Consultation on Potential Regulatory Amendments to the Playpens Regulations

Risk Management Bureau
Consumer Product Safety Directorate
Ottawa, Canada

April 16, 2013

Subject: Consultation on Potential Regulatory Amendments to the Playpens Regulations

Dear Stakeholder:

The purpose of this document is to solicit comments on a proposal to amend the Playpens Regulations. (Playpens are commonly referred to as play yards in the United States.)  Should Health Canada decide to pursue an amendment to the Regulations, comments received from this consultation will be taken into consideration in preparing a regulatory proposal for formal consultation through publication in Part I of the Canada Gazette.

Background

The Playpens Regulations came into force on September 1, 1976 and were developed to help reduce injuries and deaths that might occur in products designed to provide a safe playing environment for babies. To help further protect the safety of babies, Health Canada is launching this public consultation on potential amendments to the Regulations.

Over the years, playpen designs have evolved. The Department has identified safety concerns with particular playpen product designs available on the Canadian market. This includes playpen accessories, such as change table and sleep accessories, that attach to playpens. Additionally, Health Canada has received requests from playpen manufacturers for greater alignment of the Canadian Regulations with recognized international standards, specifically those of ASTM International.

On August 29, 2012, the U.S. Consumer Product Safety Commission (U.S. CPSC) published a Final Rule for play yards (playpens). In the Final Rule, the U.S. CPSC adopted the requirements for play yards outlined in the ASTM F406 - 12a, "Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards" (the ASTM International play yard standard). On August 29, 2012, the U.S. CPSC also released a supplemental Notice of Proposed Rulemaking (NPR) for play yards to address the improper assembly of sleep accessories to playpens. Additionally, on August 31, 2012, the U.S. CPSC released a NPR for bassinets and cradles that proposes adopting ASTM F2194-12, "Standard Consumer Safety Specification for Bassinets and Cradles" (the ASTM International bassinet standard), with which playpen sleep accessories would be required to comply. The NPR for bassinets and cradles also includes a proposed requirement for the slope of the sleeping surface of accessories to playpens.

The ASTM International play yard standard includes separate requirements for play yards (with mesh or fabric sides) and non-full-size cribs (with rigid sides). When alignment of the Playpens Regulations with the ASTM International play yard standard is referenced in this document, it is with respect to the specifications for play yards only. All cribs, including non-full-size cribs, that are sold, advertised or imported in Canada must meet the requirements of the Cribs, Cradles and Bassinets Regulations.

Industry members, public health officials and consumers have expressed confusion with regards to the products falling under the definition of a playpen in the Playpens Regulations. It is proposed that the Regulations be amended to include a definition of playpen clarifying that a playpen means a product whose primary function is to provide playing accommodation for a child and that includes sides, which are constructed of textile or other pliable materials, and a fixed floor to contain the occupant. This would clearly distinguish playpens from portable cribs. Some playpen models are referred to as "portable cribs" by the manufacturer in contradiction with other labelling that appears on the product. Portable cribs must meet the Cribs, Cradles and Bassinets Regulations. Playpens are not intended to be used for full-time sleeping accommodation; therefore, they are not subjected to the same stringent requirements as cribs. A sleep accessory (commonly referred to as a bassinet accessory in the U.S.) is only intended to be used as a sleeping accommodation for a limited time - until the baby is able to roll over. It is proposed that any playpen accessory for sleep be subject to similar requirements as stand-alone bassinets established under the Cribs, Cradles and Bassinets Regulations.

Please note that many of the proposed changes outlined in this document would involve aligning the Canadian performance requirements with the U.S. performance requirements for play yards. However, due to differences in drafting conventions between the two countries, the legal text of Canadian Regulations cannot be exactly aligned with the US requirements. There are particular requirements from the U.S. specifications that were identified as adding further safety measures to the Regulations. It is intended to minimize the burden on Canadian industry members and to facilitate compliance.

With regards to previous regulatory amendments affecting juvenile products, industry members have indicated that a coming into force period of six months is necessary when major changes to regulatory requirements are sought. This period would provide industry with time to re-design, test and supply new product models. A six month transition period is consistent with other jurisdictions. The standard transition period between versions of ASTM International standards is six months. It is proposed that a coming into force period of six months be included in the proposed Regulations.

The reported incidents, including injuries and deaths, noted in Annex A - Playpen-related Incidents and the recalls noted in Annex B - Playpen-related Recalls highlight the importance of amending the Playpens Regulations to include stricter safety requirements, such as those relating to increased side height, accessories to playpens and safety warnings.

Proposed Changes to the Regulations

It is proposed that the Playpens Regulations of the Canada Consumer Product Safety Act be amended to enhance safety through two different approaches for the performance requirements by:

1. Aligning with particular existing requirements from the Canadian Cribs, Cradles and Bassinets Regulations (proposed changes 1-2);and,
2. Further aligning Canada's safety requirements with: a) the U.S. CPCS's Final Rule for playpens (the ASTM International play yard standard) (proposed changes 3 - 19); b) the U.S. CPSC's supplemental NPR for play yards (proposed change 20), and; c) the U.S. CPSC's NPR for bassinets/cradles (proposed changes 21 - 23).

I. The following proposed amendments would align the Playpens Regulations with specific requirements already set out in the Canadian Cribs, Cradles and Bassinets Regulations. These hazards are not currently addressed in the ASTM International play yard standard:

1. Completely Bounded Openings: introducing a performance requirement and test method for completely bounded openings, and including additional specifications for openings in textile or other pliable materials;

2. Floor Pad Spacing: including a performance requirement limiting any gap between the playpen floor pad and side of the playpen to 30 mm;

II. The following proposed requirements would further align the Playpens Regulations with performance requirements from U.S. CPSC's Final Rule for play yards (the ASTM International play yard standard), supplemental NPR for play yards, and NPR for bassinets/cradles:

a) To further align with the ASTM International play yard standard:

3. Warnings: including English and French warning requirements regarding the hazards associated with improper assembly, inadequate supervision, falls, the addition of soft surfaces or items, and the proximity of cords in or around the playpen;

4. Stability: amending the performance requirement and test method for assessing playpen stability to verify that the product has three widely spaced support points;

5. Latching and Locking: establishing additional performance requirements relating to a playpen's latching and locking mechanisms;

6. Entanglement: including a prohibition for protrusions capable of entangling the occupant's clothing or any other object worn by the occupant;

7. Floor Pad Thickness: including a performance requirement for a maximum thickness of 38 mm for playpen floor pads;

8. Side Height: increasing the side height requirement from 480 mm to 508 mm (measured from the top of the floor pad to the top of the upper surface of the lowest side);

9. Corner Posts: establishing a requirement limiting the height of corner posts to 1.5 mm;

10. Open Holes: amending the dimensions specified in the performance requirement for open holes (openings or slots);

11. Side Deflection and Strength: introducing performance requirements and test methods for side deflection and strength;

12. False Latch: including a performance requirement and test method to assess for a false latching situation;

13. Top Rail Configuration: including a performance requirement and test method for top rail configuration;

14. Top Rail to Corner Post Attachment: including a performance requirement and test method for top rail to corner post attachment;

15. Floor Pad Displacement: including a floor pad displacement performance requirement and test method;

16. Floor Strength: amending the performance requirements and test methods for the static and dynamic load tests to assess floor strength;

17. Mesh Opening Sizes: amending the test method for assessing mesh opening sizes;

18. Textile or Other Pliable Material Attachment Strength: including a performance requirement and test method for the attachment strength of textile or other pliable material in alignment with the mesh/fabric attachment strength test;

19. Accessories:introducing performance requirements and test methods for accessories, such as sleep accessories and changing tables, that attach to playpens;

b) To further align with the U.S. CPSC's supplemental NPR for play yards:

20. Improper Assembly of Sleep Accessories: introducing a performance requirement and test method to safeguard against the improper assembly of key structural elements of sleep accessories, and;

c) To further align with the U.S. CPSC's NPR for bassinets and cradles:

21. Slope: establishing a requirement for the maximum slope of the surface intended to support the weight of the child in playpens and sleep accessories.

22. Rocking or Swinging: including requirements for sleep accessories that rock or swing, and including an additional specification for a means of self-leveling;

23. Side Height of Sleep Accessories: introducing a side height requirement of 192 mm (measured from the top of the pad to the top of the upper surface of the lowest side) in alignment with the required side height for stand-alone cradles and bassinets.

Description of Proposed Changes

I. The following proposed amendments would align the Playpens Regulations with specific requirements already set out in the Canadian Cribs, Cradles and Bassinets Regulations:

1. Completely Bounded Openings

The Playpens Regulations do not currently specify requirements for completely bounded openings. There are playpen models on the market that incorporate fasteners, such as zippers or snaps, into their design. The potential exists for the product's structural members, or a completely bounded opening in the textile cover, to become exposed if the product's textile cover becomes unfastened. This could result in a child becoming entrapped between, or falling through, the playpen's structural members or textile components. It is proposed that a performance requirement and test method to assess the size of completely bounded openings in playpens and accessories be included in the Regulations. Products incorporating fasteners, such as zippers and snaps, would be required to withstand a specific force without becoming unfastened. Removable covers capable of being unfastened with less than the minimum specified force would also be assessed without the zippers, snaps, etc. fastened. This would minimize the potential of completely bounded openings in the product's frame or textile components becoming exposed.

2. Floor Pad Spacing

Health Canada has received reports of incidents and concerns associated with the spacing of playpen floor pads. Floor pads that do not fit snugly against the sides of the playpen may create gaps between the pad's edge and the playpen's sides. A child could become wedged in such a gap or exposed to hazards underneath the floor pad. In order to safeguard against similar hazards, the Cribs, Cradles and Bassinets Regulations include a requirement limiting any gap between the mattress and any part of the crib, cradle or bassinet side to 30 mm. It is proposed that a requirement limiting the spacing between the floor pad and the playpen's sides to 30 mm be included in the Playpens Regulations.

II.a) The following proposed requirements would further align the Playpens Regulations with the ASTM International play yard standard:

3. Warnings

The current Playpens Regulations do not require warning labels to appear on playpens. There is the potential for serious injury or death as a result of improper use of a playpen. Health Canada is proposing that the Regulations be amended to include a requirement for bilingual warning statements, or wording that conveys the same messages, for caregivers, regarding the use of both playpens and accessories, which will alert them to further safety precautions that should be taken into account. For example, the Department is aware of a number of deaths of young children due to blind and curtain cord strangulation. The proposed changes to the Regulations would require a warning to caution caregivers about blind and curtain cord proximity to playpens. The other proposed warnings would relate to other hazards, such as those associated with improper assembly, inadequate supervision, falls and the addition of soft surfaces or items.

4. Stability

Questions and concerns regarding the applicability of the current stability requirement and associated test method for playpen models have been raised by both the test laboratories and industry. Over the years, the design of playpens has evolved from rigid structures to the playpen models now available, which are generally collapsible and relatively more flexible in design. Given the less rigid design, the appropriateness of the strict requirement that all support points shall remain in contact with the inclined plane to fulfill the requirements of the current Regulations has been reviewed. In order for a playpen to be considered stable, it is necessary, as a minimum, to have at least three widely spaced support points. In alignment with the ASTM International play yard standard, it is proposed that the requirement and associated test method for stability be amended to assess that the playpen has three perimeter support points. Additional testing specifications to assess that the support points are not in a straight line and are of a sufficient distance from one another to make sure that the product remains stable are also proposed.

5. Latching and Locking

To further safeguard playpens against unintentional collapse, it is also proposed that additional requirements relating to playpens' latching and locking mechanisms be included within the Regulations. In alignment with the requirement from the ASTM International play yard standard, the proposed amendments to the Playpens Regulations would require that any latching or locking mechanism must engage automatically and have either a single action mechanism that requires the application of at least 45 N to unlatch or unlock it or a dual action mechanism that requires separate deliberate and simultaneous actions on the part of the user to unlatch or unlock it.

6. Entanglement

As illustrated by reported incidents and voluntary recalls requested by Health Canada, the potential exists for a playpen user's clothing to become entangled on protrusions. The current Playpens Regulations do not include requirements relating to entanglement. The ASTM International play yard standard includes a requirement to address protrusions. It is proposed that the Playpens Regulations be amended to include a requirement that a playpen must not have any protrusion, attachment or mechanism capable of entangling an occupant's clothing or other object worn by the occupant, located above the upper surface of the playpen's floor.

7. Floor Pad Thickness

It is proposed that the ASTM International play yard standard requirement for a maximum thickness for floor pads of 38 mm be included in the Regulations. This requirement would help to safeguard against the pad's thickness significantly reducing the effective side height of the playpen and creating a potential hazard should the child climb or accidentally fall out of the playpen.

8. Side Height

Playpens are intended to provide a safe playing environment for children. However, falls from playpens have the potential to lead to serious injury. Data from the Public Health Agency of Canada's Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) indicates that falls are the most frequent cause of playpen-related injuries. It is proposed that the minimum side height requirement for playpen be increased from 480 mm to 508 mm (measured from the top of the floor pad to the top of the upper surface of the lowest side) such that it is consistent with the ASTM International play yard standard.

9. Corner Posts

Currently, the Playpens Regulations do not include requirements pertaining to corner posts. Corner posts may present a strangulation hazard to the occupant. An occupant's clothing may become caught on a corner post. Therefore, it is proposed that the Playpens Regulations be amended to include a performance requirement for corner posts in alignment with that found in the ASTM International play yard standard. The standard includes a requirement for corner posts that limits their height to 1.5 mm above the lowest point, within a radius of 76 mm from the centre line of the post, on the upper surface of the higher adjoining side of the product.

10. Open Holes

The Department has received requests from industry to amend the dimensions specified in the open holes requirement for playpens such that they are consistent with those of the ASTM International play yard standard. This requirement is intended to prevent the possibility of children's fingers being caught in open holes in the product. The dimensions specified for open holes in the ASTM International play yard standard are consistent with the dimensional requirements of many ASTM juvenile product standards. The ASTM juvenile products subcommittee is not aware of incident data that would support a change to these dimensions.^{Footnote 1} It is proposed that the Playpens Regulations be amended to align with the requirements for openings or slots found in the ASTM International play yard standard.

11. Side Deflection and Strength

Reports of incidents received by Health Canada, as well as voluntary playpen recalls requested by the Department, have highlighted the importance of strengthening the requirements relating to side deflection and strength. The potential for serious injury or death is created when a playpen side unexpectedly disengages, folds or deflects, reducing the playpen's side height when a child is in the playpen. It is proposed that the Regulations be amended to align with the requirements and test methods of the ASTM International play yard standard with respect to side deflection and strength to prevent playpen sides from breaking or folding when subjected to static weights.

12. False Latch

In order to further safeguard against unintentional folding or collapse of the top rail, it is proposed that the Playpens Regulations be amended to include the performance requirement and test method to assess false latching and locking mechanisms to align with the ASTM International play yard standard. These requirements would specify that no top rail must give the appearance of being in the manufacturer's recommended use position unless the locking device is fully engaged.

13. Top Rail Configuration

Health Canada has worked with companies to voluntarily recall playpens with side rails that can unexpectedly collapse while the baby is in the playpen. The resulting "V" shape created by the playpen's collapsed sides presents a neck entrapment hazard to the baby. The ASTM International play yard standard includes a top-rail configuration test. This test is intended to eliminate playpen designs incorporating a hinge or latch that is capable of creating a "V" or diamond shape when folded. It is proposed that the Playpens Regulations be amended to include the top rail configuration performance requirement and test method from the ASTM International play yard standard.

14. Top Rail to Corner Post Attachment

The ASTM International play yard standard includes a requirement for top rail to corner post attachment. This requirement is intended to prevent fatigue failures, such as broken corner brackets, loosened fasteners, etc, in the corner post attachment joints. Health Canada has received reports of incidents involving these types of failures. The requirement assesses whether corner brackets can withstand a single significantly large twisting action (moment) applied to the midpoint of the top side rails. It is proposed that the Playpens Regulations be amended to include the performance requirement and test method for top rail to corner post attachment from the ASTM International play yard standard.

15. Floor Pad Displacement

Health Canada has received reports of incidents regarding playpen floor pads that are capable of being detached from the playpen's base. This exposes the occupant to a potential entrapment hazard. A baby's head could become entrapped between the floor pad and the side of the playpen or under the floor pad. The ASTM International play yard standard includes a vertical displacement test for removable floor pads. This test involves applying a 66 N vertical force upwards to the floor pad to determine if it will displace more than 133 mm (the approximate height of the small head probe). It is proposed that the Regulations be amended to align with the performance requirement for vertical displacement found in the ASTM International play yard standard. However, it is proposed that a 90 N upward force instead of a 66 N upward force be applied to the floor pad. A 90 N force is based on the demonstrated strength of children in the age group likely to occupy a playpen (0 to 36 months) and is consistent with similar requirements in the Cribs, Cradles and Bassinets Regulations and the Toys Regulations.

16. Floor Strength

The current Playpens Regulations include a static load test, which involves the application of a 220 N force, to assess the strength of a playpen's floor. The ASTM International play yard standard also includes a static load test that involves the application of two forces - 222 N and 133 N. As Health Canada has received reports of floor boards breaking, it is proposed that the Canadian requirements be strengthened to include the application of the additional force specified in the ASTM International play yard standard. The standard includes a dynamic load test as well. As babies may jump or bounce in playpens, it is reasonable for playpens to be subjected to a dynamic load test. Therefore, it is also proposed that the Regulations be amended to align with dynamic load test from the ASTM International play yard standard.

17. Mesh Opening Sizes

Health Canada has received requests from industry to amend the procedure for the determination of mesh opening sizes found in the current Playpens Regulations such that it is aligned with the requirements found in the ASTM International play yard standard. It is proposed that the test for mesh opening sizes in the Playpens Regulations be amended to further align with the test specified in the ASTM International play yard standard. This would involve changing the specifications for the test probe designed to evaluate mesh opening sizes such that it has a full-radius tip. Additionally, the test would be amended to state that testing is to occur in the locations deemed to be the weakest or most likely to fail rather than randomly selected locations. Furthermore, this proposed change would not involve cutting a sample of mesh from the product as is specified in the current test.

18. Textile or Other Pliable Material Attachment Strength

In order to address reported incidents related to the attachment strength of textiles or other pliable materials, it is proposed that the Playpens Regulations be amended to include the test for mesh/fabric attachment strength found in the ASTM International play yard standard. This test involves applying a 130 N force to the attachment to determine if the attachment can become separated or can be inadvertently unhooked or disconnected.

19. Accessories

Many playpens are now marketed as multi-use products with various accessories, such as change table and sleep accessories, which attach to the playpen's frame. Typically, these accessories are attached to the top of a playpen, are meant to support the weight of a baby and are not intended to be installed in the use position when a baby is in the main body of the playpen. The Regulations do not currently include requirements regarding the means of attachment of the playpen accessories to the playpen's frame, the structural solidity of the accessories or warnings concerning proper use of accessories. Due to its structure, location, movement or failure, a playpen accessory may expose the occupant to a number of possible hazards, including openings that present an entrapment hazard. Health Canada is proposing certain safety requirements for playpen accessories, including stringent structural solidity requirements, performance requirements and test methods to assess entrapment hazards, in alignment with the ASTM International play yard standard.

III.b) The following proposed requirement would further align the Playpens Regulations with the US CPSC's supplemental NPR for play yards:

20. Improper Assembly of Sleep Accessories

In order to safeguard against improper assembly of sleep accessories, it is proposed that the Playpens Regulations be amended to include the performance requirement and test method to assess sleep accessories missing key structural elements. This would align with the U.S. CPSC's supplemental NPR for play yards. These proposed requirements would specify that sleep accessories must either have all key structural elements permanently attached or the accessory's sleep surface must catastrophically and obviously change by collapsing completely or tilting more than 30°.

III.c) The following proposed requirement would further align the Playpens Regulations with the U.S. CPSC's NPR for bassinets and cradles:

21. Slope

Health Canada has requested the voluntary recall of particular models of playpens because a child's weight could press the centre of the sleep accessory downwards, increasing the angled surfaces at either end of the product. If a child was left unattended in the playpen's accessory, small movements of the child could cause the child to slide into a depressed area of the sleep surface, posing a potential risk of injury or death due to suffocation. Therefore, the Department is proposing the inclusion of a requirement limiting the slope of a folding or segmented floor pad of a playpen or sleep accessory to 10°.

22. Rocking or Swinging

As new designs of playpens appear on the market, hazards not specifically addressed by the Regulations may emerge. Previously, playpen designs did not incorporate a rocking or swinging feature. In recent years, Health Canada has requested the voluntary recall of playpen models that included a rocking function for the playpen's sleep accessory. Depending on the maximum rock angle and the product's capacity to self-level, the accessory can tilt, causing an infant to roll to one side. An infant can become wedged in a corner or pressed against the side of the accessory, posing a risk of suffocation or asphyxiation. In alignment with the Canadian Cribs, Cradles and Bassinets Regulations and the ASTM International bassinet standard, it is proposed that a requirement for the maximum rock or swing angle of a sleep accessory be included in the Regulations. As well, it is proposed that a requirement specifying that sleep accessories with a rock or swing feature must incorporate a means of self-leveling.

23. Side Height of Sleep Accessories

Similar to stand-alone bassinets, sleep accessories are intended to be used until the occupant is capable of rolling over. In alignment with the Canadian Cribs, Cradles and Bassinets Regulations, the ASTM International standard for bassinets includes a requirement for an effective side height of 192 mm (measured from the top of the pad to the top of the upper surface of the lowest side). The purpose of this requirement is to ensure that a bassinet offers adequate protection to the occupant when the side is at its minimum height. The requirement is intended to prevent children from rolling or falling out of a bassinet. It is proposed that the Playpens Regulations be amended to include a side height requirement of 192 mm for sleep accessories.

Regulatory Options

The Department has identified the following regulatory options to address the health and safety concerns identified with playpens:

1. Maintain the status quo.
2. Amend the Playpens Regulations to introduce Canadian specific requirements for playpens, requirements that would align with particular existing sections of the Cribs, Cradles and Bassinets Regulations and requirements that would align more directly with the ASTM International play yard standard and U.S. CPSC proposals for sleep accessories. This would include introducing requirements for accessories that attach to playpens.
3. Adopt the specifications for playpens found in the ASTM International play yard standard.

Health Canada considers the second option to be preferable as it would increase regulatory alignment with the United States and address important safety issues, such as those associated with playpen accessories, while allowing Health Canada to establish requirements and test methods to address specific hazards identified by the Department that are not currently addressed in the ASTM International play yard standard.

Comments

The Government of Canada is committed to providing the Canadian public and other stakeholders with the opportunity to participate in the development of regulatory initiatives. You are invited to provide Health Canada with comments on the proposed options for regulatory action regarding playpens, or any other suggestions. As applicable, please supply evidence to support your comments.

Please provide your comments no later than June 29, 2013. Comments may be submitted by mail, e-mail or fax to the following coordinates.

Mail:

Playpens Consultation
Risk Management Strategies Division
Consumer Product Safety Directorate
Health Canada
269 Laurier Avenue West, 8^th Floor, Address Locator: 4908B
Ottawa, Ontario
K1A 0K9

Email: CPS-SPC@hc-sc.gc.ca; Subject: Playpen Consultation

Fax: 613-952-2551, Attention: Risk Management Strategies Division - Playpen Consultation

Stay Informed

Please refer to the Consumer Product Safety section of the Health Canada website to stay informed of this initiative.

Additionally, you may wish to subscribe to the Consumer Product Safety electronic newsletter so that you will receive the latest news and information about Health Canada's efforts in the area of consumer product safety.

Annex A - Playpen-related Incidents

Consumer Product Safety Directorate

Health Canada's Consumer Product Safety Directorate (CPSD) receives reports of incidents, including injuries, deaths and safety concerns, related to the use of infant care products from consumers, physicians, medical officers, industry, etc. Between 1990 and September 2011, Health Canada received 148 reports of incidents associated with the use of playpens.

Table 1: Distribution of Reported Incidents by Hazard Patterns Associated with Playpens Reported between 1990 and September 26, 2011

IssuesFootnote 2	Total Incidents	Deaths	Major Injuries	Minor Injuries	No Injuries
Product-Related	145	7	1	27	110
Structural Integrity	36	0	0	2	34
Side Rail Collapse	29	2	0	4	23
Fabric/Mesh	28	0	0	6	22
Other Product-Related	17	2	0	5	10
Floor Board/Pad	13	0	0	3	10
Accessory	12	3	0	0	9
Impact on Playpen	6	0	0	5	1
Assembly	3	0	1	1	1
Fall/Climb Out	1	0	0	1	0
Unsafe Environment	3	2	0	1	0
Around the Playpen	2	1	0	1	0
Within the Playpen	1	1	0	0	0
Total	148	9	1	28	110

Structural Integrity: These incidents include those related to the release of rivets and plastic pieces, stress points and cracks in the plastic of the product's frame. A number of the complaints involved babies being found with small parts in their mouths. Caregiver intervention prevented a serious incident from occurring. Such hazards would be targeted by the proposed regulatory changes relating to: Top Rail to Corner Post Attachment.

Side Rail Collapse: The majority of reported incidents in this category involved side rails collapsing spontaneously or under minor pressure. Two deaths, occurring in 1998 and 2007, were the result of the collapse of the playpen's side. Both children strangled when their necks became entrapped in the resulting "V" shape formed when the playpen side collapsed. Minor injuries, such as bruising, also occurred when the babies fell out of the playpen as a result of side rail collapse. Such hazards would be targeted by the proposed regulatory changes relating to: Side Deflection and Strength, Latching and Locking, False Latch and Top Rail Configuration.

Fabric/Mesh: Older reported incidents - from the early and mid-90s - involved babies chewing through the playpen's covering. More recent incidents - from the late-90s onwards - involved stitching unravelling and tears in the fabric or mesh. The injuries reported were the result of choking on released fabric pieces and red marks or friction burns as a result of unravelled stitching wrapped around the babies' arms, legs or necks. Some of these hazards are targeted by the requirements currently found in the Playpens Regulations relating to: Lock-stitching. Other hazards would be targeted by the proposed regulatory changes relating to: Textile or Other Pliable Material Attachment Strength.

Other Product-Related: This category includes incidents involving various product-related issues, such as the baby's foot becoming wedged in the product's carrying handle, off-gassing or toxicity concerns, sharp surfaces and stability issues. Between 1991 and 1995, two deaths were reported to Health Canada that involved a baby's pacifier cord or article of clothing becoming entangled on protruding rivets on the exterior of the playpen's top rail. This lead to a series of high profile recalls in 1998. (For more information, please see Annex B.) Such hazards would be targeted by the proposed regulatory changes relating to: Completely Bounded Openings, Stability, Entanglement and Warnings.

Floor Board/Pad: A number of reported incidents involved the baby lifting the floor pad. In some incidents, the baby was found entrapped in the playpen's floor support. Other incidents involved the floor board breaking. Concerns relating to gaps between the floor pad and the playpen's side were also reported. Minor injuries, such as bruises and scrapes, were the result of the baby becoming exposed to hazards when the floor board/pad broke or was lifted. Such hazards would be targeted by the proposed regulatory changes relating to: Floor Pad Displacement, Floor Strength and Floor Pad Spacing.

Accessory: Three of the reported deaths were related to the use of playpen accessories. In 2005, a baby died when their head became trapped between the top rail of a playpen and the bottom rail of a change table that was left attached to the playpen. In 2008, an infant died after being placed to sleep on a playpen change table accessory. Most recently in 2009, an infant died in a bassinet accessory, where the child had been placed to sleep with blankets and a stuffed toy. Reported complaints related to concerns associated with the slope of the sleep accessory, the structural integrity of the sleep accessory and the straps of the change table accessory. Such hazards would be targeted by the proposed regulatory changes relating to: Accessories, Slope, Improper Assembly of Sleep Accessoriesand Warnings.

Impact on Playpen: Minor injuries were reported associated with a baby falling and hitting the side of the playpen. These incidents resulted in injuries, such as a lost tooth, bruises and scrapes. Some babies were injured when they hit protruding bolts or plastic parts. Such hazards are targeted by the requirements currently found in the Playpens Regulations relating to: Wood or Plastic, Metal, Metal Tubing and Fasteners.

Assembly: The majority of the reported incidents in this category involved babies who were injured when their caregivers were assembling or disassembling the product. One baby's finger was amputated when it became caught in the product's hinge. The other baby required stitches after suffering a gash caused by the playpen's hinge when the baby pulled the product over on top of themselves. The other incident involved a product that could not be assembled as per the manufacturer's instructions. This hazard is targeted by the requirement currently found in the Playpens Regulations relating to: Assembly. The other hazards would be targeted by the proposed regulatory changes relating to: Warnings.

Fall/Climb Out: There was one reported incident involving a baby who was able to climb out of their playpen and suffered a bump to the head. Although there were not many incidents involving falls reported to CPSD, falls/climb out of playpens were the leading cause of injury associated with the use of playpens reported in the Canadian Hospitals Injury Reporting and Prevention Program's database. (For more information, please see the section entitled "Canadian Hospitals Injury Reporting and Prevention Program".) These incidents would be addressed by the proposed regulatory changes relating to: Side Height and Floor Pad Thickness.

Unsafe Environment - Around the Playpen: In 1999, a baby died as a result of strangulation on a cord that the child pulled into the playpen. In another incident, a baby was placed in a playpen that was situated outdoors in the proximity of a candle. The baby suffered a burn injury when the side of the playpen caught fire. This hazard is targeted by the requirement currently found in the Playpens Regulations relating to: Flammability. Additionally, this hazard and the hazard involved in the previously noted death would be targeted by the proposed regulatory changes relating to: Warnings.

Unsafe Environment - Within the Playpen: In 2010, a child suffocated on soft bedding present in the playpen. The product was situated next to the parent's bed. At the time of death, the duvet from the adult bed was found in the baby's playpen. Deaths resulting from unsafe environments within the playpen have also been noted in reports released by the provincial coroners of Ontario and British Columbia. (For more information, please see the sections entitled "Child Death Review Unit - BC Coroners Service" and "Paediatric Death Review Committee and Deaths Under Five Committee - Office of the Chief Coroner, Province of Ontario". Please note that similar reports were not available from other provinces or territories.) Such hazards would be targeted by the proposed regulatory changes relating to: Warnings.

Canadian Hospitals Injury Reporting and Prevention Program

Injury data were obtained from the database of the Public Health Agency of Canada's Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP). CHIRPP is an injury surveillance system currently operating in the emergency departments of 11 pediatric and 4 general hospitals in Canada. Data collection began in April 1990 at 10 of the pediatric hospitals (the eleventh was added in 2009) and between 1991 and 1995 in the general hospitals. It is important to note that the injuries described do not represent all injuries in Canada, but only those seen at the emergency departments of the 15 hospitals in the CHIRPP network. Fatal injuries are also under-represented in the CHIRPP database because the emergency department data do not capture people who died before they could be taken to hospital or those who died after being admitted.

A total of 704 cases of playpen-related injuries were identified in the CHIRPP database between 1990 and 2008. Over half of the incidents involved the infant falling (58.2%) [including fell out/climbed out of playpen, fell within playpen, and fell - not further specified]. Of these, 68.5% of the fall reports were out of the playpen and 28.5% were falls within the playpen. Table 2 details the cases by circumstance.

Almost a third of the injuries were caused by contact with the floor (30.9%). Additionally, 22.3% of the injuries were caused by direct contact with a playpen, and 8.2% resulted from an impact with toys or other baby articles. Table 3 details the cases by injury cause.

Overall, head, face and neck injuries accounted for 46.2% of all injuries. Of all the head, face and neck injuries, 35.4% were closed head injuries (minor closed head injuries and concussion).

Based on the information available in Tables 2 and 3, the injuries identified in the CHIRPP report can be linked to the following hazard patterns: Fall/Climb Out, Impact on Playpen, Unsafe Environment - Around the Playpen, Unsafe Environment - Within the Playpen, Side Rail Collapse and Other Product-Related.

Table 2: Injuries Associated with Playpens, Injury Circumstance, CHIRPP database, age 0-71 months, 1990-2008^{Footnote 3} (April 20, 2010 extraction)

Injury Circumstance	# of cases by age
	0-5m	6-11m	12-23m	24+m	Total
Fell out/climbed out playpen	2	33	160	86	281 (39.9)
Fell within playpen	5	53	36	23	117 (16.6)
Outside playpen (hit against)	4	10	16	17	47 (6.7)
Object, already in playpen	0	21	20	4	45 (6.4)
While being put in/taken out	11	11	9	6	37 (5.3)
Object, fell into playpen/given by siblings	8	12	9	1	30 (4.3)
Body part caught	1	6	15	3	25 (3.5)
Object, pulled in/reached for	0	11	7	3	21 (3.0)
Hit against (while inside)	1	5	5	3	14 (2.0)
Object, obtained while climbing out	1	0	7	1	9 (1.3)
Playpen tipped over/folded	0	4	3	2	9 (1.3)
Inappropriate use	0	3	2	1	6 (0.8)
Malfunction	0	1	2	0	3 (0.4)
Fell, not further specified	0	5	3	4	12 (1.7)
OtherFootnote 4	3	13	14	7	37 (5.3)
Unknown/not specified	0	4	6	1	11 (1.5)
Total	36 (5.1)	192 (27.3)	314 (44.6)	162 (23.0)	704 (100)

Table 3: Injuries Associated with Playpens, Injury Cause, CHIRPP database, age 0-71 months, 1990-2008^{Footnote 5} (April 20, 2010 extraction)

Injury Cause	# Cases
Floor	218 (30.9)
Playpen	157 (22.3)
Toys/baby articles	58 (8.2)
Furniture/large appliance/home	49 (7.0)
Other person	43 (6.1)
Objects (i.e. earrings, hair clips, coins…)	40 (5.7)
Chemicals/substances	35 (5.0)
Injured person	12 (1.7)
Other	16 (2.3)
Unknown/not specified	76 (10.8)
Total	704 (100)

Provincial Coroners

Based on the information available, the majority of playpen-related deaths investigated by provincial coroner's offices can be linked to the following hazard pattern: Unsafe Environment - Within the Playpen.

Child Death Review Unit - British Columbia Coroners Service

The Child Death Review Unit (CDRU) of the British Columbia Coroners Service reviews the deaths of all children age 18 and under in B.C. In November 2009, the CDRU released a report entitled "Safe and Sound: A Five-year Retrospective". It details the CDRU's comprehensive review of 113 sudden infant deaths occurring in B.C. from January 1, 2003 to December 31, 2007. Regardless of sleep location, it was determined that the majority of infants were sleeping in an environment cluttered by pillows, duvets, blankets, stuffed animals or bumper pads. The report makes note of three deaths where a playpen was identified as the sleep surface used at the time of death. It is noted that one of the deaths involved an infant who had been napping in a borrowed playpen and was found asphyxiated by collapsed side rails. (This death was also reported to Health Canada's CPSD. For more information, please see the subsection entitled, "Consumer Product Safety Directorate - Side Rail Collapse".)

Paediatric Death Review Committee and Deaths Under Five Committee - Office of the Chief Coroner, Province of Ontario

The Paediatric Death Review Committee and Deaths Under Five Committee of the Office of the Chief Coroner, Province of Ontario release an annual report that reviews the deaths of children under five years of age and makes recommendations to help prevent such deaths in similar circumstances. In the Paediatric Death Review Committee's reports released in 2008 and 2010, deaths related to the use of playpens were noted. (Other available reports from 2007, 2009 and 2011 did not specifically make note of playpen-related deaths.) In the 2008 report, under the section entitled, "Unsafe Sleeping and Bed-sharing vs. Co-sleeping", it was noted that the Deaths Under Five Committee reviewed 186 cases occurring over the two-year period from 2006-2007. Of these, 77 (41%) cases involved unsafe sleeping environments. Five of these deaths were related to the use of a playpen. Details were provided for one of these deaths. The baby was placed to sleep on the stomach in a playpen that contained a large pillow and blanket. In the morning, the baby was found Vital Signs Absent in the same position. In the 2010 report, under the section entitled, "Unsafe Sleep Environments and Bed Sharing", it was noted that the Deaths Under Five Committee reviewed 38 unsafe sleeping deaths in 2009. One of these deaths occurred in a cluttered playpen. This is taken to mean that the playpen was cluttered with toys, pillows, blankets and/or clothing.

Other Provincial Coroners

Information relating to deaths involving playpens was also requested from provincial coroners that do not release annual reports. The following information was received in response to this request:

Bureau du coroner - Gouvernement du Québec

Between May 2000 and May 2010, the Quebec Coroner's Office investigated five deaths occurring in playpens. Two of the deaths involved babies with pre-existing medical conditions. Two deaths were classified as Sudden Infant Death Syndrome (SIDS). Both of the babies were found on their stomachs. (Generally accepted SIDS recommendations specify that a baby should be placed to sleep on their back.^{Footnote 6}) One of the babies was put to sleep on a blanket, which was folded and placed on top of the floor pad. The baby was placed lengthwise on the playpen pad and was found width wise on the floor pad. (The slope of the floor pad is unknown.) The fifth death was classified as positional asphyxia. Extra padding and bedding had been added to the playpen. The child was found with their head entrapped between the extra padding and the side of the playpen.

The Office of the Chief Coroner of Saskatchewan

Between 2004 and October 2011, the Office of the Chief Coroner of Saskatchewan did not investigate any deaths involving playpens.

Coroner Services - Government of New Brunswick

Between 1999 and 2009, New Brunswick's Coroner Services did not investigate any deaths involving playpens.

Office of the Chief Medical Examiner - Government of Newfoundland and Labrador

Between 2001 and 2011, Newfoundland and Labrador's Office of the Chief Medical Examiner did not investigate any deaths involving playpens.

Annex B - Playpen-related Recalls

Table 1: Voluntary Recalls Requested by Health Canada between January 1995 and October 2011

Date	Issue	Hazard Pattern
July 2011	Structural Solidity - Accessory	Accessory
July 2009	Latching and Locking, False Latch, Side Deflection and Strength	Side Rail Collapse
June 2009	Slope - Accessory	Accessory
May 2009	Rocking or Swinging - Accessory	Accessory
Jan 2009	Side Deflection and Strength	Side Rail Collapse
Sept 2007	Cord/Strap Length - Accessory	Accessory
Jan 2005	Side Deflection and Strength	Side Rail Collapse
Sept 1998	Structural Solidity - Accessory	Accessory
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
Dec 1998	Entanglement	Other Product-Related
June 1997	Side Deflection and Strength	Side Rail Collapse
Nov 1996	Side Deflection and Strength	Side Rail Collapse
Jan 1995	Side Deflection and Strength	Side Rail Collapse

References

ASTM International. F406 - 12a, Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards. 2012.

BC Coroners Services. Safe and Sound: Report on Sudden Infant Death in Sleep-related Circumstances. 2009.

Government of Canada. Joint Statement on Safe Sleep: Preventing Sudden Infant Deaths in Canada. 2011.

Health Canada. Consumer Product Recalls. January 1995 - October 2011.

Health Surveillance and Epidemiology Division (Public Health Agency of Canada). Injuries associated with playpens: Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) database, 1990-2008^{Footnote 7}, ages 71 months and younger, 704 records.

Office of the Chief Coroner Province of Ontario. Report of the Paediatric Death Review Committee and Deaths Under Five Committee. June 2008.

Office of the Chief Coroner Province of Ontario. Report of the Paediatric Death Review Committee and Deaths Under Five Committee. June 2010.

United States Consumer Product Safety Commission. Safety Standard for Bassinets and Cradles, Notice of Proposed Rulemaking, CPSC Docket No. CPSC-2000-0028, August 31, 2012.

United States Consumer Product Safety Commission. Safety Standard for Play Yards, Final Rule, CPSC Docket No. CPSC-2011-0064, August 29, 2012.

United States Consumer Product Safety Commission. Safety Standard for Play Yards, Notice of Proposed Rulemaking, CPSC Docket No. CPSC-2011-0064, August 29, 2012.