There is little question the workflow automation and intelligence offered by interconnecting medical devices can improve patient safety. There’s also little doubt that there is significant market demand for such solutions.  For example, if hospitals could purchase PCA pumps and SpO2 monitors that were interoperable, i.e., the monitor could suspend drug delivery at the first indication of respiratory arrest, such a capability would quickly become a standard of care. Interoperability is a huge opportunity.

There is no doubt that there are unintended — and in some respects, unregulated by the FDA — systems of systems made up of medical devices  sold and in use by health care providers. At the most basic level, there are medical devices with serial ports that were never intended to provide connectivity (or Medical Device Data Systems as the FDA called them in a draft rule issued almost 2 years ago). At the other extreme, you have systems like closed loop infusion therapy delivery, made up of components that are both regulated and unregulated, and that were originally developed with little or no thought to the demands of interoperability. This is a problem.

The FDA’s been interested in this area for some time. Way back in 2005, the FDA held a workgroup to discuss the system of systems issue regarding networked medical devices (see the blog posts here, here and here).  The outgrowth of this meeting was IEC 80001, which is scheduled to be completed this year. In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on how to apply the Quality System regulation to wireless medical devices. (I can’t help but wonder why this is still a “draft” guidance.) Also back in 2007, the FDA provided a rather limp statement on interoperability at the 2007 conference on Medical Device Interoperability and High Confidence Software (see the posts in this search). (Offered as the first example of the FDA’s interest in interoperability is their dubious buy-in to the questionable patient safety benefits of new medical device unique device identification requirements was not inspiring — more here.) (more…)

Evidence of all of this can be found by looking back at the past 10 or more years and examining typical implementations of biomedical device connectivity to information systems.

•    Most implementations up to now have been in very specific care areas such as the ICU and OR.

•    Most implementations are relatively small in scope, often in the area of about 20 to 50 beds. Incidentally, for most US hospitals this happens to be about the same number of ICU beds per facility.

•    In the ICU, the key devices that are interfaced are typically multi-parameter patient monitors and sometimes ventilators - but vents to a much lesser degree than monitors.

•    In the OR, the key devices are typically patient monitors and anesthesia/gas machines.

•    Outside of high-acuity care areas, in the general ward there are some limited niche interface solutions for mobile vital signs data capture. Many of these are only semi-automated in terms of truly automating both the data capture and the clinical workflow.

•    For virtually all of these implementations, the data collected from the devices is identified though a mapping of the medical device’s location – that is a bed or room location identifier is used to associate the data and alarms.

•    The device workflow - that is the steps clinicians are required to perform at the bedside to interact with devices to establish connectivity – has been limited. This is because most of the devices are actually fixed to the location – i.e. the monitors in ICU are mounted to the wall and data is interface via a networked gateway with outbound HL7.  Therefore few if any steps are required by clinicians because the devices are permanently tethered to a local PC or terminal server that facilitates the data collection.

But as discussed in some of my previous market trends postings – requirements for connectivity have been changing and in some not so subtle ways. Many hospitals are (more…)

The second trend I’d like to discuss is the shift towards patient safety as one of the key market drivers for connectivity. It is probably not news to anyone that patient safety has become one of the key drivers for many healthcare IT initiatives. But what is the relationship between patient safety and MDC? Ever since the often referenced IOM report, To Err is Human: Building A Safer Health System, hospitals and vendors alike have increased their focus on driving towards significant reductions in medical errors. The industry as a whole has made great strides, but still lots of work remains.

With device connectivity, my experience has been that for at least the past 15+ years, the key driver has been making the nurse more efficient by eliminating the manual transcription of device data into the patient’s chart. One of the related benefits is a more come complete and legible patient record. However, one could argue that the more legible patient record could be achieved if the vital signs from medical devices were simply typed into the charting application manually (something that many hospitals are actually doing today). So I believe that the nursing efficiency argument holds as the primary driver – but that is starting to be challenged by the focus on patient safety as it relates to connectivity.

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A while back Ann Farrell was nice enough to bring an interesting paper to my attention. Titled, “Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes, and Threats to Patient Safety” the paper is a fascinating read for several reasons. The authors studied barcode medication administration systems (BCMA) at 5 hospitals, and identified 15 types of workarounds and 31 types of causes of workarounds. This paper provides the most detailed and comprehensive description of product and implementation shortcomings centered on the point of care that I’ve ever seen. It’s devastating. Really.

So what’s this got to do with medical device connectivity?  Two words: workflow and barcodes. Medical device connectivity is the automation of workflow through the integration of medical devices and information system. Likewise, BCMA is the automation of workflow through the use of auto ID (barcode labels and scanners) and information systems. With connectivity, attention centers on the connection; with BCMA, attention centers on the barcoding. Where should the attention be focused? Workflow.

Workflow is the Rodney Dangerfield of point of care systems. Everyone, manufacturers and clinicians both, focus on the tangible stuff, like serial cables and network connectivity or barcodes and readers. The invisible stuff, like water is to fish, is the workflow that occurs at the point of care. There are two key workflow data points that are required for a well designed product. First is capturing the complete workflow process in which the technology solution is to be used.

Framing the workflow should extend beyond the scope of the actual product, so that everything flows well at both the initiation and end of the workflow. Whether you’re a provider looking to define requirements for a vendor selection process, or a manufacturer developing a new product, use cases are an ideal tool for capturing workflow. Use cases are easy for non-engineers (product managers, application specialists, clinical analysts) to understand and use and can be structured to provide engineers with something that can easily be translated into software specifications. (more…)

Here’s an overview of the agenda:

• Define and frame medical device connectivity for this event
• Industry standards
• Regulatory issues
  • FDA’s proposed MDDS rule
  • IEC 80001
• “Systems of systems” patient safety issues
• A review of the real costs of connectivity

Day two is divided into three tracks:

• Infrastructure, especially converging medical device and enterprise networks
• Connectivity solutions, a review of the most common connectivity applications (it’s not just about EMR integration)
• Clinical and workflow impacts of connectivity

Friday afternoon, there are two great post-conference workshops. One workshop delves into Distributed Antenna Systems (DAS), describing best practices for the selection and implementation of DAS. The second workshop is for providers and manufacturers getting ready for IEC 80001. You are getting ready, aren’t you? This workshop details the standard’s requirements with special focus on the risk management process that’s at the heart of IEC 80001.

The conference well be September 10 and 11 (Thursday and Friday) in Boston, at the Joseph B Martin Conference Center at Harvard Medical School. This is a pretty snazzy venue, as you can see by the photo. (more…)

Acquiring Medical Device Data is Key to Clinical Decision Making

Medical device connectivity in the ICU is essential to supporting a complete clinical decision support framework. While electronic medical records in and of themselves offer enormous workflow benefits, the documentation and charting systems are only as good as the data they convey.

Due diligence by care providers can be augmented by automated and validated data collection, achieved through a seamless form of medical device connectivity and interoperability that is supported both inside and outside the enterprise, and follows the patient from the home to the hospital. Yet, as we know, human beings are complex systems of systems.

Decision making in the healthcare enterprise is often made on the basis of multiple parameters and in the context of the patient presentation, setting, and specific conditions relating to the reason for hospitalization and procedures. The data used in clinical decision- making originates from many sources: devices in and around the patient, laboratory and blood tests, films, and ancillary information available both prior to and during the encounter. How often should data be collected? The assessment of clinical needs change depending on the acuity of the patient and conditions present at the point of care. (more…)

The messaging middleware market is transitioning from middleware to an enterprise application. GlobeStar has been in the business just over 10 years. Unlike Emergin, who started in paging messaging,  GlobeStar got their start in the 1990s integrating Austco nurse call and Nortel’s Companion (the first wireless phone system in North America). Over the years, the company (and the market) have evolved from a single nurse call/phone integration to a platform supporting many different systems and devices both on the input and output sides — and incorporating workflow automation through rules, alert initiation, and escalation.

The conference kicked off with introductory presentations from David Tavares, CEO of GlobeStar; Dr Teresa Sustelo, President of Centro Hospitalar de Lisboa Central (a large multi hospital system); and Dr Miguel Correia, Regional  Secretary of  Health, Azores. During his opening remarks, Miguel Correia noted the broad applicability of improved messaging. He spoke to the extension of messaging systems to tracking and eventually orchestrating complext processes and tasks. This is a vital requirement in health care delivery.

GlobeStar’s technology has been applied outside health care too. They monitor automobile painting production lines and “man down” systems in mining. Miguel Correia mentioned that they’re using ConnexAll in CO2 monitoring at volcanos in the Azorres. Now they’re moving further into workflow automation.

Keynote Presentation

My keynote presentation theme was, “everything is connected” and contrasted this with provider’s tendency to only focus on the immediate problem — or what they think is the problem.

Putting the health care IT market aside, the point of care market is divided into 6 separate market segments: wireless phones, patient flow applications, medical device connectivity, messaging middleware, nurse call, and real time location systems (RTLS), not to be confused with indoor positioning system infrastructure vendors like Sonitor and CenTrak. For some time, buyer’s haven’t been able to buy a product from one of these segments without impacting one or more of the others. Connections to medical devices, and the nurse-to-patient assignment process are common points of contention.

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Medical device interoperability and standardization is a hot topic, and with the efforts surrounding adoption of the 11073 standard, IHE and patient care device frameworks, and the drive towards implementing electronic medical records, the field has become essential to the future of the healthcare industry. Yet, as we look to realign medical devices and their communication mechanisms away from proprietary intercommunication and towards standards-based communication, we should think “outside the box” to other fields, technologies and technical disciplines for inspiration and guidance on best practices. Perhaps an obvious one that comes to mind is the USB 2.0 standard. The simple idea being proffered is the ability to plug a medical device into a computing platform and have it recognized and joined automatically to the operating system. While we are a long way from this vision as a universal standard, there is ample evidence to demonstrate its feasibility in the existing Windows and MAC OS architectures today.

Driver Bundling

Key to the seamless and universal use and acceptance of USB devices is the bundling of device drivers delivered as part of base operating systems. When a new device is developed, it could be adopted for incorporation within the base Windows and Mac operating system environments. However, even before that adoption, manufacturers of these drivers could consider bundling them as part of hardware delivery. The drivers could be installed at run time or prior to usage and, from there, no other special attention would be required: attaching a medical device to an accompanying computing platform would automatically result in that device “joining” with the base operating system. The challenge, of course, is how best to develop drivers that support consistent and common access to data. While the common Patient Care Device (PCD) framework fosters such an idea, it has yet to be realized as a universal standard.

One theme embodied by the IHE medical device connectivity demonstrations featured at HIMSS 09 (pdf) in Chicago was that of following a patient from admission through a critical care room, in which patient information was gathered at the bedside from and to the various medical devices present there, including infusion, bed, monitor, and mechanical ventilation. The ability to collect and integrate these data into a bedside electronic health record was accomplished in concert among the several medical device manufacturers through access to the communication frameworks peculiar to the many vendors participating in the demonstration. The bundling of device drivers and publishing of a common syntax required to communicate with the various devices could provide a starting point for enabling universal biomedical device communication.

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]]> http://medicalconnectivity.com/2009/04/16/medical-device-open-source-frameworks/feed/ http://medicalconnectivity.com/2008/12/09/managing-patient-context-for-bedside-medical-devices-todays-situation/ http://medicalconnectivity.com/2008/12/09/managing-patient-context-for-bedside-medical-devices-todays-situation/#comments Tue, 09 Dec 2008 23:34:00 +0000 Brian McAlpine http://medicalconnectivity.com/2008/12/09/managing-patient-context-for-bedside-medical-devices-todays-situation/ Clinical users have been managing patient context in various ways with medical devices for many years. With some classes of medical devices, this is nothing new.  So you might ask — what is the big deal here with patient context and what has changed that makes this topic relevant today?

As I stated in a previous post, managing patient context is all about the clinical workflow.  My working definition of patient context for medical devices is the linking of any information produced by a medical device (including data parameters, alarms, control settings, waveforms, etc.) with a specific patient identifier.

From a patient safety perspective, the best way to establish patient context is to tag data leaving a medical device with a unique patient identifier. And ideally this should be performed at the patient’s bedside where devices can come and go. There is clinician workflow associated with managing patient context - and this is perhaps the most important aspect.

We live in a dynamic world where technologies, products, and user requirements are constantly evolving. Take wireless medical devices for example. Wireless has evolved over the past few years and adoption will increase for the foreseeable future. When connectivity is wireless, patient context becomes even more challenging.  Another example is with the evolving requirements for automatically integrating device data in to an EMR. The EMR market is moving beyond relatively simple patient monitoring vital signs interfaces and is now looking to integrate all bedside device data including smart pumps.

If you look at what is quickly evolving at the point of care today, patient context is becoming more of a challenge for vendors that manufacture the medical devices and as a result, end users (clinicians) are being asked to perform the task of establishing patient context at the point of care. So let’s look at how patient context is currently managed (if at all) and the impact on workflow. (more…)

]]> http://medicalconnectivity.com/2008/12/09/managing-patient-context-for-bedside-medical-devices-todays-situation/feed/ http://medicalconnectivity.com/2008/11/06/why-wireless-connectivity-is-different/ http://medicalconnectivity.com/2008/11/06/why-wireless-connectivity-is-different/#comments Thu, 06 Nov 2008 17:46:18 +0000 Brian McAlpine http://medicalconnectivity.com/2008/11/06/why-wireless-connectivity-is-different/ Wireless changes everything …

I have been watching the evolution of wireless bedside medical device connectivity for several years now. It is now fairly common for medical devices to communicate wirelessly and most hospitals now have the requisite Wi-Fi networks installed and operational. In fact, the saturation point of WLAN adoption in US hospitals has been reached as the numbers are quickly approaching 90% of all US hospitals.

But this posting is not about Wi-Fi or other wireless technologies used in medical devices. Rather it is about additional connectivity considerations beyond the actual wireless connection of the device to a network. Regardless of the wireless connection technology or standard used, wireless changes everything when it comes to connectivity.

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