Baby monitors designed to track physiological conditions may be inaccurate and cause parents more stress than necessary, according to a new report published in the Journal of the American Medical Association.
Researchers at the Children’s Hospital of Philadelphia studied two such monitors, the Owlet Smart Sock2 and the Baby Vida, both of which are not regulated by the FDA. Readings from the monitors were compared to Masimo‘s (NSDQ:MASI) Radical-7 device.
“We evaluated how accurate these monitors were in detecting low oxygen levels in infants. One monitor detected those levels when they occurred, but was inconsistent; the other never detected those levels when they occurred. If something is going wrong with a sick infant, you would want to know that 100% of the time,” study lead Dr. Chris Bonafide of the Children’s Hospital of Philadelphia said in a prepared statement.
Investigators examined both hypoxia and bradycardia readings from 30 infants, six months old and younger, that were hospitalized at the Children’s Hospital of Philadelphia between July and December last year. Subjects in the study wore the commercial baby monitor devices on one foot and the Radical-7 on the other.
A total of 12 hypoxia events were reported on the Masimo monitor during testing of the Owlet device, which reported at least one simultaneous hypoxia reading in all 12 patients. Researchers noted that at least once during hypoxia events the device erroneously indicated that five of the 12 had normal oxygen levels.
Results indicated that the Owlet’s overall sensitivity was 88.8% in detecting hypoxia, which was inconsistent compared to the Masimo device. For bradycardia readings, investigators said that devices that failed to detect low oxygen levels also falsely displayed low pulse rates.
For the Baby Vida system, researchers examined a total of 14 hypoxia events detected by the Masimo device, none of which were reported by the Baby Vida device, resulting in a 0% sensitivity. Investigators also reported that the Baby Vida monitor falsely displayed bradycardia in 14 patients with normal pulse rate.
Study authors warned that as more vital sign monitors enter “a largely unregulated marketplace,” physicians and parents would “need to be aware that these machines may trigger unwarrented alarm.”
The research follows an opinion piece published last year by the same researchers raising concerns about consumer use of physiological baby monitors being marketed to parents, and how such devices may cause unnecessary anxiety with no evidence of benefits.
“We previously discussed the consensus in the pediatric community that there is no medical reason to electronically monitor vital signs in healthy babies at home. Our new study adds serious concerns about the accuracy of these consumer monitors, when we compared them to a standardized hospital monitor in a cohort of sick infants. False positives raise the possibility of unintended consequences. Parents who see an abnormally low pulse rate reading might call 911, or unnecessarily rush their baby to an emergency department,” neonatalist Dr. Elizabeth Foglia said in a prepared statement.
Owlet struck back at the research, saying that its system has undergone accuracy testing “conducted by accredited third party labs” verifying that its product meets industry and regulatory standards.
The company pointed out what it claims were inaccuracies within the study, including that the study used high-risk, primarily late premature babies while its products are intended for home use with healthy babies. The company also said that its device did correctly alarm at low oxygen levels, and that there was no mention of whether the babies were moving or not “as this can significantly alter results.”
Owlet also said that testing one device on one foot and one device on the other “is against industry standards for such comparisons.”
“This study compares a consumer product for use in healthy babies with a hospital-based product being used in ill infants. Even in the hospital we don’t react to a single abnormal oximetry alarm, rather than to a trend or critically low values. As I read this study, both trending and critical hypoxia are preserved, especially device A [the Owlet]. Before we use the data in this study to discard a device that may make collection of population-based infant oximetry data possible, we need to be clear about the purpose for which the device is intended,” Dr. Larry Consenstein of SUNY Upstate said in a prepared statement.