Interoperability now

Supply chain executives need to be vocal about the need for medical-equipment interoperability

Does this sound like your ICU?
Patients surrounded by defibrillators, electrocardiographs, vital signs monitors, ventilators and infusion pumps – all from different manufacturers and unable to exchange data with each other, requiring a costly, complex information technology infrastructure and introducing the potential for miscommunication.

It’s a picture painted by the Gary and Mary West Health Institute (WHI) in its recently released report, “The Value of Medical Device Interoperability: Improving patient care with more than $30 billion in annual health care savings.”
The upshot of this electronic Tower of Babel are compromises in patient care and safety, not to mention lots of wasted dollars, says San Diego-based WHI. And it’s not likely to go away until the hospital industry demands that equipment vendors address the problem. To be sure, IDN administrators, medical staff, and biomedical and IT professionals should lead the charge, but supply chain executives should be at the table as well, particularly during contract negotiations. To be effective, though, they have to be familiar with the topic and terminology.

Seamless communication
West Health Institute, an independent, nonprofit medical research organization, in its analysis, defines medical device interoperability as the ability of medical devices and systems to seamlessly communicate and exchange information. By allowing for the exchange of data with other medical devices and with patient data sources and repositories, such as electronic health records, medical device interoperability would enhance the function of the systems and devices.

Interoperability can help organizations avoid adverse events and inefficiencies, such as:

• Redundant testing resulting from inaccessible information.
• Clinician time spent manually entering information.
•  Increased length of stay from delays in information transfer.
• Device testing and development costs.
• Provider costs to integrate devices with electronic health records.

More important, interoperability can positively affect patient care, says the organization, offering this example in its analysis: If a cancer patient’s pain medication is distributed by an infusion pump that receives direct information from that patient’s vital signs monitor, it could ensure the patient isn’t over-medicated by mistake. (Typically these systems are independent and require multiple manual settings, all of which increase the potential for error and raise costs.)

Not only should medical devices and equipment interact with each other, but they should also have the capability of interacting with the hospital’s or IDN’s electronic health record. That isn’t happening today, according to WHI. Citing a study by HIMSS, the organization points out that more than 90 percent of hospitals surveyed by HIMSS use six or more types of devices (such as defibrillators, electrocardiographs, vital signs monitors, ventilators and infusion pumps) that could be integrated with electronic health records systems. Yet only a third of the hospitals actually integrate medical devices with EHRs.

What’s more, those providers that are investing in interoperability integrate fewer than three types of devices on average, a far cry from the six to 12 devices that may be present around an intensive care unit bed. “This lack of interoperability creates significant sources of waste and risk to patient safety because of incomplete or stale information clinicians must rely on for workflow and decision making,” says WHI in its analysis.

Think holistically
Contracting executives, hospital administrators and others willing to broach the interoperability issue with vendors need to think holistically, says Aaron Goldmuntz, senior director of strategy and ecosystem engagement, West Health Institute. The purchase price of medical devices and equipment is important, but executives should take into consideration the much-bigger payoff of interoperability – improved patient care and reduced operating costs. The problem is, even if one hospital’s or IDN’s executives think big picture, progress will be slow until the entire industry gets behind the effort, he says.
Providers have their work cut out for them, as progress has been slow, says Goldmuntz, who cites a simple example. The typical cell phone employs something called “current time protocol,” meaning that its internal clock is automatically adjusted for daylight savings time or standard time. But still, in many hospitals, staff must manually change clocks come daylight savings time. It’s more than inconvenient. The lack of time synchronization among medical devices can result in inaccurate time-stamps of clinical data recorded in the electronic medical record, and can complicate the synchronization of data from multiple devices when analyzing adverse events.

Not for lack of standards
Part of the reason for limited interoperability is the high cost and complexity of medical device integration, which results from the lack of incentives for medical device and HIT companies to use open interfaces to establish interchangeable interoperability, points out WHI in its analysis. “In contrast to the ‘plug and play’ world of consumer electronics, where consumer demand for simple and seamless functionality has driven convergence on a few common standardized interfaces and platforms, healthcare providers have not required a consistent means for achieving interoperability. As a result, there is a wide range of methods used by device vendors today.”

Indeed, the lack of medical device interoperability is not due to a lack of standards, says Goldmuntz. Several medical-device-related standards are in use today, including DICOM, IHE and IEEE 11073. (See related article.) “The problem is a lack of adoption of them in a consistent way,” he says.

One of those standards – DICOM – has gained wide implementation among manufacturers of imaging equipment for one reason: Radiologists asked for it. “They wanted to check images from their homes or from the hospital, so they applied pressure for manufacturers to move toward that standard format,” says Goldmuntz. It’s similar to consumer demands for standards, such as the ubiquitous USB port.

“In healthcare, [contracting executives] have the opportunity to provide clear and consistent requirements to help vendors adopt interoperability standards.

“It’s a call to action.”

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Sidebar:
Financial impact of interoperability

The benefits from interoperability arise from four primary activities, with implications on patient care and cost, according to West Health Institute:
1. Reduction of adverse events due to safety interlocks ($2 billion).
2. Reduced cost of care – avoidance of redundant testing ($3 billion).
3. Increased clinician productivity – decreased time spent manually entering information ($12 billion).
4. Increased capacity for treatment – shortening length of stay ($18 billion).

Drug errors
Medical device interoperability will facilitate the push of test results and vital signs readings to clinicians or pharmacists and automate the integration of relevant information to inform ordering decisions, thus avoiding ordering errors stemming from lack of patient information or inadequate monitoring. Interoperability can address transcription and administrative errors by allowing EHRs, physiological monitoring devices and medication administration devices to communicate in a seamless manner.

Diagnostic errors
Diagnostic errors result from a variety of root causes, such as a failure to account for symptoms, order appropriate tests and consider all relevant diagnoses. Medical device interoperability can reduce such errors by making symptom readings available in real time and pushing test results to the care provider in a timely and clear manner.

Failure to prevent injury
“Failure to prevent injury” encompasses a variety of potentially preventable conditions. A primary example is ventilator-associated pneumonia. Interoperability can reduce its incidence by automating and facilitating the monitoring of physiological parameters and matching the ventilator support needed by individual patients. This is particularly important for managing ICU patients with dynamic vital signs and lung capacity. Interoperability supports clinicians in performing frequent “ready to wean” assessments, which leads to fewer ventilator days and thus fewer cases of pneumonia. Postoperative shock can also be addressed by improved interoperability, as integrating continuous vital signs monitoring with alarm systems has been shown to reduce its incidence by allowing earlier intervention in patients whose condition is deteriorating.

Costs resulting from redundant testing
Redundant testing stems from numerous factors, including “defensive medicine,” but it is often simply the result of misplaced, delayed or illegible hard-copy test results. Greater interoperability would allow test results to flow directly into an EHR, eliminating the problem of misplaced or illegible results. Redundant tests due to liability or other hospital policy-related justifications would not be impacted.

Costs resulting from clinician time spent manually entering information
Studies estimate that about 35 percent of a nurse’s shift time is spent on documentation. A significant proportion of this time is spent manually entering vital signs readings onto paper charts or into EHRs. Interoperability can eliminate this time by automatically sending readings from devices to EHRs. Another source of inefficiency is time spent manually programming devices (e.g., infusion pumps), which is a complex, cumbersome process today. Interoperability significantly reduces this time by enabling the automatic population of provider- ordered and pharmacist-validated infusion variables directly into the infusion device.

Costs resulting from increased length of stay
Delays in receiving test results hinder decision-making, unnecessarily extending the length of ED visits and inpatient hospital stays. By pushing test results to the clinician, medical device interoperability would accelerate decision-making, reducing length of stay and providing opportunities for “right-sizing” of departments or avoidance of future staff augmentation.

Source: “The Value of Medical Device Interoperability: Improving patient care with more than $30 billion in annual health care savings,” March 2013, West Health Institute, https://s3.amazonaws.com/wwhi.org/interop/WHI-The_Value_of_Medical_Device_Interoperability.pdf

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Sidebar:
Organizations you should know

As contracting executives discuss interoperability with their administrators, clinicians, biomed and IT professionals, and device and equipment vendors, they may hear references to the following organizations.

• IHE® – Integrating the Healthcare Enterprise
  Founded in 1997 by HIMSS and the Radiological Society of North America, IHE is a global non-profit entity that enables the collaboration of healthcare providers and industry leaders to work together to improve interoperability and exchange of health information. IHE is based on a fully cooperative partnership model with over 350 member organizations that contribute over 2,000 individual volunteers participating in IHE committees. http://www.iheusa.org/docs/IntroductiontoIHE_F2011_02_17.pdf.
• IEEE
  The IEEE Standards Association is a globally recognized standards-setting body within IEEE, which develops consensus standards through an open process that engages industry and brings together a broad stakeholder community. IEEE standards set specifications and best practices based on current scientific and technological knowledge. The IEEE-SA has a portfolio of over 900 active standards and more than 500 standards under development. Recent additions to the family of IEEE 11073™ standards approved by the IEEE Standards Association Standards Board are designed to help healthcare product vendors and integrators create devices and systems for disease management, health and fitness and independent living that can help save lives and improve quality of life for people worldwide. www.ieee.org.
• DICOM – Digital Imaging and Communications in Medicine
  DICOM is the international standard for medical images and related information (ISO 12052). It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. DICOM is implemented in almost every radiology, cardiology imaging, and radiotherapy device (X-ray, CT, MRI, ultrasound, etc.), and increasingly in devices in other medical domains such as ophthalmology and dentistry. http://medical.nema.org
• HL7
  Founded in 1987, Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards-developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7’s 2,300+ members include approximately 500 corporate members who represent more than 90 percent of the information systems vendors serving healthcare. http://www.hl7.org
• Medical Imaging and Technology Alliance (MITA)
  The Medical Imaging & Technology Alliance, a division of the National Electrical Manufacturers Association (NEMA), is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. MITA provides leadership for the medical imaging industry on legislative and regulatory issues at the state, federal, and international levels. It is also a standards-development organization for medical imaging equipment. These standards are voluntary guidelines that establish commonly accepted methods of design, production, testing and communication for imaging and cancer treatment products. Sound technical standards of this kind improve safety and foster efficiencies in how care is delivered. http://www.medicalimaging.org.
• MD PnP
  The Medical Device “Plug-and-Play” (MD PnP) Interoperability Program is accelerating the adoption of medical device interoperability to enable the creation of complete and accurate electronic health records and the cost-effective development of innovative third-party medical “apps” for diagnosis, treatment, research, safety and quality improvements, equipment management, and adverse event detection and reporting when using networked medical devices for clinical care. The MD PnP team is working to develop sharable databases, tools, and applications that will enable a broader community of researchers and manufacturers to implement medical device interoperability. http://www.mdpnp.org/devicesynchronization.html
• The Association for the Advancement of Medical Instrumentation
  AAMI is a nonprofit organization founded in 1967, which supports the healthcare community in the development, management, and use of safe and effective medical technology. The AAMI standards program consists of more than 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices. Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI and the Food and Drug Administration will host the 24th AAMI/FDA Annual International Conference on Medical Device Standards and Regulation in March 2014. www.aami.org