Tim Sohn03.31.09
Slow Motion
Interoperability is gradually making progress, but a catalyst is needed to pick up the speed.
Tim Sohn
“I think it’s important that manufacturers and developers try to design interoperability into medical devices where it’s appropriate to do so. Over the years, many have been built on different platforms. At the macro level in the healthcare system, this presents not only a tremendous amount of reworking and duplication but also great opportunities for error.”
—Martyn Howgill, executive director of InHealth, Washington, D.C.
Medical device interoperability—the ability of data to move between devices over a third-party network and affect each other—“has gone nowhere” but some advances are slowly being made, according to
Dr. Julian Goldman, founder of the Medical Device Plug-and-Play Interoperability Program, works in the Operating Room of the Future (ORF) at Massachusetts General Hospital in Boston, Mass. The ORF is a “living” laboratory where clinicians explore technology for minimally invasive surgery. Photo courtesy of Dr. Julian Goldman. |
The Connection is Key
Making sure medical devices and systems are able to “connect” is the precursor to interoperability. Connectivity is the “automation of workflow through the integration of medical devices and information systems,” explained Gee, a self-described “connectologist” who works out of Beaverton, Ore. “One must certainly have connectivity before one can hope to realize interoperability.”
Examples of connectivity, according to Gee, are:
• Admitting, discharge and transfer functions
• Managing patient context—which data goes with what patient and when
• Routing data, such as nurse-to-patient assignments
• Exporting data to other systems
• Data analysis
• Alarm and alert generation
• Message delivery and escalation
A key component to connectivity is the electronic medical record (EMR). The government set a goal five years ago of creating an electronic medical record for all Americans by 2014, but progress toward this goal has been slow. Only about 17 percent of physicians in the United States currently use electronic medical records, according to a survey published last year in the New England Journal
of Medicine.
Reasons for the low adoption rate of electronic medical records include worries over a lack of universal protocols for collecting data, including details of how the data can be shared, with whom it can be shared and the circumstances for its release; and concerns about the data being released to the wrong person. Cost also is an issue. Official estimates have put a $150 billion price tag on the task of creating an EMR for every American.
The economic stimulus package signed in February by President Obama included $19 million in incentives to jump-start the use of EMRs.
Walmart, one of the largest U.S. retail chains, plans to try its hand at selling EMRs by teaming up with Sam’s Club, its retail warehouse division, Dell and eClinicalWorks, a private software company. Walmart claims that its partnership with Sam’s Club on EMRs will make the technology more accessible and affordable.
The financial incentives in the government’s stimulus package include more than $40,000 per physician during several years for the installation and use of EMRs. Digital records remain somewhat controversial, but most health experts agree they can cut costs and boost care. Physicians in small offices are more likely to be resistant to the EMR mandate because of its cost and complexity.
Device maker B. Braun Medical Inc. has made some progress with integrating EMRs and infusion pumps. Patients’ vital information from the infusion pump is transmitted directly to the EMR.
Scott Zaffrin, manager of Infusion Systems Connectivity for B. Braun, said, “It is a very important capability. We have integrated it into our infusion pump portfolio. It’s what the market wants. Our
B. Braun is incorporating infusion pumps with electronic medical records. |
Connectivity vs. Interoperability
Connectivity is the capability of medical devices to connect to a network, but to make medical devices interoperable, they must be able to “talk” back and forth to each other—leading to a cause and effect. In some cases, interoperability could save lives.
Software for interoperability programs is run on general purpose computing platforms. Technology, however, is not the main roadblock hindering the advancement ofinteroperability. “That’s a no-brainer,” said Gee.
Compatibility of medical devices is another factor that has until recently stalled efforts to achieve interoperability. “Major point-of-care players initially developed products to perform on their propriety networks. However, due to the need for interoperability and connectivity to gain a holistic patient view, these companies realize that the industry’s direction is toward open systems. All the major players have or are starting to realign their product line with the open system movement,” said Brad Sokol, CEO of Fast Track Technologies in Chicago, Ill., who is urging passage of a unique identification system (UDI).
Renewed Push for a UDI
Sokol isn’t the only one pushing the U.S. Food and Drug Administration (FDA) to create a national UDI for medical devices. Advancing Patient Safety Coalition, an industry watchdog group, recently renewed calls for a UDI system.
The “8 L’s,” the steps necessary to reach the unique device identifier, must be followed in that exact order today, but the UDI of tomorrow will inter-relate the supply chain and clinical events. Source: Brad Sokol |
• The reauthorization, increase and addition of new user fees for prescription drug and device products for another five years
• The increase of the FDA’s regulatory authority to monitor the safety of marketed drug products and medical devices
• The addition of incentives for development and oversight of pediatric drugs and devices
• The creation of a UDI
A UDI can be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify compatible devices, such as implanted devices that can be used safely with magnetic resonance imaging (MRI) systems.
With the number and complexity of medical devices growing, UDIs would allow the FDA to quickly identify new risks and work with manufacturers to manage those risks.
“While the Advancing Patient Safety Coalition appreciates the open and transparent process the agency has followed, the time to act is now. Therefore, we strongly urge the FDA to move the rulemaking process forward this year to implement a regulated, mandatory UDI system that is globally harmonized,” a March letter from the group stated.
This request comes about a month after the FDA’s Feb. 12 public workshop in Gaithersburg, Md., on the pending rules. Sokol participated in that workshop, discussing ways a UDI can improve network interoperability and patient safety. He noted in his presentation that there are several UDI areas of network impact.
One of these areas is the electronic transfer or exchange of data from a medical device without altering the function or parameters of any connected devices. Another is billing for the device and the correct patient, also known as tracer methodology. This methodology is an evaluation process in which surveyors use a patient’s or resident’s record as a roadmap to move through an organization to assess and evaluate compliance with selected standards and the organization’s systems of providing care and services, according to the Joint Commission on Accreditation.
Other areas of network impact, according to Sokol, include automated and compliance reporting (electronic medicaldevice reporting and medical device data system), alarm management, remote monitoring and reporting system capabilities, device maintenance and troubleshooting, network conflict protocol, expansion testing to ensure compliance within quality of service and service level assurance guidelines.
“This is complicated; this is new,” Jay Crowley, a senior adviser for patient safety with the FDA, said of creating a UDI for medical devices. “We all need to figure this out.” Crowley said that patient safety is a driving force behind creating the device identification rules.
In 2007, there were 66,000 adverse-event reports connected to medical devices, and half of the products involved lacked any sort of identification, Crowley said.
There are factors that ensure the marriage of the UDI and patient safety. The UDI allows for interoperability and convergence to yield a semi-automated adverse reporting system that applies to all classes of software-enabled medical devices, said Sokol.
Advances and Solutions
David Hoglund, founder of Lake Tahoe, Nev.-based Integra Systems, and Sokol are developing a business called Medical Network Testing Services that is intended to help hospitals analyze their networks by using simulation models to determine whether the medical devices they have will work together, and the steps that must be taken to achieve interoperability.
“There is a lack of consistency among manufacturers. There’s no recipe book. The challenge that I would communicate is that the technology to do what I say exists today. The device community doesn’t need to reinvent the wheel. The device community needs to have a consistent way of testing, deploying and monitoring [networks and devices],” said Hoglund. And that’s exactly what their company plans to do.
The business’s offerings include a survey of electromagnetic interference, network traffic analysis, network predictability analysis (which analyzes efficiency, bandwidth and traffic management) and integration consulting and design of distributed-antenna-system wireless networks. The pair has secured a hospital that has agreed to test the service, according to Sokol.
Plug and Play
Another advancement in interoperability is the Medical Device “Plug-and-Play” Interoperability Program (MD PnP), which was founded by Julian Goldman, an interoperability expert and anesthesiologist at Massachusetts General Hospital in Boston, Mass., in 2004. The purpose of the program is to evaluate and adopt open standards and technology for medical device interoperability.
According to the program, there are two distinct requirements for effective interoperability in medical device systems. The first is the capability of bi-directional data communication to support complete and accurate data acquisition by the EMR from vital signs monitors, infusion pumps, ventilations, portable imaging systems and other hospital and home-based high-acuity medical devices.
Comprehensive data acquisition also will enable the development of remote monitoring, advanced clinical decision support systems, intelligent alarms and robust databases for continuous quality improvement.
The second requirement is medical device control capability to permit the integration of distributed medical devices to produce “error-resistant” systems. These systems contain safety interlocks between medical devices to increase use errors, closed-loop systems to regulate the delivery of medication and fluids, and remote patient management to support healthcare efficiency and safety.
Massachusetts General Hospital/Partners HealthCare System, Johns Hopkins Hospital in Baltimore, Md., and Kaiser Permanente in Oakland, Calif., have worked together to create interoperability requirements that they have agreed to incorporate into their procurement contracts with medical device vendors. They also have encouraged other hospitals to create similar requirements. A team of clinicians, procurement/materials managers, clinical and information systems engineers and lawyers from each hospital worked with the MD PnP for six months to write a white paper and sample language for the document. This work resulted in the creation of the Medical Device Free Interoperability Requirements for the Enterprise (MD FIRE), which was released in October 2008.
According to the developers of MD FIRE, the participating hospitals hope to document the clinical demand for device interoperability and “strongly encourage” the development and adoption of standards. “We also recognize that the necessary standards are not yet fully developed or widely implemented by medical equipment vendors,” the document stated.“We believe that changing the way in which we procure medical devices to integrate requirements for interoperability will provide a way for us to ensure patient safety, improve healthcare quality, reduce healthcare costs, and provide for more comprehensive and secure management of health information.”
The MD FIRE contains practical examples of how interoperability can improve patient safety. One example involves synchronizing the X-ray of an intensive care unit patient’s breathing cycle to improve image quality. This capability is not currently available. Another example involves a safety interlock that would stop the flow of opioid pain medication from an infusion pump and call the nurse if a patient showed signs of respiratory distress.
Regulatory Considerations
An emerging standard, IEC 80001, is the application of risk management to enterprise networks incorporating medical devices.The voluntary standard is not expected to be approved until next year.
“The FDA is acutely aware of the ‘systems of systems’ issue that has been evolving for a number of years. They were the impetus behind the creation of the IEC 80001 standard,” said Gee. The FDA initially showed its concern about medical connectivity in December 2005 during a study session that focused on a new threat, the availability of computer-controlled medical devices operating in enterprise network environments.
The standard specifies activities required of medical device and IT vendors in addition to provider organizations when one or more medical devices are connected to a network. The standard does not define specific risks; those risks must be identified and mitigated by providers.
The standard has four goals:
• Patient safety
• Effectiveness (as in the enhancement of the delivery of care through safe and effective connectivity)
• Data and system security
• Interoperability
IEC 80001 attempts to balance these goals using an ongoing risk management framework. The standard would be used when designing networks to support medical devices, integrating medical devices into the network and when changes are made to the network. The standard refers to a “responsibility agreement” where vendors contractually agree to make available to providers all the information they need to apply an effective risk management process to a system that includes their products.
Work Remains
Medical device interoperability progress is not moving quickly, but advances definitely are being made.
The reasons for the slow progress vary, but some industry experts speculated that medical device manufacturers prefer to be proprietary. Large hospitals have become the testing ground for what could be significant progress in the near future.
“In any mature market, you typically have two or three or maybe four companies who have 90 or 80 or 70 percent of the market, and then there’s everyone else. And in a market like that, how do you get innovation and change? It occurs slowly,” said Gee.