Association for the Advancement of Medical Instrumentation

January 2005, Vol. 40, No. 1

A broad consortium of medical interests has joined forces to develop an open networking standard for communication and control of medical devices.

Led by representatives from Boston-based Partners Healthcare and Kaiser Permanente in cooperation with the FDA, other health care professionals, and the U.S. Department of Defense, the group plans to incorporate existing interoperability work where possible and to develop new tools where necessary, in order to produce and implement an integrated “plug and play” medical device open networking standard within three years.

“The concept is that individual medical devices would be networked to allow the communication of data from one device to the other and the control of one medical device by another, as well as allowing the implementation of clinical rules or guidelines,” explains Julian M. Goldman, MD, of Massachusetts General Hospital, principal investigator for the project.

Such a standard would “help address the goal of integrating patient monitoring with clinical decision systems and electronic medical records,” according to Jennifer Jackson of Brigham & Women’s Hospital. “Once the medical devices know how to talk to each other, then the devices will also be able to communicate with networked information systems.”

Some clinicians have long understood the need for connectivity of medical devices. Goldman offers an example from the operating room: During a laparoscopic procedure, the surgeon and the anesthesiologist must carefully orchestrate monitoring with insufflation of the abdomen. “Here’s a teamwork issue that requires clear communication with complex activities that are interdependent—and if there’s a lapse anywhere along the way, it could cause a very serious patient problem.”

The high-reliability information systems, advisory alarms, and safety interlocks of commercial aircraft are examples of what is needed in health care settings, according to Goldman. “In medicine, we have not had the opportunity to have creative, intelligent problem solvers try to apply some of the same ideas and solutions [used in aviation] to medicine because we don’t have the infrastructure for them to create those things,” he says.

Richard Schrenker, systems engineering manager for the Massachusetts General Hospital (MGH) Department of Biomedical Engineering, also believes that plug-and-play interoperability is long overdue. In the past, plug-and-play standardization has “suffered from a Catch-22,” says Schrenker: Manufacturers didn’t develop standardized medical device communications because there was no demand for them; health care providers didn’t demand them because they couldn’t envision the problems the technology would address.

Schrenker hopes that projects like the “Operating Room of the Future” (ORF) at Massachusetts General will help to remedy this situation. In this “living laboratory,” clinicians explore new technology platforms and systems of care for performing minimally invasive surgical procedures. The plug-and-play group convened two summits in 2004 to begin the process of developing technical and clinical requirements for a bus-independent standard for devices in the ORF.

Plug-and-play leaders are currently working through the Center for the Integration of Medicine and Innovative Technology (CIMIT), a Massachusetts-based non-profit consortium of institutions including Massachusetts General Hospital, Brigham and Women’s Hospital, Massachusetts Institute of Technology, Draper Laboratory, Beth Israel Deaconess Medical Center, and Children’s Hospital Boston. The consortium brings together clinicians, scientists, engineers, and industry to focus on solutions to perplexing health care problems.

Industry partners, such as LiveData, Inc. of Cambridge, MA, see the potential of plug-and-play integration to “deliver functionality and efficiency” in a cost-effective format. “In the end, it’s about providing solutions so that clinicians can do their jobs better—improving patient safety and patient care,” says Phil Brzezinski, vice president of Health Care Systems for LiveData, maker of an electronic whiteboard being used to display patient data in the ORF.

According to Goldman, those who have previously tried to develop a standard failed to bring in several critically important stakeholders, such as the FDA, early on—making it difficult to achieve forward progress. This time around, representatives from the FDA’s Center for Devices and Radiological Health (CDRH) have joined the discussion from the beginning.

“The FDA supports the development of a medical device control and communication open networking standard. This represents a new challenge with a need to assure patient safety while incorporating new technologies,” explains Sandy Weininger, PhD, a senior biomedical engineer at CDRH.

According to Weininger, FDA has “partnered with the project team” to bring the concern for patient safety up front in the design process, to offer assistance in using a systematic development process, and to offer engineering expertise in relevant technologies—such as human factors, risk management, and systems engineering.

Organizers hope that demonstrating the potential of a plug-and-play standard in the ORF will be the breakthrough the technology has needed to gain acceptance. “The OR is just a starting point. There’s a need for this in the intensive care unit, the emergency department, and home health care,” says Goldman.

Once the plug-and-play concept is further developed and demonstrated, Schrenker believes its advantages will be obvious to the medical device industry. “When design engineers need to spend their time designing proprietary machine communications interfaces, more time can be devoted to extending functionality—which in our business translates into caring for patients,” explains Schrenker. “Similarly, the cost of regulation should decrease, as reviewers will no longer need to evaluate each proprietary interface for safety and efficacy.”

Jackson offers a hypothetical scenario: A physiological monitoring system installed at every ICU bedside in a hospital has integrated capnography licensed by the vendor from one manufacturer. Then, a nationwide change in practice calls for an updated capnography algorithm that is adopted by three other vendors—but not the hospital’s vendor.

“Do I have to tell my physicians that they cannot comply with the new trend?” asks Jackson. “Or do I have to convince my administration to find the funding to re-standardize our bedside monitoring vendor because one parameter of our systems doesn’t meet the specification anymore? It’s a no-win situation for everyone in this group.”

Instead, with a standard in place, “the users would get to choose the ’best of breed’ algorithms that provide the best patient monitoring possible for a given procedure,” says Jackson. “We could add or change parameters as needed without too much delay, and we could avoid introducing unneeded complexity to the system.”

Jackson will moderate a plug-and-play session at the 2005 AAMI Annual Conference & Expo in Tampa.

“The project will be introduced in a short presentation, but then we want the audience members to break up into groups and come up with specifications,” says Jackson. “This is a great opportunity for the AAMI audience because this community can fully appreciate the value that plug-and-play can bring to health care, and they also know what technical issues need to be addressed to create a stable system in a typically unstable environment. The new standard will not be prototyped by the end of the meeting, but we hope to walk away with a sound list of requirements from the medical devices technical community.”

Goldman’s group hopes to “show significant, tangible results within three years.” Launched in May 2004, the plug-and-play project’s first-year goals include identifying and convening key stakeholders, determining clinical requirements, refining the project plan, securing long-term funding, and establishing a plug-and-play lab that will explore different schemes for device connectivity.

The key here is to create an infrastructure,” says Goldman, “and then let the creativity of clinicians and biomedical engineers take over to do the things that have needed to be done for a long time but were technically impossible to implement.”

For more information on plug-and-play connectivity, visit the project’s Web site at mdpnp.org , or contact Sue Whitehead at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .