Category Archives: Devices

eResponder Personal Emergency Response System (PERS): it doesn’t get much simpler than this

eResponder, cellular based Personal Emergency Response System (PERS)

eResponder, cellular based Personal Emergency Response System (PERS)

Typical Personal Emergency Response System (PERS) work well around the house. They communicate reliably with a base station that’s connected to a landline and the units have long battery life. The technology is old but reliable, and the systems provide peace of mind for those who are living alone and for their kids. A greater challenge arises when trying to develop a system that works well for people who want to leave their homes and get out of range of their base stations.

The obvious solution is to use cellular technology. But cellphones are complicated for many elderly folks to use, and they have to be charged up at least every few days. Cellular service also isn’t as reliable as a landline.

For the last couple months I’ve been trying out the eResponder by Securus. It’s a small, 1.2 ounce cellphone based pendant device that you can hang around your neck or from a belt. I’ve been pretty impressed with it. In case of emergency you simply press the single button on the unit for two seconds. Within about 10 seconds you are connected to an “emergency care specialist” who asks if you need help. I’ve gotten through right away every time I’ve pressed the button. (I tell them I’m just testing the unit –and they seem cool with that.)

There is a speaker and a microphone on the device –it’s essentially a mini speaker phone. The voice on the other ends comes through loud and clear and they have had no problem hearing me. The eResponder is designed to be worn in the shower, which is a good feature since that’s where someone is likely to fall. Some, but not all other PERS systems are water resistant.

The battery life really is excellent. The company advertises that the battery will last up to 2 months between charges. I’ve been using mine a little longer than that and I didn’t even charge it up when it arrived. That’s a really great feature.

Of course there are some potential drawbacks. The system uses the T-Mobile network. I haven’t had any trouble  but if you’re not near good T-Mobile service that could be an issue for getting through to the center. Also cellphone signals don’t always reach inside of buildings in case you’re using it inside. In addition, the eResponder center uses the same location-finding system as 911 operators. That’s good but at least in my case the eResponder does not deliver pinpoint accuracy to the emergency care specialist.

When I activated the eResponder from an urban area yesterday I asked the operator to tell me if he knew where I was calling from. He answered, “Within four tenths of a mile of 284 Harvard Street.” In fact I was about 4/10 of a mile away –which would not have been good enough for an ambulance to find me. I asked if that was typical and he said that it was in fact pretty typical. He offered that he had seen situations where it located the person to within 1.2 miles of their location. I tried again this morning from the same location and was told I was within 0.6 miles of 881 Commonwealth Avenue. (Securus informs me that this information is used to determine which local emergency dispatch service to contact and isn’t meant to establish the user’s exact location. If the user is transferred to the 911 operator, that operator will have more detailed location information to find the user. Once the 911 operator hangs up, the eResponder emergency care specialist waits on the line until emergency help arrives.)

Presumably a unit with GPS would be bigger, more expensive and use more battery power but would also provide much better accuracy without needing to transfer to 911. (In fact, Securus does make an eCare+Voice device with a GPS, but its battery lasts only a few days.)

I haven’t done a rigorous head to head test of PERS systems, but based on my experience I can recommend the eResponder for people who want a PERS system that can be carried outside of the house, is easy to use and does not need to be charged frequently. Those concerned with immediate, precise location finding or who don’t reside near decent T-Mobile service should select a different solution.

By healthcare consultant David E. Williams of the Health Business Group

EarlySense makes touch-less vital sign monitoring a reality: Transcript

This is the transcript of my recent podcast with EarlySense’s president, Tim O’Malley.

David E. Williams: This is David Williams, president of Health Business Group. I’m speaking with Tim O’Malley, president of EarlySense.

Tim, thanks for joining me today.

Tim O’Malley: Thanks, David, for having me on.

Williams: Tim, can you explain, what is EarlySense? What does the company do in general?

O’Malley: For many years, healthcare providers have tried to find a way to monitor patients in almost all locations of the hospital and even in some subacute care and skilled nursing facilities, to make sure that patients were being served appropriately. So that if there was any sign of deterioration, if there was any sign of physical instability of the patient, they would have a way of capturing these things and giving them early warning that something potentially could be occurring, that could be an adverse event.

And so what we’ve done is developed a sensor that’s placed under the mattress of the patient to monitor the patient’s heart rate, respiratory rate and body motion so that we can help the caregivers avert adverse events, whether it be deterioration or falls and/or pressure ulcers that occur in healthcare settings.

Williams: So, as you mentioned, a lot of people have tried to do this in the past. I know there are various challenges in making it happen. It sounds like what you do is put the sensor under the mattress or the pad instead of on the patient. All else being equal, I would imagine that would maybe be less reliable to use. So, why did you take that approach and does it actually work?

O’Malley: I wouldn’t say it’s less reliable. I think it’s actually more reliable because signals from a traditional product that might be used in deterioration-monitoring would be an EKG lead. Anybody that has been in a hospital or healthcare setting that has seen an EKG lead set. It could be three-lead, it could be five-lead and in some cardiologist settings, it could be 12 leads where they paste electrodes onto the skin. And those are the source of the signals –electrical signals that are then interpreted by the traditional patient-monitoring product.

And there’s clearly still a very big need for that in the high-acuity areas. But when you take that technology and you push it out to the lower-acuity areas, you have the potential for a lot of problems. And problems like alarm fatigue have become a very real concern for the caregivers because you have so many alarms that are generated from this traditional monitoring system because of design for an ICU or acuity care environment. When you put them into an area that has a staff to patient ratio of 1:4 or 1:6 instead of an ICU with a staff ratio of 1:1 or 1:2, you now have the staff spending an awful lot of time trying to manage alarms and manage the technology and not as much time of potentially managing the patients.

So, when you eliminate those leads and sensors out of the patient, you also eliminate a lot of those problems. We have validation studies that compare our technology to the more traditional methods where you actually had sensors on the patient. The accuracy has been within a few percentage points.

And so it is very accurate, it is very proven. We were in about a dozen and a half hospitals in the United States and every day, there’s probably close to a thousand beds that are being used with our technology.

Williams: Say more about alarm fatigue. What is it and how does EarlySense contribute to reducing alarm fatigue? It sounds like this is a key benefit.

O’Malley:  It is indeed one of our benefits. Here again, it’s a tough situation in healthcare. You have a sicker and sicker patient population because the patient population is aging. You have patients that are having procedures much later in life that are somewhat complex. You have patients that are in their golden years having repeated procedures that are pretty significant procedures; those patients will end up post-operatively, maybe 24 hours post-operatively in the med/surg or general care environment.

And they may have comorbidities where they’re having respiratory issues or challenges. They may have some underlying cardiac problems. They may have diabetic issues.  So those patients now have many more comorbidities than just a few years ago.

So, having a piece of technology that you could put at every bed in a convenient way and be able to monitor in a way that is designed for that environment, seems to be a much better way to go. And traditional technology is designed, as I’ve said, for a higher acuity environment, which has a 1:1 ratio of staff to patient.

Alarms are really a kind of traditional threshold alarm. You hit the threshold, you go over that threshold or under that threshold, you’ll get an alarm. With our system, it uses an algorithm to look at the past record of cardiac or respiratory activity and then will actually add those things over that time so that the alarm rate is dramatically reduced. In the med/surg environment, patients are moving, they’re talking, they’re eating or interacting with family. And so, all those things have an impact on a traditional product’s capability to monitor and alarm effectively. And as a result, there’s an awful lot of nuisance alarms and false alarms.

Just recently ECRI and The Joint Commission came out with indicators encouraging caregivers to really watch this phenomena of alarm fatigue, because what happens is that the staff is just bombarded with alarms. Over time, they become desensitized  to those alarms. And that’s, unfortunately, an adverse event that’s starting to occur. That’s when a negative situation can develop.

Williams: Talk about how the changes in healthcare affect what EarlySense is doing. I’m assuming that your discussions about return-on-investment and use cases are influenced by what’s going on in the market. Can you talk a little bit about that please?

O’Malley: It’s an interesting time in healthcare for a lot of reasons. I’ve been in the industry for over 25 years now and I have seen a lot of change, a lot of very positive technological change that has improved patient care. Now healthcare is going to be forced to manage itself much more as a business and that means controlling costs

and managing the revenue streams so that they can maintain their margins. But the reality is that, in the last few years, there has been a dramatic squeeze on healthcare systems’ margins. In the new environment healthcare systems are looking for true tools to help.

Today, because of the downward pressure on margins and the move to capitation, administrators are being much more diligent in how they evaluate potential purchases. They’re not just looking at the clinical benefit, they’re also looking for economic benefit. Economic benefit could be things like how do you eliminate alarm fatigue in an environment to improve patient care? Or in the case of medical sciences, how do you take a piece of technology and put it into a general environment, like a med/surg environment, to potentially detect deterioration of a patient who otherwise wouldn’t be monitored.

Williams: With the Affordable Care Act, are there specific changes, for example, in hospital penalties for readmissions that affect the way customers think about EarlySense and affect the way that you go to market or develop products?

O’Malley: Yes. We have a customer that’s been using our technology for about two years. And just a few weeks ago, I met with their C-level people and we reviewed the effects of EarlySense in their care area: 36 beds that had been monitored on an ongoing basis.

We looked at the data. We looked at the number of falls and the number of pressure ulcers during all of 2012. And then we compared that to the areas of the hospital that are not using EarlySense and what their pressure ulcer and fall rates were.

It became very obvious that the amount of improvement on the EarlySense side of the hospital was dramatic. In fact, no falls and just a few pressure ulcers – and it was questionable whether or not they actually started before the patients were admitted — compared to the other side of the hospital that had double-digit rates of falls, double-digit pressure ulcer rates.

So then the discussion became, how do we help you get this technology to the rest of the hospital so that you can benefit from it across all the beds? Hospitals are looking at the cost of care for those particular events — pressure ulcers and falls. The beds that were monitored by EarlySense were within the $700 per patient range; the cost of care for the non-EarlySense beds was in the $15,000 range.

Hospitals are looking at these things much, much deeper in that regard. They’re looking at technology like ours that can help drive improvement, to potentially drive different numbers for them.

Williams: How does your business model work? Do you charge on a per bed basis or per day or per patient or based on outcomes.

O’Malley: It’s really quite flexible. We did an economic return on investment with a customer and sat down to review it. The resulting proposal was more of a pay-per-day-per-patient kind of proposal, which is more of the service model.

It can be a variety of different ways that people purchase it. In some cases, we really think we’re going to a revenue sharing model with institutions where we will put some guarantee in place to impact things like fall rates by X percent. And if we don’t meet those guarantees, then there are financial consequences.

Williams: Tim, Governor Deval Patrick traveled from Massachusetts to Israel back in 2011 on a trade mission and one of the tangible outcomes of that was that EarlySense decided to move its headquarters and locate in the US, in Massachusetts. It’s a couple of years or so since that occurred. And I’m wondering, what is the perspective from EarlySense on how that has worked out?

O’Malley: Massachusetts is a very rich environment with med-tech talent. There’s a lot of med-tech companies in Massachusetts. When you are a growing company like EarlySense, you have to look for people to come in to help you build out different parts of the organization. We’re clearly doing that. And so, we’ve been able to attract very talented people in Massachusetts because it’s such a rich environment for med-tech professionals.

In addition, we have also developed some pretty significant customer relationships in Massachusetts with a number of the Partners HealthCare facilities. And that exposure that we gained by Governor Patrick going to Israel and subsequently performing a ribbon-cutting ceremony with us in MetroWest Medical Center, I think certainly helps us gain exposure and credibility.

Williams: This is David Williams with the Health Business Group. I’ve been speaking with Tim O’Malley. He’s the president of EarlySense. Tim, thanks so much for your time today.

O’Malley: Thanks for having us on, David. I appreciate the opportunity to talk about our technology and how we’re able to help healthcare providers avoid adverse events.

EarlySense makes touch-less vital sign monitoring a reality: Podcast

EarlySense make a sensor that goes under a patient’s mattress and monitors heart rate, respiration and movement without needing to affix any leads to a patient. It makes it feasible to conduct monitoring outside of an intensive care unit or inpatient hospital bed, helps reduces “alarm fatigue” by cutting down on false signals, and can improve patient care by reducing falls and pressure ulcers.

EarlySense was founded in Israel and is now based in Massachusetts, the product of Governor Deval Patrick’s trade mission to Israel in 2011. The company’s CEO, Avner Halperin is a high school classmate of mine.

In this podcast interview, EarlySense president Tim O’Malley brings us up to speed on the latest developments and describes how the Affordable Care Act is creating opportunities.

By David E. Williams of the Health Business Group


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From war to bionic legs to immortality

For better or worse, war has provided the impetus for new medical technology. The latest wars in Iraq and Afghanistan have sent home many men and some women who suffered the loss of legs and arms. Although prosthetic limbs have been improving over the years, they are really no substitute for the real thing.

That’s starting to change now, as we learn from an LA Times article about a study published in the New England Journal of Medicine.

A report published Wednesday in the New England Journal of Medicine describes how the team fit [a patient] with a prosthetic leg that has learned — with the help of a computer and some electrodes — to read his intentions from a bundle of nerves that end above his missing knee.

For the roughly 1 million Americans who have lost a leg or part of one due to injury or disease, [the patient] and his robotic leg offer the hope that future prosthetics might return the feel of a natural gait, kicking a soccer ball or climbing into a car without hoisting an inert artificial limb into the vehicle.

[The patient's] prosthetic is a marvel of 21st century engineering. But it is [the patient's] ability to control the prosthetic with his thoughts that makes the latest case remarkable. If he wants his artificial toes to curl toward him, or his artificial ankle to shift so he can walk down a ramp, all he has to do is imagine such movements.

This is pretty remarkable stuff, and great news for the many people who have lost limbs and may benefit. But it also hints at ethical issues that society will have to deal with in the future as the technology gets better and better.

We’ve already witnessed the first signs of what’s to come with Oscar Pistorius, the so-called Blade Runner (and probably murderer) whose artificial legs propelled him in the Olympics at a rate that’s likely higher than what he would have been able to do with “real” legs.

Call me crazy (go ahead) but how long will it be until we have athletes who decide to get bionic replacements for legs, knees, arms, eyes –you name it? I think it will be just 20 years or so. After that, we may find a whole cadre of people taking on replacement parts –including internal organs– in order to improve their health and have a shot at something approaching immortality. If you think there’s a wide divide between rich and poor today just wait until the rich find a way to use replacement parts to increase their strength and extend their lifespans.

I hope I won’t be around to see that happen.

 

How a tough manufacturing process for Advair might help GSK

When GSK introduced its Advair Diskus to the market about 15 years ago, it wasn’t expected to be such a big hit, never mind reaching close to $8 billion in sales as it did last year. It’s actually not so abnormal for demand for new drugs to be way off their initial projections and it’s typically no big deal. If a drug is unexpectedly popular it may take a while for production to ramp up but then the problem is usually over.

But Advair is a different beast. Unlike the typical round, white pill, its complex inhaler mechanism was never designed to be produced in huge quantities in multiple locations around the world, where different environmental conditions and variations in raw materials could make it hard to duplicate. So manufacturing has been a challenge for GSK and consumed plenty of resources.

The pharmaceutical world of 2013 looks a lot different than it did in the 1990s. Advair is now GSK’s biggest product and the pipeline of potential blockbusters does not look all that promising. A normal product would have had plenty of generic competition by now, but GSK has managed to hold onto the whole market. The reason: prospective generic competitors struggle at least as mightily as GSK –and with fewer resources– to produce the darn thing. The FDA is moving, but slowly, to clear a path for generics. It’s still not clear when and if such copies will be available.

So ironically, due to GSK’s inability to anticipate the high demand for Advair and develop an easier-to-make device, the company is now benefiting from a much stronger barrier to entry on its lead product than it could ever have imagined or hoped for.

The strategy looks brilliant in retrospect. If pharma developers are smart they’ll try to pull off something similar with their next launch.

Passivity: the really exciting thing about cell phones and health

There’s a lot of excitement about what smartphones can do for health. There are tons of apps for people who want to diagnose or monitor their condition, look up information, or connect with health care resources. The Boston Globe (My cellphone, myself) highlights Ginger.jo, a company that turns the phone into a medical monitor.

It’s true that there a lot of nifty things a smartphone can do. But the biggest gains will come from technologies that don’t require us to do anything special (like enter data, prick our fingers, or attach electrodes). And there the smartphone is already making a big difference. First, many people keep their phones with them and on just about all the time. That’s a huge hurdle for other remote monitoring equipment that the smartphone has overcome by its overall usefulness. Second, the phone already has passive data gathering capabilities, e.g., with the GPS chips that track location. And third, there is tremendous data generated by the usage of the phone in terms of mapping out who is contact with whom, when, and for how long, and how apps and the web are used.

Until only recently cameras on the phone were just a curiosity or a toy. Now they are used for all kinds of serious purposes like scanning documents and depositing checks. In the next few years I expect more clever sorts of sensors for pulse, ECG, oxygen levels and more to be built into phones, either as dedicated technologies or as extensions of existing general purpose functionality –the way accelerometers form the basis for phone pedometers.

It will be fun to be a part of it.

Uneasy about robots caring for the elderly? Read this

The New York Times Bits blog has one of the better articles I’ve read about caregiver robots for the elderly. The aging population plus fewer family caregivers, fewer available human aides and relentless advances in technology are making the routine use of robotic assistants for the elderly all but inevitable.

One way or another we should expect to see robots enter the home to take care of the elderly. Certain tasks are less controversial. For example, a robot that clears dishes from the table, loads them in the dishwasher and then unloads them when they’re done isn’t that big a deal. That’s only a step or two beyond what a dishwasher does today. But even there you encounter issues of learned helplessness. If the robot can do it, why make the effort, even if effort is what provides purpose in life and staves off physical and cognitive decline?

Then there will be robots that keep track of medications and encourage people to take them on time. Those are probably good, even for non-elderly patients, because they could help boost adherence, reduce medication administration errors, and order refills in a timely manner.

It gets a little spooky when we start thinking about robots that do personal tasks, such as giving baths. And what about robots that act human to engage elders in conversation? It’s pretty clear that a lot of patients develop a relationship with such creatures, especially if they are dressed up like humans or have a human voice. On the one hand that’s a great relief to a remotely located adult son or daughter. The parent will have someone to talk to all day who keeps his/her patience and has plenty of time. But there can be feelings of guilt, too, as the son or daughter realizes they’ve delegated something critical to a machine and may even be unwittingly tricking their parent into thinking it’s human.

Things get even dicier when robots are used to monitor activities and behavior, which may lead to resentment by the parent and loss of autonomy.

I think we’ll just need to get used to these issues and work through them and that if we do so we can get to a generally happier place. The typical model I’ve seen of elders spending their last years accompanied by hired caregivers can sometimes be wonderful, but often has serious downsides.

If and when I get old and am on my own, I’ll be ready for my robot or robots.

Wanted: Advanced training for caregivers + intuitive devices

Increasingly, family caregivers with no formal training are doing the kind of work more commonly associated with hospital-based nurses: operating dialysis machines and ventilators, administering IVs and injections, and using monitors for blood glucose, oxygen saturation and more. AARPs’ Public Policy Institute and the United Hospital Fund have released a new survey on the topic. The Boston Globe has a good article on the subject.

Many of the caregivers are performing advanced tasks such as those described above, but few report getting appropriate (or any) training to do these jobs. In my experience the equipment can be complex and it’s extremely easy to make a mistake. (See my recent, related post about managing a complex pediatric regimen at home.)

It’s unlikely that a great influx of trained, affordable nurses will be arriving anytime soon, but there are a couple paths that hold promise:

  • Hands-on training for caregivers, integrated into doctor visits, with follow-up available by phone and videoconference using Skype and similar readily available technologies
  • Intuitive, consumer oriented equipment and supplies, akin to what Apple has done in the consumer electronics sector. You see it to some extent already in self blood glucose monitoring for diabetes, but there’s a lot further to go. FDA should encourage better consumer usability in its approval process
There should be plenty of profits for those who figure out how to tackle this problem.

Medical device connectivity: Interview with Capsule’s Stuart Long

Hospitals have many devices collecting data on patients, but until recently information from those devices has not been routinely integrated nor stored in electronic medical records. In this interview, Stuart Long, Chief Marketing and Sales Officer of Capsule explains the benefits of medical device integration and how it works in a hospital.

Why is medical device connectivity important, and what benefits does it bring to the patient?

Rapidly becoming a priority for many hospitals, biomedical device connectivity to the hospital network—or medical device integration (MDI)– enables medical devices to transfer patient data from the point-of-care over the network into an electronic medical record (EMR) system or other charting systems. Device integration delivers patient data to clinicians in near real time so that information supporting patient care decisions is delivered timely and accurately.  Without MDI, patient data, particularly vital signs, is transcribed on paper charts and the recording is duplicated by manually having to key the data into the patient’s electronic record. MDI helps assure data accuracy by eliminating manual transcription errors while relieving caregivers from burdensome manual tasks, enabling more quality time with patients.  The bottom line is increased patient safety and care.

 

Why is it important to automate the collection of patient data (i.e. vital signs) and how does this improve the quality of data entering the EMR?

End-to-end automation of patient data collection ensures accuracy and precision.  Full automation removes potential error points along the way as device information is sent to the EMR or other systems.  For example, as I mentioned before that many caregivers read data from a device, manually record it and then input it into the electronic system.  From an administrative standpoint, the need for absolute accuracy of data is greater than ever before.  In addition, having data in electronic format is essential to ensure the full realization of a complete electronic record, which enables data exchange with other hospital IT systems and access to this information hospital-wide. Again, from a regulatory and reimbursement standpoint, the importance of this electronic format is increasing as Meaningful Use (MU) guidelines become more defined.

 

What happens to patient data as it moves throughout the hospital? How is that data being used?

As patient data is collected through electronic means, it is aggregated from software or hardware, analyzed by the connectivity software, and translated into a format appropriate for the hospital IT system receiving the information.  Various hospital departments—whether the ED, OR, ICU or med-surg–may output device data in disparate formats, often completely proprietary formats.  That data then must be translated into a standard format for the EMR and perhaps reinterpreted once again for compatibility with specialized departmental IT systems.  As each new department inputs information, the data is normalized as required and translated for the needs of specific hospital IT systems.  In that way, device information can follow the patient through the hospital, wherever it is needed.

 

What are some of the differences across care units in the hospital? How does that impact the technology being used?

Workflow varies greatly among various care units—the ED, OR, med-surg and step-down, for example, and also varies by hospital.  Med-surg units often have many beds with a limited number of devices shared among them on mobile carts.  Intensive Care, by contrast, may rely on a greater number of devices, which are fixed in location and associated with a particular bed. A quality MDI system seeks to reduce the complexity of its technology by supporting the existing workflow already in place in a particular setting.  Capsule has different hardware and software solutions to support various settings and workflow requirements. Some are wall-mounted units that accept fixed-position devices and are already associated with a specific bed for continuous data collection. Another solution would be a mobile device interface for equipment with no fixed location, which must be associated with the individual patient for periodic data collection.  Data must be validated, and in some settings, a nurse requires flexibility about the timeframe care patients may require immediate attention before caregivers have time to accept data.

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Interview conducted by David E. Williams of the Health Business Group.

Bionic eye: seeing the future

FDA just approved an implant for certain people with severely limited vision. This “bionic eye” does not restore sight but it does help “detect light and dark and help [people] identify the location and movement of objects.” So it could be a big help from a functional standpoint for certain individuals, even though it’s far from perfect and may not be completely safe.

Fast forward a decade or two or three and imagine a time when implants (or some other approach) can restore vision to normal. That will be pretty cool for the many people whose vision is relatively poor and there will likely be a lot of demand for such treatments/devices, even from people that we would not consider visually impaired today.

But then imagine that the technology keeps advancing and gets to the point where technology can improve on natural vision, so that someone with a bionic eye becomes more like the Six Million Dollar Man, especially if they get enhancements not just to the eye but to other body parts as well. I’m in my mid-40s and have a reasonable expectation of living to the time when this moves from science fiction to reality.

If you think about it, we are already starting to get there in limited cases.  Oscar Pistorius, now infamous for other reasons, shows that a double amputee can be as fast or faster as Olympic runners. How soon until other Olympians –who already commit their lives and bodies to the pursuit of excellence– will want body modifications to improve competitiveness?

Obviously the path of medical technology will raise all kinds of ethical issues. It’s time to start the discussion.