28 Novmber 2022
New national Australian industry resource to help save babies’ lives
A new industry resource, Best practice guide for the design of safe infant sleeping environments, will help prevent the death of babies.
The guide provides manufacturers and retailers with information on the risks associated with infant sleep and how they can be mitigated.
It is the first comprehensive resource of its kind in Australia.
In Australia in 2019, two infants every week died suddenly with no clear explanation. Unsafe sleeping environments may have contributed.
Despite the significant gains over the last two decades from the ‘Back to Sleep’ campaigns, infant sleep accidents remain as a significant yet avoidable contributor to sudden unexplained infant deaths.
Education alone is not the solution.
The safety of products that relate to an infant’s sleep environment has been a cause of concern for many years. While some progress has been made by industry, the public sector and consumer groups in terms of education, standards and regulations that relate to infant sleep products, a need has identified for a more comprehensive, coordinated and evidence-based approach.
Standards and regulations rarely keep pace with product development. Further, many products (including some that claim to have health benefits or to reduce the risk factors associated with sleep-related deaths) have fallen between standards and regulatory ‘cracks’.
The infant product market had exploded in the last 20 years, both in terms of product choice and global accessibility, and only a limited number are required to comply with mandatory standards.
Some suppliers, particularly smaller suppliers and new entrants to the market, often rely solely on safety information provided by the manufacturer and this has resulted in unsubstantiated health benefit claims being made about particular products. The Federal Drug Administration in the United States and the Therapeutic Goods Administration in Australia have both taken action against suppliers of certain sleep positioners in relation to unfounded health claims.
Other products may be safe when used correctly, but can lead to injury if used inappropriately. This has resulted in mixed and often confused consumer messaging and a lack of consistency in terms of what constitutes a safe infant sleep product. Many infant sleep products are used in the absence of supervision in the home environment, so it is critical that these products meet the highest level of safety.
Chair of the Safe Infant Sleep Environments Guide Ms Susan Teerds Kidsafe Australia said that the new guide provides industry with information on what makes a sleeping environment unsafe for infants.
“This guide is based on a combination of medical (anatomy, physiology), regulatory and epidemiological expertise,” Ms Teerds said, “and highlights essential considerations for designing, marketing and supplying safe infant sleep products”.
The guide’s content is the result of collective input from an inter-sectoral working group of persons and organisations that have expertise in product safety, the safety of infants and safe sleeping (see Acknowledgements).
What is an infant sleep product?
An infant sleep product is a product that is designed or marketed towards use by an infant (children under 12 months of age) to sleep with, on, or in, or designed to be an aid for infant sleeping.
Products include, but are not limited to: household cots, portable cots, bassinets, cradles, sling carriers, bedside sleepers, cot bumpers, sleep positioners, mattresses, pillows, cocoons, baby nests, in bed co-sleepers and other devices and associated accessories (for example, apnoea and temperature monitors) that may be used in an infant’s sleep environment.
It is also recognised that infants sleep on, or in, a broad array of products that are marketed for transport or seating. Many contemporary hybrid product designs perform dual functions, such as a child car restraint that converts to a pram.
The likelihood of injury occurring in these devices depends on the design and marketing of the product, duration of use, and degree of direct supervision. Current health recommendations are that infants should not spend more than one hour in a child car restraint due to the risk of positional asphyxia.
Comfortable and versatile product design and recommendations relating to infant safety for sleep need to be balanced against the additional protection provided to the infant in the event of a crash. Specific consideration should be given to the likelihood of an infant sleeping or napping in infant products that are not specifically designed for sleeping.
Bunk beds are not included because they are not products intended for or marketed toward infants. However, bunk beds are recognised as an important sleep safety issue for children.
Whilst the focus is on sleep products supplied into the domestic market, there is a flow on continuum effect for products used in hospitals, child health facilities, early learning and commercial childcare environments. It is, however, expected that medical facilities and maternal and child health programs will have established risk management criteria in place that would mean that sleep products in that setting are used under the close supervision of a health professional in a highly controlled or monitored (for example, continuous physiological monitoring in a neonatal intensive care unit; contact support provided by health professionals in home-based community settings) environment. Notably, some products used relatively safely in a highly controlled environment such as a hospital may not be safe to use in a domestic setting.
Another example of this includes maternal and child health programs that use portable infant sleep spaces. Unlike commercially available baby boxes, these programs such as the Pēpi-Pod® and Wahakura programs in New Zealand and Queensland have recognised education, parent support and follow-up responses to reinforce ongoing safe use of the device as the infant develops, including a transition plan to a suitable infant sleep space when the baby outgrows the portable space.
Why are infants vulnerable during sleep?
In contrast to healthy older children and adults, healthy infants (children under the age of 12 months) are inherently vulnerable to sleep-related injury through a variety of mechanisms. This vulnerability evolves with age and fluctuates with other external factors, some of which are modifiable by the parent or caregiver.
This inherent vulnerability stems from the following differences between infants and older children and adults.
Compared with older children, an infant has:
- smaller more easily compressed airways
- a large, heavy head relative to body size
- a protruding occiput (back of the head), such that the head tips forward even when lying on their back on a flat surface
- more easily compressed chest wall
- less respiratory stamina
- reduced temperature control
- reduced sleep arousal to elevations in carbon dioxide
- if prone, a reduced ability to lift their face away from any obstruction (mattress/pillow).
These anatomical (structural) and physiological (functional) vulnerabilities are unique to an infant’s chronological age and development stage.
In addition, infants may have as many as seven upper respiratory tract infections in their first year of life, especially if there are older siblings. Even mild illnesses result in a degree of respiratory compromise. There are a variety of factors that can further compound this vulnerability, such as prematurity or low birth weight (<2500g), exposure to cigarette smoke, drugs or alcohol both in utero and after delivery, medical conditions, other intercurrent illnesses and the immediate sleep environment.
Many (but not all) sudden unexpected deaths in infancy (SUDI) occur during sleep.
SUDI is a category of deaths in which an infant dies suddenly, usually during sleep, with no immediate obvious cause at the time of death. SUDI includes deaths that are later explained by natural (for example, infection) or external causes (for example, fatal sleep accidents) and deaths that remain unexplained after a thorough investigation (for example, Sudden Infant Death Syndrome [SIDS], undetermined deaths).
Contributors to the Safe Infant Sleep Environments Guide include:
• Consumer Product Injury Research Advisory Group
• Kidsafe Australia
• Queensland Child Death Review Board
• Queensland Injury Surveillance Unit
• Queensland Paediatric Quality Council Infant Mortality Subcommittee
• University of the Sunshine Coast
Special thanks from the Chair Susan Teerds to Dr Ruth Barker, Professor Jeanine Young AM and Dr Catherine Niven.
Contact: Susan Teerds
CEO Kidsafe Qld Inc
0411 104 833