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Marketing wearable home baby monitors: Real peace of mind?

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MEDICINE AND THE MEDIA
Marketing wearable home baby monitors: real peace
of mind?
The peace of mind for which parents buy expensive but unregulated wearable monitors, and on
which their marketing depends, may be illusory, David King writes
David King clinical lecturer in paediatrics, Academic Unit of Child Health, University of Sheffield,
Sheffield S10 2TH, UK
Wearable devices for infants are a growing industry. In April
2014, the US company Owlet announced that it had raised
$1.85m (£1.2m; €1.5m) to develop and launch a “smart sock”
that can be attached to a newborn baby’s ankle to monitor its
vital signs.1Parents can use a smart phone to check heart rate,
oxygen concentrations, and skin temperature and to receive
alerts if the child rolls over.
Owlet’s chief executive, Kurt Workman, is ambitious. “We see
the wearable future will include every single baby coming home
from the hospital with a wearable monitor,” he told the
Telegraph.1The company states that these devices will give
parents “peace of mind and maybe even a full night’s sleep.”2
The product is still in development but can be reserved online
for $250.
Another company, Rest Devices, has developed Mimo, which
is available for $199.99. This is a baby grow with inbuilt sensors
that monitor a baby’s respiratory rate and temperature.3
Sproutling is another start-up company aiming to capitalise on
this market. It has released details of a device to be worn around
a baby’s ankle that can monitor heart rate and temperature and
will sell at a recommended price of $299.4
Sudden infant death syndrome
To older paediatricians this may sound familiar. In the 1980s
and 1990s a plethora of similar products was developed and
sold with the intention of reducing sudden infant death syndrome
(SIDS). Unfortunately epidemiological studies showed that such
devices had no effect on the incidence of SIDS in healthy
infants.5-7 The American Academy of Pediatrics states that home
cardiorespiratory monitors should not be used as a strategy to
reduce the risk of SIDS.8
Home monitoring may be justified in some situations, such as
for preterm infants or infants who need oxygen. But in these
cases parents and other caregivers should be trained in
observation techniques, operation of the monitor, and infant
cardiopulmonary resuscitation.9
Owlet, Rest Devices, and Sproutling do not claim that their
devices reduce the risk of SIDS. However, parental fears about
SIDS have driven the development of their products—and the
themes in their marketing. Workman, in a press release for the
Owlet monitor, said that part of the inspiration for the product
was that he “had a cousin pass away from [SIDS].”10 The chief
executive of Sproutling, Chris Bruce, was quoted in Time
magazine as saying that the idea for the product arose because
he was incessantly checking the baby monitor after the birth of
his first child to make sure she was still breathing.11
In its promotional video, Owlet shows a mother saying that she
is “one of the mums who puts my fingers in front of [my baby’s]
nose to make sure she is breathing and my hand on her chest to
make sure it is going up and down.”12 Rest Devices does not
mention SIDS in its marketing but does state that use of its
device gives “relief from that heavy anxious feeling” and “keeps
babies safe.”3
Both Sproutling and Rest Devices include a disclaimer on their
websites to say that there is no evidence that their devices can
reduce the risk of SIDS.3 4 However, in the case of Rest Devices
this disclaimer is in small print under its terms of service and
is not prominent.
Regulatory approval not needed in the US
None of these products requires approval from the US Food and
Drug Administration. They are not yet available in Europe, and
it is unclear whether regulatory approval will be needed here.
Owlet and Rest Devices originally wanted their products to be
sold as medical devices and were planning to gain FDA approval
before launch. However, representatives from both companies
have said that the time and expense that this process would have
required made it unfeasible.13 14
They both acknowledged that they modified their products so
that they could sell them direct to consumers without any need
to apply to the FDA. Owlet’s cofounder Jacob Colvin explained
that the alarm was removed so that it could be sold as an
d.a.king@sheffield.ac.uk
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BMJ 2014;349:g6639 doi: 10.1136/bmj.g6639 (Published 18 November 2014) Page 1 of 2
Feature
FEATURE
unregulated monitoring device.12 Similarly, Dulcie Madden,
head of Rest Devices, said that by removing any alarms and
making the Mimo a product for consumers, rather than a medical
device, the company could circumvent the need to apply to the
FDA for regulatory approval.13
Owlet states on its website that the device “alerts you if
something appears wrong with your baby’s heart rate or the
amount of oxygen in his/her body.”1Rest Devices claims that
its product allows parents to see their “baby’s breathing patterns,
in real-time.”3Sproutling says that it will let you know “if your
baby is sleeping soundly or if something is wrong.”4No
published data support any of these claims, and because the
devices are being sold as consumer rather than medical devices
such data are not required. Ideally, manufacturers would be
required to undertake observational studies or randomised trials
to support any claims they make concerning the utility and
efficacy of wearable devices in infants—even if they are
categorised as consumer devices.
But until that time medical professionals and consumers need
to be aware that such devices have no proved use in safeguarding
infants or detecting health problems, and they certainly have no
role in preventing SIDS. Healthcare professionals should not
recommend these products to reduce parents’ fears of SIDS but
should instead focus on interventions that have been proved to
work, such as encouraging parents to put infants on their back
to sleep.8
Despite disclaimers in small print on the companies’ websites
saying that the products are not medical devices, parents may
not be fully aware of the implications of this when spending
several hundred dollars on these products. Manufacturers should
place prominent disclaimers at the point of sale to emphasise
that they are not medical devices and that no evidence shows
that they reduce the risk of SIDS or have any other health
benefits.
Workman told me that Owlet was planning to place a disclaimer
on its website saying that the device did not reduce the risk of
SIDS. He was keen to emphasise that its main function was to
offer parents “reassurance.” In addition, he wished to highlight
that some small trials were ongoing and that the company
eventually planned to apply for FDA approval. Rest Devices
and Sproutling did not reply to my attempts to contact them.
Are the manufacturers of these wearable devices for infants
being completely transparent with their future customers? If
they are not, the risk is that the substantial amounts of money
that parents pay for such devices might lull them into a false
sense of security.
Competing interests: I have read and understood the BMJ Group policy
on declaration of interests and declare the following interests: none
Provenance and peer review: Not commissioned; not externally peer
reviewed.
1 Peck S. Baby monitor 2.0 is born: but does it spell the end of maternal instinct? Telegraph
2014 Apr 24. www.telegraph.co.uk/women/mother-tongue/10785072/Baby-monitor-2.0-
is-born-but-does-it-spell-the-end-of-maternal-instinct.html.
2 Owlet. Introducing the Owlet smart sock. www.owletcare.com. Accessed 10 Nov 2014.
3Rest Devices. Stay connected with the Mimo baby monitor. http://mimobaby.com. Accessed
10 Nov 2014.
4 Sproutling. Meet Sproutling. The smarter baby monitor. www.sproutling.com. Accessed
10 Nov 2014.
5Hodgman JE, Hoppenbrouwers T. Home monitoring for the sudden infant death syndrome:
the case against. Ann NY Acad Sci 1988;533:164-75.
6 Ward SL, Keens TG, Chan LS, Chipps BE, Carson SH, Deming DD, et al. Sudden infant
death syndrome in infants evaluated by apnea programs in California. Pediatrics
1986;77:451-8.
7Ramanathan R, Corwin MJ, Hunt CE, Lister G, Tinsley LR, Baird T, et al. Cardiorespiratory
events recorded on home monitors: comparison of healthy infants with those at increased
risk for SIDS. JAMA 2001;285:2199-207.
8 Task Force on Sudden Infant Death Syndrome, Moon RY. SIDS and other sleep-related
infant deaths: expansion of recommendations for a safe infant sleeping environment.
Pediatrics 2011;128:e1341-67.
9 Committee on Fetus and Newborn. American Academy of Pediatrics. Apnea, sudden
infant death syndrome, and home monitoring. Pediatrics 2003;111:914-7.
10 Owlet Press Release. Owlet baby care creates the first wearable tech for babies, sending
heart rate & oxygen levels to a parent’s smartphone. 26 Aug 2013. www.owletcare.com/
Media%20Kit.zip.
11 Begley S. The Sproutling is like Fitbit for your baby—but better. Time 2014 Aug 7. http://
time.com/3086806/sproutling-baby-monitor.
12 Owlet Care. Owlet vitals monitor—see your child’s heart and oxygen levels on your
smartphone. www.youtube.com/watch?v=q-5YDBp63uk.
13 Rollins Center for Entrepreneurship and Technology. IBMC 2013: team Owlet—1st place.
www.youtube.com/watch?v=rS6fHW9pRek.
14 Startup Bootcamp. Dulcie Madden (Rest Devices). www.youtube.com/watch?v=-
GxILsGkRAc.
Cite this as: BMJ 2014;349:g6639
© BMJ Publishing Group Ltd 2014
For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
BMJ 2014;349:g6639 doi: 10.1136/bmj.g6639 (Published 18 November 2014) Page 2 of 2
FEATURE
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... There is lack of evidence that medical monitors and non-medical devices are helpful in the prevention of SIDS [5]. Nonmedical baby monitors containing sensors for vital parameters have been criticized due to inaccuracy, lack of published supporting data and technological limitations [6,7]. Motion trackers, detecting motion over 3 space axes by means of gyroscopes, accelerometers and magnetometers have been developed and are mounted in mass produced devices like smart-phones and -watches. ...
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... Another risk of digital monitoring tools is that they foster a false sense of complacency when parents believe the monitor will compensate for their lack of vigilance or an unsafe sleep environment. Little is known about whether these devices enable intervention should the infant experience a physiological crisis, and all these devices carry disclaimers that they cannot prevent SIDS 36 . Although widely available and used by parents, there are concerns about the suitability of these products for use by the public; one digital infant monitoring product was removed from the US market when the Food and Drugs Administration (FDA) warned that the product was a medical device requiring FDA approval to be marketed and sold 37 . ...
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... Indeed, while many parents infer that the Owlet is a device to prevent Sudden Infant Death Syndrome (SIDS), the Owlet is not certified as a medical device, and in the fine print it warns that it, in fact, cannot prevent SIDS. The device has been the subject of warnings from the American Academy of Pediatrics (Bonafide et al., 2017;King, 2014), which notes that the Owlet and similarly wearables can both provide false warnings, needlessly distressing parents, but also falsely reassure at times when it should not, and in both cases this impacts negatively on a child and parents' health. However, despite these limitations, the company behind the Owlet continually imply that their smart sock is a viable safety measure for infants, and have enlisted a large number of parental influencers, including celebrity parent influencers such as Katherine Heigl, to promote the Owlet on their social media presences (Leaver, 2017). ...
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Home monitors designed to identify cardiorespiratory events are frequently used in infants at increased risk for sudden infant death syndrome (SIDS), but the efficacy of such devices for this use is unproven. To test the hypothesis that preterm infants, siblings of infants who died of SIDS, and infants who have experienced an idiopathic, apparent life-threatening event have a greater risk of cardiorespiratory events than healthy term infants. Longitudinal cohort study conducted from May 1994 through February 1998. Five metropolitan medical centers in the United States. A total of 1079 infants (classified as healthy term infants and 6 groups of those at risk for SIDS) who, during the first 6 months after birth, were observed with home cardiorespiratory monitors using respiratory inductance plethysmography to detect apnea and obstructed breathing. Occurrence of cardiorespiratory events that exceeded predefined conventional and extreme thresholds as recorded by the monitors. During 718 358 hours of home monitoring, 6993 events exceeding conventional alarm thresholds occurred in 445 infants (41%). Of these, 653 were extreme events in 116 infants (10%), and of those events with apnea, 70% included at least 3 obstructed breaths. The frequency of at least 1 extreme event was similar in term infants in all groups, but preterm infants were at increased risk of extreme events until 43 weeks' postconceptional age. In this study, conventional events are quite common, even in healthy term infants. Extreme events were common only in preterm infants, and their timing suggests that they are not likely to be immediate precursors to SIDS. The high frequency of obstructed breathing in study participants would likely preclude detection of many events by conventional techniques. These data should be important for designing future monitors and determining if an infant is likely to be at risk for a cardiorespiratory event.
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This Policy Statement was retired May 2012 More than 25 years have elapsed since continuous cardiorespiratory monitoring at home was suggested to decrease the risk of sudden infant death syndrome (SIDS). In the ensuing interval, multiple studies have been unable to establish the alleged efficacy of its use. In this statement, the most recent research information concerning extreme limits for a prolonged course of apnea of prematurity is reviewed. Recommendations regarding the appropriate use of home cardiorespiratory monitoring after hospital discharge emphasize limiting use to specific clinical indications for a predetermined period, using only monitors equipped with an event recorder, and counseling parents that monitor use does not prevent sudden, unexpected death in all circumstances. The continued implementation of proven SIDS prevention measures is encouraged.
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Despite a major decrease in the incidence of sudden infant death syndrome (SIDS) since the American Academy of Pediatrics (AAP) released its recommendation in 1992 that infants be placed for sleep in a nonprone position, this decline has plateaued in recent years. Concurrently, other causes of sudden unexpected infant death occurring during sleep (sleep-related deaths), including suffocation, asphyxia, and entrapment, and ill-defined or unspecified causes of death have increased in incidence, particularly since the AAP published its last statement on SIDS in 2005. It has become increasingly important to address these other causes of sleep-related infant death. Many of the modifiable and nonmodifiable risk factors for SIDS and suffocation are strikingly similar. The AAP, therefore, is expanding its recommendations from being only SIDS-focused to focusing on a safe sleep environment that can reduce the risk of all sleep-related infant deaths including SIDS. The recommendations described in this report include supine positioning, use of a firm sleep surface, breastfeeding, room-sharing without bed-sharing, routine immunization, consideration of a pacifier, and avoidance of soft bedding, overheating, and exposure to tobacco smoke, alcohol, and illicit drugs. The rationale for these recommendations is discussed in detail in this technical report. The recommendations are published in the accompanying "Policy Statement--Sudden Infant Death Syndrome and Other Sleep-Related Infant Deaths: Expansion of Recommendations for a Safe Infant Sleeping Environment," which is included in this issue (www.pediatrics.org/cgi/doi/10.1542/peds.2011-2220).
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In the absence of controlled studies, there is no compelling evidence that monitoring is effective in preventing deaths from SIDS. In many instances monitoring is not appropriate, either because the risk is not sufficiently enhanced or the physiological criteria used to identify infants are not valid. The data available do not show any advantage for monitored infants. More than 10 years of widespread home monitoring of infants has not advanced our knowledge of either the cause or the mechanism of death from SIDS. Rates have declined, but it is unlikely that the decline can be attributed to monitoring. SIDS remains the number one medical cause of death during the first year of life after the neonatal period. Home monitoring is expensive, and evaluation and management of monitored children has diverted financial resources from other lines of endeavor which could be more fruitful. Bergman, Beckwith and Ray voiced their concerns in 1975 regarding the lack of conclusive proof that SIDS is related to sleep apnea, the absence of supporting scientific evidence that home monitors can prevent SIDS, and the potential adverse effects on the emotional health of the family. These concerns are as valid in 1987 as they were in 1975.
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Home apnea/bradycardia monitoring is frequently used in the management of infants at increased risk for sudden infant death syndrome (SIDS). However, some infants have died despite evaluation by infant apnea programs, and the benefits of home monitoring remain unproven. To determine the SIDS rate and risk factors of infants evaluated by infant apnea programs, 31 apnea programs and ten home monitor vendors in California were surveyed. Eleven (35%) of the apnea programs and four (40%) of the vendors responded. Information was obtained on 26 infants who died. Thirteen (50%) deaths were due to SIDS. Abnormal sleep studies did not predict death. Fifteen infants died despite a recommendation for home monitoring. Seven deaths occurred in association with technical errors or noncompliance with monitoring. Four deaths were due to nonaccidental trauma. The apnea programs evaluated 3,406 infants during a 5-year period; 1,841 had monitoring recommended. Term infants with apnea, subsequent siblings of SIDS victims, and infants evaluated at referral centers were more likely to have monitoring recommended than premature infants with apnea or infants evaluated at nonreferral centers (P less than .0001). Infants who had monitoring recommended were at equal risk of dying of SIDS as those who did not.
Baby monitor 2.0 is born: but does it spell the end of maternal instinct?
  • S Peck
Peck S. Baby monitor 2.0 is born: but does it spell the end of maternal instinct? Telegraph 2014 Apr 24. www.telegraph.co.uk/women/mother-tongue/10785072/Baby-monitor-2.0-is-born-but-does-it-spell-the-end-of-maternal-instinct.html.
Owlet vitals monitor-see your child's heart and oxygen levels on your smartphone
  • Owlet Care
Owlet Care. Owlet vitals monitor-see your child's heart and oxygen levels on your smartphone. www.youtube.com/watch?v=q-5YDBp63uk.
The Sproutling is like Fitbit for your baby-but better
  • S Begley
Begley S. The Sproutling is like Fitbit for your baby-but better. Time 2014 Aug 7. http:// time.com/3086806/sproutling-baby-monitor.
Introducing the Owlet smart sock. www.owletcare.com. Accessed
  • Owlet
Owlet. Introducing the Owlet smart sock. www.owletcare.com. Accessed 10 Nov 2014. 3