Why Your Baby Breathing Monitor Should Be Medically Certified

Every new parents’ greatest concern is the health and comfort of their newborn. That’s why the Snuza HeroMD has been designed to help promote safe sleep for parents and infants worldwide, and undergone stringent and rigorous clinical testing to become the world’s first medically certified portable baby breathing monitor. 

On the whole, babies are incredibly resilient, but tragically, some do succumb to incidences of Sudden Infant Death Syndrome. SIDS (the sudden and unexpected death of a baby where no cause is found), or other more preventable causes like positional asphyxiation or accidental suffocation usually involve a cessation of baby breathing during sleep, combined with a parent being unaware or unable to respond in time. Knowing and reacting early improves the probability of a positive  outcome.

The Snuza HeroMD exists to alert parents if there is a cessation of breathing, by raising awareness so they are able to respond. That’s why it has undergone the rigorous medical device certification process and continues to adhere to stringent regulations to maintain the certification. This includes a mandatory Clinical Evaluation phase to prove that the Snuza HeroMD is able to reliably detect the cessation of breathing in infants, earning it the status of being a true apnea monitor worthy of medical device certification. Today it’s one of few devices on the market with this badge. 

Unfortunately for many parents, they are unknowingly investing in baby breathing monitors that have not been clinically evaluated and certified, which means they have not gone through the required processes to prove safety or efficacy, thereby creating a significant risk.

Ensure your baby breathing monitor is medically certified.

Even though the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK has reinforced the importance of having this medical device certification by ruling that all* baby breathing and movement monitor devices are now required to apply for Medical Device Certification and become compliant in order to be allowed on the UK market. We are still seeing breathing monitors without this certification being marketed on leading online platforms and in high street retailers.  

You can easily check for a “relevant medical device conformity mark, either a CE mark or a UKCA mark, or a combination of those markings”, with the manufacturer’s Notified Body number alongside it. You can also look at the ‘disclaimer’ section of breathing monitor websites - many of them hide the fact that they aren’t medical devices in the small print. 

*This decision does not apply to stand-alone audio/visual monitors, which simply provide parents and caregivers with a live audio or audiovisual feed of their baby. However, audio/visual monitors with a built-in breathing/movement monitor will require certification.