Market Trends Series #2: Patient Safety
This is the second post as part of an ongoing series that discusses the market trends that are affecting the evolution of medical device connectivity (MDC) technology. I received some good comments from my previous post – please consider sharing your thoughts, ideas, and experiences.
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.
It’s All About Workflow
Okay, it’s not all about workflow, just mostly, as you’ll see.
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.
First Ever Medical Device Connectivity Conference
Can you believe it? Connectivity started in the 1980s, and it’s taken over 25 years for the first medical device connectivity conference to be held. I am fortunate to be serving as the program chair for the conference, responsible for the topics covered and finding speakers (you can download a program here — pdf). Unlike other conferences that address connectivity as one of many issues, this meeting is all about medical device connectivity. This is the first of what will be an annual meeting delving into connectivity in depth, tracking changes over time.
Here’s an overview of the agenda:
- Define and frame medical device connectivity for this event
- Industry standards
- Regulatory issues
- “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.
How Medical Device Connectivity Can Improve Outcomes in the SICU
In this article I will walk through typical decision-making processes within the surgical intensive care unit (SICU) related to respiratory weaning in order to highlight the key requirements associated with that area and to illustrate the importance of medical device connectivity in acute care environments as a necessary adjunct and enabler for complete documentation and clinical decision making at the bedside.
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.
GlobeStar Systems World Connex — Day One
I’m at GlobeStar System’s annual user group meeting this week, in Lisbon, Portugal. Attendance is about 150, equivalent to last year’s meeting.
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.
Medical Device Open Source Frameworks
The Big Picture
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.
