Connected medical devices (CMDs) have become invaluable tools within the medical industry. Each CMD saves from four to 36 minutes of nursing time, and prevents up to 24 data errors daily. On a daily basis, they can save over 100 hours of nursing time in a typical hospital, which allows nurses to spend more time with patients and thus improve the quality of care. Also, by stopping over 800 data-collection errors each day, hospitals can greatly enhance efficiency and patient safety.
The benefits are clear, but how can hospitals move easily to this type of environment? Moreover, what role does the product manufacturer play to make it happen?
More than ever, hospitals need to connect their devices to an electronic medical record (EMR)—too many still operate as independent “islands” of functionality and data. CMDs will play an increasingly prominent role in this environment, particularly outside of the hospital in terms of managing chronic conditions and preventing hospital readmissions.
It’s the responsibility of medical-device manufacturers to help translate device data into a format that can be read and understood by EMRs. They must also support standard wireless-networking security protocols, dual-band wireless communications, and multiple interfaces to help hospital customers realise the potential benefits of device connectivity.
Data Requirements, Regulations Promote Device Connectivity
To deliver high-quality care and meet regulatory mandates, hospitals must collect increasingly detailed clinical data from inpatients and simultaneously reduce staff costs. In the near future, hospitals also must assume responsibility for the data required to achieve measurably superior outcomes beyond their walls. Obtaining such data 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.
These devices come in many different forms and levels of complexity, from tongue depressors to artificial hearts. More medical devices that produce electronic data continue to arrive on the market. Driving this surge is the addition of sensors to formerly mechanical-only devices, such as the new e-Knee prosthesis.
Though device connections can be used to remotely monitor, control, and configure devices, their patient monitoring function 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 EMR, the completeness, timeliness, and accuracy of the data is much greater than what could be manually charted by nurses. On top of that, it improves the potential quality and safety of care while greatly reducing the time and cost required to collect and chart the data.
In short, the best practice for preventing hospital readmissions includes the use of connected devices in care facilities and patients’ homes. Utilising remote device data keeps patients in the comfort of their own homes, and therefore avoids unnecessary hospital care.
Medical Device Market Summary
Most electronic medical devices are still found in hospitals. Many are of the common variety, with IV pumps, physiologic monitors, and vital signs monitors making up 85% of the total (Fig. 1).1 Hospitals also use dozens of other less customary devices.
However, very few of these devices are currently connected to a hospital network. That said, the number of connected medical devices in hospitals could easily grow by a factor of ten (Fig. 2).2
Reliable statistics aren’t available for the use of electronic medical devices outside hospitals. Nonetheless, a dramatic ramp-up in CMD usage is expected, such as in nursing homes, doctors’ offices, and other healthcare facilities. However, the greatest growth will likely be seen in patients’ homes and other locations outside of formal care environments, because potential improvements in data-collection efficiency, cost, and timeliness run greater outside of healthcare facilities (Fig. 3).3
Benefits Of Hospital Device Connectivity
Research shows that nurses spend approximately two and a half hours per shift on documentation activities, which cuts into the time they spend on direct patient care and ultimately leads to more stress on the job. CMDs help remedy that situation by automating a significant amount of nursing documentation.
Improved Clinical Decision Support Value
Perhaps the number one source of value derived from EMRs is clinical decision support (CDS). Basic CDS includes 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 can 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. As a result, it helps 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.
Another CMD-driven CDS capability is the ability to receive global alerts for each type of device. For example, networking older IV pumps without safety alerts could allow hospitals to create their own real-time alerts based on current data. These alerts could be sent to nurses in time to avoid dangerous and costly errors—in essence, making “smart pumps” out of “dumb” pumps. Potential candidates for this type of CDS include IV pumps, ventilators, and cardiac monitors.
Improved Analytical Value
Devices that connect to the network 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 (thus requiring training for nurses), and determine whether certain times of day see greater numbers of errors, etc.
Electronic medical devices aren’t reimbursed separately, but many are associated with procedures that do maintain separate charges. Accurate, complete, timely data on device use can be part of an audit to identify and capture missed procedure charges.
Increased Nursing Satisfaction
Nurses don’t like transcribing data from medical devices. It’s tedious, error-prone work, and it gobbles up valuable time that otherwise could be spent on patient care. Hospitals that have implemented CMDs find that their nursing staff greatly prefers reviewing imported data to transcribing them directly. One medical centre spokesperson, referring to CMDs, says that “this application is the only time I have seen a nurse hugging an information systems employee.”
As stated earlier, the operational benefits of device connectivity are greater outside of hospitals. That’s because physician offices, post-acute and long-term care facilities, and especially the patient’s home are not only less “wired” than hospitals, but have fewer staff available to collect data manually. Therefore, it becomes more challenging to manually collect device data outside the hospital without remote-patient-monitoring (RPM) devices.
RPM devices will help mitigate the need for nurses outside the hospital environment. They automate data collection and reduce the required number of home visits.
Device Connectivity Challenges
In spite of the substantial benefits of CMDs, a great deal of frustration exists among hospitals and medical device vendors over the technical and operational challenges of connecting their devices. One major challenge concerns the translation of device data from numerous proprietary device formats into something that can be read and understood by EMRs and other information systems. Other key challenges include support of standard wireless-networking security protocols, support of dual-band wireless communications, support of multiple interfaces in addition to serial connections, and minimising the burden of testing to ensure device compatibility.
In addition, device manufacturers must perform a balancing act: The need for stable product designs that can last many years to recoup the high costs of device development versus the rapid evolution of technical capabilities and standards.
The increased interest in CMDs for hospitals centers on the incorporation of device data into EMRs. This helps create a more complete and accurate picture of patients’ conditions and enhances clinical decision support and analytics capabilities, leading to improved care processes and patient outcomes. Most hospitals have dealt with this issue one device at a time, since each device vendor has its own proprietary data format. However, burgeoning data volumes and the growing number of networkable devices has made it an unwieldy process.
To take that burden off device manufacturers and individual hospitals, some device connectivity vendors are designing translation software into their modules. These solutions can translate data into HL7 and other standard formats.
Wireless Network Security
Cisco, which has become the dominant infrastructure provider in hospitals, is known for providing very secure wireless access points. The company initially developed the Extensible Authentication Protocol (EAP) standard to provide increased security. Cisco’s latest standard is called PEAP (protected EAP).
It’s important that device manufacturers support a hospital’s preferred security protocol (likely PEAP or EAP) to avoid costly workarounds. In many cases, workarounds aren’t 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. To make the transition from 2.4GHz 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. However, serial ports are very slow, and have been largely replaced on many common devices by faster and smaller USB ports. Other common interface options include the even faster SPI 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 workarounds and sub-optimal performance (inability to send all required data in a timely manner).
Hospitals assume that CMD vendors have tested the compatibility of their devices with all common wireless configurations. However, the reality is that most device manufacturers lack such testing expertise. One alternative is to engage a specialized testing company to perform detailed and specific testing, but the cost can be prohibitive. On the other hand, 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 concerns the device’s lifetime. Medical device models, which take much longer to get to market and incur a more costly development cycle, must last longer than consumer devices with their typical one-year lifetimes.
It is very difficult for device manufacturers to go directly to RF chip vendors to obtain the chips they need in relatively small quantities. 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 doesn’t change. Rather, the required revisions 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 inexperienced in providing wireless-network connectivity and implementing connected devices in a complex hospital environment should seek expert partners. This will 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 specifically affect your devices.
- Fully understand the secondary uses of the data from your devices, and the potential business value of the 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 versus building wireless connectivity into your devices. Develop a formal plan, which includes budget and timeframes for execution, and then 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 those devices that require the greatest amount of charting time and those with 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.
- Medical Devices Landscape: Current and Future Adoption, Integration with EMRs, and Connectivity, HIMSS Analytics, 2010.
- Medical Devices Landscape: Current and Future Adoption, Integration with EMRs, and Connectivity, HIMSS Analytics, 2010.
- Black Box Estimates