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Location Estados Unidos
The use of a baby monitor is a choice personal to every parent. Parents who do decide to use a breathing monitor like the Snuza HeroMD do so because it gives them additional peace of mind that they need. For example, they will be alerted if their baby stops breathing unexpectedly, allowing them to respond immediately to the situation.
In certification, we trust
Therefore, parents put a great deal of trust in these devices. Recent research by The Medicines and Healthcare Products Regulatory Agency (MHRA) found that parents expect monitoring products to be regulated to a high degree, in part because of their medical functions, in part because they are attached to the baby or placed in the cot.
Further, they found that parents assume that these products are regulated as medical devices - that is, to the same standards as an equivalent product used in a healthcare setting - and that they would not be allowed to be put on the market without being tested and certified. As a consequence they do not seek to check the regulatory status of the products themselves, assuming that this has already been done.
Expectations vs reality
Unfortunately, we are still many baby monitors sold as breathing monitors that lack the appropriate certification. These products are marketed and sold on leading online platforms and in high street retailers.
What to do?
On the bright side, consumers 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. 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, which most busy parents don’t have time to read.
Research has shown that parents were confused and in some cases angered by the disclaimers that state the products are not medical devices and should not be used as medical devices. This has given them an overall distrust in the category, tarnishing the reputation of genuine medical devices.
The real thing
Unlike most other baby monitors purporting to be breathing monitors, the Snuza HeroMD is a certified medical device that has passed stringent clinical evaluation for efficacy and reliability. It is one of the only such devices on the market and passes annual testing with ease. This is a device that parents can trust for the safety of their precious baby.
In certification, we trust
Therefore, parents put a great deal of trust in these devices. Recent research by The Medicines and Healthcare Products Regulatory Agency (MHRA) found that parents expect monitoring products to be regulated to a high degree, in part because of their medical functions, in part because they are attached to the baby or placed in the cot.
Further, they found that parents assume that these products are regulated as medical devices - that is, to the same standards as an equivalent product used in a healthcare setting - and that they would not be allowed to be put on the market without being tested and certified. As a consequence they do not seek to check the regulatory status of the products themselves, assuming that this has already been done.
Expectations vs reality
Unfortunately, we are still many baby monitors sold as breathing monitors that lack the appropriate certification. These products are marketed and sold on leading online platforms and in high street retailers.
What to do?
On the bright side, consumers 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. 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, which most busy parents don’t have time to read.
Research has shown that parents were confused and in some cases angered by the disclaimers that state the products are not medical devices and should not be used as medical devices. This has given them an overall distrust in the category, tarnishing the reputation of genuine medical devices.
The real thing
Unlike most other baby monitors purporting to be breathing monitors, the Snuza HeroMD is a certified medical device that has passed stringent clinical evaluation for efficacy and reliability. It is one of the only such devices on the market and passes annual testing with ease. This is a device that parents can trust for the safety of their precious baby.