Patient monitors: a segment poised for growth and innovation

May 19, 2016
by Lauren Dubinsky, Senior Reporter
Wearable monitoring technology has increasingly become a fixture in health IT headlines, and the number of companies that want to demonstrate the value of their wearables in the clinical setting has also grown. While industry experts readily acknowledge the potential of these solutions to improve care, they generally regard it as a market in its infancy. However, with a few medical-grade wearables like VitalConnect’s VitalPatch and iRhythm’s ZIO XT Patch on the market, there may be a day when patients will no longer be tethered to monitors. But a few technical challenges, such as ensuring the wireless network is reliable, will need to be ironed out first.

While wearables are the flashiest technology on the market, the traditional patient monitors have undergone some significant advancement in recent years. They can be integrated with a hospital’s EMR, monitor end tidal CO2 and be paired with clinical decision support tools to make sure the clinicians get the most useful information.

No strings attached
“I think that the monitoring package will become wireless, will become smaller, will become less of a hindrance to patients, and probably provide more information,” says Dr. Steven Steinhubl, director of digital medicine at Scripps Health. Scripps Health has conducted a number of studies investigating the usefulness of wearables for certain indications. Scripps launched a home-based clinical trial in November that uses the ZIO XT Patch to identify people with asymptomatic atrial fibrillation.

The study will span three years, and so far the researchers have enrolled about 300 participants out of the targeted 2,000. Their goal is to see if they can screen people in the general population without having them come to the hospital.

The ZIO XT Patch is worn as an adhesive patch on the chest and it continuously records heartbeats for up to 14 days. Traditionally, Holter monitors are used for this purpose, which involves wires and ECG leads, and the patient has to wear a box on their belt. “[The ZIO XT Patch] is much easier, much more convenient and [provides much] more information for [the] patient’s heart rhythm,” says Steinhubl.

Wireless wearable sensors made it into ECRI’s Top 10 Hospital C-Suite Watch List for 2016. ECRI thinks that wearables could have real-world benefits in outpatient settings for 24-hour monitoring for chronic conditions like Alzheimer’s disease, diabetes, epilepsy, cardiac arrhythmias, heart failure and pressure ulcer development. ECRI has observed that certain wearable sensors have been approved by third-party insurance companies to replace the Holter monitor for home ECG recording.

MD Buyline also believes that wearables hold promise for outpatient settings. “I think that patients who have traditionally been in the hospital to be monitored will have the option of being monitored from home,” says Brandi Crow, clinical analyst at MD Buyline. Hospitals are looking into medication adherence monitoring and blood glucose monitoring so they can get a good profile on how the patient is responding to different medications, and then be able to trend it.

Also, in the case of heart failure patients who weren’t adherent to their diet and had too much sodium, the doctor can receive alerts about that and address it before patients are readmitted. “The whole goal is to keep people out of the hospital. It seems like the hospital would want that, but with reimbursement and value-based care, it is changing everything,” says Crow.

Not ready to take over
Wearables are exciting, but they aren’t advanced enough yet to take over the turf of traditional monitors. The most that wearables can do is monitor heart rate, respiratory rate and ECG, but in an inpatient setting you need to also be able to monitor end tidal CO2. “Traditional patient monitors that are mounted on the wall, plugged into a centralized system — they can monitor a lot more parameters than the wearable sensors that are being offered right now,” says Kerry Riek, associate in the applied solution group at ECRI.

The reliability of the wireless network is also a concern for high-acuity patients in particular. “There is a chance that a wireless signal can drop out and I’m not sure how robust redundancy is for wireless networks in hospitals,” says Riek. For now, there seems to mainly be an interest in using wearables as a supplemental technology for lower-acuity monitoring and helping nurses with some of their tasks. VitalConnect’s VitalPatch, which is a Band-Aidlike, disposable wearable, was designed for those purposes.

“We are not so much a replacement for that spot check as we’re a supplement that gives you updated information showing that a patient’s condition may have changed between the times when you are picking up some of these other measures,” says Valeska Schroeder, senior vice president of product management at VitalConnect. But Scripps’ Steinhubl believes that eventually wearables will replace traditional monitors.

“I think that in the future, if you are sick enough to be admitted to the hospital, that means that you are probably sick enough to be monitored continuously, and right now the vast majority of people in the hospital aren’t,” he says.
Technicians have to watch telemetry systems all night and listen for alarms that go off, but Steinhubl thinks that with wearables there will be much more personalized care with better data analytics, so clinicians get earlier warning signs of any pending deterioration.

He believes the monitors and the information obtained won’t change, but how that information gets to the monitors will change and the type of information will most likely improve. In the ICU, most patients don’t have continuous blood pressure monitoring, but if it can be done noninvasively then all patients should be able to benefit from it.

Philips entering the market
In late February 2016, Philips Healthcare announced that it will introduce a wearable biosensor solution for at-risk patients in low-acuity hospital settings such as the general ward. The biosensor monitors heart rate, respiratory rate, skin temperature and other factors and then transmits the data to a clinical decision support software application to notify the clinician when the patient is deteriorating.

The idea for this biosensor came as a result of conversations Philips had with providers that were looking to help at-risk patients in low-acuity hospital areas through recovery and transition to home care. Philips has plans to launch a portfolio of integrated solutions that connect with analytics tools. “It’s less and less about the actual data — you sometimes think this data does a great job because it’s so big and great — but they are after actual situation data, which is predictive and helps them to save lives and costs,” says Carla Kriwet, CEO of patient care and monitoring solutions at Philips.

Integrating with EMRs
“It is no longer about just collecting and presenting information at the bedside or at the central stations. Information now needs to flow seamlessly to the EHR,” says Jeff Corliss, marketing executive of medical devices and informatics at Mindray. According to MD Buyline, 85 percent of patient monitors purchased today are bought with integration in mind. Major vendors like Philips, GE Healthcare, Nihon Kohden, Welch Allyn, Spacelabs and Mindray are able to integrate with leading HER vendors like Cerner, Epic and MEDITECH.

“It’s ridiculous to spend that much money buying a new telemetry system or upgrading a current system and not having device integration,” says Crow. “It’s such a time saver and a patient safety factor that it pays for itself.” It’s not a costly investment because it mostly involves software and wireless connectivity. With hardwire monitors, it’s not a big project because those are plugged into the network, but telemetry systems can cost about $1,000 per monitor.

Also, the productivity that hospitals gain on the nursing side and having that information in real time are worth the investment. For physicians who come by to look at the EMR, they won’t have to wait 30 minutes to an hour for the technician to enter the vital signs. Welch Allyn’s Connex Spot Monitor, which received FDA approval in January, is designed to wirelessly transmit data directly to the EMR. The company has been integrating their monitors with EMRs since 2007, but this is the first time it offered a monitor that is designed for both acute care and physicians’ offices.

“It’s something hospitals are interested in because they understand how busy nurses are and the issues with accuracy if they are writing down vitals for a patient on a sticky note,” says Alton Shader, president of Welch Allyn. It’s a way to ensure that they have the most updated and accurate data in the EMR, which is critical since hospitals are increasingly using that data to create care plans for their patients.

Mindray responded to the trend by offering simplified connectivity solutions including its eGateway, which serves as a “single pipe” from Mindray monitoring technology to the hospital’s EHR. The eGateway is based upon industry standards, including HL7 and the IHE PCD protocols, designed to support fast integration within the hospital IT environment.

In 2006, some of the early adopters started looking into device integration, but when the HITECH Act of 2009 was put into place it didn’t include integration so interest declined. However, more hospitals have started looking into this again over the past 15 months, according to Jeff McGeath, senior vice president at Iatric Systems. “Now people are still shopping, but they want to base it on what they need for clinical improvement and quality improvement measures, and not something to be handed to them through huge legislative incentive programs,” says McGeath.

Iatric Systems is a third-party company that assists hospitals when they want to integrate their monitors and EMRs. Halifax Regional Medical Center in North Carolina was interested in this because of the potential benefits, but the monitors kept dropping off of their wireless network. “The nurse would walk into the room and go to the patient and [the monitor] would say, ‘no network,’ and then they would have to reboot the monitor to reconnect it to the wireless network,” says Robert Gordon, senior IT leader at Halifax Regional Medical Center. “It would take up to two minutes for the monitor to reconnect and nurses aren’t very patient.”

Another issue was the fact that the monitors captured a lot of data that they didn’t necessarily need. To solve that, the nurses looked at the data and decided what really needed to be in the EMR, and Iatric made sure that only that information was entered. Once all of those problems were fixed, the medical center was able to reap the benefits of integration. Most notably, they saw a reduction in error rate and the nurses saved five to 10 minutes every two hours for each patient.

Monitoring a new parameter
Two or three years ago, being able to monitor end tidal CO2 was seen as something that was nice to do, but now it’s becoming almost a standard, just like pulse oximetry, blood pressure and temperature. “Everyone thinks about oxygen, but if your CO2 level is going up that tells me quickly that there is something wrong with your respiratory status, rather than waiting for your oxygen levels to drop,” says Jeff Moffatt, senior marketing manager of interoperability and integration at Dräger.

When the American Heart Association came out with the 2015 CPR updated guidelines, it was strongly recommended to do end tidal monitoring. In addition, the Joint Commission put out guidance for monitoring patients who are on opioids and called for CO2 to be more of a standard of measurement. There has been a great deal of research done that has shown that if you manage a patient’s pain with drugs like morphine, you can improve their condition and get them out of the hospital quicker, says Moffatt. Because of that, there has been an increase in pain management as well as an increase in monitoring these patients.

“One death can really make a big financial impact on a hospital if there is litigation,” says MD Buyline’s Crow. “Buying monitors to make sure that the patients are safe and have good outcomes just makes sense.” Many monitoring systems on the market offer end tidal CO2 monitoring, including Welch Allyn’s Connex Vital Signs Monitor. “As hospitals are more interested in tracking the deterioration of their patients and respiratory depression, end tidal CO2 is definitely a parameter that we’re hearing more about and offering to more of our customers today,” said Welch Allyn’s Shader.

Clinical decision support
In early March, Philips announced the launch of its IntelliSpace Console Critical Care, which is a cloud-based decision support dashboard for the ICU. It was the result of a multi-year clinical study and research collaboration with the Mayo Clinic and Ambient Clinical Analytics. “The complexity of the data you get in the ICU is immense,” says Kriwet. “If you look at the EMR systems right now, it’s totally impossible even for experts in our house to understand what the data is about. At the same time, you are at the point where people are in a situation of life or death.”

The Philips dashboard gives clinicians access to patient data across multiple systems and EMRs to help them analyze and prioritize complex patient data quickly. It’s especially important to have the capability in the ICU where every second matters. The IntelliSpace Console is being hosted on Philips’ HealthSuite digital platform, which is an open, secure, cloud-based platform that can collect, store and analyze data from multiple sources. The Mayo Clinic developed it under the product name AWARE and Philips will be working with Ambient Clinical Analytics to bring it to market in the second half of 2016. “In these critical times it’s so important to make sure that the data you have is organized in a way that is useable for you,” says Kriwet.