Baby Monitors, SIDS and Effectiveness

The "back to sleep" campaign, advising parents that babies should sleep on their back on firm mattresses, has decreased the incidence of SIDS, which was already rare, by over 50%.

But many babies seem to sleep better on their stomachs, leaving parents with a dilemma. This has created a niche for devices that have breathing alarms and claim to allow babies to sleep on their stomachs.

However, these devices are sold as consumer devices, NOT medical; and therefore are not subject to FDA regulation and approval. Their claims have not been proven or studied.

Here's what you need to know:

• These devices are not regulated by the FDA and may be marketed with the vague enticement of “keeping babies safe.”
• One device is a sock that measures heart rate and oxygen concentration. Other monitors provide various data; for example, an ankle monitor tracks heart rate and temperature.
• These devices do not have alarms; they are sold as consumer products rather than as medical devices.
• In addition to wearable monitors, smartphone applications are available for parents to monitor heart rate, oxygen concentration, and skin temperature.
• Although the product materials state that they are not intended to prevent SIDS, safety is being emphasized in the marketing materials. No published data are offered to support safety claims.
• Some devices are marketed at costs of US$200 to US$300.

Although they may be justified and effective in some cases, parents should not rely on these completely.