Archives: 6/2011

9bk9pf29 Taking a Look at Innovations in BionicsThe PBS NewsHour recently ran a piece that looks at how bionics are changing the lives of people with disabilities.

In the piece, PBS NewsHour correspondent Miles O’Brien interviews two well-known bionics designers, Dean Kamen, founder of Deka Research & Development and creator of the DEKA “Luke” Arm, and John Fogelin, VP of Research and Development at Berkeley Bionics, which is developing the eLegs device. O’Brien also speaks with a couple individuals who have benefited from bionic technology, including an Iraq veteran and a double amputee paralympian.

Link @ PBS: Minds, Machines Merge to Offer New Hope for Overcoming Impairments

Medgadget coverage on some of the technologies mentioned in the video: DEKA Arm, eLegs, Rehabilitation Institute of Chicago arm, UPitt Brain Computer Interface, BrainGate neural interface system, USC/Second Sight Artificial Retina

(hat tip: BoingBoing)

vb58w4fs Vasomedical’s New BIOX 2302 ECG Holter/BP Monitor and Model 1804 Monitor Get 510(k) ClearanceVasomedical has announced FDA 510(k) clearance of its BIOX 2302 combination ECG Holter/ambulatory blood pressure monitor and Model 1804 ambulatory blood pressure monitor. The BIOX 2302 expands on the 2301, which we covered last year, with a 12-lead ECG, while the Model 1804 provides stand-alone blood pressure monitoring. The BIOX 2301 and 2302 are the only FDA cleared devices which provide ECG Holter and BP monitoring in a singe unit.

More details from the press release:

With the new clearance by the U.S. FDA, Vasomedical now offers both 3-channel (Model 2301) and 12-channel (Model 2302) Combined Holter ECG/ABP Monitors. While they can also be configured by the user to record ECG or blood pressure data only, the newly cleared Model 1804 and the previously cleared Model 1305 provide economic alternatives for applications where only blood pressure or ECG recording is needed. All Vasomedical-BIOX™ series monitors work with the CB Series Analysis Software, also previously cleared by the U.S. FDA, for data scanning, analysis and reporting.

Press release: Vasomedical Receives FDA 510(k) Clearance on Two New Devices…

Product pages: Vasomedical-BIOX™ 2301/2302 Combined ECG Holter and ABP Monitor; Vasomedical-BIOX™ 1804 Ambulatory Blood Pressure Monitor System…

Flashback: Vasomedical-BIOX 2301 for Monitoring of ECG and Blood Pressure Gets 510(k) Clearance…

a51b1y0z The Future of Tele ICUs: An Insiders PerspectiveMary Jo Gorman, M.D., MBA, is the CEO of Advanced ICU Care, a medical service company headquartered in St. Louis, Mo., which provides high-quality care to patients in the intensive care unit. For more information, visit: www.icumedicine.com.

America’s ICUs are in crisis. Consider these staggering statistics: Today’s ICUs Serve 4 million patients annually, with roughly 20 percent mortality rates among those treated. On average, every patient admitted to the ICU suffers 1.7 potentially life threatening errors every day and estimates show that patients only receive half of the therapies that they should. And 50,000 patients annually die in the ICU from preventable deaths.

But research indicates that ICU patients have lower risks of death and shorter ICU and hospital stays when an intensivist is on duty in the ICU and oversees patient care. The mortality reduction has ranged from 15 to 60 percent lower than in ICUs where there are no intensivists. However, the Committee for Manpower for Pulmonary and Critical Care Services predicts a shortage of 10,000 ICU physicians, called intensivists, who have extra training to specialize in the care of the ICU patient. This   national shortage of intensivists makes it extremely difficult to find intensivists that can provide 24/7 care for today’s ICU patients.

The answer to solving this crisis has emerged from the world of telemedicine.

Tele-ICUs Improve Outcomes, Save Lives

A tele-ICU uses state-of-the-art equipment to connect patients to intensivists 24 hours a day, seven days a week, from anywhere in the country – or the world. These doctors and nurses, at a centralized location, use remote-control cameras, video conferencing and continuous monitoring technology to access real-time patient information – including vital signs, physiologic data, medications and lab results. The intensivists and nurses also have access to patients’ complete medical history and local attending physicians’ care plans and can talk to patients directly. This technical leverage allows a qualified medical team to care for large numbers of patients and meaningful impacts the labor shortage.

On a personal note, this technology has changed the course of my career and allowed me to have an impact on patients in ways I would have never imagined. In my work early in my career as an intensivist, I saw that there is a significant lack of access for all patients to expert ICU treatment. In addition to lack of access, there is a lack of a systematic approach to the care of the patient. In fact, medical literature demonstrates that there is a lag of more than 15 years between evidence-based care and delivery to the patient. This statistic is unacceptable, and I saw that a standardized approach to the care of the ICU population delivered by telemedicine was a way to help the problem. With the notion that every ICU patient, no matter where they live, deserves to be treated by an intensivist, in 2005 we launched Advanced ICU Care, the first and only private tele-ICU company in the nation.

My goal, through telemedicine technology , was to create a completely new model of bringing the highest standard of ICU care to hospitals that otherwise would not be able to either recruit the appropriate number of intensivists, establish an ICU management program, or afford the technology on their own. Previously, the technology we use had been acquired only by large, multi-hospital systems with in-house intensivists. Few people were familiar with the concept at the time, so it was a risky endeavor to convince client hospitals and investors to commit to our program.

The technology we use, manufactured by Philips VISICU, uses sophisticated algorithms to detect and advise our clinical staff in St. Louis to important trends and changes in our patients’ condition from any of our partner hospitals. The program uses extensive reporting – including daily management and ICU benchmarking of outcomes. Our site provides some examples of what the technology looks like to the patient.

Utilizing the technology and our unique process improvement program has led to great results for the patients we care for and for my company. Our results are consistent with the results of various academic studies that continue to prove that tele-ICUs save lives. Our partner hospitals – 17 hospitals in nine states – have found 40 percent reduction in ICU mortality on average and 25% length of stay improvement as well as improved performance across key quality best practice measures.

Two recent studies have added to the consensus that tele-ICUs are the key to improving America’s critical care. “Hospital Mortality, Length of Stay and Preventable Complications Among Critically Ill Patients Before and After Tele-ICU Reengineering of Critical Care Processes,” – published  in the Journal of the American Medical Association – found that tele-ICU intervention was associated with lower hospital and ICU mortality, shorter hospital and ICU lengths of stay, significantly higher rates of adherence to critical care best practices and lower rates of complications.

And a study released in December by the New England Healthcare Institute (NEHI) and the Massachusetts Technology Collaborative also found that patient mortality decreases significantly – as much as 36 percent – when hospitals adopt tele-ICU technology.

The Future of America’s ICUs

These results prove that tele-ICUs should – and most likely will – be an integral part of America’s critical care future. The government is taking steps to pave the way to that future as well. In May, the Centers for Medicare and Medicaid Services (CMS) took a huge step in support of telemedicine by implementing a new credentialing and privileging process for telemedicine providers. Under the new rule, hospitals will no longer have to credential and grant privileges to each clinician who provides telemedicine services to its patients from an off-site location. Instead, hospitals can rely on the credentialing and privileging decisions of the clinician’s home hospital or facility.

And in June, Health and Human Services Secretary Kathleen Sebelius pointed to tele-ICUs the type of innovation that can serve as a model for providers around the country as they try to cut costs and improve patient safety and care.

As regulations make it easier for tele-ICUs to treat patients, technologies continue to improve. Doctors are now using mobile apps and devices such as iPads to help detect sepsis in the ICU. As a CEO and an intensivist, I am proud to be part of this revolutionary time in critical care services. This is just the beginning.

amkjkqky The Future of Connected Health Devices: Interview With IBMs Heather FraserIBM has just released a groundbreaking executive report that discusses the future of connected health devices, by analyzing who will most benefit from them, what kind of people will be the early adopters, and how to go about developing new products. In a nutshell, the IBM study predicts that the next generation of healthcare devices “will increasingly come to the aid of the world’s one billion adults who are overweight, the 20 percent of smokers globally who are trying to quit, those who are suffering from hypertension and 14 percent of the elderly worldwide who live alone.” The study forecasts that this consumer segment is ready for connected health devices and that users are willing to pay up to $100 for them, a critical price point in almost 75% of people surveyed.

Based on the study’s results, IBM predicts that we will go social when it comes to our health. For example, 86 percent of device users are demanding real-time information and feedback. Also, social networks and social support have real health benefits, as they promote more effective behavior change, such as better success at dieting or quitting smoking and becoming less sedentary. Lastly, future health devices will have a real social value, as they will allow patients to stay connected with their network of supporters and family members.

We took the opportunity to ask a few follow up questions to Heather Fraser, Global Distribution and Life Sciences lead at IBM Global Business Services, and one of the authors of the report.

Medgadget:  Your study identified $100 as a key price point for market adoption of connected devices. What technological, economic, or other factors do you see hampering devices from reaching that goal?

Heather Fraser: Our survey respondents said they will be more open to paying for devices that met their needs in the future. More than one-third of the respondents are willing to pay for devices in 2 years, although currently less than one-tenth are paying some out of pocket cost for their devices today. Of those respondents planning to buy a new device in the next two years, 79% of them expect to incur some out-of-pocket expense not to exceed $100.

This will require

  • manufacturers to come up with affordable devices
  • implementing incentives such as decreased insurance premiums to capture more consumers
  • looking at costs shared between consumer and payer – this could be outcomes based in nature

Medgadget. Does the multitude of free medical smartphone applications pose a challenge to companies providing their own specialty software to interface with their devices, or do you see companies opening up their device data for easy access to 3rd party developers?

Heather Fraser: On the contrary, we see the rapid adoption of mobile devices and adoption of apps ( 10% of apps downloaded from Apple iTunes Store are related to healthcare, medical or lifestyle) as providing a new level of comfort for consumers with communications and entertainment technologies , influencing how they want to manage their health.

Medgadget. What medical conditions do you envision will drive the greatest growth in this market?

Heather Fraser: Companies pursuing business opportunities in health device market and particularly amongst the information seekers need to decide which conditions offer the best opportunity and then understand the information needs of that group. They need to check that data can be collected; will be accepted readily and will be used to support any treatment. This could be done along with healthcare professionals and patient advocacy groups for example.

Examples of medical conditions which fit in the information seeker category and offer significant populations are:

ADHD: 5.3million children aged 3-17, diagnosed with Attention Deficit Disorder in the US
Obesity: $63Billion spent globally on the top ten selling diet drugs
High blood pressure : 600M People globally suffer from Hypertension

Medgadget. Is this “gamification” of health and fitness just a fad, or will games play a greater role in the future of medicine?

Heather Fraser: The later. To reach the ‘Information seekers’ consumers, device makers need take a different approach to solution design to motivate the user to continue to use their device. They need to focus on making the actual device easy to use for the target audience and also helping the consumers manage their health conditions by setting up rules. For some consumers offering the use of games to ‘reward’ for persistence and compliance is a great motivator (e.g. Bayer Didget offering ‘gaming ‘ rewards for kids that regularly monitor their diabetes and stay within defined limits or alerts to contact your health professional if a reading exceeds a given level on more than 2 occasions in a row )

Medgadget: Do you see Google’s announcement that they are shutting down Google Health as a signal of greater than expected challenges existing in the industry?

Heather Fraser: According to our study 77% of the respondents said that keeping their data private and secure was critical, confirming that privacy and security of personal health data is a minimum requirement for connected health devices.

Full IBM report: The future of connected health devices: Liberating the Information Seeker.

t34bq3422 Is Hemova Port The Next Generation Vascular Access for Hemodialysis?A graduate student team from Johns Hopkins won the 2011 ASME Innovation Showcase for their Hemova Port device.  Hemova Port would be implanted under the skin in the leg to provide a safer method of performing dialysis, hopefully minimizing infection, clotting and stenosis of blood vessels. The device is currently undergoing pre-clinical trials on animals and a company is being formed to commercialize it.

The Hemova device is equipped with two valves that can be opened by the dialysis technician with a syringe from outside the skin. The technician can similarly close the valves when the procedure is over, an approach that helps avoid infection and clotting. The device also includes a simple cleaning system, serving as yet another way to deter infections.

Currently, most dialysis access sites are in the arm or the heart. The Hemova device instead is sutured to the leg’s femoral vein, avoiding the unnaturally high blood flows that cause vessel narrowing when dialysis machines are connected to veins and arteries in the arm. The student inventors say the Hemova Port’s leg connection should allow the site to remain in use for a significantly longer period of time.

Full story: Student Team Wins Top Prize for Device That Could Cut Risks in Dialysis Treatment…

fj2032ed St. Judes Neuromodulation Showing Effectiveness Against Migraines
St. Jude Medical is touting results of a study of its Genesis neuromodulator for controlling serious migraines.  157 patients with an average of 26 days of headaches per month were implanted with the Genesis and compared to a control group that had the neurostimulator activated after 12 weeks.

Considering all the participants, after one year there was a reported good or excellent headache improvement in 66 percent of the implantees.  Here are the findings from the initial 12 weeks as reported by St. Jude:

  • Patients who received stimulation reported a 28-percent decrease in their number of headache days (seven less days a month) compared to the placebo group which reported a 4-percent decrease (one less day per month).
  • Overall disability as measured by the Migraine Disability Assessmentfeb52tj0 St. Judes Neuromodulation Showing Effectiveness Against Migraines

    questionnaire (MIDAS) indicated participants in the active group had a 41-percent improvement compared to a 13-percent improvement in the placebo group.

  • Zung Pain and Disability Index (PAD) scores improved in the active group by 20 percent compared to an 8-percent improvement in the placebo group.
  • In addition to the standardized scales (MIDAS and PAD), patients were asked to subjectively assess their pain relief. The active group reported 42-percent pain relief compared to 17 percent in the placebo group.
  • Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12-week end point, 53 percent of patients in the active group ranked their relief as excellent or good compared to 17 percent in the placebo group.
  • When asked to rate the effect on their quality of life, 67 percent of the active group reported improvement compared to 17 percent in the placebo group.
  • The active group reported 51-percent satisfaction with headache relief compared to 19 percent in the placebo group.

Reuters is reporting that this might not be enough for the FDA to grant approval for this indication.

Press release: St. Jude Medical Reveals Randomized Clinical Trial Data Demonstrating Benefit of Neuromodulation for Chronic Migraine…

15439rj Stanmores Juvenile Extendible Femoral System Gets U.S. Green LightUK-based Stanmore Implants received FDA approval for its Juvenile Tumour System (“JTS”) non-invasive extendible distal femoral replacement.  Indicated for use in pediatric ortho oncology surgeries, the implant can later be slowly extended using an external magnet system without having to perform another invasive procedure on the patient.

At its core, the JTS implant is lengthened by a small yet powerful gearbox, which drives the extension. Remarkably, the gearbox is able to output ample force to lengthen the limb via a speed reduction ratio of 13061:1. With the implant in place, the limb is periodically lengthened by placing the limb into the external drive unit.

f902ejj Stanmores Juvenile Extendible Femoral System Gets U.S. Green LightBy passing electric current into an electric coil, the drive unit produces a rotating magnetic field at 3000rpm. This rotation is captured by the magnet within the implant and is passed through the gearbox to extend the implant. The implant will grow at 1mm every 4 minutes, thereby slowly stretching the soft tissues.

Press release: Stanmore receives US FDA approval for its JTS non-invasive extendible implant…

098jf2 BioFriend BioMask Going on Sale in U.S.
Hong Kong-based Filligent has received FDA regulatory approval to bring company’s BioFriend BioMask to the U.S. market. The surgical mask actively provides both anti-viral and anti-microbial protection, and is used just like any other mask.

More details from the product page:

f93ejgflj BioFriend BioMask Going on Sale in U.S.

This mask uses a proprietary hydrophilic plastic coating on the outer layer that rapidly absorbs infectious droplets away from the surface of the mask and into the inner layers where pathogens are inactivated (killed) by low pH and the natural ions, copper and zinc.

Antimicrobial protection
Over 350x greater barrier protection
Kills 99.9% of pandemic influenza on contact, including H1N1
Also effective against TB1, rhinovirus, MRSA & measles
Pandemic & seasonal precaution
Reduces risks of cross-contamination
- hands – equipment – surfaces
Self-sanitizing for extended wear2
Easy breathing
Engineered to fit a broad range of face sizes and shapes
Durable (logistics, storage, shelf life)
Safe: non-irritant, non-toxic
Protects patients & surgeons from spread of infective agents
CE certified: EN14683, Type IIR surgical mask
Exceeds ASTM F2100-07 high barrier surgical face mask standards

Press release: Filligent Makes History – Receives FDA Approval …

Product page: BioFriend BioMask …

g2wfkw Meducation, a Multi Lingual Drug Regiment App, Wins Harvard ChallengeChildren’s Hospital Boston and Harvard Med School just announced the winner of their “SMART” Platform Apps Challenge, a contest of web applications that take advantage of data within electronic medical records.

Meducation, made by Polyglot Systems, is a simple tool for clinicians and pharmacists to print out easily understood personal medication instructions, including a choice for those instructions to be in any one of twelve languages. There are also demo videos available when referencing something a little more complicated than oral pills, such as asthma inhalers.

Some features of the app from the product page:

  • generates a printable CMI sheet containing both the SIG (instructions for use) and a medication-specific drug monograph for each medicine;
  • provides such information at a 5-6th grade reading level with particular consideration for low health literacy;
  • supports printouts with ample white space and multiple font sizes to increase comprehension and to improve readability for elderly and visually impaired patients;
  • provides animated, visual demonstrations of complex medication techniques for viewing at any time over the web and in multiple languages;
  • utilizes the Universal Medication Schedule, a research-based visual aid shown to reduce medication errors and improve adherence;
  • and supports efficient, cost-effective, and verifiable translation into other languages.

Meducation info page: Meducation …

Press release: “SMART” Health App Competition Concludes, Names $5,000 Winner …