Boston Sci Braggs on Wireless Latitude Patient Management System
Boston Scientific announced this week the release of data from the first 10,000 patients enrolled in their RAPID-RF study. Of course the announcement is everywhere – the actual data is no where to be found (perhaps the results printed on dead trees are available at the Heart Rhythm Society meeting this week).
The idea here (pioneered by Biotronik, by the way) is that wireless connectivity can be used to communicate clinically significant events to the physician between pacemaker clinic follow ups. Theoretically this informaiton could trigger interventions before regularly scheduled follow ups that can result in better patient care and outcomes. From the press release:
Of the 56,000 monitoring months included
in the 10,000-patient population over a mean follow-up of five months,
the LATITUDE Patient Management system detected 597 patients with
sustained atrial arrhythmias for more than 24 hours and 968 patients
who received shock therapy for spontaneous ventricular arrhythmias.
“The ability to detect and notify clinicians of these types of
events sooner can impact patient outcomes,” said Leslie A. Saxon, M.D.,
Chief of the Division of Cardiovascular Medicine, University of
Southern California, and national Co-Principal Investigator for the
RAPID-RF Study that is characterizing types of clinical event
notifications and interventions with the wireless system. “For example,
patients with atrial fibrillation, particularly those with heart
failure are at risk of stroke. Early identification of this arrhythmia,
which may be asymptomatic, enables physicians to intervene with
treatments to mitigate this risk.”
So apparently the benefits of notification of clinicians before regularly scheduled follow ups is still theoretical. Boston Scientific goes on to brag, “Boston Scientific has the only remote patient
management system that is capable of monitoring virtually all its
implantable cardioverter defibrillator (ICD) and cardiac
resynchronization therapy defibrillator (CRT-D) patients between
follow-ups, and alerting physicians to important clinical events
through either wireless or wanded technology.” While this carefully worded run on sentence may be literally true, Biotronik and Medtronic both have similar wireless capabilities. And St Jude announced yesterday their newest ICD and CRT-D devices that include limited wireless capabilities:
CRT-D devices (with radiofrequency telemetry) have just received
European CE Mark approval. RF telemetry enables secure, remote
communication between the implanted device and the programmers in a
clinician's office. Wireless communication occurs while the device is
being implanted and when patients see physicians for follow-up visits,
allowing for safer, more convenient care and device management. The
feature is currently under review and is pending U.S. regulatory
approval.
Pictured right is Biotronik's CardioMessenger, the first with a wireless gateway for transmitting data inside and outside the patient's home.
[Hat tip: Wireless Healthcare]
Biosign Reports Study Results on Continuous Glucose Monitoring
Wireless Healthcare reports that startup Biosigns Technologies successfully validated the accuracy of their noninvasive continuous glucose meter in a study including 120 participants with blood glucose levels ranging between 3.5 and 27.4 mmol/L. The Biosign device, called the UFIT, also measures heart rate and blood pressure, but the released study results do not include accuracy data for those additional parameters. The unit is apparently part of a wireless remote patient monitor, providing access to patient data for patients, physicians, pharmacists, insurers and pharmaceutical companies.
UFIT(R), which uses a non-invasive, web-enabled device that straps around a patient’s wrist, responds to the need for an easy-to-use self-monitoring system that reliably and simultaneously captures key data on heart and blood, including heart rate, blood pressure, blood oxygen and blood glucose. The system is intended to optimize the management of chronic diseases such as high blood pressure, heart disease and diabetes.
The developments at the MeMeA workshop represent important steps in enabling UFIT(R) to comprehensively serve the multi-billion dollar personal health monitoring market. Ninety percent of chronic disease management takes place in the home.
Uh, actually the personal health monitoring market is not a multi-billion dollar market, since there’s no reimbursement for the kind of monitoring Biosigns describes. But the device sounds pretty cool.
This Biosign-sponsored study assumed that the arterial pulse, a rich source of clinically relevant information (e.g., rate, rhythm, pattern, pressure and oxygen), could also provide information on blood glucose.The study gathered glucose measurements from 120 participants with blood glucose levels ranging between 3.5 and 27.4 mmol/L.
The results show a tight statistical correlation (0.998, Pearson substantial equivalence) between UFIT(R) and laboratory analysis of blood glucose, with a low (1.63%) average of the mean percent difference between the UFIT(R) measurements and the laboratory analysis. The correlation was obtained post-hoc by comparing a feature extracted from the radial artery pulse with laboratory blood glucose data. The methodology resembles that used to correlate HbA1C with the direct measurements of glucose in drawn blood.
There is no discussion of the number of samples compared to the UFIT sensor. Sorry, no photos could be found on the device – perhaps someone can send me one?
UPDATE: Reader Bernard Farrell points us to this site, that offers some background info and a pessimistic assessment of the Biosigns technology.
Nursing Shortage Inspires Legislation
Health Affairs reports on nursing issues – the House of Representatives is looking to enact the Safe Nursing and Patient Care Act of 2007 (H.R. 2122) to limit the amount of mandatory overtime a nurse may be required to work.
According to CQ HealthBeat, Stark said, “We limit the time that truck drivers and pilots can work to protect public safety,” adding, “Safe nursing is in the public interest as well.”The bill cites as evidence, a study published in Health Affairs [free access] which found that nurses who worked shifts of twelve and a half hours or more were three times more likely to commit an error than nurses who worked standard shifts of eight and a half hours or less. The bill was co-sponsored by Reps. Steven C. LaTourette, R-OH, and Jan Schakowsky, D-IL.
Health Affairs also has a new article that reviews surveys of nurses, physicians and hospital execs on the US nursing shortage and patient care.
“Most respondents found that the major effects of the nurse shortage to date have been in the areas of communication, nurse-patient
relationships, hospital capacity as measured in the management of bed availability, and quality of care, reflected by timeliness, efficiency, and patient-centered care.”
You can read an abstract here; full text for a mere $12.95.
New Regulation Tracker
There's lots of good news today, so let's get started. In fact there's lots of good news almost every day – but who's got time? I try my best to drink from the fire hose of news when I can. And one area that I've avoided all together is the content that's published every day in the Federal Register. You know, all the advisories, new regulations, proposed rules, etc. that is placed in the public domain via the Federal Register.
Well now there's help. The Justia Regulation Tracker web site has a search engine for the Federal Register and an RSS feed. I've loaded the RSS feed into my NetVibes page, and I'll be adding a link to the Justia site under the Resources tab, Important Reference Web Links.
Now you too can sip along with me from the fire hose of regulatory ephemera – what fun.
[Hat tip: Healthcare Law Blog]
