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Board of Review Inquiring into the Nature and Characteristics of Baby Walkers

Overview

The Board of Review has submitted its Report and Recommendation to the Minister of Health, pursuant to subsection 9(4) of the Hazardous Products Act, and has unanimously recommended that the Government of Canada maintain the ban prohibiting the advertising, sale and importation of baby walkers. A baby walker is defined in the Hazardous Products Act as follows:

Baby walkers that are mounted on wheels or any other device permitting movement of the walker and that have an enclosed area supporting the baby in a sitting or standing position so that their [sic] feet touch the floor, thereby enabling the horizontal movement of the walker.

Background

As baby walkers increased in popularity in the 1970's and 1980's, concerns arose about injuries suffered by some children while using them. In the ensuing years, two distinct approaches emerged in an effort to eliminate or reduce injuries to children from baby walker use.

In Canada, an agreement was entered into in 1989 between government and industry, imposing stringent voluntary safety standards for baby walkers. However, manufacturers decided, for economic reasons, not to meet those safety standards, and new baby walkers were not sold in stores. The voluntary standard therefore effectively resulted in a ban on the sale of baby walkers in Canada.

In the United States, mandatory and voluntary performance standards for baby walkers were developed, under the applicable legislative framework, to reduce injuries to children. Other countries also adopted baby walker safety standards. Baby walkers continued to be sold throughout the world, except in Canada.

Despite the unavailability of baby walkers at the retail level in Canada, some people obtained them from other sources, including flea markets and garage sales, or imported them from other countries. As a result, baby walkers were still used, and related injuries continued to occur. From 1999 to 2004, Health Canada reviewed the situation and considered the options available to reduce or eliminate baby walker-related injuries. That detailed and comprehensive exercise culminated in the recommendation of the Minister of Health to ban baby walkers under the Hazardous Products Act.

On March 23, 2004, Canada became the first, and to date the only, country in the world to ban baby walkers in order to prevent injuries to children. The Government of Canada implemented this ban, on the recommendation of the Minister of Health, under the Hazardous Products Act, by including baby walkers as a prohibited product that cannot be advertised, sold or imported. On May 21, 2004, a distributor of baby walkers requested the Minister of Health to refer the governmental order banning baby walkers for review. On June 2, 2006, as required by law, the Minister of Health established the Board of Review to conduct an inquiry into the nature and characteristics of baby walkers and to submit a report and recommendations. On the same day, the Board of Review's website provided the public with information and material, including a timetable for the inquiry. In total, twelve parties ultimately participated in the inquiry.

The following parties appeared before the Board during a hearing that was conducted in Ottawa, Ontario from December 4 to 8, 2006:

• Attorney General of Canada on behalf of Health Canada
• Canadian Paediatric Society
• Children's Hospital of Eastern Ontario
• Institut national de santé publique du Québec
• Safe Kids Canada
• Dr. Richard Stanwick, Chief Medical Officer, Vancouver Island, British Columbia

The following parties submitted written representations to the inquiry:

• Alberta Centre for Injury Control and Research
• Durham Regional Health Department, Ontario
• Dr. John Leblanc, Associate Professor of Pediatrics, Dalhousie University, Halifax, Nova Scotia
• Northern Health Authority (Injury Prevention Program), Terrace, Prince George and Fort St. John, British Columbia
• Peel Public Health, Region of Peel, Brampton, Ontario
• Toronto Public Health

During the course of the inquiry, the Board of Review was provided with evidence not only from Health Canada's review concerning baby walkers, but also from many other sources, including medical witnesses, health and advocacy organizations, data, and mothers whose children fell or were injured in baby walkers. In addition, the Board of Review received evidence concerning the situation in other countries, particularly the United States. The Board of Review therefore had a significant body of additional evidence, over and above that originally amassed by Health Canada, to assist in its assessment of the nature and characteristics of baby walkers.

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Meaning of "Nature and Characteristics"

At the outset, it must be noted that the jurisdiction of the Board of Review is expressly limited by the Hazardous Products Act to conducting an inquiry into the "nature and characteristics" of baby walkers. The meaning of the phrase "nature and characteristics", as used in the Hazardous Products Act, was therefore of seminal importance to the approach adopted by the Board of Review. The analysis on that point is contained in section 7.2.1 of the Report at pages 101 to 103. Following its consideration of the meaning of "nature and characteristics", the Board of Review concluded that the fundamental question to be determined in the inquiry was whether baby walkers are hazardous in nature, in the sense that they are intrinsically dangerous. The Board of Review further concluded that the question could only be answered after an identification and assessment of the typical characteristics of baby walkers and the consequences arising from those traits.

This Overview does not summarize all of the evidence referred to in the Report and Recommendation and relied upon by the Board of Review in reaching its decision.

Characteristics of Baby Walkers

The Board of Review found that a baby walker has four principal characteristics: mobility, height elevation (caused by its support of a child in a sitting or standing position), an enclosed area where a child sits or stands, and portability. Each of these characteristics generates consequences, all of which were the subject of evidence at the inquiry.

Mobility

Mobility is the main, distinguishing characteristic of a baby walker; without its wheels and capacity for horizontal movement, a baby walker would be transformed into a stationary activity centre, a product that is not regulated in Canada under the Hazardous Products Act. Mobility is undoubtedly the feature that children enjoy the most in a baby walker. However, it is precisely that ability of a baby walker to move easily from one location to another, propelled only by a 5 to 14 month old child, which generates various consequences, including a high rate of speed, a corresponding inability to supervise properly, and an increased exposure to situations involving risk.

Considerable evidence at the inquiry raised concerns directly related to the mobility characteristic of a baby walker. Indeed, from the perspective of the expert witness Dr. Gary Smith, from the Children's Hospital in Columbus, Ohio, the entire crux of the problem with baby walkers, what he termed their "intrinsic danger", related to the dramatic increase in mobility given to a child too young to recognize danger and speed, and the corresponding inability of any person to supervise adequately. His position was echoed by the witness Allison Hewitt, the Executive Director of Safe Kids Canada, who stated that the "mobility feature inherent in a baby walker" created a risk of injury for a child. That concern was also expressed by Health Canada in its internal letter dated September 19, 2003 that formed part of the public consultation package, indicating that baby walkers provided children with an "abnormal degree of mobility at a vulnerable stage in their development", thereby exposing them to risks. In addition, the Risk Analysis prepared for Health Canada referred to the "relatively rapid motion" that could result in "catastrophic falls". Finally, the witness Dr. Sarah Reid of the Children's Hospital of Eastern Ontario noted that a child who would normally sit or crawl basically became ambulatory in a baby walker, but lacked depth perception or any concept of danger. The essential point made in all of the evidence relating to mobility was illustrated by one of the mothers whose child fell down stairs in a baby walker at the age of seven months, at a time when he was unable to crawl or move from one place to another on his own; it was the baby walker and its ability to move him around the house that placed him in a dangerous situation.

Evidence presented to the Board of Review from virtually every source consistently established the main consequence from the mobility characteristic as being the high rate of speed, one metre or three feet per second, rapidly attainable by a child propelling a baby walker. Indeed, as early as 1985, the Canadian Paediatric Society raised the problem of speed, and issued a warning that careful supervision was "mandatory". Most of the governmental documents, including the Risk Analysis, the Regulatory Review, the Order banning baby walkers and its accompanying Regulatory Impact Analysis Statement  ("RIAS"), made reference to the high speed at which a baby walker can move and the risks potentially flowing from it. Every medical witness who testified also raised that concern, noting that the danger or risks caused by the speed of movement in a baby walker can prevent a caregiver from reacting before an incident occurs.

The second mobility-related consequence addressed in evidence was the inability to supervise adequately. Two of the expert witnesses, Dr. Smith and Dr. Colin Macarthur, tied this consequence directly to both the mobility characteristic and the speed of baby walkers. Indeed, Dr. Smith stated that the mobility and speed put parents at "an amazing disadvantage" in supervising a child who was "dashing across a room" in a baby walker. That link was also explicitly made by Safe Kids Canada, which asserted in its written representations that "optimum" supervision was not possible, as the speed of a baby walker could prevent a parent from reacting to a problem or keeping a child within reach. The difficulties involved in supervising a child using a baby walker were also amply demonstrated by the data from the National Electronic Injury Surveillance System ("NEISS") in the United States, indicating that the vast majority of baby walker injuries have occurred "even where parents were in the same room or area" as the child. In addition, much of the governmental documentary evidence confirmed that experience from a Canadian perspective. For example, the Regulatory Review noted that the speed of a baby walker "...outpaces the reaction time of supervising caregivers", the internal Health Canada letter in the public consultation package stated that "...even the most attentive parents may not be able to react quickly enough", and the RIAS made a similar reference. However, perhaps the most compelling evidence concerning the difficulties involved in supervising a child using a baby walker was provided by the three mothers who testified that the incidents with their children occurred suddenly in the presence of supervising adults.

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The third consequence of the mobility characteristic that was established in the evidence was the increased exposure to risk for a child who was too young developmentally to assess or deal with a situation involving danger.

With respect to the question of the exposure to risk from baby walkers, Dr. Macarthur testified that there was "...some risk associated with their use". There was evidence before the inquiry from other sources, such as the RIAS, suggesting that the risk of injury from baby walkers was "high". However, the weight of the evidence adduced at the inquiry, notably data from the Canadian Hospital Injuries Reporting and Prevention Program ("CHIRPP"), supported Dr. Macarthur's testimony that the exposure to risk was relatively low, although the resulting injuries could be very serious. In particular, the CHIRPP data from 1990 to 2002 confirmed that baby walkers accounted for only 3.6 percent of all injuries to children in the 5 to 14 month age group.

Entirely apart from the question of the level of exposure to risk, the evidence overwhelmingly established that, as a result of its capacity for rapid, horizontal movement, a baby walker could subject a child to a danger of falling, primarily down stairs. That risk was apparent throughout virtually all of the evidence adduced at the inquiry. Indeed, the entire motivation for the review of the baby walker situation by the Consumer Product Safety Commission in the United States, culminating in the implementation of the voluntary performance standard ASTM F-977-96 ("revised ASTM standard") to reduce injuries to children, was due to concerns relating to the risk posed by falls down stairs. The CHIRPP data also confirmed that the risk of falling down stairs itself engendered another important consequence: 88 percent of children who fell down stairs suffered serious head injuries, such as intracranial injuries, concussions, and skull fractures.

In addition to the risk of falls, the evidence also demonstrated that baby walkers could increase access to dangerous objects by rapidly propelling a child into difficult situations. The evidence established two categories or types of such injuries: injuries that occurred due to the horizontal movement of a baby walker, and proximity injuries where its height elevation enabled a child to reach up and pull something down. Since proximity injuries are made possible by both the mobility and height elevation characteristics of a baby walker, they were considered by the Board of Review in the next section which deals with height elevation.

With respect to injuries, other than stair falls, directly related to the horizontal movement of a baby walker, the expert witness Dr. Richard Stanwick, the Chief Medical Officer of the Vancouver Island Health Authority, introduced into evidence the NEISS raw data case reports for the years 2002 to 2005. Those case reports provided examples of children who suffered burns from coming into contact with hot fireplaces, heating vents, stoves, barbecues and a car muffler. Some other incidents in the reports revealed children who had obtained access to poisons, garbage and pets, and who had sustained injuries caused by people tripping over baby walkers.

Finally, the evidence established that a child can be subjected to danger due to the actions of a sibling pushing the baby walker or otherwise interfering with its proper use. For example, that danger was highlighted in the NEISS data from 1993 to 1994, indicating that another child was directly implicated in 10 percent of all baby walker incidents, while five percent of stair falls involved another child. The NEISS raw data case reports from 2002 to 2005 also revealed instances of sibling involvement.

Height Elevation

The second characteristic of a baby walker is the height elevation that it gives by supporting its occupant, a 5 to 14 month old child, in a sitting or standing position. This increased height generates one main consequence: a child at that elevation is exposed to the risk of suffering a proximity injury by reaching up to a higher, otherwise inaccessible area and pulling something down.

The evidence at the inquiry concerning the height elevation characteristic established that a baby walker provided support in such a way that it enabled a child either to sit in the seat or stand upright with feet touching the floor. As Dr. Reid explained it, a baby walker permitted a child to become "basically ambulatory" and to have "increased height", rather than sitting, playing or crawling, as would be expected at that age. On the same issue, the Risk Analysis specifically noted that the added height was one of the characteristics of a baby walker, and that it gave a child "increased reach". The RIAS accompanying the Order banning baby walkers also specifically made the point that a child in a baby walker could "reach high areas" that were normally inaccessible.

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A significant amount of evidence was adduced to establish that the risk of a child suffering a proximity injury was the main consequence arising from the height elevation characteristic of a baby walker. From the perspective of the parties participating in the inquiry, this was an important issue, since the performance requirements in the revised ASTM standard which was implemented in the United States addressed only the stair fall problem and were not intended in any manner to deal with proximity injuries. The fact that the revised ASTM standard did not address at all the issue of proximity injuries was expressly confirmed by Dr. Smith in his evidence. Safe Kids Canada also indicated in its written representations that nothing in the revised ASTM standard would adequately limit the ability of a child to reach a dangerous object and suffer a proximity injury. That position was a recurrent theme throughout most of the governmental documentary evidence, particularly the Risk Analysis, the Regulatory Review, and the RIAS accompanying the Order banning baby walkers. In addition, Dr. Smith testified that, after the implementation of the revised ASTM standard in the United States in 1997, the Children's Hospital in Ohio began to see proportionately more proximity injuries and fewer injuries from stair falls.

With respect to the risk created by the elevation of a child, the Risk Analysis noted that a baby walker became "a platform to access dangerous household objects normally out of reach" to a child of that age. In that same vein, Dr. Reid specifically stated in her testimony that the elevation of a child in a baby walker created an increased risk of a child suffering a proximity injury. Dr. Stanwick made a similar observation while discussing two proximity injuries that he had treated early on in his career, noting that a child who was upright was exposed to "a whole raft of risks". In highlighting the proximity injuries outlined in the NEISS raw data case reports, Dr. Stanwick stated that children of that age were not "developmentally able to be upright", and encountered situations of risk because baby walkers gave them that opportunity.

The question of the risk posed by the elevation characteristic was also specifically addressed in the CHIRPP data which indicated that proximity injuries accounted for only 4.9 percent of baby walker injuries. However, the data indicated that those injuries were frequently very severe. In particular, the 4.9 percent of proximity injuries accounted for 42 percent of all hospital admissions for injuries associated with baby walkers, most of which were related solely to burns and scalds. In commenting on the data, Dr. Reid emphasized that the rate of hospital admissions for proximity injuries was "much higher" than for falls, where only approximately 11 percent of children were admitted to the hospital. The level of severity of injury possible in a proximity injury was demonstrated in the evidence of one of the mothers concerning the life threatening burns suffered by her daughter in an incident that happened suddenly in the presence of three adults.

Enclosed Area

The third characteristic of a baby walker is the enclosure where a child sits or stands. This is a feature that parents significantly appreciate, especially those who use it to enable them to do other things while the child is occupied in the baby walker. This characteristic serves to distinguish a baby walker from a "push toy", which contains no enclosed area and requires a child to stand and push the apparatus. The main consequence arising from this characteristic is that it prevents a child from getting out of a baby walker which may, in turn, lead to a risk of injury.

Evidence adduced at the inquiry from several witnesses, including Dr. Lynn Warda of the Winnipeg Children's Hospital and Drs. Reid and Smith, made reference to the enclosure characteristic during the course of their evidence. In addition, the Hazardous Products Act has specifically defined a baby walker as having "an enclosed area" to support the child in a sitting or standing position.

Those same witnesses addressed in evidence the main consequence of the enclosure characteristic: the inability of a child to get out of the baby walker. However, the approaches that they took to the related question of the risk of injury differed in some respects.

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In the evidence of Drs. Warda and Reid, the inability of a child to get out of a baby walker was inextricably linked with a risk of injury. During his testimony, Dr. Smith made it clear that head injuries were the principal result of falls down stairs in baby walkers. However, he testified candidly that the enclosure of a child in a baby walker may actually confer some "protective advantages, depending on the mechanism", by shielding the lower extremities and abdomen during a fall. Dr. Smith's position on the question of the risk flowing from the enclosure characteristic was consistent with the evidence of Drs. Warda and Reid in relation to head injuries, but made an additional point concerning the protective capacity of a baby walker.

Portability

The fourth characteristic of a baby walker is its portability. The ability of a baby walker to be easily carried to different locations for use is perhaps one of its most popular traits. However, that portability can lead to unforeseen consequences involving risk.

Evidence in the Risk Analysis established that parents and caregivers can sometimes develop a "false sense of security" about the safety of a child using a baby walker, not believing that an injury could occur. That point was reiterated in the written representations of Dr. David McKeown, the Medical Officer of Health of Toronto, who expressly linked the false sense of security with the limited risk perceptions of parents. Dr. Reid reinforced that notion, noting that parents have not succeeded in many instances in perceiving or recognizing the danger in ordinary things or objects when a child was elevated in a baby walker. That limited ability to perceive risk has resulted in the inadvertent exposure of children to danger, particularly where a baby walker has been moved from its normal area of use, typically within the family home, to another place.

In terms of the consequences related to the portability characteristic, evidence demonstrated that unanticipated risks have occurred when baby walkers were used in other locations, particularly outdoors. Indeed, Dr. Warda expressed surprise that parents used baby walkers so frequently outdoors and on porches, decks and landings where the openings were larger than the width specified in the revised ASTM standard. The NEISS raw data case reports between 2002 and 2005 recorded numerous examples of baby walker injuries that occurred outdoors, including a near drowning in a pool, falls off porches or steps, and severe burns from a car tailpipe and barbecues. Those reports also revealed some incidents that happened at other locations, including the homes of grandparents. In addition, Dr. Stanwick noted that other problems could arise from using baby walkers outdoors, such as the contamination of friction strips by dirt which could affect their braking ability. An example of an incident arising when a baby walker was taken for use in a different location was also given in the evidence of one of the mothers whose daughter was severely injured while using her baby walker at her grandparents' home.

Nature of Baby Walkers

The Board of Review found that, when considered both individually and collectively, the four principal characteristics of a baby walker and their consequential effects are imbued with elements of risk and danger that can lead to the injury of a child. Since the nature of a baby walker is necessarily defined by those characteristics and their consequential effects, the Board of Review concluded, on the basis of the evidence, that the nature of a baby walker is hazardous, in that it is intrinsically dangerous.

Conclusion of the Board of Review

In Canada, the notion of the responsibility of the state to protect people, particularly children, is reflected in our framework for decision-making at the federal level in situations involving a risk of serious harm, as well as in our jurisprudence and the applicable legislation. In circumstances giving rise to "a risk of serious or irreversible harm", the "precautionary approach" applies to governmental decision-making. That approach requires such decisions to be made "to meet society's expectations that risks be addressed", even in circumstances where scientific information may be inconclusive or lacking in full certainty. It is a proactive method of decision-making that provides considerable flexibility in its processes and execution. In addition, the jurisprudence in Canada has expressly underscored the special responsibility that exists in relation to children by approving the principle that the state may intervene when necessary to safeguard a child's autonomy or health, although such intervention must be justified. Finally, the Hazardous Products Act is devoted exclusively to the regulation of hazardous products to protect people from harm, and permits a broad discretion to be exercised in determining what constitutes a "hazardous product". It was within this overall context that the Government of Canada considered the question of the risk to children posed by baby walkers before implementing the ban.

In developing the foundation for the governmental decision-making exercise, Health Canada led and managed a methodical, comprehensive and objective review of all aspects of baby walkers. It commissioned risk and cost-benefit analyses, conducted scientific tests, collected data, consulted with medical associations, advocacy organizations and the public, researched scientific literature, and considered the approaches and positions taken elsewhere in the world.

Throughout its review, Health Canada was keenly aware of and sensitive to the creation and implementation of the revised ASTM standard in the United States to reduce baby walker stair fall injuries. Although Health Canada found that the revised ASTM standard had certain negatives, such as its failure to address proximity injuries or to eliminate stair falls, it must be recognized that the legislative framework in the United States is different than in Canada. In particular, the American legislation enshrines a preference for compliance with adopted and implemented voluntary standards that will "eliminate or adequately reduce an injury risk" over the enactment of statutorily mandatory standards or prohibition. The revised ASTM standard and its effect in reducing stair fall injuries were carefully considered by Health Canada in developing its position on baby walkers, but its implementation in the United States was quite properly not in any manner viewed as being determinative of the question.

It is useful to emphasize that, in the extensive evidence received by the Board of Review during the course of the inquiry, there was one point that was the subject of unanimity from all of the medical community, particularly from the highly qualified medical witnesses who testified: baby walkers should be banned and not available for use by children. The reasons typically advanced in support of that position were that baby walkers caused unnecessary and frequently severe injuries, were lacking in any developmental benefits, and were easily replaceable by safer alternatives.

In its analysis on nature and characteristics, the Board of Review determined that a baby walker is hazardous in nature, in that its characteristics and their consequences are imbued with elements of risk and danger. In the circumstances, the Board of Review has unanimously agreed that the ban implemented by the Government of Canada on the advertising, sale and importation of baby walkers was justified on the basis of the available evidence.

In addition to its Recommendation, the Board of Review has made two observations for consideration by the Minister of Health: a proposed amendment to the Hazardous Products Act to enable a board of review to terminate an inquiry summarily in certain circumstances, and a suggestion that Health Canada examine the collection of childhood injury data.