Julian Goldman, M.D., attending anesthesiologist at Massachusetts General Hospital and medical director of Partners HealthCare System Biomedical Engineering in Boston, has a vision for the next generation of medical devices working in clinical environments: those devices will interconnect freely with other medical devices and readily integrate with medical systems. The result, he says, will greatly improve patient care and reduce medical accidents.
That vision is a far cry from today’s clinical environments, but the industry has reached a critical threshold for connectivity, says Goldman, who is also director of Medical Device Plug and Play (MD PnP), a group that was formed 10 years ago to promote medical device interoperability. He says technology is moving toward smarter sensors and actuators, but believes the real driver will be connectivity technology, which will open up new categories of devices.
Goldman notes that hospitals are not in the business of building these devices and filing with the FDA (Food and Drug Administration) for approval, but they do have an interest in better data acquisition. At a time when many hospitals are still adopting and expanding their use of electronic health records (EHRs), those efforts are shining a light on the inadequacies of medical device interfaces, he says.
Presently, it’s possible to start a transfusion on a patient knowing that the patient could have a transfusion reaction, but the best it can do is monitor the patient, says Goldman. “We still don’t have a way to stop the infusion pump using additional data,” he says. Stage 3 meaningful use talks about knowing which devices are on the patient, which means that it will be necessary to read the device ID through the network.
Goldman has taken a systems engineering approach to device interoperability, encompassing the acquisition of the data, where it is being transmitted, and existing barriers to its deployment and implementation. Much of his work as focused on focus medical body area networks (MBANs), which are low-power wide area networks that consist of multiple sensors, worn on the body that transmit data to controllers.
The technology has been gaining momentum since the Federal Communications Commission allocated a spectrum for MBANs in May 2012. Among the vendors that have been developing MBAN-based technology are GE Healthcare and Phillips Healthcare, according to Goldman.
Julian Goldman, M.D.
Goldman considers MBAN technology an enabler of miniature smart devices. Localized devices can, for example, provide better bed detection for the patient who gets out of bed and starts wandering. “We will have better sensors that enable patients to get up soon after an injury or surgery, and see if they are ambulating safely. We can do some of those things today; it’s just that those devices are more cumbersome and more limited,” he says.”
Mainstream devices such as activity sensors connect to platforms—smartphones or laptop computers—that have been designed from the ground up to accept them. That can serve as a model for their clinical counterparts, which don’t yet exist but are under development, he says.
Goldman says that progress has been made in laying the foundation for an ecosystem for interoperable medical products. The FDA has issued mobile medical application regulatory guidance, which he sees as a pathway to implement medical applications on standard off-the-shelf computing hardware. He notes that there is a demand among hospitals to drive open interfaces as a means for them to swap equipment.
He adds: “We are starting to see some convergence, and we are no longer hear large companies say, ‘our hospitals, our customers, don’t want this.’ Two years ago, that’s what I heard. That’s progress.”
Vendors Advance Toward Smart Devices
Tim Gee, principal at Medical Device Connectivity, Beaverton, Ore., says there a strong market demand for workflow automation and integration of medical devices. He defines a smart device as one that knows the patient it is associated with, and is able, in the device itself, to handle some of the basic workflow functions.
According to Gee, the next big milestone in Stage 3 meaningful use from a connectivity standpoint in interoperability of infusion pumps. “One of the problems of a drug error reduction system is supposed to solve is that you misconfigure the pump because you are doing it manually,” he says. Yet automating complex workflows has proven to be very difficult.
Historically, third-party vendors have been quicker to respond to market demands than traditional medical device manufacturers, many of which view connectivity and workflow beyond the direct use of their products to be outside their comfort zone Gee says. Yet medical device manufacturers that have done so have distinguished themselves and helped transform their segment of the market. One example is Alaris, a brand of San Diego-based CareFusion Corp., which developed the first drug-error reduction system for infusion pumps.