Running Medical Device Software on Shared Computers
The following question came up on the biomed listserv:
Has anybody wrestled with the idea of placing patient-care applications on the laptop COWs (Computers on Wheels) in Hospitals?
There is a new series of USB-connected Ultrasound transducers that can do many ultrasound procedures, including Bladder Scanner functions. It operates on any laptop, when loaded with the manufacturer’s software. I can foresee many other patient-care functions vying to share the computers already in the patient vicinity.
Any guidance on this subject?
Here’s my reply:
As others have pointed out, you are right to be concerned about the safety of mixing regulated medical device applications and applications from any other source on the same computer. Moving forward without the proper information does expose your hospital to additional risk. At minimum you may be using the device “off label” if you unwittingly fail to follow the manufacturer’s instructions. (Note that the FDA’s interest in “off label use” centers on patient safety, where manufacturers may promote products for uses they were not designed and tested, or when manufacturers make an application with an easily cleared intended use knowing the market will buy and use the product for a more difficult intended use.)
You will need some information from your medical device vendor with the USB scan head and associated software.
Questions on General Purpose Computers
How specific are their specifications for the computer (hardware configuration, operating system, any additional libraries or applications) that is used to run their medical device?
Regardless of how specific their specifications may be, you must use and maintain your system (the USB scan head heads, application software and general purpose PC) in accordance with the vendor’s directions for use, or you will be using the system “off label.” The actual specifications can be high level, indicating a PC of any make or model as long as it includes a specific processor class and minimum speed, and meets minimum required memory and disk space, and a minimum version for the operating system. Alternatively, the vendor may be obsessively specific, calling out computer manufacturer and model, the specific CPU, the required version of BIOS, and even specific versions of operating system components.
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.
