Potential risk of falls from infant incubators and radiant warmers

On this page

• Infant incubators and radiant warmers
• Risk of falls
• Managing the risk
• Reporting events

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:

• abrasions and bruises
• skull fracture
• brain hemorrhage (bleeding in the brain)
• long-term neurological issues

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:

• media reports
• the scientific and medical literature
• Canadian incident reporting database
  • search conducted in January 2022
  • 3 reports in the Canadian database of infant falls from these devices and no reported deaths
• recalls of infant incubators and radiant warmers
• manufacturers' responses to information requests

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:

• be trained on how to operate the infant incubator or radiant warmer in your facility as per the manufacturer's operating instructions
• ensure that non-health professional caregivers know how to properly close and secure or lock the access doors and/or panels of the device
• ensure before and during use of the device that safety checks/inspections and preventive maintenance are conducted as indicated in the manufacturer's instructions

Non-health professional caregivers

Non-health professional caregivers should:

• understand that these devices should be operated by a trained operator
• receive proper instruction from a health professional on how to use the device, including how to properly close and secure or lock the access doors and/or panels

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.

• Contact the manufacturer if there's a technical problem with the device.
  • They must provide manuals and training on how to use the device.
  • They must tell you what to do if you experience an adverse event or if the device fails.

Health Canada encourages you to report adverse events:

• Consumer Medical Device Report Form

Report a medical device problem:

• Consumer
• Hospital
• Health care provider