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Medical Certification: Why Your Baby Monitor Should Have One


 

There’s one question every new parent asks during the first few months of newborn nap time, and that is: “Is he/she breathing?”. This constant concern about the safety of the little life you’ve brought into the world can lead to all types of anxieties as a new parent (nevermind the constant checking on your infant as they sleep). What if we told you there’s a way to help alleviate this anxiety around nap time (and get some rest yourself) with a lightweight and portable  piece of baby MedTech? Meet the Snuza HeroMD


The Snuza HeroMD is the world’s first medically certified portable baby breathing monitor. It’s development was fuelled by the founder of Snuza’s own concern with infant deaths that involve a baby that stops breathing during sleep, and their caregiver not realising nor being able to intervene in time. These deaths are usually related to incidents of SIDS (Sudden Infant Death Syndrome), accidental suffocation or positional asphyxiation, which are possibly, in some cases, avoidable. 

Educating new parents and raising awareness about how to reduce the risks of medical incidents, such as SIDS, is the mission of organisations like the UK’s Lullaby Trust. By providing research-based advice on safe sleeping products and practices, The Lullaby Trust aims to reduce the number of SIDS-related deaths in the UK, which currently stands at around 200 cases per year. This mission was one that resonated strongly with the team at Snuza, and so in 2019, The Lullaby Trust and Snuza joined forces, showcasing how MedTech such as the Snuza HeroMD apnea monitor could be used to support safe sleep practices. Today, parents who have sadly lost a baby to breathing-related incidents like SIDS are able to receive a Snuza HeroMD through The Lullaby Trust for their rainbow baby.


The Snuza Hero MD provides peace of mind, with the medical industry stamp of approval

With the amount of unregulated baby sleep products on the market, it was important for Snuza to ensure that the Snuza HeroMD met only the highest standards of safe sleep regulation. This meant seeking certification from European Medical Device Regulators. And so in 2016, after several years of development, Snuza undertook a rigorous medical device testing process for their Snuza HeroMD device. The results clinically proved that the Snuza HeroMD is able to detect the slightest breaths (or lack thereof), certifying it as a true infant apnea monitor worthy of medical device status. As of late 2021, it is still the only certified portable device on the market, giving parents peace of mind that they’re choosing a baby breathing monitor with the medical industry's stamp of approval. It was this badge of trust that made it the tech product of choice for The Lullaby Trust’s mission. 


Medical certification of baby breathing monitors is now mandatory

The UK’s MHRA (Medicines and Healthcare products Regulatory Agency) recently made a significant change to regulation of baby breathing monitors that all new parents should take note of: it’s now mandatory for all* baby monitor devices to apply for Medical Device Certification and become compliant in order to be sold in the UK. Consumers are encouraged to look 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. The Snuza HeroMD is ahead of the curve and has proudly had medical device certification since 2016 making it a frontrunner in the category.


The world’s first medically certified portable, wearable baby breathing monitor

The Snuza HeroMD advocates for a safe sleep space, and supports babies and parents alike with a 20 second philosophyaccording to the World Health Organisation,  it takes just 20 seconds for apnea episodes to be considered critical. Being notified about such events as they occur, and being able to quickly respond, increases the probability of a positive outcome. It can easily be the difference between a scary moment and a tragedy.

Snuza HeroMD clips onto your baby’s nappy/diaper or elasticised pants, monitoring their breathing by detecting the movement of their tummies as they breathe. If breathing is not detected for 15 seconds, the device will buzz with a vibration stimulus in an attempt to wake the baby. If breathing is still not detected for a further 5 seconds (at 20 seconds), the device sounds an audible alarm to alert you.

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