>> Robert Adler: So we welcome
everybody to the meeting this morning.
And I want to thank all of you for
coming because we know you all are very,
very busy professionals in the fields
of medicine, public health and advocacy,
and you've come from far and wide to
attend this meeting on crib bumpers
because it's a really important issue,
and we recognize that you believe
it to be so and we agree with you.
So just a word of history, I think
you all know that in May of 2013,
the commission granted a petition from the
Juvenile Products Manufacturers Association
for the commission to address the
risks associated with crib bumpers.
In granting the petition, the commission
instructed staff to look beyond the specifics
of the petition request to identify any and all
regulatory actions the commission might take
to address the risk of injury
associated with bumpers.
In response to the commission's direction on
September 12th of this year, CPSC submitted--
staff submitted a briefing package to us.
In it, as I understand it, staff
estimated based on their evaluation
of the 100 plus fatalities known to the
commission where a crib bumper was present
in the sleep environment that on average only
about one suffocation death every other
year could be attributed to crib bumpers.
I certainly appreciate the professionalism
and dedication of CPSC staff but I am aware
that other experts in the field
have looked at the same data
and other information have reached different
conclusions about the risk of crib bumpers.
It's always been my practice in
situations like this to listen
to all voices who wish to be heard.
So I've agreed to meet with those who wish
to comment on staff's analysis especially
with respect to assessing and interpreting the
fatality and injury data before the agency.
I should also add at this point that last
week a majority of the commission voted
to commence rulemaking under Section
104 of the Consumer Product Safety Act
to address the hazards associated
with crib bumpers.
Under this approach, the agency can regulate
crib bumpers as durable infant products,
and we have Nancy Cowles here who was very
involved in the drafting of Section 104
and we're delighted to have her here
so she can make any relevant comments
about the advantages of rulemaking
under Section 104.
As I've said, I want this meeting to
be about you, your data, and expertise.
I don't-- I want this to be a dialog between us
and between you, so please don't be surprised
if I interrupt you mid-slide
to ask you questions,
and feel free to ask one another
questions or make comments
as people make their presentations.
I remind observers that the only
speakers today will be the panelists.
If you have questions for them, I'm sure
they would be happy to discuss them with you
after the panel either by
phone or through email.
Let me repeat one point.
This is my meeting.
I'm not intending to be possessive
about it, but I'm one commissioner
with a group of outside technical expert.
This is not an official hearing of the
Consumer Product Safety Commission.
I'm pleased that there are staffs of other
commissioners in attendance, and I invite anyone
who wishes to arrange a meeting
with them to do so.
I'm sure they'd be delighted to talk to you.
As a point of information, because the
commission has voted to proceed with rulemaking
on crib bumpers, I plan to submit the
data and remarks you provide today
into the official record of this proceeding
once the record is open for comments.
So, what you say and what you
submit will be put into the record.
Three quick logistical points.
The meeting this morning is being voice cast
but not video cast as we previously announced.
I want to apologize for that.
Please note, however, that those who wish
to view and those people who are listening
in to wish to view the PowerPoint slides
as they're being discussed today can do
so by downloading them from CPSC
website's public calendar page
and following along as the
speakers discuss them.
On that point, I'm going to
ask a favor from the speakers.
Will you please reference the slides
as you-- by number as you proceed.
Also, if you're going to speak, there's a
little bar on the microphone in front of you
that will turn the red light on and
that means your microphone is on.
This is being recorded and the
recording will be placed into the record.
And the bathrooms are outside the security
desk, across the hall so folks should be--
should feel free to come and go as they need to.
Again, thank you so much
for your time and expertise.
I'm eager to hear your thoughts on how best
to protect our most vulnerable consumers
in their most vulnerable moments.
What I'd like to do now is go around
with introductions and I'm going
to start on my left with Jen Feinberg.
>> Jennifer Feinberg: Hi, I'm Jen Feinberg.
I'm Senior Counsel to Commissioner Adler.
>> Dr. N.J. Scheers: N.J.
Scheers from BDS Data Analytics.
>> Ami Gadhia: Hi, Ami Gadhia with
AAP's Department of Federal Affairs.
>> Dr. Rachel Moon: Hi, I'm Rachel Moon.
I'm a Pediatrician at the University of
Virginia and I'm Chair of the American Academy
of Pediatrics task force on
sudden infant death syndrome.
>> Dr. Andrea Gielen: Good morning.
I'm Andrea Gielen.
I'm a Professor and Director of the Johns
Hopkins Center for Injury Research and Policy.
>> Teri Covington: Good morning.
I'm Teri Covington.
I'm the Director of the National Center
for Fatality Review and Prevention.
>> Nancy Cowles: I'm Nancy
Cowles, Director of Kids in Danger.
>> Sarah Klein: Sarah Klein, Chief
Counsel for Commissioner Adler.
>> Robert Adler: And Dr. Thach, may we
ask you to introduce yourself, please.
>> Dr. Bradley Thach: Yeah.
I'm Bradley Thach.
I've spent some time writing papers on the
crib bumper issue and I'm Professor Emeritus
at Washington University School
of Medicine and St. Louis.
>> Robert Adler: Thank you very much.
And now, Dr. Scheers and Dr. Thach,
we look to your presentation.
>> Dr. N.J. Scheers: Thank you.
Good morning.
Arrow forward.
Chew gum and walk at the same time.
The purpose of this review is to look
at crib bumper deaths that we documented
in our 2016 Journal of Pediatrics article.
We had looked at 48 deaths caused
by crib bumpers from 76 deaths
that had been originally identified.
43 of these we were able to match
to the recent CPSC briefing package.
Five bumper deaths we didn't
match because they were in the 80s
and the CPSC briefing package started in 1990.
So, for these 43 deaths, we thought 37 were
diagnosed as asphyxia/suffocation deaths
in specifically described bumper involvement.
So, wedged between pillow and bumper
pad, face pressed against bumper pad.
There were six SIDS and SUID that were likely
bumper-related, head hanging off recliner
and face pressed against crib bumper.
Now, for the 48 deaths, 32 of them we
judged were not involved with clutter.
Wedging between a bumper and a mattress,
13 of those, 12 face against bumper,
three where the arm was caught between
the bumper and the mattress/side rails
with face pressed against bumper, wedged
between crib and bumper after a likely climb out
and we gave our logic of why we think
the infant stepped on the bumper,
and strangulations from a bumper tie.
Now there were wedgings with the bumper
and I guess you could call
that clutter if you want to.
It's wedged between a bumper and something
else, so pillows, recliners, a cosleeping twin,
and one wedged in a crib depression.
This was a crib with structural integrity
problems but the infant was in a depression
with the bumper around her head preventing
her from turning her head to breathe.
Now the staff review of addressability
of the 43 deaths were three were likely,
17 were unknown and 23 were considered unlikely.
So here are the ones that are likely.
Oh, I'm not saying the slide I'm on.
I'm so sorry.
Slide 7. In these cases, the staff
agreed with medical examiner.
And you can see positional asphyxia laying
face down in a bumper, this middle one,
nose and mouth into a bumper, and
the third one I had no picture,
suffocated in corner of the
crib against a bumper.
And you'll notice the middle
picture has a problem with the crib.
The crib is broken but it
has not affected the bumper.
The infant's face is against the bumper.
Now for the next series of
cases, I'm going to talk
about where the staff disagreed
with medical examiner.
Slide 8. This is a baby face against bumper.
You can see the crib has lots of things in it.
There is an empty space where
the baby was found.
The autopsy, very specific, infant
found in a corner of the crib covered
by a pad that would cause asphyxiation.
The CPSC team said the addressability
was unknown.
Several concerns.
One, the baby was sick, had respiratory
infection and been on antibiotics for five days.
The pediatrician, however, who was treating
him when interviewed said we don't think
that the illness was severe
enough to cause a death.
The second concern was this is a seven-month
old and should be developmentally able
to move its head but the baby didn't.
Here is a case of wedging with the bumper and
you can see the indentation in the bumper pad.
This is slide 9.
Again, a very specific autopsy
finding, infant became wedged
between the mattress and
the bumper pad of the crib.
CPSC team thought this was
unlikely to be addressable.
And the reasoning was you can't tell--
they could not tell if the face was
truly into the bumper or into the place
where the bumper and the mattress intersect.
They also saw blanching lividity that to them
meant the baby was face down on the mattress
and so they considered the
bumper incidental to the death,
again disagreeing with the medical examiner.
This is a case-- you see a positioner in the
crib and to the right there's an empty space
where the baby rolled over into the mattress.
This was a cerebral palsy child.
And-- but again, the autopsy was very
clear, asphyxiated due to obstruction
of the nose and mouth by the crib bumper.
Here, the staff misidentified
a picture as a recreation.
The father recreated the death
scene but there was no photograph.
I called the medical examiner, asked
if they had recreation photograph
and she said no, they hadn't taken one.
Here is a picture where you
see-- oops, where am I?
Slide 11, I believe.
You see a finger pointing to
where the infant was found.
The police officer is doing the pointing.
The autopsy, probably asphyxia due
to obstruction of the nose and mouth.
Found unresponsive, wedged between
bumper of the crib and the mattress.
Again, CPSC team disagreed, said it
was unknown if it was addressable.
And the reasoning I could find was limited and
conflicting information in the case report.
Slide 12. This is a stuffed animal, bunny
rabbit who was used to recreate the death scene.
And again, you see a crib
with lots of stuff in it.
The autopsy said, A, infant reportedly
found face-down with face wedged
between mattress and bumper pads of the crib.
And then sudden interesting things, suffocation
in non-standard sleeping environment.
So I called the ME and asked
what exactly did that mean
and she said we think a standard sleeping
environment is a crib with mattress and a sheet.
Slide 13. Baby rolled out of a
positioner, face against the bumper.
That is very specific, the autopsy, once again,
face wedged between crib bumper and mattress.
The CPSC team thought the
addressability was unknown
and said it was not specified
whether the baby's face was
against the comforter or
against the crib bumper.
I just have a couple more of these.
Slide 14. Well, you see the wedging and
the autopsy said positional asphyxia,
face between pillow and crib bumper.
The CPSC team said they were not sure
whether the nose and mouth was pressed
into the nursing pillow or bumper.
But of course with the wedging,
that doesn't matter.
Wedging is two surfaces, you take one
away and the wedging doesn't occur.
And my last case is a sudden infant death
case that we thought was likely suffocation.
This was 1992.
Death scenes were not prevalent.
And CPSC was doing a soft
bedding study at that time.
I was the team lead.
And CPSC's investigators were going into
the homes quickly after the baby died,
interviewing the parents,
asking them to place a doll.
This is actually a CPSC photo.
The medical examiner did the
autopsy the day after the baby died,
was not aware of CPSC's results or the
picture and so classified this as a SIDS.
So my conclusions are these cases
illustrate that crib bumpers can cause deaths
and there's many more of them
than the CPSC staff identified.
The CPSC team often disagrees with
the medical examiners and pathologists
but that's not highlighted
anywhere in the briefing package.
There's an occasional mention of the--
what the ME said but there's no--
the reader doesn't understand the extent which
the team disagrees with the medical examiners.
Thank you.
>> Robert Adler: Thank you very much.
Dr. Thach?
>> Dr. Bradley Thach: Yes.
I don't have a designation
for the number of the slide.
Anyway, this is apparent
life-threatening events or ALTEs,
as it is known, associated with crib bumpers.
OK. There were a number of incidents identified
from CPSC databases January
1990 to October 2012.
There were 146 incidents.
From these, we identified 11
apparent life-threatening events.
OK. The next slide is the baby monitor
alarm presumably indicating not breathing
or perhaps low heart rate and mom found
the infant face pressed against the bumper.
Another case was baby monitor alarmed and a
six-month old female infant was found with head
between crib bumper-- crib and the crib bumper.
The lips were blue and the infant was pale.
And the-- uh-oh, I'm switched
out over here somehow.
Hold on.
>> Dr. N.J. Scheers: We can hear you, Brad.
>> Dr. Bradley Thach: Coming down on it.
>> Robert Adler: This is slide 19,
for those who are following along.
>> Dr. Bradley Thach: This is slide 19?
>> Robert Adler: Yes.
>> Dr. Bradley Thach: My
computer keeps cutting out.
OK. So the next case was mom found bumper.
The baby was blue, limp, and not breathing.
Somehow this was told respiratory
distress syndrome but it's clear
that it was-- the face was against the bumper.
The next case is mom found kind of lodged--
mom found the infant lodged in the corner
under bumper pad with the arm stuck
through crib slats, face red
from not being able to breathe.
And the next case is mom found the infant
wedged between bumper pad and mattress
and the diagnosis was transient cyanosis
probably secondary to position found.
Then there were some cases of
choking, ingestion or strangulation.
A mom found-- a mom of-- a mother of
a female infant swallowed a piece of--
the infant swallowed a piece of
plastic from the crib bumper.
The next case, baby monitor
alarmed, seven-month old infant found
with crib bumper strap obstructing her airway.
The next case is a six-month old
infant suffered respiratory--
suffered temporary anoxia from suspected
strangulation from tie down straps.
Infant stopped breathing but the
infant's cousin rescued her in time.
And then we go to problems with
infants falling out of the crib.
A 10-month old infant fell from the
crib, stepped on the crib bumper.
And the diagnosis when they went to the
emergency room was closed head injury.
A 17-month old infant, mom thinks baby
climbed into the bumper pads and fell out
and the diagnosis in the emergency
room was closed head injury.
The next one, victim pulled herself
up and stepped on the crib padding.
Crib was at the highest mattress setting
and the diagnosis in the ER was head injury.
And the final one is--
Or did I already do that?
Suffered temporary anoxia from suspected
strangulation from tie down straps.
Infant-- no, I already said that.
OK. Here, the falls.
>> Dr. N.J. Scheers: It was the last one, Brad.
>> Dr. Bradley Thach: Hello?
>> Dr. N.J. Scheers: It's the last one.
>> Dr. Bradley Thach: Can you hear?
>> Robert Adler: It's the last one on the
slide, nine-month old female used her bumper pad
as a step, climbed up and leaned over--
>> Dr. Bradley Thach: Yeah,
climbed up, leaned over the side
of the rail, lost her balance and fell.
Looks like that's it.
>> Dr. N.J. Scheers: Yes, I'd like to say,
we said 11 ALTEs, I found another one,
so there's actually 12 that
we showed in the slides.
The interesting things about this is that
when we did an analysis for our paper,
the youngest babies were veneer
suffocations about five months old on average.
The strangulation, chokings were about
seven to eight months old on average.
And the falls were 11 months old on average.
There were no ALTEs for limb
entrapment or miscellaneous.
>> Robert Adler: Dr. Thach or Dr.
Scheers, I do have a question.
When we're looking at these,
what you could call, near misses,
is there anything that would distinguish them
from the fatalities other
than fortuity and luck?
Did you see any pattern that would explain why
there was no fatality other than somebody came
in and found the child or pure luck?
>> Dr. Bradley Thach: I think in most
cases, someone came in and found the child.
It was in most of the cases.
I don't know what you mean by pure luck.
>> Robert Adler: That would be pure luck
that somebody walked in before the child--
>> Dr. Bradley Thach: Yeah, right.
>> Robert Adler: -- and saw the
child and saved the child's life.
But otherwise--
>> Dr. Bradley Thach: Yeah.
>> Robert Adler: -- that child
would have become a fatality.
>> Dr. Bradley Thach: Right,
that's the case as I see it.
>> Robert Adler: Thank you very much.
Ms. Covington?
And welcome.
[ Inaudible Remark ]
>> Jennifer Feinberg: While they're working on
the slides, I had a question for Dr. Scheers
and Dr. Thach which is Dr. Scheers, in your
presentation, you distinguished your conclusions
from those of the staff and I
was just curious on the ALTEs.
I just couldn't remember--
[ Inaudible Remark ]
>> Dr. N.J. Scheers: I'm sorry.
There are no staff determinations on the ALTEs.
>> Jennifer Feinberg: OK, thank you.
>> Teri Covington: As we get
going on this, I'll start talking.
I was asked to present on data that we have
in the National Child Death
Review Case Reporting System
which I'll explain a little bit what that
is and they're considered non-CPSC cases.
We worked with Dr. Scheers a couple years
ago to try to match the cases that we had
in our database with the cases that CPSC had
and I think you identified two or three that--
where they actually were the same case.
So in the--
>> Dr. N.J. Scheers: There were three.
>> Teri Covington: In the cases
that I'll present that came
after November 2013 are new
cases that weren't known.
I'll skip through some of
these slides real quick.
I just wanted to mentioned
what child death review is
so you have a perspective on
where these cases come from.
Child death review is a multidisciplinary case
review that usually happens in communities
across the country, where people
come together and review the deaths
of child-- preventable child deaths.
And the team typically brings a whole
lot of information to the review
that have coroner reports, medical examiner
reports, death scene investigation reports,
law enforcement interviews,
and medical records, et cetera,
et cetera, and they talk about the case.
And the purpose of child death review is
really to identify risk factors in areas
where a community could prevent deaths.
In United States, we have child death
review in all 50 states, 37 have local teams
and then 12 states have only state level teams.
We also-- and I should say that our
center is funded by HERSA primarily,
although the CDC also funds a Sudden
Unexpected Infant Death Case Registry
which funds a good number of states to review
100% of all of the sudden and unexpected deaths
which has given us a little bit
more robust data into the system.
In 2005, we designed a case reporting system
so that teams could enter
their data into a database.
And we built this system that allows data to
be collected, entered, analyzed and aggregated
across local, state and at the national level.
So we now have access to the real rich
case information that comes from the teams.
It's a web-based system.
There's about 1200 data elements and it's
housed at the Michigan Public Health Institute.
So I'm going to skip to here.
Just so you get a sense of the system,
there's 45 states that voluntarily use it now.
We've got about 2000 users, about 1300 teams,
and we have about 167,000
deaths now in the database.
But the system has gone through
a number of permutations.
I think we're at version 4.1 right now and I'll
explain to you why that's important in terms
of trying to understand the bumper pad cases.
The limitations are is that except in
a few states that review 100% of all
of the sudden unexpected infant deaths,
the data can't be used as population data.
You can't calculate rates.
And that little sentence supposed to mean
there may be cases with a good amount
of missing or incomplete information.
It's a voluntary system and it's up
to the states to put in what they can.
Also child death review standards vary
across jurisdictions as to the quality
of scene investigations and case reviews.
And then there are times where teams may
classify a death differently than the coroner
or medical examiner would, but it allows us--
there's a place in the report from where you
can actually designate that that happened.
We have a number of questions
related to sleep related deaths.
I'm just going to show you, these are just-- so
you can see what the forms look like and this,
by the way, I'm so-- we're so
bad at numbering our slides.
This is slide 8.
So, there's a whole section in the form
that regardless of whether a death comes
in as a suffocation, a SIDS or undetermined,
those are the main SUID categories,
a team can go to this section that
says was the death related to sleeping
or the sleep environment for
children under the age of five.
And then it allows the team, there's a whole lot
of questions about where was the sleep placed,
were they sleeping alone, what was in the
crib, et cetera, et cetera, or the sleep place.
Were they overheated, was the face-- where was
the child's face when found, where was the neck
when found, was the airway
obstructed, et cetera, et cetera.
The two most important things that are--
for my presentation is that we changed
the form in late November of 2013.
Before that, we-- what we realized
is that we couldn't narrow it
down to what was really the main factor
causing the problem in the sleep environment.
So prior to 2013, we asked questions
such as was the face fully obstructed
or partially obstructed, how, between,
wedged into, pressed into, et cetera,
and with what objects, and teams
could check all of those boxes.
So it was really difficult in looking at our
analysis because we have a number of cases
where bumper pads were listed
within a lot of other things
but we were having a hard time identifying
what was really the most problem
in the sleep environment.
After 2013, we changed it so that a team could
say bumper pad present, yes or no, where was it,
on top of, under, next to or
tangled around the child or unknown,
and if present, did it obstruct the airway.
So the data-- I have seven
cases from teams or from 2014
and that's pretty much what we've
got in the database right now.
It takes about a year for the
teams to get this information in.
We've got seven cases where it was
the bumper pad that was listed solely
as the item that obstructed the airway.
So, just to give you the data, we downloaded
data for this presentation or actually
for some work we were doing a little while ago
and the data that we're looking at is not 167,
it's only 95,000 deaths because
the teams have to tell us--
states tell us when the data is clean and
ready to be used for national analysis.
There were 16,140 SUID cases in there.
87 of those were checked
under that sleep related item,
62 cases where the bumper pad was
checked as relevant to the death,
and 55 of those where they checked that
piece that I talked about before 2013,
and then seven cases where they listed
it specifically causing the obstruction.
So, I wanted to also say that the good news
is that all 62 of those, there's also a place
in the form where teams can mark whether or
not there was a death scene investigation
and who conducted it and we were
really happy to find out that all 62
of those had had a death scene investigation.
And this is-- N.J. had-- Dr.
Scheers had shown some pictures
but this is what we're hoping typically you
would have in a death scene investigation.
It would be a description of where the
child was placed and where it was found.
Just so you can see, these are the agencies that
had conducted the death scene investigations
which we were pleased with and
they're not mutually exclusive.
But there were, in our opinion, probably
quality death scene investigations conducted
in these cases.
So, in looking at the data that was
collected through November 2013,
we had 55 cases where the bumper pad at least
was checked as an object relevant to the death.
And then we had the seven where
they actually checked the bumper pad
and that it was present and
it obstructed the airway.
Of the-- out of all 62 cases, what we did then
is the teams write narratives and every one
of these cases had a written narrative.
I think there was one that
did not and it's the narrative
where we can find most of the rich information.
The teams tend to write really long narratives.
They talk about a lot of things.
They talk about the family, the condition of
the house, the family's socioeconomic status.
Oftentimes they talk about whether drugs or
alcohol were present, et cetera, et cetera.
There's a lot of information in the narratives.
So we pulled the narratives and we found 30
out of the 62 where it was specifically stated
that the child was found
pressed into the bumper.
And the cause of death of those 30-- I
don't have the percentages here, I'm sorry--
was external asphyxia, undetermined,
medical condition SIDS which is interesting
because that's a very small percentage
of these, and then undetermined
if it was actually a medical or external injury.
But more than half were listed as asphyxias.
When we looked at the narratives, there are
only 13 states that we got this data from.
So, at the time, I mention-- I
should mention, we've brought states
into this progressively over the years.
So from the early years when we first opened
the system up to states in about 2008,
we had very few states using the system.
It's really-- it's gone-- states
started entering the data more
and more over the last few years.
So 13 states were reporting cases and
most of those reported one or two cases
but we had a several large population
states that had five to seven of the cases.
27 of the cases the child was under
the age of one and there were three
where the child were ages one to four.
More than 90% were sleeping in cribs and
more than 90% were in their own homes.
I just wanted to give you a sense of some--
I went last night and I could have
given you the narratives on all 30
but I thought we really don't
have time for them.
But I wanted to give you a sense
of what we read in the narrative
because it's pretty explicit
what they're writing.
The decedent was laid to sleep on his right
side in a crib, used rolled up blankets
for bumper pads and found unresponsive with
his head wedged against these bumper pads.
Another is that the decedent is a six-month
old male who died due to positional asphyxia.
He was found unresponsive in his crib
with his face pressed into the bumper.
Decedent was placed face up in his crib covered
by light bedding and found face up in his crib
with the bumper pad fully covering his face.
This was according to ME but not documented by
anyone else, the child was found on her side
with face against crib rail and bumper pad.
Another was that at approximately 4 a.m.
the father found the deceased unresponsive,
lying prone in a crib, with its face next
to the bumper pads at the edge of the crib.
The deceased had apparently been
placed in the crib on a pillow
and it appeared it had slid/rolled
off the pillow onto his stomach
with his face placed next to the bumper pads.
Baby was fed a bottle then placed
prone in his crib for a nap.
Father last saw him alive, went on to
check on him and found him lying prone,
more on his right side, with his
face up against the crib bumper pad.
Another was simply child
found against bumper in crib.
And this was a six-month old white male
found unresponsive and lying on his side
with face fully prone in bumper pad.
Child discovered on tummy with nose
pressed into bumper pad on crib.
And this one was a two-month old
female originally suspicious of SIDS.
Autopsy report revealed that the child was
found in the crib corner with face covered
by a bumper guard and the other
side against the mattress.
Positional asphyxia.
The coroner ruled that the death was
accidental due to positional asphyxia
as the side was found close to
the bumper guard pad of the crib.
And then, we had a number of that.
I'm not ready to talk about
these other ones yet.
But this was where he'd been placed on his
back, was found face down with his face pressed
against the bumper pad in
the corner of the crib.
He had just begun to roll over recently.
And then finally, the mother awoke
to check on the baby and found him
in prone position completely covered
by the blanket with his face pressed
into the bumper pads in the crib.
And then we had a number where it wasn't--
there were pillows mentioned as well.
That seemed to be somewhat common and I meant
to count down how many had pillows as well
as bumper pads but what we often saw, almost
always saw is that they were placed on a pillow,
they rolled off the pillow and
they rolled into the bumper pads.
So there's sort of a couple
of demons in the story.
This was the 19-day old black female.
The mother put her head propped
face up on top of an adult pillow.
After checking, she was found wedged
between the pillow and the baby bumpers.
This two-month old and 12-day old
black female died of asphyxia.
It was reported that she was found face down
in a crib with her face buried in the space
between a pillow and the bumper pads.
And then the mother has placed baby supine on
mattress with head resting on an adult pillow.
She saw the baby and then four hours
later, the baby was prone and wedged
between the adult pillow
and the bumpers of the crib.
So these are pretty much similar to the examples
that Dr. Scheers had given you
but they're different examples.
I just wanted to make the point
that they're not the same cases.
And then, this is another example.
The child placed on his back on a Boppy pillow,
found six hours later on his side with his face
in the pillow and wedged between
the pillow and bumper pads.
And then another who was
placed to sleep in a crib
in an adult size pillow and/or wedged pillow.
The child was placed to sleep on
his side and found in the morning
with his face pressed into the bumper pad.
And those are my examples for you and
that's pretty much what I have to present.
>> Robert Adler: So I guess my first question is
you've given us scenario on some of the cases.
May we get your copies of the
narratives for all of these 30 cases?
That would be terrific.
>> Teri Covington: Yeah.
Absolutely.
I didn't think you'd want to hear them
all during this 15-minute presentation.
>> Robert Adler: Actually I would but--
>> Teri Covington: OK.
>> Robert Adler: But at least
enough to have it so we can put it
in the record and we thank you very much.
Dr. Moon and Ms. Gadhia.
By the way, we're running ahead of
schedule so there's no need to speak fast.
I think most of the people in the
room listen fast but there's no need.
So, again, for those of us on the table, if
we have questions or comments, I invite them.
>> Dr. Rachel Moon: I've confused everybody
because I didn't-- I don't have any slides.
Good morning, Commissioner Adler and CPSC staff.
My name is Dr. Rachel Moon and I'm the Division
Chief of General Pediatrics and a Professor
of Pediatrics at the University
of Virginia School of Medicine.
I've spent over 20 years studying infant
mortality, safe and unsafe sleep products,
and sudden unexplained infant death.
I have done occasional work for the
CPSC as a paid outside consultant
on consumer products designed
for infant use since 2012.
And I very much appreciate
Commissioner Adler's invitation to speak
to you all today regarding the September
CPSC staff briefing package on crib bumpers.
I'm speaking here today on behalf of the
American Academy of Pediatrics or the AAP
and I'm the Chair of the AAP's task
force on sudden infant death syndrome.
Just two days ago, on October 24th, the AAP task
force on sudden infant death syndrome released
or updated recommendations for
safe infant sleeping environment.
These updated recommendations
reiterate unequivocally
that bumper pads are not recommended by the AAP.
Bumper pads have been implicated in deaths
attributable to suffocation, entrapment
and strangulation and with new safety
standards for crib slats are not necessarily
for safety against head entrapment.
While the peak age range for SIDS, accidental
suffocation and strangulation deaths
and ill-defined deaths is between the ages
of one and four months, new evidence shows
that soft bedding continues to pose hazards
to infants who are four months and older
and is indeed the predominant
risk factor for this age group.
Educational and intervention campaigns
are often effective in altering practice
and pediatricians continue to engage
in such educational campaigns.
However, pediatricians' warnings
against bumper--
against crib bumpers are frustrated
when the CPSC's own messaging
on crib bumpers is modeled at best.
The AAP warns against the use of many
different kinds of soft bedding largely
because of the risk of suffocation,
entrapment and strangulation.
CPSC data show that pillows are associated
with many accidental suffocation incidents
when placed under or close to a sleeping infant.
Quilts, comforters, sheepskins and other
soft bedding have also been associated
with an increase risk of sudden infant death.
Therefore, the AAP recommends that infants
should be placed on a firm sleep surface covered
by a fitted sheet with no
other bedding or soft objects
to reduce the risk of SIDS and suffocation.
With regards to bumper pads, I'd like
to share the AAP position as stated
in Monday's policy statement
and technical report.
The data show that bumper pads and
similar products attaching to crib slats
or sides are frequently used with the thought
of protecting infants from injury and indeed,
bumper pads were initially developed to
prevent head entrapment between crib slats.
However, newer crib standards requiring
crib slats spacing to be less than 2
and 3/8 inches have obviated
the need for crib bumpers.
In addition, infant deaths have
occurred because of bumper pads.
You've already heard from Dr. Scheers and Dr.
Thach and Ms. Covington about their research.
Dr. Scheers' and Dr. Thach's case series
using 1985 to 2005 CPSC data found
that the deaths attributed to
bumper pads occurred as a result
of three different mechanisms, suffocation
against soft pillow like bumper pads,
entrapment between the mattress of
the crib and the firm bumper pads,
and then strangulation from the bumper pad ties.
However, in 2010, CPSC White Paper
that reviewed the same cases concluded
that there were other confounding factors such
as the presence of pillows and/or blankets
that may have contributed to
many of the deaths in the report.
The White Paper pointed out that available
data from the scene investigations, autopsies,
law enforcement records and death certificates
often lack sufficiently detailed information
to conclude how or whether bumper
pads contributed to the deaths.
Three more recent analyses of CPSC
data have also come to this conclusion.
The two most recent ones concluded again that
there was insufficient evidence to support
that bumper pads were primarily
responsible for infant deaths
when bumper pads were used per
manufacturer instructions and in the absence
of other unsafe sleep risk factors.
However, Dr. Scheers and Dr. Thach
in their reanalyses of CPSC databases
which was published earlier
this year found that the rate
of bumper pad related deaths has increased.
Although they recognize that changes in
reporting may account for at least part
of the increase, they also
concluded that 67% or two-thirds
of the deaths could have been prevented
if the bumper pads had not been present.
Other researchers have concluded that the use
of bumper pads only prevents minor injuries
and that the potential benefits
for preventing minor injury
with bumper pad use are far outweighed
by the risks of serious injuries
such as suffocation or strangulation.
Additionally, most bumper pads
obscure infant and parent visibility
which may increase parental anxiety.
There are other products such as mesh crib
liners and crib slat covers that attach
to crib sides or crib slats and
claim to protect infants from injury.
However, there are no published
data that support these claims.
Pediatricians were fond of saying absence
of evidence is not evidence of absence.
And without published or peer-reviewed data
to demonstrate that these other products
that attach to crib sides or crib
slats such as the mesh crib liners
or crib slat covers do not pose a potential
for suffocation, entrapment or strangulation.
These products cannot claim to be
safer alternatives to crib bumpers
and the AAP does not recommend their use.
We urge CPSC to look to peer-reviewed data in
making these and other safe sleep assessments.
Although nearly 100% of parents are aware
that babies should sleep on their back,
fewer than 50% are aware that babies should
not sleep with soft bedding and we believe
that this is largely because of the
confusing messages that parents receive.
They see advertisement after advertisement for
bedding including crib bumpers and thus believe
that they are not good parents
unless they provide a soft,
comfortable sleep environment for their infant.
Unfortunately, these good
intentions often end up badly.
We believe that when crib bumpers when
used solely for the use of infant younger
than six months of age are allowed to be sold.
This confuses the safe sleep
message for parents.
I cannot tell you how many times
I've heard from a parent the belief
that if they sell it, it must be safe.
A surprising number of parents believed
that there is an agency out there
that tests all infant products before they go
on the market to make sure that they are safe,
in other words an FDA for infant products.
Unfortunately, as we all know, there
is no such agency and we understand
that the CPSC is not a proactive agency
that tests products before they're sold
but a reactive agency that
alerts consumers with problems
with products that are already on the market.
With regards to reasons that parents use
crib bumpers and the misconceptions therein,
our qualitative research with mothers of
infants account that the primary reasons
for purchasing crib bumpers are that, one,
they're cute and, two, because parents believe
that crib bumpers will prevent serious injury
largely from head trauma and limb entrapments.
With regards to head trauma, I'd
like to apologize ahead of time,
I'm a little bit of a science geek which is why
I'm here and so I'm going to take everybody back
to high school physics where we
learned the formula F equals MA
or force equals mass times acceleration.
So, the force needed to incur major head
trauma, which I consider concussion or worse,
requires either a large mass or
large acceleration or both, OK.
So, the 50% are for weight which is
what on earth we use to represent mass.
For a six-month old, 6.5 kilograms
or approximately 14 pounds, OK,
and the reason I'm using the example
of a six-month old is that's what the
manufacturers have said is the age limit
for the crib bumpers.
So, one estimate of the force required
to sustain a concussion is approximately
95 g-forces or if you use physics units,
in newtons, which is the universal
unit for forces, 931 newtons.
I know I'm getting leads here.
If one assumes that this estimate is true, then
for a 6.5-kilogram baby to generate enough force
to sustain a concussion, he or she
would need to accelerate at the rate
of 103 meters per second squared, OK.
>> Robert Adler: I think
you said 143 in your paper.
>> Dr. Rachel Moon: 143, yes.
To give you a point of reference, a car
that goes from zero to 60 miles per hour
in three seconds has an acceleration
of nine meters per second squared.
So, in other words, an infant, in order to
seriously injure their head against the crib has
to get a serious running
start and you would need more
than the crib distance to
get that running start.
So, the second concern that
parents have is limb entrapment.
The majority of these entrapments are
reported after the age of six months
which is past the age limit
for a crib bumper use.
Therefore, if the product is used
according to manufacturer instructions,
then the product should not even
be in the crib with these infants
and therefore would not prevent limb entrapment.
Even if we consider crib bumper
use after the age of six months,
I think that all of us would agree that although
they cause momentary distress on both the part
of the parent and the infant and the caregiver,
this is a fairly benign condition
compared to infant death.
We therefore respectfully disagree with and
are admittedly perplexed by CPSC staff finding
that the risks of bumpers do
not outweigh the benefits.
We believe the benefits to be nonexistent
particularly if the bumpers are used
as the manufacturers intend
and the risk to be substantial.
We also believe that it doesn't
make sense for the CPSC staff to say
that there is insufficient evidence to support
that bumper pads were primarily responsible
for infant deaths when the bumper pads were used
per manufacturer instructions and in the absence
of other unsafe sleep risk factors and then
used prevention of infant limb entrapment
by using bumper pads against
manufacturer instructions as a reason
to not recommend action on bumper pads.
The CPSC's own website states that CPSC
is charged with protecting the public
from unreasonable risks of injury or death
associated with the use of the thousands
of types of consumer products
under the agency's jurisdiction.
CPSC is committed to protecting consumers
and families from products that pose a fire,
electrical, chemical, or mechanical hazard.
A ban on crib bumpers unequivocally
meets the standard and mission.
Crib bumpers are associated with deaths and
they pose a mechanical hazard to infants.
But rather than recommending a ban on bumpers,
the September staff briefing package seems
to take the stance that unless death
occurs in association with the bumper--
crib bumper in the absence
of any other risk factor,
they will not recommend action to bumpers.
This is not the agency's mission and this
is not how pediatricians look at safe sleep.
On the contrary, when determining
the safety of sleep environment,
we look at the totality of the circumstances.
We ask if anyone in the family smokes, if
the baby is breastfeeding or formula feeding,
and whether the baby-- if
the family is bed-sharing.
We understand that elimination of each
risk factor can contribute incrementally
to sleep safety.
The presence of crib bumpers
is one of these risk factors.
We also understand that the CPSC has to
look at the overall impact of any action.
For instance, it is impractical
to ban all soft bedding
as other population groups
besides infant use soft bedding.
However, crib bumpers are supposed to be used
only by infants younger than six months of age.
Therefore, we believe that the ban would
have little or no negative impact on the rest
of the population but would have a tremendous
positive impact on infant sleep safety.
If crib bumpers, as they are currently being
used by consumers, whether in cribs with infants
with quilts, with other soft bedding
or with sleep positioners are involved
in one infant death after another, the way to
protect the public is to disallow their use not
to contort reasoning to permit
the use of crib bumpers.
The staff package clearly states
that soft bedding is a suffocation
hazard despite its ostensible purpose
of keeping an infant warm.
However, the staff package
does not support a ban
on crib bumpers even though they pose the same
hazards as soft bedding because staffs say
that bumpers ostensibly serve
the purpose of protecting infants
from crib-- from limb entrapment.
This is logically inconsistent, confusing
to consumers, and deadly for infants.
A ban on crib bumpers would reinforce
the message that no soft bedding
of any kind should be placed
inside a baby's crib.
There's one surefire way to prevent infant
deaths from crib bumpers, don't use them ever.
The AAP reiterates the true quest of
the commission, to ban crib bumpers.
Thank you.
>> Robert Adler: Thank you very much.
Just a couple of quick reactions
to what you said.
First of all, with respect
to education campaigns,
I think the commission follows the
philosophy that was enunciated by our chairman
at a recent conference on information and
education which is there's a hierarchy
of public health approaches and the
first approach is always to try to design
out the problem because, as I keep
saying, it's easier to redesign products
than it is to redesign consumers.
And if a redesign won't work, if it's
impossible for a variety of reasons,
then you try to guard against a hazard.
You put some kind of protective barrier
between the hazard and the consumer.
And then the third one, if you can't find
a way to approach either through a redesign
or through guards is to use education so we
certainly understand education has its place
but I, for one, am skeptical that education
would ever be beyond and it's part of a totality
of approaches and I appreciate
your remarks there.
Also, I just can't resist being amused by
your statement that newer crib standards
on slat width because when I first came to
the commission back in '72, we had that 2
and 3/8 slat width requirement so that just
makes me feel a little bit younger to hear
that you're calling it one of
the newest standards on the--
>> Dr. Rachel Moon: Well, anything I can
do to make all of us feel younger is--
>> Robert Adler: Yeah.
I do-- I still remember when I was
talking to one of the staff experts
which showed my complete
naivety about human factors
because I'm a lawyer and I
said, what's the problem?
The kid can't stick its head through even
wider slats so why not have wider slats
and so with his very patient response he said
the problem isn't that the kid sticking its head
through the slats, the problem is the head
won't go through the slats but the body will
and that's where you were getting the deaths.
And that-- the reason I mentioned
that is it's not intuitive.
Looking at a crib, you would never imagine
that that's how death would occur to infants
and so that's why it's so important to have
scientists like folks here and technical experts
to actually look at the data
and can make expert judgments
and who actually understand physics side.
We'll make one last observation.
You're absolutely right that we are not
like the Food and Drug Administration.
We don't require pre-market approval
of children's products although survey
after survey shows that most
people think we do, but we don't.
I will say and again I'm going to give
some congratulations to folks in the room
but in particular, Nancy Cowles who is one
of the moving spirits behind the requirement
for third party testing for children's
products and that is a compromise
between the FDA pre-market approval
and what the commission operated before
in the mode you said which was reactive.
So, we think that is a big step forward and
we have somebody here to thank for that.
So I thank you very much for
your remarks and, Ms. Gadhia,
do you have anything to add to Dr. Moon's--
>> Ami Gadhia: No, nothing to add.
Informal comment, I'm just happy to
participate in the discussion later on.
>> Robert Adler: OK.
Any other comments?
Thank you so much for your remarks.
We really appreciate it and I
think we have reached the point
where we are going to have a break.
I'm sorry, yes.
>> Jennifer Feinberg: Just one quick question.
You mentioned additional
recent analyses, are that--
are these the articles that were handed
out that you were referencing or--
>> Dr. Rachel Moon: What was
handed out are the recent--
the policy statement and the technical report
that were just released on--
published on Monday.
>> Jennifer Feinberg: OK.
And then the recent analyses that you're
referring to on your remarks on page four--
>> Dr. Rachel Moon: Let's see.
Was that the pediatrics article
from earlier this year?
The recent analyses-- so the more recent
analyses were the staff briefing package
and then Dr. Scheers' and
Dr. Thach's 2016 paper.
>> Robert Adler: Thank you very much.
We are at a point of taking a break
and as I said we are running
ahead which is not a bad thing.
So, why don't we take a 20-minute break, OK.
>> So back at 10?
>> Robert Adler: Well, one of the things we're
doing is waiting for Dr. Sharfstein so I want
to make sure we get the timing
right to get him here
so that he arrives here and
doesn't leave quickly.
So, we'll-- if we have to convene more
quickly to accommodate him, we will.