Achieving Medical Device Connectivity

In order to deliver high-quality care and meet regulatory mandates, hospitals must collect increasingly detailed clinical data from inpatients, while reducing staff costs. In the near future, hospitals must also take responsibility for the data required to achieve measurably superior outcomes beyond their walls. Obtaining the additional data required to manage and coordinate care inside and outside the hospital, without spending a fortune on staff, requires the ability to automatically retrieve information from medical devices.

Consequently, connected medical devices (CMDs) are becoming invaluable to the medical industry. Each CMD saves from 4 to 36 minutes of nursing time and prevents up to 24 data errors daily. They can also save over 100 hours of nursing time per day in a typical hospital, giving nurses more time with patients and improving the quality of care.

But while the benefits are clear, what is less obvious is how hospitals can easily move toward this type of environment, and what role the product manufacturer can play in making it happen.

Already CMDs come in many different forms and levels of complexity, from tongue depressors to artificial hearts. The number of medical devices that produce electronic data is growing as sensors are added to devices that were formerly only mechanical in nature, such as the newly-developed e-Knee prosthesis.

While device connections can be used to remotely monitor, control and configure devices, it is their patient monitoring function that adds the greatest value. Patient physiology data; drug administration data including dose, timing, rate, etc.; ventilator therapy data; and many other key pieces of information can be recorded to help medics provide optimal care to patients.

When these devices are automatically connected to an electronic medical record (EMR) the completeness, timeliness and accuracy of the data that becomes available is much greater than what could be manually charted by nurses. What is more, the potential quality and safety of care improves, while the time and cost required to collect and chart the data is greatly reduced.

In short, the best practice for preventing hospital readmissions includes the use of connected devices in care facilities and patients’ homes. By making use of remote device data, patients can be kept in the comfort of their own homes, and therefore avoid unnecessary hospital care.

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Today most electronic medical devices are found in hospitals. Hospitals today use a vast number of common devices (Figure 1), with IV pumps, physiologic monitors and vital signs monitors, making up 85 percent of the total. Hospitals also use dozens of other less common devices.

However, very few of these devices are currently connected to a hospital network. As indicated in Figure 2 below, the number of connected medical devices in hospitals could easily grow by a factor of ten.

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Reliable statistics are not available for the use of electronic medical devices outside hospitals, but their number is expected to grow even more dramatically. The need for more accurate, timely and efficiently collected data will increase the use of CMDs in nursing homes, doctors’ offices and other healthcare facilities. However, the greatest growth is expected to be in patients’ homes and other locations outside of formal care environments, because potential improvements in data collection efficiency, cost and timeliness are greater outside of healthcare facilities (Figure 3).

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Benefits of connectivity

Research shows that nurses spend approximately 21⁄2 hours per shift on documentation activities, reducing the amount of time they spend on direct patient care and increasing job stress. CMDs can automate a significant amount of nursing documentation. This in turn can help increase time devoted to patient care, which can improve patient outcomes.

Clinical decision support (CDS) capabilities are the number one source of value from EMR systems. Basic CDS includes such things as drug selection and dosing alerts, electronic order sets, and duplicate lab test alerts. Beyond these basics lies a world of value, much of which requires more detailed data, collected more frequently than most hospitals are able to afford.

Emerging, high-value CDS applications include clinical surveillance systems that can review large volumes of clinical data and highlight patient risks when they occur, to guide real-time changes in care. CMDs can dramatically reduce the cost of data collection for these systems, making them a practical alternative for more hospitals.

Devices that connect to the network also add analytical value. If all of a hospital’s smart pumps are connected to the network, then pump data can be aggregated to show trends in unsafe pump programming, which nurses need to be trained in, and determine whether a greater number of errors are made during certain times of the day.

Connectivity challenges

In spite of the substantial benefits of CMDs there is a great deal of frustration among hospitals and medical device vendors over the technical and operational challenges of connecting their devices. The key challenges include translation of device data from numerous proprietary device formats into something that can be read and understood by EMRs and other information systems, supporting industry standard wireless networking security protocols, supporting dual band wireless communications, supporting multiple interfaces in addition to serial connections, and minimising the burden of testing to ensure that devices are compatible. Device manufacturers must also balance their need for stable product designs that can last many years to earn back the high costs of device development, with the rapid evolution of technical capabilities and standards.

The primary reason for increased interest in CMDs in hospitals is the need to incorporate device data into EMRs. This helps to create a more complete and accurate picture of patients’ conditions and enhances clinical decision support and analytics capabilities, improving care processes and patient outcomes. Most hospitals have dealt with this issue one device at a time, since each device vendor has their own proprietary data format. Given the increasing data volumes and the growing number of networkable devices, this is becoming more difficult.

Some device connectivity vendors are designing translation software into their modules, to take the burden off device manufacturers and individual hospitals. These solutions can translate data into HL7 and other standard formats.

Wireless network security

Cisco is the dominant infrastructure provider in hospitals and is known for providing very secure wireless access points. Cisco initially developed the LEAP standard, which was designed to provide increased security; their latest standard is EAP. It’s important that device manufacturers support a hospital’s preferred security protocol (likely LEAP or EAP) to avoid costly work-arounds. In many cases, work-arounds are not feasible and the hospital will instead select another, compliant device vendor.

Support for EAP and other common wireless networking security protocols requires that wireless networking vendors add special software, memory to store and run the software, and additional processing power.

The most commonly used wireless band is 2.4GHz, which doesn’t require a specific FCC license. The 5GHz band, which was formerly restricted to government and military uses, is now an emerging standard for hospital device use, given its superior performance in an environment with lots of potential interference. During the transition from 2.4 to 5GHz device connectivity modules must include the RF chips and firmware to support both bands.

Serial UART is the traditional and stable network standard but serial ports are very slow, and have been largely replaced on many common devices by USB ports, which are faster and smaller. Other common interface options include SPI, which is faster still, and I2C. Some devices, such as EKGs require the faster SPI interface to accommodate the high volume of data available from the device.

Device manufacturers must support all common network interfaces to avoid costly work-arounds and sub-optimal performance (inability to send all required data in a timely manner).

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Testing Requirements

Hospitals assume that CMD vendors have tested the compatibility of their devices with all common wireless configurations; however, such testing requires expertise that most device manufacturers do not have. One alternative is to engage a specialised testing company to do detailed and specific testing, but this can be quite costly. Alternatively, the device manufacturer can incorporate a third-party wireless module into their device and rely on the module manufacturer’s testing processes, which are typically robust.

One other consideration for device manufacturers is device life. Medical device models, which take much longer to get to market, and have a more costly development cycle, need a longer life than consumer devices which are replaced yearly.

It is very difficult for device manufacturers to go directly to RF chip vendors to get the chips they need in the relatively small quantities they need. In addition, these chips are updated every year or two, and a medical device vendor can’t afford to revise their hardware that often. The component isn’t guaranteed for the long life of the device, and frequent software changes require costly chip modifications. Purchasing and integrating a third-party networking module mitigates these issues because the connection from the device to the module does not change – the required changes are made inside the module.

These technical challenges are far from insurmountable. Device networking experts have identified optimal solutions that address each of these provider concerns. However, device manufacturers who are not experienced in providing wireless network connectivity and implementing connected devices in a complex hospital environment should seek expert partners to avoid compromising patient health and customer relationships.

Recommendations for Device Manufacturers

-Fully understand the regulatory and strategic issues that promote wireless device connectivity, and how they affect your devices specifically.
-Fully understand the secondary uses of the data from your devices, and the potential business value of these data.
-Quantify the business benefits of wireless networking of your device – what’s the financial, clinical, operational value add?
-Fully understand the technical issues and costs associated with adding wireless connectivity to your devices.
-Quantify the tradeoffs of buying vs. building wireless connectivity into your devices. Develop a formal plan, budget and timeframes for executing the plan, and assign it to one of your best project managers.

Recommendations for Hospital Executives

-Document the amount of time required to collect and enter medical device data in your hospital -ICUs and Medical/Surgical units. Document or estimate your current error rate for manual device data transcription.
-Determine which devices require the greatest amount of charting time and which have the highest error rates. Estimate the hard benefits of CMDs, starting with those described in this report.
-Calculate the cost of purchasing new connected devices to replace the most costly and error prone device types, or connecting existing devices via standalone serial port device servers.
-Develop a business case based on your unique costs and benefits to support the purchase and implementation of CMDs.