Does Remote Patient Monitoring Require "Proof"?

Posted by Tim Gee on May 15, 2007 in Real Time Location Systems | 0 comments

Vince Kuraitus responds to my previous post, “Impact of Remote Monitoring Still Inconclusive,” and provides an impassioned case to move ahead with the deployment of RPM (remote patient monitoring).

Actually, his position is very similar to the physician's presenting at last week's conference on Rapid Response Systems (RRS) in Pittsburgh. Both RPM and RRS are poor subjects for traditional RCTs (randomized controlled trials). As one presenter stated, “the efficacy of system changes cannot be “proven” in a traditional sense.” Instead, like Vince, the conference's faculty appealed to common sense suggesting observational studies and looking for biological rationales. Evaluating the cost of adopting RPM is important, as is evaluating the cost of inaction.

In the comments to Vince's blog post Gordon Norman, EVP and Chief Medical Officer of disease management company Alere notes, “appropriate RPM, deployed for the right patients with certain chronic
conditions collecting suitable biometric and other data in
consumer-friendly ways can augment the effectiveness and efficiency of
DM programs.” Norman further observes:

Vince also summarizes his own favorite research studies on RPM in his post -  be sure to read the whole thing.

So What's Wrong with USB Connectivity

Posted by Tim Gee on May 11, 2007 in Real Time Location Systems | 0 comments

Reader Bernard Farrell (who's got a terrific diabetes oriented blog) ask about my recent slam on USB connectivity for medical devices.

Medical device connectivity is all about workflow, not just getting data out of a device and into some software application. At one extreme you have the user look at a device, manually record the data, go to an information system, pull up the appropriate patient and key in the data, indicating the time the data were “acquired”. This process is obviously labor intensive and prone to many types of errors.

The best kind of connectivity is that which becomes invisible, requiring the minimum intervention on the part of the user. The best connectivity at the present time is wireless where the user easily establishes patient context at the patient attached device. Data is then acquired automatically (the frequency and specific data elements) according to a predefined protocol or configured by the user. While attached to the patient, the device system manages the connectivity and patient context (not a trivial task in some use models) and notifies the user only when there is a problem requiring manual intervention. Finally, when the device is removed from the patient, the patient context and data connection are broken down, freeing system resources for other patients and connections.

USB connectivity is “crude” in that most of the manual steps outlined above are still manual; the USB only eliminates the need to manually record and enter data. The user must still be in the presence of the device to extract the data (via the USB drive), and must convey it over to the receiving computer, pull up the correct application, indicate where the data is to go, and properly identify the patient. The two problems here are staff productivity (and the likelihood that data collection will be late or not occur at all), and the risk of attributing the data to the wrong patient. Those are two big problems, both of which could result in an adverse event.

There are other forms of “crude” connectivity that suffer from similar productivity and safety problems. Connectivity that does not establish patient context in the patient connected device (common with serial interface connections) has patient identification risks. The device docking approach used by many point of care diagnostic devices runs the risk of delays in getting data into the chart – or possibly never getting into the chart. And wired connectivity of any kind is a frequent victim of forgetfulness, yanking sockets out of walls and/or damaging cables as devices are moved while attached to the network.

Connectivity also impacts the patient. Wearability, mobility, and patient comfort are affected by the quality of the connectivity implemented by a device. Poor implementations can result in false positive alarms, leads-off situations, and extra work and hassle toileting the patient. Even open heart patients are encouraged to start waking shortly after surgery, and a portable device that's not wireless is, well, silly.

To all of this, you can add my previous observations on the data security risks posed by USB connectivity. Pictured right is another snazzy USB drive, known as the stick.

CMS Set to Ratchet Down Home Health Reimbursement

Posted by Tim Gee on May 11, 2007 in Real Time Location Systems | 0 comments

The feds prepare the next phase in their transformation of the health care industry with the release of proposed new Prospective Payment System (PPS) rules published May 4th in the Federal Register (I found the proposed rule using the Justia search engine mentioned yesterday). The Home Care Automation Report reports:

I spent some time looking at remote monitoring and home health care delivery several years ago. The vast majority of home health care agencies were not interested in adopting point of care technology that was not reimbursed, regardless of how much it might improve productivity and lower costs. From my occasional exposure to this market since, that attitude has not changed much. It would seem that in the near term, home health agencies will have little choice:

Perhaps downward reimbursement rate pressures will spur technology adoption that will reduce the cost of care delivery – like remote monitors that cut down on required caregiver home visits – without CMS reimbursing for the actual use of the technology.

In a more, ahem, rational market, providers would be constantly innovating to reduce costs in light of capitated reimbursement. In fact some industries are quite adept at reformulating themselves in response to changing markets. To all of our frustration, health care is not one of those flexible and constantly changing industries. While the science of medicine is always innovating, the business of delivering health care has a strong aversion to change.

Pictured right are some of the ViTel Net home monitoring devices, shot at last summer's Healthcare Unbound conference in Boston.

Private Equity Will Hasten Health Care's Transformation

Posted by Tim Gee on Apr 17, 2007 in Real Time Location Systems, Remote Monitoring, Wireless Medical Devices | 0 comments

Tony Chen at the Hospital Impact blog has a great post on the tsunami of recent deals in health care. These deals are changing the health care industry. Outsiders in the form of private equity investors and insider hospital M&A are gobbling up failing organizations or those weakened by market changes for which they have ineffective responses. Newly recast ventures that are successful will reward effective change which will drive additional change.

The change required is not the simple head count reduction, and trying to figure out how to do the same old thing with fewer people. What is needed are fundamental changes to the way that care is delivered. These are the changes that will reduce length of stay and improve both patient safety and outcomes. Hospitals today are stuck between a rock and hard place – the rock is the inexorable reduction in reimbursement, and the hard place is the increased visibility and transparency surrounding patient safety and outcomes.

Here are a couple quick examples of the change I'm referring to. Almost every hospital boards patients in the emergency department (ED) to a greater or lesser degree. These patients, shuffled off to out of the way halls awaiting admission, are cared for by off-service nurses (ED nurses) at ever worsening – and sometimes hair raising – nurse to patient ratios. A few heretical hospitals have started boarding those patients awaiting beds up on the floors, on their service. Consequently, each nursing unit could have 1 or 2 extra patients – receiving appropriate care (because they're in the appropriate unit) and at a nurse to patient ratio that is only slightly impacted by a couple extra patients. To someone from another industry this makes admirable sense. From my peers, I've heard excuses ranging from “it's jut not done” to “we can't do it because of fire codes (or department of health regs, etc.)”.

The other example is variable acuity care delivery. Hospitals are organized into units that are specialized based on the level of care, nursing vigilance, therapies that can be delivered, and staff training. This regimented organization was used in manufacturing 20 years ago. Like manufacturing in general, manufacturing healthy patients is not a steady state process. Consequently, census in units varies wildly from unit to unit and day to day. Some units are habitually over capacity, and represent the most common patient flow bottleneck found in hospitals – those over capacity units are critical care units with patient monitoring. Variable acuity units are an analog to manufacturing clusters or pods where the physical environment is quickly modified to adjust to new requirements. Rather than transferring patients because of needed patient monitoring, or a more sophisticated therapy, those patients are kept in their unit and those resources are brought to them. Monitoring patients outside traditional monitored units is a growing trend – half of the telemetry transmitters in hospitals are used on non-cardiology patients. Implementing variable acuity care units is not easy; it requires some pretty fundamental changes.

So, how do you accommodate falling reimbursement and demands to improve patient safety and outcomes? The opportunities to improve operations are many, almost as many as the excuses used to avoid substantive change. As private equity and M&A roils the health care industry, smart people will ask the hard questions with increasing fequency, and change will come.

Pictured right, “resistance is futile.”

ED Diversion Continues to Challenge

Posted by Tim Gee on Apr 12, 2007 in Real Time Location Systems, Remote Monitoring, Wireless Medical Devices | 0 comments

The California Healthcare Foundation has underwritten a study looking at ambulance diversions across the state. Findings in this phase 1 report showed that state wide emergency departments (EDs) were on divert an average of 10% in 2005. Emergency department closings to ambulances continue to confound hospital administrators. You can read about a recent survey showing patient flow as an increasing problem here.

ED diversions also frustrate policy wonks and consultants due to the almost total absence of public reporting. Certainly hospitals (and their state associations), emergency response districts, along with some local and state governments, know their emergency room diversion statistics – they just aren't publicly available. Even though access to data is improving, organizations like the CHF have to pay to collect much of their data.

As expected, the study finds that ED diversions occur mostly in urban areas. Increasingly districts and hospitals are implementing “no diversion” policies – in other words they simply take the patients that they used to refuse – even though in most cases little or nothing has been done to improve emergency department overcrowding or patient flow.

You can download your version of the first report here.

Medical Devices and Electromagnetic Interference

Posted by Tim Gee on Apr 11, 2007 in Patient Safety, Real Time Location Systems, Standards & Regulatory | 0 comments

The delivery of health care is an inherently mobile activity, with patients moving though the care delivery process and almost all health care workers in constant motion. So it's no wonder that wireless technologies have been adopted with gusto.

Electromagnetic interference (EMI) has been a concern with medical devices since their inception. This EMI can be divided into intentional and unintentional interference. Intentional interference typically comes from radio frequency (RF) radiators like walkie-talkies, wireless phones, WiFi radios, and cell phones that use frequencies and specified power levels that may interfere with the operation of other radios or electronic devices. Unintentional interference is caused by things like paper shredders, bad florescent light ballasts, and noisy electric motors (from blow dryers to elevators).

Any electronic device can be affected by EMI, including medical devices. The wireless features of medical devices (or any other wireless device, for that matter) can also be affected. The larger medical device vendors have dedicated engineers and techs who do EMI testing and troubleshoot interference problems at customer sites.

In an effort to promote best practices regarding the use of mobile wireless communications and computing technologies in health care facilities, standards committees TC 215 and ISO 35.240.80 have created recommendations for
electromagnetic compatibility (management of unintentional
electromagnetic interference) with medical devices. Here's the abstract:

You can buy your copy of the standard for a mere 132.00 Swiss Francs here. The Medicines and Healthcare products Regulatory Agency (the Brit's equivalent to the FDA) has free recommendations based on the standard here. And you can read a paper on cell phone use in hospitals from last fall here.