With all the buzz about a national health IT infrastructure, electronic health record interoperability, and standards, increasing focus has come to the medical device connectivity standard known as IEEE 1073.

Efforts to create a medical device connectivity standard go back to Hewlett Packard and the Medical Information Bus, and its evolution into the IEEE 1073 standard. The 1073 effort has been ongoing, in one form or another, since the 1980s and is now known as ISO/IEEE 11073. The group has done some very valuable work, exploring the requirements and structures for a medical device connectivity standard. Politically, 11073 has made great progress. The standard has been adopted as part of the Consolidated Health Informatics initiative, and is included in the Certification Commission for Healthcare Information Technology electronic medical record certification process. The standard is also the principal standard used by the Integrating the Healthcare Enterprise patient care device committee.

Despite all this, 11073 has not been able to generate meaningful adoption by the industry. The only vendor I know that has adopted 11073 is Philips, and its implementation is limited. It seems medical device vendors prefer proprietary architectures that lock in customers by erecting high changing costs. An increase in customer choices created by standards-based interoperability is inconsistent with traditional industry strategy. According to health care providers that I have talked to, the current standard suffers from too much complexity.

Medical device connectivity is certainly complex. The foundation involves establishing and maintaining patient context, making sure the right data is reliably associated with the correct patient. This seemingly simple requirement varies greatly based on how things are connected (RS-232, Ethernet, WLAN, etc) and the use cases involved (roaming device with multiple patients, continuous patient connection). In addition, each class of medical device has its own specific workflow to automate. Infusion pumps have to deal with the drug-delivery process; ventilators have their own therapies to support. Patient monitors share requirements for surveillance and alarm notification with both infusion pumps and ventilators. On top of all this, there needs to be a messaging system that ensures that the right data message gets to the right person or system. And behind the scenes, some sort of “flight recorder” to provide feedback is needed. Oh, and of course, caregivers (not to mention IT) would like one system that supports all the devices on their unit, not a different system for each type of device.

One difference I see between 11073 and the evolution of digital imaging and communications in medicine (DICOM) is the lack of facilitators. Back in the early 1990s, companies like DeJarnette and Merge Technologies provided software tool kits that most vendors used to implement DICOM. An extension of software libraries included products like the MITRA broker that provided DICOM interoperability services between modalities and information systems. If there are 11073 facilitators out there, they are well hidden.

The other day I stumbled across an interesting paper about developing standards. Standards are developed in two ways: They either formalize existing practice, or they invent new practice without experience. By necessity, the long effort of 11073 has been inventing new practice, blazing a trail for the industry. The author of this paper used CORBA as an example of why standards tendto be more successful when they formalize existing practice rather than invent new practice.

While the medical device industry has looked to purpose-built connectivity solutions like 11073, general-purpose computing technology has evolved considerably. Today’s networks with SNMP and QoS, and software technology like SOAP and XML, make it possible to implement connectivity using existing IT standards rather than a purpose-built standard. Both health care IT and medical device vendors are currently building connectivity based on existing IT standards. Companies like Cerner, Cardinal, Emergin, and others are pushing the boundaries of connectivity and workflow automation without 11073.

So, is 11073 a viable standard? A lot of great thinking has gone into 11073. But what is needed now are facilitators—some way to make adoption easy. Otherwise, these de facto IT standards will proliferate, and over time we will end up formalizing what becomes existing practice.

Tim Gee is principal of Medical Connectivity Consulting in Beaverton, Ore. For more information, contact us at [email protected].

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