BOSTON -- A volunteer committee of biomedical engineers is modeling the process of medical device interoperability regulatory submissions for the Food and Drug Administration (FDA) -- which the committee hopes may represent the bedrock of future regulations and potentially influence how the agency examines the safety of devices and how they interact with a hospital's IT infrastructure.
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The Medical Device Interoperability Safety Working Group has no bearing on actual FDA policy. But it hopes a mock 510k device submission will help guide regulators toward policies that enhance patient safety by focusing on the right aspects of interoperability and human interaction with devices, said Michael Robkin, Anakena Group principal and member of the interoperability group. He presented at The Center for Business Innovation's 3rd Annual Medical Device Connectivity Conference & Exhibition.
The committee originated at a FDA workshop in January 2010; the proceedings are archived for viewing on the web.
ICE: Hospital IT's infrastructure silver bullet
The idea behind the group's submission was to take a device compliant with the Integrated Clinical Environment (commonly referred to as ICE and enumerated in detail in the ASTM F2761-0 standard) and evaluate it on its own merits, examining connectivity hazards and risks.
This represents a new, single-component approach to the FDA medical device submission process. Present regulation is structured as "pair-wise," meaning whole systems must be re-cleared by the FDA when a manufacturer brings to market a new device that can to be added to it.
This makes large systems difficult to expand from a regulatory perspective, even when technology exists to plug in more devices. One theoretical example might be a central patient monitoring system in which X-ray, pulse oximeter and patient-controlled analgesia (PCA) infusion pump interoperate to: detect when a patient controlling his own pain meds causes blood oxygen to dip too low, trigger the pump to shut off and summon a nurse to the bedside.
"A component [level] approach will allow components to be cleared individually, without having to enumerate every single possible combination of use of those components," Robkin said. This, he added, will be enabled by standardizing interfaces between components and then analyzing each component's safety responsibilities and risks. "Thus the assembly of those components in the system by the end user -- such as a hospital -- is not a regulated activity."
The idea of ICE architecture for patient care systems is gaining momentum. Robkin participates in the Medical Device Plug-and-Play Interoperability Program, or MDPnP, which won a five-year, $10 million National Institute of Health grant to develop a model hospital intranet using ICE components.
MDPnP's goals include creating a structure on which hospitals and manufacturers can model their own real-life plug-and-play networks, as well as operating a lab where they can perform real-world research, tests and validation on their ICE devices in combination with one another. The FDA is a participant in the program as well.
The FDA has accepted the medical device interoperability group's mock 510K submission for a ventilator weaning system that uses ICE compatible components. It included hazard analysis not only of the sensors and other devices involved in the system, but also how users interacted with the devices as well as the device-to-device message delivery system.
The agency is using the submission for "further internal work on a regulatory pathway," Robkin said. Part of that pathway could include Underwriter Laboratories' UL 2751. Titled Interoperable Medical Device Interface Safety, this standard is now in early development. Eventually, compliance with that standard could ultimately be part of the approval process, with manufacturers using it to support their cases for FDA clearance, Robkin said.
ECRI weighs in on medical device interoperability
Medical device interoperability might be a tenet of the ONC's meaningful use idea but it's still a relatively new idea, said another presenter, Jim Keller, vice president of health technology evaluation and safety at ECRI Institute.
Quoting a HIMSS Analytics/Lantronix survey, Keller noted the following.
- One-third of the 825 hospitals participating in the survey have an interface between their devices and an electronic health record (EHR) system.
- Physiologic monitors (24.3%), fetal monitors (19%), electrocardiographs (15.1%) and ventilators (9.3%) are most likely to be connected to EHR systems.
- While most connections are direct, 11% use hubs.
- Automatic charting is the most common reason for connecting devices and the EHR.
Some clinical systems have more advanced interoperability than others, he said. Examples include picture archiving and communications systems (PACS), fetal monitoring systems and anesthesiology equipment. In these cases, advanced medical device interoperability aids care, automates charting and enables exchange of information with other applications on the network.
Advanced medical device interoperability aids care, automates charting and enables exchange of information with other applications on the network.
Other applications, such as computerized physician order entry, EHR systems and smart infusion pumps, are just now emerging in their interoperability. Ventilators, too; their alarms can be ported to many outlets in a hospital communications systems.
On the development horizon, meanwhile, are operating room integration systems and clinical decision support tools that can automate or at least assist in some aspects of patient care.
It's a big deal. Ultimately, medical device interoperability can potentially save hours of data entry that now is manually keyed from one system to another, eliminating errors humans invariably make when they're doing it. Eventually, interoperable systems will also reduce billing errors and enable new analytics processes clinical leaders can use to improve care, Keller said.
"Depending on how you define interoperability, it's been going on for a good while," he said, referring to localized communication between, for example, devices and an EHR system. "Getting into an HIE level of communication -- that's really got a ways to go," though, before it happens on a widespread basis among hospitals.