Medical Device Communications, Technology Management and

Manufacturers TodayJohn Rhoads, PhD

Interoperability and Standards ArchitectPhilips Healthcare, CTO Office, Patient Care and Clinical

InformaticsJune 2, 2012

CE-IT Session at AAMI Convention

Prospect

• How medical device communications needs to change to further contribute to better clinical outcomes

• How medical device communications needs to change to help your technology management

• How you can be influential in the way this is done

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Improving Clinical Outcomes

• Medical device data are an aid to the practice of medicine

• JOB ONE of medical device design has always been, and always will be, achieving safety and essential performance in the operation of the device itself

• Communicating the potentially valuable data from the device has been relegated to a lesser role in the past, but it is being recognized as truly important

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• Proposition 1: clinical situational awareness is key to outcomes

• Proposition 2: automated recording and dissemination of device data extends clinician awareness and helps with distracting and time-consuming documentation tasks

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Benefits to be hoped for from standards-based communications

• Barrier-free flow of information to where it's wanted, when it's wanted

• devices and systems more substitutable• enables freer "best of breed" selection• composable - systems can freely include

more kinds of devices and decision support resources

• clinical decision support algorithms can take account of more physiological signs

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What else besides surveillance and documentation?

• ASTM Integrated Clinical Environment, IEEE 11073 Medical Device Communications, HL7, IHE PCE

• ICE: focus on integrating heterogeneous systems of systems including command / interventional functions going out to therapeutic devices

• IEEE 11073 Medical Device Communications: focus on fundamentals: nomenclature, domain information models

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IHE Patient Care Devices

• Distributed event processing, including distributed alarm systems

• Point-of-care identity management – strengthening the bond between the data and the right patient

• Detailed specification of data exchanges for particular kinds of devices (ventilators, infusion pumps, pulse oximeters)

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Uptake has a long way to go

• When you look at real hospitals, automated charting of physiological indicators is mostly in the future

• Per HIMSS analytics 2010 study, 74% of hospitals don't have automatic data charting of monitors, and for other devices the figures are lower, often much lower

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What if device communications gets in the way of safety and essential

performance• For some devices, are communications

funtions dispensable?• If implementation of communications an

afterthought, it may not reach industrial strength

• Bad design flaws, e.g. single-threading or insufficient computing resources to do what needs to be done are a real threat

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One approach: isolation

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• One powerful processor for monitoring functions with real-time operating system

• Another powerful processor is a Windows PC available for, for example, CDS algorithms

Clinical Decision Support

• From just the facts, to higher order pattern recognition

• Example: smart alarm processing – does the total picture suggest that this is not really a situation requiring human attention

• Example: algorithms that assist early detection of problems (Protocol Watch to help track Surviving Sepsis Campaign guidelines)

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Medical equipment management

• Medical devices cannot make their best and most efficient contribution to clinical outcomes if it is too difficult and unreasonably labor-intensive to keep the equipment operating safely and reliably

• Chances are most institutions are not enlightened enough to give you a big increase in CE workforce…

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IHE PCD is working on MEM, but it is a struggle getting volunteer CE

collaborators• Uncle Sam wants you• No need for a heavy commitment – we’ll

accommodate you. Just stating your wants and ideas is great. If you want to offer spec-writing expertise, fantastic. You can have fame and fortune in the glamorous world of standards. Well, OK, maybe that’s slightly overstated…

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How to have influence

• Learn what is there and what is coming• Educate your colleagues (fellow CEs of course

but also other hospital functions)• Make your vendors know your expectations• Influence procurement specs to take account

of device communications• Jump in and participate in standard and

profile development – your input is needed!

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