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Patient Monitors: sleek, new wearables are attracting attention but traditional monitors remain standard

May 18, 2015
by Lauren Dubinsky, Senior Reporter
The patient monitoring market is exploding, with wearable technologies ranging from activity trackers like Fitbit and the Apple Watch, to patches that monitor ECG, skin temperature, and heart and respiratory rate. But the question is which ones are actually useful for physicians.

The patient wears the device around their neck, on their wrist or attached to their skin and it continuously monitors their vitals in real time so their physician can stay informed on the status of their health. But the problem is that physicians are being hit with a tidal wave of information and a drastic change in workflow is needed for them to stay afloat.

Since the wearable industry is still in its infancy, problems like these are still being ironed out. Companies are working on solutions to get physicians the most important information they need at the time they need it.

But even with this influx of sleek, new wearables, there’s still a need for the larger, more comprehensive monitors commonly used in the intensive care units. However, that could change within the next few years.

Wave of wearables
The global wearable medical device market is expected to grow by 21.3 percent and generate $41.3 billion in revenue by 2020, according to a recent IndustryARC report. Many companies, both OEMs and start-ups, are interested in breaking into this market but not all of them are sticking around.

The one way to separate a consumer wearable from a medical diagnostic wearable device is whether it has approval from the FDA. Vital Connect’s HealthPatch MD scored approval last April and partnered with the telemedicine company, LifeWatch, in November to roll the patch out to hospitals.

It weighs less than 10 grams, is less than a quarter inch thick and is worn on the patient’s skin to continuously measure ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture and steps.

The patch itself is disposable but the sensor chip inside of it is reusable. It can communicate with a smart phone and the data can be sent into the cloud where it can be stored and sent to a physician’s smart phone or a nursing station.

Another company making a splash is Sotera Wireless with its ViSi Mobile System, which received FDA approval in October 2013. It weighs just over four ounces and straps onto a patient’s wrist in the ICU or on the general medical-surgical floor to continuously measure ECG, heart rate, respiration, skin temperature and noninvasive blood pressure. All of the information is sent to a central nursing station and a mobile device, and is also automatically entered into the patient’s EMR.

Philips Healthcare has a range of cableless, wearable sensors on the market including the Philips Mobile CL noninvasive blood pressure cuffs, SpO2 sensors and respiration accessories. When they are used in conjunction with the Philips Cableless Measurement pods, they gather vital sign data as the patient moves throughout the hospital.

“Monitoring is becoming more available and more ubiquitous,” says Dr. Joseph Frassica, vice president and chief medical informatics officer and chief technology officer of Philips Healthcare. “We realize that moving monitors that are geared to and calibrated for the very sick patient in the ICU to lower-acuity settings is probably not the best strategy for health care systems because those monitors that provide enough vigilance for a very sick patient can create quite a bit of noise in a low-acuity setting.”

The cableless sensors are part of Philips IntelliVue Guardian Solutions, which utilizes the information from the sensors to generate acuity scoring so that nurses and physicians can be alerted when a patient is deteriorating. “Guardian automates that acuity scoring so that it happens in real time as the measurements are taken,” says Frassica. “It can potentially activate rapid response teams where they’re needed in a much more efficient way.”

A mix of excitement and skepticism
When it comes to these technologies, physicians have mixed emotions. They’re excited because they see the potential but also skeptical because of the fear that it may interfere with the doctor-patient relationship. Dr. Steven Steinhubl, director of digital medicine at Scripps Health, has encountered a few physicians in the field who express hostility toward the outpatient wearables.

“The hostility isn’t directed toward the technology itself,” he says. “There is the idea that this technology is going to take away the doctor-patient relationship even more.” They think the patient isn’t going to come into the office to discuss their health because they can now remotely send them the wearable information. But Steinhubl tries to explain to them that when well incorporated, these technologies can actually improve that relationship because patients still need a 45 minute office visit with an expert diagnostician and educator who can understand and synthesize all of the complicated wearable data.

Physicians are also concerned about the exorbitant amount of information the wearables produce. “Now they can have this ongoing, constant record over a period of time to learn a lot more about what’s going on with that patient versus just a snapshot when they come into the see them,” says Eric Selvik, vice president of marketing at Vital Connect. “But they are also a little bit wary because it’s a lot of data and they can be a little oversaturated.”

That oversaturation can be detrimental to hospitals. “It’s so much information and the problem that has occurred in the industry is that most people opened up all of that data to the care professionals so they’re seeing every blood pressure reading five times a day from a patient and it’s screwing up their workflow,” says Sean Slovenski, CEO of Intel-GE Care Innovations, a joint venture between Intel Corporation and GE that conducts research on these wearable devices to advise health care organizations.

To solve that, Vital Connect is working with physicians to understand what information they need, so they can create algorithms in order to provide them with only that information. Care Innovations already has its own software and analytics platform for that called Health Harmony, which was launched in November.

The platform figures out what pieces of information the physicians need to prompt them to interact with their patients. Instead of giving them 12 vital readings a day on a patient who just left the hospital with congestive heart failure, they aim to only give them one reading when the vitals fluctuate in an unusual way.

The platform includes a patient portal so the patient can collect and share information on their vitals, a view for the clinician into the portal so they know when to intervene and a view for the family care giver who delivers about half of the care in the home.

Cost is also a concern for physicians since hospitals and practices don’t have as much money to spend in this new health care environment. CMS is currently not providing reimbursement for these technologies, but industry experts believe that hospitals will see a return on investment through avoiding readmissions and satisfying incentives. It’s a given that if a hospital can continuously monitor a patient both in their general wards and at home, they will be able to spot a problem before it becomes costly.

“To put a thousand dollars of equipment into someone’s home, who could cost you several hundred thousand dollars if they get readmitted, is cheap,” says Slovenski. In addition, earlier this year CMS set monthly reimbursement for managing two chronic conditions in individuals. Steinhubl thinks that’s an area where wearables can be used as part of the solution.

What about the traditional monitors?
The traditional patient monitors might not be as sleek and attractive as the new wearable technology, but they’ve still come a long way in the past few years. One of the most notable advancements in recent years is that many of the patient monitors can be integrated with the EMR now. “That’s huge because it saves nursing time,” says Brandi Crow, clinical analyst at MD Buyline. “You don’t have to double document everything.”

When she was working as a nurse in an ICU about ten years ago, she would have to document full blood pressure, heart rate, and cardiac output every 15 minutes, and sometimes even every five minutes, and then enter all of it into the EMR. “That’s a lot of time for data entry, but now with device integration, it can be integrated with the nurse call system, the IV pumps, the ventilators and everything can then be documented in the EMR,” she says. “It has to be validated by whoever is documenting, but it goes in there and you’re not having to double enter and waste a lot of time.”

Welch Allyn released its new Welch Allyn Connex Spot Monitor (CSM) on March 30, which can wirelessly transmit information into the EMR both in a hospital and office setting. “Many customers today have our products out there that aren’t connected to their EMR, and this product is designed with connectivity in mind to bridge the gap for that,” says Garrison Gomez, senior director of integrated solutions and diagnostic cardiology at Welch Allyn.

Gomez claims that this is the only patient monitor on the market that goes across both the hospital and office setting. They have done interoperability testing with EMR partners ahead of its launch and Cerner and Epic are now integrated with the monitor. The next big trend coming down the pike is having it so patient monitors can communicate with other devices. “If you could get the data from these different devices and they could talk to each other, you could utilize the data to help provide better care in real time,” says Jeff Moffatt, senior marketing manager for monitoring and IT systems at Draeger.

End Tidal CO2 monitoring is now becoming a requirement in the med-surg area because of the realization that postoperative pain management patients need to be monitored carefully in order to prevent an overdose.

If a patient-controlled analgesia pump (PCA) and an End Tidal CO2 monitor could communicate with each other, the monitor could alert the PCA pump if the patient’s respiratory status is being suppressed and automatically lock the patient out, preventing them from administering any more dosages.

Draeger is one of the leaders in this area with the introduction of its Smart Device Connect (SDC), which is an open protocol. SDC is not intended to be proprietary—the idea is for medical device manufacturers to adopt these open standards so a range of different devices can communicate.

“The idea of having these closed and open loop functionalities have really taken interoperability to the ultimate level,” says Moffatt. “But at its basic level, the SDC is going to allow devices to talk to each other so you can do things like share alarm data and vital sign information and have more interoperable remote control.”

In with the new and out with the old?
Even with all of the wearables coming to the market, there’s still a need right now for the traditional monitors. Critically ill patients in the ICU require the comprehensive and thorough monitoring only they can provide.

“Heavy duty equipment like that can monitor to a level of accuracy that something held in your hand or placed around your neck or stuck in your watch can’t quite get to at this point in time,” says Slovenski. However, in the next five to 10 years, that could change if the technology improves. “Technology only gets better, faster, cheaper and more accurate over time,” says Slovenski.

Almost all of the experts DOTmed spoke with agree that wearables will replace Holter monitors in the near future. In fact, Steinhubl believes that Holter monitors should be replaced right now. He conducted a study at Scripps almost a year ago that compared a wearable patch and a Holter monitor and found that the patch was much more convenient — it diagnosed 60 percent of clinically significant dysrhythmias and had a lower overall cost.

In general wards, nurses will usually make rounds every six to eight hours to measure patients’ vital signs, but Steinhubl believes that hospitals would benefit from continuous monitoring. “When someone is in the hospital it seems almost ludicrous that you’re not monitoring them 24 hours a day, seven days a week,” he says.

When it comes to hospitals’ goals, nothing is more basic than saving lives and they can achieve that with these wearables that track vitals continuously. As the health care industry moves into an increasingly value-based landscape, saving lives also yields many financial benefits for hospitals.

“It’s only a matter of time that any monitoring equipment in the hospital and anywhere else will eventually be replaced by something much smaller, just as accurate and much less expensive, that the person can have on them anywhere they are,” says Slovenski.

But when that happens is anyone’s guess. “It could be next year — someone could have a major breakthrough — or it could be in 20 years but it’s coming and it will happen for sure,” says Slovenski.