Potential risk of falls from infant incubators and radiant warmers

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Infant incubators and radiant warmers

Infant incubators (including infant transport incubators) and radiant warmers are authorized for sale in Canada. They have been marketed in Canada for several decades.

Infant incubators and radiant warmers are often used in hospitals (usually in a neonatal intensive care unit). They provide climate-controlled environments and external sources of heat for premature babies (born more than 3 weeks early) or ill newborns.

Risk of falls

A fall from an infant incubator or radiant warmer may cause minor to severe issues for the infant, such as:

In extreme circumstances, a fall may even lead to death.

Health Canada has reviewed the potential risk of an infant falling through the access door or panel of these devices. We reviewed relevant information from:

Our review indicates that shared improvements to the design or labelling of all affected devices would not reduce the risk of falls without possibly introducing other risks.

As there are no other suitable devices on the market, we have determined that the benefits continue to outweigh the risks. In addition to when using these devices, there is always a risk of an infant falling if placed on an elevated surface.

Managing the risk

While the number of serious adverse events in Canada appears to be low, the risk of falling is severe and can be life-altering for the child and family.

It's important to educate and raise awareness to increase the safety of infants in Canada who require use of these devices.

Health professionals

Health professionals should:

Non-health professional caregivers

Non-health professional caregivers should:

As we do for all health products, we will continue to monitor safety information involving infant incubators and radiant warmers to identify and assess potential harms. We will take appropriate and timely action should new health risks be identified.

Reporting events

It's important to monitor issues with a medical device so you can take action before an adverse event occurs.

Health Canada encourages you to report adverse events:

Report a medical device problem:

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