MedWorm: Technology Consultants

Going off the grid - the rise of “direct practice” medicine

Crossover Healthcare — Fri, 16 May 2008 05:57:11 +0100

Grid (grĭd) n. Something resembling a framework of crisscrossed parallel bars, as in rigidity or organization An interconnected system for the distribution of electricity or electromagnetic signals over a wide area, especially a network of high-tension cables and power stations. The interconnected system employed by the Medico-Industrial complex to create a third party payment systems which artificially creates complexity, increases costs, reduces quality, eliminates accountability, and destroys the patient-physican relationship. As has been documented in this blog, I have been on a health care finance reform journey the last six months. I was fortunate to be given the opportunity to work with Lemhi Ventures (outstanding group of health care innovators) on looking at new models of health care delivery, financing, and insurance. During the course of that project, I learned a ton about the nature of health insurance, current status of health plans (there has been plenty of interesting news the last six months on them here, here, here, and here), followed closely the presidential debates on health care reform and become familiar with many of the innovators within this space (Prometheus, Alan Goroll, etc) A new article just published by MDNG Live (the same magazine that featured my cover story “Meet Your New Patients” last month) showcases Jay Parkinson with the catchy title, “Jay Parkinson Sells Out!”. Catchy because one thing I don’t think you will be able to call Jay is a sellout. In fact, his “stick to my guns; this is how I believe medicine should be practiced” approach has enamored him to the public media and vicariously documented the groundswell of interest in this “new” health care delivery model. “New” in quotes, of course, because there is nothing new about this model of care delivery - a patient and a physician entering into a trusted relationship wherein the physician provides services that are valued by the consumer who pays cash for them. The millennial update is that physicians can now do this in new ways, with new devices that have become commonplace in every day life except for in the inane and archaic world of health care. The article provides some excellent insight into Jay’s serendipitous timing, his unprecedented publicity, and the phenomenal response from what must feel like the entire civilized world (7M hits the first six months his site is up). I particularly appreciate Jay’s candor with regards to the unsustainability about his original model, and how the timing of meeting with someone of Nat Findlay’s caliber has helped him accelerate his compelling vision. It is a great read and highlights what I must say feels like a groundswell of interest of people wanting to increase the value they are getting from their health care expenditure. In fact, the current disdain of the market has to do with the incredible complex, archiac, byzantine, and backward health care morasses that has been built up, institutionalized (”thats the way we have always done“), and now will be jealously guarded as innovators continue to chip away at the very foundation of what has become the American Health Care “System”. This revolt of both patients and providers off the traditional medico-industrial grid, is similar to the “awakening” that occurred to Keanu Reeves in the Matrix. The overwhelming theme in all my conversations with both the physicians and the patients who are entering into these “direct practice” (the PC way to say Concierge Medicine) relationships is one of liberation, of freedom, and of doing things the way that they should be done. The providers get to provide a much higher level of care, to truly get to know their patients as they are incented to spend appropriate time with them, and over time get to know them within their unique social/cultural context as well (hence the house calls become important). The patients love the access, the attentiveness, and are willing to spend cash to have the type of unhurried, contemplative time with their physicians that is required to develop a trusted relationship and deliver high quality care. The numbers are compelling as well: Current Hamster Wheel Model (Dr. running in between patients in 12-15 min increments) 2,500 patient population OK, its actually 17.5 minute increments Tons of paperwork, administrative burden, frustrations, lack of care coordination, ? quality Even when patients satisfied with the physician, they hate the experience (long waits, no personalization, unintelligible interactions with health care system) Avg Salary = ~$150,000 Direct Practice Model (Direct relationship with patients) 500 patient population $1,500 access/retainer fee Paced, minimal practice overhead, positive interactions, care coordination, increased quality Love the physician, love the experience (no headaches, no paperwork, transparent pricing) 24/7 access, same day appointments, multiple other amenities Avg Take Home = ~$500,000+ (this is conservative) So if these numbers are this compelling, what prevents the entire Primary Care Physician pool from Going off the Grid to practicing medicine in this way? Courage? Fear? Lack of Systems? Inertia? Clearly, the case is more complicated than I make it hear. Clearly, there are major policy implications, and reverse access issues for those who can’t “afford” this type of model (but certainly find a way to buy $2,000 plasma TV’s). Ultimately, as more physicians move this direction (or are dragged by their patients), the biggest challenge will be from the medico-industrial complex itself who has fed off the plugged in physician nodes for decades. How many breakaway nodes will it take before enough people are “off the grid” that the grid begins to lose its source of power and ultimately collapses. It is coming. To quote the Silver Surfer: “All that you know is at an end“ See you in Berlin! (Source: Crossover Healthcare)

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Information therapy conference in june in washington dc

Project Health Design Blog — Fri, 16 May 2008 04:00:00 +0100

Posted May 16, 2008 by Lygeia Ricciardi On June 12-13, the 2008 Ix Conference, WIxRED: Next-Generation Patient-Centered Care, will take place in Washington DC. Dovetailing with National Health IT Week, the Ix Conference is presently the only partner event of... (Source: Project Health Design Blog)

Health social networking

Dr. Subrahmanyam Karuturi — Fri, 16 May 2008 04:00:00 +0100

HealthChapter.com is a health based social network of people sharing their disease experiences, treatment options, knowledge and giving support to other people suffering from similar health problems. Its a place to talk about how to live well with disease, ask questions, share information about what is working for you, get sympathy, exchange ideas, request and recommend the best doctors, support and friendship from other patients suffering from the same disease. You can also talk about what drugs, herbs, supplements and alternative methods work. By sharing your health experiences, you can help others and improve their quality of life. HealthChapter.com Support Groups help you to overcome the health problem by networking with people all around the world who have a similar health problem. Even volunteers, caregivers and medical professionals can join and throw a helpful advice and cheer up a fellow human being. HealthChapter.com is just a hub connecting people from all around the world to share their health experiences and seek help.Our Mission : HealthChapter.com provides a platform for its members to network and help each other to achieve a better health and a quality life. By joining HealthChapter.com, you can write a new chapter in your Health Life. Join Now!At HealthChapter.com you can- Find & make friendship with people who have similar health problems- Share your Health Experiences- Know about the latest research regarding your disease and treatment options- Get advice from people suffering from a similar health problem- Join 700+ support groups- Find people who have similar interests and hobbies- Learn from others how they are coping up with your disease condition- Give mental support to other people- Family and Friends of the diseased can also join and know others experiences- You can recommend doctors- Latest news of the concerned disease is available in the respective group- You can share your photos and videos with other members- You can write your disease experiences on a blog- You can join HealthChapter.com as a anonymous member and keep your identity private- Start a blog and share your story with others- Join a Support Group and you can network with people all around the world who suffer from your health problem- Make new friends and share your progress with the treatment options- You can exchange private messages with other members- You can get email updates of your activity on HealthChapter.com (Source: Dr. Subrahmanyam Karuturi)

Spongebob squarepants musical rectal thermometer

Medgadget — Fri, 16 May 2008 04:00:00 +0100

The title seems to speak enough for itself. This thing could also be used orally or underarm. More on the craze at Cartoon Brew... Product page: Musical SpongeBob™ Digital Thermometer ... (Source: Medgadget)

Ifs advanced femtosecond laser from amo approved

Medgadget — Fri, 16 May 2008 04:00:00 +0100

The FDA has given approval to Advanced Medical Optics to market the company's new iFS™ Advanced Femtosecond Laser system, a 5th generation device, for IntraLASIK procedures. Features of the device from the press release: Capable of creating a corneal flap during the LASIK procedure in less than 10 seconds, the iFS(TM) Advanced Femtosecond Laser's unique inverted bevel-in side cut angle is designed to provide a virtually effortless flap lift, increase post-operative flap adhesion and enhance the biomechanical stability of the post-LASIK cornea. With full customization capabilities, it also produces an elliptical flap to enhance surgical options and includes IntraLase-Enabled Keratoplasty (IEK). Additional features of the 5th generation IntraLase femtosecond technology include: Higher repetition rate Tighter spot separation; lower energy High-resolution digital video microscope New contemporary user interface, keyboard and touch screen Ergonomic design for maximum surgeon comfort Press release: Advanced Medical Optics Receives FDA Clearance For iFS(TM) Advanced Femtosecond Laser ... (Source: Medgadget)

Public invited to see nanosoccer 2008 us robocup open

Medgadget — Fri, 16 May 2008 04:00:00 +0100

For this one, your glasses ain't gonna be much help. The National Institute of Standards and Technology (NIST) will be hosting for the second time the world's most puny sport, and you are invited. This year, three student teams (Carnegie-Mellon University, the U.S. Naval Academy, and the University of Waterloo, from Ontario, Canada), will participate in a public exhibition at the 2008 US RoboCup Open in Pittsburgh, PA, May 25 to 27, a competition "where miniature "soccer players"--computer-driven robots six times smaller than an amoeba operating on a field the size of a grain of rice--will show off their skills." So, what does it have to do with medicine? Consider the following: The nanobots will be demonstrating agility, maneuverability, response to computer control and ability to move objects—all tools that future miniaturized mechanized workers will need for tasks such as microsurgery within the human body or the manufacturing of atom-sized components for microscopic electronic devices. RoboCup is an annual international competition designed to foster innovations and advances in artificial intelligence and intelligent robotics by using the game of soccer as a testing ground. NIST’s goal in coordinating competitions between the world’s smallest robots is to show the feasibility and accessibility of technologies for fabricating MicroElectroMechanical Systems (MEMS), tiny mechanical devices built onto semiconductor chips and measured in micrometers (millionth of a meter). The soccer nanobots are operated by remote control under an optical microscope. They move in response to changing magnetic fields or electrical signals transmitted across the microchip arena. Although the bots are a few tens of micrometers to a few hundred micrometers long, they are considered “nanoscale” because their masses range from a few nanograms to a few hundred nanograms. They are manufactured from materials such as aluminum, nickel, gold, silicon and chromium. Among the nanosoccer drills that will be demonstrated in Pittsburgh are the two-millimeter dash in which nanobots seek fast times for a goal-to-goal sprint across the playing field; a slalom course where the path between goals is blocked by “defenders” (polymer posts); and a ball handling exercise that requires robots to move “nanoballs” (spheres with the diameter of a human hair) into the goal. One team even plans to conduct its runs underwater to lessen friction. RoboCup and NIST are jointly organizing the upcoming U.S. Open nanosoccer demonstration as the final step toward the first official Nanogram League competition for soccer nanobots at the 2009 international RoboCup event in Austria. Full story: Public Invited to See Nanosoccer Robots in Action in Pittsburgh... (Source: Medgadget)

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Leica introduces new stereomicroscopes m205 fa and m165 fc

Medgadget — Fri, 16 May 2008 04:00:00 +0100

Leica Microsystems has introduced two new stereomicroscopes, Leica M205 FA (top) and M165 FC (below). The devices are based on the company's innovative FusionOptic™ technology that utilizes normal human neurology to increase the resolution of stereomicroscopes (for details, see our Nov. 2007 post:FusionOptic™ technology). German Healthcare Export Group provides the details: The Leica M205 FA and M165 FC stereomicroscopes are Leica Microsystems‘ latest addition to its innovative M series for demanding fluorescence applications in developmental, molecular and cellular biology. Combining the revolutionary FusionOptics™ technology with the successful TripleBeam™ principle, the fully automated Leica M205 FA creates fluorescence images of exceptional quality. Used for the first time in the M series, FusionOptics™ (patent pending) takes advantage of a neurological phenomenon: The left beam path produces great depth of field, while the right beam path provides a high-resolution image. The human brain itself then combines the best information from both channels, using it to compose an image whose resolution and depth of field have never been achieved in any stereomicroscope before. With its fully apochromatic optics, the largest zoom range on the market (20.5:1) and the top resolution performance of up to 1050 lp/mm, the Leica M205 FA is able to show the viewer details that used to be invisible. The TripleBeam™ principle, with its patented third beam path reserved exclusively for fluorescence illumination, delivers evenly illuminated, reflex-free fields of view at all zoom settings. Besides this, the FluoCombi III™ objective revolver features the unique capability to exploit all the advantages of both stereo and high-resolution micro-objectives on one instrument with a simple switch. It enables parallaxfree imaging from overview magnification to the finest detail. Time-intensive studies of living organisms and documentation of complex images series and multifluorescence images are made possible and instantly reproducible by motorizing focus, zoom, filter changer, iris diaphragm fluorescence intensity manager and microscope stage. An external SmartTouchTM control unit ensures convenient control of all microscope functions using a clearly arranged touch display and freely programmable control buttons. The microscope is fully integrated in the modular software solutions Leica AF6000 E to AF6000. For documentation, image overlay and time series, the Leica AF6000 E is recommended as an introductory software package. This can be upgraded to the Leica AF6000 as necessary to suit applications ranging from multi-channel fluorescence, time and z series with parallax correction to 3D reconstruction. The Leica M165 FC continues the tradition of high-quality manual fluorescence stereomicroscopes. With this microscope, the classical stereo-optics approach has been exploited to the utmost optical limits. The fully apochromatically corrected 16.5:1 zoom – combined with TripleBeam™ and FluoCombi III™ – guarantees high-contrast fluorescence images down to the finest structures of the specimen. Encoded zoom, iris diaphragm and objective revolver allow configuration parameters and optical data to be reproducibly read out at the computer. Product pages: Leica M205 FA and Leica M165 FC German Healthcare Export Group: Leica Microsystems Combines FusionOpticsTM with TripleBeamTM... (Source: Medgadget)

Bush -- political treason in israel? (philly daily news)

I'm Gina Smith — Fri, 16 May 2008 00:46:42 +0100

An unbelievable article from the Philadelphia Daily News on Bush's bizarre remarks in Israel. Article excerpted below. Thanks to truthout for the link.By Will Bunch. I've seen a lot of sad things in American politics in my lifetime -- the resignation of a president who became a national disgrace after he oversaw a campaign of break-ins and cover-ups, another who circumvented the Constitution to trade arms for hostages, and yet is now hailed as national hero. And those paled to what we have seen in the last seven years -- flagrant disregard for the Constitution, the launching of a "pre-emptive" war on false pretenses, and discussions about torture and other shocking abuses inside the White House inner sanctum. But now it's come to this: A new low that I never imagined was even possible. President Bush went on foreign soil today, and committed what I consider an act of political treason: Comparing the candidate of the U.S. opposition party to appeasers of Nazi Germany -- in the very nation that was carved out from the horrific calamity of the Holocaust. Bush's bizarre and beyond-appropriate detour into American presidential politics took place in the middle of what should have been an occasion for joy: A speech to Israeli's Knesset to honor that nation's 60th birthday. But here's what he said:JERUSALEM (CNN) – In a particularly sharp blast from halfway around the world, President Bush suggested Thursday that Sen. Barack Obama and other Democrats are in favor of "appeasement" of terrorists in the same way U.S. leaders appeased Nazis in the run-up to World War II. "Some seem to believe we should negotiate with terrorists and radicals, as if some ingenious argument will persuade them they have been wrong all along," said Bush, in what White House aides privately acknowledged was a reference to calls by Obama and other Democrats for the U.S. president to sit down for talks with leaders like Iranian President Mahmoud Ahmadinejad. "We have heard this foolish delusion before," Bush said in remarks to the Israeli Knesset. "As Nazi tanks crossed into Poland in 1939, an American Senator declared: 'Lord, if only I could have talked to Hitler, all of this might have been avoided.' We have an obligation to call this what it is — the false comfort of appeasement, which has been repeatedly discredited by history."As a believer in free speech, I think Bush has a right to say what he wants, but as a President of the United States who swore to uphold the Constitution, his freedom also carries an awesome and solemn responsibility, and what this president said today is a serious breach of that high moral standard. Of course, there are differences of opinion on how America should handle Iran, and that's why we're having an election here at home, to sort these issues out -- hopefully with respect and not with emotional and inaccurate appeals. Not only is the president's comment a gross misrepresentation of Barack Obama's stance on the issue, but ironically, it comes just a day after his own Secretary of State, Robert Gates, said of Iran: "We need to figure out a way to develop some leverage . . . and then sit down and talk with them." Is Gates a Nazi appeaser-type, too? And Bush has been hardly consistent on this point, either. Look at his own dealings with oil-rich Libyan dictator Moammar Gadhafi, linked to deadly terror attacks like Pan Am Flight 103. But what Bush did in Israel this morning goes well beyond the accepted confines of American political debate, When the president speaks to a foreign parliament on behalf of our country, his message needs to be clear and unambiguous. Our democracy may look messy to outsiders, and we may have our disagreements with some sharp elbows thrown around, but at the end of the day we are not Republicans or Democrats or liberals or conservatives. We are Americans. And you, Mr. Bush, are the leader of us all. To use a diplomatic setting on foreign soil to score a cheap political point at home is way beneath your office, way beneath your country, and way beneath the people you serve. You have been handed an office once uplifted to great heights by fellow countrymen from Washington to Lincoln to Roosevelt to Eisenhower, and have plunged it so deeply into the Karl-Rove-and-Rush-Limbaugh-fueled world of political destruction and survival of all costs that have lost all perspective -- and all sense of decency. To travel to Israel and to associate a sitting American senator and your possible successor in the Oval Office with those who at one time gave comfort to an enemy of the United States is, in and of itself, an act of political treason. In another irony, this comes from an administration that has already committed such grave abuses that its former officials are becoming fearful of traveling overseas, lest they be arrested for war crimes. Despite the alleged crimes and misdemeanors of the Bush administration, the Democrats who control the House have until now been restrained in their use of the impeachment process, hoping that the final eight months of our American nightmare can pass by quickly. Indeed, one has to wonder how much of Bush's outrageous statement this morning arose from fear -- fear that a President Obama will go after his wrongdoing in 2009. Today, it's a whole new ballgame. I believe this treacherous statement by a U.S. president in Israel is a signal to the Democrats in the House in Washington, that it's time to play its Constitutional role in ending this trauma, before even greater acts against the interest of America are wrongly committed in our name. (Source: I'm Gina Smith)

The medical home hits the ruc

e-CareManagement — Fri, 16 May 2008 00:14:28 +0100

Today’s post (#2 in a series) tackles several questions: What is the American Medical Association/Specialty Society RVS Update Committee (RUC)? What is the RUC’s role in the Medicare Medical Home Demonstration project? How are people reacting to RUC recommendations for PCMH reimbursement levels? What is the American Medical Association/Specialty Society RVS Update Committee (RUC)? The AMA formed the RUC to act as an expert panel in making recommendations to CMS on the relative values of Current Procedural Terminology (CPT) codes using the Resource Based Relative Value Scale (RBRVS). The RUC is composed of 29 members, only 5 of whom are primary care physicians. The RUC has come under severe criticism as being an enemy of primary care. For example… (more…) Share This Article Series - The Medical Home: End of the Honeymoon The Medical Home: Confusion Over Care Management FeesThe Medical Home Hits the RUC Previous in series Related posts (and # of comments) The Medical Home: Confusion Over Care Management Fees (0) The Medical Home: Advancing, But Still Many Questions (1) The Cats are Herding! (5) Resources (1) Porter/Teisberg JAMA Article: Out-of-the-Box or Out-of-Touch? (6) (Source: e-CareManagement)

Cda - the american bridge from hl7 v2.x to v3?

NeoTool Healthcare IT Blog — Thu, 15 May 2008 22:45:34 +0100

At last week’s HL7 Working Group meeting, it became clear that US adoption of the HL7 Version 3 Standard is still years away, with one lone exception: Clinical Document Architecture (CDA). It seems as though implementation of the larger standard is still seen as a herculean task, requiring not just a rework of HL7 2.X import/export modules but also a potential overhaul of applications’ underlying database schema and object model. But the Structured Documents committee (SDTC) has done a nice job of achieving one of its primary design principles concerning HL7 CDA – minimizing technical barriers to implementation. That mantra has no doubt helped the SDTC create a standard that comprises the ‘piece’ of HL7 V3 that American vendors are willing to incorporate in the not-so-distant future. Given the lack of a national mandate to move to HL7 Standard V3 that exists in other countries, as well as the lack of demand for V3 in the US marketplace, CDA could be the much needed beachhead for the standard in this country. As more and more vendors implement CDA and get a small taste of the V3 methodology and associated benefits, the more adventurous (and deep-pocketed) software providers will tip-toe further into the newer HL7 standard. Until then, the burning question remains: which comes first – provider demand for or vendor support of V3? (Source: NeoTool Healthcare IT Blog)

Medicare dare

The HIT Transition Weblog — Thu, 15 May 2008 14:28:21 +0100

On yesterday's CMS NPI Roundtable, the fine folks (and I truly mean that) from the Office of E-Health Standards and Services repeated their admonishment that they can't investigate a suspected violation without someone filing a complaint. You can remain anonymous, they said, but remember that if you do, it can be hard to reach resolution, because the process is designed to elicit a back-and-forth exchange between the parties to reach consensus. They said, in the 500 or so transaction complaints filed thus far, there have been no instances of retribution. (Go tell that to your CFO, quick!) What they did not mention is that OESS never publishes the results of such disputes, much less details of the proceedings. What they did not mention is that there have been absolutely no fines imposed for transgressing the Transactions and Code Sets Final Rule in the four and a half years since the end of the October 2003 contingency. (Thought Experiment: Apply those same enforcement rules to traffic violations and imagine what the fenders on your car would look like. That's what TCS looks like.) But even as we careen toward May 23, with 80 - 90% of claims currently being submitted in a way that would fail the NPI-only edits Medicare insists it will put in place on that date (this according to our survey, based on provider's own reports of all claims, not just Medicare claims), who is going to volunteer to take on the biggest gorilla in the healthcare jungle? Um, how about me? Look, the reason I can say the things I say here, the things you readers tell me you wish you could say, but can't, is because my little company does not rely on Medicare for a single penny of its meager operation. That's the good news. The other news? We rely on you. You've already seen that we can and will file and prosecute challenges in the standards arena, when we submitted a direct challenge to Medicare's Secondary Provider edits (that eleventh hour change they talked about on yesterday's call went out via email overnight -- and it's still noncompliant, and it will still cause massive disruptions to provider revenues). It took a while, and we kept quiet about it, but we got the opinion we knew was right. X12 took the daring step to stand up for the rules we created together as an industry. Will OESS do the same? I'd like to see. Would you? Here's the deal I will offer you. You help us do it, and we will share the results here. Right in the great wide open. We need to sell some papers. We need you to buy a copy of our NPI Contingency Status Survey report -- not cheap at $995, but well worth the price of admission. You get the full results of the survey, plus the analysis of why continuing forward on the course we are on will snare the industry in a needless and heedless mess, and what can be done about it -- inside your organization and as an industry -- if we act now. And, under our Buy-One, Send-One deal we will send even an additional electronic copy of the analysis to the trading partner or government official of your choice. (This is a limited time offer. Your mileage may vary. Not to be taken with alcohol.) The report will be available as soon as I can get all the rest of the words and charts poured into the massive document. But you can buy it now. If we can sell ten copies -- just ten! -- we will take the fight to OESS to enforce against Medicare. We will tell them that admitting they are violating their own regulation is not enough. They need to stop it before the bounce claims from here to Timbuktu. And we will share the process with you. Go. Buy it. Help us out here, folks. We're doing this for you. http://surveys.hittransition.com/npi (Source: The HIT Transition Weblog)

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Fusion man - i wish i could fly

Positive Technology Journal — Thu, 15 May 2008 14:20:00 +0100

'Fusion Man', aka Yves Rossy, flies with a jet-powered single wing over the Alps in Bex, Switzerland, Wednesday, May 14, 2008. An ancient dream comes true... (AP Photo/Anja Niedringhaus) http://wtop.com/?nid=218&sid=634384&pid=0 (Source: Positive Technology Journal)

Further feedback on the demise of q&a

Liberating the literature — Thu, 15 May 2008 13:47:00 +0100

Further to a post last Friday (click here).Why will you cease operations on 27th June? Is there any point inlobbying to try & keep your service available? If so, who should I contact (from a v satisfied customer!)Why is the clinical Q&A service being axed? It is excellent and will be sorely missedWhat a desperate shame this service is to discontinue! I have only just discovered it and have found it enormously useful because it is evidence based. Please feel free to pass this message on to anyone who has influence over this decision.Why is the NLH Q+A service ceasing operations? Has the funding been pulled? Will there be an alternative service?This service has greatly improved my practice it has been a great resource i cant believe its being withdrawn i will find it a great lossInteresting- found this site via google- I see it's a pilot and about to be withrdrawn. I never heard of it- was it something that we should have been informed of? muight have been useful (or not) but if we had known about it we might at elast had the chance to try it out. More wasted NHS money on something not discussed with users and not properly tried and evaluated?We will miss your service greatly! Is it migrating somewhere else/what alternatives are there?Is there a replacement once the current service close in June? it has been a very helpful service for lots of us in primary careI'll add extra comments as and when I get a decent batch.... (Source: Liberating the literature)

Quality standards in q&a

Liberating the literature — Thu, 15 May 2008 12:15:00 +0100

At the start of the week I had the pleasure of presenting at the 2008 Clinical Librarian Study Day. I was tasked with talking about quality standards in Q&A. This was a tough subject to do justice. I've worked hard for ten years on Q&A yet had never really thought about 'standards'. So it took a while to distill my thinking into reasonable standards.I came up with two types of standards:EasyRealEasy standards are the ones I consider self-evident e.g.Competency in searching various databasesReturn answers in an agreed timeKeep responses to a reasonable (brief) lengthAnswers should be referencedBut adhering to these standards means very little.Real standards are the ones I think mean something and are perhaps less obvious and I came up with 7:Competency of answererTransparencyCommunicationFeedbackCorrectness of answerBoundaries of Q&AQuality controlCompetency of answerer. It's relatively straightforward to search medline and learn to appraise. However, it's much harder to understand the clinical context. This involves trying to understand the motive for the question, what it actually means, the sort of evidence required and knowing when the question has been answered.Transparency. This is not as simply as linking to an article informing users about the process. It's ensuring that they actually know what the process is and potential shortcomings. Communication. Linked with transparency this relates to simple things such as using a clear narrative to more interesting challenges - such as explaining uncertainty.Feedback. Is there easy feedback from the user but also from others viewing the service? We receive a small amount of feedback, we should get more!Correctness of answer. Is the correct answer given? A tough question to answer..Boundaries of Q&A. A bit vague this one, but when/where should a 'quick and dirty' Q&A service operate. I often worry that we spend too little time on questions, rushing off to answer the next one. Other areas worry me such as high-risk questions - but then we pass them through to our clinical director to check. But every now and then I worry that we're going beyond what we should be doing.Quality control. Is there a QC system? We have internal and external systems, I'm pretty sure they're robust - but an important standard all the same.With ATTRACT and the NLH Q&A Service we could improve, I'm thinking particularly of transparency and feedback. We'll be addressing both these issues (and others) with TRIPanswers.Of the seven I think the two really important standards are Competency of answerer and Transparency. (Source: Liberating the literature)

Masterclass event - social networking in the nhs

Informaticopia — Thu, 15 May 2008 08:38:00 +0100

(Source: Informaticopia)

Haemacure link to webcast of presentation at the biotech/pharma/healthcare investor forum

Medical Hemostat — Thu, 15 May 2008 04:00:00 +0100

Haemacure Investor presentation available HERE (Source: Medical Hemostat)

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Paper-based diagnostic microfluidic devices

Medgadget — Thu, 15 May 2008 04:00:00 +0100

MIT Technology Review is reporting that researchers at Harvard are using paper as the building block material for creating small microfluidic devices, potentially allowing to make cheap disposable diagnostic tests. A pinprick of blood or drop of urine soaked up at the edge of the Whitesides device moves naturally through the paper, in much the way that wine will spread through a paper napkin. But the paper is treated with a hydrophobic polymer, which directs the liquid along prescribed channels. Once the liquid reaches the wells at the ends of the channels, it interacts with reagents, turning the paper different colors. The colors can be matched to those on a color key, much as they are in a pH test. One test design that looks like a miniature, three-branched, geometric tree might have wells at the end of two branches for a glucose assay and one at the end of the third for a protein assay, for example. The design dispenses with expensive components common in conventional microfluidic devices: chemical reactions that color parts of the paper replace sophisticated sensors and analyzers, while using paper's natural capillary action to absorb liquids avoids the need for external pumps or power sources. Diagnostics for All--a spinoff cofounded by Whitesides and Harvard visiting scholar Hayat Sindi, with the support of partners from MIT--is commercializing the technology. Instead of etching channels into a material, as most microfluidics designers do, Whitesides and Sindi were able to take advantage of the network of channels inherent in paper; the hydrophobic polymer simply seals off the channels that the researchers don't want to use. "What's really clever about this system is that they've actually patterned the whole volume of the substrate," Folch explains. "The paper itself forms a network of capillaries." More at MIT Tech Review... (Source: Medgadget)

Tumor targeting, immune system evading nanoworms

Medgadget — Thu, 15 May 2008 04:00:00 +0100

Scientists from UC San Diego, UC Santa Barbara, and MIT developed metal nanoparticles, that can, because of their shape and polymer coating, evade the body's immune system, allowing for free movement around the body. Additionally, a coating of a special peptide F3 molecule allows the nanoparticle to hone in on tumor cells. Perhaps this is the complimentary technology that is required to make the Kanzius Machine effective against tumors? The scientists constructed their nanoworms from spherical iron oxide nanoparticles that join together, like segments of an earthworm, to produce tiny gummy worm-like structures about 30 nanometers long—or about 3 million times smaller than an earthworm. Their iron-oxide composition allows the nanoworms to show up brightly in diagnostic devices, specifically the MRI, or magnetic resonance imaging, machines that are used to find tumors. “The iron oxide used in the nanoworms has a property of superparamagnetism, which makes them show up very brightly in MRI,” said Sailor [Michael Sailor, a professor of chemistry and biochemistry at UC San Diego who headed the research team --ed.]. “The magnetism of the individual iron oxide segments, typically eight per nanoworm, combine to provide a much larger signal than can be observed if the segments are separated. This translates to a better ability to see smaller tumors, hopefully enabling physicians to make their diagnosis of cancer at earlier stages of development.” In addition to the polymer coating, which is derived from the biopolymer dextran, the scientists coated their nanoworms with a tumor-specific targeting molecule, a peptide called F3, developed in the laboratory of Erkki Ruoslahti, a cell biologist and professor at the Burnham Institute for Medical Research at UC Santa Barbara. This peptide allows the nanoworms to target and home in on tumors. “Because of its elongated shape, the nanoworm can carry many F3 molecules that can simultaneously bind to the tumor surface,” said Sailor. “And this cooperative effect significantly improves the ability of the nanoworm to attach to a tumor.” The scientists were able to verify in their experiments that their nanoworms homed in on tumor sites by injecting them into the bloodstream of mice with tumors and following the aggregation of the nanoworms on the tumors. They found that the nanoworms, unlike the spherical nanoparticles of similar size that were shuttled out of the blood by the immune system, remained in the bloodstream for hours. “This is an important property because the longer these nanoworms can stay in the bloodstream, the more chances they have to hit their targets, the tumors,” said Ji-Ho Park, a UC San Diego graduate student in materials science and engineering working in Sailor’s laboratory. Press release: UC San Diego Researchers Target Tumors with Tiny 'Nanoworms' ... (Source: Medgadget)

Study: riata high-voltage leads show "performance and reliability"

Medgadget — Thu, 15 May 2008 04:00:00 +0100

St. Jude Medical is giddy with excitement about the results of four studies presented at Heart Rhythm Society's 29th Annual Scientific Sessions in San Francisco this week. The multicenter studies have shown that the company's Riata ST Optim leads, designed for implantable cardioverter defibrillators (ICD) or cardiac resynchronization therapy (CRT-D) devices, perform extremely well in clinical settings. The company describes these leads as "highly advanced tachycardia pacing leads, with an overlay of St. Jude Medical's innovative Optim insulation and a design intended to ease implant, and promote reliability." The studies analyzed the experience of 7,498 patients who were implanted with Riata leads as part of their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) systems. All sites participating in the four studies (ACT, OPTIMUM, RHYTHM and PAS; see below for a description of the studies) were monitored. To ensure the data were as accurate as possible, each patient's source records were individually reviewed to be certain that all lead-related complications (further sub-categorized as fracture, insulation damage, perforation or dislodgment) were reported. The data showed that adverse event rates for all categories of lead-related complications were very low. Overall, the Riata leads' fracture rates were 0.09 percent (9 in 10,000), insulation damage rates were 0.13 percent (13 in 10,000, with no insulation failures exhibited in Riata leads utilizing Optim(R) insulation), perforation rates were 0.31 percent (31 in 10,000), and dislodgement rates were 0.88 percent (88 in 10,000). These adverse events rates are significantly lower than many previously reported rates in the medical literature on ICD leads. The results are believed to be the largest and broadest analysis of lead-related complications ever to be presented, especially with complete data monitoring, and unlike reports of single-center experiences or case reports, should best represent real-world experience in a wide range of implanter's hands. The results from these studies are particularly significant given the duration of follow-up, which was a median of 22 months for the four studies. Press release: Results from Studies Evaluating High-Voltage Lead Performance Presented at Heart Rhythm Society's 29th Annual Scientific Sessions ... Product page: Riata® ST OptimTM Defibrillation Lead ... (Source: Medgadget)

Using lasers for aligning bio molecules

Medgadget — Thu, 15 May 2008 04:00:00 +0100

Argonne Laboratory researchers have developed a method to align molecules using lasers, which may eliminate the need to crystallize large groups of molecules for synchrotron X-ray diffraction. Crystallization allows scientists to create a periodic structure that will strongly diffract in specific directions when bombarded with X-rays. From the resulting diffraction pattern, scientists can construct a real-space image of the crystal. However, without crystallization, when X-rays collide with multiple, randomly oriented molecules, they diffract in different directions, making it impossible to create a composite diffraction image, said Argonne Physicist Robin Santra. Some molecules, such as many involved with drug interaction, cannot be crystallized, and imaging would require numerous samples to bombard in order to get a full composite picture. Young's laser technique allows for millions of molecules suspended in a gaseous state to be aligned so that, when bombarded with X-rays, they all diffract in the same way. The resulting images are at atomic level resolution and do not require crystallization. "Understanding the structure of the approximately 1 million human proteins that cannot be crystallized is perhaps the most important challenge facing structural biology," Young said. "A method for structure determination at atomic resolution without the need to crystallize would be revolutionary." Young and her team have successfully aligned molecules using a laser, probed the aligned ensemble with X-rays and shown theoretically that the technique could be used for X-ray imaging - see E. R. Peterson et al., Applied Physics Letters 92, 094106 (2008) - but they require a proposed upgrade to the Advanced Photon Source facility located at Argonne before X-ray diffraction can be done experimentally. Press release: Argonne scientists use lasers to align molecules ... (Source: Medgadget)

The trials and tribulation of going paperless with an ehr

Australian Health Information Technology — Thu, 15 May 2008 04:00:00 +0100

The following set of sagas appeared in the last little while. The Five Biggest Mistakes of EHR Implementation Five facilities share their stories of EHR disasters so others can learn from their mistakes. By Ainsley Maloney "Learn from the mistakes of others. You can't live long enough to make them all yourself." The above quote by Eleanor Roosevelt is the theme of our article and the hope these five facilities had when they opened up to ADVANCE and bravely shared their stories of EHR disasters and downfalls. One facility watched as money drained out of its practice and its patients switched doctors; another made its physicians' workday even more cumbersome than it had been in the paper world; and a third unknowingly put its patients at great risk just by updating its system. In the end, however, all shared one remarkable similarity: They never gave up on their EHRs. Read their stories and share their experiences. Hopefully you can learn from their mistakes. Disaster at the... This is the initial part of the post - read more by clicking on the title of the article. David. (Source: Australian Health Information Technology)

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Video comments now enabled via seesmic

Wireless Doc — Thu, 15 May 2008 03:06:22 +0100

Now, if I need to demonstrate something, I can use Seesmic for producing a video, or allow a commenter to upload a video reponse to a post. Let's see if this works. And it does. (Source: Wireless Doc)

Healthcampmd in june

The Healthcare IT Guy — Thu, 15 May 2008 02:32:03 +0100

HealthCampMD (http://barcamp.org/HealthCampMd) will look at Social Networks, Web 2.0 technology and Data Portability as it might impact the Health Care industry. This will be a meeting of minds of technologists and health care professionals interested in the evolution of the Health Care industry. Check out the information page at http://barcamp.org/HealthCampMd and sign up! If you live nearby in MD, VA, or DC please pass along this message. (Source: The Healthcare IT Guy)

Well, if green aliens are really coming to visit ...

I'm Gina Smith — Thu, 15 May 2008 01:39:36 +0100

... at least they picked the en vogue color. It's cool to be green. Crazy-bizarre story out of London today excerpted below. But before you read it. Consider. Maybe they're coming to stop us from firing up the new CERN particle accelerator some physicists think will suck the world into a black hole. AGH! Could world news get any weirder? Ask me tomorrow.By Jeremy Lovell LONDON (Reuters) - Aliens from outer space have been visiting Britain for years and UFO sightings doubled after the film Close Encounters was released in 1977, according to secret files collating reports by members of the public. The alien craft come in all shapes, sizes and colors but their occupants are uniformly green, the Ministry of Defence files show. The archives (at www.nationalarchives.gov.uk/ufos) are the first batch of a four-year release programme of all the ministry's UFO files from 1978 to the present day. The ministry dismisses 90 percent of the reports as having mundane explanations and leave 10 percent with a question mark and the assurance they are no defence threat. A 1983 report from a 78-year-old out fishing at midnight tells of following aliens in green overalls on to a spaceship and then being told to go away because he was too old and decrepit for their purposes. Two years later, a typewritten letter to the ministry tells of an alien spaceship being shot down in the river Mersey in northern England by another spacecraft and of the author developing a warm friendship with an alien called Algar. Just as Algar was about to reveal himself to the government he was killed by other aliens, the author of the letter writes. He was still in telepathic contact with an alien called Malcben from the planet Platone in the Milky Way, the author added. Written at the top of the letter is the terse comment "No reply." The ministry has files on 11,000 sightings dating back to the 1950s. A few of the sightings made it into the national press and all were checked out in case they were Soviet aircraft probing Britain's defences during the Cold War. "Clearly some reports remain unexplained but we have found no evidence that these phenomena represent a threat to national security and therefore cannot justify devoting Defence resources to their investigation," said an official letter in 1985. WORKING PARTY The term Unidentified Flying Object was coined in a U.S. Air Force report three years after the description 'flying saucer' was applied to a sighting in Washington State in June 1947. In Britain, so worrying was the spate of reports that a secret Flying Saucer Working Party was formed to check them out. Like the U.S. Air Force, it concluded flying saucers did not exist. But its final report in 1951 was still classified "secret/discreet" and given very limited circulation. Not all sightings can be easily dismissed as the working of overwrought or intoxicated minds, or triggered by watching Steven Spielberg's Close Encounters of the Third Kind. Royal Air Force personnel, civil aviation pilots and air traffic controllers have also reported sightings and radar tracks that remain unexplained despite high-level investigation. Among the most famous was the sighting on two occasions of unexplained bright lights landing near a U.S. airbase in Rendlesham Forest in southern England. Even the deputy commander of the base put his name to that 1980 report. (Editing by Robert Woodward) (Source: I'm Gina Smith)

Health 2.0 - clinical trials

eHealth — Wed, 14 May 2008 22:34:39 +0100

A new way to search for clinical trials is now available through Emerging Med. Wrapping clinical trials information from the NIH with a set of tools and services, this new site offers a range of services. You can create a profile to be notified of clinical trials and utilize the matching system to get a referral for treatment. Phone support is also available. There are some good suggestions on when to search, for instance, Just before a biopsy (to study tissue from a tumor) Just before the first surgery or radiation treatment (neo-adjuvant studies) Just after surgery or radiation treatment (adjuvant studies)To protect privacy, they suggest that "Create a Patient Profile form can also be filled out anonymously". The service is now integrated into Revolution Health%sq243%s cancer pages. There was a recent article in the Wall Street Journal as well. Perhaps utilizing this tool within the context of a broader set of tools such as Rev Health is a better route to go. But the set of services appear unique.Technorati: Health 2.0 (Source: eHealth)

Medicare: "we know we are violating hipaa standard"

The HIT Transition Weblog — Wed, 14 May 2008 20:12:31 +0100

We eagerly dialed in to today's CMS NPI Roundtable call wondering how -- or whether -- they would deal with the opinion we sought out -- that Medicare's policy that providers falsify claims data by saying they had referred patients to themselves when a referrer's NPI was unavailable is, in fact, a violation of the 837 standard. In X12's authoritative interpretation of their own guide, trading partners may not "modify the definition, meaning, or intent of the Implementation Guide." In other words, the Referring Provider stuff needs to refer to the actual referring provider -- payers (yes, even Medicare!) are not allowed to redefine what goes in there. Because the implementation guides are incorporated into the HIPAA Transactions and Code Sets Final Rule by reference, this makes Medicare's demand a HIPAA violation. But it's again worth noting that this sort of shell game (once the province of wayward Medicaid plans who wanted providers to send nonstandard Type of Service codes in fields intended for other purposes) was so vehemently out of bounds, the language was added to the regulation itself, where it says that a Covered Entity cannot "change the definition, data condition, or use of a data element or segment in a standard." (§ 162.915(a), Federal Register / Vol. 65, No. 160, p. 50368). In a remarkable bit of bureaucratic candor, Pat Peyton acknowledged, "We are aware that our policy is not in compliance with the implementation guides." (Source: The HIT Transition Weblog)

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Rating your own emr

EMR and HIPAA — Wed, 14 May 2008 18:45:11 +0100

Some people have asked me how I rate the EMR I work with every day. I can’t bring myself to do it. It’s unfair to me and the people I work with. It’s not that I don’t have strong feelings about my EMR. I really do. I know the pros and cons, the ins the outs, and everything in between. However, it’s just hard rating my EMR and hopefully I can help you understand why. My job is to implement this EMR the best way possible. That’s what I do. It doesn’t matter if it’s good bad or ugly. It’s counter productive for me to rate how good my EMR is. It is what it is. I haven’t been assigned the task of selecting an EMR. I’m not paid right now to see what other EMR vendors might be better than the one I have. I’m paid to do my very best at implementing the EMR that was chosen. I don’t want to sound harsh here, but I think that many of the EMR failures are due to people worrying too much about what other EMR software can do and not enough about what their EMR software can do. The question shouldn’t ever be, can our EMR software do this? Instead you should ask, “how can we do this with the EMR software we’ve chosen?” This is two very different perspectives that reap very different results. I’m not talking about someone who is in the process of selecting an EMR. I’m talking about someone who has already selected an EMR. It reminds me about one of my favorite quotes about marriage that says, “When you’re dating keep both eyes wide open, when you get married keep them closed.” You could just as easily say, “When selecting an EMR keep both eyes wide open, but once you’ve chosen an EMR keep both eyes closed and make the most of it.” Of course, one thing I can’t help doing is answering people’s questions about EMR. I’ve had dozens of people call me about my EMR and I just love talking to them about the benefits, challenges and hassles of my EMR. (Source: EMR and HIPAA)

Cpoe update

Candid CIO — Wed, 14 May 2008 16:25:41 +0100

Leapfrog has released a CPOE test. This does not appear to be the tool that Leapfrog promised in 2001. The tool was supposed to be developed by FCG. There is no mention of FCG (or their new owner, CSC) in the press release. In 2008 Leapfrog won’t be releasing the results. However, the hospitals will need to pass the test in order to claim that they have fully implemented the CPOE leap. I am predicting this will be delayed. But, I am a skeptic. Perhaps I should not be. There has been a lot of positive progress at the Leapfrog Group in the short time since Leah Binder took office in March 2008. We are finally moving the CPOE leap from an honor system. That is to be applauded. It will be interesting to see the impact on the total number of hospitals making the leap. If the test is added to the 2009 CPOE leap requirement I suspect we will see a decline of hospitals meeting that standard. In January 2006 I counted 63 hospitals claiming to have made the CPOE leap and another 58 claiming to be within 12 months of that goal. This month I count 144 hospitals claiming CPOE implementations that meet Leapfrog definition. I will let you decide if that is good progress or not. Anecdotally, the three in my area that said they were 12 months away at the start of 2006 are still not claiming the leap. One is still 12 months away and the other two are now claiming to be in the planning stages. I guess that is the nature of an honor reporting system that has no real incentives. I wish Leapfrog were doing more to publish an analysis of their surveys. I had to add up 50 different separate queries to do this math. There are still a lot of questions. What percent of hospitals submit a survey? What percent of those are claiming full implementation of CPOE and other leaps? Which software vendors are supporting CPOE? When I have spare time I will do some more investigation. (Source: Candid CIO)

Another milestone - 50,000+ searches in a day

Liberating the literature — Wed, 14 May 2008 07:13:00 +0100

Yesterday, TRIP was searched 51,021 times, the first time we've been searched over 50,000 times per day.This increase must be down to the significant increase in users who are coming back on a more regular basis.What's the next milestone? 2 million searches per month, 400,000 per week or 75,000 per day.... (Source: Liberating the literature)

Out of hibernation

Neil Versel's Healthcare IT Blog — Wed, 14 May 2008 04:52:00 +0100

It's been since March 29 that I've updated this blog. That was much longer than I had anticipated. I know it's been too long when I start getting e-mails wondering what happened to me. Honestly, I didn't realize this blog was that popular. Aw, shucks. I know some people have noticed that I haven't been writing much lately for Digital HealthCare & Productivity either. I will have stories there next week, however.As I mentioned nearly two months ago, I was buried in a huge assignment from Doctor's Digest. I'm actually still working on some loose ends. I also took 10 much-needed days for a vacation in Italy. (Thanks, Jane Sarasohn-Kahn for your tips on Florence.)What's the occasion of this post? I have plenty of material saved up that will not make it into Doctor's Digest, and I do plan on posting some of it here once the copy is finalized, likely sometime in June. For now, I choose to comment on next week's TEPR Conference. The sponsoring organization, the Medical Records Institute, is expecting just 2,000 people and little more than 100 exhibitors this year. That's half what the conference drew at its peak three or four years ago. As of today, some of the invited speakers had not even been confirmed. The spin I'm getting is that the number and quality of educational sessions have been increased. I'll buy that one because last year featured presentations only from actual users, not vendor representatives.Also, MRI is planning some special things for next year, the 25th edition of TEPR. First off, it will be in Feb. 1-5, 2009, rather than the spring, on account of HIMSS '09 being in April to accommodate the Chicago weather. (FYI, it was 48 degrees on the shores of Lake Michigan yesterday, May 12. Consider yourself warned.) I will be happy to go to Palm Springs, Calif., for a February TEPR next year. Secondly, MRI is planning to pump up attendance next year by rolling back prices on registration and exhibit space to the level of the first conference in 1985. A major focus of this year's event is going to be the cell phone as a conduit for interoperability. The iPhone certainly is a big part of that. Somehow, I don't expect Dr. James Mault of Microsoft to mention the iPhone during his TEPR keynote next Tuesday, however.Speaking of Microsoft, this is the first time I've blogged on my new HP Pavilion notebook, running Windows Vista, and it's really slow when I want to highlight blocks of text for hyperlinks. At least one other site I've used recently recomments the Mozilla Firefox browser for a Java application. I wonder if I'm having a similar problem here. Any thoughts? (Source: Neil Versel's Healthcare IT Blog)

U.s. department of defense picks new quikclot(r) combat gauze(tm) as first-line hemostatic treatment for all military services

Medical Hemostat — Wed, 14 May 2008 04:00:00 +0100

WALLINGFORD, Conn., May 14 /PRNewswire/ -- Z-Medica Corporation (Z-Medica), a medical products company focused on innovative blood clotting nano-technologies, announced that the United States Department of Defense has selected the company's newest hemostatic product, QuikClot(R) Combat Gauze(TM) brand, for all military services as the first-line hemostatic treatment for life-threatening (Source: Medical Hemostat)

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Turkish hemostat - ankaferd bloodstopper

Medical Hemostat — Wed, 14 May 2008 04:00:00 +0100

Ankaferd Bloodstopper is a stable and sterile medical product of standard vegetable content which serves as a hemostasis regulator and displays fast haemostatic effect when applied to control minor or major hemorrhages due to exterior wounds, traumatic cuts, dental operations, spontaneous or surgical procedures. The product appears to be registered in Turkey only currently. (Source: Medical Hemostat)

Hemcon completes acquisition of alltracel pharmaceuticals

Medical Hemostat — Wed, 14 May 2008 04:00:00 +0100

HemCon Medical Technologies Inc. said Wednesday it has completed the acquisition of Dublin, Ireland-based Alltracel Pharmaceuticals in a cash-for-stock deal. The purchase occurred through Castlerise Investments Ltd., a newly formed wholly owned subsidiary of HemCon. Alltracel will operate as a wholly owned subsidiary of HemCon and maintain its headquarters in Dublin. Combined revenue is expected (Source: Medical Hemostat)

Telemedicine demonstrating value

RHIOs, Health Information Exchange & Healthcare IT — Wed, 14 May 2008 04:00:00 +0100

Here is an interview (see below) of Dr McConnochie on a Rochester based Pediatric Telemedicine program "Healthy Access". There have placed telemedicine equipment at childcare programs so a child can have a tele-consult with a physician without leaving the child care center in case of illness. This has proved to be a real convenience for families, but has also shown to reduce ED visits. See this press release:Telemedicine a Cost-Effective Alternative to ER VisitsThe bottom line from their study: A 24% reduction in ED visits in the group of children using telemedicine and a savings of $14/child per year for the insurers. Also see David William's Healthcare Business Blog for his thoughts on this program. Complete Dr. McConnochie interview from the 11-21-07 Newscast Rand: For many busy adults, balancing busy careers and parenting is tough. When a child gets sick at day care or school, figuring out how to get them to the doctor’s office can be a challenge. But a project designed at the University of Rochester Medical Center used technology to bring the doctor’s office to child care centers and schools. The project is called Healthy Access and began in 2001 in five inner-city child care programs in Rochester, New York. Today the telemedicine network has grown to 22 sites, including suburban elementary schools and child care programs and 10 primary care practices. We’re joined`now by Dr. Kenneth McConnonchie, the principal investigator for the project. Dr. McConnonchie welcome, would you please tell us how Healthy Access works? Dr. McConnonchie: Well, let’s say we have two-year old Sally, and she wakes from nap time with a fever or holding her ear. As with any child care program, the parent is contacted, but instead of the dreaded call to come pick up your child and don’t come back without a doctor’s note, child care staff, in this case, offers telemedicine as an option. Almost always, the parent chooses telemedicine. The trained child care staff person, known as the telehealth assistant, also uses this contact to obtain any history about the illness episode not already known. Then, at the child care site, the telehealth assistant collects additional information, including images, video clips and audio files, about the child’s condition and medical history. We use a digital camera with special attachments to take detailed, high resolution eye, ear drum, mouth, and skin images. We also capture lung sounds using an electronic stethoscope. Rand: Is all this technology a bit scary for small children? Dr. McConnonchie: Some may wonder whether the child might be frightened by the whole process, given the fact that usually a parent is not present at the telemedicine visit. Experience, however, shows that quite the opposite is true. Consider the fact that child care and school are like a home- away-from-home for children that they serve. Staff there care for these children almost every day. In child care, many children spend more waking hours with their teacher than with their parents. In contrast, young children know the doctor’s office only as a place they go for shots, and that’s a scary place. Another advantage of the child setting, child care setting at school, is the children love to see themselves on TV, so to speak, and that’s their experience with telemedicine. Rand: So then what happens with all the information that’s collected? Dr. McConnonchie: Having acquired all the information, the information is then sent by the telehealth assistant to the child’s primary care practice, where a clinician can use the information to diagnose or treat the patient. If necessary, the clinician conducts a live video conference with the patient, staff, and sometimes parents, to help diagnose the child. If a prescription is appropriate, after diagnosis, the physician can instantly fax it to the pharmacy for delivery to the child care center or school. Once the visit is complete, parents get a personalized letter about the visit and any useful information that the doctor wants them to have, such as a standard handout on ear infections. With an evolving illness, the clinician generally discusses findings and recommendations directly with the parents by phone. For children with a primary care doctor who is not participating, or who have no PCP [primary care physician], the visit is done by the default clinician. This responsibility is usually filled by our primary care pediatric practice at the University of Rochester Medical Center. All local insurance organizations, including Medicaid, Managed Care and SCHIP plans are reimbursing for telemed visits. The default clinician would also see children with no insurance in case there was a participating PCP who’s group refused, so that’s an overview of how it works. Rand: Dr. McConnochie how effective has your network been? Dr. McConnonchie: Well, to date, we’ve conducted more than 5,500 visits between child sites and the ten physician offices using telemedicine. Since the program began, we’ve been able to show a 63% reduction in absences from child care due to illness. As we like to put it, it’s health care when and where you need it by people you know and trust. Rand: What’s been the reaction of parents react to this technology? Dr. McConnonchie: Well, some parents were initially skeptical, understandably so and appropriately so, about using telehealth to treat their children, but as the program moved along, parents have gained confidence in telemedicine. Parents tell us that without telemedicine in place, illness in their children result in much more – would result in much more time lost from work, more in-person doctor visits, and more emergency department visits, and our data supports their claims. Rand: So, what’s the next step for this program? Where do you see it going? Dr. McConnonchie: We think the technology could be used in many additional settings. Obvious examples are group homes for developmentally disabled, assisted living facilities, summer camps. The burden of morbidity for children or adults in each of these settings is high, yet access to care in these settings is often problematic. For example, in-person access for a developmentally delayed child or an elderly individual in an assisted living center often requires a wheel chair van and multiple attendants. Retail-based medical clinics are rapidly developing in many communities around the United States. While extremely appealing to the consumer because of their convenience, retail- based clinics disrupt continuity of care with the medical home. People are seen in retail-based clinics by a nurse practitioner in the store, not by their doctor’s office. Retail-based telemedicine access points, in contrast, would provide the same level of convenience as retail-based clinics while maintaining continuity of care. People would go to the store for access, but with telemedicine, they could be readily seen by a clinician from their own doctor’s practice. Rand: Regarding the training involved in this program, what does it take to become a telehealth assistant? Dr. McConnonchie: Well, that’s a very important question and for long-term sustainability, that’s an important issue. The telehealth assistants, as we call them – actually we call them CTAs for Certified Telehealth Assistant. We train them and we certify them. The certification reflects the fact that they’ve gone through the training program and then demonstrated, over a couple of months, visit by visit evaluation, including sample visits or trial visits – that they can perform at a high level. So then we issue – having gone through this – then we issue the certification, and if someone doesn’t do enough visits to maintain their certification, they’re de-certified. But the basic training, the initial training, just takes a couple of weeks and I think one of the strengths of this whole system is that we, you know, we can take a child care staff person without – who never had – most of whom have not had prior health care training. Some have been trained by – been trained as nursing assistants, CNAs, Certified Nursing Assistants, who work in assisted-living facilities, for example – and with relatively brief training, get them up to speed. Rand: Who funds the staff and training? Dr. McConnonchie: Well, at the child care site, or the child-end or patient-end of the process, the telehealth assistant is, in most settings, is someone who’s employed/hired by the child site itself. Now, in many day care centers, particularly large ones, there is a health person. This expands the health person’s role and gives them a lot more tools. I would say it makes them a lot more useful, so given that child sites have – child care sites have found that they’re now attracting families that they haven’t attracted before, simply because they’ve got child care. They have found that it’s worth their while from a program development perspective. For sites and many child – certainly many of the city child care sites are also a part of family advocacy programs. Those sites take the perspective of, you know, they want to do everything they can to support families, get families back on their feet, to keep parents on the job, and the like. So they go out and raise their own funding to support this health person or the telehealth assistant. City schools are a little different. Their mission is different. Their budgets are much bigger and they’re much less, you know, personally oriented. Charter schools and actually the parochial schools, in our experience, have functioned more like the, like the child care centers that are very family oriented. So, the – at this point, that’s where the funding comes from. Our very first programs, we provided the funding for the telehealth assistant, so it came from our federal funding. Actually, back then, it was the U.S. Department of Commerce Technology Opportunities Program, the very first programs. Rand: Dr. McConnochie, let’s talk technology for a minute. If someone is thinking about starting this up, what equipment do they need? Dr. McConnonchie: Well, we have – we started off with commercially available pieces and we put them together into a functioning model, but certainly not a very efficient model, and certainly not one that was reliable enough or user-friendly enough that a busy pediatrician in their office practice would tolerate it. Faced with, you know, the implied problems, a commercial venture has grown out of our efforts. It’s called TeleAtrics. The initial role, from my perspective, as the Director of Healthy Access – the initial job of TeleAtrics was to develop, you know, the kind of platform that was needed, that – and basically the platform is a web based platform. There’s a central server where records of all the visits reside. At the – you know, at the child site, it’s a very secure system. It’s a lock-down system accessible only through a bio-metric log on by the telehealth assistant. The bio-metric log on is a fingerprint reader. People can’t be surfing the web at that end. And it’s basically a computer dedicated – it’s basically a plain vanilla PC with a couple of peripheral devices, the main – there’s a Logitech video conferencing camera, pretty simple straight forward. Anybody can set that up. There’s – what’s called a Camscope and that’s kind of the all-purpose camera which has different attachments that, kind of, optimize it for looking at ear drums and looking at throats or skin or eyes that actually – the Camscope can also be used to focus across the room. It can be used as a video conferencing camera. It’s a very, very flexible and useful tool. In addition, there’s the electronic stethoscope and that’s basically it. As I said, it all attaches to a plain vanilla PC which is locked down. The software that resides on the server guides the telehealth assistant through the process. We have a training manual that guides them through the process and makes it very clear under what circumstances you definitely need to get ear images and under what circumstances you definitely need to get lung sounds. You don’t need to get lung sounds on every child, certainly not a child whose chief complaint is a skin rash, particularly if the child is acting well. But, so the software guides and teaches, if you will, for the telehealth assistant. Rand: What about on the clinician’s end? Dr. McConnonchie: The software at the other end, at the clinician end, first of all, it captures and displays, in an efficient way, the information that – both the text information, as well as the images, and video clips and lung sounds that are – have been captured by the telehealth assistant, what the – actually at the clinician end – what the clinician sees. On the left hand side of his monitor is a waiting room, where children waiting to be seen by telemedicine are listed, and then there’s a media column – if he clicks on one of those visits, a media column and the rest of the visit opens up. The media column is right there and he, basically, has thumbnails of all the images and audio clips and video clips, and then right next to that is the text that’s summarized from the telehealth assistant, and then you scroll down, open and expand boxes for recording through the standard physician’s history, past medical history is available. Rand: This is Health Care 411, if you just joined us we’re talking with Dr. Kenneth McConnochie, the principal investigator of the Healthy Access telemedicine project at the University of Rochester Medical Center. Dr. McConnochie how are you evaluating the impact of this technology on health care quality? Dr. McConnonchie: A couple other simple, but, I think, very important measures are continuity of care with visits and also ability to complete visits. In terms of continuity of care, for children who have a participating PCP, the question is, what proportion of those visits do the – does the PCP squeeze in to his busy office practice? And basically, we’re asking them to squeeze those visits in as they come up. The answer is that it varies - some – but the average is about 83%. It varies from about 60% to about 95%. I think the 83% average is pretty darn good considering, especially, that so many of these visits would have ended up in the emergency department. Our – sort of prior to getting this going – we conducted some interviews at some inner city and suburban child care sites, and talking to the inner city families, we asked them – if you were to call your child’s practice in the afternoon about – your child’s sick and you really would like him seen today – 75% of parents said that they would be told to go to the emergency department. So, the point here is, obviously, the additional cost of the emergency department visit, but also, that’s not continuity of care, obviously. So there’s one important effect. The other effect, in terms of completing visits – by that, I mean, a visit seen by telemedicine – what, in what proportion of the time did the clinician feel comfortable/confident with both their diagnosis decisions and their treatment, and being able to, not just make treatment decisions, but actually implement the treatment, and that’s about 96% of the time. So, 96% of visits are completed. Obviously, this is not – you know, these are visits that arise in child care and school settings, that the child wasn’t sick, most of the time, when they went off to child care in the morning. So these are not terribly serious problems, but from a medical perspective, but they are quite serious from a social perspective if moms can get called and told to pick up the child. Rand: Have you gotten any feedback from people who are in the actual doctor’s office, whose visits were interrupted by one of these calls? Dr. McConnonchie: Well, yeah, not directly, cause they’re – and I wouldn’t expect to, cause no single visit is going to be interrupted. A doctor’s not going to get up in the middle of the visit and say, “Sorry, I’ve got to go take a telemedicine call.” The visits are completed. Now I am active as a clinician myself and our fairly busy primary care practice – what often happens is – the tele – not every telemedicine visit needs a – the real time video conference component. Many do not. So, I can do many other things that I’m doing – while I’m supervising residents, say, and then pick up the phone or look at the telemedicine visit and make my decision very quickly, and pick up the phone, call the parent or call the telehealth assistant, and just squeeze that in. So, basically, often the decision making part, it’s all so well presented and the images are so crystal clear, when things go well, as they usually do, my decision making just takes a matter of seconds. The communicating and the documentation takes a little more time, but it’s not something that I can’t do, you know, fitting it in between patients or between other things I’m doing in a clinical setting. So these visits are very efficient. Rand: Have any of the parents expressed concern about sick kids being allowed to stay in the classroom? Dr. McConnonchie: I don’t think so. It’s a question that comes up. You know, first of all, the issue of – does the child stay or go home – in the – that basically boils down to a decision between the parent and the child. I’m sorry – between the parent and the child care site. If the child care site says that your child cannot participate, is feeling so droopy that, you know, we have to spend – our staff has to spend so much time with your child that, you know, we can’t attend to other children, we can’t care for other children, we can’t teach other children – then, you know, the child needs to be picked up. It’s not an arguable point. The question of communicability – you know, there are, from a strictly medical perspective, you know, most of the times, the viruses that you’re dealing with are just ubiquitous. Children with a common cold, who could be coughing and sneezing and spewing those viruses all over the place – you know, the guidelines say that that child can stay. Um, the child with conjunctivitis, which is pink eye, which is a little more visible, from a specifically contagious disease perspective – that child is no more and probably less contagious than that child with a cold. You know, again, to me, that’s – from a medical perspective, I can put my two cents in and say what I just said, but the final decision is up to the child care site and the parent. – If the child care site – if their guidelines say the child needs to go home, the child needs to go home. That’s it.The American Academy of Pediatrics and their, sort of, school health handbook very much emphasizes the fact that most children with minor illnesses are safe for them to stay and that the decision to leave should be based, primarily, and in most instances, on the ability of the child to learn and participate. Rand: It seems there are obvious advantages to parents and children – in terms of this being less disruptive to both of their everyday routines. Have you noted any other benefits? Dr. McConnonchie: We have evaluated – we have published some preliminary analysis which has convinced the local – I should say preliminary analysis of cost effectiveness, which has convinced the local Medicaid, Managed Care, and commercial insurers in the Rochester area to continue reimbursement beyond the end of the current demonstration project for children who are at currently participating sites. We’re right now in the middle of a much more elaborate cost effectiveness analysis, including a few thousand children followed over various periods of time. We expect that this is going to show consistent with the preliminary analysis – that the Healthy Access telemedicine model is highly cost effective. Why? Well, many emergency department visits by children could have been handled via telemedicine. In our community, many problems that would have led to ED visits have now been managed by the telemedicine model instead. Our studies indicate that payers reimburse ED visits at least five to- seven-fold greater than for office visits or telemedicine visits for the same problems. So we anticipate substantial reduction in net health care costs for managing childhood illness, even after paying for telemedicine infrastructure, such as the telehealth assistants and the equipment. Considering the impact of telemedicine on absence from child care or school, and on parent absence from work, we expect that from a societal perspective – in other words, going beyond just the health care perspective – that cost effectiveness will be even greater. So, we’re optimistic based on our final analysis that insurers will expand telemedicine reimbursement for all children locally and, eventually, nationally. Rand: Dr. McConnochie thank you so much for joining us today. Dr. McConnochie: Well, thank you very much, it’s been a pleasure. Rand: Dr. Kenneth McConnochie is the principal investigator of the Healthy Access telemedicine project at the University of Rochester Medical Center.http://www.healthcare411.org/trans/HC411_trans_20071121_Full.htm (Source: RHIOs, Health Information Exchange & Healthcare IT)

Challenges facing translational biomedical research

FutureHIT - Speculations on the Future of Health IT — Wed, 14 May 2008 04:00:00 +0100

I was at two different meetings last week at the NIH in Bethesda, MD, both of which were related to the fostering of clinical research networks. The first meeting, called "Clinical Research Networks: Building the Foundation for Health Care Transformation", was the culmination of the NIH Roadmap "Re-Engineering the Clinical Research Enterprise" program, in which a dozen academic health centers and other research institutions fulfilled contracts to do research and develop tools and techniques for the creation, care and feeding of clinical research networks. The network concept was defined broadly to include disease-focused networks, practice-based research networks (PBRNs), transplant donor/recipient networks, and others. There were keynote speakers from the NIH leadership, but the bulk of the meeting consisted of panels composed of principal investigators discussing the lessons learned in the fulfillment of their contractual obligations. While each contract produced some sort of intellectual property, but the lessons learned were the primary goal of the program, and the lessons were rich and diverse. The second meeting, "Accelerating the Dissemination and Translation of Clinical Research into Practice", was a closely related follow-on open to a much broader audience. It was more of a mix of speakers and panels, and covered a lot more ground. It included a speaker on the translation of knowledge into practice in an agricultural extension program, an admirable (and rare) attempt on the part of the medical research community to learn from unrelated disciplines with similar problems. There were representatives of many stakeholder communities within the realm of translational research, from high-ranking executives of funding agencies to physicians in private practice. The theme of both meetings was the need to accelerate translation of research into practice. There is broad consensus on the need to move to a translational research paradigm. There have thus far been two types of translation in common biomedical parlance: Type 1 (T1) translation, translating basic science discoveries into cutting-edge therapeutics; and Type 2 (T2) translation, translating cutting-edge therapeutics into mainstream primary care. There is talk of the need for a third translational layer (T3), bringing evidence-based medical knowledge into everyday life at home, at work, and in the community at large. Two themes emerged that I think define the current state of clinical research informatics, and in fact biomedical informatics in general. The first theme is the precedence of cultural and political barriers to adoption over technical challenges. The second theme is patient empowerment, the shift toward patient ownership of and responsibility for their electronic health records. Politics Trumps TechnologyMake no mistake: in terms of obstacles to progress in biomedical research informatics, and in particular such distributed operations as multi-site clinical trials and practice-based research networks, the technological challenges are formidable. Nonetheless, technology was anecdotally noted by several speakers at last week's events as constituting 10% to 20% of the picture. By and large, the political and cultural barriers are not a matter of malfeasance. Some of the political challenges do involve a certain level of villainy, particularly in the defense of disciplinary and organizational silos and personal turf. The vast majority of political and cultural barriers I've encountered stem from problems among those eloquently stated by Jonathan Grudin in his paper from the early 1990's entitled "Groupware and Social Dynamics: Eight Challenges for Developers". These include disparities of work and benefit; critical mass and Prisoner's Dilemma problems; disruption of social processes; failure to account for necessary exceptions to standard operating procedures; unobtrusive accessibility in normal workflows; difficulty of evaluation and justification; failures of intuition; and unanticipated complexities in system deployments. I can't go into all of these here, but let's look at a few that characterize different major problem areas. Disparities of work and benefit Disparities of work and benefit arise when complex systems require effort on the part of individuals and groups who receive no direct, immediate benefit in return. One example from my own domain is the need to acquire research data at the point of care. If there is an Electronic Data Capture (EDC) system for such data acquisition, it is unlikely to be the same system in which clinical care and operations data are entered. Dual data entry imposes a burden on the clinical staff for which they receive no additional compensation or other ancillary benefit. We encountered this problem in an effort to automate EDC for a study conducted through primary-care provider (PCP) practices that are members of a PBRN. The idea of a direct login to an EDC system to capture data during patient encounters was a non-starter. Disruption of social processes Aside from the work/benefit disparities, many physicians view data entry as a demeaning activity, especially he or she is over forty or so. Such physicians capture data in handwritten notes or oral dictation. In clinical research, tracking custody and transformation of data from the original source of truth is a requirement, and the source documents must be retained in the original or a facsimile form (e.g., scanned image of a paper form). In such a situation, either the clinician must be convinced to let go of the social norm, or an additional burden is imposed on the research staff and IT systems. Solutions Our solution was two-pronged. First, the research data set consisted almost entirely of data points of significant value to the provider-patient relationship; some were captured at the clinic, but others were captured elsewhere and transmitted to the clinician from the patient's hospital and a telephone- and Web-based depression surveillance program. The additional effort involved in data capture during patient encounters was offset by its immediate usefulness in patient care, and the automated transmission of additional information from outside sources provided a benefit that could not easily be obtained in any other way. Second, we were able to piggy-back study recruitment and EDC onto a prompt and reminder system, Cielo Clinic, which produces a problem summary sheet that is bi-directional, used both for data presentation and capture. Cielo Clinic began life as ClinfoTracker, a product originally developed by family physicians within our Health System for internal use that has been spun out commercially after extensive internal testing and refinement in real-world clinical environments. [Disclosure: I do some consulting for Cielo Medsolutions, so be aware of my potential bias.] Adopting Cielo Clinic involved some effort on the part of clinicians and support staff in the PCP offices, but its added value manifested in immediate benefits: aside from the obvious beneficial effect on patient care, Cielo Clinic alerted the clinician to the need for evidence-based billable procedures that might otherwise have been overlooked, thus providing a positive effect on practices' bottom line. This financial incentive is difficult to quantify prospectively, but the technology transfer to Cielo put the burden of proof on people with a vested interest in finding believable quantitative revenue increase estimates. Primary care is not a hugely lucrative venture in most cases, so this incentive is more significant than we may wish it were. Data capture could be either direct EDC or paper form-based, but because the hard-copy Cielo Clinic Problem Summary List is capturing clinical care information, offices with paper-based charts would retain it anyway, eliminating extra effort in tracking the original source of truth. Likewise, the secondary data entry involved in maintaining the problem summary list has both near- and long-term clinical benefit, given the focus on capturing research data that is durectly relevant to patient care. Patient empowerment The second sea change, the shift to a consumer-centric healthcare system, is closely related to the structural contradictions that are threatening to tear the US health care system apart. The US healthcare system is costlier by far, by any measure, than its equivalent in any other developed nation. The quality of care, defined in terms of outcomes on a statistical basis, is among the lowest among these same nations, again by almost any measure. The US healthcare picture is characterized by dramatic breakthroughs at the cutting edge of medicine and mediocrity throughout the day-to-day operations of most points of care in the system. In an odd sort of way, the pressure from the payer side to contain costs synergizes with the healthcare consumer's desire for quality care. Patients want all the necessary tests, and only the necessary tests, to diagnose and determine the appropriate therapy for their conditions. With the wealth of information available via commercial online search engines, patients and their loved ones come to the physician-patient relationship more informed than ever before - in many cases where a rare disease is involved, more informed than the physician. Patients frequently come into the exam room with Web page printouts and a host of questions and ideas that challenge the paradigm of the physician as the expert and the patient as a passive recipient of diagnoses, prescriptions, and advice. Dimensions of Trust At present, "more informed" does not necessarily entail "better informed". But to be fair to the search engines, without contextual knowledge they are flying blind when attempting to divine the meaning of seekers' often brief and sometimes cryptic queries. An online EMR, such as those now being deployed by Google Health and Microsoft HealthVault, could be a big step toward provision of the necessary context. Trust is the big issue here, and trust is multi-dimensional. Will consumers learn to trust massive online repositories to take custody of their health records? Will Google, Microsoft, and the others who will be competing in this space prove worthy of consumers' trust? And finally, will online search produce information consumers should trust? The jury is still out on all of these. (Source: FutureHIT - Speculations on the Future of Health IT)

Force feedback haptic technology used in surgical drilling simulator

Medgadget — Wed, 14 May 2008 04:00:00 +0100

Haptic technology is probably finding more use in medicine than in any other industry, most famously found in the Da Vinci robotic surgical system. (Our mistake, Da Vinci is not a haptic device --ed.) Medic Vision Ltd., a Melbourne, Australia company that builds surgical simulators, is now using the popular PHANTOM force feedback device from SensAble in its new surgical drilling simulator, providing realistic feeling while reducing the need for smelly cadavers to train on. The Mediseus® Surgical Drilling Simulator is the world's first commercially available solution for temporal bone drilling to rely on the same viewing and operating technology as surgeons use during actual procedures: a simulated stereoscopic 3D microscope, and a sense of touch. Instead of holding a computer mouse, trainees hold a PHANTOM® haptic device from SensAble, which provides force feedback -- pushing back on the user's hand -- as they perform the surgical procedure. Medic Vision engineers also used SensAble's Open Haptics® toolkit to render haptic data so that the PHANTOM devices provide the synchronous "feeling" of the procedure in time with the on-screen graphics updates, as well as audio cues. The Mediseus® Surgical Drilling Simulator allows ENT surgical residents to train on the entire cortical mastoidectomy curriculum, learning the procedure from start to finish, obtaining unlimited practice, and refining their knowledge through heavily catalogued advice and events. A telelearning capability also allows remote, haptically-enabled, surgeon-guided training. For example, a surgeon using a Mediseus® simulator in Australia can train a resident on a Mediseus® in Sweden -- guiding the trainee through the procedure haptically, so that the trainee "feels" the surgeon's correct drilling procedure. "By using SensAble's high fidelity haptic technology, our Mediseus® simulator can distinguish between the feeling of different parts of the temporal bone drilling procedure - from the lightweight feeling of the cutting/polishing burrs, to the slightly different feeling of irrigators and other instruments used during the procedure," said Ross Horley, CEO of Medic Vision, Ltd. "Surgical residents can experience what actually takes place in the operating room, including the sights, sounds and the feeling of the procedure, in a safe and controlled environment until they achieve mastery." Press release: Medic Vision Ltd Utilizes SensAble Technologies' Haptic Devices to Deliver Realistic Surgical Drilling Training ... Product page: PHANTOM ... (Source: Medgadget)

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Novel surgical biomaterial receives regulatory approvals

Medgadget — Wed, 14 May 2008 04:00:00 +0100

CorMatrix, an Atlanta, Georgia company, has received FDA approval to use its CorMatrix ECM™ material during cardiac procedures for "suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects", according to a company representative. Additionally, CorMatrix received EU's CE Mark for its CorMatrix ECM for Pericardial Closure bioscaffold and plans on marketing the material in Europe this year. From a press release obtained by Medgadget: The company's platform ECM Technology, an extracellular matrix biomaterial, provides a natural bioscaffold that enables a patient's own host cells to repopulate and repair damaged tissues. The CorMatrix ECM is currently FDA cleared for the reconstruction and repair of the pericardium. The additional indication expands the use of the implant to include suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects. "We have used the CorMatrix ECM to close the pericardium for the past two years. An intact pericardium plays an important role short and long term for the patient, both anatomically and functionally. Surgeons typically prefer to restore structures to their normal anatomy whenever possible, which we have been able to do in a safe and effective manner using the CorMatrix ECM. Post-operative CT scans on patients in which we have closed the pericardium have demonstrated the re-established pericardial anatomy complete with normal pericardial space," said Douglas Boyd, M.D., Chief of Cardiothoracic Surgery at the Cleveland Clinic in Weston, Florida. "The ease of use and post-operative results make it an excellent option for pericardial closure and now for other cardiac tissue repair applications," continued Dr. Boyd. "As with pericardial closure, intracardiac repair using the CorMatrix ECM restores the natural anatomy of the heart. We are pleased that this additional approval will allow us to use the material beyond the pericardium." Following implantation by a surgeon, CorMatrix ECM Technology products act as a scaffold into which the patient's own cells migrate and integrate, stimulating the body's innate wound-healing mechanisms to repair tissue at the site of implantation. As the patient's cells populate the matrix they lay down their own collagen, which matures over time to form a functional tissue repair. The implanted ECM material is gradually replaced and resorbed by the body as the patient's tissue is remodeled. CorMatrix technology page... (Source: Medgadget)

An update about the 2nd annual diabetesmine design challenge

Medgadget — Wed, 14 May 2008 04:00:00 +0100

Co-sponsored by Medgadget, the 2nd Annual DiabetesMine™ Design Challenge, "a competition designed to foster innovation in diabetes design and encourage creative new tools that will improve life with diabetes," is gathering up steam. As we have reported before, the contest is looking for unique, practical, and novel design ideas that may one day be applied to real products for diabetics. The winners of the design challenge will receive both prize money and consulting time with design firm IDEO. How much money? Now even more of it! Please note the following newly announced updates to the competition: increased prize money (we have an additional $200 from DexCom and an additonal $1000 from two anonymous sponsors, bringing the total to $3200) we'd now like to open up to "paper" submissions as well as YouTube videos (requirements are a 2-3 page written "elevator pitch" plus supporting graphics). extension of the submission deadline to midnight PST on Monday, June 16, 2008. Winners will be announced on Friday, June 20, 2008. Press release: DiabetesMine™ Announces Diabetes Design Contest to Foster Innovation for Life with Diabetes; Good Design can Transform Life for Diabetics... More at Diabetes Mine... (Source: Medgadget)

How dangerous is moon dust?

Medgadget — Wed, 14 May 2008 04:00:00 +0100

At the National Space Biomedical Research Institute, scientists are studying the human physiologic response to prolonged exposure to lunar dust, the particles of which might pose a threat to human lungs: During the Apollo lunar missions in the late 1960s and 1970s, the clingy particles were easily transported via spacesuits into the lunar lander following moonwalks. The amount of dust inside the vehicle was so great some astronauts reported they could smell it. Even though there were no known illnesses due to exposure, lunar dust is a concern because it has properties comparable to that of fresh-fractured quartz, a highly toxic substance. However, the Apollo flights lasted only a few days. During the proposed return to the moon, astronauts will be exposed to lunar dust for longer periods of time, including missions that could last months. Due to the moon’s reduced gravity and the size of its dust particles, the respiratory system’s process to remove unwanted matter may not work as efficiently as it does on Earth. “In the moon’s fractional gravity, particles remain suspended in the airways rather than settling out, increasing the chances of distribution deep in the lung, with the possible consequence that the particles will remain there for a long period of time,” Prisk said. The lungs are a highly sensitive organ because of the large surface area that delivers oxygen molecules through a thin membrane directly to the blood. The health risk to astronauts increases as dust particles go deeper into the lungs. To conduct the research, scientists take measurements during flights on NASA’s Microgravity Research Aircraft. These airplanes are used to provide short periods of reduced- and zero-gravity during a series of steep climbs and descents. “During the portions of the flight in which gravity is reduced to levels seen on the lunar surface, we inject particles into a mouthpiece through which the study participants breathe,” Prisk said. “Subjects breathe in and out, and we measure how the particles behave and how many end up inside the lung.” Prisk said the research flights have been beneficial so far. “With the reduced-gravity flights, we’re improving the process of assessing environmental exposure to inhaled particles,” he said. “We’ve learned that tiny particles (less than 2.5 microns) which are the most significant in terms of damage, are greatly affected by alterations in gravity.” The next step is to investigate the risks and determine ways to limit exposure. Press release: Astronaut health on moon may depend on good dusting... (Source: Medgadget)

Sepet extracorporeal liver assist device ok'ed for pivotal clinical trial

Medgadget — Wed, 14 May 2008 04:00:00 +0100

SEPET™ Liver Assist Device, a blood purification technology designed by Arbios Systems, Inc., a Pasadena, CA company, has been given FDA's Investigational Device Exemption (IDE) status. The clearance paves the way for the company to begin a pivotal clinical trial. The device, a filter with special qualities, is designed for use with a standard blood dialysis system. We first reported about SEPET™ Liver Assist Device back in April 2005. More about the technology, and the planned trial: The SEPET™ Liver Assist Device is a novel blood purification therapy designed for use with a standard blood dialysis system. It comprises a sterile, single-use, disposable cartridge containing microporous hollow fibers with unique permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma of specific molecular weight and size is expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins such as ammonia, as well as various mediators of inflammation and inhibitors of hepatic regeneration). These substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, accelerating damage to the liver and other organs, including the brain and kidneys, and suppressing the ability of liver cells to function and to proliferate or regenerate. SEPET™ is further designed to retain in the circulating bloodstream numerous larger, beneficial molecular weight blood proteins, including a powerful promoter of liver regeneration, Hepatocyte Growth Factor (HGF), various immunoglobulins, such as IgG, IgM, and others, and various complement species that are important for retaining active immune protection against infection (which often exacerbates liver failure). SEPET™ also retains most of the blood clotting factors, which are important for preventing bleeding—another common and potentially lethal complication of liver failure... There are three segments to the pivotal trial design. During the first segment of the trial, 5 non-randomized patients will be treated with SEPET to allow us to validate the patient selection criteria, clinical protocol, case report forms, and other trial related documents. During the second segment of the trial, we expect to enroll 116 patients in this randomized, controlled phase of the trial. This segment is targeted to achieve the co-primary endpoints, which are 1) the percentage of patients achieving improvement in hepatic encephalopathy ("HE") grade by a minimum of two grades by the end of Day 7 in the SEPET treatment group versus the standard medical care group, using a 1:1 randomization between the two groups; and 2) the 30-day transplant free survival rate in all patients (i.e. control and treatment groups) who do reach a two grade Pending review and approval by the Data Safety Monitoring Board, the third segment would permit the size of the trial to be increased by an additional 52 patients, if the co-primary efficacy endpoints are reached or have not reached statistical significance but have shown a positive trend. If the co-primary endpoints of the trial are reached upon completion of segment two, extension of the trial into segment three may result in the achievement of statistical significance of one or more secondary endpoints of the trial relating to clinical, functional, and reimbursement advantages for SEPET-treatment over standard medical care. To be a candidate for the pivotal trial, a patient must have chronic liver disease and be experiencing an acute episode that results in hospitalization with an HE grade of between II and IV. In addition, the patient must not be responding satisfactorily to standard medical care (e.g. fluid replacement, antibiotics, lactulose) for 20 to 26 hours prior to randomization. Patients contraindicated for a liver transplant (e.g. advanced liver cancer patients and drinking alcoholics) are excluded from the trial. Product page: SEPET™ Liver Assist Device... Press release: ARBIOS RECEIVES APPROVAL FROM THE FDA TO INITIATE PIVOTAL TRIAL FOR SEPET™ LIVER ASSIST DEVICE... (Source: Medgadget)