Smartphone-Integrated Infant Physiologic Monitors
In retrospect, it was only a matter of time before digital, health-related "wearables" would infiltrate the lucrative baby care market. The large, plastic, audio-only baby monitors of the past are rapidly being replaced by physiologic sensors that, combined with a smartphone app, are capable of measuring heart rate, blood oxygen saturation, respirations, and change in body position. These sensors, which are integrated into a sock or a "onesie" or clipped onto a diaper or sleeper, send an alert to the caregiver's smartphone when one of the monitored parameters drifts outside of preset ranges.
This technology is highly appealing to certain new parents, despite price tags ranging from $150 to $300. In addition to the expense, serious questions have arisen about the accuracy, effectiveness, and safety of these devices. To date, manufacturers have sidestepped the cost of regulatory oversight by the US Food and Drug Administration (FDA) by avoiding any direct assertions that their monitoring devices can prevent sudden infant death syndrome (SIDS), but such a claim is implied. Instead, manufacturers profess to be selling "peace of mind."
In a recent commentary, Christopher P. Bonafide, MD, MSCE, and colleagues outlined their concerns about the general public's premature and widespread adoption of these devices, before accuracy, effectiveness, and safety have been ascertained. There are, they write, "no medical indications for monitoring healthy infants at home." Medscape recently spoke with Dr Bonafide to expand on these concerns and provide guidance to clinicians who have the opportunity to educate and advise new parents about the use of infant physiologic monitors.
Medscape: Tell us about smartphone-integrated infant physiologic monitors. What do they monitor? How many different devices are available in the United States?
Dr Bonafide: The available products range in style from diaper clip devices (sensors that detect the infant's breathing/movement) all the way to devices that have pulse oximetry and heart rate monitoring. The market is growing rapidly, and at this stage, between five and 10 different models are available for purchase.
A range of technology is at play. Pulse oximetry-based devices attach to the infant's foot and provide heart rate and blood oxygen saturation based on photoplethysmography. Models that measure respirations do so not with impedance, but with a motion sensor or accelerometer that detects movements of the chest or abdomen. Manufacturers have taken the approach of measuring a subset of these physiologic parameters, but not all in a single device.
Medscape: In the JAMA commentary, you focused on healthy infants, emphasizing that there is no role for smartphone-integrated physiologic sensors in this population. Is this type of home-based monitoring appropriate for any other groups of infants, such as premature infants or the siblings of babies who died of SIDS?
Dr Bonafide: The reason why we don't monitor healthy infants in general (and this is regardless of whether it's an over-the-counter device or a medical monitoring device approved by the FDA) is that no benefit has ever been shown from doing so. Some big studies have looked at this, but no evidence has suggested that monitoring a baby continuously or during sleep can prevent SIDS.
Not only is there no benefit, but there is potential harm. Whenever you do a test, whether it's a blood test or using a device that measures vital signs continuously, you risk detecting some changes that aren't clinically important. In the context of infant monitoring, you might detect a heart rate that truly is elevated because the baby is crying. The heart rate rises to 200 beats/min, and an alarm goes off. When the baby stops crying, the heart rate goes back to normal. Or the baby has a brief, resolving oxygen desaturation while asleep.
What should the parents do? They are now put in the position of making a medical decision on the basis of data they have not been trained to interpret. We've already heard reports of parents bringing their babies to emergency departments after alarms from these devices, where the infants might be subjected to blood tests, radiography, and even admission to the hospital. This brings a lot of anxiety to the parents, and there are financial implications as well.
We are often asked about monitoring for babies who were very premature, or who have chronic cardiac or respiratory conditions. Parents of ill or otherwise vulnerable infants should always feel empowered to talk to their doctor if they feel that their baby is at risk. They can then have an informed conversation about the best way to keep their baby safe at home. In most cases, it is unlikely to involve a home monitor. And if the baby does meet criteria for monitoring, we should be recommending monitors that have been cleared by the FDA as medical devices.
If parents have already purchased one of these devices and are using it at home, I would urge them to have a conversation with their pediatrician and make a plan for how they will respond to alarms when they occur—because they will.
Are They Safe?
Medscape: In addition to anxiety and unnecessary testing following a false positive alarm, what other safety issues have you identified with these devices?
Dr Bonafide: It's important to recognize that unlike other medical devices, these infant monitoring systems have not been cleared by the FDA. When new medical devices come on the market, they have to go through a clearance process and a 510(k) application must be submitted. The device-makers would have to show substantial equivalence—in other words, that their device is at least as good, accurate, and safe as existing legally marketed medical devices. That will require the companies to generate data and prove to the FDA that their devices meet those standards.
These consumer monitors are currently regulated only by the Consumer Product Safety Commission (CPSC)—the same group that regulates and reports on the safety of desk chairs and lawnmowers. The CPSC mainly looks for major safety issues, such as potential for strangulation or catching on fire. It's not the same level of scrutiny that characterizes an FDA evaluation.
Another concern is the lack of quality control in the manufacturing process, especially with respect to the source of the device's components. Device manufacturers may be buying sensors from third-party sources, using one supplier one week and another supplier the next. It's challenging to ensure consumers that the devices are safe if the components come from a range of suppliers with potentially different quality standards.
As something new on the market, it's a fair question to ask whether we know for certain that these devices are not going to harm the infants on which they are used. You may recall that the early pulse oximeters would sometimes cause burns. Furthermore, some of these devices must fit tightly around the baby's foot or ankle to achieve an accurate reading, which poses a risk for blisters and skin breakdown if worn for a prolonged period. It's in our best interests to evaluate these devices not only for accuracy, but also for safety. No one has done that.
Are They Accurate?
Medscape: You have mentioned that there are questions about accuracy. Can you elaborate on what we know about the accuracy of the various devices?
Dr Bonafide: Accuracy is important in two aspects of these devices: the hardware and the software. The hardware issue pertains to the accuracy of the device attached to the baby. Is it measuring what it's supposed to be measuring? What's the quality level of that device? Is it capable of capturing an accurate signal?
The software component addresses how the raw signals coming from the device are processed to display pulse or oxygen saturation. Rendering those signals into numbers on the smartphone screen involves measuring, smoothing, and averaging. We just don't know how accurate these numbers are because the manufacturers have not been required to submit data to any third party, such as the FDA.
So the answer is that to date, we know nothing at all about the accuracy of these devices. But even if they turned out to be highly accurate, the clinical appropriateness of monitoring healthy infants would remain in question.
Medscape: In your commentary, you also mention that we don't know anything about the effectiveness of the monitors. What do we hope to see in terms of effectiveness?
Dr Bonafide: Because there currently is no indication for use, we don't have any outcome to measure that would demonstrate effectiveness. I would direct that question to the companies selling these devices. I would say to a company such as Owlet, which claims to have 80,000 customers, show us the data that suggest these devices are detecting clinically important changes, and let's compare those data with the false-alarm rate. I haven't yet seen any compelling data from the monitor companies. They should share the findings of their internal research in a peer-reviewed journal.
There are plenty of anecdotes out there, some of which are used on the manufacturers' websites in videos to sell the devices. Parents tell stories of an alarm going off, and the baby had some formula in his mouth and they patted him on the back and he was fine. Most normal babies have intact neurologic systems that protect their airways. If they have formula near their airway, they are able to clear it on their own. It's impossible to know from such stories whether these devices are actually helping to detect anything that is clinically important.
Medscape: What should clinicians tell parents who ask about using these physiologic monitors at home? How do you help parents make more informed decisions about spending hundreds of dollars on a baby monitoring device?
Dr Bonafide: It's a good idea for pediatricians to ask whether new parents are using one of these devices. If they find that parents are using them on normal, healthy babies, clinicians should be clear that there is no evidence that monitoring has any benefit, and could potentially lead to harm.
It's a bad idea for parents of babies who are chronically ill with pulmonary disease or who need home oxygen to use these devices. If a baby really needs continuous monitoring, that should be done with medically prescribed FDA-approved monitors.
Say that a parent comes in for a newborn checkup and says, "I've read about these $250 pulse oximeters. Should I get one?" Pediatricians should discourage these purchases. There is no good reason to monitor a healthy infant, and these devices generate a lot of alarms. A parent who was using one of these devices told me, "The alarm only wakes me up an extra four or five times a week." All of those were false alarms. The baby was fine. That's a big deal if you are already sleep-deprived.
The danger of these devices is that in a sense, they boil a baby down to a number. That number is no guarantee of either illness or wellness. I suspect that most parents who are hoping that the devices will give them peace of mind and make life easier will be disappointed.
Medscape: What do you do when you are called by a parent in the middle of the night because their infant monitor has alarmed?
Dr Bonafide: The response from the pediatrician on the other end of the line should be, "How is your baby doing now? What's going on?" If the answer is, "I checked, and the baby is fine," then they probably don't need to go to the emergency department. Most likely, it was just a false alarm.
But this is something that every pediatric practice needs to prepare for. They need to decide collectively what their response is going to be to parents who call and say that their infant monitoring device is alarming. This is a problem, because we don't know the accuracy of these devices. We don't know whether we can trust them. It's a challenging position.
What Does the Future Hold?
Medscape: Do you see a future role at all for infant home monitoring devices?
Dr Bonafide: There is certainly an opportunity for research in this area, because there are categories of babies who might benefit from an FDA-approved monitoring device. But we don't know that yet. For example, many babies are kept in the neonatal intensive care unit for long periods after an apnea or bradycardia event. Could an FDA-approved that has been studied in that setting be useful in the home setting, allowing babies to be discharged earlier? Maybe. If that were the case, parents would receive guidance from healthcare providers about what to do when an alarm goes off. Potentially, these devices could substitute for some of the existing FDA-approved monitors (which are clunky, not wireless, and not very portable) for use in the home.
If the device companies are interested in breaking into that area, they should think about partnering with academic organizations and children's hospitals to do the necessary studies.
Medscape: What else would you like healthcare providers to know about infant physiologic monitors?
Dr Bonafide: One thing that has come up is that parents may be using these devices to make them feel okay about unsafe sleep practices, such as prone positioning, cosleeping with their babies, or having objects in the crib. They believe that the monitors will prevent SIDS.
But before parents buy one of these devices, it's important for us to make sure they are following the American Academy of Pediatrics (AAP) recommendations that we actually know can reduce the risk for SIDS. I tell parents to put their baby to sleep in a crib or bassinette that is "quite boring"—a flat, firm crib mattress with a tight-fitting crib sheet, and no crib bumpers, pillows, loose blankets, or stuffed animals. I encourage breastfeeding, which provides many benefits in addition to reducing the risk for SIDS.
Another AAP recommendation is having the baby share a room, but not a sleep surface, with the parents for at least the first 6 months of life. Rather than purchasing a monitoring device with unproven benefit and possible harm, parents should follow the evidence-based AAP recommendations for safe sleep.
© 2017 Children's Hospital of Philadelphia and Medscape
Cite this: Warn Parents About Harms of Baby Monitoring Apps, Ped Says - Medscape - Feb 22, 2017.