster" that I've discussed in an earlier article.  http://medicalremoteprogramming.blogspot.com/2009/11/digital-plaster.html
Or something else.  I do not know, but it would be interesting to find out.  If I have any informational, I'll post it.  If you have any information, please enlighten us with a comment.

The second issue of note is the discussion in the article regarding payment, and who will do it.  Given the convoluted nature of our system of payments, this will be the most difficult issue to resolve, I believe.  It's ironic considering that remote monitoring saves money.   I think the technical issues will be minor in comparison.  I hope I am proved wrong.

Remote Monitoring/Programming and Diabetes Management

Diabetes management is a personal area of concern for me.  No, I'm not diabetic.  However, my late mother-in-law was.  She had Type II diabetes; however, she was not overweight.  She died of a sudden cardiac arrest that was a direct result of her diabetes.  Although she did a great deal to manage her diabetes, her insulin would swing widely.  Those wide swings damaged her heart muscles leading to a cardiac arrest.  I can't help but believe if remote monitoring had been available to her, that she should would be alive today.

In the past my primary topical area has been cardiac rhythm management.  I plan to broaden my focus. Diabetes management using remote monitoring and even remote programming will be a topical area of increasing focus in this blog.  In later weeks I plan to branch out into COPD.

For those of you who have domain expertise in diabetes management and COPD, I would appreciate your comments.  You can make your comments in the comment area of this blog or email them to me.  Whatever way you feel the most comfortable.

To get things started, I have three links that I would like share.  The first link is a blog article titled, "Finding patterns in diabetes treatment may be key for telemedicine."  The article is a brief discussion about a presentation by Dr. David Klonoff of Mills-Peninsula Health Center and UC San Francisco.  His focus was on Type I diabetics, however, I believe what he discussed has significant implications for Type II diabetics as well.  Dr. Klonoff's interest is technology "...for automatic measurement of blood glucose, automatic dose calculation, and automatic insulin delivery."  From the article ...

For this ideal scenario to develop, five technologies need to be solved, and Klonoff sees printed electronics being used in every one:

• Self-monitoring of blood glucose
• Continuous (and ultimately non-invasive) monitoring of blood glucose
• Alternate routes for delivering insulin rather than needles, such as micro-needles. (Klonoff referred to work being done at UC Berkeley; I saw some demonstrated at the University College Cork/Ireland (PDF poster here) although using traditional semiconductors, not printed electronics.)
• Artificial pancreas
• Telemedicine

 In the quotation above, there are several links.  The one of greatest interest to me and to this forum, is the "non-invasive" link.  This will link you to an article titled, "The Search for Noninvasive Glucose Technology That Works: Where It Stands Now".


The article is a discussion of a need for a means for non-invasive monitoring of glucose levels.  The capability of having a non-invasive means of monitoring glucose levels would go a long ways towards supporting automatic, remote monitoring of glucose levels.  This could be an extension of the body area networks work (BANs).  So if anyone has any ideas in this area, apparently this is a wide open area for invention.

Finally, I want to provide a link to a brief report by the Whittier Institute of Diabetes.  The report is undated, but a brief review of the document's properties indicated that it was created in 2004.  It's not as recent as I would like, however, I believe that it's findings are relevant.  In summary, it showed that even relatively crude means for monitoring diabetes could lead to some positive outcomes at relatively low cost. 

 

How to Hack Grandpa's ICD

I've discussed possible communications security problems with implanted devices in an earlier post.  The link below provides a link to a University of Washington study that was published in 2008 in IEEE Symposium on Security and Privacy. Here's a link to the University of Washington article. 

Researchers find implantable cardiac defibrillators may expose patients to security and privacy risks


The article includes a link to the published paper.  I suggest that you download the paper and read it. 


Although the article was published in 2008, I believe it still has relevance.  First, it references a Medtronic Carelink Home Monitoring unit that I am quite certain is still in widespread use.  Second, they reverse engineered the Medtronic unit to create their own system that could mimic the Medtronic unit.  Although I am not an electrical engineer by any stretch of the imagination, I can attest to soundness of their methods.  I have worked with a variety of engineers who have tested communications system security using similar methods.  Furthermore, I have worked with engineers who have successfully cracked harden communications systems.  Thus I shall continue to monitor developments and findings in this field because this could impact the engineering of the communications systems for remote monitoring and programming.


One of the flaws in the Medtronic unit that made reverse engineering relatively easy was that the data was not encrypted.  I do not know if currently any or all communications between home monitoring units from any device company and implanted devices is encrypted.  Encryption adds significant overhead to communications.  Thus it makes the communication between the device and a home monitoring unit significantly longer.  It can impact battery life because encrypted transmissions have more bytes to transmit.

One of the potential limitations to hacking implant radio communications is the extremely low power level of that communication. The low power levels suggest that the hacker would have to be in close proximity to the device, within three meters.  However, their article did not extensively investigate the communications distance issue or methods that might be used to get around the proximity problem.

Third, the authors also had access to a Medtronic programmer.  A study of the operations of the programmer enable the authors extend their capabilities to hack communications with the implanted device. 

The scariest part of the article is a discussion of how it would be possible to kill a person with an ICD using the device they constructed.  Here's that section of the article (edited):

Inducing fibrillation

During implantation surgery, it is common for a physician to test the newly implanted ICD to ensure that it can both sense and appropriately treat a cardiac
condition known as ventricular fibrillation (V-Fib), one of the most common kinds of heart rhythm problems. Accordingly, the ICD has several testing modes in which it can induce VFib.  Such a test — called an electrophysiological (EP) study — is normally conducted with cardiologists standing by to stop the fibrillation if the ICD fails to do so. ... [a] programmer sends the ICD a sequence of commands that ... [a] shock to be applied to the patient’s heart at a precise point in the patient’s cardiac rhythm, with the goal of inducing V-Fib. When its automatic therapies are enabled, the ICD should immediately detect and treat the fibrillation by delivering the proper therapy. ... We then used our commercial programmer to conduct an EP study ... We then replayed a recording of the EP study command sequence via our software radio. At least three of 30 replay attempts succeeded. We successfully triggered command shocks via replayed commands even after turning off all of the
ICD’s automatic therapies.
Quoted from:
Halperin, D, Heydt-Benjamin, T., Ransford, B., Clark, S., Defend, B., Morgan, W., Fu, K., Kohno, T., Maisel, W. Pacemakers and Implantable Cardiac Defibrillators:
Software Radio Attacks and Zero-Power Defenses, IEEE Symposium on Security and Privacy, 2008, pp 1-14.

A more complete article on the NIST Grant fund BANS research

I have added a more complete article without comment regarding the NIST funded study to advance the capabilities of Body Area Networks (BANS).  It appears to be largely taken from the press-release from Worcester Polytechnic Institute.  

Here's the link: http://itisinteresting.me/2010/03/1-2-million-award-from-nist-facilitates-groundbreaking-study-of-wireless-body-area-networks/

Overcoming the Power Connudrum

I have written about the power consumption issue in earlier articles.  I now include a link to another article that discusses further positive developments in towards solving the power requirements problem inherent in remote patient care.  Here's the link to the article: Breakthroughs with Sensing in the Human Body By Dr Peter Harrop, Chairman, IDTechEx

The article discusses the following developments towards solving the power problem.  The two fundamental areas are:

1.  Advancements in reducing the levels of power required for body sensor nets.  
2. Methods for harvesting power: either from the wearer or from the environment.

Developments in power for portable and wearable devices are worth watching because the capabilities of remote patient care are limited primarily by power requirements.  Power requirements for pacemakers, ICDs and CRT(-D)s devices have by in large been met, that is, for those devices where the communications requirements are minimal.  However, as communications requirements increase, so will power consumption. And all indications are that data traffic requirements will increase, thus the need to both find more power and reduce power requirements will increase as well.


I shall continue to publish further developments in this area.

An another article on BANs

Another article on Body Area Networks and the Federal Government's continuing interest in furthering its development.  Here's the link to the article: http://www.informationweek.com/news/healthcare/mobile-wireless/showArticle.jhtml?articleID=224200068

Much of the work seems analogous vehicle telemetry research and development. One of the applications for the technology we developed at Rosetta-Wireless was for the transport of vehicle telemetry over the commercial wireless network in real-time or near real time.  The problem that we solved was handling gaps, faults and multiple types of wireless connections while the vehicle was in motion.  Again, body data will need to be transported over wireless using a robust logical connection to overcome the imperfections of the wireless network and perform the task without burdening the user - an extremely important consideration.

The next article will discuss the implications of HE75 and the means, methods and importance of not burdening or overtaxing the user.

Human Factors Issues in Remote Monitoring and Remote Programming

Series Overview and Background
 
Human factors issues related to remote monitoring and remote programming (remote patient care) will predominate in my postings over the next several months.  If I learned anything while working at St. Jude Medical, I learned the value of human factors engineering in relationship to remote monitoring systems.  Before I discuss what I learned, I want cover a few issues regarding remote patient care.

If you talk to a device clinic clinician, that person will have few difficulties in communicating to you the value of remote monitoring technology.  I heard stories from cardiologists that before remote monitoring technology was in place that device nurses would have to telephone device patients.  The emotional strain on the nurses was so great that device nurses would burn-out in two years.  

Remote monitoring provides a service to patients and their caregivers.  Most patients do not want to come to the device clinic and caregivers would rather that they did not.  Remote monitoring lengthens the time between clinic appointments.  Furthermore, remote monitoring can detect signs of potential problems much earlier than a visit to the clinic.  Remote monitoring can keep patients out of emergency rooms and can provide patients with a better quality of life.  Finally, remote monitoring can lower the cost of care while improving it.


Among the medical trail blazers, there is an interest in remote programming.  The ability to remotely make changes in the operation of a medical device could enable caregivers to be more proactive and provide patients with care where ever they are located, rather than just in the clinic.  This capability significantly lowers barriers and limitations on patients and their caregivers.  Patients can lead more free and independent lives and less tethered to clinic appointments.


Sounds wonderful, doesn't it?  Remote patient care technology does provide the underlayment, the enabling capability.  However, remote patient care system cannot be limited to the technology.  From my perspective working at St. Jude Medical, roles of caregivers and patients have been under valued, misunderstood or neglected in the development of systems to provide remote patient care.  I cannot speak for other medical device manufacturers.  I can say, because this is public information, that St. Jude Medical's remote monitoring system has come under fire because of issues related specifically to the performance and design of the user interface of their remote monitoring system.  

I am not singling-out St. Jude Medical regarding the design and implementation of their remote monitoring system.  St. Jude Medical implemented a beneficial and desired medical system.  However, it appears that they failed to understand two essential elements who are just as essential to the remote care system as the hardware and software.  Thus the current state of St. Jude Medical's remote monitoring system serves as a starting point for the articles that will follow this one.


My next two articles will focus on the new AAMI/ANSI standard HE75 due to be officially released in April 2010.  I cannot quote from the document at this time, however, I can say that HE75 is founded on the basic foundations of human factors. Thus, from that standpoint, there is nothing new about what is contained in HE75. I know several people on the HE75 committee and I can say that they are consumate human factors professionals, and dedicated to the profession. 


I can also say that should the FDA adopt this document (and all expectations are that the FDA will adopt it), the relatively lax approach that FDA approach to usability and human factors will come to an end.  There is a massive body of literature that documents the massive number of injuries and deaths from medical errors, and some of those medical errors can be traced back to poor device designs.  It may well be that the FDA will believe that it is time to "crack down" on poorly designed medical system user interfaces.  Furthermore, medical systems are becoming increasingly more powerful and complicated, thus the capability to do injury to patient will increase.  Thus, the need to insure that medical devices and their user interfaces will meet specific and unambiguous performance standards before being approved by the FDA.


I plan to focus specifically on medical devices related to remote patient care in this blog.  However, I may stray from time to time when there is something that seems particularly relevant or interesting.


I shall not discuss anything regarding future St. Jude Medical products or services in this blog.  However, I can discuss some of the issues I faced in general terms to illustrate points.  I suspect that the experiences I relate will resonate with others.


Next time: Human factors in the research and development of medical devices.

Development of BANS Expected to Accelerate

For those not in the "know," BANs is an acronym for Body Area Network.  It is a technology to capture and transmit body-related telemetry.  The National Institute of Standards and Technology (NIST) has granted the Center for Wireless Information Network Studies at Worcester Polytechnic Institute (WPI) Worcester, MA, $1.2 million over three years to advance BANs technology.  The research will focus on the propagation of radio waves around and through the human body. This could have real potential for the development of robust communications standards to enable medical devices to send and receive data and instructions over wireless networks.  This research is something to watch.

http://medicaldesign.com/engineering-prototyping/research-development/development-bans-expected-accelerate-032210/

Receiving a NIST grant is a significant achievement.  I was the Principal Investigator on a $2 million, two year grant to Rosetta-Wireless.  The NIST vetting process is arduous, but the grants generally fall into the seven figure range over two to three years.  I know that wireless data communication is an important area of interest to NIST particularly as it relates to medical applications, more specifically into the areas of wireless medical monitoring and remote programming.  I know that NIST has continued hopes for a medical application of the technology that my company, my research and development team created.

For those who have an interest in BANs, one of the technical problems is getting the data collected by BANs back to a location where medical professionals can review and evaluate it. And, if need be, make changes remotely in the operation of the implanted medical system (e. g., pacemaker, ICD, insulin pump, etc.).  If you review some of my earlier posts, you'll note that I have described methods to transport data and instructions over the commercial wireless network from and to a patient's implanted medical device. 

I shall continue to bring to light any further developments in BANs.

Revamping the Revenue Generation Model in the Medical Device Industry

My fourth posting on this blog on 29 September 2009 was part of a multi-part examination of Medtronic's remote programming patent (US Patent # 7,565,197 that was granted in 21 July 2009).  I suggested that the patent patent implied two directions in the development of medical devices:

1. The development of a single, common hardware platform based on a generalized processor, similar to TI's low power processor. (Add urls).
2. Medtronic device capabilities would be defined primarily by software.  Furthermore, the patent defines a capability for software to be downloaded to a device, thus defining the capability for updating the software on the device.

We've learned that there are technologies in development that could significantly increase the battery life of devices: maybe at some point eliminating the need for battery replacement all together.

Today, physicians, hospitals and device manufacturers receive the bulk of their payment when a device is implanted or replaced.  Thus, the current business model of device manufacturers relies on primarily on product such as an ICD or CRT and leads.


However, the Medtronic patent suggests the possibility, maybe even the likelihood of strategic shift from a product to a licensing business model. This would suggest a business similar to software companies who charge a flat or yearly fee for the use of software.  Instead of a replacement, the patient receives a software upgrade and the device company receives payment for the software upgrade.  This is one step removed from a pure product to a service-oriented model, but it still treats the software as a product.  Nevertheless, it provides flexibility to the medical device company in that revenue comes less tied to the sale of objects, and more tied to the services provided to the customer.


An even more innovative approach and more in-line with a service-oriented business model would be to have the software redefine the capabilities of the device itself while implanted in the patient.  For example, upgrade an ICD to a CRT-D by changing software.  I do not know the technical, implantation or leads-related issues of doing this, however, from a software standpoint, there should be nothing stopping a device manufacturer who has taken the common hardware design approach.

A pure service-oriented model would change on the basis for the services provided.  Since I'm a technologist and not an MBA who has worked in the device industry for decades, I cannot define all the possible revenue-producing services medical devices with remote monitoring and remote programming could provide device companies.  I can say that the services that medical device companies can provide medical care providers and their patients is becoming less and less tied to the devices themselves. So a more service-oriented perspective in the medical device industry seems warranted.  

It seems apparent that for medical device companies to expand their services and patient-care and management capabilities with information-based services over the communications infrastructure, they are going to have to change the way they receive revenue.  The current business model and means of generating revenue does not provide incentives to companies to expand into information based services given the current product-based revenue model currently in use.  I suspect that in a relatively short time, Medtronic will propose a new revenue model.  I shall be watching for the signs.

Essay: Economical Medicine

To my readers:  I have been engaged in high-priority activities for my current client and have unfortunately neglected this blog.  I plan on publishing a flurry of articles from now to the end of this year.  Furthermore, I am re-initiating my review of patents and patent applications.


Preface

In this essay I discuss some of my observations regarding the US medical system.  I discuss what I consider could be the impact of remote monitoring technology on US medical practice.

I hope that people outside of the United States read my blog.  I provide my perspective as one US citizen about the US culture and medical practice.  I hope that others may chime in, and provide their perspectives regarding the US medical system, their own medical systems (if citizens of another country) and provided me with their perspectives.  

I argue that remote monitoring can provide high quality health care at a lower cost.  Remote monitoring provides lower cost health care primarily by keeping people out of the hospitals.  As a result, the huge infrastructure devoted to hospital will likely whither.  Hospitals will always have a place, but they'll become smaller and targeted to providing critical services such as trauma care, critical care and post-operative recovery.  People will spend less time in the hospitals, but physicians and automated care-givers will be able to monitor patients where ever they are located - mostly, away from the hospital.


But before I discuss my views on remote monitoring and it's place in economical medicine, I discuss my concepts of economical medicine.


Economical Medicine

My home is Chicago, Illinois, and over the last few years, I have seen a spat of new hospital construction.  Admittedly, there are areas where there are too few hospital beds and services.  I have been astonished by the amount of recent construction. It seems that the hospital are competing with each other to see who can provide the newest, most up to date hospital.  Furthermore, many of these same hospitals purchase the most expensive scanning equipment available and build large testing laboratories.

The United States provides some of the worst and the best medical treatment available in the industrialized world.  If you want something extra-ordinary performed, come to the US.  Where the US fails is providing mundane care to the majority of its populace. Our outcomes for the extraordinary are fabled, but the US ranks 37 in the WHO health care rankings behind countries such as Costa Rica, Columbia, Dominica, besides the obvious ones such as France, Switzerland, Austria, Italy, etc.

A landmark study published in 2000 showed that the US has the most expensive health care system in the world based on per capita and total expenditures as a percentage of gross domestic product.  

In 1998 the US spent $4,178 per person on health care in 1998.  The study median was $1,783 and the closest competitor was Switzerland at $2,794.  US spending as a percentage of gross national product was 13.6 percent. The countries closest were Germany (10.6%) and Switzerland (10.4%).  And things since 1998 have only gotten more expensive in the US to the point where the US care costs have reached crisis proportions.

Yet in the midst of an attempt to repair the US crisis, members of the US Congress, including nearly every member of the Republican party, have demonized any attempt to make the cost of health care more reasonable.  Particularly, when the costs of US health continued to increase at a pace that would eventually drastically lower the standard of living of the majority of Americans. Why is this?  

The roots of the opposition are clearly political and rooted in the economic interests of primarily the US health insurance companies.  Health insurance companies nearly own and operate many members of the House and Senate on matters of health care.  And these health care companies decided to declare war against any and especially a strong public insurance option - e. g., anything close to Medicare for the rest of us.  However, there is cultural resistance as well.

Culturally, Americans are profligate. We are a non-economical culture and that believes itself to have no limits.  Our sense of limitlessness is our greatest strength and weakness, and it has been running out of control for a long time. 



Americans build roads and cars instead of building trains and tracks.  We built muscle cars with large and powerful engines for decades instead of fuel-saving vehicles.  We built suburbs along our superhighways and commute long distances to work in vehicles that consume excessive amount of fuel.  We built large houses and houses with little insulation that consume excessive amounts of fuel to heat and excessive amounts of electricity to cool and light.  Growing up in this culture, my sense is that many Americans construe excess with the good life.  That need not be case.

We have a medical system that costs too much, delivers too little, places undue burdens on it's practitioners such as malpractice insurance costs and excessive paperwork.  In addition it has been perceived by a wide variety of players as a way to make massive, excessive amounts of money.  Getting fairly paid for a medical service, product or drug is a good thing.  Excessive payments can corrupt or bankrupt an entire system. 



Lower Cost Does Not Necessarily Equal Lower Quality


Over the past several decades we have be privy to a revolution, a revolution in ubiquity of computer power.  Compare the cost of an 1984 Apple Macintosh or a 1984 PC with one today.  The costs are either comparable or lower, but the computational power has skyrocketed from then to now.  Everything in the computational and communications sphere has increased while the cost has decreased.  Supercomputers and supercomputer availability, rare in the 1980s and early 1990s, has exploded in the last decade.  Sophisticated hand held computers with voice and data capabilities that dwarf the powers of 1990's desktop computer are available for hundreds of dollars.


Remote Monitoring


Remote monitoring is a minor outgrowth of the computing and data communications revolution.  It makes some use of the continuing computer and telecommunications developments, but so far, relatively little.  However, the potential is there as well as the interest in spreading the capabilities of the computing and communications revolution to the medical community.  In fact, I believe that many computer scientists and engineers consider medicine one of the last frontiers to thoroughly swept-up in this revolution.


Medicine by nature is a conservative discipline.  It deals with people's lives.  In the US there's the added problem of the legal profession and malpractice insurance companies breathing down a physician's neck.


I believe that the medical industry finally fully leverages the capabilities of the computer and communications revolution, medical costs will be lowered, people will spend either no or little time in hospitals.  Physicians will have the capability of tuning the dosages of medication in real time.  Sophisticated computer systems that have made use supercomputer models will be able to determine the medical status of a patient in real time or near real time.  These systems will be able to determine if a patient is showing signs of a pending medical crisis and requires intervention before the crisis appears.


All this can be available to the citizenry at a cost that would surprise you.  This is the ounce of prevention on a grand scale.


I shall continue to discuss economical medicine in future articles and how leveraging the computational and communications revolution will contribute to providing better medical care at a lower cost.

Biotronik TRUST Studies: Reprinted Abstracts and Commentary

What follows are published abstracts of the Biotronik studies that provided evidence that Home Monitoring can substitute for quarterly check-ups for ICD patients.  That care of ICD patients can be just as effective with one per year in-clinic check-ups instead of the normal three month in-clinic check-ups.  This was supported primarily by 2008 study.

The 2009 study is a logical follow-up to the 2008 study. This study provided evidence that the Biotronik remote monitoring (Home Monitoring) system can provide early-warning notifications of significant cardiac events faster and more effectively than quarterly, in-clinic visits.  This study has wider implications.   It provides evidence that remote monitoring can provide the kind of care that at one time could only be provided in hospitals.  Furthermore, it demonstrates the kind of capability necessary to provide the kind of early warning that can keep specific, targeted populations out of hospital, thus providing more economical and more desirable health care.

These studies are reprinted with permission from Biotronik.  (I have no affiliation with Biotronik.) 


2008 Study


Evaluation of Efficacy and Safety of Remote Monitoring for ICD Follow-Up:

The TRUST Trial

Authors: Niraj Varma, Cleveland Clinic, Cleveland, OH; Andrew Epstein UAB Medical Center, Birmingham, AL; , Univ of Alabama Birmingham Medical Center, Birmingham, AL; Robert Schweikert Cleveland Clinic, Cleveland, OH; , Akron Medical Center, Akron, OH; Charles Love, Davis Heart and Lung Research Institute, Columbus, OH; Jay Shah, Carolina Cardiology Associates, Rock Hill, SC; Anand Irimpen; Tulane University Medical Center, New Orleans, LA

Background: Remote monitoring (RM) of ICDs may provide daily, automatic device and patient status data and cardiac event notifications. TRUST tested the hypothesis that RM was safe and effective for ICD follow-up for 1 year in a prospective, randomized controlled clinical trial.

Methods: 1282 patients were randomized 2:1 to RM or to conventional (RM disabled) groups.Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. In the RM arm, RM was used before office visits (OVs) at 3 and 15 months. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. Conventional patients were evaluated with OVs only. Follow up was “actionable” if system reprogramming/revision or change in anti-arrhythmic therapy occurred. Scheduled and unscheduled OVs (including responses to event notifications in RM) were quantified for each individual patient per year (pt yr) of follow up. Incidence of death, strokes and surgical interventions (morbidity) was tracked in both groups. 

Results: RM and conventional patients were similar in age (63.3 ± 12.9 vs 64.1 ± 12.0 yrs, p = 0.30), gender (71.9% vs 72.4% male, p =; 0.89), pathology (LVEF 29.1 ± 10.8% vs 28.6 ± 9.8%, p = 0.47;coronary artery disease 64.5% vs 71.4%, p = 0.02), medications (Beta blockers 79.5% vs 75.9%, ACE inhibitors 42.4% vs 46.8%, ARBs 7.8% vs 9.9%, p = NS), indication (primary prevention 72.3% vs 74.2%, p = 0.50), and dual chamber implants (57.9% vs 57.0%, p = 0.76). RM reduced scheduled OVs by 54% and total OVs by 42% without affecting morbidity. Event notifications were managed using RM alone in 92% of cases. Of the remainder resulting in unscheduled OVs, 52.2% were actionable. RM improved adherence to follow-up. 

Conclusions: TRUST demonstrated that remote monitoring is safe, decreases the need for in-office visits, provides early detection of significant problems, and improves ICD surveillance without increasing unscheduled office visits. In conclusion, remote monitoring is a safe alternative to conventional care.


2009 Study


EARLY DETECTION OF ICD EVENTS USING REMOTE
MONITORING: THE TRUST TRIAL
 
Authors: Niraj Varma, MD, FRCP, Andrew Epstein, MD, Anand Irimpen, MD, Robert Schweikert, MD, Jay Shah, MD, Lori Gibson, DVM and Charles Love, MD. Cleveland Clinic, Cleveland, OH, University of Alabama Birmingham Medical Center, Birmingham, AL, Tulane University Medical Center, New Orleans, LA, Akron Medical Center, Akron, OH, Carolina Cardiology, Rock Hill, SC, Biotronik, Inc., Lake Oswego, OR, Davis Heart & Lung Research Institute, Columbus, OH

Introduction: ICDs have extensive self-monitoring capability with diagnostic data available at interrogation. Remote Monitoring (RM) may facilitate data access but this has not been tested. The secondary endpoint of the TRUST trial tested the hypothesis that RM with automatic daily surveillance can provide rapid notification thereby facilitating prompt physician evaluation.

Methods: 1312 patients were randomized 2:1 to RM or to conventional (C) groups. Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. RM was used before office visits (OVs) at 3 and 15 months in RM group. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. C patients were evaluated with OVs only. Unscheduled checks between these time points were tracked. The hypothesis was tested by determining time elapsed from first event occurrence in each patient to physician evaluation.

Results: RM and C patients were similar (age 63 ±13 vs 64 ±12 yrs; gender 72 vs 73% male, NYHA class II 56 vs 61%, pathology LVEF 29 ±11 vs 28 ± 10%; CAD 65 vs 72%, amiodarone 14 vs 14%, primary prevention indication 72 vs 74%, and DDD implants 58 vs 57%). Median time to evaluation was < 3 days in RM compared to < 30 days in C (p < 0.001) for all arrhythmic events (figure) including silent episodes eg AF. System (lead/ generator) problems were infrequent (20 events in RM +C).

Conclusions: Remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation.

Commentary

2008 Study


Of significant interest would be morbidity rate.  The remote monitoring group showed a .9% higher death rate than the conventional group.  This result was also nonsignificant.  The nonsignificant difference appears to be expected outcome.  Demonstrating a negative - or no difference - is always a concern in research because of the logical problem in demonstrating that something did not happen or that there are no difference between the groups.


I have an additional concern with respect to the unbalanced design.  Unbalanced designs have lower  power of your statistical power - that is, the ability to reject the null hypothesis - than balanced designs. And that would be of concern in study where the expected outcome is no difference.  However, the numbers are extremely large that should off-set the reduction in statistical power created by the unbalanced design.  Since I do not have the raw data, I cannot be sure.  Nevertheless, this seems reasonable. 


The remote monitoring group did have a slightly higher rate of unscheduled appointments - .6 per year in the RM group and .5 in the conventional group; and the actionable percentage was .7% higher in the RM group. The differences could be considered marginally significant with a p = .104. If I understand the circumstances correctly, it seems reasonable that remotely monitored patients would have a higher rate of unscheduled appointments.  Remote monitoring should have the capability of earlier detection of arrhythmic events.  Thus a detected cardiac event would trigger the patient's to request that the patient come to the clinic as soon as possible thus an unscheduled appointment would be registered.  One might expect remotely monitored patients would have appointments that are more demand or situation based than regular, scheduled appointments.




In spite of this difficulties of this design, the conclusions of this study seem reasonable in that the remotely monitored patients who received in-clinic check-ups once per year had similar outcomes to those who receives conventional care with four in-clinic visits per year.


A point of interest.  No comparisons were made between Biotronik and remote monitoring systems provided by other companies such as Medtronic, St. Jude Medical or Boston Scientific. I understand the difficulties and roadblocks in the attempt to assess whether the other systems would be just as effective.  However, Biotronik effectively side-stepped the issue by comparing their home monitoring system against conventional care thus avoiding comparisons with other remote monitoring systems.  Biotronik focused on effectiveness against conventional care and in this case they were successful.


2009 Study

As a study to show the effectiveness of remote monitoring, I believe this study is more effective.  First, it's a better design in that the expected outcome is to reject the null hypothesis - that is, to find a significant difference.  Second, there is a clear case made by the findings that remote monitoring leads to earlier discovery of an adverse event.  One truism in medicine, particularly when it comes to cardiac events, is the earlier the discovery, the better the outcome.  Another thing, ICD patients have been identified as a vulnerable population and rapid reports of adverse events within this population are particularly welcome.


In theory, over time patients remotely monitored should show better outcomes than those who are not.  The data in these two studies does not show that.  However, data from other studies are starting to demonstrate that remotely monitored patients are less likely to be admitted to the hospital.  This is a new area of technology and more research is required.  However, the trends are favorable for remote monitoring.


In this study, the Biotronik remote monitoring system reported arrhythmic events.  The data reported was not early warning or predictive.  The capability to collect predictive data would increase the value of remote monitoring.  Predictive data would allow the clinic (or computer system) following the patient to intervene before the adverse event occurs.  In this study, this was not the case.