e-HealthExpert.org - Primum non nocere

Israel's business newspaper Globes is reporting that MAZOR Surgical Technologies has received approval from the FDA for the company's combined SpineAssist navigation and C-Insight imaging system. As we have reported before, Mazor's SpineAssist device is a miniature robotic guidance / perioperative planning system designed for treatments of spinal compression fractures and other vertebral surgical issues. From the product pages: SpineAssist The system consists of a miniature device that mounts above the patient’s spine, and a workstation running advanced surgical planning software. SpineAssist’s software allows surgeons to perform 3D, CT- based preoperative planning on a personal computer at their own convenience prior to surgery. Using a virtual catalogue of surgical implants, surgeons can view and position implants within each vertebra or disc on three planes: AP, lateral and axial. A special feature in the software is used to review the planning slice by slice in sequence. The software supports a range of measurements including Cobb angle, lordosis and kyphosis. The surgeon can view a simulation of the correction they are planning, which is especially useful in deformity and scoliosis cases. The software also calculates rod length and curvature. The SpineAssist workstation connects to a fluoroscopic C-Arm and performs automatic CT-to-fluoroscopy image registration based upon 2 fluoroscopic images. The workstation is used to control the precise motion of the miniature device to the preplanned position. C-InSight C-InSight is an add-on to existing C-Arms, converting 2D scans to 3D images intraoperatively. In line with FDA guidelines for radiation reduction, C-InSight provides 3D images at radiation exposure levels as low as 5%-10% of other intraoperative 3D scans, making is safer for both the OR team and patients. C-InSight can often eliminate the need for a post-operative CT scan. C-InSight quickly connects to any C-Arm with a video output (via BNC cable) and converts 2D scans to 3D images in 2 minutes. A short in-service will get the OR technicians / staff ready to operate the C-InSight. The easy step-by-step instructions assure consistent performance. Here's Ori Hadomi, CEO of Mazor explaining the system on Fox Business News: Demo video of C-InSight: SpineAssist promo: Globes: Mazor wins FDA nod for combined surgical systems... Product pages: SpineAssist; C-InSight... Flashback: SpineAssist Gets New FDA Approval... Michael

Pyng Medical out of Richmond, British Columbia has received US regulatory approval to market the FASTx Sternal Intraosseous Device that provides quick vascular access via bone marrow. Features of the device from the product page: Vascular access within 10 seconds; fluids and medications to the heart in 30 seconds Automatic depth control prevents over-penetration Delivers fluids and medications as quickly as a central line, with shorter access time Can be inserted during other resuscitation procedures Can deliver any fluids or medications that can be delivered via IV For use in adolescents from 12 years of age and older Designed for single, sterile use—no cross-contamination Flexible tubing with subcutaneous portal; strain-relief target foot ensures line does not dislodge Can be inserted in moving ambulances, aboard helicopters, and on stretchers Skill mastery within minutes; skill retention not dependent upon frequent practice or use Press release: Pyng Medical Corp Receives US FDA 510(k) clearance for FASTx... Product page: FASTx Sternal Intraosseous Device... Flashback: The Fastest Way To a Man's Heart is Through FAST1 Intraosseous Infusion System;... Michael

A team of researchers at the University of Chicago Hospitals' Pediatric Epilepsy Center are working on a system which can monitor epileptic sufferers around the clock. Patients will be able to use their smartphones to record and send data to their doctor for review. The system, being developed in collaboration with Chicago based Wave Technology Group, can provide text message alerts to the patient or caregivers about potential upcoming seizures. Additionally, the system will be cheaper and more portable than current EEG monitoring solutions. Wave hopes to attain FDA approval for the system by the end of next year. From BusinessWeek's coverage: The prototype now in development includes a small 16-channel amplifier - smaller than a credit card -- that would be attached by wires to sensors on a patient's head. In the current design, a hat with a pocket sewn inside would be used to carry the amplifier. The software would control the gathering of brain wave data by the amplifier and the ability to send it via Bluetooth to a smartphone carried by the patient, and from there to a typical cellular network for transfer to a monitoring center. BusinessWeek: Smartphone app would constantly monitor epilepsy patients.... Product page: Wave EEG Monitor... (hat tip: iMedicalApps)... Smit

InfraReDx of Burlington, Mass just announced FDA clearance of their LipiScan IVUS Coronary Imaging System. Coronary angioplasty used to be based on the premise that areas of arterial narrowing seen on angiography were the most critical zones to stent, believing them to be the cause of heart attacks. Thinking has changed, however, and there is some research showing that plaques that may not cause much narrowing of the arteries may be the ones prone to rupture and thrombosis. This has led to a plethora of innovation in coronary imaging systems and technologies. We reported in 2008 about InfraReDx's near-infrared sprectroscopy coronary imaging system. The Lipiscan IVUS adds intravascular ultrasound to their device and is reportedly the first to combine intravascular ultrasound as well as near-infrared sprectroscopy to characterize intravascular plaques. The catheter-based system can be used during angioplasty to identify plaques that are likely to rupture and lead to a heart attack. It can also be used to predict stenting complications such as restenosis. Once stenting has been performed, IVUS can be used to analyze how effective a lesion has been stented. Here is more from the press release: The NIR spectroscopy identifies the chemical content of the plaques; the IVUS provides an image of plaque structure and stent features. The Company expects to conduct a broad commercial launch of the system within the U.S. by year-end 2010, and anticipates regulatory approval and launch in Europe during 2011. David Rizik, M.D., medical director of Invasive Cardiology at Scottsdale Healthcare Shea Medical Center, commented, "Patients are increasingly presenting to the cath lab with complex lesions, such as left main disease, multi-vessel disease and bifurcation lesions. In these patients, angioplasty guided by angiography alone is inadequate to prevent potential complications such as restenosis, stent thrombosis, and peri-procedural myocardial infarction." He continued, "To address these challenging cases, we have already incorporated the use of the original LipiScan system to help us identify lipid core plaques that complicate stenting. We are excited to acquire the next-generation LipiScan IVUS, as the addition of IVUS technology to the LipiScan platform will transform this novel diagnostic tool into a truly indispensible component of our lab." Press release: InfraReDx Receives FDA Clearance for LipiScan IVUS Coronary Imaging System... InfraReDx homepage...... jhbarad

AngioDynamics of Latham, NY has announced a new access kit for its VenaCure EVLT system, which provides a minimally invasive method for treating varicose veins using laser ablation via fiber. The company states that the new .018" access kit reduces the number of parts in the system, speeds up treatment times, and will result in greater patient comfort. From AngioDynamics' press release: The new .018-inch system for the VenaCure EVLT access kit reduces the number of components involved in gaining access for the procedure. The new kit provides a longer .018 inch nitinol long-access wire. The distal tip on the Trè-Sheath™ dilator is resized to accept a .018 inch nitinol access wire, eliminating the need for a micro-access sheath, as well as the need to exchange wires during the procedure. This ultimately reduces an eight-step process to four. Press release: AngioDynamics Expands Its VenaCure EVLT ™ System to Offer Physicians Fewer Procedure Steps and a Faster Procedure Time... Product page: VenaCure EVLT™ System...... Smit

The developers of Instant Heart Rate, a new Android app, claim that they can use your phone's camera to measure your heart rate. When a user places their index finger over the camera lens, the app will supposedly be able to detect slight changes in skin color as oxygenated blood passes through with each heart beat, and can use this color change to determine heart rate. Although commenters at Android and Me report fairly accurate results, we were unable to get consistent readings with the app. Readers who wish to try Instant Heart Rate for themselves can install it using the QR code to the right, or by searching for the app in the Android marketplace. Product page: Instant Heart Rate monitor for Android... (hat tip: Android and Me)... Smit

Researchers at the University College London have developed a method to acquire multispectral images of the ocular fundus using LED illumination and a high-sensitivity CCD camera. Multispectral imaging makes it possible to visualize the different light absorbing characteristics of chromophores, the color-defining parts of the molecules. The five distinct colored compounds prevalent in the eye; retinal hemoglobins, choroidal hemoglobins, choroidal melanin, retinal pigment epithelium melanin, and macular pigment can be discriminated in the multispectral images. Because the system is faster than previous multispectral imaging methods, it allows for important features such as small retinal blood vessels and microhaemorrhages to be resolved. Parametric maps calculated from the images might help in early diagnosis of several diseases. The work is published in the journal Review of Scientific Instruments. Full story from American Institute of Physics : LEDs Illuminate Eye for Ocular Disease Screening... Article: Multispectral Imaging of the Ocular Fundus using LED Illumination (.pdf)... Wouter Stomp

The FDA ruled recently that CollPlant's Vergenix product, human recombinant collagen grown from genetically modified tobacco plants, will be treated as a device as opposed to a pharmaceutical. This will make the approval process easier for CollPlant and get them to market quicker. We reported on CollPlant's collagen expressing tobacco back in 2006 and Vergenix is the company's flagship product. Vegenix will be used as a dressing for acute and chronic wounds to facilitate healing and act as a scaffold for fibroblasts and epithelial cells to bridge wounds. From the company's website: Vergenix™ Wound Dressing is an advanced wound care device indicated for the treatment of acute and chronic wounds. Based on Collage rh™ collagen, Vergenix™ Wound Dressing is composed of pure recombinant human collagen type I produced in transgenic tobacco plants. The entire manufacturing process involves no animal-derived or human-derived materials. Therefore, Vergenix™ offers a non-allergenic and a pathogen-free scaffold for a safe and physiologically relevant environment. Vergenix™ Wound Dressing is an excellent choice for safe and successful wound management. Video and links below the fold:... jhbarad

The Wall Street Journal has a very good article covering the well-known "medical alert bracelet," and its many modern spin-offs. When a patient comes into the emergency room they don't always have the mental faculty to answer important questions about their medical conditions, and their family members are often not immediately available. Medical alert bracelet systems help convey to doctors critical information about patients quickly so that they can focus on delivering good care and avoiding devastating medical errors. The options available include standard engraved bracelets, pre-loaded flash drives, and cards containing login info for websites loaded with a patient's info. The system, however, is not perfect. Most of these medical alert systems cost a decent amount of money, and require extra effort either on the patient's or doctor's part unless it is integrated with an electronic medical record system like Kaiser Permanente's. Another issue is that because there are so many different medical alert systems, doctors and first responders might not know how to access all the information, or might not be able to access it quickly enough. Here is a clip from the article: New bracelets and other medical-identification systems can fill in first responders on practically a patient's complete health history. They're a far cry from the simple identification bracelets of the past, which with a few engraved words informed medics that a person was, perhaps, allergic to penicillin. They can steer first responders to a secure website or toll-free phone number, or initiate a text message, to get the medical and prescription history of a patient who may be unconscious or unable to talk about their condition. Of course, wearing the traditional clunky metal medical-alert bracelets might be a turnoff to some, and too visible a reminder of a disease or condition. That's one reason a number of jewelry companies make bracelets, necklaces and watches that look like real bling—Tiffany & Co. has a gold bracelet for $2,250, for instance—and some pendants can easily be hidden under clothes... "Many patients have situations that are so much more complex than just the penicillin allergy that can be noted on a bracelet," says Robert Pearl, chief executive of the Permanente Medical Group, part of nonprofit health system Kaiser Permanente. "We also have to look for drug-drug interactions, drug dosages, or compare an old EKG against a new one if you are having chest pains," he says. Kaiser last... jhbarad

Novo Nordisk recently released an iPhone app meant to help physicians determine the insulin needs of their diabetic patients. The app is meant for healthcare professionals (it starts by asking if you really are a healthcare professional), but anyone may download it. The app conveniently assumes you will be using Novo Nordisk's insulin analog product line which includes their long acting (Levemir), short acting (NovoLog) and their NovoLog Mix 70/30. From the press release: Novo Nordisk announced today the availability of NovoDose™ – the first-ever mobile insulin dosing guide for physicians to look up dosing guidelines and blood glucose goals for their patients with diabetes, a disease that affects nearly 24 million Americans. The guide is available as an application on iTunes and is specific to Novo Nordisk’s modern insulin analog portfolio: Levemir® (insulin detemir [rDNA origin] injection), NovoLog® (insulin aspart [rDNA origin] injection), and NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]). The app itself is pretty looking, but not particularly functional. It contains some basic information about the different insulin analogs, suggestions for titrating and calculating mealtime doses, and some studies backing up the recommendations. It is reminiscent of a pharma pamphlet in its presentation. It does not contain any calculators or input functions. The app might be helpful at times in an outpatient setting, but it is not the comprehensive insulin dosing calculator that health professionals might be looking for. Product page: NovoDose... iTunes link... Press release: Novo Nordisk Creates "App" to Help Doctors Dose Insulin, Supporting New Trend in Diabetes Care...... jhbarad

The National Science Foundation is profiling cardiac stent research being done by collaborators from University of Houston and University of Zagreb in Croatia. They're using mathematical computer models to optimize for different characteristics that stents exhibit, helping to design new stents and help simulate ones that are on the drawing board. Together with her collaborator, Josip Tambaca of the University of Zagreb in Croatia, and her doctoral student, Mate Kosor, Canic wrote a much simpler program that approximates stents as meshes of one-dimensional rods. This program let the researchers achieve the same result using just 400 nodes. Using their simplified model, the researchers have examined the designs of several stents on the market to see which structures seem to be best for specific blood vessels or procedures. For instance, they found that stents with an "open design"--where every other horizontal rod is taken out--bend easily, which makes them good to put in curvy coronary arteries. Canic and Tambaca have also used the model to design a stent with mechanical properties specifically tailored to an experimental heart-valve replacement procedure. She found that this specialized stent works best for the procedure when it's stiff in the middle and less stiff at the ends. In addition, she has found that combining "bendiness" with radial stiffness--where you can bend the stent into a U shape, but you can't squeeze the tube shut--produces a stent with less chance of buckling than those that are currently in use. Today, Canic is helping a team at the Texas Heart Institute study an unusual source for stent coating: ear cartilage. The team believes this easy-to-harvest tissue will make stents more biocompatible, though they don't yet know how ear cartilage cells grow or behave in environments like human blood vessels. Canic is using her computer programs, developed together with Tsorng-Whay Pan, Roland Glowinski and students, to simulate how blood interacts with the stent-coating cartilage cells and how the cells stick (or don't) to the stent surface. She plugs in different fluid thicknesses and shear forces of blood flowing over the stent to see what might encourage the cartilage on freshly coated stents to stabilize quickly. The models have helped her collaborators learn the best conditions to test in follow-up experiments as they search for ways to pre-treat stents before doctors implant them. Full story: Scientists Use Math to Build Better Stents...... Michael

To kick off the new school year Epocrates is giving all U.S. medical students a free copy of its popular Epocrates Essentials suite which typically costs $159. Today is the last day of the offer so do it now before the clock strikes midnight and you turn into a pumpkin. Compared to the Epocrates Rx, which has always been free, this version includes an infectious disease treatment guide, alternative (herbal) medicines, disease monographs and diagnostic and laboratory tests. This version of Epocrates is available for the iPhone/iPod touch, Palm, Blackberry, and Windows Mobile. Link: Free Epocrates Essentials for Med Students... Product page: Epocrates Essentials... Michael

InSightec out of Tirat Carmel, Israel is reporting that its ExAblate MRI guided focused ultrasound system has been used for the first time to treat prostate cancer. ExAblate is already being used around the world for treatment of uterine fibroids and bone metastases (except in U.S. where FDA is yet to approve it for that indication). In this latest study seven patients in Russia and Singapore with localized low-risk prostate cancer have undergone treatment. “Unfortunately current treatment alternatives are accompanied by relatively high levels of adverse events which significantly impact the quality of life of prostate cancer patients. The most common are incontinence and impotence”, says Dr. Kobi Vortman, President and CEO of InSightec. “Due to the introduction of PSA screening tests, prostate cancer is diagnosed at an earlier age thereby increasing the necessity for a treatment option that minimizes adverse events. The ExAblate prostate system has been designed to provide effective treatments while minimizing the debilitating side-effects caused by damage to functional areas of the prostate and neurovascular bundles, thus the system is expected to enable patients to return to normal life within a day or two while maintaining their quality of life.” The ExAblate system, which has been in clinical use for the treatment of uterine fibroids globally and bone metastases outside of the US, is an Image Guided, Non-invasive, Robotic Acoustic Surgery system integrating real time magnetic resonance imaging to visualize the tumor, surrounding tissue and the energy delivery path together with high intensity focused ultrasound beam which is delivered with millimeter precision to destroy the cancerous tumor without damaging surrounding tissue, which is the cause of most complications. The use of real-time 3D MR thermometry provides accurate closed-loop monitoring of the treatment outcome and ability to adjust the treatment according to specific patient physiology, in real time. Press release: ExAblate® MR guided Focused Ultrasound System is being used for the first time for Non-invasive Treatment of Prostate Cancer ... Flashbacks: Brain Surgery With MR Guided High Intensity Focused Ultrasound ; FDA Expands Indication for Insightec's Uterine Fibroid System; Noninvasive Palliation of Pain of Bone Mets; ExAblate Making Waves in US; ExAblate 2000 (hat tip: Globes)... Michael

Medtronic has launched the new CE marked Resolute Integrity drug eluting stent for the European market. The device is meant to provide easier navigation through vasculature thanks to implementation of "continuous sinusoid technology." Based on the engineering advance of continuous sinusoid technology, the Resolute Integrity Stent System has been shown in bench testing and in blinded in vivo physician assessment studies to be significantly more deliverable than the current market-leading alternatives. Coupled with the MicroTrac delivery system, continuous sinusoid technology improves deliverability without compromising other important stent design characteristics like radial strength. It also improves the stent’s conformability – the ability of the stent to conform to the natural shape of the vessel and maintain apposition to the vessel wall after inflation with the balloon catheter. The Resolute Integrity drug-eluting stent (DES) combines continuous sinusoid technology with two key elements of the original Resolute DES: the cytostatic antiproliferative drug zotarolimus and the highly biocompatible BioLinx polymer. Press release: Medtronic Launches Resolute Integrity Drug-Eluting Stent In Europe ...... Michael

Lenovo asked Medgadget to test and review the company's latest computer called Multi-Touch m90z ThinkCentre, an all-in-one model that Lenovo designed for medical professionals, amongst others. This model is a desktop built into a 23 inch touch-screen monitor. Options on the model vary from 2 to 4 GB of RAM, a 320 or 500 GB hard drive, and numerous processor options (tested on an impressive Intel Core i5-650 running at 3.2 GHz). Though not DICOM compliant, the color-rich 1080p HD LCD monitor is topped with a glossy overlay that allows for easy disinfection wipe-downs. The touchscreen technology in the m90z is different than in common touch operated devices because it's actually using little cameras built into the bezel to see where your fingers come in contact with the screen. Because this does not rely on measuring electrical impedance or the force applied to the screen, you can use gloved fingers, backs of pens, and even hemostat tips if necessary to control what's on the screen. Keep in mind that Windows 7 itself isn't particularly great for touch operation, but medical applications designed for touch control are able to take advantage of this screen's excellent sensitivity. Due to the touch screen, Lenovo designed the model to sit at an angle (either 15 or 45 degrees) in order to prevent tip-over. Some users may prefer a more standard zero degree viewing angle which could be achieved through either a wall mount or the use of the Extend Arm accessory. The model might topple if a user pushed hard enough at the screen when the Extend Arm is extended up to its maximum though, so watch out. Testing indicated that passwords for some security enabled sites and programs could not be entered through the touch screen, a security feature and occasional annoyance. As a result of the inability to perform some security enabled functionality through the screen, it is essential that a keyboard is maintained. We would suggest that Lenovo add a groove or bracket to the top of the unit that would allow for a keyboard to rest if the unit has been wall mounted. A wireless keyboard is an optional accessory. There's a built-in webcam, but in a nice touch Lenovo also added a security-enhancing manual shutter that closes the eye of the camera and turns off the mic. This feature can ensure that the web cam is not-operational, eliminating... Michael

Many drugs that would benefit from transdermal delivery are either made of molecules too large to penetrate the skin or are hydrophilic and so don't absorb very well. To overcome these limitations, Purdue University scientists have created a pump to literally push drugs through microneedles of 20 micron diameter. The pump requires no batteries and is activated by pushing your finger against it for about twenty seconds. The pump contains a liquid that boils at body temperature so that the heat from a finger's touch causes it to rapidly turn to a vapor, exerting enough pressure to force drugs through the microneedles. The liquid is contained in a pouch separated from the drug by a thin membrane made of a rubberlike polymer, called polydimethylsiloxane, which is used as diaphragms in pumps. Researchers have filed an application for a provisional patent on the device. Ziaie has tested prototypes with liquids called fluorocarbons, which are used as refrigerants and also in semiconductor manufacturing. Press release: New pump created for microneedle drug-delivery patch... Michael

Moving MRI images of the heart and other organs are nothing new. However, up until now these were always reconstructed afterwards by combining signals and images from the same cardiac phase acquired during breath-holding into the resulting images. Researchers at the Max Planck in Göttingen have now proven it is possible to acquire images in real-time with up to fifty frames per second. Previously it was only possible to acquire images at a maximum rate of about one per second. They have used a combination of fast low angle shot (FLASH) gradient-echo imaging sequences, radial encoding and an iterative image reconstruction by regularized nonlinear inversion to greatly speed up imaging acquisition. The main improvement lays in the iterative reconstruction which has previously been used for reducing CT radiation dose, but has now shown to be very useful in MRI as well. For example, the images of a cross-section of the heart shown above were acquired at 33 milliseconds per image giving a framerate of 30 images per second, with an in-plane resolution of 1.5 millimeters and a slice thickness of 8 millimeters. Linked in the press release is a video of the beating heart and an impressive movie of movements during speech production. The possibility to do real-time dynamic imaging opens up a lot of new opportunities for MR imaging, including, for example, swallowing studies, cardiac and abdominal imaging without breath-holding and interventional procedures using MRI. In principle this technique is possible to implement on most current scanners, however the main limitation is the amount of computing power required to perform the real-time reconstruction. Currently one minute of images requires half an hour to process. However, the authors expect improvements in the image reconstruction algorithms for parallelized GPU's and other improvements to reduce reconstruction time and improve image quality. The results are published online in the journal NMR in Biomedicine. Make sure to check out this jaw dropping video: Press release: Going live to the beating heart... Article abstract: Real-time MRI at a resolution of 20 ms...... Wouter Stomp

Exmovere out of McLean, Virginia claims to have developed baby clothing that can monitor heart rate, "emotional state", and level of activity, and relay that information wirelessly to a computer or cell phone. Paranoid parents will be able to keep a virtual eye on their kids 24/7, and maybe worries about SIDS and infant sleep apnea can be diminished. An initial production of 1,000 units will be made available in 2011 to select customers. Company CEO David Bychkov announced that "Each Exmobaby onesie will come with a baby-safe, rechargeable Zigbee wireless transceiver that snaps into a pouch. From there, the data is transmitted to a nearby PC or cell phone in order to keep parents and other caregivers informed of a baby's status. This continuous monitoring in real time will allow for an 'emotional umbilical cord' between mother and child." Exmobaby parents will be able to see icons representing their baby's heartbeat, emotional state and activity level on their cell phones. This is especially important for first-time mothers re-entering the work force, parents concerned about the vigilance of their babysitter, and childcare centers juggling the needs of multiple children. Exmobaby will also become one of the first mainstream consumer products utilizing the Zigbee wireless standard. Zigbee is a standard using a WHAN (wireless home area network) and is targeted at radio frequency applications requiring lower data rate, longer battery life and network security. This is particularly well-suited for Exmobaby moms as it is cost-effective, reliable and compatible with a wide range of USB and mini SD-slot dongle devices, such as cell phones. In early 2011, Exmovere will begin its limited edition marketing campaign where it will release only 1,000 Exmobaby pajama kits, available in blue or pink, to select buyers from a waiting list. Included with these kits will be an Exmobaby garment set, one Zigbee transceiver, PC and cell phone monitoring software and six months of online service. Press release: With an Eye to New Moms, Exmovere Unveils Biosensor Pajamas for Babies... Michael

Welch Allyn, in an attempt to improve patient monitoring and record keeping, has unveiled the Connex Electronic Vitals Documentation System. The system revolves around the Connex Vital Signs Monitor 6000 designed in collaboration with frog design, a San Francisco-based product development firm. The Connex system automatically records data coming from various patient monitors and sends it to the Electronic Medical Record for long term storage. Additionally, it displays relevant information and can raise an alarm if trigger parameters are met. To give you a taste of how this system came to be, frog design has an overview on the company's blog outlining the design process. The Connex VSM (CVSM) is a full-color, touch screen device that acts as three devices in one—providing comprehensive patient documentation on a single display. This documentation includes automatic measurements such as heart rate, blood pressure, temperature and pulse oximetry; manual parameters such as respiration, height, weight and pain level; and modifiers such as body position, O2 therapy details and others. The CVSM also gives the clinician the ability to control alarms, patient data and monitoring in a customized manner for each patient, and they can document this data right on the device—eliminating the need to locate a PC and transcribe it later. The CVSM also enables two-way wireless communication from the bedside. It associates ID numbers to names to help clinicians properly identify patients and allows them to customize which ID fields are required and how they're displayed, including simultaneous display of multiple forms of ID. The wireless technology is built right into the system allowing the monitor to act as a true mobile device, and it works with current wireless networks to deliver up-to-date patient demographics. Press release: Welch Allyn Unveils Cure for Vital Sign Documentation Errors at the Point of Care... frog design: How to Build a Better Vital Signs Monitor...... Michael

Reader's Digest recently published an essay by Shannon Brownlee and Jeanne Lenzer about medical device dangers that manufacturers know about but don't properly publicize. In the end, the article calls for a registry of all medical devices in the US so all defects and problems can be tracked, something like the aviation industry's FAA database. Short of a registry, experts want to: * Require all cases in which a patient is seriously hurt by a Class III device to be reported to the FDA, not just those that the company decides are due to its product. * Create an independent panel to routinely monitor the MAUDE data-base -- and give the panel access to company data when there appears to be a problem with a device. * Stop payments, often called kickbacks, from device makers to physicians and hospitals in exchange for using the company's device. A Medgadget alumnus, now employed in the implantable medical device industry, wrote in with the following comment: As a guy employed by a medical device company I think It's a relatively fair shake, at least as well as you could hope for from Reader's Digest. Crafting a system to opening and accurately monitor medical device safety would be functionally impossible. We (device mfgs) are required to do root cause analysis on any adverse events already, but like the article says, we tend to keep it internal as long as possible. This means a team of engineers works their ass off to get to the bottom of things and writes up a report that is reviewed and signed off by management. Unfortunately, that takes time, and inside our corporate walls we have access to only the most basic clinical info on the patient (meds, other conditions, etc...but no direct access to "the scene of the crime"). On the clinical side, the MD's are welcome to come to whatever conclusion s/he feels like. Based on my experience in ortho, I've never seen a surgeon chalk up a complication to their own butterfingers (even when that's the case). The culture of MDs is to never admit weakness/guilt/failure/errors/lack of knowledge. I'm not saying there aren't reasons for this (patient/staff confidence, liability), but it's a reality. You'll never, ever hear a surgeon say "Yep, I messed that up". ...whereas the culture in engineering is the opposite. Improving on failures is our stock and trade. Thus, in an engineering root... Dan Buckland